IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-05-25

DGFT Committee Minutes

Document text

==> picture [1 x 7] intentionally omitted <==

----- Start of picture text ----- . ----- End of picture text -----

Officeof Directorate General of Foreign Trade New Delhi -

Para 4.7 Decision(DRAFT)

MEETING NUMBER: 3/82-ALC4/2014 MEETING DATE ; 08.05.2014

but actually held on 25.06.2014 The Meeting No. 3/82 of 2014-15 to consider the cases/fissues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied products and failing under Chapter 29 and 30 was scheduled for 08.05.2014 but actually heid on 25.06.2014 under the Chairmanship of, Shri Jaikant Singh, Addl. DGFT in Room No.17, Udyog Bhawan, New Delhi.

==> picture [1 x 1] intentionally omitted <==

----- Start of picture text ----- : ----- End of picture text -----

Following members were present:-

Shri D.N. Mathur, Consultant, Department of Pharmaceutical Shri Jasbir Singh, Consultant, Department of C&PC Shri Nirmal Kumar, Deputy Director General of Foreign Trade Dr, Nitin Jain D/o Biotechnology The committee went through the minutes of earlier NC -lll meeting No. 2/82 dated 24.04.2014 held on 29.04.2014 and approved the same.

The follawing casesfissues were discussed and the committee took the decision as mentioned against the case.

Case No. B-22 Mis Yasho industries Pvt Ltd. Meeting No.03/AMIS dated ~ 25.06.2014 ENo, 01/82/50/00784/AM13/DES-HE RA No. 03/05/040/478/AM1]4 Adv. Lic, No. 0310749089 dated 11.09.2013 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 1401 0/95/2011-Ch II dated 21.05.2014, it was decided to ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is less:

==> picture [379 x 79] intentionally omitted <==

----- Start of picture text ----- Export product Exp. | SiNo. | Import items Qty. allowed Qty. crvvareD i kg 0405 Kg FLAKES/POWDER) r3.___Lacrivampctay[0.200 ke ----- End of picture text -----

RA may take appropriate action as per the decision ofNorms Committee,

Case No, B-23 Mis Creek Insulations Chemicals Pvt Ltd. ca ® Meeting No.03/AMI5 dated ~ 25.06.2014 FNo. 01/82/50/390/AM06/DES-III gn, beets ENo, OVS2/S0/S14/AMOG/DESAN gees EPat ae

r ENo, 01/83/50/1 104/AMOTIDES-Iil _ | BLNo. 01/82/50/1143/AMO7/DES-HI . Adv. Lic. No. 0310339307 dated 14.07.2005 Ady. Lic. No. 0310342179 dated 09.08.2005 Ady, Lic. No. 0310403021 dated 69.10.2006 Ady. Lic. No. 0310403738 dated 11.10.2006

The Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/115/2014-PI(Norms) dated 21.04.2014 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

==> picture [2 x 2] intentionally omitted <==

----- Start of picture text ----- , ----- End of picture text -----

==> picture [425 x 461] intentionally omitted <==

----- Start of picture text ----- | SLNo. | import items For Export of 1000 MIU (Imports in Kgs) Oxytocin Solution Oxytocin Power/ Solution BP/EP/USP AMINO ACID-L-PROLINE 1.797 ) 2.386 3. AMINO ACID-L-ASPARAGINE 3.273° 4.639 AMINOMONOHYDRATE ACID-L-GLUTAMINE 2.866 . [4079 AMINO ACID-L-ISOLEUCINE 1.09 1.36 16.| AMINO ACID-L-TYROSINE 1.884 2.50 P8. | S-BENZYL-L-CGLYCINE ETH Y LST E STIN E R HCL 4.363,504 | 45 . 50382 BENZYL CHLOROFORMATE 20.15: 27.337 (STABILIZED 97%} . 10. | N.N. DICYCLO HEXYL 18.58 23.63 CARBODIIMIDE ~ GLACIAL ACETIC ACID 89.42 “Not applied 4-NITROPHENOL 8.49 10.965 DIETHYL ETHER DRIED $32.09 642.0 14. ISO AMYL NITRITE ant 2.72 fitres 2.30 litres HYDROGEN CHLORIDE GAS [136 So f e Rowasit C«| 2.88 Ethy! Alcohol (undernatured) | [| 438.60 Litres Note:Since the licences are very ofd and actual imports and exports have already been completed RA is advised to redeem the imported items and their quantities actually imported or recommended above whichever is relevant and lower, licence wise. RA concernedmay take further necessary action as per above decision of NC. ----- End of picture text -----

Mis Jubilant Life Science Ltd., Noida. Meeting No.03/AM15 dated — 25.06.2014 ENo. 01/94/180/0004 1/AMILS/DES-IIT

Decision: Committee considered case as per agenda and it was decided fo advise the firm to apply for bulk drug to be fixed and on the basis of the take licence as per SION.

Wis The Andhra Sugar Ltd. Meeting No.03/AMIS5 dated — 25.06.2014 F.No. 01/82/162/00917/AM L2/DES-IIL

RA No. 26/02/040/00001/AMLI Adv. Lic. No. 2610010636 dated 04.01.2011 Committee considered the case as per agenda and in consultation with technical. authority present in the meeting. It was decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:Export product | Export Qty. [SINo.[Importitems_| Qty. allowed Acetyl Salicylic | 1 Kg. Salicylic Acid | 0.807 kg _ acid (Aspirin) r2. [EthylAicohol _—*0.925ke

RA may take appropriate action as per the decision ofNorms Committee.

Case No. B-26 M/s Shiva Pharma Lid. Meeting No.03/AM15 dated ~ 25.06.2014 FNo. 01/82/162/00016/AM 13/DES-IE Ady. Lic. No. 3410025487 dated 30.10.2009 Ady, Lic. No. 3410025693 dated 25.11.2009 Adv. Lic, No. 3410026511 dated 03.03.2010 Adv. Lic. No, 3410027522 dated 16.07.2010

it was decided to defer the case for 24.07.2014 for comments ofDepartment of C&PC.

Case No, B-27 Mis Encube Ethicals Pvt Lid, Meeting No.03/AM15 dated — 25.06.2014 F.No. 01/82/50/003435/AM1 1/DES-ilf RA No. 36/02/040/0000 AMI Ady. Lic. No. 0310571323 dated 24.06.2010 Decision: It was decided to defer the case for 03.07.2014 for comments of Department of MSME.

Case No, B-28 Mis Encube Ethicats Pvt Ltd, Meeting No.03/AMIS dated ~ 25.06.2014 E.No. 01/82/50/00232/AM 12/DES-HL RA No. 03/95/040/01167/AM12 “Ady. Lic. No. 0310625603 dated 07.04.201 1 ; Decision: The committee noted that the norms fixed by NC for the export of Sodium Fusidate 3% Ointment, 15 em Tube was as per actual past production consumption data duly certified Chartered Accountant furnished by the firm along with the application.

==> picture [21 x 15] intentionally omitted <==

----- Start of picture text ----- os ----- End of picture text -----

Case No. B-29 Meeting No.03/AMI15 dated ~ 25.06.2014

Mis Encube Ethicals Pvt Ltd. F No. 01/82/50/00708/AM12/DES-1IE F.No. 01/82/50/01180/AM12/DES-IT] ; F.No. 01/82/50/00423/AM13/DES-IM] Adv, Lic. No. 0310646711 dated 05.08.2011 Ady. Lic. No. 0310664617 dated 14.11.2011 Adv, Lic. No. 0310697620 dated. 06.06.2012

Decision: Committee considered the case as per agenda and it has been observed that there are no wastage norms for excipients in the SION A 1931. Hence, excipients have been allowed on net to net basis in all cases of Pharmaceutical formulation. However the company may apply for amendment in SION A-1931 as per Policy Provision for induction of excipients in the SION and the same may be considered by Norms Committee on the basis of all-industry Data on wastage.

Case No. C-6 “—"T'Wis Reliance Industries Led. Meeting No.03/AM15 dated ~ 25.06.2014 F No. 01/82/50/0040/AM14/DES-Ill

een Decision: Coramittee considered the case as per agenda and In the light of written comments forwarded by Petrochemical Division of Department ofChemicals and Petrochemicals vide their U.Q No. 46011/18/2014-PCLi dated 22.05.2014, it was decided to amend the description of import at sl. No.3 of the published SION No. A-1475 for the export product ” Porified Terephthalic Acid (PTA)” as details given below: SION No. | From — To {Import item Si. No. 3) _| (import item Si. No. 3) Aciais [Catalyst T &P PTA purification catalyst i 0.50% palladium on carbon

==> picture [412 x 199] intentionally omitted <==

----- Start of picture text ----- iE(Case No.28/2882- “ipa ame VLAN (Meat NovDates/82-——(Status:Case | lALca/2012 (LABORATORIES LIMITED “ALC4/2014 (Deferred ; ee ere 808.2004 nal eee REA File — ‘Lic. No/Date:0910053660 ‘(Defer ; || (AQFileHO1/82/0S0/00995/AMI3/ Jr09724/040/00270/AMI3/ 04.09.2012 a. “Date:24.07-2014 | 1 ‘Decision :In the light of written comments received from Department ofPharmaceuticals | | vide their OM No. 3501 1/205/2013-Pi(Norms) dated 01.042014, it was decided to call | (from the firm the details of Past Production vis-a- vig Actual consumption of inputs duly | | certified by Central Excise Authorities. | t“\Gase No.:2/20/82-ALC4/2013 (Party NamecTORRENT ‘MeetNo/Dates/#2-——_Status:Case ae “PHARMACEUTICALS LTD. jALC4/2014 Approved 4 | fQFie SSRLAFIe ‘[Lic.No/Date:0810115340 DeferDate: | ----- End of picture text -----

“5

==> picture [427 x 591] intentionally omitted <==

----- Start of picture text -----

|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
|||Decision|: Committee considered case as per agenda and|in consultation with technical authority|
|||‘present in meeting, decided to ratify norms under Para 4.7 of|HBP v1 as per SION A-442|with 2 %|||
|4|wastage:|
|||||Export product|Export|SLNo.|| Import items|Oty, allowed|
|i:|Qty.|
|||[|Malsidomine|
|||[|Molsidomine2#' g|m|e|tablet|ZoamehabletLOB meftablet|||
|Meet No/Date3/82-——(Status:Case|||
|Icase!|[No15/33/82.—~—~S*«SParty][WimeIND][ SWIFT]|
|||jALcsno12|“LABORATORIES LTR,|SALCA/2014|“Deferred|4|
|ad|{|(08.05.2014|i|||
|13 HQ File|.|(RLA Pile|{Le|NofDate:2210019390|“Defer|4|
|F|OU/S2/0S0/01162/AMI3/—:22/24/040/000397AMI3/O9TN 2012|“__ate:24.07.2014|
|(Decision|:It was decided to defer the case for 24.07.2014 for comments ofDepartment of|||
|||\ALC4/2012|[LABORATORIES LTD,|—_ALC4/2014|land Re-indexed|[|]|
|4|THQ File|(RLAFile|“[Lic.No/Date:2210013450|(Defer|||
|||RO1/82/0SQ/00966/AMI3/|22/24/04|
|||Decision :It was decided to defer the0/0005 case /AMIS/ for 94.07.2014[1722012 for comments of|Department_Pase.052014| of|
|||Pharmaceuticals,|nan|
|lease Nesivuaaiea|Party|NamesGADILA”|[Meet|Novbate382- ~~|Status:Case|
|||sALC4/2012|‘HEALTHCARE LTD.,|\ALC4/2014|[Deferred|1|
|si|eee oe|0808-20|cs a|
|~|DieNo/Date08 10117315|Defer|||
|||HQFile IRLA|[File]|
|5|:01/82/0S0/01318/AM13/__(:08/24/040/00256/AMIY|02.01.2013|-____Date24.072014|
|||[Decisionduly certif s|i|ted was by decided Quality -Control to remind Incharge.the firm to furnish a.|copy ofMaster batch Formula|||
|"lease|Ne“aiGwe2-ALCADOT2|Pony NameMOREPEN|Meet NovDat:382-~|StatuCase|
|i|“LABORATORIES LTD.&|AALCARO14|Deferred|4|
|TL|emessessi|sta ss JMOREPENINTERNATION||[08.05.2014|ee|
|l6 HQFie|—|TRLA File|—|{[Lic.No/Date:0510343975|Defer|:|
|["||:01/82/050/01038/AMI3/—_:05/24/040/00389/AMI3/|23-07-2018|oss _[Date:27.07.2034)|
|||Department‘Decision|“It|ofwasPharmaceuticals.decided|to|defer|the|case|for 24.07.2014|for want|of comments|of!|
|1\Case No.:28/4/82-ALC4/2013|[Party|Name: MYLAN|(Meet No/Date:3/82-|——(Status:Case|
|7|‘LABORATORIES LIMITED||ALC4/2014|(Deferred|||

----- End of picture text -----

==> picture [418 x 563] intentionally omitted <==

----- Start of picture text ----- 1:01/82/050/00069/AM 14/ |:09/24/040/00520/AM13/ 105.02,2013 ‘Date:27.07-201 4 Boh <s pe . — ae — ~ ee “or eee (Decision In the light of written comments received from Department of Pharmaceuticals vide itheir OM No, 35011/490/2013-PI(Norms) dated 21.04.2014, it was decided to ratify norms under: (Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 4 oH Hines | ‘| Export product | Exp. Sl.No. | Import items aty. | cd Oty. allowed Ls ke/kg 4 1 DARUNAVIR. 4 (38)-3-{tert-Butoxycarbonyl)amtino-1 -chiora-4-pheay!- 159 | | 4|| (CHLOROKETONEROUTE) 2-butanone (Chloroketone} 4i i 2 (38, 385, 6aR }-hexabydrofuro{2,3-b}furan-3-yi 4. 4 | | aitrophenyl carbonate (Nitro Complex) 0.82 | : 8 300 | 9 | sopropyl alcahe 3.76 ‘| ‘Triethylamine 0.376 4 / il N-Methy1-2-pyrrolidone : Not shown | in RXN i Acetic acid 4.59 | : Hewane 0.37 | ("fase Nosis1r3542- ‘(Party Name:FORACE [Meet No/Date:3/82-|[Status:Deffered | | TALca2012 [POLYMERS (P) LTD. “ALC4/2014 Jand Re-indexed ig HOFie “RLAFe [ LOL/82/050/01298/AM13/ (205/23/040/00459/AMI9/ ~ [Lie(07 . No/Date:0502.2013 10345208{Date:08.05.2014 [Deter | [|] ‘Decision “It was decided to defer the case for 24.07.2014 for comments of Petrochemicals |  DivisionofDepartmof Ch e micalsnt and Petrochemicals. 1sae Nocaiaian-ALCa013 Party Name MOREPEN Moet No/Datei3/82-"Status:Case i: [LABORATORIES LTD.& —ALC4/2014 (Deferred | : ens _|MOREPEN INTERNATION 08.05.2014... Feces 'g ‘HQ File— RLA File — “Lic.No/Date:05 10350279 ‘Defer | |:01/82/050/01480/AM13/ —__908/24/040/0048 AMIS) 26.03.2013, Date:24.07-2014 | Decision :It was decided to defer the case for >4.07.2014 for comments of Department of ----- End of picture text -----

==> picture [1 x 18] intentionally omitted <==

----- Start of picture text ----- ; ----- End of picture text -----

”

==> picture [424 x 597] intentionally omitted <==

----- Start of picture text ----- inSS ENTERPRISE ALCIZOIE erred | THQ File | [301/82/050/001] 12/AM 14) | / (RLA:24/247040/0000VAMI4) File — “Lic.(09.04.2013 No/Date:2410038645-" Defer[Date:24.07.2014 | Decision: It was decided to deferthe case for 24.07.2014 for comments of Petrochemicals | | Divisionof Department ofChemicals and Petrochemicals, oo es | [Gise No BGISRALCAROTS Party NameLAKE Meet Novbates/80-(StatusiCase . i |CHEMICALS PRIVATE —/ALC4/2014 Deferred i liviHQ File (RLAFile - ~~ (Lic. No/Date:0710094921 Defer ~~ | POL82/050/00036/AM14/ OT24/4ON000V/AMI4! (18.04.2018 Date:24.07-2014 i [Decision : it was decided to remind the firm to furnish complete technical details as per i (CaseNoc87/14/82-~~~ PartyName:ASTRIX. [Mect No/Datesi/82-[Status:Case— | lALc42013 ILABORATORIES LTD, ALC4/2014 ‘Deferred REA File "Tie No/Date:0910055844 [Defer 2| (01/82/050/00672/AM14/HQ File —psrearoqovooo0sraMaa) (23.04.2013 Date:24.07.2014| | (Decision It was decided to defer the case for 24.07.2014 for comments of Department of | | Pharmaceuticals: espe enna ee (“ieese Nowa7oaa. ~~ (Pany Name:AGOG PHARMA [Meet No/Dates/82-|Status:Case | |ALCA?2013 ‘LTD. AALCA/2014 {Deferred A \slHoFie ”~«SiRLAN ide meee (Lic. No/Date:03 10733767 Defer | 7 01/82/050/003S3/AMI14/ __203/9.4/040/00075/AMIA! —109.05.2013 _ Date:24.07.2014) | (Decision «It was decided to defer the case for 24.07.2014 for comments of Department of | Pharmaceuticals. ("Gece Nowiaaiioiea: Party NamesWOCKHARDT — (Meet No/Date:/62- ~~ StatusrCase | jALcsne13 ‘LIMITED “ALC4/2014 [Deferred | laiHOFie~~ RLAFie "Lic. No/Date:03 10734494 Defer j |) HOV/82/050/0032S/AMI4/ —_[:03/95/040/00101/AMIA! 45.05.2013 _—__Date:24.07.2014 | | Decision ‘It was decided to remind DCGI to furnish their comments. The case was | (YGase [Nowt32/1482-] | |ALca2013 ‘PartyTORGANICName:BL IND U STRIES,EDIP Meet ALC4/2014No/Date:3/82- ~"(Status:Case[Deferred | \g(HQFile ————RLA File __Lic.No/Duate:0310735418 [Defer | | hOLS820500071 TAMIA) (03/94/040/00067/AMI4/ 23.05.2013. ____(Date:24,07.2014 | | ‘Decision -[t was decided to defer the case 24.07.2014 for comments of Department of | | (Chemicals and Petrochemicals. | es ts ts ststnsesss| Fe cenit tcetna icin anita 1c a hnennanne entreea eaert ae ----- End of picture text -----

==> picture [416 x 593] intentionally omitted <==

----- Start of picture text -----

||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|||1ALC4/2033|(PHARMA LIMITED|JALC4/2014|Deferred|:|
|LS|cceceece|wees|seusmmanastasneaeatlegs|ius|sso|canes|tect|$08.05.20048|en|||
|Defer|||
|116,HQ|File|IRLA File|‘Lic.No/Date-0910056110|
|||:O1/82/050/01028/AMI4/|__|-09/24/040/00058/AMI4)|23.05.2013|[Date:24.07.2014|
|||Decision :Reply received from the firm and sent toDepartment of|Pharmaceuticals for|||
|||their comments.The|case|was|deferredfor24.07.2004|
|[ease Noats371482.|(Party|NamexCALYX|(Mest No/Date:382-[StatussCase|||
|||JALC4/2013|{CHEMICALS|&|JALC4/2014|‘Deferred|||
|||HQ File|(RLA File|je|NovDate:0310736138|(Defer|
|||01/82/050/0071B/AMI4!|—_(:03/94/040/0053T/AMID/|(30.05.2013.|____Date:07.08.2014|
|t|en ne|Nay|SEK,|TUG|TNPTE|<|NEOOET|TOT|
|||‘Decision ;|In the light of written comments received from Department ofPharmaceuticals|||
|17|vide their OM No. 35011/736/2013-PI(Norms)|dated 21.04.2014,|it was decided to call|||
|||from the firm the following technical details:|i|
|||1. Complete technical details as per Appendix 33|;|
|||2. Past production vis-avis Actual consumption of|inputs duly certified by Central Excise|||
|||(The case was deferred for 07.08.2014|||
|ceneriwaeeeanennsnnnuainnrreny giesac chai ganntuinsarayaytse|aatromnneinnolin sr|Ye|AmeNnANSe See NHBCLUM ESae ca bivtivaeatst Scotia|hebben|iain|Seninane|sini|aes|
|||1ALC4/2013|{LIMITED|(ALC4/2014|‘Deferred|
|[1g|[HQ|File|)|ORLA Fe|“Lie.|No/Date:09 10036288|Defer|||
|||SONB2/0S0/0074|VAMI4/|—__:09/24/040/00087/AM14/ 706.2013|_,_.|Date:24.07.2014|
|||(Decision|‘It was decided to defer the case for 24.07.2014 for comments of|Department of|||
|||Pharmaceuticats,|easton|
|(iGase Novia.|Pasty NamesGLAND|“(Mest No/bate:3/82-|~~|[Status:Case|||
|||jALcs2013|IPHARMA LIMITED|jaLca/20l4|[Deferred|||
|Pe|cease|ha|it|sgt|$O805.2014|ne|ene|pene|
|lig|HQFile|(RLAFie|———-—~_{Lic.|NoDiate:0910056304 Defer|:|
|||s01/82/090/00662/AM14/__:09/24/040/00106/AM14/|10.06.2013...|Pate:24.07.2014)|
|||Decision|:Reply|received|from|the|firm|and|sent|to|Department|of Pharmaceuticals|for||
|[-[GeseRecvoon.1||ALC4/2013|PayDRUGS namenALLAD&|NeeVALCA/2014Norbasiao-|Soren‘Deferred|4|
|ta|[PHARMACEUTICALS|108.05.2014|:|||
|AIMEE|ee|
|.|HORie|~—~——~C*CSRLA Fite|SSCL. NoDate-0410147196 Defer|||
|[20|-01/82/050/00382/AM14/|| 204/24/040/00048/AMI4/|(17.06.2013. _Date:24.07.2014|
|(Decision|:|it was decided to give last reminder the firm to furnish the following technical|||
|details:|||
|||js The firm has applied the norms from Guannosine. However, the chemistry|is given from|||
|||2-Amino Adenosine|Stage.|cee|es|||

----- End of picture text -----

| Copy of technicalliterature insupport of yields[envisaged] may be furnished. | | Past production vis-avis Actual consumption of all the imported inputs duly certified by | (Central Excise Authority for past 3 years may be furnished ; | [The case was deferredfor 24.07.2014.

("Tease| |ALC4/2013Nos07i2/e2‘(Party[LABORATORIES Name:SMILAX LIMITED"MestALC4/2014No/Date:3/82- ~~ (Deferred|Status:Case|| | THQ File RLAPie = —~—~—~—CLieNo/Date:0910056355 (Defer | 201/82/050/00464/AM14/ ‘(:09/24/040/001 13/AMI4/_ 17.06.2013. Pate:24.07.2014[|] | [Decision :It was decided to remind the firm to furnish the following technical details from | 21 ithe firm: | | @ End use of Export product . In case of Drug- intermediate, name of the bulk drug | manufactured from it may be given, | _ (b) Stepwise complete and balanced chemical reaction showing utilization of ethyl Cyano | | Acetate and Diethyl malonate, their Mot. Wt. and % yield on molar basis. i.1 (Case(ALCA2013Nolin. (Pty{PHARMANnesBLISS LTD. GS "MeetJALCA/2014 NefDues82- Situs‘Deferred || | TAQ Fite TRLAFile ————~—« (LieNo/Date:0310738193 (Defer | | -:OUB2/0S0/004S2/AM14/ —_:03/94/04Q/0024S/AMI4/ (19.06.2013 _.ipae2. 7 20N4 Pe Decision zit was decided to remind the firm to furnish the following technical details: | FL COA for foreign supplier indicating Potency of Nystatin imported under present A.A | | 2. Detailed calculation of arriving at the quantity ofAPI applied. | Ffease No.83710182[Party Name:VIVEK Meet No/Date:3/82-—[Status:Case | 1 JALCA2013 (PHARMACHEM (INDIA) jALCA/2014 Deferred 4 l3lHOFie~~~(RLAFile ————~—<Lie. No/Date:1310043416 [Defer |) O1/82/050/00366/AMI14/ 5 13/24/040/00032/AMI2/ 19-06.2013 _/WDater24.07.2014) | (Decision ‘It was decided to call for copy DML (Drug Manufacturing Licence) from the | [ease Nosaa/iaiga- ~~ arty Name:INBOFIL (Meet No/Dates/82-Status:Case| ALCa2013 , INDUSTRIES LTD. yALCA2014 (Deferred | balHOFile ~<A Phe ~“(Lie.No/Date:03 10738404 ‘Defer | _ :01/82/050/00446/AM14/ [:03/94/040/00197/AM14/ (20.06.2013 (Date:24.07.2014) | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | PALca20i3 —— GUTSTRINGS PVT.LTD. ALC42014 Deferred

10 .

| THQFile , IRLA File — - ‘Lic. No/Date:05 10358000 ‘Defer [| HOLB2/050/00294/AM14/ :05/24/040/00091/AMI4/ 25.06.2013 Date:24.07.2014 | Decision :1t was decided to defer the case for 24.07.2014 for comments ofDepartment of | LPcsp a opainsvigssaeseassseases| (I€ase: No90/14/82-——~=~=«SPartyNName-MYLAN‘Meet No/Date-3/2-(Status:Case ALC4/2013 /LABORATORIES LIMITED JALC4/2014 Deferred | ‘6HQFile IRLA File ~ {Lie-No/Date:0910056460 [Defer | | OL/82/050/00675/AMI4/ _:09/24/04/00128/AMI4/° (26.06.2013 _[Date:24.07,2014 | Decision :It was decided to deter the case for 24.07.2014 for comments ofDepartment of | i (Pharmaceuticals. | |(CaseALCS/2013Not72/14/82(Party[DIAGNOSTICSName:RECKON PVT. LTD.[Meet|ALC4/2014No/Date:3/82-—(StatusiCase‘Deferred | | HQFile LAB aaa ir Nomaws41b0s7266 (Deer | :OL/82/0S0/007S7/AMI4/ :34/24/040/00044/AMI4/ 27.06.2013, [Date:24.07.2014, 27‘Decision ‘Department of Biotechnology vide their letter NO. BT/IL/05/398/2013-PID | ‘dated 26.12.2013 has requested the firm to furnish the copy of Manufacturing process | 1 (flow chart, copy DML (Drug Manufacturing Licence),Batch Manufacturing Record and | | ‘jelarification on the quantities of import inputs (whether it is in Grams or in Milligrams) , mentioned in the application. . ("EaseF No201/0/82-—~SPam NamesSHASUN Meet NovDate:3/82- ~~ (Status:Case | JALC4/2013 [PHARMACEUTICALS (ALC4/2014 Deferred 4 cee LIMITED 08-08.2014 J | HQFile RUA File [Lie NofDateco410147S51 [Dofer 4 | POLS2/0SO00384/AMI4/ —O4/24/040/0006"AMI4! (27.06.2013 |Date:24.07 2014, ?8 Decision : In the light of written comments received from Department of Pharmaceuticals | | ivide their OM No, 35011/715/2013-PI(Norms) dated 21.04.2014, it was decided to call _ from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. |

==> picture [405 x 119] intentionally omitted <==

----- Start of picture text ----- JALCA/2013 SPHARMACEUTICALS LTD JALC4/2014 Deferred } Ip9 HQFile ~~ IRLA File "Lie. NofDate:34 10037281 Defer a EOUB2OSOMOTSWAMIA! —:34/24/040/00065/AMI4/ 01.07.2013 | Date:24.07.2014) | ‘Decision tit was decided to defer the case for 24.07.2014 for comments of Department of WPharmnacenticas. a ee cg ss nasal (Gase No24/12/82- ————Party Name: WOCKHARDT (MeetNo/Date:3/82- —“Status:Case BOIALCE#/2013 LIMITED 4ALC4/2014 wos» sDeferred | ----- End of picture text -----

;

==> picture [417 x 645] intentionally omitted <==

----- Start of picture text ----- 11 | HO1/B2/0S0/00448/AMI14/ __:03/95/040/00256/AMI4/ 02.07.2013. Dater24.07.2014, | Decision :It was decided to remind DCGI to fumish their comments. The case was) | deferred for24.07.2014 ee ( (ease Nowaatzina: (Barty NamesENCUBE [Mest No/Date382-[Status:Case | (ALC4/2013 |ETHICALS PVT LTD ALC4/2014 “Deferred 4 13, HQFile BLA File Lic. No/Date:03 10740922 Defer | [ :01/82/0S0/00468/AM14/ __/:03/94/040/00306/AMI4! 10.07.2013 Date:24.07.2014 ; Decision :Reply received from the firm and sent to Department ofPharmaceuticals for | | theircomments.Thecase was deferred for24.07.2014. IGase Nowteoviaisa- ~~ [Pary Name:ALCHYMARS [Meet N/Date:382-"[Status:Case | 1ALC4/2013 4ICM SM PRIVATE LIMITED jALC4/2014 (Deferred | i32 HQ File : eeIRLA File — {Lic No/Date:0410147942 Defer ~~ P" LOus2sqoo7as/aMi4s —:04/24/040/000S0/AMI4/ (11.07.2013 ____ Date:24.07:2014 | 1 ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | [Gise NowsaT 8. ALCAROTS Party NemecTORRENT Meet No/Dates/82- ~~ [Status:Case j | {PHARMACEUTICALS LTD, |ALC4/2014 Approved | | HoFie “RLA File Lie No/Date:08 10122789 [Defer Date: | | 01/82/050/01035/AM14/ _— f08/24/040/00157/AM4 NS07-2013 : | [Decision » + Committee considered case as per agenda and in consultation with technical | “authority present in meeting, decided to ratify norms under Para 4.7 of HBP v1 as per SION A-412 [|] with 2 % wastage: | [33| Export product Export SLNo. | Import items Qty. allowed ; 5 ‘| Torasemide Tablet $ mg i 1No. t. Torasemide 5.10 mg/tablet ' +| 4| TorasemideTabletten Heumann 3 mg Bi | ‘( Torasemide Tablet 10 mg | 1 No. Forasemide 10,20 me/tablet i | | ) T ablettenorasemide Heumann 10 mg 4| | ALC4/2033 |PHARMA LIMITED _ALC4/2014 [Deferred | alHQFie —SSS~*«SRLA hile — ~~ [Lie No/Date:09 10056772 ‘Defer | 4 Decision : In the light of written comments received from Department of Pharmaceuticals | | Wide their OM No. 3501 1/696/2013-PI(Norms) dated 21.04.2014, it was decidedto call J ----- End of picture text -----

;

==> picture [466 x 573] intentionally omitted <==

----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|4|
|a4{from\- Completethe firm technicalthe|followingdetails astechnical per Appendixmee 33 for conversion ofRCB Diol to|j|
|||‘Recuronium Bromide used in the export product.|||
|A|| *Copy ofMaster Batch Formula duly verified by Quality Control Incharge|:|
|| * Batch Log Sheet for the recent 5 Batches. Central Excise Certificate for past 3 years.|||
|||||+ Past Production vis-a-vis Actual consumption ofraw|materials duly certified by Central.|||
|||[Excise Authorities.|.|||
|||[The case was deferred for 24.07.2014.|||
|Gate|esas:|ary|Name|STERICON|Mee|Nevbares-|BttiCoe|||||
|1|sALC4/2013|{PHARMA PVT.LTD.|JALC4/2014|4Deferred|5|
|gs(HO File|—|(Ria File—|[Lic.No/Date:0710096793|(Defer|~~|
|||:01/82/050/00613/AMI4/|_207/24/040/00 LO7/AMI4F|17.07.2003|ooo|_[Date:24.07.2014)|
|||(Decision It was decided to defer the case for 24.072014 for comments of|Department of|||
|,|F PPharmaceuticgls.|et|ge ||
|("lease Now2i/12/e2-|~~ Party Name: WOCKHARDT|[Meet No/Dae3/83-——StatusCase|
|||[aLca2o13|(LIMITED|JALC4/2014|‘Deferred|
|[|36 HQ01/82/050/00445/AM14/file|~~ ~——~—~SRLLA'£03/95/040/00306/AMI4/ le—|~~807.2013Lie|No/Date:03 1074|1992__(Date:24.07.2014‘Defer|é|||
|||Decision|:It was decided to remind DCG! to furnish their comments. The case|was|||
|[_Hdeferted||(deferred forFor 24,07.2014..tO|rie|aura sneitee R|GS|SSS}|
|(> \Gese Nesoari7is-|‘(Party NamerBHARAT|[Mea Novbate3/@2-——“(Status:Case|||
|1|JALC42013|‘PARENTERALS LTD,|JALca/2014|‘Deferred|||
|a7 HQ|File|eS|TIRLAFIG|~|‘Lio No/Date:3410037475|‘Defr|
|||601/82/050/00930/AMI4/|‘34/21/040/00163/AMI4|BOF ZONE|ee|as|_Date.24.07.2014|
|||(Decision|“Tt was decided to defer the case for 24.072014 for|comments ofDepartment of|||
|eine Naceiaan:|Par|Name UNTTOLES LIFE|[eet|NofDuei-|Stace|
|||laLca2o13||SCIENCES LTD.|JALC4/2014|‘(Deferred|||
|eee|neettengne se|~|nthnstnagaacmnnseecempoasm|0808-2084|||
|RLAFile —|[Lic No/Date:0310742481|[Defer|—|
||||iHQ:01/82/0S0/00476/AMI4/fie|1.93/95/040/00305/AMI4/|(23.07.2013.|(Date:24.07.2014|
||3¢Decision|:It was decided to remind the firm to furnish the following technical details:|||
|||iL. Technical details as per Appendix 33 for conversion of|Gadolinium to Gadopenteate|
|||(Dimeglumine.|||
|||2. Volume ofthe Injection /Vial to be exported.|||

----- End of picture text -----

==> picture [432 x 598] intentionally omitted <==

----- Start of picture text ----- t [PHARMA LIMITED JALC4/2014 ‘(Deferred | ‘59 HQ File IRLA File * Lig.No/Date:0910056894‘Defer | 01/82/0S0/00946/AM14/ —__:09/24/040/00176/AMI4/ 24.07.2013 Date:24.07.2014) | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | i jALC42W3 LABORATORIES LIMITED laLcanot4 ‘Deferred | j40 HO File 'RLA File Lie NovDate:0910056909Defer | POL/S2/050/0063 VAMI4? :09/24/040/00185/AM14) 5072013 wn me OTE | Decision :It was decided to send a copy of application again to Department of | ‘Pharmaceuticals for their comments. The case was deferred for 24.07.2014 4 TW suttisatdntciinmnnman’nasrnc thsi SOE Sie iat dustin esinbeivntetnignoe ebbceis SiG AE Lele ie neta ee abe ibe nha ttaniniisintetehtinnetin Ntiintiitinilasiawsvnininiieianiamoinn ene [""} IALC4/2013[Case Noszan7ig "Pony/LABORATORIESNameSMILAX LIMITED(Meet(ALC4/2014 No/Date:3/82-—«*(Status:CaseDeferred 4 ee 01, ee re 141 HQ File meeeIREA File SSL NeoDDate:0910056902 [Defer | 1 1:0 82/050/00886/AM 14/ ‘:09/24/040/00180/AML4/ (25.07.2013 (Date:24.07 2014) | (Decision sIt was decided to defer the case for 24.07.2014 for comments of Department of | | Pharmaceuticals ee eae en |[> 1ALC4/2013[ease No.45/t2/82- PartyPVT LTD, Name:AMI ORGANICS"JALCA/2014Meet Novbate:3/42-"Status:Case‘Deferred | a eee Seer 10, | \giHOFile RLAFile ~~~ Lic,No/Date:5210040038 Defer i ( ROU/827030/00467/AMI4) —:52/24/040/00015/AM14/ 30.07.2013 i, /\ONO24. 07.2014) | Decision ‘It was decided to defer the case for 24.07.2014 for comments of Department of 7 1 [Case‘No.11/10/82-ALC4/2013 PartyName:MICRO (LTD JALC4/2014 ‘Deferred | | LABS |Meet No/Date:3/82-(Status:Case | | HQFile SS CRLA Fileee Lig,No/Date:0710097 180 [Defer | 43 .01/82/0S0/00184/AMI4/ —:07/24/040/0011/AMI4/ [30.07.2013 Dater24.07.2014) | ‘Decision :Jt was decided to call from the firm detailed justification for the import of| | 41039.076 kg of API against the present advance authorization. The case was deferred for, (ICase No.:22/14/82- ‘Party Name:MSN ‘Meet No/Date3/82- Status:Case | JALC4/2013 ‘LABORATORIES PRIVATE /ALC4/2014 (Deferred | 44 Q File ocoramia NSN Oe TLic. No/Date:0910056971 Defer 3 | :01/82/050/00607/AM14/ __-09/24/040/00192/AM14/ 31.07.2013 (Date:24.07.2014) | (Decision It was decided to defer the case for 24.07.2014 for comments of Department of | [Pharmaceuticals sn oe pitnngeangeannsal oo ----- End of picture text -----

PCase No.48/14/82.PayNameLOUIS (Meet No/Date:3/82-— Status:Case | 1ALC4/2013 PHARMACEUTICALS PVT JALC4/2014 Deferred | | HQ File IRLA File ~ "Lie No/Date:0910057008 Defer | | 01/82/050/00633/AM14/ —:09/24/040/00200/AMI4/ (02.08.2013 “Date:24.072014 | ‘Decision :It was decided remind the firm to furnish the following information:: 45(a) Complete technical details as per Appendix 33. | | (b) COA of imported R.M. from the Foreign Supplier. | (©) COA of the export item. | :@ Past production vis-a-vis actual consumption of inputs duly certified by Central Excise | | Authority. \ ( (Case No.101A382- —~—«@Parly Name:RA CHEM Meet[No/Datec3/82-—(Status:Case] | |ALC4/2013 (PHARMA LIMITED ‘ALC4/2014 JApproved | Le ee en ce | | [HQ File ——RLAP ie ~~ ‘Ge-NomDate:0910057030 [Defer Date: | | O1/82/05Q/00S7/AM14/—__-09/24/040/00204/AMI4/ 05.08.2013 a | Decision : In the light of earlier decision taken by NC in its 1/82 meeting dated 10.04.2014, it | [was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by (AG the firm, whichever is less: { | Export product Exp. Qty. | SLNo. | import items ° . Qty. allowed | | |_| DANTRON kg 1. 1,8-Dinitro Anthraquinoline | [ [Case NowasstaigaPantyName:ACEBRIGHT(Meet No/Date:3/82- —‘(Status:Case| | TALCA/2013 A(INDIA) PHARMA PVT LTD, JALC4/2014 “Deferred i 47 HQ File ——— TRLA | 1:01/82/0S0/00630/AM14/——1:07/24/040/00137/AM14/File ——06.08.2013{Lic No/Date:0710097392| Date:24.07.2014°[Defer | | Decision :It was decided to remind the firm to furnish complete technical details as per! "CaseNosd0/14/82—«PartyName-CTX (Meet No/Date:3/82-[Status:Case | (ALC42013 [LIFESCIENCES PVT LTD, |ALC4/2014 ‘Deferred | | Horie RL File ~ Lic. No/Date:03 10744552 [Defer \ 14g:01/82/0S0/00625/AM14/ —:03/94/040/00307/AM14/ 07.08.2013 Dater24.07.2014, Decision zit was decided to call from the firm following information:| | @ Complete technical details as per Appendix 33. i ; b) Past production vis-a-vis actual consumption of inputs duly certified by Central. Excise | PANTIE ee ieee |

==> picture [437 x 606] intentionally omitted <==

----- Start of picture text ----- tog if | iThe case was deferredfor 24.07.2014 i i:1 HALC42013(CaseNos165/14/82- “PartyALIMITEDName:MEDREICH (Meet4ALC4/2014No/Date:3/82- ‘Deferred(Status:Case 4 [yg HQFile ~ARLA File en Lic-No/Date:07 10097410 Defer | ROL/82/050/00750/AMI4/ :07/24/040/00135/AMI4/ (07.08.2013 /Datec24.07.2014, | ‘Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | } \Pharmaceuticals 4 canterna ls ace desanasnnnanansvasivies sacunananaisscastsesssrocovscmunmvonsnmosieieiarret-eroyeruopataathe tt afibie Ott aa Bait aN OHI RENARD SRR RRNORE RATA SOOCIA ARNT UBO SGML Shc HOOMONOAAIRAao ceronicstontonnenisanivvtnenorsrtemeretinerwmescriiveesni—rh-hiverait cata saan count . i:[Case No34/13/82- PartyName:WANBURY (MeetNo/Date:3/82-—‘(Status:Case | TALC4/2013 LIMITED(FORMERLY ALC4/2014 ‘Deferred } | THO File IRLA Fite ~~ (Lie. No/Date:03 10744838 [Defer | SOLOI/82/0S0/00S10/AMI4/ —_:03/95/040/00132/AMI4) (12.982013 saunas _[Date:24.07.2014) 7 Decision33, : It was decided to call from the firm complete technical details as per Appendix |} |_The case was deferred for24.07.2004 i:[Case No.s147/4ig2- "Party [NameMYLAN] MeetNo/bate3/82- ——(Status:Case | | TALCA/2013 {LABORATORIES LIMITED Alcan ‘Deferred ‘i 51H File (RLA File ~~ [Lie.No/Date:0910057191 Defer | [: 101/82/050/00732/AMI4/(Decision :It was decided —__:09/24/040/00201/AMI4/ to defer the case for 24.07.2014(14.08.2013for comments of(Date:24.07.2014Department of || { [ase i (ALC4/2013No.:122/14/82- Party {LIMITED(FORMERLYNameWANBURY {ALC4/2014Meet No/Date:3/82- —«(Status:Case‘Deferred |; GQHQFile «SRL Fle Lic. No/Date:0310745264 | Defer | | [:O1/82/0S0/00707/AMI14/ —_03/95/040/0020/AMI4/ 14.08.2013 Date:24.07.2014 | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | T\Gase Now66/1482. ~~ ‘(Party Name:SRINI ~~~ Meet No/Date:3/82-——(Status:Case | 1ALC4/2013 /PHARMACEUTICALS LTD., JALcan2014 [Deferred | 153 HQ File ~RLA File ‘{Lic.No/Date:09 10057203 Defer | | KOUS2/050/0065/AMLA/ — 09/24/040/00216/AMIA/ [16.08.2013 _Deaaranlt | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | P PPharmaceuticgs eevee erp [7 [Gase Nowizirtarea. Party Name: WANBURY [Meet No/Date:3/82-~ (Status:Case | |, ALCa2013 ‘LIMITED(FORMERLY jALC4/2014 {Deferred | MQ FieREAie [beNovDate:0310745576Defer ----- End of picture text -----

==> picture [425 x 597] intentionally omitted <==

----- Start of picture text -----

||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|_|Decision|:It was decided to defer the case for 24.07.2014|for comments of|Department of|||
|||Case No,:34/14/82-|aParty Name:SMILAX|Meet|No/Date:3/82-|Status:Case|=|4|
|||jaLcao13|SLABORATORIES LIMITED|(ALC4/2014|(Deferred|||
|55|HQ|File|IRLA File|Lie.|Nefiate:0910057244|[Defer|||
|[||GOUS2/0SO/0061/AMI4/|—_|:09/24/040/0023/AMI4/|(19.08.2013,|_Date:24.07.2014)|
|||{Decision|:It was decided to defer the case for 24.07.2014 for comments of|Department of|
|(AP armacemticas|ees|msggonsi|se sesssscc||
|||[Case|No.:117/14/82-|‘(Party|Name:MAC|CHEM|Met|No/Date:3/82-Status:Case|||
|||(ALC4/2053|“PRODUCTS (INDIA)|\ALC4/2014|(Deferred|||
|i(76|{HQFile:01/82/050/00702/AMI4/  —————”:”~—”:CSRLLA_:03/95/040/00407/AMI4/idee|~~"(20.08.2013 (Lie.|No/Date:03 10745962Date:24.07.2014Defer|"||
|||Decision|‘It|was|decided|to|call|for|DML|(Drug|Manufacturing|Licence)|percentage!|
|*|||content of buffering|agent in|the|export product|from|the|firm.|The|case was|deferred|for)|
|[Case|Nosa6miai2-|Party Name:MYLAN|Meet|NovDate:3/82-|[Status:Case-|
|}|(ALC42013|{LABORATORIES LIMITED|(ALC4/2014|Deferred|i|
|||cei ieee|ie,|0805201|||
||157RO1/82/oso/oo61THQ|File|VAMI4/REA=|-0s/4~ao/00I9N/AMIA/File|—SSS™S*SL|20.08.2013teNo/Date-00910087247‘\Date:24,07.2014),(Defer|
|||‘Decision|‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of|4|
|| pPharmacenticals|ep|||
|[|(Case Nos3/12/62-AL.C4/2013|Party|Name:ACTAVIS|Mest No/Date:/82-(SintussCase|
|i|¢PHARMA|(ALca/2014|[Deferred|||
|i|[MANUFACTURING|[08.05.2014|||||
|PSiHe||File|RLAF|ile—SSCLic,NoDdate:0410148864Defer|
|||GOLB2/0S0/00427/AMI4)|—_:04/24/040/00095/AMI4/|22.08.2013|_.ipawaao7 201g|
|[Decision|:It was decided|to send a copy of application|again to DCGI|for their comments|
|__Asolutionof import items|contains|8% water).The|case|was|deferredfor|24.07.2014.|
|[Case|No.:32/14/82-|[Party|Name:ALEMBIC|[Meet|No/Date:3/82.|‘Status:|Deffered||
|}|JALC4/2033|{PHARMACEUTICALS LTD|jALC42614|and Re-indexed|||
|(59|[HQ|File|~|REAFile|(Lic. No/Date:3410037709|Defer||
|||ROW/E2/0SO/006IV/AMIA/ —|:34/24/040/00110/AMI4/|22.08.2013|Date:24.07.2014|||
|||[Decision|:|It was decided|to defer the case for 24.07.2014 for comments of|Department of|||
|5D Arar|
||g|Case Nos10/17/88-|(Party|Name:-BELOOR|BAYIR|Meet|No/Date:3/82-|‘Status:Case|:|
|LJALC32013|, BIOTECHLTD, =|ALCAR0I4.|Deferred’|

----- End of picture text -----

17 | figrite RUA File TieNoyDates0 | fOU/SS/OSO/NOLIZ/AMIA! O724/040/001S0/AMIA) 22.08.2013710097664___Date:24.07.2014[Defer || | [Decision vIt was decided to defer the case for 24.07.2014 for comments of Department of : ‘“Case NowdT/482Party Nane:VIVIMED LABS [Meet NovDate:3/2-Status‘Case | » (ALC42013 SLIMITED HALC4/2014 Deferred 4 le [HQ File “ORLA File — [Lic No/Date:0910057280 Defer | |) LOV/82/050/00632/AM14/ __:09/24/040/0025/AMIY 22.08.2013 Pate:24.07.2014 { Decision ‘It was decided to defer the case for 24.07.2014 for comments of Department of | F ppharmaceuticals, a (> \ase Nos 6it482(Party NamesRIOCARE INDIA ‘Meet No/baie3/&2-—Status:Case[|] | (ALC4/2013 [PRIVATE LIMITED. {ALC4/2014 ‘Deferred | se nn CnEnEneneenrrenee FOROS.2014 eaepupn snl 7 ““RLABe@ ‘LieNo/Date:0310746634 (Defer | 4| (HQRO1/82/0S0/00700/AM14) File __:03/95/040/00402/AMI4/ 23.08.2013 - —,,., Date:24.07.2014[|] | ‘Decision : In the light of written comments received from Department of Pharmaceuticals | | Wide their OM No. 3501 1/635/2013-PI(Norms) dated 04.03.2014, it was decided to call | gg fom the firm the following technical details: 4 Pi) Export Items 1 and 3 are APT's (100%) and should not fall under chapter 30. The firm | | jshould be advised to give correct and relevant HS code 4 ' ii) whether any chemical reaction is involved in the manufacture of Dimethicone. If so, | | complete details of reaction, Mol, weight and % yield on molar basis may be furnished. | | lili) Past production vis-a-vis actual consumption of inputs duly certified by Central Excise | | Authorities be furnished for last 3 years. | | The case was deferred for24.07.2014. | Gane asaaiiasas Pay Name MAKCOR (Meet NofDute 762. (SntusCase + ALCA2013 ILABORATORIESLTD. ALC 4/2014 (Deferred | eeFag PROS ONE Sh ocseseessl | THQ Fileee RAFile ee Lic. No/Date:08 10124120 ‘Defer | gg (O/820050/00564/AM14) _:08/24/040/00232/AM[14] 26.08.2013. _ Date:24.07.2014 | ‘Decision[talongwith] :[ list] It was[ of][Approved] decided to[ items] remind[ showing] the firm[ composition] copy ofDrug[ of][export] Manufacturing Licence[ product.] | (Gace Nouisziaisz —~—~—(Panry Name:MYLANee NomDatea/82 —Status:Case | | ALca2013 [LABORATORIES LIMITED ALC4/2014 [Deferred | gs(HQFie a ETARIC ~~ ——~=~S~SCS*U Lie No[/Datex091005] 7368 [Defer | | 101/82/050/0073T/AMI4/ (09/24/040/002 1 /AM14/ 127.08.2013 ‘\Date:24.07.2014) | (Decision :It was decided to defer the case for 24.07.2014 for comments of Department of — | Pharmaceuticals. enees tes ass |

==> picture [410 x 573] intentionally omitted <==

----- Start of picture text ----- i:| (ALC42013ICaseNo.:116/14/82-—~—-Party(SCIENCESNante:UNIJULES LTD. LIFE 1ALC4/2014[Meet No/Date:3/82- ‘DeferredStatussCase erste te gp OB OS PONG | ig HOFile = = ~~RLAFile = ———~—Lite. No/Datec0310747079 (Defer i 4, #01/82/050/0070/AMIL4/ :03/95/040/00215/AMI4/ 27.08.2013 tees (Date:24.07.2014 ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | | (Pharmaceuticals. | (7 [ease NoSi/L4/82-ALCAR015 [Party Name:RATNAMANI BIO Meet No/Date;/82-[Status:Case it {CHEMICALS & JALC4/2014 ‘Approved | | a SPHARMACEUTICALS PYT, 68.05.2014 4 i i ‘LID | | ; | THQ File IRLA File ‘Lic.No/Date:3410037783 Defer Date: | | sO1/82/0S0/00636/AML4/ ——:34/24/040/00125/AMI4/ (02.09.2013 | |{ [Decision{Petrochemicals: In the vide light their of U.Owritten No. comments14010/23/2014-Ch received fromIl dated Department24.06.2014, of Chemicalsit was decided! and! i to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the! | ‘firm, whichever is less: | i: Export product Exp. | SLNo. | Import items Qty. allowed | i ~ | 2,3-Dichtoro Tol 079 k | | P.3-Dichloro Benzoyl Chloride lke ews 1.079 ke | | : 2. Cuprous Cyanide 0,604 kg | | RA may take appropriate action as per the decision ofNorms Committee. | 1 "Tease No.:43/16/82- “(Party NameSYMBIOTEC Meet No/Date:3/82- ——[Status:Case | ALca2013 ‘PHARMALAB LTD., ,ALC4/2014 “Deferred 1 (67: HQ File| ~~ IRLA File Lie. No/Date:5610002765 Defer | EOL/S2/0SO/00RSO/AMI4/ —:S6/24/04Q/OD0IT/AMI4/ (03.09.2013 _Date:24.07.2014 | PharmaceuticalsDecision It wasfordecidedtheir comments.to send Thea copycase wasofdeferredapplicationfor 24.07.2014again to Department of | (fase Noi83/14/82- Party Name:STERILE INDIA [Meet NovDate:3/82-StatusrCase “| 7; ALCa/2013 (PRIVATE LIMITED JALC4/2014 ‘Deferred : leg| HQFile1:01/82/050/00638/AM= = = 14/ (RLAFile£05/24/040/00203/AM14/ i05.09.2013 je.No/Date:05 10364653 I Date:24.07.20144[Defer | | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | fPiharmaceuticats, aon tinea sens ----- End of picture text -----

==> picture [430 x 584] intentionally omitted <==

----- Start of picture text ----- IALCa014—=—=~~S«~C i erred:—S ° [jAucanoi3 [LIFESCIENCES 1 [ip] 4 THQ File "~~ ARLA File — Lie. No/Date:34 10037845 (Defer ~~ | | pOI/B2/SO/0076VAMI4/ __:34/24/040/00132/AM14) 106.09-2013 os _[Date:24.07.2014) | (Decision It was decided to defer the case for 24.07.2014 for comments of Department of | [7 [Casesaith Paty NameNTAS (Meet No/Date382-———(StatussCase | ALC4/2013 |PHARMACEUTICALS LTD., /ALC4/2014 (Deferred | }70 HQ fie ~~ RLAFile ~ “ {Lic No/Date:0810124544 [Defer"| Loie2/0so/o06gg/AMI4/ | :08/24/040/00242/AM14/ (06.09.2015 ‘Date:24.07,2014) f [Decision “It was decided to defer the case for 24.07.2014 for comments ofDepartment of | | Pharmaceuticals, ({Gase No.:56/14/82-a aSVIVER (Meet NovDate/@2- ——(Status:Case | | ALC4/2013 IPHARMACHEM (INDIA) —/ALC4/2014 [Deferred | 200 spel cece TEac an ©$0808. bay [HO File , TRL File 7 “Lic. No/Date:13 10044273 (Defer 4 | 501/82/0500064 1/AMI4/ __[13/24/040/00021/AML4/ 19.09.2083 ‘Date:24.07.20 14) | [Decision “It was decided to defer the case for 24.07.2014 for comments of Department of | © (Gae Nosi62= Yay NamesGTREX Mest Notas 82. Sttu:Case 1 TALC4/2013 -PHARMACEUTICALS JALC4/2014 ‘Deferred | RLA File — [LicNo/Date:0910057517 Defer | nHOQFieLF" ho1/82/050/00916/AM14/ —:09/24/040/00258/AM14) {10.09.2013| Pate:24.07.2014) i (Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | | Pharmaceuticals. ean atnoea | Cc (Case Nosl@9/14i82~—iParty NamesMACLEODS-“““lMfeet No/Date:3/82- —(StafusiCase + JALC4/2013 » ‘PHARMACEUTICALS LTD. |ALC4/2014 |Deferred | ae ec essen (OB OP OUcc: a ee WyiHOFie (RLAFile ———~—=—sLic. NoDate:0310748925 ‘Defer | 2018 [Date:24.07.2014 | OUS2/0S0/00734/AMI4/ 203/95/040/00465/AM14/ O09. | ‘Decision It was decided to defer the case for 24.07.2014 for comments ofDepartment of | | Pharmaceuticals, ee cu (Gace Nosaa0sa. ary Names VASHASHVT Most NoyDate3/82-[StatwsCase | jALca/2o14 ; JRASAYAN PVT.LTD ALCA2014 (Deferred : baiQFie ORLA le{LieNo/Date:5210040190 [Defer i | pOL/S2/0S0/00224/AMI5/ —_:52/24/040/00022/AM14/ [12.09.2013 — qDate:24.07.2014) 3 |. ‘Decisionie :Reply received and sent to Department ofC&PC for their comments. The case | ----- End of picture text -----

==> picture [411 x 581] intentionally omitted <==

----- Start of picture text -----

-ALC4/2013 {LABORATORIES LIMITED (ALC4/2014 {Deferred ee ee ‘os HQFile (REAFie =———S—~S~SCSWL ic No/Dates 0910057546 [Defer / | O1/82/0S0/00925/AMI14/ ——|-09/24/040/00261/AM14/ 13.09.2013 ‘Date:24,07.2014 | | [Decision :It was decided to defer the case for 24.07.2014 for comments of Department of i: p Pharmaceuticals, ee peop ps pep it pgengesesssse| | (ALC42013 “PHARMA PVT.LTD., HALC4/2014 ‘Deferred | i | 08.05.2014 4 { | (HQ File ARLA File Lic. No/Date:07 10098284 | Defer | |g :01/82/050/00823/AMI4/ ———|:07/24/040/00201/AM14/ 16.09.2013 ‘(Date:24.07.2014 | [Decision : It was decided to remind the firm to furnish a copy ofDrag Manufacturing | pcenee, from the firm, for each export item. | | [The case was deferred for 24.07.2004 este (" [Case Nosisi/taia- ~~ Party Name:THINQ "Meet No/Date:3#2-Status:Case | JALC4/2013 /PHARMA-CRO LIMITED (ALCA2014 (Deferred ' eee (O805-204 |lg '8:01/82/0S0/00736/AM14/[HQFile ~———~CSRLA|:03/95/040/00432/AM14/Pile sS*~~CS~S«Lc(16.09.2013NevDates0310749651Defer‘(Date:24.07.2014 | | Decision :It was decided to remind the firm to furnish complete technical details as per! ||Appendix33. The case was deferred for 24.07.2014 P\Case No.35/17/82- —~—~«(PartyName:SMS ——~—~(MeetNo/Date:3/83-—(Status:Case JALC4/2013 |PHARMACEUTICALS LTD (ALC4/2014 (Deferred Ce| ee re bpessmnuunns earns ope OOSLON Naces cane HHQ File —IRLA File / Lic. 178) -01/82/050/00897/AM14/ —:09/24/040/00083/AMI4/ 18.09.2013NofDate:0910057602 ‘[ D efat e r:24.07.2014| | Decision : It was decided to call from the firm complete technical details as per Appendix | [°"[Case Nowdsvt6ig2- Party Name:SHASUN "Meet No/Date:3/82-Status:Case | )eeJALC4/2013 AMITED[PHARMACEUTICALS 805-208jALC4/2014 (Deferred i | [HQFile / IRLAFile Lic. NoDate:0410149960 [Defer — | qo }OVB2I0SO/O0SSIAMI4/ —:04/24/040/00127/AMI4/ 18.09.2013 Date:24.07.2014, | [Decision :, it was decided to call from the firm a copy ofMaster Batch Formula duly | : certified by Quality Control Incharge. : L. {he case was deferred for 24.07.2014 ppp | [Case No.:49/16/82-—~—~—«(Party Name:SOFTGEL ——‘(Meet No/Date:3/82-—=(Status:Case | #80: ALC4/2013 |HEALTH CARE PVT.LTD., (ALC4/2014 _ Deferred 4 ----- End of picture text -----

==> picture [407 x 642] intentionally omitted <==

----- Start of picture text ----- 21 || $01/82/050/00862/AMI4/© _:04/24/040/00100/AM14/ (18.09.2013, __. Date:24.07.2014 | | PPharmaceuticas,Decision :It was de c ided toe defer theests case for 24.07.2014 tsetse for comments ofDepartmentsess of | [4 [CaseNo.:68/14/82-—=~=SParty Name:NIFTY LABS [MectNo/Date:3/82-—([StatusrCase (ALCA2013 JPVT LTD., jALC4/2014 Deferred | |s1 HQ File IRLA File — Lie. No/Date:0910057606 (Defer | ROL/82/0SO/006S3/AMI4/ [:09/24/040/0028/AMI4/ 19.09.2013 _ Date:24.07.2014 | ‘Decision tt was decided to defer the case for 24.07.2014 for comments of Department of | {Case No.:64/17/82-~~" arty Name:RA CHEM [Meet No/Date:3/82-—‘(Status:Case | SALC4/2013 IPHARMA LIMITED jALC4/2014 ‘Deferred ; Ce ee une ee ep peiiareyey, @80520164 js2 HQ File —RLAFile [LieNo/fate:0910087630 (Defer | [Decision :It was decided to defer the case for 24.07.2014 for comments of Department of ' | (Pharmaceuticals. | mooetusivnannnsasisinannereHin tS SLAMS gH HH MAPLE PIER NOPE N US COLLAR DECPocrenvivtnentiavinaivnannanint nevi erties cnsndcnwihayer gna asnncnin ciehnnnatm anes None p AANA Rain OL NEY Adie benins inna moensnmacven esr esioebnnelonsnin nin naman oon adanintatabetinianned [| [CaseNo.:8125/82- PartyName:RANBAXY[Meet No/Date:3/82-—“(StatusiCase| \ALC4/2013 [LABORATORIES LTD (ALCa2014 [Deferred ig3 HQ File IRLAFile _—-_Lic.No/Date:0510366184 Defer | POLRZ/OSO/ONZ/AMI4/ —:05/24/04000207/AMI4/ 19.09.2013 _Date:24.07.2014 (Decision iIt was decided to defer the case for 24.07.2014 for comments of Department of [Case No.53/17/82- ~~‘ Party Name: HETERO DRUGS (Meet No/Date-3/82. ~‘(StatusiCase | ALC4/2013 (LIMITED, JALC4/2014 Deferred (34 HQ File IREAFile——S*~~~SC Lic No [/DDate0910057642] | Defer | | -ROVS2/0S0/00915/AMI4/Decision :it was decided to:09/24/040/00293/AM14/ defer the case for 24.07.201420.09.2013for commentsDate:24.07.2014, of Department of | || |GasejaLca2013No.162/17/82- —~=SParty‘LABORATORIESName:SMILAX LIMITEDMeet(ALC4/2014No/Date:3/82-—‘Status:CaseDeferred || Leite tibetan, (805204 gsHQFile = RLAFile SSL NevDate:0910057671 (Defer | | RO1/82/050/00924/AM14/ __/-09/24/040/00292/AM14/ 24.09.2013, secu OMNO24 07.2014) | [Decision ‘It was decided to defer the case for 24.07.2014 for comments of Department of | LWPharmaceuticals,cos spouse nitty agutgesugnsssgassasisscins teausssumnnch 186 |ALC4/2013 SVISRAM&CO.LTD. . JALC42014 Deferred | Soo chicane pt goatee isa bate ster saatasnnna pry 805-2014 oo ed ----- End of picture text -----

| OMS2/0SO/00966/AM14/ __:03/94/040/00S02/AMI14/ (26.09.2013 Date:24.07.2014: | [Decision iIt was decided to defer the case for 24.07.2014 for comments ofDepartment of ! I rien : | [Case No:14/16/82-——~—~=sWParty Name:SHAMSHREE Meet No/Date:3/82-© [StatusrCase | 4} HALC4/2613 {LIFESCIENCES LTD., JALC4/2014 iDeferred i ig7 HQ File IRLA File - [Lic.No/Date:2210014253 (Defer | | (01/82/050/00827/AM14/ _ [22a ndomooseramna/ 30.09.2013 [Pavcaorzoi4 | Decision zit was decided to defer the case for 24.07.2014 for comments ofDepartment of | | pPharmaceuticas, ep 1P'ICase Nos4i/17/82-——~=~SCParty Name: HETERO.LABS Meet No/Date:3/82(Status:Case | JALC4#2013 LIMITED ALC4/2014 Deferred \ Crete et agate, (280520 leg| HQFile = RLAFile ‘Lic.No/Date:0910057783‘Defer (Pharmaceuticals.4| :PO1/82/0S0/00903/AM14/[Decision :It” was decided:09/24/040/00317/AMI4/ to defer the case for 24.07.2014(01.10.2013 for comments ofDate:24.07.2014)Department of :| [JGase No.:46/97/82-© Party NamesINCHEM Meet No/bate:3/82Status:Case| | JALC4/2013 TLABORATORIES PRIVATE |ALC4/2014 \Deferred ‘go HO File REA File ~ILic.No/Date:0910057784 (Defer 489%) 4 : : : | POL/S2/050/00908/AM14/ :09/24/040/00288/AMI4/ 01.10.2013, ____ Date:24.07.2014 | Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | ("\€ase No48/17/82- —~=—=~S«SPartyNameINCHEM {Meet No/Dare:3/82-TStatus:Case | | JALC42013 [LABORATORIES PRIVATE |ALC4/2014 ‘Deferred Pope ee, AIMITED 08052014 loo| HO1/82/050/00910/AM14/HQ File —:09/24/040/00287/AMI4/(RAYFile Lie.(01.10.2013No/Date:0910037785Date:24.07.2014,Defer | | (Decision :It was decided to defer the case for 24.07.2014 for comments of Department of : (JPharmacemticasocsuce ness sneasensessecssnsnas sss ceanepnanuussaganin units asssssenssse ("Case No.:32/16/82-——~—*Party Name:FINE CURE (MeetNo/Date:3/82-(Status:Case 1 (ALC4/2013 . “PHARMACEUTICALS LID. JALC42014 {Deferred { ep bette 08052014 orHQFile| RA FileSSL icNeDates0810125295| Deer | | KOL/82/0S0/00845/AMI4/[Decision :It was decided —:08/24/040/00292/AMI14/ to defer the case for 24.07.201403.10.2013for comments ofDate:24.07.2014,Department of | [ "(CaseNo:39/16/82—~—~«(iPatty Name:SANMAR Meet No/Date:3/82‘(Status:Case | (92 ALC4/2013 (SPECIALITY CHEMICALS ALC4/2014 Deferred Ll. ne IMT ep OBOS20M

==> picture [2 x 2] intentionally omitted <==

----- Start of picture text ----- . ----- End of picture text -----

==> picture [443 x 606] intentionally omitted <==

----- Start of picture text ----- 1 :01/82/050/00852/AMI4/ (04/24/040/00146/AMI4/(03.10,2013 Date:24.07.2014 | | {Decision :It was decided to remind the firm to furnish the following technical details: | | {L. Complete set of Application | i 42. Details of manufacturing process of 4 chlorobutylveratrate 60% solution in Methyl- | | [Ethyl-Ketone with chemical equations, molecular formula, molecular weights. | |B. Yield obtained in each step. | | 4, Authentic technical literature in support of yield obtained. | 4 ‘S. Material balance. 4 | |6. CA certificate certifying the production of export item achieved by firm for the past | three years and corresponding consumption of each input, | j 7. Detailed calculations, arriving at the norms applied for. : | Whe case was deferredfor 24.07.2004 | ( (ease No.2717/82-ALC4?2013 Party Name:TATVA= eet No/Date/82- ——‘(Status:CaselApproved || . Ve ICHINTAN PHARMA CHEM = [ALC4/2014] es peta PNET cc 08.05.2004 oe heey ~~~ RLAFUe —_ "(ie No/Date3410038104 [Defer Date: 4 || HQ-RO1/82/050/00869/AMI4/ Fie :3.4/24/040/00159/AM14/ YOBN2003 ee beep i | (Decision : In the light of written comments received from Department of Chemicals and | | (Petrochemicals vide their U.O No. 14010/37/2014-Ch II dated 21.05.2014, it was decided | | {to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the: 2 |ao93Pee\firm, whichever is less: | : | Export product Exp. S.No. } Import items aty. | to Qty. allowed | | | DICECTCAT-18 (METHYL Tig a | ALAMINES36 or O85 kg | | | | TRIOCTYL AMMONIUM TR) Octyl Decyl Amine Tri (C-8, C- | || CHLORIDE) 10) ALKYL AMINE | || METHYL TRI (C-8, C-10) ALKYL | | | AMMONIUM CHLORIDE CAS No. | | | 63393-96-4 ASSAY 88 - 9206 io (Meet 2 [No/Date:3/82-][(StatussCase] [|] [lease No3anigrg?- ———=—~—Party [NamecELPPE][ee] | ALcano13 (CHEMICALS PRIVATE = ALC4/2044 [Deferred | loq HQfie OCSt~CS~=<Cs<S RA Pile - ‘(Lic No/Date:0310752484 ‘Defer 4 [ O1/82/050/00979/AM14/ —/203/94/040/00552/AMIM (07.10.2013 Date:03,07.2014 | (Decision <It was decided to defer the case for 24.07.2014 for comments ofDepartment of | o\Gescodtantaisa. ary Names TAS" Mees No/Date32-(Status:Case | | [aLcao13 (PHARMACEUTICALS LTD., ALC#/2014 [Deferred | | eee Fi OB OS ONE es Mesceses we ose ss cl 95 HQFIe ““RLAFile ———SSS~S*~~SC<ieNo Date 08 {0125470 ‘Defer | | 701/82/050/00825/AM for comments of Department of | | Decision :It was decided14! __708/24/040/00303/AM14/ to defer the case for 24.07.201408.10.2013 ___. (Date:24.07.2014) ----- End of picture text -----

[ease Nowaemteisa[PartyNameINTAS (Meet No/Date:3/82-—Status:Case | | (ALCA4/2013 ‘PHARMACEUTICALS LTD., VALC4/2014 Deferred 4 Ig9g HQ File ~"IRLAFile a “<< FF NoiDate:0810105462 [Defer YF :01/82/050/00839/AM14/ —_:08/24/040/00302/AMI4/ (08.10.2013 {Date:24.07.2014) | DecisionPharmacenticals,“It was decided to deferp th e case foreps 24.07.2014 for commentsnn ofDepartme n t of | t| (ALC42013(Case No.:24/16/82-=" IPVT.LTD.party[Name:S.M.] HERBALS SALCA2014[Meet}Ne/bate:3/82‘Deferred[Status:Case | ee nr ce | | [HOFile ~IRLA File : TLic.No/Date:0510367885 [Defer— | | s01/82/050/00837/AM14/:05/24/040/00232/AMI4 08.10.2013 en, Date:24.07.2014, ‘Decision :It was decided to call from the firm the following technical details: i ' COA from foreign supplier for relevant import consignment for the imported input. | | '» COA from Independent and approved Testing Laboratory for export product. | | ' Stepwise process with wastage envisaged in the process. i |The case was deferredfor 24.07.2014. ["[aseNo.:13/16/82-ALC42013 PHARMACEUTICALS LTD, jALC4/20146 Approved | aa Party NamesTORRENT [Meet No/Date:3/82Status:Case | |logHQFie FRLA File oe [Lie[No/Date:0810125464] (Defer Date: | | :0US20S0/00826/AM14/ —-08/24/040/00296/AMI4/ 08-10-2013 : jauthority present in meeting decided to ratify norms under para 4.7 of HBP as per SION A-412) | (Decision :Committee considered the case as per agenda and in consultation with technical) | with 2% wastage. 1[7 JALC42013(Gase No.s2nintg2Party(LIMITEDNameiEVTANLABS (MeetiALC4/2014No/Date:3/82-—‘[Status:Case‘Deferred | looHQFile IRL File ~~~ Lic.No/Date:0910057882 [Defer | ( 101/82/050/00889/AM14/ [-09/24/040/00340/AM14/ (09.10.2013. Pate24.07.2014, | [Decision It was decided to defer the case for 24.07.2014 for comments of Department of | | pPhharmaceuticals. [lace: IALC4/2013Nowiianss2.——~—~—*(PartyName:MELZERICHEMICALS PVT. LTD (MeetALC4/2014 No/Dates3/#2-—‘Status:Case[Approved | | HQPile SSSS'IRLA Pile——~—~SSS~SCSCS Lic No/Daate:3 110060644 [Defler Date: [200 LO1/S2/0SO/01169/AM14/ SB L/83/040/00116/AMI4/ —(09-10.2013 el | ‘Decision : In the light of written comments received from Department of Chemicals and | ‘Petrochemicals vide their U.O No. 14010/72/2012-Ch I dated 22.08.2013, it was} | decided to ratify norms under Para 4.7 of HBP v1 as per details given below or.as applied

| i Export product Exp. Qty. | SLNo. | import items Oty. | ; allowed ||| Trista. 2. | Paraformaldehyde 91-93% “) 0.326kg | | | triazineHydroxyethyl)-S| LRA may take appropriateaction as per thedecision Of Norms Committee eed [ "(Case No.:73/14/82- © Pay Name MSNvane Mest No/Date:s/82-" ~~ Status:Case | ‘| aLcanos JLABORATORIES PRIVATE |ALC4/2014 ‘Deferred | CO PMITED = 08.052014 ee eee 101 | } HQ File ‘RLAFile , ~~ {Lie No/Date:0910057878 (Defer | ROVS2/OSO/O06S8/AMI4/ :09/24/040/00325/AMI4/ 09.10.2013, sep ‘pate2ao72014 | DecisionPharmaceuticals,sit was decided to defer the case for 24.07.2014 for comments ofDepartment of | pu pss ese se cesses | [Case No36/7/82- SS PartyName:MYLAN [Meet No/Date:3/82(StatusiCase | 4 (ALC4/2013 “LABORATORIES LIMITED ALC4/2014 Deferred : |/102/HQ Fite IRLA File —TLie.No/Date:0910057877[Defer| | POLB2/050/00898/AMI4) —:09/24/040/00300/AMI14/ 09.10.2013,paso ij (Decision “It was decided to defer the case for 24.07.2014 for comments of Department of [Pharmace ations. en sagusisgsstieieec| [ (Case No.28/16/82(Party Name:NECTAR [Meet No/Date:3/82‘[StatusiCase | | |ALC4/2013 ‘LIFESCIENCES LIMITED, JALC4/2014 {Deferred fod i 408.05.2014 | 103| [HO File IRLA File [Lic.No/Date:22 10014277 [Defer | | xO1/82/050/00841/AMI4/ |2224/040/0004K/AMI4! [09.10.2013 sn EO MOI2A 07-2014 | | ‘Decision “It was decided to defer the case for 24.07.2014 for comments ofDepartment of | {Pharmaceuticals. 4 iain semaine Anneimceainninnnicnentniniinin iC nit miata attic an amen meneinindhivntithitaadditatcdstetiececesteasee| [74 ICase No.26/17/82-ALC4/2013. PartyJPVT LTD. Name:AMEORGANICSSALC4/2014‘Meet No/Date:3/82-‘Deferred[Status:Case|| ‘104 [HQ File —RLAFile |e NofDete:s21 0040265 Defer : | | ROUS2/050/00868/AMI4/ _1:52/24/040/00024/AMI4/ (10.10.2013 ___Date:24,07,2014) | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of 1 UC cae ent nt stat seems aie, pata | (7| "ICase[No.:55/17/82-] ~~ (Party Name:SHODHANA(Meet No/Date:3/82-Status:Case ALC42013 LABORATORIES LTD 1ALC4/2014 3Deferred t | JHQFile UREAFile [Lic No/Date:0910057889 [Defer _ = i

==> picture [438 x 612] intentionally omitted <==

----- Start of picture text -----

|||||||||||
|---|---|---|---|---|---|---|---|---|---|
|"|Decision||Pharmaceuticals,:It|was|decidedto|defer|the|case|for24.07.2014forcomments|ofDepartmentof ||
|[Case|Nosi37/23/82-|Party Name:MANGALAM|[Mest No/Date:32.StatussCase|||
|.|||TALC4/2013|‘DRUGS & ORGANICS|1ALC4/2014|‘Deferred|=:|
|Dn|IMITED|reese,|,(08.05.2014 ed utes|
|106|HO File|'RLA File|—_|‘Lic.No/Date:0310753231|Defer|
|||-ROVS2/0S0/01T84/AMI4/ :03/9S/040/004S4/AMI4/|11.10.2013|Date:24.07.2018|
|||Decision|It was decided to defer the case for 24.07.2014 for comments ofDepartment of|||
|(Pharmaceuticals,|
|[fea||ALca/2013|[Now37/17/82-]|——~—~—~=«Party(LABORATORIESName:MYLAN LIMITEDven||ALC4/2014Mest|NovDate:s/82-|~~ [Status:Case‘Deferred|4|
|i‘107|||DecisionpOUR2OS0/0089%7/AMI4!HQ File|:It was decided~IRLA—:09/24/040/00316/AMI4/ to defer File the case for 24.07.2014(31.10.2013~|[Fie.No/Date:0910057908for comments ofDate:24.07.2014/Department[Deter|——_ of|
|fo:|.|P|
|(Pharmaceuticals,|
|[|[Case|No38/16/82-(BartyNameINTAS|Meet|No/Date:3/82-—‘(Status:Case|||
|||\aLca/2013|'PHARMACEUTICALS|—/|ALC4/2014|‘(Deferred|||
|Ao:|ILTD.,|408.05.2014|:|i|
|‘tos|HQ File|{RLA File|[LieNo/Date:081012561 6|Defer|||
|j||POVB2MSO/008S/AMI4/Decision|:It was decided——:08/24/040/0032/AMI4/ to defer the case for 24.07.2014(14.10.2013for comments ofcsi,Department(2tE24.07.2014 of||||
|1|[Case|No.:38/17/83-|SS|Party|Name:MYLAN|[Meet|No/Date:3/83-|—(Status:Case|||
|||ALc4/2013||LABORATORIES LIMITED|lALca/2014|‘Deferred|||
|ie|eet|808208|sessasssgl|
||(log/HQ|File|IRLAFile|=———S=Sw|Lc.Nep/Date=0910057914| Defer|||
|HOL/R2/050/00900/AMI14/|—__:09/24/040/00322/AMI14/|(14.10.2013|Date:24.07204|
|Decision|:It was decided to defer the case for 24.07.2014 for comments of|Department of:|
|Pharmaceuticals.|
|:|JALC42013|LABORATORIES LTD|jALC4/2014|Deferred|:|
|‘o/HQFile||GOI/82/0S0/00831/AMI4/REA —_:09/24/040/0032VAMI4/File|——SS*S*~*~S~S:CSLie Ne/DDate:0910057916[14.10.2013|Date:24.07.2014'‘Dee fer|||
|:|‘Decision|ilt was decided to defer the case for 24.07.2014 for comments of Department of|||
|("Fase No.:39/17/82-|SS|Party|Name:ASTRIX|(Meet|No/Date:3/82-—‘StatusiCase|
|||jALCa/2013|4LABORATORIES|LTD.,|— /ALC4/2014|‘Deferred|t|
|NO|ie|ee ee 08020|ceustsseseasse||
||1|HQFile|~~|——~—“—SRLAile|stsSt—~S~S "Fie No/Date:0910087944|[Defer|as|
|RONS2/SO/0090/AMI4/ —209/24/040/00312/AMIA/|17.10.2013|<page|DAtC24.07.2014|||

----- End of picture text -----

==> picture [427 x 625] intentionally omitted <==

----- Start of picture text ----- | [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | {_fPiharmacenticas, esa spt e | A (ALC4/2013 DELIVERY SOLUTIONS (ALC4/2014 i Deferred 112 HQ File IRLA File ~ ~~” Lic. No/Date:0310753955 ‘Defer | 7 :01/82/0S0/00884/AMI4/ (O3/24/040/00458/AMI4) l7i0203 se, JDAET24 07.2014 | | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | Pharmaceuticals, _ | (Case No.:67/17/82- ‘|Party NamecCOVALENT “"[Meet No/Date:3/82-—(StatusCase i jALCa/2013 {LABORATORIES PRIVATE JALC42014 “Deferred 4 eet, LIMITED 08.05.2014 | 1113| HQ File IRLA File | Lic.No/Date:0910057945 Defer 4 HOUIB20SO/0092/AMI4/ :09/24/040/00286/AMI4/ 17.10.2013, Daate:24.07.2014| | ‘Decisiontye iit; was decided to defer the case for 24.07.2014 for comments ofDepartmentP of: J, WParmaceuticals, spe post geo Co‘Case No5/17/82-ALC4?2013"PartyName:TIDE ——~—‘/Meet No/Date-3/82- ‘(Status:Case. INDUSTRIES JALC4/2014 [Approved | JBQFile " IRLAFHe ~~ Lic.No/Date:3410038223 [Defer Date: | | SOM/82/0S0/00867/AMI4/ ——:34/24/040/00177/AMI4/ i020 oe Bi| Deeision : In the light of written comments received from Department of Chemicals and. | ; Si | ‘Petrochemicals vide their U.O No. 14010/40/2011-Ch II dated 05.06.2014, it was | ; ‘4 idecidedapplied byto theratify firm, norms whicheverunder is less:Para 4.7 of HBP v1 as per details given below or as,| ; (| Export product Exp. | SINo. | Import items Qty. allowed [| | : Lauryl Nitrile Lkg 1. Laaric Acid 1.22 kg Le | TALCa/2013 ILABORATORIES LTD, — [ALC4/2014 (Deferred | ais{HQFile| EOL/S2/050/0092= =—<“is~s“‘“‘;2zR@‘W/AMI4/ :22/24/040/000S0/AM14/ ‘Rd! ~~Lic.No/Date:221001430021.10.2013, (Dates24.07.2014[Defer | (Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | (Pharmaceuticals, eee | | [case No10823/82- |Party Name:SYMBIOTEC (Meet No/Date:3/82-[StatussCase | _ (116 ALC4/2013 ‘PHARMALAB LTD., JALC4/2014 Deferred jo Li ptt tie (08052014 Se . ----- End of picture text -----

==> picture [444 x 603] intentionally omitted <==

----- Start of picture text ----- | 01/82/050/0115S/AM14/_ augSOPAMAOMOO2WAMI4/ = (21.10.2013 Date:24,07.2014 | | Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | .WPharmaceuticals, ee eo | [Csse Nosassiga- [Party NamesTATVA eet No/Daes82-~~ (Status:Case } dALC&2014 ; ICHINTAN PHARMA CHEM IALC4/2014 {Deferred { Fo RUPLI 08052018 staal |i7HQFile ~———~CS:*~SRAPde ~~ Lie-No/Date:34 10038266 Defer “| HOUS2/S0/00217/AMIS/ (34/24/040/00184/AMI4/ 21.10.2013, sessg (EOMNO24.07.2014 ; | [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | [Case No:1/5182-ALC4/2014 [Party NameEYTAN LABS [Meet NeiDate3i82- ~~ StatusiCase | : SLIMYTED jALC4/2014 Deferred | ‘ugiiQ| File REAFile FieNovDate:0910057009(Deiee | | p01/82/050/00005/aMI5/ san,LONZ4MAD0OSS4/AMI4I 24102013 space, Late24.07.2014) Decision ‘It was decided to defer the case for 24.07.2014 for comments of Department of | [Pharmaceutics tt | [Coe Nossori7i¢a. Party Name SHAMSHREE Mee NfDateS782-(StatusCase | 4 JALC4/2013 | LIFESCIENCES LYD., jALCA?2014 {Deferred l119 HQ Fite — “TRLAFIe [Lic.No/Date:2210014319 Defer || HOW82/050/00922/AMI4/ __:22/24/040/000S1/AM14/ 4.102013. (Date:24.07.2014| [Decision ‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of| (APhnarmace tics, ts tao |4 (CaseNo.:138/23/82-—=——”Party Name:MIDAS CARE[Meet No/Date:3/82-—|Status:Case | jALC4?2013 (PHARMACEUTICALS PVT JALC4/2014 Deferred | i120 HQFile RLA Fite— [Lie No/Date:03 10755504 (Defer 4 | HOUS2/0S0/0LIBS/AMI4/ _:03/95/040/00S99/AMI4/ 25.10.2013 _.-|Date:24.07.2014 | | (Decision “it was decided to send a copy of application again to Department of C&PC for ro(Case No.:100/23/82- ~~ [Party Name:SYMBIOTEC [Meet No/Date.3/82. [Status:Case |} [ALC42013 sPHARMALAB LTD. BALC42014 i Deferred F} | +01/82/050/01 IAVAMIA) _S56/24/040/00025/AM14/ 25.10.2013 cy Date:24,07.2014 | | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | occ4 _— i(Case No36/1982- Panty NamesSOHAM [Meet No/Date3/82-(StatusiCase ae /122\ALC4/2013 JORGANICS PVT LTD “ALC4/2014 Deferred om oe, Me 08.05.2014 swiss binarusunegevel un. ----- End of picture text -----

==> picture [440 x 608] intentionally omitted <==

----- Start of picture text ----- | |-01/82/050/00981/AM4/ . [5183/0400012~aMa) 29.10.2013 Date:24,07.2014 | Decision :It was decided to send a copy of application again to Department of) |___ Pharmaceuticals for their comments.The case was deferred for24.07.2014 | [ALC42013 ‘PHARMA LTD. JALC4/2014 {Deferred ; {HQ File IRLA File ‘Lic. No/Date:03 10756546Defer | | O1/82/0S0/00959/AM14/ —_-03/94/040/00687/AM14/ 01.11.2013 -Date:24.07.2014} ; Decision :it was decided to remind the firmto furnish the following technical details: | | 1, COA for foreign supplier indicating Potency of Nystatin imported under present A.A 4 2.[ Detailed calculation of arriving at the quantity ofAPI applied. :| | [Case Nouo2i/@2-ALCA2013 Panty Name: ASHO [Meet No/Dase/82- Status:Case | 44 JINDUSTRIES PVT.LTD. IALC4/2014 ‘Approved | ne Oe 0 eos | [HQ Fite IRLA File ) ‘{Lic.No/Date:03 10756660 (Defer Date: | | ROV/S2/0S0/01039/AMI4/ —:03/9S/040/00617/AMIA) —OLIN2013 | | Decision : In the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/95/2011-Ch It dated 21.05.2014, it was; | ldecided to ratify norms under Para 4.7 of HBP vi as per details given below or as| | '24 applied by the firm, whichever is less: | | ' Export product Exp. | S.No. | Import items Qty. ; | | Qty. allowed | | BISMUTH DIMETHYL lkg 71. 7 0,.982ke | prriocarBpamate BISMUTH NUTRATE [7i [easeNo.:3/16/82-ALC42013[PartyName:AUROBINDO[Meet No/Date:3/82- (Status:Case a | PHARMA LIMITED (ALC4/2014 ‘Approved | | JHQFieee ee | | HOUB2/0S0/00816/AMI4/~— ——”~—”—CIRLLA——:09/24/040/00366/AMI4/Fife——S—S—S*~~~<CS«L05.11.2013ic Nate 20910058142 Defer Date: | ‘Decision : In the light in the light of earlier decision taken by NC in its 21/82 meeting dated, it | ‘was decided to ratify norms under para 4.7 of HBP v | as per details given below or as applied by! 1 125 the firm, whichever is less: | i | Export product Exp. SLNo. | import items Qty. | | aty. allowed = | || CEFIXIME (CEFIXIME 0816 |) |yo| TREHYDRATE) EnoanticromosActivated Carbon} [ Carbon oo 0.100See! iYo co ----- End of picture text -----

==> picture [411 x 596] intentionally omitted <==

----- Start of picture text ----- | ee__|FormamideDimethyl! (DMF) P1252 || | | Methylene Chloride 3,253 to{ |6. |MethanolSS=«*d i : 7. 2-Mercaptabenzothiazoyl -(Z)-2-(2- 0.820 i i Aminothiazoyl-4yl)-2- ( [MICA] [Ester] ) fl 3 Tripheny! Phosphine 0.820 | j laa may take appropriate action as per the decision of Norms Committee. . | {Case No.:40/3/82-ALC4/2014 |PartyName:ADCOCK (Meet No/Date:3/82--(Status;Case | ie INGRAM LTD, “ALCS/2014 [Approved | | {HO Fie ° (RLAFie [Lie.No/Date:0710099539 [Deter Date: | : /:01/82/050/00044/AMU5/ _ _FO7RarodoMNZ2/AMIA, (11.11.2013. esses L ss “| | ‘Decision : in the light of eartier decision taken by NC in its 11/82 meeting dated 05.09.2013, it was) : ‘decided to ratify norms under Para 4.7 of HBP v1 as per details given below ar as applied by the firm, | phichever is less: i ip6 | item of Export Quantity | S.No | Import items For Export of 1 Nos. | | Norgesic Tablets/ 1 No. i fo Norflex CO Tablets : 7 ikg 3. | ORPHENADRINE CITRATE 35.7 mg | 4] NORGESIC TABLETS BPYEP/USP/PH.EUR : “| and NORFLEX CD q AP PABLETS 2 PARACETAMOL DC 459.0 mg , (BHEP/USP/PH.BUR) 272N i1 | CtsMICROCRYSTALLINE neaeeemn | 45.M525 me i| | __|RA may take appropriate action as per the decisionof Norms Committee.—e— [Case1 No.:33/t782- Party Name:EMCURE (Meet NovDate:3/82-~"Status:Case| ALC4#2013 IPHARMACEUTICALS LID. (ALC4/2014 , Deferred : ja74 Ha File ~~~-S{RLAFile=SOSOC=~CS [Lic.No/Date:31 1 0 610 3 (Defer | 3101/82/050/00895/AM14/ 13 1/83/040/00149/AM14/ a E.11.2013 ‘i Date:24.07.2014! | Decision ilt was decided to defer the case for 24.07.2014 for comments of Department of La Pharmaceuticas. a goo ["ICaseNo.:39/3/82-ALC4/2014 Party Name:ADCOCK Meet No/Date:3#82- ~~ Status:Case| Pg INGRAM LTD, jALC4/2014 ‘Approved | | eee Se 0805-2014 esses ees | THO File , "LA File — Lie.No/Date:0710099547 [Defer Date: | 2g: rOU82/050/00043/AMIS/ :07/24/040/0022/AMI4/=12.11.2013 ccsneasl | ‘Decision ? In the light of earlier decision taken by NC in its 13/82 meeting dated 03.10.2013, it was | | decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | [Whichever is less: | ----- End of picture text -----

==> picture [439 x 638] intentionally omitted <==

----- Start of picture text ----- 31 | : [Export Product SS0 4 | 1. Neulin 125mg tablets - Theophylline 125 Mg +Guar gum 4.375 Mg | ; | 2. Newlin 200mg tablets - Theophylline 200 Mg + Guar gum 7.00 Mg t 1 | 3. Newlin 250mg tablets - Theophylline 250 Mg + Guar gum 8.750 Mg 4 | _ 4. Neulin 300mg tablets - Theophylline 300 Mg + Guar gum 10.5 Mg | | 4 S.NO. | Import Items For export of 1 No, NeulinTablets | ] {Quantity in mg) | i:ae i25mg_ |200mg [250mg [300mg | Bo Theophylline BP/EP/USP/ | 1275mg | 204.0mg | 2550mg | 306.0me | ae GuarPH.EUR AnhydrousGum tH (BP powder | i PH.EUR) /EP /usP/ . | 4.375 7.00 8.75 10.5 || i HINDUSTRIES LTD, JALCA/2014 ‘Deferred | ||1129OL/82/0S0/0L0S4/AMI4/1HQ File ) —_:03/04/040/0071/AMI4/‘RLA File —14.11.2013[Lic.No/Date:0310757929oo , ates24.07.2014[Defer| | __.|Petrochemicals[Decision :It Divisionwas decidedof Departmentto defer oftheChemicalscase forand24.07.2014Petrochemicals.for comments of| || 1ALC3/2013[Case Notoran/es-" ‘EXPORTERS(Pany Name: METRO. PRIVATE~ ~~"= [ALC4/2014Meet No/Date:3/82- (Statns:Case‘Deferred -| | (HQ File REA File Lie.No/Date:0310758099 Defer S130 EONBSAMSO/MOI29/AMIA/ ——:03/9S/040/0059G/AMI4/ 8.112013 ___Date:03.07.2014 | | Decision :it was noted that the comments furnished by Dept. of pharmaceuticals vie OM. 4 INo. 35021/01/ 2014-PI (Norms ) dated 4.3.2014 stating that export is used as an anti! | diarrheal medication for pigs and poultry. Accordingly, Committee decided to transfer |ithe case to DES-3for necessary action | [ [Case No.:66/23/82. SS Party Name:STERICON (Meet No/Date:3/82- (StatusiCase 5 HALC4/2013 ‘PHARMA PVT.LTD., SALC4/2014 ‘Deferred | 131 | |HO File —— (RLA File _ ~ _[Lie-No/Date:0710099690 ‘Deter | -pO/82/050/011LVAMI4/Decision :It was decided to:07/241040/00259/AM14/defer the case for 24.07.2014 AB 1E2013for commentsDate:24.07.2014) ofDepartment of | Pharmaceuticals (7 ease No.:45/17/82-ALC4/2013 [Party Name:TORRENT [Meet No/Date:3/83-—(Status:Case. | ‘| YPHARMACEUTICALS LTD. (ALC4/2014 {Approved | ls2HQFile RLAFile iLic. No/Date:0810126495 Defer Date: | | O182/0S0/00907/AMI4/ —-08/24/040/0035/AMI4/ 18.11.2013, Decision :Decision :Committee considered case as per agenda and in consultation with |... |___ltechnical authority present in meeting decided to ratify norms under para4.7 of HBP as per SION) oo... ----- End of picture text -----

==> picture [421 x 635] intentionally omitted <==

----- Start of picture text ----- : 32 i] .|RA concernedmay take further necessaryaction as per above decisionofNC. | | JALC4/2013 |CHEMICALS PVTLTD /ALC4/2014 (Deferred | ||133 HQ File —REAFileSS*S™”S:*CSLNo /Date:0510371304 (Defer | | BOU82/0S0/00985/AMI4/ —__:05/23/040/00334/AM14/ 20.11.2013, , Date:24,07.2014 | [Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | bo [PHARMA LIMITED JALC4/2014 ‘Approved i ee 8052014 ae ee |1 HQFie CRLAFiIe ~~ [Lie.No/Date:0910058254 [Defer Date: | EOUS2U0SO(0RTZAMI4) —:09/24/040/00407/AMI4/ 20.11.2018 i ae | ‘Decision : Committee considered the case as per agenda and in consultation with) | technical members present in the meeting and it was decided to ratify norms as per revised. SION A-2611 details given below or as applied by the firm, whichever is less: it (a) Export product Export SI.No. | Import items Qty. | , 4 Qty. allowed : i 2-Aminomethyl-7-Chloro- 1 Kg. 1, 2-Amine-§-Chioro-2-Fluoro | 0.932 kg - | ; | 2,3-Dihydro-5-(2- Benzophenone | || Fluorophenyl)-1H-1,4- 2, Chioro acetaldehyde ~ 0.698 kg | | | Benzodiazepine Dimateate Dimethyl acetal : | Manganese Dioxide O.852kg | - 4. Dimethy! Sulfoxide 0.406 kg) | JRA concerned may take further necessary action5. as| Acetoneper above decision of NG. 0.405kg | | [Case No.:111/23/82- Party NameTATVA [Meet NovDate3/82. [StatusrCae | 4 JALC4/2013 iCHINTAN PHARMA CHEM (ALC4/2014 ‘Approved | Fg PMTLTD 08082018 || HQFileRa Pile——SS””S:”S*SCie No/PDate34 10038488 “(Defer Date: | SOV/S2/0S0/01158/AMI4/ :34/24/040/00202/AM14/ 20.11Ce | | (Decision : In the light of written comments received from Department of Chemicals and) [135 decided1Petrochemicals to ratify normsvide their underU.O ParaNo 4 . 7 of14010/99/2012-ChHBP v1 as per detailsII dated given below09.05.2013, or as appliedit was) | | 4by the firm, whichever‘ is. less: 43 ||| Methyl Tributyl 1kg 1 Tributylamine 0.625 kg | | |] Ammonium Chloride | | CAS No. 56375-79-2 L || Assay 759 (=/-296) ee | ae ----- End of picture text -----

;

==> picture [430 x 560] intentionally omitted <==

----- Start of picture text ----- _ CaseNocisong/s2. Patty NamecUNITED "(Meet No/Date/2-—StatusCase | | JALC4/2013 PHOSPHORUS LTD. HALC4/2014 ‘Deferred | a cet anne ete 80520 cect tana [136 HQ File IRLA File : “Lic.No/Date-03 10758627 |Deferod | LOVB2S/OLISTIAMLA) —_03/95/o4n/00495/AMI4/ 21.11.2013 [Date:24.07.2014, | Decision :It was decided to defer the case 24.07.2014 for comments of Department of | | ChemicalsandPettochemicals, | | [Case No:2/23/82-ALC42013 [Party Name:CROWN [Meet No/Date:3/82.(StatusrCase| fo (CHEMICALS PVT.LTD., —-[ALC4/2014 “Approved | | JHQFite ~RLAFe SSS Lic-No/IDate-0310758837— (Defer Dates | 1:01/82/050/01049/AM14¢ {:03/94/040/00735/AM14/ 122.11.2013 | | : Decision : in the light of earlier decision taken by NC in its 25/82 meeting dated 29.11.2012, it was | Idecided to ratify norens under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | [Mticheve is lass: i | 3} Export product Exp. SILNo. | Import iterns Qty. | (7 Qty. allowed : ; ] Piperonal Min. Purity 1kg Catechol (Min. Purity 99% 0.862 kg | | 98% Dichloromethane (Min. Purity G.703kg =f i 99% | 7 4 3. Dimethylsulfoxide (Min. Purity 0.875 kg i ae 99% : Joi Hexamine (Min. Purity 96%) |1000kq| To4 |S. _| Toluene (Min. Purity 97% 0.430kg | ae Isopropyl Alcohol (Min. Purity 0.220kg |, |__|RA 99%) | may take appropriate action as per the decision of NormsCommitee. = | “ALC4/2013 ‘CINDIA) PHARMA PVT = [ALC4/2014 ‘Deferred | lissHQFile “TRLAFe 1Lic. No/Date:0710099923 [Defer | ; (Decision It was decided to defer the case for 24.07.2014 for comments ofDepartment of | (Pharmaceutics, cssets fo=(Case No.:1/23/82-ALC4/2013 sCHEMICALSParty:Name:CROWN PVT.LTD.,‘Meet|AL©4/2014No/Date:3/82-~~ Status:CasejApproved || [ HQFieIRLA File[Lie No/Date:0310759268 [Defer Date: | | 201/82/050/01048/AM14/ /:03/94/040/00733/AM 14/ 26.11.2013 a a | ° ‘Decision : in the jight of earlier decision taken by NC in its 25/82 meeting dated 29.21.2012, it was | | ‘\decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firen, | | whichever is fess: i ----- End of picture text -----

==> picture [416 x 626] intentionally omitted <==

----- Start of picture text ----- 34 | 4 | Piperonal Min. Purity 1 kg Catechol (Min. Purity $9% 0.862 kg | | 98% 2, Dichloromethane (Min. Purity G703kg | po 99% j Bo:| | 99%Dimethylsulfoxide (Min. Purity | OB7S kg ;| foits4 |14.| 5. | HexamineToluene (Min.(Min,PurityPurity97%96% 11,000kg0.430 kg |!| i Isopropyl Alcohol (Min. Purity 0.220kg | |..[RA 99% | may takeappropriate action as per the decision of NormsCommittee. ssssusaussnge [ [case No<3/23t2-ALCWZ013 Party Name:CROWN ~~ eet NorDate3783- ~~ SiaeasCase| Deere (CHEMICALSPVT.LTD., —ALC4/2014 ‘Approved | | be sissenwiigcciesag, COOS2014 | JHQFie —RLAFile Lig No/Bbatez0310759273[Defer Date: | | 301/82/0S0/01050/AM14/ POS/94/040/00734/AMI4) (26.11.2013, bo | | |Decision + In the light of earlier decision taken by NC in its 25/82 meeting dated 29.11,2012, it was | | [decided to“whichever is ratify less: norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,| i : Export product SILNo. | impart items Qty. | eo) allowed | | | Piperonai Min, Purity tkg Catechol (Min. Purity 59% 0.862 kg |i i 3} 98% 2. Dichioromethane (Min, Purity 0.703 kg Hl , 99% = z Dimethyisulfoxide (Min. Purly | O875kq 7] i 9 q i Hexamine (Min. Purity 96% 41.000 kg | a Toluene (Min. Purity 97% [0430kg] fi Isoprapyl Alcohol (Min. Purity 0.220kg |! a. 99% | |.__RA may take appropriate action as per the decision of Norms Committee. Po"| Ease No.:129/23/82-"PartyName:HETERO LABS [Meet No/Dates/82- [Status:Case | [ALC4/2013 {LIMITED /ALC4/2014 (Deferred : 4) HOFile ~ (RLAFile SS “Lic. No/Date:0910058346 Defer ~~ y | :01/82/0S0/01176/AMI4/ p0924/040/0042VAMI4/ 26.11.2013 (Date24.07.2014 | ‘Decision It was decided to defer the case for 24.07.2014 for comments of Department of | J lcsa | JALC42014 ILABORATORIES (P) LTD., [ALC4/2014 [Approved | HQFie REA File’ "Lic. No/Date:0910058342 [Defer Date: 142. 01/82/0S0/00189/AMIS/|:09/24/040/00414/AM14/ (26.11.2013 ee ee | Decision ‘In the light of written comments received from Department of Pharmaceuticals | | ivide their OM No. 3501 1/725/2012-PI(Norms) dated 21.4.2014, the committee decided: - : ito ratify the norms under Para 4.7 of HBP v1 as per details given below or as applied by; ----- End of picture text -----

==> picture [445 x 644] intentionally omitted <==

----- Start of picture text ----- 35 4 i Export product Exp. Qty. | SLNo. | Import items Qty. allowed | 14 kg/kg | | Atorvastatin ikg 1. (4R-CIS)-1,1-dimethylethyl-6- 0.733 | | Calcium Cyano methyl-2,2,dimethyl 1,3- 1 fo dioxane-4-Acetate | | | Methyl isobutyry] acetate 1.646 |..JRA may takeappropriate action as per thedecision of Norms Committee. 7 ("Case| No.:77/23/82-———=—~~*PartyName:SHASUN‘MeetNo/Date:3/82-‘{Status:Case| JALC4/2033 , PHARMACEUTICALS (ALC4/2014 ‘Deferred 4 |143 {HOHOUS2OSO/OII24/AMI14/ File —(:04/24/040/00183/AMIA/IRLA File Lie-NofDate:041015225827.11.2013 (Date:24.07.2014|‘Defer | (Decision sit was decided to remind the firm to furnish a copy ofMaster Batch Formula 4 in certified by Quality Control Incharge. | |[The case was deferred for24.07.2016 ; [Case| No.:94/23/82-"Party Name:DHANUKA [Meet No/Date:3/82-—‘|Status:Case | eeJALC4/2013 [LABORATORIESa LTD. 2JALC4/2014 ‘Deferred i |i144 [HQ File IRLAFie ————S~S~SCS Lic.NDDate0510372219 (Defer | | PONS2/0SO/O1141/AM14/ —:05/23/040/00342/AM14/ _ (28.11.2013 | sete ,Pate24.07 2014 i, [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | Pharmaceuticals, pe i | IGase No.75/23/82-ALC4/2013 PartyNamePCLOIL& "Meet No/Date:3/82-~/Status:Case | i ISOLVENTS LTD., JALCA2014 jApproved || JHQFie — IRLAFie ——S—~~~:”:””S*C Lit N/Eate05 10372153 (Defer Date:| y| pOL/82/0S0/0L122/AM14/Decision :Committee considered}os/24/040700221/aMta) case as per agenda andeecarin consultation with technical authoritya| |” 45(Presentwastage.in meeting decided to ratify norms under para 4.7 of HBP as per SION A-1303 with 2% | } 3) Export product Exp. SiNo, | Import items Qty. 4 too Oty. allowed | ; ‘| PVC Plasticizer Phthalic Anhydride 0.400 kg | Po22 Ethyihexanol (Octaonol) 0.700kg [ease| No:148/23/82- —=~=@PartyName:CTX—~—~sMeetNo/Date:3/83-(Status:Case| |ALC4/2013 ‘LIFESCIENCES PYT LTD, ALC4/2014 ‘Deferred | HagHQFie =———s—<“<i~“‘“‘éiRRARide: LicNosDate-0310760 166 [Defer | SOV/S2/0S0/0119S/AMI4/ —_<03/94/040/00S98/AMI4/ 02.12.2013 Date:24.07.2014 | (Decision iit was decided to defer the case for 24.07.2014 for comments ofDepartment ofF oe LfPharmacenticas sees euesgutaaniin aati uataumrunee ead! ----- End of picture text -----

==> picture [408 x 639] intentionally omitted <==

----- Start of picture text ----- 36 == Case No.:13/23/82-ALC4/2013‘Party Name:¥ ASHO"Meet NovDate:3/82-(Status:Case| 5 INDUSTRIES PVT.LTD. iALC4/2014 [Approved | | | ; 08.05.2014 | 3 | HQFile IRLA File ‘Lic.No/Date:03 10759990 [Defer Date: | pOI/82/0S0/01L060/AMI4/ :03795/040/00696/AM14/ (02.12.2013 i | (Decision : In the light of written comments received from Department of Chemicals and| | (Petrochemicals vide their U.O No. 14010/95/2011-Ch Il dated 21.05.2014, it was | (decided to ratify norms under Para 4.7 ofHBP v1 as per details given below or as applied | aby the firm, whichever is less: | { | Export product Exp. | SLNo. | Import items Qty. allowed i i Qty. | | DIPHENYLAMINE ( ocD 0.620kg | ___ RA may takeappropriateaction as per the decision ofNoms Committee. (| [Case(ALCSH/2013No.starrasiaz PHARMACEUTICALSParty [Name:AGIO——-(Meet] LTD jALC4/2014 [No/Date:3/82.StatusrCase] Deferred |4 liqg(HQFile ==———s—~<CS~S‘“<s~SRA Ride SS [Lie.No/Date:03 10760371 [Defer | | POWR2/0S0/O1194/AMI4/ _:03/94/040/0070S/AM14/ (03.12.2013 . _[Date:24.07.2014 | ‘Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | [Case{ALC4/2013No:11223/82- Party Name:CADILA (Meet No/Date:3/82-— (Status:Case| JHEALTHCARE LTD., jALCS/2014 ‘Deferred 4 j4ag/HQFile ARLA File ~~ Lie, No/Date:08 10126887 Defer ' | -pOVB2/0SO/011S9/AMIA/ __:08/24/040/00387/AMI4/ MOET 2013, Date:24.07.2014) : ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | Pharmaceuticals. ( [Case No.:6613/82-ALCa7201a(Party Name:GLAND ‘MeetNo/Date:3/82-Status:Case = ‘PHARMA LIMITED JALC4/2014 ‘Deferred | ;‘so/HQFile= —~—~<SRLN FileS~~S«wSeo Dante0910058454 (Defer 4 | +:01/82/050/00070/AM15/ _. $09/24/040/00422/AMI4/ (04.12.2013 __Date:24.07.2014/ [Decision ‘It was decided to defer the case for 24.07.2014 for comments of Department of | (Pharmaceutics, atss sos [Case No11623/82-‘Party Name:ALCHEM Meet No/Date-3/82. (Status:Case | | |ALC42013 “INTERNATIONAL LTD. —//ALC4/2014 (Deferred i [HQ Fite — IREAFileSS™S™~~CSOSCL itN/DaatendS10372635 (Defer... | :01/82/0S0/01163/AM14/ | -05/23/040/00341/AM14/ 05.12.2013 ‘|Date:24.07.2014)° ----- End of picture text -----

==> picture [409 x 612] intentionally omitted <==

----- Start of picture text ----- | Decision :It was decided to defer the case for24.07.2014forcomments of Departmentof |fa[CaseNo.:62/23/82-ALC42013PartyName:LAKE ‘Meet No/Date:3/82- _Status:Case| (CHEMICALS PRIVATE JALC4/2014 [Approved | | HO Fite RLA File — ‘LieNo/Date07 10100274" Defer Date | ROUS2/OSO/0LIO9/AMI4/ BOTRAMADOO2IVAMIA 05.12.2018 | | ‘Decision * In the light of earlier decision taken by NC in its 45/82 meeting dated 07.02.2012, it was | jdecided to ratify narms under Para 4.7 of HBP v1 as per details given below or ag applied by the firm, | | {whichever is less: | i Qty. allowed | | | Midazolam 2-Aminomethy}-7-Chloro-2,3- 252kg | | | Maleate Dihydro-5-(2-Flurophenyl)1H-1,4- | i Benzodliazepine Dimaleate i | ‘ Triethyl Ortho Acetate [1.18kg |i |__|RA concerned may take furthernecessaryaction as per above decision of [NC.] (7 [Case No.:18/23/82- —=—=«—Party Name:NAPROD LIFE Meet No/Date:3/82. Status:Case | : (ALC4/2043 [SCIENCES PYT. LTD. JALC4/2014 iDeferred | Fe ee Neuen, (0805204 |153| HQ File ~IRLAFile Lic. NofDDate:0310760768(Defer 4 POL/B2/050/01065/AMI4) FO03/95/040/00712/AM14/ 05.12.2013 se spas EO OA 7 2014 | RD.5 Decisiona sit. was decided to defer the case for 24.07.2014|for comments of Department of|i ia©; [Case No.117/23/82-ALC4/2013 INDUSTRIESParty Name:YASHO PVT.LTD.5 JALC42014(get NovDate:3/82-"“[Status:Case|[Approved | a eee ee 2 . | ROUS2/0S/01064/AMI4/ ——:03/95/040/00705/AM14/ 05.12.2018 sesnesces| | ‘Decision + In the light of writte: comments received from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/95/2011-Ch. ft dated 2.4,2013, it was decided to ratify norms | ;H 194i| onder Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | || 4 Expart product Export §.No Import items Quantity Allowed | | Quantity kg/ke i [Methyl Eugenol | 1 kg i Clove Leaf Oif (Eugenol Content 4.40 78%) . I [ease| No.:138/3/82- ——~—~—~—~PartyName:AUROBINDO- [MeetNo/Date:3/82-(Status:Case ALC4/2014 PHARMA LIMITED “ALCA4/2014 [Deferred | HQFile RLAFile ~—S*CSLieNo Date0910058481 (Defer al ----- End of picture text -----

||<br>Decision *Itwasdecidedtodefer thecasefor24.07.2014forcommentsofDepartment of|<br>Pharmaceuticals.|
|---|
|i(Case Now12073782-“PartyName:INCHEM<br>(Meet No/Date:3/82-~~ IStatus:Case<br>Yo<br>JALC2014<br>LABORATORIESPRIVATE JALCS/2014<br>[Peterrea<br>4<br>1156<br>HQ File<br>—<br>(RLAFHe<br>~ [Lic.No/Date:0910058483 Defer<br>|<br>HO182/050/00124/AMIS/ _:09/24/040/00416/AM14/ (06.12.2013 ces ge ANE24 07.2014<br>|<br>[Decision :Itwasdecidedtodeferthecasefor24.07.2014forcommentsofDepartmentof/<br>Pharmaceuticals,|
||<br>KseNoctissven.<br>Puy NameNECTAR<br>estNofbaie3/3-Stams:Case<br>|<br>jALcano14<br>{LIFESCIENCES LIMITED, |ALC4/2014<br>‘Deferred<br>;|
|s7 HoFile<br>=<br>==———~<“<s~*‘<=é‘RARS “Lie.No/Date:2210014426Defer<br>|<br>fOL/R2/0S0/00119/AMI15/<br>|22rearoan/o006B/AMLay 06.12.2013 ecg EMO 4O7.2014<br>|<br>(Decision iitwasdecidedtodeferthe casefor24.07.2014forcommentsofDepartment of|<br>[PPharmacetie|
|(CaseNo.:96/a5/82-<br>|Party Name: MOREPEN<br>[Moet No/Date3182.SiatuarCase<br>+<br>1ALC42013<br>‘LABORATORIESLTD. —|ALC4/2014<br>(Deferred<br>||
|[158HO PileAREAFile(Lic.No/Date:0510372885 (Defer<br>|<br>|<br>-O1/82/0S0/01143/AMI4/—_|:05/24/040/00313/AMLA/<br>09.12.2013<br>__.{Date:24.07.2014)<br>|<br>‘Decision Itwasdecidedtodefer thecasefor24.07.2014forcommentsofDepartment of|<br>[Pharmaceuticals<br>—|
||<br>7abca/2013<br>(LABORATORIESLTD<br>JALC4/2014<br>[Approved |<br>i eeeeeLOBOS2014<br>he<br>|<br>| WHQFieREAFile ~—=SS*S*S*S:SLGep<br>Novato0310372882 (DeferDate: |<br>|<br>ROLS2/0SO/OII6S/AMI4’ —_:05/24/040/00312/AM4) (09522013<br>|<br>‘Decision 7 Inthe lightof **e**arlierdecisiontakenbyNCin its12/82 me**e**tingdated 19.09.2013, itwas<br>|<br>decided to ratify norms und r Para 4.7 ofHBP v1 asper detailsgiven b low or as applied bythe firm,<br>;<br>i<br>[whichever is less::|
||is9|Exportproduct<br>Exp.Oty.<br>Importites<br>Qty.allowed<br>|)|
|_<br>(| Sertraline<br>Lkg<br>Activated Carbon<br>0.029|
|,<br>| Pharmacopeal<br>/4.|CR) MandelieAcid<br>0,392<br>:<br>il Grade)<br>~~<br>:<br>i<br>4-(34-Dichloropheny!) 1-<br>3.27<br>|<br>:<br>Tetralone<br>4|

| A may take spmroeratenas, Pi |[Case No.VAS ALCARDS SPECIALITIESFoy Nene SCTEGH PYT. LTD, estjALC4/2014NtDui2- ~~ SatnaApproved | fo 4 308.05.2014 | | | Hho File 'RLA File ‘[Lic.No/Date:0310761103 Defer Date: | | POLR2ASO/OLOSB/AMI4) FO3/9S/040/00603/AM14/ ——09.12,2013. ee | ‘Decision :committee considered the case as per agenda and in consultation with ihe | technical authority present in the meeting and it was decided to ratify the norms under’ | [Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is) (160: 4 4 | ai | Export product Exp. SINo. | Import items Qty. allowed | - Qty. ke/ke | | | Mucifize Effervescent Tablets lke 1. N-Acetyi-L-Cysteine | 600 mg/tablets | 3 4 Each Tablet contains N-Acetyt-L, N-Acctyi-L-Cysteing i | (| Cystiene 600 mg : |... [RA concemed may take further necessary action as per above decisionofNC, ad [ [Case No.263/23782-"(Barty Name:AMi ORGANICS [Meet No/Datea/8i-"ietaceaae | JALC42013 IPVT LTD. 4ALC4/2014 ‘Deferred 1161HO File ° URLA File ~ Lic, No/Date:5210040485 [Defer ~ : +01/82/050/011 10/AM14/ on SUAZMOAOO00Z7/AMIAE = 110,12.2013 poste sen, EOAUE24.07.2014 | | [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of [Kise Novssana- ~~ Pag NanedAGSONFAL fe No/Date:3/82- (Status:Case | | JALC42013 /PHARMACEUTICALS LTD. |ALC4/2014 ‘Deferred | he HQFile IRLA File— [Lic.No/Date:0510373220 [Defer — | 01/82/050/01142/AM14/ 105/23/040/00368/AMI4/ 11.12.20) Bee cpa, ate:24.07.2014 | | Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | f ese Nesansis-ALCaANS Fay NaneiUAXO ~~ fe Naa. iii fo (CHEMICALS PVT LTD JALC4/2014 (Approved | : FQ Fite REA File Se Novae 107 aS (Defer Date: | | x0182/050/010SS/AMI4) 103/95/040/00725/AMI4; 11122013 a : (185 Decision * Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details giver} below or as applied by the firm, whichever is less:~ | |_ LExport product __[ Export [SiNo. [importitems | Quantity Allowed |)

==> picture [423 x 617] intentionally omitted <==

----- Start of picture text ----- 46 | i Povidone lodine 10% Solution | 1kg 1. Povidone $ |1.02 kgper kg ; | | (Available lodine NLT 1% w/v) lodine contained in the || | | export : 7 "IGaseNo.137/3/82-ee [Party Name-SUVEN LIFE Meet No/Date:3/82--~[Status:Case | laLea2o14 {SCIENCES LIMITED. jALC472014 “Deferred { (164| HQ File” URLAFie « [Lie.No/Date:0910058555 [Defer | 201/82/050/00141/AM15¢(Decision —__:09/24/040/00427/AM14/ 112.2013. Date:24.07.2014| | jPharmaceuticals,‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of . scutes og pees eett sete ge ccc [Case No.:141/3/82- ~~ Party Name:COVALENT [Meet Novbatei/&2-(StatussCase ~ | jALC4/2014 (LABORATORIES PRIVATE |ALC4/2014 ‘Deferred cease IMITED 08.05.2014 ee |4 (HQPie ERAFite Lie NofDate:0910058567 [Defer | | 1:0 1/82/080/00145/AM15/ :1:09/24/040/004 18/AM14/ 4 12.12.2013 ‘Date:24.07,2014 | | |Decision : In the light of easlier decision taken by NC in its 21/82 meeting dated 06.02.2014, it) | [was decided to ratify norms under para 4.7 ofHBP v I as per details given below or as applied by the firm, whichever is less: | ; if Export product Exp. | SI.Ne. | Import items - | Oty. fo 4 Qty. allowed | 6s keke | | | (CEFEXIME (CEFIXIME 4. Activated Carbon [ Carbon 0.100 | RIHYDRATE) Enoanticromos Zz [2._| Dimethyl Formamide (DMF) [1584 | i Methylene Chioride “faas3s Pd 5. 2-Mercaptobenzothiazoyl -(Z)- | 0.820 | to 2-(2-Aminothiazoy!-dyl)-2- ( | fofo |G. _| Triphenyi Phosphine 0.820 |i | eNostisayez Pay NanciALCHEM Sew Naat: StatwnCase | J ALC42013 ANTERNATIONAL LTD. —_ALC4/2014 (Deferred | ‘166| HQFileHO1/82/050/01162/AM14/~~ ~sIRLAFieSS [Lic No/Date:05 10373480 [Defer : | _05/23/040/00365/AML4/ J3322013 ‘Date24.07,2014 | | Decision It was decided to defer the case for 24.07.2014 for comments of Department of | |Pharmaceuticals. code ess ----- End of picture text -----

==> picture [424 x 638] intentionally omitted <==

----- Start of picture text ----- 41 || (Case No.:136/3/82-- ‘(Party Name:AUROBINDO-[Meet No/Date:3/82-(Status:Case | jALC42014 \PHARMA LIMITED jALC4/2014 ‘Deferred | | Horii RCA File [LieNofDate0910058582 Defer { -ROLIS2/050/00140/AMIS/ _:09/24/040/00438/AMI4/ 43.12.2013 [Date:24. 07-2014) | (Decision : The Committee considered the case as per agenda and in light of written comments) A received from Department of Pharmaceuticals and in consultation with technical authority? | |present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as | applied by firm whichever is lower:- 4 | i Export product Export Qty. import items Qty. 67 allowed 5 bo ke/kg | | || RAMIPRIL 1 Kg. {3,5,s)- 2-Azabicyclo(3,3,0)-Octane- 0.83 i si i Carboxylic Acid Bezylester Hel. | i ; : 1,3-Dieyelo Hexy! Carbodiimide 0.858 : | ' 3, Activated Carbon [ Carbon 0.054 | : Eneanticromos i i Triethylamine | 0.767 5}| 4| Di lsopropyt Ether( Iso Propyl Ether } 2.62 i | ‘ Metharel 3.32 : to 7 Methytene Chloride 165 | Lo |RAmay take Sppropriate action asper thedecision of Norms Committee, | PO" (Case No.147/3/82- [Party Name:AUROBINDO Meet No/Date-3/82.‘StatussCase | | lALCano14 ‘PHARMA LIMITED 1ALC4/2014 Deferred | ltegHQFile| ~———SSS—~*~SRA SS —TLic.No/Date:0910058609Defer | | ROVS2/0S0/001S1/AMIS/ _:09/24/040/00440/AMI4/ 13.12.2013 a ‘[Date:24.07.2014 | Decision It was decided to defer the case for 24.07.2014 for comments ofDepartment of | (Pharmaceuticals, a oo | | Case No1398/62- Paty Name:SMILAX "Meet NovDate/82°‘StatusiCuse i /ALC4/2014 ‘LABORATORIES LIMITED. JALC42014 Deferred | jegHQFile =~”: FiteSSS ~~ {Lie.No/Date:09 10058595 Defer “y : Loiaosomoiasamisr __hosrea/oaoyooas vamttay 13.12.2013 Date:24.07.2014| | _ Decision : It was decided to defer the case for 24.07.2014 for comments ofDepartment | | L Sri | ( f€ase Now:40/3/82-ALC4/2014 Party Name:VIVIMED LABS iMeet} fd No/Date:3/82-[Status:Case LIMITED |ALC4/2014 jApproved | [170( THQFileREAFile SO ~“{Lic. No/Date:0910058608 ‘Defer Date: | | ):01/82/050/00144/AM15/ ___:09/24/040/00446/AM14/ 8822018 | E -90r ar searnreapveneUrtnigarencumarTcaccmereen ae | {Decision : In the light of earlier decision taken by NC in its 17/82 meeting dated 05.12.2013, it was | ‘decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Ce a ----- End of picture text -----

==> picture [407 x 557] intentionally omitted <==

----- Start of picture text ----- | | Export product Exp. Si.No. | Import items Oty. allowed | 7 Qty. i | | |AVIS(AVOBENZONE) | 1 kg 1. PARA TERTIATORY BUTYL 1.148 kg i , BENZOIC ACID (PTBBA) i oo ACETYL ANISOLE 0.929kg | | | ACTIVATED CARBON 0.025 kg i | SODAMIDE 0.206 kg |, RA May take appropriateaction asperthe decision ofNormsCommittee, || (CaseNo.s83/23/82- “(PartyName:SHIVA(Meet NovDate:3/82-(StatustCase| JALC4/2013 {PHARMACHEM LTD, JALC4/2014 ‘Deferred | Ce 08204 117) HQ File , "RLAFile Lic. No/Date:3410038734 Defer | POUS2/050/0LI30/AMIA) —:34/24/040/00231/AMI4/ (16.12.2013 ‘[Date:24.07.2014) | [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | (APharmacenticals, to"CaseNo.:88/23/82-ALC4/2013Party Name:DHANUKA (Meet No/Date:3/82- IStatus:Case! \LABORATORIES LTD. JALC4/2014 [Approved | re: ee 2 | JHQFie ~IRLA File “[Lic-Novtbate:0510373696 ‘(Defer Date: | || HOVS2/050/011SS/AMI4/Decision : in the light of _:05/23/040/00375/AMI4/earlier decision taken by NC in its 15/8217.12.2018,meeting dated 31.10.2013, it was: | idecided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | prcever is lass: i | [Export Product Export | S.No | Import Product Quantity || fo Qty. Allowed |] (CEFPROZIL USP/BPIEPAP ikg 7-PACA og] | Powder HEXAMETHYL DISILAZANE _| 0.342 ; i N.N,DIMETHYL FORMAMIDE | 5.82 _| fo METHYLENE CHLORIDE 2.86 |i io dOP-Hydroxyphenyl glycine / fo ETHYL CHLORO FORMATE — | 0.383 ZZ 18.|ACTIVATED CARBON 0.0386 | TRIMETHYL CHLORO 0.230 i ; 4 N-METHYL MORPHOLINE 0.0043 | bo METHANE SULPHONIC ACID | 0.016 i ----- End of picture text -----

==> picture [425 x 583] intentionally omitted <==

----- Start of picture text ----- | {HQ File ~~ ~IRLA File ~~ [Lie.No/Date:0910058622 Defer | 501/82/050/00037/AMI5/ |:09/24/040/00466/AMI4/ 203 spss, Date:24.07,2014) Decision :It was decided to defer the case for 24.07.2014 for comments of Department of LpPRarmacetic s,s eseo ooooo |14[Case No:34/3/82-ALC4/2014 Party Name:HETERO LABS (Meet.No/Date:3/82- ‘|(Status:Case. LIMITED jALCa2014 [Approved | | THO File REA File ~~ Lie.No/Date:0910058619Defer Date: | i 1:01/82/056/00038/AM15/ 1:09/24/040/00473/AM14/ ly. 12.2013 | | 1174 (Decision : Committee considered case as per agenda and in consultation with technical i authority present in meeting decided to ratify norms under para 4.7 of HBP as per details given’ 3 below or as applied by the firm, whichever is fess: } | i a | || Export product Exp. Qty. {| SLNo. | import items Qty. allowed | PRRAVIRENZ ikg 1. EFAVIRENZ (PURITY949) 1.02 i L@uRITY 99.5%) | | Case No.:36/3/82-ALC4/2014 [Party Nama HETERO LABS [Meet No/Date:3/82- (Status:Case| ee| | LIMITED {ALC4/2014 Approved | || THQFile (RLAFile ee hte"[Lie.No/Date:0916058621 4:[Defer Date: / { 4:01/82/050/00039/AM15/ 09/24/040/00469/AM14/ R7A2.2013 Fi 4 | [Decision tin the tight of earlier decision taken by NC in its 33/82 meeting dated 21.03.2013, it was: | idecided to ratify norms under Para 4.7 of HBP vi. as per details given helow or as applied by the firm, | ‘whichever is less:- | + "a! Export product Exp. Import items Qty. fl 14 Qty. Allowed | | |) Capecitabine 1 kg j1. | D-Ribose 09 |4. | S-Fluorocytosine ——SCS~S~S™S OB | | ___ Development Commissioner may take further necessary action as per above decisionof NC. _ j | CaseNo119/3/82- Party Name:HETERO LABS (Meet No/Date:3/82-(StatussCase”“| i TALC4/2014 LIMITED JALC4/2014 : Deferred 4 1176 HQ File oo IRLA File oe " [Lic.No/Date:0910058620 Defer 1 | :01/82/050/00123/AMIS/ AO9/24/040/00470/AMI4/ 17.12.2013 Date:24.07.2014| i ‘Decision i It was decided to defer the case 24.07.2014 for comments ofDepartment of ©| a. Pharmaceutical, eer es ae ----- End of picture text -----

;

==> picture [483 x 633] intentionally omitted <==

----- Start of picture text ----- 4a , to| (CaseNo.:98/3/82-ALC4/2014[Party Name:VIVIMED LABS [Meet No/Date:3/82- (StatusiCase ‘LIMITED 1ALC42014 “Deferred j 177 HQ File ERLA File [LicNo/Date:0910058626 [Defer | EOH82/050/00102/AMIS/ _:09/24/040/00448/AM14/ 17.12.2013, “_Date:24.07.2014 | [Decision :It was decided to defer the case 24.07.2014 for comments ofDepartment of : [Chemicalsand Petrochemicals, ui sss cope Caset 2ALC4/2013Noz30n5/62- "Party{INDUSTRIESNeme:AART] LIMITED (Met4ALC4/2014NofDate-3/82-Status:Casei Deferred |4 1178,HQ File IRLAFie _ ~ Lie.No/Date:0310762301 [Defer ; =| | OI/82/050/01086/AM14/ _103/94/040/00760/AM14/ co P8N22013 __ (Date:24.07.2014 | | Decision :It was decided to defer the case 24.07.2014 for comments of Department of | { __Chemicals and Petrochemicals. eu eaee piping isungsiggessene 4 1ALC4/2013 :NNDUSTRIES LIMITED JALC42014 ‘Deferred | [179| LOL/B2/0SO/01097/AMI4/HQ File “REA —_203/94/040/0076/AM14/File [18.12.2013[Lic.No‘Date-0310762302 escent deenaDefer | | Decision :It was decided to defer the case 24.07.2014 for comments of Department of | . | 'Pharmaceuticals. | yo["\Case No.:68/3/82-ALC4/2014 PantyName:PORUS (Meet No/Date:3/82- ‘Status:Case | [LABORATORIES PYT LTD. (ALC42014 Deferred i i180HQ File TeIRLA File ie No/Date:09 10058633 [Defer | ROW/82/0S0/00072/AMIS/ :09/24/040/00463/AMI4/ 18.12.2013 Date:24.07.2014 | ‘Decision it was decided to send a copy of application to Department of Pharmaceuticals , ("TGaseaNo.:94/3/82-ALC4/2014Party]Name:SOMU ORGANO ‘Meet No/Date:3/82-—‘Status:Case Fcc (CHEM PVT.LTD., SALCA/2614 ‘Approved | cummins beens ce, O80520 JHQFie REA File—SSS*~~SS«wLie No ate=0710100652 [Defer Date: | , | $01/82/050/00098/AMI5/ —:07/24/040/00320/AM14/ 18.12.2013, a | (Decision : In the light of written comments received from Department of Chemicals and | Fi 181 dtunder|Petrochemicats Para 4.7 of vide HBP their v1 as U.O per No, details 14020/151/2011-Ch. given below or as{] applied dated 12.4.2013, by the firm,it whichever was decidedis toless: ratify norms || | | Export product Export Import items Quantity bo Quantity Allowed : | TP T3-CYCLOREXANEDIONE tke 1 RESORCINOL 1.24 kg |.) (C¥CLOHEXANE-1,3-DIONE) : || DIHYDRO RESORCINOL Z ----- End of picture text -----

==> picture [450 x 591] intentionally omitted <==

----- Start of picture text ----- _(Case No.:146/82-——S«PartyNName:LOUIS” [Meet No/Date:3/82- (StatusCase | | VALC4/2014 ‘PHARMACEUTICALS PVT /ALC4/2014 (Deferred / ETD 08.05.2014 A etppsecec| . | HQ File 'RLA File ~~ [Lic-No/Date:0910058653 [Defer “| | EOUS2/0S0/00150/AMIS! —__:09/24/040/00476/AMI4/ 19.12.2013. ssere | [Decision ‘In the light of written comments received from Department ofPharmaceuticals | {| vide their OM No. 35011/724/2013-Pl(Norms) dated 21 .04.2014, it was decided to call |182 from the firm following information:- | , | | (a) Complete technical details as per Appendix 33. | {(c)(vb) COA COA of of theimported export R.M,item. from the Foreign Supplier. | | © Past production vis-a-vis actual consumption of inputs duly certified by Central : | jExcise Authority. | _\Thecase was deferredfor24072014 cst tines | Case Nows9/25f82- Party Name:RENOWN "Meet No/Date:3/82-[StatusiCase | . | JALC42013 IPHARMACEUTICALS PVT JALC4/2014 iDeferred 3 ias[HQFile BLA File ——v—" (Lic.No/Date:34 10038760 [Defer| | ROMS2/0S0/0LIZ6/AMI4/ __:34/24/040/00225/AM14/ 19.12.2013. sacs gn AOMEDAOT 2014) | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of } _ {Pharmaceuticals, | Nitin hiatal at ecaitbatt ti cncttec age eatags tte tecate ote oa aneceaate ta aaih i:(Case No.:84/23/82-ALC4/2013 Party Name:TRANSPEK [Mest No/Date:3/82- (StatusyCase| fo4 HINDUSTRY LIMITED (ALC4/2014 (Approved | | THQFie IRLAFie Lic. No/Date:3410038767 (Defer Date: | | [OUB2/0S0/01I3/AMIA) ESARAOAO/N0236/AMI4/) (19.12.2013 ‘Decision > In the fight of written comments received from Department of Chemicals and [is][ fess:] | [18][4][ junder] [Petrochemicals vide [ Para][ 4.7][ of][ HBP] their [ v1][ as] U.O [ per] No. 14010/6/2011-Ch. [ details][ given][ below][ or][ as appiied] If dated 08.05.2014, [ by][ the][ firm,] it [ whichever] was decided to ratify norms! | | Export product - Export import items Quantity i 13 Quantity Allowed | | | NEO DECANOYE CHLORIDE TT kg 1 VERSATIC ACID (NEO 0.990 kg i 4 FE LIQUID DECANOIC ACID) ; 14 LIQUID L.RAmay take appropriateaction as per thedecisionof Norms Committee, setiunangunerennsesal mo(Case No.:91/23/82-ALC4/2013 (Party Name:INTAS [Meet No/Daie3/83- ‘Status: fog PHARMACEUTICALS LTD., JALC4?2014 Approved [185| HQ Fileoo IRLAF ileSSS Lic Nopate<0810137281 [Defer Date: } ROUB2/0SO/IIS8/AMI4/ _208/24/040/00408/AML4/ 20.12.2013 ee, eee : Decision * Committee considered case as per agenda and in fight of earlier decision taken in el ©. ss ----- End of picture text -----

==> picture [423 x 582] intentionally omitted <==

----- Start of picture text ----- i ‘decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm | : [richever is lower:~ 4 | Aspirin Enteric | 1 Kg. Acetyl Salicylic Acid EP/BP/USP | 4874.58 ka | | || Coated Microcrystalline Cellulose Phi02 [5956.00 ko i i| || Tablets 81 mg TrethylEudragitCitrate £-30 D Ph.Eur 55 4366.00118.00 kg kg ;| toa_ Relevant IGSILICA Gel Canister |packingAs per policy || fo3 . , Relevant50 mi HDPE white | As per packing policy || if Bottie :| L__IRA concerned may take further necessary action as per above decisionofNC. se eitptstageastses| (Case No88/23/82- Party Name:PARENTERAL [Meet NovDate.3/@2. ~~ [StatusiCane | | (ALC4/2013 (DRUGS (INDIA) LTD., JALC42014 ‘Deferred | 196| |HO File —REAFile (Lie. No/Date:5610003400 Defer ROW/B2/0SC/01132/AM14/ —/:56/24/040/00033/AM14/ oo PO0N22013 ,.Date:24.07.2014) ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of (Pharmaceuticals, | [Case Noci4siait” ~~ ary Name:AUROBINDO Meet No/Datei83- ”~ Btatus:Case’ | | JALC4/2014 (PHARMA LIMITED JALCA720 i4 ‘Deferred i lis7 HQ File IRLA File ~~ - “Lic No/Date:0910058692 Defer , | || :01/82/050/00149/AMI5/ _SOSAAMADO0GES/AMI4/= (23.12.2013 cn... #Pate:24,07.2014) | Decision :it was decided to defer the case for 24.07.2014 for comments of Department of | Pharmaceuticals. sects seg aan yeti gti sane| |(Case No.11/3/82-ALC42014 [Party Name:MICRO LABS (Meet No/Datea/a2.(StatustGace Poy ‘LTD “ALC42014 ‘Deferred | {1g| {HQ File | / “(REA Fie ~ ~ [LicNo/Date:0710100791 [Defer ~ | POL/82/0S0/0001S/AMIS/ —_[:07/24/040/00318/AM14/ 23.12.2013 ‘(Date:24.07.2014) | {Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | ../Pharmaceuticals —— | [Case No:90/25/82-ALCA/2013 Party Name:CADILA ~~ Meet No/Daiei82-‘StatasiCase ; | ‘PHARMACEUTICALS LTD. “ALC4/2014 Approved i i ee ee ce (805.2014 ss | [HQ Fite RLAF Ie «Lie NovDate:0810127360 Defer Date: |(189 ROMS2/0S0/011S7/AMI4/ _:08/24/040/00403/AM14/ (24.12.2013_a ce | | [Decision : In the light of earlier decision taken in meeting No.23/82 dated 06.03.2014, it was 1 | ‘decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | ----- End of picture text -----

==> picture [440 x 643] intentionally omitted <==

----- Start of picture text ----- 47 ~ | ' Qty. ~~ [allowed | J kglkg if | [CILOSTAZOL Tkg 1. 5-(4-CHLOROBUTYL)-1- 0.88 | i CYCLOHEXYL- tH-TETRAZOL i fo 2 6-HYDROXY-3, 4-DIHYDRO i 1H)-QUINOLINONE 2 | i __ pA may take appropriate action as per the decision of NormsCommittee. = ciecstasststssetopsnsct | [Case No41/23/82-- (Party Name:HEMMO [Meet No/Date:3/82- (Status:Case | i jALC4/2013 PHARMACEUTICALS JALC42014 (Deferred | ee PRIVATE LIMITED. 08-05.2014 [190HO File oO IRLAPile~~ [Lic No/Date:03 10763218 Defer| | -R01/82/050/01088/AM14/ — _ PO394/040/00749/AMI4) (24.12.2013 -een | [Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | | ICase No.:27/23/82- {Party Name:SANDOZ (Meet No/Date:3/82-——(Status:Case ) 1ALCs2013 JPRIVATE LIMITED JALC4/2014 ‘Deferred |‘191 HQ File IRLA File [Lie-No/Date:0310763292Defer | DecisionOV/824050/01074/AMI14/It was decided to03/95 /040/00738/AMI4/ defer the case for 24.07.2014ba.12.2013 for comments of DepartmentiDate:24.07.2014) of )[Case No.1142/3/82- (PartyNameSRIAMLABS ‘aect NovDaacbas~~ TStatus:Case | 1ALCA/2014 ‘PRIVATE LIMITED JALC4/2014 (Deferred i lyon| HQ File REA File —Lie.No/Date:0910058708 [Defer ~ | | x01/82/050/00146/AM15/ O9/24/040/00439/AM14) 4.122013. cases cane, (ate:24.07.2014) La Decision It was decided to deferthe case for 24.07.2014 for comments ofDepartment of APRarmaceuticals. ep — (Case No.:187/3/82. [Party Name:ATLAS FINE[Meet No/Date:3/82- (Status:Case | | jALC4/2014 °CHEMICALS PYTLTD = [ALC4/2014 Deferred | lo3(HQFile| ~—S—~—*~CS~SREANFide oo {Lic.No/Date:031 0763403 ‘Defer F | ROLS2/0S0/00161/AMIS/ —:03/94/040/00647/AM14/ 76.12.2013 [Date:24.07.2014) |. [ChemicalsDecision ‘Itand wasPetrochemicals. decided to defer the case 24.07.2014 for comments ofDepartment of | ( [Case No.:97/3/82-ALC42014 [Party Name:SATYA MeetNo/Date:3/82- [Status:Case| | | |DEEPTHA JALC4/2014 Deferred } a PHARMACEUTICALS LTD [08.08.2014 ee ee gqHQFile = ——~~~<CSRA Fide SSS " (Lie. No/Date:09 10058730 [Defer | :01/82/050/00101/AMI15/ £09/24/040/00482/AM14/ (26.12.2013 _ Dater24.07.2014 | | ‘(Decision iIt was decided to defer the case for 24.07.2014 for comments of Department of; | _ {Pharmaceuticals. conte meee” be oe ----- End of picture text -----

==> picture [418 x 583] intentionally omitted <==

----- Start of picture text ----- 1 (ALC4/2014 (PHARMACEUTICALS HALC4/20 l4 Deferred : | fo ‘LTD., 108.05.2014 | | i 195 HQ File IRLA File (LieNo/Date:09 10058728:(Defer 1 | POI/82/0S0/00148/AMIS/ :09/24/040/00471/AMI4/ 26.12.2013 __ {Date:24.07.2014; | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of LRtac ["«(Case No65/23/82- Party Name:RANBAXY (Meet No/Date:3/82- —‘Status:Case | | (ALC4/2013 {LABORATORIES LTD jaLca20 14 ‘Deferred t i eee, eeC2 1196| RO1/82/0S0/0LL12/AMI4/HO File ~RLAFe——-05/24/040/00258/AM14/Lie. 127.12.2013No/Date:0510374575 [Defer[Date:24,07.2014 | || Decision(Pharmaceuticals :It was decided to deter the case for 24.07.2014 for comments of Department of;| -_(Case No.:71/23/82- (Party Name:RANBAXY (MeetNo/Date:3/82-—-(Status:Case | (ALC4/2013 JLABORATORIES LTD jALC4/2014 (Deferred | [197HQ Fite —RLAFile Lic, NoDdate:0510374576 (Defer ~ | HOUS2/0S0/01LIBAMI4/ :0S/24/040/00317/AMI4/ 27.12.2013 fo Met 072014) | [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of } IE hh "(Case| No.:64/23/82-~~ (Party Name:S.M. HERBALS |MeetNo/Date:3/82.~~ (Status:Case \ALC4/2013 ‘PYT.LTD, 1ALC4/2014 (Deferred | [HQFile ~IRLA File ~~ [Lic.No/Date:03 10374573 (Defer [19gfO1/82/050/01 11 /AMIAS posraaioayrOOS2VAMIA4! (27.12.2013. Pate:24.07.2014) | Decision ‘It was decided to remind the firm to furnish the following technical details: + |  (COA from foreign supplier for relevant import consignment for the imported input. « } (COA from Independent and approved Testing Laboratory for export product. » Stepwise | -? 1ALC42014‘Case No.:143/3/82-————‘(Party“LIMITEDName: VIVIMED | [CABS] JALC4/2014[Meet No/Date:3/82- Status:CaseDeferred || cc a getup, 0805204 |ago/HQFile RA File —S*SCw Lic No/Date:0910058745(Defer | DecisionEOL/S2/0S0/00147/AMIS/ilt was decided— to:09/24/040/0046V/AMI4/ defer the case 24.07.201427.12.2013for comments of DepartmentDate:24.07.2014 of |__(Chemicals and Petrochemicals. [Case No.:43/29/62- Party Name:ANUH PHARMA Meet No/Date:i/82-Status:Case | jALcan013 iLTD. jaLca2014 ‘(Deferred | i (nQFile ————””~—~C~S~*sSRLA Fide ~~ Lic.No/Date:03 10763631 [Defer Lin LOLS2/050/01090/AMI4/ _:03/94/040/00770/AMI4/ 30.12.2013. Date:24,07.2014) ----- End of picture text -----

==> picture [464 x 645] intentionally omitted <==

----- Start of picture text ----- 45 “| Decision :It was decito de ef r thed case for24.07.2014for comments of LMP Department of | att ca a a a pntntgasencssneeciiiiceec..| | jALC4/2014 PHARMA LIMITED {ALC42014 : | ee ee 0 | THQ Fite ~RLA File ~Lic.No/Date:0910058765Defer SS i (Decision : The Committee considered the case as per agenda and in light of written comments | ireceived from Department of Pharmaceuticals and in consultation with technical authority / present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as! ‘| ‘applied by firm whichever is lower:- | ol! . , | ys) Export product Export | SLNo. | Import items Oty. allowed : | | GABAPENTIN 1 Kg. i, 1, L-CYCLO HEXANE DI ACETIC | 1.63 : 4 ACID MONO AMIDE ca ACETONE 1.54] i | CARBON ENOANTICROMOST (| 0.014 | 4 ACTIVATED CARBON | to 4. ISOPROPYL ALCOHOL 1,894 i to 5. AMBERLITE RESIN IRA-67 0.00125 litre/kg | 1ALC4/2013 INDUSTRIES LIMITED jALCA2014 Deferred | bogHQFile "REA File SSS ‘Lic.No/Date:03 10763628 (Defer | {o1/e21s00LOOMAMI4! | OS/94040Q0T1VAMI4/ 30.12.2013 Date:24,07.2014 | (Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | IEdna: [~[€ase No.:22/8/82-ALC4/2014 Party Name:GLAND [Mest No‘Date:3/82-‘Status:Case | fo /PHARMA LIMITED laLca2014 {Deferred : Fe lOOSIM | HQFile "SRE File oo Lic.No/Date:09 10058787 (Defer | (Decision ‘Reply received from the Firm and send to Department of Pharmaceuticals. It | : was decided to defer the case for 24.07.2014 for comments of Department of | tod"(ease No.:96/3/82-ALC42014PHARMA[Party Name:GLAN LIMITE D . ‘MeetJALC42014 No/Date:3/82. ‘DeferredBist Case ‘| THQFile ~~ Fite — ‘Lic. No/Date:09 10058788 (Defer | POFLOLS2I0SO/ODIOAMIS/ —_:09/24/040/00481/AMI4/ 31.12.2013, _,Dater24.07.2014 4 _Decision :Reply received from the Firm and send to Department of Pharmaceuticals. It | | was decided to defer the case for 24.07.2014 for comments ofDepartment of en fy PPlarmaceuticads ns spspuprssisnssssnsapussiestisseceseuttt|in ioe. ----- End of picture text -----

==> picture [442 x 660] intentionally omitted <==

----- Start of picture text ----- 50 i; | LABORATORIES PRIVATE 3ALC4/2014 ‘Deferred 205HQ File IRLA File [Lic.No/Date:0910058791 Defer ( ROES2/050/00027/AMI5/ :09/24/040/00486/AM14/ 81.12.2013 = Date:24.07.2014] | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of (Pharmaceuticals espe | | Po|(CaseNo.:88/3/82-ALC4/2014(Party Name:MYLAN ~~ [Meet No/Date:3/82- —(Status:Case | Dea \LABORATORIES LIMITED [ALC4/2014 Deferred | 1206 bee (080520 eset | HQ File IRLA File ~~ Lie. [No/Date:0910058792] Defer Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | ROUB2/0S0/00092/AMIS/ __ 09/24/040/004S/AMI4/ (31.12.2013 Date:24,07.2014] (Paracel | [Case No24araie2- [Party Name:SAFECON [Meet No/Date:3/82-~~ (Status:Case | | lALCano14 LIFESCIENCES jALcar2014 ‘Deferred |207,ROW/S2/050/00248/AMI5/HQ File __/:61/24/040/00023/AM14/“(RLAFie Lie. cn HN22013No/Date61...,,10001119 Pate:24.07.2014|[Defer | {Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | LpParmace tices a cs sa sss | ALC4n013 (CHEMICALS PVT.LTD., JALCan014 [Deferred Fee eeu ph eaee (BOS204 | ln08HO File RLAFile ~~ Lie. No/Date:03 10763764 [Defer | | -OL/82/0S0/01102/AM14/ —|:03/9S/040/00791/AMI4/ 31.12.2013, “Date:24,072014 ; [Decision ‘It was decided to defer the case for 24.07.2014 for comments of] ..... Petrochemicals Division of Department of Chemicals and Petrochemicals =| | [Case No181/3/82- [Party Name:AKZO NOBEL"Mest No/Date:3/82-(Status:Case | | jALcano14 HINDIA LIMITED ALC4/2014 (Deferred 4 jog (HQFile CS “IRLA Fite — ‘Lic No/Date:0210198392 [Defer 4 | HOWB2/0SO/00185/AMI5/ __(:02/24/040/00053/AMI4/ (02.01.2014 ———Date:07.08.2014| | (Decision : It was decided to defer the case for 07.08.2014 for comments of Department | it4 ofPharmaceuticals Wf| [Case No:53/23/82- Party Name:EXCEL —=(Meet No/Date:3/82-—‘(Status:Case | | (ALC4/2013 JINDUSTRIES LIMITED —/ALC4/2014 (Deferred eee See2 bioHQFie = = = ~——~—SRLAFile ag, (eiciNo/Date:0310764365 [Defer | | 01/82/050/01100/AM14/ ——(:03/94/040/00744/AMI4/ (02.01.2014 ‘Date:24.07.2014; | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | IIEhear aa - ----- End of picture text -----

St _

==> picture [412 x 592] intentionally omitted <==

----- Start of picture text ----- || (CasejALcs20t4 No.:114/3/82- LIMITEDPartyName:HETEROLABS1ALC4/2014Meet No/Date:3/82-‘(Status:Case‘Deferred Ft aap bcp tm see sswues, (08052014 | 1[211: HOPSs File tienen!IRLAgL etinainninnin Fileatid igcamtnn aah an anenhnnnecae[Lic No/Date:0910058802ginfoneDefer cman| -KOLB2/050/00118/AMIS/ f09/24/040/00497/AMI4/ jono12014. pay, E2888:24.07.2014 | | | [DecisionPharmaceuticals.‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of | Da| [Case No.:38/3/82-ALC4/2014 Party Name:PARENTERAL (MeetNo/Date:3/82-—‘(Status:Case| [eee (DRUGS (INDIA) LTD., — ALC4/2014 [Deferred | 212 segue tps, O805201 [ HQ File (RLAFile Lic No/Date:5610003472 [Defer | HOLS2/0S0/00042/AMIS/Decision :it was decided:56/24/040/00036/AMI4/ to defer the case for 24.07.0 2 014.01.2014 for comments| of DepartmentDate:24.07.2014 of | (Pharmaceuticals. |1"(Case No.118/3/682-— Bary Name:PARENTERAL Moet No‘Date:3482-"~ StatussCase | JALC4/2014 IDRUGS (INDIA) LTD., jaucuno 14 ‘Deferred | 213| HQ File RLFile SSCS «Lie.NoDate:$610003471Defer | | RONS2/050/00122/AMIS/Decision sit was decided _:S6/24/040/00035/AMI4/ to defer the case for 24.07.2014(02.01.2014for comments —__—Date:24.07.2014) of Department of | (Pharmaceuticals. "(CaseH No.:24/3/82-ALC4/2014 Party Name: VIVIMED LABS (Meet No/Date:3/82- (Status: | :i ‘LIMITED£ Hi}jALC4/2014 JApproved. j? / ‘HQ File” —SRLA File , [Lic No/Date:09 10038808 [Defer ; “4 | POLS2/050/00028/AMIS/ —:09/24/040/00492/AMI4/ (02.01.2014 a Pae2A 072014 ; Decision i {In the light of earlier decision taken by NC in its 17/82 meeting dated 05.12.2013, it was) | decidedjwhichever to isratify less: norms under Para 4.7 of HBP vi as per details given below or as applied by the firm,}| a 4) Export product Exp. SLNe. | Import items Oty. allowed | i: Oty. | | [AVIS(AVOBENZONB) | 1 kg PARA TERTIATORY BUTYL 1.148 kg | A BENZOIC ACID (PTBBA | = ACETYL ANISOLE 0.929 kg | | ACTIVATED CARBON 0.025kg || |4.| SODAMIDE 0.206 kg || : |6.|5. | METHANOLTOLUENE 4.001.00 kg kg : 1S) . INDIA LIMITED 1ALC4/2014 ‘(Deferred i” ----- End of picture text -----

==> picture [2 x 29] intentionally omitted <==

----- Start of picture text ----- : ----- End of picture text -----

==> picture [447 x 631] intentionally omitted <==

----- Start of picture text ----- 52 [ p0U82/0S0/00049/AM15/ __(:02/24/040/00168/AM13/ 03.01.2014 Date24.07 2014 | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | J PPharmace tics. ct ee | [Case No.:89/3/82-ALC4/2014 [Party Name:ASTRIX (Meet No/Date:3/82-‘(Status:Case “| | |LABORATORIES LTD, ALC4/2014 ‘Deferred | | re oe eninge, C805206 |[216HQ File ~~ IRLA File Lic. No/Date:09 10058826 [Defer oars | -#01/82/050/00093/AMIS/_:09/24/040/00496/AML4/ 6012014 ___ Date24.07.2014 Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | (Pharmaceuticals, | {CaseNo186/9/8-~~ Party Name:MVLAN ~~ {MeeiNo/Datesa/ai-(GtatusiGase| | \ALC4R2014 {LABORATORIES LIMITED [ALC4/2014 Deferred | 217 HQ File =—<“<i«~=‘S RACPit [Lic No/Date:0910058825 [Defer a : +-01/82/050/001 DO/AMIS/ __09/24/040/00484/AMI4/ 06.01.2014 __Date:24.07.2014 | | [Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | J pPRarmace thas. | JALC4/2014 “PHARMA LIMITED JALC4/2014 [Deferred : is| /HQ File REA File ~~ “ILie.No/Date:0910058829 (Defer | | -pOL/B2/0S0/00197/AMIS/ _|:09/24/040/00494/AMI4/ 06012014 [Date:24,07.2014| LAP (Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | harmaceuticads, ap ps soo (easefo4 No.:91/3/82-ALC4/2014 [Party NameS1 GROUPINDIA“(Meet No/Date:3/82-—-‘(Status:Case {LIMITED jALC4/2014 /Approved | || [HQ Pie REA BileSeNovate 0310764670 ‘(Defer Date: | j POU/B2/0S0/00095/AMIS/ [03/95/040/007S4/AMi4/ (06.01.2014 sin beasts : ‘(Decision : fm the light of written comments received from Department of Chemicals ond PP (Petrochemicals vide their U.O No. 14010/2/2012-Ch. Hl dated 21.05.2014, it was decided to ratify norms: lndes Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | | _| Export product Expert | S.No. | impart items Quantity | | Quantity Allowed i |) 3.3.35 PRIMETHYL 1kg 1 ACETONE 1.536 kg i | | CYCLOHEXNONL i i(Case No.:37/3/82-ALC4/2014 [Party Name:NECTAR [Meet No/Date3/83-‘StatusiCase ape 1220, LIFESCIENCES LIMITED, ALC4/2014 (Deferred ctSeer ° ----- End of picture text -----

==> picture [408 x 551] intentionally omitted <==

----- Start of picture text ----- | -HOM82/050/00041/AMIS/ _1:22/24/040/00077/AM14/ 07.01.2014 ‘[Date:24.07.2014 Decision ‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of | (Parmacet a apts sie. | | (Case No.1213/82- SS PartyName:NECTAR (Meet No/Date3/82-. -‘(Status:Case | | jaLcs2e14 (LIFESCIENCES LIMITED, ALC4/2014 [Deferred 01 HO File “IRLAFile ———SSsLie. No/Date:2210014501[Defer 4 [o1/e2/050100 I25/AM15/ |22/24/040/00078/AM i4/ (7.01 2014 | Date:24.07.2014; | _ [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | 1. [Pharmaceutics esp st inepecece epee ("Case No:116/3/82- ~~ Party Name: VUAYASRI© (Meet No/Date:3782-[Status:Case | t JALC4/2014 JORGANICS LTD HALCA2014 ‘Deferred 4 ee pices loxos204 ce higegseseesce| [229| (HQ File RTA File | — [Lie No/Daseso9 10058840 [Defer ' | HO1/82/050/00120/AM15/ :09/24/040/00402/AM)4/ OTOL 2014... Date:24.07.2014 (Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | (| [ease Nos180/3/83- ‘(Party Name: VISION DRUGS [MeetNo/Date'3/82-(StatusiCase| lauca2o14 PVTLTD laLcarzo14 (Deferred Ce ee OROS20M ba3/HQFile| RLAFile SSCS Lig.NovDDate:0910088839(Defer | [DecisionO1/82/0S0/00184/AMIS/:It was decidedcane OWZAMAOAOAZE/AMIS!to defer the case for 24.07.2014(07.01.2014 for comments of Date:24.07.2014) J Department of | [Phanmmace tices. apn pees |4 |Case No.:178/9/82-ALC4/2014 ;POLY[Party AMIDESName:HINDUSTAN & FIBRES 3ALC4/2014Nest NofDate:32-Status:Case[Approved | | THQFile REA ite iLic. No/Date:03 10765125 (Defer Date: | q 1:0 1/82/0S0/00182/AM15/ |:03/94/040/00835/AM 44/ (08.01.2014 : i } Decision * In the light of written comments received from Department of Chemicals and! | ‘Petrochemicals vide their U.O No. 14010/90/2011-Ch. il dated 05.06.2014, it was decided to ratify norms: | lunder Para 4.7 of HBP vi as per details given below or as applied by the firm, whichever is fess: : | | Export product Export | S.No. | Import items Quantity | | Quantity Allowed | | || CYCLOHEXYLSUPER ACETATE- PHENOL Hl | 2 CATALYST5%RHODIUM ON ALUMINA 0.00012 ke ‘| | | [3| ACETIC ANHYDRIDE 0.300 kg | ----- End of picture text -----

==> picture [436 x 559] intentionally omitted <==

----- Start of picture text ----- | JHQ File ~RLA File [Lic.No/Date:09 10058858 Defer 1 BOV/82/050/00094/AMIS/ :09/24/040/00468/AMI4/ (08.01.2014 = Date:24.07.2014/ | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | L.JPharmace tics. ssp ts ee , ALC42014 'BIOPRODUCTS LTD., jALC4/2014 {Deferred | HQFie ERE File — "Lic.No/Date:09 | 10058863 Defer | £:01/82/080/00207/AMI5/ — ‘}:09/24/040/00362/AM14/ (8012014. [Date:24.07.2014 | | (Decision :Department ofBiotechnology vide their letter No. BT/IL/05/382/2013-PID j (226 {dated 29.08.2013 has mentioned that the norms for the export item called DTP-HEPB | |(Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does | | (Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type in the | | ‘application. You are requested to furnish the following information: (Drug Manufacturing Licensing ofthe export product (DML enclosed with the application idoes not mention the export product. | | [To submit QA approved Batch Manufacturing Record. | | {Complete technical details as per Appendix 33. ‘ (CaseNo.:200/3/82- (Party Name: WEXFORD [Meet No/Date:3/82-Status:Case| 3 JALC4/2614 LABORATORIES PLTD IALC4?20 l4 Deferred ; te be (80520 {207| HOIS2/050/00204/AMI5/HO File IRA_:07/24/040/00337AMI4/File (08.01.2014“Lic. No/Date:0710101sg 186 [DeterDANE24.07.2014:— | ‘Decision It was decided to defer the case for 24.07.2014 for comments of Department of sr | JALC4/2013 jName:ARIHANTANAM 4ALC4/2014 [Approved | Fc HPECAREPVT.LTD. (08.05.2016 | “HQ File” —RLAFile Lic. NoviDate:031076533 Defer Date: | 4 01/82/050/01089/AM 14/ 1503/94/040/0088 1/AM 1 4/ 49 | 4 | Decision : Decision : In the light of eartier decision taken in meeting no. 10/82 dated 22.08.2013, | | “was decided ta ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the| r ‘firm, whichever [is] [less:] | 4 | Export product Exp. | SLNe. import items Qty. allowed {kg) | | || Lumefantrine ike [2 (Dibutylamine Methyl}-2,7- | 0.8693 kg } bog Dichloro-4-fluoren | . Methanol (DBA) oe ----- End of picture text -----

==> picture [422 x 606] intentionally omitted <==

----- Start of picture text ----- ~ | [Case No.:95/3/82-ALC4/2014 [Party Name:CHIRAG (Meet No/Date:3/82-.—~—(Status:Case | “ENTERPRISE (ALC4/2014 {Approved — | HQ File RLA File Pie No/Date:2410040582 (Defer Date: | HOW/82/050/00099/AMI5/ __:24/24/040/00024/AMI4/ 09.01.2014 | [Decision > fn the fight of written comments received from Petrochemical Division of Department of, | iChemicais and Petrochemicals vide their U.O No. 46011/1/2007-PC- II dated 29.05.2014, it was decided to! : ratify norms under Para 4.7 of H&P vi as per details given below or as applied by the firm, whichever is! ; less: ‘ | | Export product | Exp. S1.No. | Import items Qty. allowed |) | [REGENERATED I ke 1. ACRYLIC PLASTIC 1.63 kg : | METHYL STRIPS/OPPOUTS/MEX LOT OF a| 4 METHACRYLATE ACRYLIC SHEETS & CUT THEREOF/ i | ;E> MONOMER9996) [PURITY. ACRYLICCODE 39208119) PLASTIC SCRAP (ITC HS |f |____|RA may take appropriate actionas per the decision ofNormsCommittee. == a[Cass New36r3A2-ALCALZONS |‘PartyName:GLOBAL (Meet No/Date:3/82- ——StatuszCase | to (CALCIUM PRIVATE jALcar2oi4 ‘Approved : ee EMITED, 805.2018 5 HQFile ~IRLAPile ——SS”S”~™”«SLe Nov/DDate-0710101210 [Defer Date: | 4 401/82/050/00040/AMI5/ 4:07/24/04(/00337/AM i4/ (09.01.2014 | . | Decision ? In the light of written comments received fram Department of Chemicals and) | ‘Petrochemicals vide their U.O No. 14010/56/2011-Ch, i] dated 23.05.2012, it was decided to ratify norms | | junder Para 4.7 of HBP vi as per details given below ar as applied by the firm, whichever is less: | i | Export product Export Import items Quantity | | Quantity Allowed | 930) GLUCONATE Grade a oo 3 0.560 kg | ; LACTIC ACD | | | -) MAGNESTOMLACTATE 1 kg i 0.390 kg i | B GLUCONATE LACTIC ACID ' | __/RA may take appropriate action as per the decision ofNormsCommittee, nase [Tease No.:229/3/82-ALC4/2014 Party Name:PARAGON"Meet No/Bate:3/82- ‘Status:Case 123 1] INDUSTRIES 3ALC4/2614 (Approved 4 i | 08.05.2014 i | ----- End of picture text -----

==> picture [426 x 605] intentionally omitted <==

----- Start of picture text ----- | 901/82/050/00233/AM15/ __(:0824/040/00448/AM14/ (09.01.2014 : | | |Decision > In the light of written comments received from Department of Chemicals and : /Petrochemicals vide their U.O No, 14010/124/2011-Ch. {I dated 02.04.2014, it was decided to) | ‘ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, | ) whichever js less: | | | Export product Export Import items Quantity | Fo | Quantity Allowed | | 12,3 Dichloro 1:4 i ; - 1.00 kg | | || Naphthaguinone Lkg Sodium Naphthionate [Icase No.:2i/23/82- Party Name:UNITED (Meet No/Tvate:3/82-a[SiatesiCase | | JALC42013 |PHOSPHORUS LTD. |ALC4/2014 ‘Deferred | 232| HQ File IRLA File _ ‘Lic. No/Pate:03 10765258 (Defer 4 | 301/82/050/01068/AMi4/ _503/95/040/00590/AMI4/ 09.01.2018 _[Date:24.072018| ‘(Decision :It was decided to defer the case for 24.07.2014 for comments of | |___Pettochemicals Division of Department ofChemicalsand Petrochemicals tessa [Case Nosi94/3i62- Panty Name:LOUIS ~~ [Meet Nofiate:382-[StatussCase | 1 JALC4/2014 PHARMACEUTICALS PYT jALC4/2014 {Deferred : | HQFie REA File Lic. No/Date:0910058903 (Defersonora | ROVS2/0SO/00198/AM1S/ _:09/24/040/00520/AMI4/ {10.01.2014 Date:24.07,2014/ | [Decision : It was decided remind the firm to furnish the following information:- 233 (a) Complete technical details as per Appendix 33. | | (b) COA of imported R.M. from the Foreign Supplier, | (c) COA of the export item. | | @) Past production vis-a-vis actual consumption of inputs duly certified by Central | | Excise Authority. | ALC#2014 “LIMITED \ALC4/2014 (Deferred | pe te heteett O8OS20 / b3g[HOFile ~————”—~CS~SR Fide ~— ILic.No/Date:0910058896 [Defer | Decision :It was decided to defer the case for 24.07.2014 for comments of Petrochemicals Division of DepartmentofChemicalsand Petrochemicals lee[GeALCA2014 Nagano Pay“LIMITEDName VIVIMED LABS /ALC4/2014(Mee Naat (DeferredBatwa ob| a| (JRO File Rha Fite ie Nomate:0910058898 Defer ----- End of picture text -----

| Decision :It was decided to defer the case for 24.07.2014 for comments of Department of Pharmaceuticals _ |[easeNos19/23/82-— Party)Name:DANOPHARM (Meet No/Date:3/82-(StatustCase | JALC4/2013 ;CHEMICALS PRIVATE —/[ALC4/2014 “Deferred | |1236HQ File “REAFile LicNo/Date:03 10766076 [Defer | -ROI/B2/050/01066/AM14/ §:03/94/040/00772/AMLa/ c e (OL2014 _Date:24.07.2014) | ‘Decision It was decided to defer the case for 24.07,2014 for comments ofDepartment of| Pharmaceuticals 4 | (Case No2197/%82. ~~ Party Name:MALLADI ~~ [Mest NorDates/83(StatussCase “| | lALCaota JDRUGS & JALC4/2014 ‘Deferred i [PHARMACEUTICALS (08.05.2014 : | P70 Fite IRA File Lie: No/Date:04 10154188. Defer | ROM82/050/00201/AMI15/ :04/24/040/00218/AMI4/ (13.01.2014 Date:24.07.2014. | [Decision rit was decided to defer the case for 24.07.2014 for comments of Department of | (Case Nos134/3/82Party NameSHASUN ~~ [Meet Noviate 382°~Status:Case| 4 (ALC4/2014 {PHARMACEUTICALS (ALCA/20 14 {Deferred / | THQFile [RLA File— ~~ [Lic-No/Date:0410154220 Defer | POW82/050/00138/AMIS/ POF2A40/00Z26/AMI4) (13.01.2018 = Date:24.07,2014] (238 Decision : In the light of written comments received from Department of i ‘Pharmaceuticals vide their OM No. 35011/715/201 3-PI(Norms) dated 21.04.2014, it was | 4 Control‘decided Incharge. to call from the firm a copy of Master Batch Formula duly certified by Quality| cr‘Case No.1188/3/82-ALC4/2014 [Party Name:SHIVAM OILS & (Meet No/Date:3/82-~~ "Status:Case | to “PROTEINS INDUSTRY, —|ALC4/2014 “Approved Te 08052018 re || (HQFile ="—”—”—CSERLAFile SSCS [Lic. No/Date:56 10003558 _ ‘Defer Date: | | #O1/82/050/00192/AMI15/ __56/24/040/00040/AMI4/ (13.01.2014 oe en i | [Decision : In the light of written comments received from Department of Chemicals and! (239 Petrochemicals vide their U.O No. 14010/17/2014-Ch. II dated 27.05.2014, it was decided to | ratty forms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: | | | Export product Export import items Quantity | | ; Quantity Allowed | : || SOYA LECITHIN 1k 1 LIQUID LECITHIN 1.01 kg ae | | Feed Grade § Non Edible grade eared | aes

==> picture [425 x 585] intentionally omitted <==

----- Start of picture text ----- [ (Case No.:189/3/82-ALC4/2014 (Party NameSTERLING Meet No/Date'3/83. ~~ StatustCase| ae (AUXILIARIESPVTLTD =—ALC4/2014 \Approved | | ee 18.05.2014 | JHO File , “IRLA File — Lic. No/Date:03 10766062. (Defer Dates | | (:01/82/050/00193/AMI5/ ROSIOSMAOMOSIGIAMI4! 13.01.2014 sscssag al | (Decision : In the light of written comments received from Department of Chemicals and} | Petrochemicals vide their U.O No. 14010/64/2013-Ch. Il dated 24.06.2014, it was) | decided to ratify norms under Para 4.7 of HBP v I as per details given below or as! : ‘applied by the firm, whichever is less: | Export Product Quantity [SiN [import Product [Guanity |‘240| STERO DEIPA85 (2- ikg 1 me | 0-362 keg i 4)| Hydroxyethyi)-2-propainolaine} PROPYLENE OXIDE |F || | sterocaretN60 (Sorbitan | 1 kg STEARIC ACID 0.227 kg : | Mono Stearate Ethoxytate) 2 SORBITOL 70% 0.208 ke | | ColyerIN stan ikg 1 LAURIC ACID 0.150 kg i | | Moto Lange 2 (0.196 1 | Moro Laurate} 2 SORBITOL 70% G.196 kgkg i | '| STERO 2-EHA 2570 (2-Ethyt | 1 kg 1 2-ETHYLHEXANOL = | 0.111 kg | 4 ‘| Hexanol Poly Glycol Ether) : |_ RA may take appropriate actionas per the decision of Norms Committe. : | (Case No.:190//82-ALC42014 [Party Name:STERLING [Meet No/Date:3/83-‘StatusrCase| fog \AUXILIARIES PVTLTD —[AL.C4/2014 Approved : [HQ File oS IRLAFile [Lic NovDate:0310765989 [Defer Date: | | PONB2/ASO/001D4/AMIS/ ‘103/95/040/00605/AM14/ cen (AOL204 | Decision : In the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/64/2013-Ch. I] dated 24.06.2014, it was ‘241 decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as, | applied by the firm, whichever is less: | | |_Export Product import Product sani — (1 STEROMDEA( METHYL — | 1 kg 1 MONO METHYL 0.274 kg i +: DIETHANOL AMINE) AMINE i |__RA may take appropriate actionas per thedecision ofNorms Committee. == J | JALcane14 REMEDIES LTD., JALC4/2014 [Deferred / | HQFie UREAFile ~~ {Lie.No/Date:2210014517 Defer ee ae 1. -01/82/050/00183/AM15/ son SPRPMOAQIOODTIAMIA/ = 13.01.2014 Date:24,07.2014) ----- End of picture text -----

“a

J. [Decision :It[was][decided][to][ defer][the][case][for][24.07.2014] for comments of Department of| Pharmaceuticals: sss tsetse sooo ooo A [ [Case No.:196/3/82Party Name:ARUDAA VIS “Meet No/Date:3/82-(Status:Case | | jALC4/2014 LABS PRIVATE LIMITED JALC4/20 14 (Deferred Doe eens hes 808204 acd 1243 1H File ~ _ IRLAFie Lic. No/ate:0410154292‘Defer ~~ | POLS2/0S0/00200/AMIS/—:04724/040/00219/AMI4/ 15.01.2018 eiuaiocao Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | |..(Pharmaceuticals, 7 iCase No.:182/3/82- © TParty Name:AUROBINDO [Meet No/Date:3/82-(Status:Case | | (ALC#/2014 |PHARMA LIMITED ‘aLca2o.4 Deferred lan BOR foaa HQ File ~IRLA File {Lic No/Date:0910058925 [Defer ~ | BOVB2/0S0M0186/AMI15/ 09/24/040/005 16/AMI4/ 15.01 2014 a, (Date:24.07.2014 | | Qo Decision ‘It was decided to defer the case for 24.07.2014 for comments of Department of| Parma tia ea pnts ee.| | (Case Nos25/25/82Party Name-GLENMARK [Meet NoVDate:3/82-[Status:Approved| | TALC4/2013 iGENERICS LIMITED TALCAA2014 : 4 | THQFile ~ (RLAFie [Lie No/Date:0310766291 [Defer Date | | s01/82/050/01072/AM14/ —(:03/94/040/0088S/AMI4/ 15.01.2014 | i [Decision tin the light of earlier decision taken by NC 35/82 meeting dated 25.11.2008 and ey | iconsultationjper details below with or technical as applied authority by firm present whichever in meetingis lower:- decided to ratify norms under para 4.7 of HBP as}j as. Export product | Export . | Si.No. | import items Qty. po aty. allowed | || Atovaquone ike. on 4-4(Chiorophenyl} Cyclohexane Carboxylic | 2.00 kg | boa 2, 2-Chioro 1,4 Napthoquinone L2.62kg | 14 3. Methylene Chioride [6.25kg toh 4. Acetonitrile 6.50 ke | yo H [ (Case No.:22/23/82-ALC4/2013 [Party Name:NEW ALLIANCE (Meet No/Date:3/83-StatussCase| tod IDYE-CHEM PVT. LTD,, jALC4/2014 , ‘Approved - | THQFile Ra Fite Vie. No/Date:03 10766188 [Defer Date: | | p01/82/0S0/01067/AMI4/ HO3/9SM040/00802/AMIA/ 15.01.2014 td (246 Decision : In the light of written comments received from Department of Chemicals and) i [Petrochemicals vide their U.O No. 14010/13/2012-Ch. Il dated 27.03.2014, it was decided to} | ‘ratifywhichever normsis less:under Para 4.7 of HBP v1 as per details given below or as applied. by theen fr,ce eee caret edaeemeeeeieeeeeeeeecemmeiee eee i a a

==> picture [427 x 641] intentionally omitted <==

----- Start of picture text ----- 66 | [exportproduct——SSSC*SP Export’ | S.No, | Import items"| Quantity) bo Quantity Allowed |, || MAGNESIUM DISODIUM EDTA (MG 1 bianiiee reTra | C8228 | 4 | CONTENT 6% +/-0.5%) [EDTA MAGNESIUM | 1kg CETIC i lea A ACID | | | EDTA ACID) | (7"IGaseNo.:33/23/82-ALC4/2013(Party Name:NEW ALLIANCE (Meet) [No/Date:3/82-] —‘(Status:Case’ on (DYE-CHEM PVT. LTD, JALC4/2014 [Approved | || (HQFie ~~ TRLA Fille OO ‘Lic No/Date:0310766192 ‘Defer Date: ; i| . [ecenenencarrincapO1/82/0so/o1080/AMI4)cant 203/95/040/00804/AMI4/A NI15.01.2014AAIANAND Nodetaii | | [Decision : In the fight of written comments received from Department of Chemicals and | ita ifyPe t rochemicalsnorms undervide Paratheir4.7 U.OofNo. HBP14010/13/2012-Ch.v1 as per details gl i vendatedbelow27.03.2014, or as appliedit wasby decidedthe firm,to: | 247 |whichever is less: | ; | Export product Export $.Na. | Import items Quantity | Quantity Allowed | i” q | ETHYLENE 6.791 kg / | || CALCIUM DISODIUM EDTA (CA CONTENT| 5 DIAMINE TETRA | | {) 10% +/-0.5%) [EDTA CALCIUM 10%} kg ACETIC ACID | 3 | eteeeeete (EDTA ACID | | ; _[RAmay take appropriate action as per the decision of NormsCommittee, = [Case No126/23/82- [Panty Name:RIOCARE (Meet No/Tate:3/82- Status:Case | jALC42013 INDIA PRIVATE LIMITED. jALC4/2014 Deferred : nee: SE kc 32 || ROLR2/0S0/OL073/AMI4/[HQFileRA—:03/9S/040/00822/AMI4/File— hic.15.01.2014 No/Date:0310766258Dat[D e fer:24.07.2014)| | [Decision In the light of written comments received from Department ofPharmaceuticals | | ivide their OM No. 35011/635/2013-Pl(Norms) dated 04.03.2014, it was decided to call | - ‘from the firm the following technical details: | "i Export Items | and 3 are API's (100%) and should not fall under chapter 30. The firm | | (should be advised to give correct and relevant HS code . ; | tii) whether any chemical reaction is involved in the manufacture of Dimethicone. Ifso, | / ‘complete details ofreaction, Mol. weight and % yield on molar basis may be furnished. | Ai) Past production vis-a-vis actual consumption of inputs duly certified by Central | (Excise Authorities be furnished for last 3 years. ____ [The case was deferred for 08.05.2084 grits ("lease_ [No.71/3/82-ALC4/2014] : “HEALTHCAREParty Name:STERLING LIMITED Meet= ALC4/2014No/Date:3/82-—Status:Case;‘Approved | 1| ROV/82/0S0/00075/AMI5/THOFile sooorsiamis) 3Cuneo1/83/040/00184/AMI4/Lie—ESON2014No/Date:3 ny110062132 [Defer Date: ----- End of picture text -----

==> picture [406 x 633] intentionally omitted <==

----- Start of picture text ----- 61 | Decision :Committee considered case as per agenda and in consultation with technical authorty| ; ipresent in meeting decided to ratify norms under para 4.7 of HBP as per SION A-442 with 2% | | wastage. yo |__| RA may take appropriate: action: as per the decisionvs of Norms Committee,. ; ["ICase No.:16/23/82-—=—~=~=SParty Name:NEW ~~ MeetNo/Date:3/82-'Status:Case J 2ALC4/2013 (ALLIANCE DYE-CHEM jALC4/2014 Approved j De PVELTB, 0 0805.2014 wl | HO Fiie “RLA File je NofDater0310766418 | DeferDate. ROL/B2/050/01063/AMI4/ ——03/95/040/00801/AMI4/ (16.01.2018 | | “Decision ; In the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/13/2012-Ch, Il dated 27.03.2014, it was decided to! (250 ‘yatify [whichever] norms [is] [less:] under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | —_ Export product QuantityExpert S.No. | import items AllowedQuantity - |[i || TETRASODIUM EDTA TETRARYDRATE | 5 kg Tea ee Ne 0.717 kg : | | 99% +/- 0.5% (EDTA TETRASODIUM 99%} EDTA ACID) ( [Case No31/23/82-— Party Name:NEW ‘(Meet No/Date:3/82-Status:Case | | [ALC472013 IALLIANCE DYE-CHEM jALC42014 “Approved j Lt ee VT ETD 805.204 | THO File —ARLA File {Lie No/Date:03 10766423 ‘Defer Date: i :01/82/050/01078/AMI4/ $:03/95/040/00803/4M 14/ 16.01 2014 4 | | Decision t In the light of written comments received from Department of Chemicals and| | “Petrochemicals vide their U.O No. 14010/13/2012-Ch. fl dated 27.03.2014, it was decided to| 23)whicheveratify no r msis less:under Para 4.7 of HBP vl as per details given below or as applied by the fm,: | q Export product Export | S.No. | import items Quantity | ; Quantity Allowed | | | MANGANESE DISODIUM EDTA (MN i ETHYLENE DIAMINE O.763kg 4 il| MANGANESECONTENT 13%13% +/- 0.5%) [EDTA 1 kg TETRAEDTA ACID ACETIC ACID Ht| "Tease No.:202/3/82-—=—~—~—~S*«SParty Name-PARENTERAL“ [Meet No/Date:3/82--[Status:Case | JALCa2014 (DRUGS (INDIA)LTD., —_ALC4/2014 [Deferred |losQ[HQFile ~~ IRLA File | Lie, No/Date:5610003580‘Defer | | :01/82/050/00206/AM15/ __|:56/24/040/00041/AM14/ (16.01.2014 = _Date:24.07.2014. Decision sit was decided to defer the case for 24.07.2014 for comments of Department of | ----- End of picture text -----

==> picture [404 x 566] intentionally omitted <==

----- Start of picture text ----- oe Nontogiaen pany ene:SEV ea Nee Statusose ’ - -ALCH#2014 ‘DEEPTHA ALCH2014 ‘Deferred : : (PHARMACEUTICALS LTD (08.03.2014 i : D3 uOKie SSt*~~~SRRLA ‘le omen ic.No/Date:0910058953 Defer - 3301/82/050/00202/AM LS! :09/24/040/00523/AM 14! 16012014 = = — Date:24.07.2014. : ‘Decisioniit was decided to deferthe case for 24.07.2014 for comments of Department of Pharmaceuticals. | Oc NpSTBALCAAOLE ary NemeDii ipa StaGee : St PHARMACEUTICALS ‘ALCA2014 Deferred i : “PRIVATE LIMITED 08.05.2014 : : as4 HHO File RLA File ‘Lic.No/Date:0910058977 ‘Defer . 103 /82050/00036/AM LS! 709/24/060/005 19/4M L4f 17,01,2014 Date:24.07.2014) - “Deeision sit was decidedto defer the case for 24.07.2014 for comments af Department of Pharmaceuticals. “Case No.:82/3/82-ALC4/2014 Party Name-ENVEE DRUGS “Meet No/Date:3/82-Status:Case co PVT LTD ALCA2014 ‘Approved | . HQ File OO RLA File Ce “ Lic.No/Date:34 10039039 “Defer Date: | 5G L/82/05000086/AM1 5/ S424 /40MO2SUAM LAS A7OL2014 a : : ‘Decision ; In the light of earlier decision taken in meeting no. 4/82 dated 04,04,2023, it was decided te i : ‘ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is : "233 ‘less: : : Export product Export 5.No Import items Quantity Allowed ; Quantity keke i | 1 Clabetasole Lkg 1 Betamethasone BP/USP/IP 1.04 + | Propionate : : ‘RA may take appropriate action as per the decision of Norms Cormmittec. i Case Nos 174/3/82-ALC4#2014PartyName:GLENMARK = Meet No/Date:3/82- “Status: : ‘GENERICS LIMITED ALC42014 Approved | HO Fite coco sane sn RLmig mee Lie No/t003 10766603 eles Sate: | > 01/82/050400175/AM 1 5/ 03/94/040/007 B9/A M 14? 47.01.2014 : : - Deeision :in the light of earlier decision taken in meeting no. 19/82 dated 02.01.2014, it was decided to : ‘ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, whicheveris : fess: ‘256 | Export Product ' Pravastatin Sodium Tab 10 MG 20 MG, 40 MG and 80 MG TAB "| S.NO. | import items For export of 1 No. Pravastatin Sodium Tablets oo (Quantity in mg} _ 4 10 mgTablets 20 mgTablets | 40 80 . 4 mgTablets | meTablets |. , Mannitol 25 (Pearlitol 25 C) | 104.005 “204.005 416.02 | :RA may take appropriate action as per the decision of Norms Committee. ; y : ----- End of picture text -----

==> picture [408 x 543] intentionally omitted <==

----- Start of picture text ----- ("Case No.:183/3/82-ALCS/2014 [PartyName:GRANULES [Meet No/Date:3/82-_[Status:Case | fy INDIA LIMITED JALC4/2014 iApproved | | THQFile RLA File = ‘|Lic.No/Date:0910058955 (Defer Date: | POL/82/050/00187/AMIS/ -09/24/040/00498/AMI4/ 17.01.2018 / i (Decision : Committee considered case as per agenda and in light of earlier decision taken in’ 4 sez meeting held on 29.11.2011 and in consultation with technical authority present in meeting, | } ‘decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm; whichever is lower:- 1 as7 | Exped product "Ep: Gy. | SIN. | Irnpor fiems iy slowed) | ‘| ibuprofen Granules DC | 1 kg. 1. Ibuprofen 0.66 kg | | | Grade bx 2. | Mee Starch | ; 3. 0220Micro Crystalline Celiulase 0.100kg || i Powder fo 4. Starch Pregelatinised O.080kg {| ; | 5. Colloidal Silicone Dioxide O010kg | to |6 | Stearic Acid O01Skg || fo Cross Carmellose Sodium 0.020kg | 1 | 8. | Polyvinyl Pyrollidine 0.016 kg |) [ oe [RA concerned may take further necessary actionas per above decisionof NC. us - (7 €ase No.:43/3/82-ALC4/2014 Party Name:INDO PHYTO.“(Meet No/Date:3/82-” (Status:Case | fo (CHEMICALS PYTLTD = ALC4/2014 ‘Deferred bsg (HOFile ~ IRLA File ©” [Lic.No/Date:05 10376464 (Defer | | FOL82/0S0/00047/AMIS/ —:08/23/040/00420/AMI4/ 17.01.2014 Date:07.08.2014 |Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of | jCase No.:195/3/82-ALC4/2014 Party Name:JAINEX Meet No/Date:3/82- {Status:Case:, fo ISPECIALITY CHEMICAL — {ALC4/2014. [Approved | | TRQFileRUA File ~ (Lic.No/Date:3410039038 Defer Date: | | (DecisionROUS2/0S0/00199/AMISY: In the light—of 34/24(040/00249/AMI4)written comments received from17.01.2014Department of Chemicals and aso Petrochemicals vide their U.O No. 14010/16/2014-Ch. I] dated 13.06.2014, it was decided to! | ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, jwhichever is less: | ||| Export product Export Import items Quantity || : Quantity Allowed = [ ----- End of picture text -----

==> picture [429 x 586] intentionally omitted <==

----- Start of picture text ----- to IPETROCHEM PRIVATE JALC4/2014 ‘Approved Fc mena, DIMITED 0805-2014 se | HQ Fite “IRLA File Lic. No/Date:05 10376326 (Defer Date: | 4 1101/82/050/00045/AM15/ 1:05/24/040/00205/AMI4/ 17.01.2014 : } ; | (Decision : In the light of written comments received from Department of Chemicals and) | Petrochemicals vide their U.O No, 14010/18/2014-Ch. 11 dated 28.05.2024, it was decided to. | ‘ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, pao onenever is less: | Export product Export | S.No. | Import items Quantity | 4 Quantity Allowed |, oyco_ a Iso Nonanol 0.754kg |u | Dilso Nonyl Adapate (DINA) 1 kg Py on | fo Adapic Acid 0.385kg |. ( [Case Nowa4/3/82-ALCA2014 Party Name:PAYAL [Meet No/Date:3/82-"[StatussCase| D4 /PETROCHEM PRIVATE 1ALC4/2014 [Approved | | 7HQ File = s—~<CSsé‘“‘z RARd ~~ (Lic, No/Date:0530376368 Defer Date: | | COUS2/0S0/00048/AMIS/ —(:05/24/040/00300/AM14) 17.01.2014 | Decision : in the light of written comments received from Department of Chemicals and (Petrochemicals vide their U.O No. 14010/18/2014-Ch. |i dated 28.05.2014, it was decided to 261 [tity norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, | | inal is less: | : Export product Export | 8.No. | Import items Quantity i yo4 Quantity Allowed | 4 a toe 0.754 kg | | iso Nonanol 4 ] Adapic Acid 0.385ke |. | "| Di Iso Nonyl Adapate (DINA) ike | | iu . ‘Ra may take appropriate action as perthe decision ofNormsCommittee.= "(Case; No.:42/3/82-ALC4/2014[Party Name:PAYAL [Meet No/Date:3/82-(StalusrCase| -POLYPLASTPVT.LTD., |ALC4/2014 Deferred | ee tt 808204 pez lHQFile RL File SSCL ie No /Dates0510376324 (Defer ° | | ROUS2/0S0/00046/AMIS/ <05/24/040/00204/AMI4/ (17.01.2014 sess DBUE24.07.2014 | |—{Decision :It was decided to defer the case for 24.07.2014 for commentsofDepartment of | | o63 (Case No.72/3/82- ‘Party Name:ADCOCK “Meet No/Date:3/82-... (Status:Case..|... .. 5 JALC4/2014 JINGRAM LTD, JALC4/2014 Approved. 20 ----- End of picture text -----

==> picture [407 x 258] intentionally omitted <==

----- Start of picture text ----- | THQ File 'RLA File ~ [Lic.No/Date:07 10101398 ‘Defer Date: | | :01/82/050/00076/AM15/___:07/24/040/00363/AMI4/ 20.01.2014 : | -—cneee in ann REIN I" ERE "RRR een cane Lem Oar enammainanns seaimamna aienea*saer man Yaa IPar e-em ERNE EERRRAAERRSE | ‘Decision : In the light of earlier decision taken by NC in its 31/82 meeting dated | (21.02.2013 , it was decided to ratify norms under Para 4.7 of HBP v1 as per details. | given below or as applied by the firm, whichever is less: | fo 3 | _| Export product Exp. SLNo. | Import items Qty. allowec! || Acurate Tabs-Paracetamol 450 | 1 no. of Doxylamine Succinate USP/Ph. | 5.10 mg | 1 mg+Doxylamine Succinate 5 | tablet Eur Grade i | [| mg+Caffeine 30 mg+Codeine : : Phosphate 10 mg+Colour 2 CaffeineAntydrous BP | 30.6 mg | | quinofone Yellow 2 mg Tablets 201 0/USP/EP/PH, EUR/BP yd 3. Codiene Phsophate | 10.2 mg | io BP/USP/EP/PH. BUR 4 fo5 4. Color Quinoline Yellow Cl/20mg : RA may take appropriate may take appropriate take appropriate action as per the decision ofNorms Committee. as per the decision ofNorms Committee. per the decision ofNorms Committee. the decision ofNorms Committee. decision ofNorms Committee. ofNorms Committee.Norms Committee. Committee. ' ----- End of picture text -----

==> picture [407 x 333] intentionally omitted <==

----- Start of picture text ----- : RA may take appropriate may take appropriate take appropriate action as per the decision ofNorms Committee. as per the decision ofNorms Committee. per the decision ofNorms Committee. the decision ofNorms Committee. decision ofNorms Committee. ofNorms Committee.Norms Committee. Committee. ' | 'CaseNos8i/3/82- [Panty Name:ADCOCK [Meet No/Date:3/82-“Status:Case | HALca204i4 HINGRAM LTD, 1ALC42014 iApproved : | (HO File ) (RLAFiIe [Lic.No/Date:07101 01399 (Defer Date: | | OI/S2/050/00085/AMIS/ —(:07/24/040/00362/AMI4/ 20012014 | ‘Decision : In the light of earlier decision taken by NC in its 31/82 meeting dated| | 121.02.2013 , it was decided to ratify norms under Para 4.7 of HBP vi as per details | given below or as applied by the firm, whichever is less: | 4 : Export product Exp. | SLNo. | Inport items Oty. allowed | | 1 Acurate Tabs-Paracetamol | 1 ne. Doxylamine Succinate USP/Ph. | 5.10 mg 4 | 450 megt+Doxylamine | of Eur Grade | { || Succinate $ mg+Caffeine | tablet | F “| 30 mg+Codeine Phosphate 2. CaffeineAnhydrous BP j 30.6 mg | 4 4 Yellow : 3. Codiene Phsophate | 10.2 mg i | 2 mg Tablets | | 4 BP/USP/EP/PH. EUR q Color Quinoline Yellow C1 47005 | 2.0 mg | |___RAmay take appropriate action as per the decision ofNorms Committee, i ----- End of picture text -----

==> picture [453 x 589] intentionally omitted <==

----- Start of picture text ----- ~ po [CHEMICALS PVT.LTD, ALC42014 ———S*«S Approved | THQFie (RLAFile = —S~S«~«CL'c N/Doate0310766925 [Defer Date: | | pO1/S2/050/0010S/AMIS/ _:03/94/040/00889/AMId/ = 20.01.2014 | Decision : in the light of earlier decision taken by NC in its 25/82 meeting dated 29.11.2012, it was | |decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,, | “whichever is less: : / | Export product Exp. Si.No. | import items Qty. 1 4 Qty. allowed 1 | Piperonal Min. Purity 1kg Catechol (Min. Purity 99% 0.862 kg | | | 98% 2. Dichioramethane (Min. Purity O703kg | , 3 99% | fo Dimethylsulfoxide (Min. Purity OTE kKg || to 99% | | Hexamine (Min. Purity 96% 1.000 kg | |fo , Toluene (Min. Purity 97%! 10.430kgfi : 4 isopropyl Alcohol (Min. Purity 0.220kg I | 99% RA may take appropriate action asper the decision of Norms Committee. | ("CaseiNo.:102/3/82-ALC4/2014 (Party Name:CROWN iMectNo/Date:3/82- Status:Case) {CHEMICALS PYT.LTD,, jALC4/2014 ‘Approved Dene 805.201 ad || JHQFile ———~—<“C—s~—~—“‘“‘s«s—C—~SR PeSS~~C~S*~=S«wL ReNeate-03 10766921 “DeferDate: | | ROLS2/0S0/00106/AMIS/ _ SO3/94/040/00890/AMI4/ 20.01.2018 4. || ‘|Decisiondecidedjwhichevertoisratify? less:in thenormslight ofunder earliePa r adecision4.7 of HBPtakenvi byas NCper indetailsits 25/82givenmeb e tinglow or datedas applied29.11.2022,by theitfirm, was||: 1..| Export product Exp. SI.No. | Import items Qty. (266; Qty. allowed | | | ||| 98%Piperonal Min. Purity 1 kg 2. CatecholDichloromethane(Min. Purity(Min.99%Purity O.703kg0.862 kg || | | 99% | /1 | Dimethylsulfoxide99%! (Min. Purity O875kg i , ae Hexamine (Min. Purity 96% 1.000kg | i [5 __| Toluene (Min. Purity 97%) _ 0.430 kg | yo isopropyt Alcohol (Min. Purity 0.220kg | | 99% i fd “VET PVT. LTD “ALC4/2014 ‘Rejected | bop HQFile ———<“<—~é“‘«‘~wRLA‘@Rde:=C:titi‘(‘i‘SCS~*™S ‘Lic.No/Date:0810128144 [Defer Date: | | GO182/050/01032/AM14/ _:08/24/040/00456/AMI4/ 20.01.2014 | ‘Decision ; It was noticed from the online agenda that RA has issued license under Para | 4:71 ofHBP v1. Hence it was decided to withdraw the case, ----- End of picture text -----

==> picture [432 x 636] intentionally omitted <==

----- Start of picture text ----- 67 : | (Case No.:673/82-ALC42014 Party Name:ADCOCK Meet No/Date:3/82~ | ~— [Status:Case. |INGRAM LTD, HALC4/2014 Approved | | (HQ Fite - ~~ REAFie ~—— Bie: No/Date:0710101431 [Defer Date: | GOU82/0S0/00071/AMIS/ |:07/24/040/00379/AMI4/ 201204 | ‘Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.05.2013, i | (was decided to ratify norms under Para 4.7 of HBP vi as per details given below or as; | applied by the firm, whichever is less: | : Export product Exp. SLNo, | Import items Qty, i | Paracetamol 450mg + 1 1. Doxylamine Succinate USP/Ph. | 5.10 kg i | | 5mg +Doxylamine Codeine Succinate | tablets BP/EP/USP/PH.EURCodiene Phsophate analf | Phosphate 10mg Tablets Colour Yellow 14037 1H ae |ing.||CodeineParacetamol Phosphate 450mg + million1 BurDoxylamineGrade Succinate USP/Ph. |pes5.10 kg |i || | Doxylamine10mg+ Caffeine Succinate 45mg+ | tablets Po12. BP/EP/USP/PH.EURCodiene Phosphate 10.2 kg | Smg Tablets 3._| Colour Yellow 14037 TH [243 kg | toafo (spectColou r acol)Quinoline Yellow WS aaai | | Paracetamol 450mg + i L. Doxylamine Succinate USP/Ph. | 5.10 kg | i | Caffeine SOmg + milion EUr Grade Pte | : ‘| Doxylamine Succinate | tablets [3 Codiene Phosphate 10.2 kg | | 5mg | + Codeine P| BP/EP/USP/PH.EUR eke | | Phosphate 10mg Tablets 3. Colour Yellow 14037 IH Donot | i : match with |) | 4 MBF | Paracetamol 450mg + i Doxylamine Succinate USP/Ph. [5.10 kg | | |) Doxylamine Succinate | tablets i | | Smg + Codeine 2. Codiene Phosphate 02kg | | [ease No:88/S/82-ALC42014 [Party Name:ADCOCK Meet No/Date:3/82-[StatusiCase| yo ‘INGRAM LTD, 2ALC4/2014 sApproved | 269HQ| File aang (Realei. eet Licce (@808-2018NovDate:0710101433 [Deter Date: | p01/82/0S0/00089/AM15/ __:07/24/040/00373/AM14/ 21.01.2014 ees Se |. ‘(Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.05.2013, it iWas decided to ratify norms under Para 4.7 ofHBP v1 as per details given belowor as, ----- End of picture text -----

==> picture [412 x 578] intentionally omitted <==

----- Start of picture text ----- | ‘applied by the firm, whichever is less: | fa Oty. allowed | | | Caffeine 30mg + million EUr Grade | || || DoxylamineSmg+Codeine Succinate | tablets mRBP/EP/USP/PH.EUR _ fe |i if 7 : || Phosphate 10mg Tablets i alia +| >|| ParacetamolCodeine Phosphate 450mg + million1 a DoxylamineeeSuccinate USP/Ph. | 5.10 kg | || Doxylamine1Omg+ Caffeine Succinate 45mg+ | tablets [2 CodieneBP/BP/USP/PH.EUR Phosphate esW2kg |)| | | Sg Tablets 3. Colour Vellow 14037 14 2aske | i 4. Colour Quinoline Yellow WS fee | , | (spectracol) | || ||4 ParacetamolCaffeine 50mg + 450mg + million1 DoxylamineBUr Grade Succinate USP/Ph. Prk || 4 4 Doxylamine Succinate tablets | 2, Codiene Phosphate 10.2 kg : ||| Smg+ Codeine BP/EP/USP/PH.EUR | | | Phosphate 10mg Tablets | = 3. |Colour Yellow 14037 IH Donotmatch with || 14 MBF | | Paracetamol 450mg + } 1. Doxylamine Succinate USP/Ph. | 5.10 ke | | | Caffeine 45mg + million EUr Grade | | Doxylamine Succinate —_| tablets , || ||| PhosphateSmg + Codeine 10mg Tablets P|2. BP/EP/USP/PH.EURCodiene Phosphate lO2ke | LL. [Ramay ake appropriate action as per the decision of Norms Committee, [[Case Nostesraz- "(Party Name-BENZO CHEM MeeNo/Date:3/82-—“StatussCase | 4 |ALC4/2014 JUNDUSTRIES PRIVATE :ALCAI20 14 (Approved IME ce PROS | lnoRie——~—~”~”SRLAFle,=——S~S~*~S~CSCSCS Lie NeDiates03ON 1076711 (Defer|Dae: | :01782/050/00173/AMIS/ ——:03/94/040/00868/AM14/ 8 | | Se ee nn (20. 27 (Decision ‘Committee considered case as per agenda and in light of written comments, 0 forwarded by Deptt of C&PC vide their U.O.No. 14010/29/2011-Ch.ll dated 29.05.2014 and in: | “consultation with the technical authorities present in the meeting decided to ratify norms under’ | ‘para 4.7 of HBP as per details below or as applied by firm whichever is lower:- | | ; Export product Exp. SLNo. | Import items Qty. allowed | ----- End of picture text -----

==> picture [446 x 591] intentionally omitted <==

----- Start of picture text ----- nS aeon 1g Paraformaldehyde 1.032kg | | i Sodium Cyanide O570kg | | | 1 Caustic Soda Flakes O.500kg i 5. | Thionyl Chioride O.880kg | 4 | RA concemed may take further necessary action as per above decision ofNC i [: [easeIALCARO14 No.:103/3/82- —=~S«PartyName:BLISSGVS[PHARMA LTD. “MeetTALCA/2014 No/Date:3/82-(Status:Case‘Deferred j (27) [HO File ) “{RLA File ~[Lic-No/Date:03107671 19 Defer | : | GOL/B2MS0/00107/AMIS/ ——-cO3/94/040/00942/AMI4/ 21.01.2014 Date:24.07.2014) | [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of 4 Cc [Case No.19VA0R2-ALCA2016,Party Name:ENVEE DRUGS Meet No/Date:3/82-‘Status:Case | t ‘PVT LTD JALC4/2014 ‘Approved | | (HQFIe =——<“<t~‘“‘~RWLA Pde: S~CSCSCL | POLVB2/0SO/O19S/AMIS/ :34/24/040/00254/AMIA 21.01.2084ie, NoDate: 3410039064 (Defer Date: | | (Decision : In the light of earlier decision taken in meeting no. 17/82 dated 10.04.2014, it was! : decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the | 272 firm, whichever is less: | | Export product | Export S.No | Import items Quantity | i Quantity Allowed kg/kg | | 4 Clobetasole 1 ke 1 Betamethasone BP/USP/IP 1.04 ‘ 4 | Propionate i i | BP/USP L __/RA may take appropriate action as per the decisionof Norms Committee, [iCase No.:i72/3/82-—=~=S~S PartyName:HINDUSTAN [Meet No/Date:3/82- (Status:Case | ALCA2014 “POLYAMIDES & FIBRES ALC4/2014 jApproved | cee HAMEED OROS RON ee : 1:01/82/050/00176/AM15/ /:03/94/040/00896/AM14/ 3 ; ; 3 Decision :Committee considered case as per agenda and in light of written comments forwarded t by Deptt. of C&PC vide their U.O.No. 14010/90/2011-Ch.H dated 05.06.2014 and in: | ‘consultation with the technical authorities present in the meeting decided to ratify norms under | ‘para 4.7 ofHBP as per details below or as applied by firm whichever is lower:- | ----- End of picture text -----

==> picture [406 x 576] intentionally omitted <==

----- Start of picture text ----- | | ORTHOTERTIARY BUTYL [1k ORTHO TERTIARY 0.990 kg | | | CYCLOHEXANOL BUTYL PHENOL | ae ‘|; 2. 5% RUTHENIUM ON 0.000015 kg | i CARBON CATALYST : fo 3, _ 0330kg | 1. i RA concerned may take further necessaryaction as per above decision of NC i | (Case No.:186/3/82- PartyName:PUNIAB [Meet No/Date:3/82-—Status:Case “| + IALC4/2014 (CHEMICALS AND CROP /ALC4/2014 ‘Deferred | 274 |HQ File (RLA File ~~ Lic.No/Date:0310767043 Defer SS | RON/B2/0S0/00160/AMIS/ SO3/95/040/00796/AM14/ (21.03.2014 ‘Date:24.07.2014) | (Decision It was decided to defer the case for 24.07.2014 for comments of | ___Petrochemicals Divisionof Department ofChemicals and Petrochemicals | [CaseNo.:83/3/82-ALC4/2014 ‘Party Name:KARNATAKA Meet No/Date:3/82-—[StatusiCase | 4 JANTIBIOTICS & HALC4/2014 jApproved 1 to | ‘PHARMACEUTICALS ——08,05.2014 | | 2.) rr | 4HO File ~IRLA File - ° ~ [Lic No‘Date:0710101505 [Defer Date: | | 01/82/050/00087/AM15/ ——:07/24/040/0038V/AMI4/ 22.01.2014 a : [Decision : In the light of earlier decision taken in meeting no. 16/82 dated 16.08.2012, it) : [was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as a7s [applied by the firm, whichever is less: | i | Export product Exp. StNo. | Import iterns Qty. allowed | | | Kanamycin Acid Sulphate | 1 Vial 1. Kanamycin Acid | 4.39 gm i | | for Injectin BP 1 gm, Vial Sulphate Sterile BP : || Size 10 mi : i _RA may take appropriate action asper the decisionof Norms Committee. | [Case No.:208/3/82- |Party Name;OGENE ‘(Meet No/Date:3/82- Status:Case {J ALC4/2014 [SYSTEMS INDIAPVT. [ALC 4/2014 . (Deferred | | HOFile ceeere, REAP Ie Lie. NoDate:091005901 ‘(Defer | 276 |:01/82/050/00212/AM15/ —|:09/24/040/00S1S/AMI4/ 7 ‘Date:07,08.2014 3 fo | (22.01.2014 | | | {Decision:It was decided to defer the case for 24.07.2014 for comments of Department of) Chemicals and Petrochemicals . | Gp (Case Nost70/82- SS PartyNName:ALKYL ‘(Meet No/Date:3/82- Status:Case > ALC#2014 AMINES CHEMICALS LTD |ALC4/2014 Approved : ----- End of picture text -----

==> picture [426 x 574] intentionally omitted <==

----- Start of picture text ----- 1 |:0.1/82/050/00174/AM15/ :03/94/040/00867/AM14/ a Fi | | ‘Decision : Committee considered case as per agenda and in light of written comments; | forwarded by Deptt. of C&PC vide their U.O.No. 14010/85/2012-Ch.H dated 12.11.2013 and in} [consultation with the technical authorities present in the meeting decided to ratify norms under: ipara 4.7 ofHBP as per details below or as applied by firm whichever is lower:- | 4 Export product Exp. SLNo. | Import items Qty. allowed | | | Acetonitrile rs Acetic Acid 1146 ke |iCaseNo.:55/3/82-ALC42014 ‘Party Name:AUROBINDO Meet No/baie-a/82--~ [Status:Case | | PHARMA LIMITED jALC42014 (Deferred | 27g HQFile REA Bile ~~ {Lic.No/Date:0910059035 [Defer | | 201/82/050/00059/AM15/ }:09/24/040/00529/AM14/ (23.01.2014 ‘Date:24.07.2014 | || PharmaceuticalsDecision ‘It was decided to defer the case for 24.07.2014 for comments of Department of| ewe a 7"toTCaseNo.:60/3/82-ALCa2014 Party Name:AUROBINDO [Mooi No/Datesi/82-~ (StatasiCase | 279 [PHARMA LIMITED /ALC4/2014 IDeterred | | HQ File REAFileOO (Lic. No/Date:0910050028. [Defer ~ | | :01/82/050/00064/AMI5/ nn, SO92AOAOIONSEVAMI4/ 123.01ORF en... (Date24.07.2014) | (DecisionPharmaceutics:It was decided to defer the case for 24.07.2014 for comments ofDepartment of tts ie | [~Iease No.:21/3/82-ALC4014 Party Name:KUDOS (Meet A No/Datei3/8-~ [StatuscCase | iggo |CHEMIE LTD., |ALC4/2014 |Peferrea : | HQ File (RLAFile OSLic No/Date:2210014543 [Defer | | p01/82/050/00025/AMIS/ EA2P4/04Q0007S/AMI4/ (23.01.2014 {Date:24.07.2014) \WPharmaceuticdls‘Decision ‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of| ee sss eases| i([CaseNo.:12/21/82- PartyName:KUDOS [MeetNo/Date:3/82- ‘StatusiCase | eeejALC4#/2013 J CHEMIE LTB., 7ALC4/2014 (Deferred 4 2g)'HQFile REAFeee rsnpaiaacn ‘Lic.OOS No/Date:2210014544 LON seed[Defer cece |F | ‘(Decision ‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of| Ii suse ----- End of picture text -----

| THQ Fie Ra File “Lic No/Date:0510376990 (Defer F | fO1/82/0S0/00191/AMI5/ :05/23/040/00413/AM14/ 4012014 ‘[Date:24.07.2014) || jPharmacenticals,‘|Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | sees ussacsnse| [Case No.:109/3/82-AL C4014‘(Party Name:ANUH PHARMA Meet No/Dates/82.~™Status:Case | esfo 4LTD. epapaesees,, (08.08.2014IALC4/2014 ‘Approved | | a re THOFile ~— [BLA Fil ig: No/Bate:0310767734 [Defer Date: | | (Decision >; Committee considered case as per agenda and in light of earlier decision taken in| | (19/82 meeting held on 09.08.2011 and in consultation with technical authority present in meeting, 283 decided to ratify norms under para 4.7 of HBP as per details below or as applied by fin: | iwhichever is lower:~ | | [Export product Exp. Gly. | SINo, | Import items Oty. | | allowed |! Erythromycin Propionate |4K. 7. Erythromycin Thiocyanate 0.900 KGA i 1. IRA concerned may fake further necessary action as per above decision ofNC. be usgintins ptssteesse Z| | GaseRociiaaisa. Pay Nane:CROPNOSYS et Neale: Siaai€ase | SALC42014 JUNDIA) PRIVATE LIMITED JALCA/2014 Deferred | sa (HQFile ~~ IRLA File | ic No/Date:0310767733 [Defer ‘| | ROL/S2/050/00112/AMI15S/ :03/94/040/00908/AM]4/ 24012014... Pate:24.07.2014; | Decision It was decided to defer the ease for 24.07.2014 for comments of| lL. [Petrochemicals Division ofDepartment ofChemicals and Petrochemicals. = wl fd |PETROCHEM PRIVATE |ALC#2014 jApproved | fo /LIMITED 08.05.2014 | | { HQ File URLA File Lic. No/Date:0510376976 [Defer Date: | [| 01/82/0S0/00024/AMI5/ HOS/24/040/00386/AMI4) 24.01.2014 a | (Decision + In the light of written comments received fram Department of Chemicals and; | "Petrochemicals vide their U.O No. 14010/18/2014-Ch. Il dated 28.05.2014, it was decided to; i ‘ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,’ pesyeheneve is less: | | | Export product Export | S.No. | Import items Quantity | | i Quantity Allowed E _ oe _— PURE TERE PHTHALIC | 0.447kg | | | DLOCTYL TERAPHTHATATE (DOTP) ike ft ACID iq . _RAmay take appropriate action as per the decision of Norms Committee, eel

==> picture [424 x 607] intentionally omitted <==

----- Start of picture text ----- | [CaseNo.:1103/82-ALCa?014(Paryy to NameiPAYAL ~~ Meet No/Datei/82. ~~ ‘SiatusiCace| | ;PETROCHEM PRIVATE —|ALC4/2014 [Approved | j HO Pie (RLA Fie say tea O51O57075 Beier Dae | 01/82/050/00114/AM15/ _ aug $05/241040/00357AM14/ see AOL2018 ee 4 ‘Decision > In the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.O No, 14010/18/2014-Ch. It dated 28.05.2014, it-was decided to; (286 atifyWhicheve no r msis less: under Para 4.7 of HBP v1 as per details given, below or as applied by the firm, : q Export product Export | $.No, | Import items Quantity i | 4 Quantity Allowed || fod oe Apres 1 PURE TERE PHTHALIC | 0.447kg | i Di OCTYL TERAPHTHALATE (DOTP) 1 ke ACID L _[RA may take appropriate action as per the decision of Norms Committee, _ stants eee | JALCaR2014 _GENERICS LIMITED jALCA2014 (approved (RQ Fe ie © |Lie.No/Date:0310767985 101/82/0S0/00177/AMI5) [Defer | 7 1:03/94/040/ OOS9S/AMI4i 701.2014 | cette Pate:08.05,2014) | | Decision :in the tight of earlier decision taken in meeting no. 19/82 dated 02.01.2014, it was i | | decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the 3 firm, whichever is tess: | p87, Export Product | | | Pravastatin Sodium Tab lOmg 20 MG, 40MG and 80 MG TAB | | | S.NO. | Import Items For export of 1 No. Pravastatin Sodium Tablets i | | (Quantity in mg} 4 Bo AO mgTablets | 20 mgTablets | 40 80 | | : meTablets |mgTablets | | [2 [[|] Mannitot 35 Pearlitol25 C) | 104,008 104,005 |207.92 i. RA may take appropriate action as per the decision of NormsCommittee... tatters| 41602ec| : | GeseNo.188ai83. ~~~ ~Iany Name BRAGHT ~~~ ecrNolbuie 8c ~Rishaneas| || /ALC4/2014 PHARMACEUTICALS PYT jALC42014 ‘Deferred 4 oss re rt 08.05.2014 sss | THQFile a Fe oe © |Lic-No/Date:03 16768015 [Deter | 01/82/050/00162/AMI5/ AO3S/0AVOOBEYAMI4/ 27.01.2014 wy DORE || Pharmaceuticals,Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment4.O7 2014} of se ttt eo fap Case Naci8902- fay NamePRACHT—~pacernaibac82. ean a| P°"ALC4/2014 ‘PHARMACEUTICALS PYT-ALCaR201g Deferred ----- End of picture text -----

==> picture [414 x 595] intentionally omitted <==

----- Start of picture text ----- | THO File ‘RLAFile Lic. No/Date:03 10768009 [Defer | | :O1/82/0S0/00163/AMIS/ —/:03/95/040/0086V/AMI4/ 27.01.2014 sDate:24.07.2014; | (Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | © Pharmaceuticns: enna 1 [Case No.:19/3/82-ALC4/2014Party Name:VARUN MeetNo/Date:3/82- Status:Case | ae SMEDIMPEX INC. jALCA/2014 (Deferred | ‘290HQ File ° ~RVAFHe “LicNofbate:0510377141 Defer | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of | |__ Petrochemicals Division ofDepartmentofChemicalsand Petrochemicals 0) (\Gase Nout 76362-ALC4/2014 Party NamecAMBUSA Moet No/Date:3/82-——[Status:Case, | | JINTERMEDIATES LIMITED (ALC4/2014 ‘Approved | |e een ener ee| | HQ File _ :RLA File ~~ Lic.No/Date:03 10768184 Defer Date: | + :01/82/050/00180/AM1 5/ 1:03/94/040/008 18/AM14/ 28.01.2014 4 | | Decision : in the light of written comments received from Department of Chemicals and | [Petrochemicals vide their U.Q No. 14010/103//2012-Ch. li dated 21.05.2014, it was decided 10) bo Paty norms under Para 4.7 of HBP v1 as per details given below or as applied by the fim | whichever is less: | | Export product Export Import items Quantity / } i Quantity Allowed = |} | RENS ACHQ-CARBETHOXY AMINO- ik 1.280 kg { __SNAPHTOL-7-SULFONIC ACID) & L . i may take appropriate action as per thedecisionof NormsCommittee. pops i ("lace No338/5/82-ALCARO14 [Party NameESTEEM (Meet NovDate:3/82-Status:Case| i | AINDUSTRIES PVT. LTD, ALCa/2014 ‘Approved ee eee © 08.05.2084 Nest | HO(01/82/0S0/00242/AM1S/ Fite an“IRLAFUe17/24/040/00106/AMI4 Lic.28.08.2004 No/Date:1710005661ese (Defer Date: | i Decision : in the light of written comments received from Department of Chemicals and, | Petrochemicals vide their U.0 No. 14010/78//2012-Ch. {I dated 20.05.2014, it was decided to: | ‘ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, | (292. whichever is less: | Fe 4 : | | Export product Export | S.No. | Import items Quantity |; | | Quantity Allowed |, ||| PRODUCT-PPG-2025 (POLYALKYLENE 1, |MONO PROPYLENE 0.035 kg | ae GLYCOL H | | GLYCOL) ; ; 24 ee i kg (Appearance: Colourtess ; | | | Aspect: Liquid) Viscous Liquid , 0.965kg | i PROPYLENE OXIDE... ----- End of picture text -----

==> picture [425 x 538] intentionally omitted <==

----- Start of picture text ----- | (CaseNost74/3/82- (Party Name:IPCA "(Meet NoDate:3/82-—StatusiCase | jALC42014 LABORATORIES LIMITED aLowania ‘Deferred | tp beeing, (0805204 JHQ File JRLA File ~~ (Lic. No/Date:03 10768207 Defer E | | 01/82/050/00178/AMI5/ 03/94/040/00923/AM14/ 28.01.2014 _Date:24.07.2014) || Jauthority| Decisionpresent: Committeein meetingconsidereddecided tocaseratifyasnormsper agendaunder paraand4.7in ofconsultation HBP as perwith detailsiccricalbelow! parr @s applied by firm whichever is tower:- | | TRIAMCINOLONEExport product USP §I.No. | Import items Oty. allowed | | ( Tks. 1. 20 Dioxopregna-1,4,9(11), 16 1.00 kg ;| | BASE ) Tetragn-2)-Yiacetate [(3][ -][ TR)] L [RA concemed may take further necessary action as per above decision ofNC, Z (1 fCase No.:175/3/82- SC PartyNameIPCA SMe No/Date:3/82-—Status:Case | (ALC4/2014 iLABORATORIES LIMITED JALC4/2014 {Deferred | | THO File ~ “URLAFIe (Lig. No/Date:0310768214 Defer . iV82/0SO/0O179/AMIS/ _|:03/94/040/00932/AML4/ (28.01.2014 {Date:24.07-2014) | | Decision : Committee considered case as per agenda and in consultation with technical: authority present in meeting decided te ratify norms under para 4.7 of HBP as per details below | poser as applied by firm whichever is lower:- j fo-| Export product ExportQty, | SINo.| Import items Qty. allowed i|) |] TRIAMCINOLONE + kg. 1. 20 Dioxopregna-1,4,9{11), 16 4.00 kg | Tetraen-21-¥lacetate (3 - TR} (Case No.:69/3/82-ALC4/2014 (Party NameOTSUKA _—“(Meot No/ate:3/82- (Status: a4 CHEMICAL (INDIA ) ALC4/2014 Approved eeu PRIVATE LIMITED 08.08.2018 | HQFile ====———~—<“—st:~—:—CR Pde Lic No/Date:0510377267 ‘Defer Date: | :01/82/050/00073/AM15/ —:05/24/040/00402/AMI4/ 28.01.2014 | Decision = In the light of earlier decision taken in meeting no. 21/82 dated 06.02.2044, it was | 1995, decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the : ee whichever is lower: | | | ttem of Export Quantity | S.No | Item of Import Quantity | | Aliowed kg/kg if; j | 7-Phenylacetamideo-3- | 1 kg 1, Penicillin G Potassium | 2.85 | | | Chioromethyl "Crystals i ----- End of picture text -----

==> picture [405 x 462] intentionally omitted <==

----- Start of picture text ----- : 76 |||Lester (GCLE) amen FomamigeChioride fs | While/Light [Powder] Yellow [ 165 -MereaptobenzothiazoleTisoprepyl Alcohol 12510.811 | |(Case No.:1000/82-ALC42014 [Party Name:ARIHANTANAM (Meet No/Date3/@2-—(Status:Case| D4 ‘LIPECARE PVT. LTD. {ALCA/2014 (Approved | eee ee 25) | HO Fite IRLA File ) [LicNo/Date:0310768439 Defer Date: | | HOIS2/0S50/0104/AMIS/ — 303/94/040/0097/AM14/ 29.01.2014 |Decision : In the light of earlier decision taken in meeting no. 3/82 dated 02.05.2013, it, (296 was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as! | ponies by the firm, whichever is less: } 1 (Export4 product Exp.Qty. SiNo. | import items Qty. allowed | | _Artemether 1 Ko Artemisinin 1.235 ke i |[RA may take appropriateaction as per the decision ofNorms Committee. [Case| jALca2014Nostodisig2- PartyCHEMICALS NamesSIRMAXO PVTLTD "Mest= ALC4/2014 No/Dae:3#2-""/Status:Case| Approved || | HQ File IRL File ) "Lie NovDat-0310768423 [Defer Dats | ROL/BQ/0SO/001OB/AMIS! | (S03/95/040/00863/AMIA/ 29.01.2004 een | | ‘Decision : Committee considered case as per agenda and in consultation with technical jauthority present in meeting decided to ratify norms under para 4.7 of HBP as per details given’ | ‘}below or as applied by the firm, whichever is less:- : Export product Export| SLNo. | Import Quantity Allowed f 4 Oty. items | | | Povidone iodine 10% Solution |1kg | 1. Povidone 1.02 kgper— kg | |_| (Available lodine NLT 1% w/v) lodine contained in the) | : export | ----- End of picture text -----

==> picture [404 x 123] intentionally omitted <==

----- Start of picture text ----- | JALC4/2014 JEXPORTS PVT. LTD. yatoazoi4 ‘Deferred | bog HQFite REA File Lie. No/Date:0810128498 [Defer| | pO1/S2/050/00234/AM15/ __|-08/24/040/00474/AMI4/ (29.01.2014 iDate:24.07.2014) | {Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | PPharmaceutions opus suasssusnpsnpassiasssusasnsssesisnsusseengsanes | [Case Noi210/3/82-ALC4/2014 [Party Name-TIDE ——=S“Meet No/Date:3/82-——Status:Case| 299° INDUSTRIES “ALC4/2014 “Approved 5 ne: Cn Lsce ----- End of picture text -----

==> picture [412 x 592] intentionally omitted <==

----- Start of picture text ----- | Hofie REA itle —SSSSSSCLic ovate: 34100309134 [Defer Date: | XO1/82/0S0/00214/AMI5/ ——:34/24/040/00257/AMI4/ 29-01-2014 A |: (Decisiona :. In the. light. of written comments received from Department of. Chemicals. and|| | “Petrochemicals vide their U.O No. 14010/40//2012-Ch., II dated 21.05.2014, it was decided to; | ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | -|whichever is less: } | | Export product Export | S.No. | Import items Quantity | | i Quantity Allowed |, [ [CaseNo.:93/3/82-ALC4/2014 ‘Party [Name:BIOLOGICAL][ E] [MeetNo/Date:3/82- —‘(‘Status:Case| boa ‘LTD HALC4/2014 |Approved | Se ee | [HQ File [RLA File ~~ [Lio-No/Ddate:0910059124 | -ROL/82/0S0/00097/AMIS/ ——209/24/04Q/00S49/AM14/ 30.08.2014[Defer Date: | Decision : In the light of earlier decision taken by NC in its 11/82 meeting 05.09.2013, it was decided to | | iratify norms under Para 4.7 of HBP vi as per details given below aor as applied by the firm, whicheveris | Less: | | [item of Export item of Import Quantity allowed ke/kg || od 1 kg As per a : A 2304 of HBP |: | | VACCINE BP/TETANUS cern | ; PEPTONE PLUS) 4300) ADSORBED-10ML20 DOSES As per A 2304 of HBP-Ii | 1 | Ree i | 6. | siLicon EMULSION 0.043 kg | - ; PHOSPHATE As per A 2304 of HBP-Ii | Poy TAG 2 PLUS} 3 Boy VM LABELS . 4 to VIAL MONITOR LABELS) | |{RAmay take appropriate action as per the decisionof Norms Committee. | [~" [ase No207/3/82- ‘(Party Name:BIOLOGICAL EB (Meet No/Date:3/83-—‘|Status:Case | jaLcarot ‘LTD “ALC4/2014 [Approved | HQFile ee ARLA File Lic. No/Date:09 10059125 [Defer | ----- End of picture text -----

| ‘Decision It was decided to defer the case for 24.07.2014 for comments of Department | | lof Pharmaceuticals. | “ Resets guessssne s n ppp ast st ngs aserenetacnuncesensimucssses| 7" fease No.:209/5/82-—=—=~—=Party Name:DRREDDYS (Meet No/Date:3/82-—‘|Status:Case_: | jALC4/2014 (LABORATORIES LIMITED .ALC4/2014 Doterred |302 HQ File ee IRLA File ~~ [Lie No/Date:09 10059127 Defer | | 201/82/050/00213/AMI5/ :O9/24/040/00S40/AMI4/ 30.01.2018 Date:24.07.2014 | Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | [Case Noi77@/83(Party Name:INDO AMINES (Meet No/Date:3/82-/Status:Case | JALC42014 ‘LIMITED jALC4/2014 ‘Deferred } Se ne: See ce | 1303 [ HQLOU82/050/00181/AMIS/File IRLA—:03/94/040/00958/AMI4/ File ~30.01.2014Lic No/Date:03 10768616 [DeferDate:24.07.2014) |__ PD e trochemicalscision sit was Div dec i dedsion to deferthe case for 24.07.2014 for comments of [ of Department of Chemicals and Petrochemicals [ease No.:138/782-ALCAR014 Party Name'SOMU "Meet NovDates/82-[StatussCase yo {SOLVENTS PYT. LTD JALC4/2014 Approved 5 | (HQFie “IRLAFie © (Lic. No/Date:0710101788 ‘Defer Date: | | 01/82/050/00139/AMI5/ ___:07/24/040/00387/AMI4/ 30.01.2014 | (Decision : In the light of written comments received from Department of Chemicals and. “504i ‘Petrochemicals: fatify norms under vide theirPara U.O4.7 of No, HBP 14010/151//2012-Ch, vi as per details given| datedbelaw 16.05.2014,or as appliedit wasby decided the firm, to!B { whichever is less: . | | 1 Export product Export {| S.No. | Import items Quantity i 14 . Quantity Allowed | / | 2ETHYL HEXYL ACETATE ik I 2-BTHYL HEXANOL 0.822 kg | | «| OCTYL ACETATE 6 OCTANOL | io fa may take appropriate action as per thedecision of NormsCommittee. | |{CaseJALCa/2014 No.:223/3/82(SCIENCESParty Name:UNIJULES LTD. LIFE (MeetjALC4/2014 No/Date:3/82‘Deferred[Status:Case | 0s HOFie (RLAFile | —~—_LLie.No/Date:0310768632 [Defer | , -:01/82/0S0/00227/AM15/ —:03/9S/040/00867/AMIA/ 30.01.2014 (Dae24 971201) | ‘(Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | [Piharmaceuticals, apnea 1" ICase No152/3/82-ALC4/2014 ‘Party Name:AARTI—~—«(Meet No/Date:3/82-——‘|Status:Case | 306! INDUSTRIES LIMITED 1ALC4/2014 — ‘Approved |

==> picture [409 x 594] intentionally omitted <==

----- Start of picture text ----- | SOI/82/0S0/00156/AM15/ _:03/94/040/00708/AMI4/ 31012014 = ; (Decision 3 Committee considered case as per agenda and in consultation with technical | authority present in meeting decided to ratify norms under para 4.7 of HBP as per details given | | jbelow or as applied by the firm, whichever is less:- | | Export product Export | SINo. | Import items Qty. allowed oe | Qty. ke/kg | | | PERINDOPRIL ERBUMINE [4 kg 1. (2as,3as,7as) OCTAHYDRO 0.947 i | 4 INDOLE-2-CARBOXYLIC i ____[RA concernedmay take further necessary action as per abovedecisionof NC f || ICase(ALCa2014 No:206/3/82- Party“PHARMAName:AUROBINDO LIMITED ALC4/2014[MeetNofDate:3/82-~~ ‘Deferred(Status:Case || ov HQFile ——S—S~CSRLLAN Fle “Lic. | No/Date:0910039129 ‘Defer : | DecisionGOL/82/050/002:It was LOAMIS/ decided [oszaosoosseamiato defer the case for 24.07.201431.01.2014 for commentssen, of DepartmentHDatec24. 07-2015) of | | |Pharmaceuticals. | (Tease No. 164/3/82-ALC4/2014 [Party Name:CAMPHOR & Meet No/Date:3/82-Status:Case | HALLIED PRODUCTS JALC4/2014 jApproved eee eee LAME, NOBOS2004 | | THQ File IRLAFie ‘Lic. No/Date:0310768971 (Defer Date: | | pO1/82/050/00168/AMIS/ —_03/947040/009S6/AMI4/ 03.02.2014 : (Decision : In the light of written comments received from Department of Chemicals and | jPetrachemicals vide their U.O No. 14010/20//2012-Ch. il dated 14.01.2014, it was decided to ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, | | whichever is less: | ‘ | Export product Export | S.No. | Import items Quantity | i: Quantity Allowed || | | ASTROMUSK CONCENTRATE ) 0.580kg | A STYRENE : ( [ease NosiS47@2-ALCA2014 Party Name:IPCA (Meet No/Date:3/82-StatusiCase| 4 “LABORATORIES LIMITED #ALC4/2014 iApproved 1 ||pO1/82/0S0/001S8/AMIS/HQFieRA—:03/94/040/00931/AMI4/File oo E21,Lic.No/Date:0310768981 a Defer Date: ----- End of picture text -----

==> picture [412 x 620] intentionally omitted <==

----- Start of picture text ----- | Decision : In the light of earlier decision taken in meeting no, 33/82 dated 21.03.2013, it was decided | | ‘ito ratify norms under Para 4.7 of HBP v2. as per details given below or as applied by the firm, whichever is? 1 Hess: { | } Prednisalone Sodium | 4 Kg. 2 Prednisotone (Prednisolone Base} 0.90 kg i | | Phosphate | "RA may take appropriate action as per the decision of Norms Committee. i , (Case No.:165/3/82- Pary onal anomraneyee Meet NevDatesi82-“[StatusiCase | | jALC4/2014 (Name: MANGALAMORGANICS [ALca/2014 Deferred 4 |bio HQFile — ——”S—”:~CS~SRLA Fie SSCS ‘Lic.No/Date:0310768928[Defer ; | :01/82/050/00169/M15/ O3/earoanions4B/AMIa/ 03.02.2014 {Date:24.07.2014 LI Decision :1t was decided to defer the case for 24.07.2014 for comments ofDepartment of| c c ca _ r© (Case No.:212/3/82-ALC4/2014 [Panty NameSHIVA ~~ [Meet Novbate3/83-StatussCase| | | /PHARMACHEM LTD, JALC42014 (Approved | | 7HO File : IRLA File ~ ~ hic. No/Date:34 10039176 [Defer Date: | { :01782/050/00216/AM IS! gt SM2AOAOMOZ68/AMI4/ 03.02.2018 | Decision : Jn the light of written comments received from Department of Chemicals and | (Petrochemicals vide their U.O No. 14010/164/2011-Ch. tf dated 21.05.2014, it was decided to: 4 ratify norms under Para 4.7 of HBP vi as per details given belaw or as applied by the firm, P Ll iwhichever is less: : | | Export product Export | S.No. | Import items Quantity | fog Quantity Allowed _ |! | | OCTANOYL CHLORIDE (CAPRYLOYL kg Octoic Acid / Octanoic 0.982kg |, | | CHLORIDE) Acid/ Caprylic Acid 2 | IRA may take appropriate action as per the decision of Norms Committee. | aaa IY TENS Sb propriate action as per the decision ofNorms Committee, [Iease Noslt1382- [Party Name:SRIAM LABS Meet No/Date:3/82- [Status:Case { |ALC4/2014 “PRIVATE LIMITED 1ALC4/2014 {Deferred 4 312 HQ File——v ~IRLA File— ~~ |[Lic. No/Date:0910059150 Deter | | ROUS2/0S0/00115/AMI5/ __:09/24/040/00S09/AMI4/ 03.02.2014 iDate:24.07.2014) | Decision :it was decided to defer the case for 24.07.2014 for comments of Department of| (Pharmaceutics ease| No.:201382.—~—SOS Party:Name:YASHASHVI Meet No/Date3/82- Status:Case {ALC4/2014 JRASAYAN PVT.LTD SALC4R014 “Deferred ; _BQFile RLAFIe “Lie No/Bate:3210040666 [Defer 7 ----- End of picture text -----

==> picture [407 x 223] intentionally omitted <==

----- Start of picture text ----- | [Decision :It was decided to defer the case 24.07.2014 for comments of Department of | [Chemicalsand Petrochemicals, [Case Now188/3/82-"Party Name:ALKYL AMINES [Meet No/Date:3/82-(Status:Case i JALC42014 ‘CHEMICALS LTD JALC4/2014 [Approved =| |} HO:01/82/050/00159/AM15/ File 'RLA703/94/040/0091 File VAMI4/ {Lic.No/Date:0304.02.2014 10769007 :[Defer [Date:] |4 _| Decision :Committee considered case as per agenda and in light of written comments forwarded| |31 consultationiby Deptt. withof C&PCthe technicalvide theirauthoritiesU.O.No.present14010/85/2012-Ch.]in the meeting decideddatedto ratify12.11.2013normsandunderin , 4 para 4.7 ofHBP as per details below or as applied by firm whichever is lower:- 4 | ‘| Export product Exp. SLNo. | Import items Qty. allowed | || Acetonitrile lkg | ‘Acetic Acid 1,46 ke | ----- End of picture text -----

==> picture [405 x 339] intentionally omitted <==

----- Start of picture text ----- | i RA concemed may take further necessary action as per above decision ofNC 7 [ase No399/382-aLCa2014 Party Name:AVA (Meet No/Date:3/82-—[StatusrCase_ foo ICHEMICALS PVT.LTD. NALC4/2014 ‘Approved | | THQ Fite” (RLAFic =”~ [beNofDate:0310769004 [Defer Date: | 5 OU/S2/050/00103/AMIS/ —FO3/94/DAQ/O9SAMI4! =— 04.02.2014 | ‘Decision 3 In the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.Q No. 14010/157/2011-Ch. It dated 29.05.2014, it was decided to’ | ‘ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,! P 1S whichever is less: | + | Export product Export | S.No. | Import items Quantity / to Quantity Allowed | || DISODIUM MANGANESE EDTA ikg Ethylene Diamine Tetra | 9.690kg | | (Manganese Content 12.5% +/- 0.5} Acetic Acid 3 |____|RAmay take appropriate action as per the decision of NormsCommittee. ((Case No.:26/3/82-ALC4/2014 Party Name:MEDICEF MeetNo/Date:3/82-.—‘(Status:Case Jog SPHARMA, SALC4/2014 iDeferred 4 ‘316 HQ File TRLAFie {Lic No/Date:2210014587 [Defer 2 pOL/82/050/00030/AMIS/ 22/24/040/00080/AMI4/ 04.02.2014 {Date:24.07.208 | [Decision ‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of | [Pharmaceuticals ----- End of picture text -----

==> picture [406 x 584] intentionally omitted <==

----- Start of picture text ----- , 4 ‘PHARMA, “ALC42014 ‘Deferred i 317/HQ| Fite IRLA File _ [Lie [No/Date:2210014589] (Defer | ‘301/82/050/00031/AMIS/[Decision ‘It was decided_|:22/24/040/0008/AMI4/to defer the case for 24.07.201404.02.2014for comments ofDepartmentDate:24.07.2014| of | Pharmaceuticals. | [Case No.:28/3/82-AL04/2014 [Party Name:MEDICEF [Meet No/Date:3/82- (Status:Case A “PHARMA, (ALC4/2014 ‘Deferred (319| ROL/82/050/00032/AMI5/1HQ File - __;22/24/040/00082/AMI4/RLAPIe = 04.02.2014.Lic. No/Date:2210014588Date24.07.2014[Defer “ | Decision ‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of | :1Case& No.:87/3/83-ALC4/2014: LIMITEDiPartyName:VIVIMEDLABS 1ALC4/2014Meet No/Date3/82- ‘Deferredif Status:Case|ii B19 [HQ File ~RLAFile Lic. No/Date:0910059155 Defer | -ROU/S2/0SO/00091/AMIS/ _:09/24/040/00S44/AMI4/ (04.02.2014 ——Date:24.07.2014) | Decision :It was decided to defer the case 24.07.2014 for comments ofDepartment of | O°" (CaseNowlt7/3/82- [Party Name:VIVIMED LABS [Meet No/Date:3/82- ‘StatusiCase 1ALC4/2014 JLIMITED |ALCA/2014 ‘Deferred I |(320 HQ File ~RLAFile Lie No/Date:0910059156[Defer | | ROVS2/0S0/00121/AMIS/Decision :It was decided|:09/24/040/00543/AMI4)to defer the case 24.07.2014(04.02.2014. for comments of Department (Date:24.07.2014) of | |_Chemicalsand Petrochemicals | |P"ICase No.:232/3/82-——=~S*«*PartyName:CADILA [Meet No/Daie:3/82- _(Status:Case~| jALCa2014 JHEALTHCARE LTD., {ALC4/2014 “Deferred 21 HQFile TRLAFe ‘(Lic No/Date:08 10128700 [Defer } | ROLS2/050/00236/AMIS/ —__08/24/040/0048S/AMI4/ 05.02.2014 Date:24.07.2014 | Decision It was decided to defer the case for 24.07.2014 for comments of Department of (Pharmaceuticals, _. i (Case No2213/82- [Party Name:CIPLA LIMITED (MeetNo/Date:3/82- —(Status:Case | lALCaror4 ALC4/2014 (Deferred oo (HQFile RLAFie ~ [Lic.No/Date:03 10769240 [Defer | | :01/82/0S0/00225/AMIS/ $:03/94/040/0099S/AML4/ sp 0592 | 20N4 ee (ater24.07.2014| f [Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | PPro, a ee san sesamin tates ----- End of picture text -----

==> picture [441 x 615] intentionally omitted <==

----- Start of picture text ----- || JALCa2014(CaseNo.:222/3/82-tPartyName:CIPLA LIMITED (Meet“ALC4/2014No/Date:3/82- (Status:Case‘(Deferred || $393.HQ File : (RLA File ~ie-No/Date:03 10769244.[Defer | 201/82/050/00226/AMIS/ :03/94/040/00985/AMI4/ 05.02.2014 sae2407 2014 | (Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | (Pharmaceuticals. ; | TiCaseNo.:224/3/82-‘Party Name:CIPLA LIMITED Meet No/Date:3/82- (Status:Case | |ALC4/2014 | HALC4/2014 {Deferred 4 524 HQ File “RLA File Lie. No/fate:03 10769253Defer : |:01/82/0S0/00228/AMIS/ en, EO3/OAI040/00979/AMI4i 05.02.2014 Date:24.07,2014) | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | | Li Phrarmaceuticals, sa ppg =; JALCAH20(Case No225/9/82-bE :Pary‘Name:CIPLA: LIMITED 4ALC4/2014[Meet No/Date:3/82-—‘(Status:Casei Deferred || bbe| sHQFileKO1/82/050/00229/AMIS/== —|:03/94/040/00991/AMI4/RLA File (Lie:05.02.2014 NovDate:03 10769247‘(Date:24.07.2014.Deferee | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of how ‘Pharmaceuticals. cape ptt tip te py stettppitigasiis ivity ttt sptsue nissan! - [Case No,:153/3/82-ALC4/20t4 [PartyNamelPCA “Meet No/Date:3/82-——|Status:Case | ; 4 [LABORATORIES LIMITED (ALCS 2014 iApproved | | HQ File REA Fite OO “Lic. No/Date:03 10769229 ‘Defer Date: | | OL/S2/0S0/00157/AMI5/ ——:03/94/040/00976/AM14/ 0.022014 J i Decision : In the light of earlier decision taken in meeting no. 23/82 dated 06.03.2013, it was | | decided< to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the jI | firm, whichever is less: : 4 | Export Product Export S.No import Product Quantity 4 4 Quantity Allowed | 4 | Allopurinol Lkg 1 (3-Amino Pyrazole 1.5384 kg q , Carboxamide i to Hemisulphate | : TRA may take further appropriate action as per the decision of Norms Committee. | [lease| JALC42014 No:149/3/82- === ‘LABORATORIESPartyNName:MOREPEN LTD., ‘(Meet— |ALC4/2014No/Date:3/82-.“Status:Case_ Deferred | TestP27HOFie esses ests copes tp caresessnsceng, BOS 2OME Necser | | 01/82/0S0/00153/AM15/ :05/24/040/0042/AMI4/RLA File Lic.(05.02.2014No/Date:0510378413 -(Date:24.07.2014[Defer || |_ Decision :It was decidedto deferthe case for 24.07.2014 for commentsof Departmentof | ----- End of picture text -----

==> picture [409 x 616] intentionally omitted <==

----- Start of picture text ----- 84 [Case Nostesioi2- Party Name:CIPLA LIMITED [Meet Novbate3/82- [StatusiCase | | JaLcano14 | JALC4/2014 Deferred = ee ee) : p28| HO File IRLAFile Lic NoyDate:0310769592 DeferSSS | Decision801/82/050/00172/AM15/:It was decided__f3ai040/01009/AMI4/ to defer the case for 24.07.201406.02.2014 for comments apg: of DepartmentDANI24.07.2014 of | |[CaseNo.:239/3/82-ALC4/2014 PartyName:ESTEEM Meet No/Dates/82- Status:Case| io fNou s taues PVT.LTD, —_ALC4/2014 jApproved | [s 805-2014 | [HQ File (RLAFile Lic -No/Date:1710005681 (Defer Date: | | ROUB2/OSO/N0243/AMIS/ EIT24/O40/00109AMI4) = 06.02.2014 Fe | {Decision : in the light of written comments received from Department of Chemicals and! i] : | iPetrochemicals vide their U.O No. 14010/78/2012-Ch. I dated 20.05.2014, it was decided ta, | ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, | whichever is fess: | | Export product Export | S.No. | Import items Quantity ff / | _ | Quantity Allowed | ||| VENOXY-TRF (PATTY ALCOHOL Ca a eOHOL 0.298kg | |] ETHER) Lhe (C12. OL) F D4 ETH ; (Colourless clear insoluble 3 i 4 (Appearance: Colourless clear to turbid liquid : | liquid) . 3 ETHYLENE OXIDE 0341 kg | tg {Colourless clear figuid | | 3 PROPYLENE OXIDE 0.360kg | i Colourless liquid | PleasePl |No.:199/3/82-ALC4/2014 |Party Name:KUTCH Meet No/Date:3/82.—‘StatuszCase! “CHEMICAL INDUSTRIES —JALC4/2014 ‘Approved { | HQFile “REA File ~~ {Lic.No/Date:3410039199 [Defer Date: | || POVB2/MSO/00203/AMIS/ __|:34/24/040/00270/AM14/_06.02.2014. ee re | ‘Decision : In the light of written comments received from Department of Chemicals and | /Petrochemicals vide their U.O No. 14010/17/2012-Ch. 11 dated 29.05.2014, it was decided to, : :ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | pv cheer is less: . |iH | ; Export product Export | S.No. | Import items Quantity | foi Quantity Allowed |; || oerayLuexviwireate kg fT 2 ETHYLTHY: REXANOL 0.764kg||| ----- End of picture text -----

==> picture [407 x 586] intentionally omitted <==

----- Start of picture text ----- | (ALCs2e14 “PHARMACEUTICALS LTD. |ALC4/2014 ‘Deferred | 1331 HO File IRLA File |LicNo/Date:03 10769509 (Defer| | HOUB2/050/00154/AMI15/ __(03/95/040/00879/AMI4/ 06.02.2014. Daate:24.07.2014) | Decision tlt was decided to defer the case for 24.07.2014 for comments ofDepartment of | i )DRUGS PVT LTD. IALC4/2014 [Deferred |[932(HQ File ~~ RLAFile — Lic. No/Date:0910059218 (Defer a | 101/82/0S0/00012/AMI5/ hogearodorosse/AMI4/ [07.02.2014 _ cect sans EOME2AO7.2014) [Decision sit was decided to defer the case for 24.07.2014 (WPRarmacemticads, aetna susefor comments of Department of |to[CaseNo.40/3/82-ALC4/2014 PartyName:ARENELIFE MeetNo/Date:s/82- ~~ [Status:Case SCIENCES LIMITED. |ALCa/2014 [Deferred ; eeee0 al 333 HO File — TRLAFie \Lic.No/Date:0910089227 [Defer ; 601/82/050/00014/AM) | (Decision :It was decided5/ to }09woa0/o0ssa/AMial defer the case for 24.07.2014(07.02.2014for comments of Date:24.07.2014)Department of | (Pharmaceuticals, [use No.:89/3/82-ALC4/2014 Party(SCIENCESName:ARENE LIFE /Meet}No/Date:3/82- Statas:Case ee LIMITED, 1ALC4/2014 Deferred | jaa[| Ho File ~ IRLAee File — 2Lie.No/Date:0910059222 (Defer | | OUBS2/050/00063/AMI15/Decision :It was decided to09/24/040/005S1/AMIA/ defer the case for 24.07.201407.02.2014for comments= ofDepartment ofDate:24.07.2014} [ieICaseNo.:49/3/82-ALC4/2014|PHARMAPany Name:AUROBINDO LIMITED (Meet,ALC4/2014Nees. Beaune‘Deferred || 39HQFile TRA File "Lig. No/Date:0910059197 [Defer i || (Decision01/82/050/00053/AMIS/ —_:09/24/040/00562/AM14/rit was decided to defer the case for 24.07.2014(07.02.2014for commentscss ofngDepartmentAte24.07,2014 of || OCase| |ALC4/2014 Nos151/82- ——SParty‘| Name:CIPLA LIMITED JALC4/2014Meet No/Date:3/82-(Gtatus:Case‘Deferred || a hee (8052014 | 936| POLS82/0S0/001SS/AMIS/HO File —ARLAF—:03/94/040/01022/AMI4/ie ° Lie(07.02.2014 No/Date:0310769755= Date:24.07.2014)(Deter | | (Decision :It was decided to defer the case for 24.07.2014 for comments of Department of| J. APbarmaceuticas, ae ty susmsssnunsuatstannnnntoe she teste| ----- End of picture text -----

==> picture [405 x 589] intentionally omitted <==

----- Start of picture text ----- ("Case| Nos211/3/82-~~ PartyName:DEEPAKMeet No/Date:3/82- (Status:Case| ALC42014 _ NITRITE LIMITED “ALC4/2014 ‘Deferred i 1537| HQ File 'RLA File . “[Lic.No/Date:3410039219 (Defer /01/82/050/002 I5VAMIS/ (34/24/040/00201/AMI4/ 07.02.2014 Date:24.07.2014 | [Decision :It was decided to defer the case 24.07.2014 for comments of Department of | 1yd[CaseNo.:84/3/82-ALC4/2014Party Name:STERICON Meet No/Dates3/82- Status:Case_ ‘PHARMA PVT.LTD., JALC42014 ‘(Deferred | 33g} HQ File 'RLA File ~~ [Lie.No/Date:0710102047] [Defer :-bO1/82/0S0/00088/AMIS/ | 07/24/040/00419/AM14/ 107,02.2014 {Date:24.07.2014: | Decision :[t was decided to defer the case for 24.07.2014 for comments of Department of | (Pharmaceuticals, oo inane spsipsiinuinsiicsccsse [| |ALCa2014feaseNostéoiea- PayLABORATORIES Name:TITANPVT."Meet LTD. (ALC4/2014Novbate/82-" ~~ [Approved(Status “|| | JHQ File {RLAFile (Lie. No/Date:03 10769650 [Defer Date: | -ROUS2/OSO/OOIGA/AMIS/ —-03/9S/040/00840/AMI4/ 7.022014 | 4 [Decision :Committee considered case as per agenda and in consultation with technical authority | ‘present in meeting decided to ratify norms under para 4.7 of HBP as per details given below or as! lapplied by the firm, whichever is less: 4 + | Export product Export | SLLNo. | Import items Qty. allowed |, fy Qty. per unit of || i export product |) | LECPELLETS 60 % Lkg 1. DIDANOSINE USP/BP 0.606 kg/kg / | IRA concerned may take further necessary action as per above decision of NC with1% 5 [A 4[Case No.:84/3/82-ALC4/2014 |LABORATORIESPantyName:ASTRIX LTD, (Meet—ALC4/2014 No/Date3/82- (Deferred[Status:Case | Fe ums duncan, O805204 | (340 HQ File “IRLAFie [Lic.No/Date:09 10059230 [Defer | | HOU82/0SO/000SB/AMIS/ :09/24/040/00SS2/AMI4/ 10.02.2014. Date24.07.2014 | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of [Pharmaceuticals ee | ("TGase No.:167/3/82- "(Party Name:CIPLA LIMITED [Meet No/Date:3/82-[StatusiCase | ALCano14 | (ALC4/2014 Deferred =| | HQ File IRLA File Lic.No/Date:03 10769983 /Defer | | #01/82/050/0017/AMIS/:03/94/030/01028/AMJ4/ [10.02.2014 Date:24.07.2014) ----- End of picture text -----

==> picture [405 x 610] intentionally omitted <==

----- Start of picture text ----- | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | LPhammaceuticals [ [Cee Nos64isR2-ALCH2014 Paty NemeARENE LIFE [Meet NovDete 3/2~"TBtatus:Case | | | ISCIENCES LIMITED. JALC4/2014 Deferred 44 4 108.05,2014 - 4 342" INQ File :IRLA File Lic. No/Date:09 10059247Defer : || hO1/82/0S0/00068/AMIS/ :09/24/040/00SS4/AMI4/1102.2014 eu, Dater24.07.2014) Decision sIt was decided to defer the case for 24.07.2014 for comments of Department of | &~ [Case No923/82-ALCA?2014 ary NamesSHASUN Meet NofDatei/82-~[Status:Case | 4: |)PHARMACEUTICALS 1ALC4/2014 ‘Deferred | | Ha File IRLAFile |[Lic.No/Date:0410155099 [Defer | ROL/S2/050/00096/AMI5/ —:04/2A/04O/00244;AMI4/ 11.02.2014 Date:24.07,2014 | (Decision : Committee considered case as per agenda and in light of written comments ; forwarded by Deptt of Pharmaceuticals and in consultation with technical authority present in + imeeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm ty43 Whichever is lower:- : | | Export product Exp. Qty. | SNe. | Import items Qty. allowed | | PPARGXETINE TABLETS [Tkg U7, PAROXETINE 22.66 mg/20 mg | | || 20MG HYDROCHLORIDE | Tablet 4 | || PAROXETINETABLETS 17 kg 1. PAROXETINE ‘| 33.99 mg/30 mg i | | 30MG HYDROCHLORIDE | Tablet | | __ [RA concemed may fake further necessary actionas per above decision FNC "CaseaNo.:217/3/82-ALCa/2014 (PartyNameSOMU [Meet No/Date:3/82- ~~ [Status:Case| ee tet Moe(SOLVENTS PVT. LTD 0805201SALC4/201 4 Approved | | THQFile URLAFile ~~ Lie.No/Date:0710102067 Defer Date: | | pO1/82/050/00221/AMIS/ _to72ag4onoatsiaMs ee 022014 | | ‘Decision : In the light of written comments received from Department of Chemicals and, | Petrochemicals vide their U.O No. 14010/151/2011-Ch. it dated 16.05.2014, it was decided to, | ‘ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, PS whichever is less: | | | Export product Export | S.No. | Import items | Quantity fo ‘| Quantity Allowed ||] 2s Bthyl Hexyl Acetate I kg 2 Ethyl Hexanol 0.822kg | || Octyt Acetate Octanot / i _RA may take appropriate action as per the decisionof Norms Committee, | (345 [Case No.:215/3/82-ALC4/2014 Party Name:TATVA... Meet No/Datea/83- Status:Case ----- End of picture text -----

==> picture [416 x 633] intentionally omitted <==

----- Start of picture text ----- 88 Op CHINTANPHARMA CHEM |ALC4/2014.—~—=«Approved Bc| pee titanEME Deena, OBOS2014 sheen | | THQ File IRLA File ‘{Lic.No/Date:3410039259 Defer Date: | POL/S2/0S0/00219/AMIS/ :34/24/040/00275/AMI4/ 11.02.2014 | ; [Decision : in the light of written comments received from Department of Chemicals and : [Petrochemicals vide their U.O Ne. 14010/37/2011-Ch. Il dated 19.08.2013, it was decided to. | whicheverfev normsis less:under Para 4.7 of HBP vi as per details given below or as applied by the firm,: | 4) Export product | - Export | S.No. | Import items Quantity | fo: Quantity . Allowed | | 1 kg TRIPHENYL 0.806kg | | | | PHOSPHONIUMMETHOXY METHYL CHLORIDE TRIPHENYL PHOSPHINE. (Case No.:46/3/82-ALC4/2014 Party Name:ARENE LIFEIMeet No/Date:3/82-—(Status:Case to |SCIENCES LIMITED. ALCA2014 Deferred 4 he espe, OBOS2014 546| ROL/82/050/000SO/AMIS/HQ File REA:09/24/040/0055S/AMI4/ FIe 12.02.2014(Lie. No/Date:0910059260 Dates24.07.20141(Defera Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | | ‘Pharmaceuticals, i | ase No.s47/3/82-ALC4/014 Party Name:ARENE LIFE [Meet No/Date:3/82-—‘(Status:Case | ; | “SCIENCES LIMITED. ALC4/2014 Deferred | ee ee he, ee re | 347/HQFile RLAFHe -__[bie-No/Dae:0910059259 [Defer | | OL/82/0SO/0005/AMES/ _:09/24/040/00S3S/AM14/ (12.02.2014 _ Pas2aera0.| | [Decision :It was decided to defer the case for 24.07.2014 for comments of Department of = ICase No.:61/3/82-ALC4/2014 [PartyName:INCHEM (MeetNo/Date:3/82-—‘Status:Case “| yf (LABORATORIES PRIVATE TALC4/2014 iDeferred : ag| HO1/82/0S0/00065/AMI5/ HQFile == __|:09/24/040/00S68/AMI4/REA File SSCLic12.02.2014NoDatex0910059258 Date:24.07.2014Defer f | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of : (ease| (ALC4/2614Now1133/82-——~SC@Party”LABORATORIESName:RANBAXY LTD Mest/ALC4/2014 No/Date:3&2- [StatueDeferred - i.| . e q HQ|hOL2/OS0/00117/AM15/File ee, :05/24/040/00332/AM14/RLAFIe bic412.02,2014 No/Date:0510379.132.... [Defer Date:24.07.2014)°*| ----- End of picture text -----

==> picture [406 x 607] intentionally omitted <==

----- Start of picture text ----- |f Decision :It was decidedto defer the case for24.07.2014for comments of Departmentof| PPhharmaceutiogts, ecm sane saps [toy[Case No.:70/3/82-ALC4/2014PVT.LTD.[Party Name:S.M. HERBALS /ALC4/2014[Meet No/Date:3/82- —(Status:Case|‘Approved | | THQ File IRLA File ~ “Lie.No/Date:0510379128 [Defer Date: 4 -01/82/050/00074/AM15/ :05/24/040/004237AMI14/ 12.02.2014 4 i | Decision : In the light of earlier decision taken in meeting no, 16/82 dated 21.11.2013, it was | decided to ratify norms under Para 4.7 of HBP v | as per details given below or as applied by the’ | ifirm, whichever is less: | | | Export product Exp. SLNa. | import items Qty. i | Aty. allowed | | 1 eyinofine Based ikg 1 Quincline Based Alkaloid - 1.0346 ke | i: ‘|4; ChemicalCamptothecin} ( Camptothecin% [(][Chemical][)] A: || ) (NMT 95 %) | | HPLC Purity Not Less | Than 98.5% | 1" (CaseNo.:48/3/82-ALC4/2014 Party Name: VIVIMED LABS Mest No/Date:3/83- [Status:Case 4 (LIMITED JALC4/2014 ‘(Deferred | 11951BOL/82/050/00052/AMIS/HQ File :09/24/040/00S82/AMI4/JRLA File ~~ {Lie(12.02.2014No/Date:0910059263(DeferDate:24.07.2014 | | [Decision :it was decided to defer the case for 24.07.2014 for comments of Department of -_Case Noi 125/82 (Party Name:VIVIMED LABS Meet No/Date3/82- Status:Case | / lALC4/2014 “LIMITED 1ALC4/2014 ‘Deferred | is HQFileREA File Lic. No/Date:0910059262 (Defer 4 | pOI/82/0S0/00116/AMI5/ |:09/24/040/00564/AM14/ 12.02.2014 (Date:24.07,2014) | Decision iit was decided to defer the case for 24.07.2014 for comments ofDepartment of i |("Case No.s183/82- ——~=~S*Paty Name:ADCOCK Meet No/Date:3/82-[Status:Case| |ALCan014 ‘INGRAM LTD, JALC4/2014 ‘Approved to : 08.05.2014 4 j || jHQ801/82/050/00022/AMI5/ File — :07/24/040M041/AMI4/aRLA File 13.02.2014|Lic.No/Date:0710102145Defer Date: | 4 53 Decision : In the light of earlier decision taken by NC in its 31/82 meeting dated | | (21.02.2013 , it was decided to ratify norms under Para 4.7 of HBP v1 as per details | | given below or as applied by the firm, whichever is less: | | ‘4 Export product Exp. | SI.No. | import items Qty. allowed | Lf ary. | ----- End of picture text -----

||<br>[Paracetamola50 = ]2—«[1.<br>Doxylamine Succinate USP/Ph. [510mg<br>|<br>|<br>; mg+Doxylamine<br>no,<br>EurGrade<br>||
|---|
||<br>| Succinate 5<br>of<br>[2.<br>CaffeineAnhydrousBP<br>30.6mg<br>|<br>|<br>| mg+Caffeine30<br>tabl<br>- |2010/USP/EP/PH. EUR/BP<br>i<br>|: mg+CodeinePhosphate |et<br>3,<br>Cadiene Phsophate<br>10.2mg<br>i<br>|<br>| 20mgrColour<br>BP/USP/EP/PH. EUR<br>|<br>|<br>i quinolone Yellow 2mg<br>4.<br>Color QuinolineYellowCl<br>2.0mg<br>|<br>1-4 Tablets<br>47005<br>/<br>|_.RAmaytakeappropriate actionas perthedecision<br>of Norms Committee,|
|(CaseNo.:208/82-<br>|Party Name:FORACE(Meet NofDate/2- ~~[Status:Case|<br>{ALC4/2044<br>POLYMERS(FP)LTD.<br>JALCA/20ig<br>{Deferred<br>4|
|i354.<br>HQ File<br>wT<br>IRLA File<br>—<br>Lic.No/Date:0510379284Defer<br>|<br>|<br>(O1/82/050/00209/AMIS/<br>—:05/23/080/00466/AM14/<br>13.02.2014———_Date:24.07,2014<br>|<br>|<br>(Decision :Itwasdecidedtodeferthecasefor24.07.2014forcommentsof<br>\<br>|<br>Petrochemicals DivisionofDepartmentofChemicalsandPetrochemicals ||
|1<br>(Case No.:2/3/82-ALC42014 [PartyName:SCOTT-EDIL<br>[MeetNo/Date-3/83-(Status:Case.-<br>oo<br>PHARMACIALTD.,<br>(ALCA/2014<br>Deferred<br>4|
|[355°<br>HO File<br>RLAFile<br>[Lic.No/Date:2210014609[Defer<br>i<br>4<br>01/82/050/00006/AM<br>I5/<br>222/24/040/00089/AM14/<br>113,02.2014<br>(Date:24,07.2014]<br>|<br>Decision :Itwasdecided todeferthecasefor24.07.2014 forcommentsofDepartmentof|<br>(Pharmaceuticals,|
|"aseNo.:73/3/82-ALC4/20:14(PartyName:ARENE<br>LIFE Meet No/Date:3/82-<br>Satucse<br>14<br>“SCIENCESLIMITED.<br>JALC4/2014<br>‘Deferred<br>i|
|356 HQFile<br>|RLAFile<br>‘Lic,No/Date:0910059285 [Defer<br>|<br>|<br>SOL/S20S0/0007V/AMIS/—:O9/24/040/00536/AMI14/<br>[14.02.2014<br>“_Date:24.07.2014,<br>:<br>Decision :Itwasdecidedtodeferthecasefor24.07.2014forcommentsofDepartment of|<br>( Pharmacemticals,<br>eps<br>ooo<br>||
|[Case Noz131/3/82-——~=~S*SPartyName:ASTRIX<br>(Meet No/Date:3/82- —‘(Status:Case<br>|<br>JALCa2014<br>|LABORATORIESLTD.<br>—_ALC4/2014<br>(Added<br>||
|as7HQFile<br>~IRLAFile<br>‘Lic. No/Date:0910059289(Defer<br>|<br>|<br>POW/82/0S0/00135/AMI5/<br>-09/24/040/00S76/AMI4/<br>14.02.2014<br>Date:24.07.2014<br>|<br>‘Decision<br>:Itwasdecidedtodefer thecasefor24.07.2014forcommentsofDepartment of|<br>(<br>Pinarmacenticas.<br>eps sptnppgeessiics<br>susticesseec|
|("CaseNo.:9/3/82-ALC4/2014(Party NameSMILAX<br>MeetNo/Date:3/82-—=“Status:Case|<br>fo<br>)LABORATORIESLIMITED |ALC4/2014<br>Deferred<br>|<br>ss<br>eeeeSe<br>|<br>jHQFile<br>==—————<“CS~*é‘éRRLA<br>PileSS”*~*~*~*CL:<br>ieNoo/Date-0910059308 Deer<br>|<br>|<br>:01/82/050/00013/AMI5/<br>—_:09/24/040/00584/AM14/<br>14.02.2014<br>_ (Date:24.07.2014<br>west<br>ieeeeennnmnceeee<br>DCE<br>SIR<br>an|

_og. [DecisionPPmarmmacenntica:It wasdecided seusto defer thecase for24.07.2014psfor commentsseofDepartmentof | : Tease |Noz63/982-ALCA0L4 ary Name:TADIMETY Moet Nobsie3/82-StatuscCase Po JAROMATICS PVT. LTD )ALC4/2014 JApproved | |josHQ(:01/82/050/00067/AM File —RLAFile1 5/ 41:07/24/040/00425/AM14/SSS -414,02,2014LieNo/Date:07101021684(Defer Date: : | {Decision : In the light of written comments received from Department of Chemicals and | | ‘Petrochemicals vide their U.O No. 14010/57/2010-Ch. 1 dated 10.02.2014, it was decided to, | uratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | P59 ‘whichever is less: | | | Export product Export | S.No, | Import items Quantity ; _ Quantity Allowed || | ' Phenoxy Ethyl ISO Butyrate ] ISO Butyric Acid 0.498 kg |

[Case No.218/382-ALCA2014 Pary Name:ANUPAM (Meet NovDate:3/82- ~[Statns:Case| gf IRASAYAN (INDIA) LTD HALCA/2014 sApproved | ‘HQ File ~IREAFHe ~~ ALje, No/Date:52 10040759 ‘Defer Date: | | :01/82/050/00222/AM 1 5/ 1:52/24/040/00048/AM 14} 417.02,2014 4 4 | Decision < In the light of written comments received from Department of Chemicals and! | ‘Petrochemicals vide their U.O No. 14010/30/2013-Ch. Il dated 20.02.2014, it was decided to) || (rattywhichevernormsis tess: under Para 4.7 of HBP v1 as per details given below or as applied by the wm: : | Export product Export | S.No. | Import items Quantity | 4 , Quantity Allowed | | 2AMINO-4-TRIFLUORO METHYL4 — | | kg Sa 1.232 kg / . | | CHLORO DIPHENYL ETHER DENZOTRIFLVORIDE | i 2. 0.803 ke) : | PARA CHLORO PHENOL L __Ramay take appropriate action as per the decisionof Norms Committee. | (7l€aseNo.:127/3/82- SS PantyNameNECTAR "~~ [Mest No/Date-382-“/Status:Case + JALC4/2014 (LIFESCIENCES LIMITED, JALC4/2014 Deferred j te (805204 GgeHQFie = = IRLAFile =—SS™S~SC*wL ie No/Date 2210014613 Deer | | [01/82/050/00131/AMI15/ ——_/|:22/24/040/00091/AM14/17,02,2014 “Date:08.05.2014 | | (Decision : It was decided to defer the case for 24.07.2014 for comments of Department | . | [of Pharmaceuticals. cs uuusssnststgusegunspinaneassssesssascage an | wets ee

tog | JALC4/2014 “Approved | |_ 1HQ File IRLA File “LicNo/Date:0710102209‘DeterDate:| | ROLB2/050/00008/AMIS/ _:07/24/040/00420/AM14/ _ se HA TO2204 : Decision : In the light of earlier decision taken by NC in its 16/82 “meeting date, 3 ell 1.2013, it was decided to ratify norms under Para 4.7 ofHBP v1 as per details given | 82 below or as applied by the firm, whichever is less: | ||| Export Product Export | S.No. | Import items Qty. allowed | | | Clomipramine Hel | Tg. 1 Bromo 3 Chioro Propane 0.85 kg j 1 | 3 Chiora iminodibenczyl 0.91 kg [Case No.:29/3/82-ALC4/2014 [Party Name:R L FINE CHEM"Meet NofDates/82-/StatusrCase to | JALC4/2014 [Deferred | |363HO File —IRLAFile (Lic.No/Date:0710102208(Defer | | 301/82/050/00033/AMI5/ POT24040/00422/AMI14) (17.02.2014 _Date:24.07.2014, (Decision It was decided to defer the case for 24.07.2014 for comments ofDepartment of | ("Case No.31/3/82-ALC4/2014 [Party Name L FINE CHEM Meet tod No/Date:3/82-‘[Status:Case | | | i 4ALC4/2014 [Approved } | HOFie “IRLA File ie Novidate:0710102207 ‘(Defer Date: | | :01782/050/00035/AMIS/ POTRAAONOAAAMIA, (17.02.2016 | [Decision i (n the light of earlier decision taken in meeting no. 1/82 dated 04.04.2013, it was decided to PO (ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is | ess: | 1 3} Export product Exp, Qty. SIL.No. | Importitens aty. : 1 | allowed | | | Doxilamine Succinate 11 Kg. 2 Acetyl Pyridine 0,58 kg f | | BPruSsP Tetrahydrofuran 1.03 kg | i __Ra may takeappropriate actionas per thedecisiof N o rmsn Committee, coeptisttiseiece i 4 PHARMA LIMITED ALC4/2014 Approved | HQFile a Fie Lic. No/Date:0910059336 ‘Defer Date: | | ROMS2/0S0/00132/AMIS/ | 09/24/040/00563/AMI4/ 18.02.2016 365; Decision ; The Committee considered the case ag per agenda and in light of writtense comments’beepers | lreceived from Department of Pharmaceuticals vide their OM No. 35011/4/201 i-PI(Norms) dated | | /28.11,2011 and in consultation with technical authority present in meeting, decided to ratify. morms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-:|

==> picture [437 x 614] intentionally omitted <==

----- Start of picture text ----- | [ecoieee SoaISTSeeaioe) | | Tenofovir Disoproxil | 4 Kg. a | | Fumarate (R)-(4)-Propviene Carbonate 0.7938 kg | togfy (4.| Carbon Enoanticormgs( Activated Carbon) |O.016kg ne 2.0867 kg | 14 Diethyi-p-Toluenesulfonyloxymethyl 2.025 kg i Phosphonate : 14i | 9. |Acetateisopropyi haa ke | Methane Sulphonic acid [0.7074 kg | i : 14. rag[Toews od 16.15. Wvtaniae_—_ 006g] | Stean/Thermal Coat. (Non. Cooking)Conus AsPolicper Fuel || i. RA concerned may lake further necessary action as per above decision ofNC, sty | [CaseNo.r130/3/82- "Party Name:AUROBINDO [Meet NovDaieaiai~~ Status:Case | i dJALC4/2014 iPHARMA LIMITED (ALCA/2014 {Deferred 4 1366| HO File ~IRLA Fite — [bic No/Date:0910059321 [Defer | ‘0 VB2/050/00134/AMIS/ pO%24/0A0/00S87/AMI4/ 18.02.2014—— _|Date:24.07.2014 i. [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of Pharmaceuticals, | (Case No.:242/8/62- “panty Names CABILA"Meet No/Date:3/82. ~~ (Status:Case | | JALC42014 (HEALTHCARE LTD., (ALCanoi4 (Deferred | 367 (HQ File ARLA File ~~ {Lic No/Date:08 10128924 (Defer. “| | GO182/050/00246/AMI5/ -08/24/040/00S05/AM14/ co,f8022014 __Date:24.07.2014, | ‘Decision :it was decided to defer the case for 24.07.2014 for comments ofDepartment of | | Pharmaceuticals, i [ Case No.t66isa- ~~~ ars NanesViva¥ ~~~ ee NofDasei85-”IGinaace | JALeanor (PERFUMES PVT.LTD. —ALC4/2014 Deferred {|beg|e HQFile eeRAGeFile sestonLie:(08052018 No/Date:03 10770668oe(Defer ~~| | -$01/82/050/00170/AM15/ 1:03/95/040/00916/AM tay 80220104 _ Datei? 072014) Decision :it was decided to defer the case for 24.07.2014 for comments of Department of| ESS a osc eet teagan eames [Case No:82//2-ALCA7014 Pary Nane:ALEMBIC ~~ Nice No/BatSili: ~~ Siac - : |PHARMACEUTICALS LTD |ALC4/2014 (Deferred. | L_HQFile TnRLATite pee ae ----- End of picture text -----

==> picture [414 x 582] intentionally omitted <==

----- Start of picture text ----- | ‘Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of ; [Case No.:68/3/82-ALC42014 [Party Name: HETERO LABS‘Meet yd No/Date:3/82-(Status:Case | ‘LIMITED JALC4/2014 ‘Deferred | 's70 HO File RLAFie ~Lic.No/Date:0910059337 Defer “| : 01/82/0s0/000697aMA5/_ ADPAAOAO/OOSOSIAMIA! (19.02.2014 __(Dates07.08.2014) | Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of | | (Pharmaceuticals. | (Casei No.:124/3/82-ALC42014 PartyName:MYLAN [Meet No/Date:3/82-” Status:Case | Fc “LABORATORIES LIMITED /ALC4/2014 “Approved | ue bene 080820 esses! | [HQ File REAFile Lic.No/Date:0910059354 Defer Date: | | ROUB2SO/DOIZ8/AMIS/ :09/24/040/00581/AMI4 (19.02.2014 ee : | ‘Decision * in the light of earlier decision taken in meeting no, 13/82 dated 03.10.2013, it was decided | 4 ito ratify norms under Para 4.7 of HBP vi. as per details given below ar as applied by the firm, whichever is 4 ‘Hess: | | ‘| Export praduct Exp. SiLNo. | Import items Qty. allowed | | Qty. kg/kg | | | Sodium borohydride 0.331 tog D {-) Mandelic Acid 0.392 | Case No.125(3/82- Party Name: MYLANMeet No/Date:3/82- ~[StatusCase | (ALC42014 [LABORATORIES LIMITED (ALC4/2014 Deferred i b22HQFile RA File SSS ‘Lic.No/Date:0910059353 | Defer 1 | f0182/0S0/00129/AMIS/ _09/24/040/00S70/AMI4/ 19.02.2014 Date:24.07.2014 | | [Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of (Pharmaceuticals. i ‘rte ttn yet estan yaa ennasranaunnsticrnnvanesnainasnincn yysntotgs sitet ynontataatedCnnsortnsonmatnans ees eubvementsietatiat ed tbat | (ALC4/2013 ‘LABORATORIES PVT LTD. |ALC4/2014 Deferred | b73,HQFile REA File (Lie. No/Date:0910059356 ‘Defer | HO1/82/0S0/01094/AM14/ __-09/24/040/00S8S/AMI4/ 19.02.2014. cages, OANE2A.07,2014 | Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | (Pharmaceuticals, | ----- End of picture text -----

==> picture [450 x 635] intentionally omitted <==

----- Start of picture text ----- 95 Fi| JALC4/2014[Case No.:216/3/82- ‘(Name:SENTISSPHARMA[Party (ALC4/2014eal© {Deferred(Status:Case 4| e714 HQFile RLAFile SSS Lie No/DDate:0510379833 Defer— | ROV82/0S0/00220/AM15/ :05/24/040/00431/AMI4/ 19.02.2014 ‘Date:24.07.2014) | Decision:It was decided to defer the case for 24.072014 for comments of Department of Pharmaceuticals, | [Case No.:126/3/82-ALC42014 Pary Name:ADCOCK "Meet No/Dates@2- ~~ (Status:Case fo INGRAM LTD, ALC4/2014 (Approved | || THQ PieREieLie. No/Date:0710102311 Defer Date: | OM/82/0s0/00130/AMIS/ LOTRAMAYIONRIAMI4 21.02.2014 ee ee Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.05.2013, i ‘was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as! japplied by the firm, whichever is less: | | Export product Exp. SLNo. | Import items Qty. - | | | Paracetamol 450mg+ | 1 1. Doxylamine Succinate USP/Ph. [S.10kg || ||| | DoxylamineSmg+ Codeine Succinate _| tablets | CodieneBP/EP/USP/PH.EUR Phsophate ees || . | | Phosphate 10mg Tablets | Colour Yellow 14037 TH ae ly75|| Codeine Phosphate million Eur Grade oH : | 10mg+ Caffeine 45me+ | tablets [2. ~ | Codiene Phosphate 10.2 kg | = 4. Colour Quinoline Yellow WS 4.56kg |, | | (spectracol) | | | Paracetamol 450mg+ 1 | Doxylamine Succinate USP/Ph. pike | | | Caffeine 50mg + million £Ur Grade ; | || Doxylamine Succinate | tablets [2. Codiene Phosphate 10.2 kg E || Phosphate 10mg Tablets 3. Colour Yellow 14037 TH Do not i po MBF ; | | Paracetamol 450mg + i 1, Doxylamine Succinate USP/Ph. | 5.10 kg | | | Doxylamine Succinate | tablets | | | Smg + Codeine 2. Codiene Phosphate 10.2 kg | . ||RA may take appropriate action as per the decision ofNonms Committee, ----- End of picture text -----

==> picture [424 x 627] intentionally omitted <==

----- Start of picture text ----- [[Case No.:86/3/82-ALC42014 Party Name:AKZO NOBEL Mee No/Date 38.“ Se“| 1 4 JINDIA LIMITED ALC4/2014 ‘Deferred | 1576 HQ File IRLA File ‘Lic.No/Date:0210200380 Defer ~ F | borS2MS0/00090/AMI5/ FO2/24/040/00197/AM 14s 121022014 ‘Date:24.07,2014) (Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | | ‘ALC4?2014 ‘| JALC42014 (Deferred | hOWs2/050/ 377/BQ File oo IRLA File saecrs.,,,, (ieNo/Dates0810129084 Delse 4 / DO245/AMIS/ 08/24/040/00483/AM14; 21022014 (Date:24.07.2014 Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | |[CaseNow 17/3/82.© Barty NametEYTAN LABS MeatNo/Date:3/82-[StatusveaseDeterred! JALCanor4 LIMITED 1ALCA/2014 j 4 |(378HO File (RLAFile ia) Lit NoVDaie:0910059370 [Deter Dates | 01/82/050/0002 1/AMIS/ _ ‘09/24/040/00561.AM14/ ANO22014 07082014 | [lt was decided to defer the case for 24.07.2014 for comments of Department of! | | , (CHEM-TECH LTD. - JALC4/2014 Approved | | :01/82/050/00244/AM15/ san, (CS | BQFile RLAFile — » LieNovDate:0810129083 Defer Dae | | AMOAV/O0SOO/AMI4/ (21022014 | | ‘Decision > in the light of written comments received from Department of Chemicals and) : [Petrochemicals vide their U.O No. 14010/60/2012-Ch. Il dated 28.01.2014, it was decided to! | ‘ratifywhichever normsis underless: Para 4.7 of HBP vi as per details given below or as applied by the firm, | 1 | | | Export product Export [| §.No. Quantity i | Quantity Allowed || | DASA (44 DIAMING SULFANILIDE) 2 | asiume on 0,468 kg | Aes‘otantniagnatnceccsonnc yin ader ua acrita weet mycoses | JRA may take appropriate action as per the decision of Norms Committee, ; ele se amen. Ten it esis act cnet teenage cal (380; ‘LIMITED JALC42014 ‘Deferred | oe ee 08052014 eed ee 6 cnc ----- End of picture text -----

==> picture [405 x 633] intentionally omitted <==

----- Start of picture text ----- 97 | -OI/82/050/00019/AMIS/ __209/24/040/00598/AM14/ (21.02.2014 __Datex24.07.2014) ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | | (Case No.116/3/82-ALC4/2014 Party Name: VIVIMED LABS [Meet No/Date:3/82-‘Status:Case4 po LIMITED sALC4/2014 (Deferred | [chiang fuasinnneeec, O8OS204 Iza) -ROL/B2/050/00020/AMI5/HO File IRLA -09/24040/00S92/AMI4/File ~[Lie.No/Date:0910059375 21.02.2014 Date:24.07.2014)Defer | [Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | | (Pharmaceuticals. "ICase No.:236/3/82-ALC42014 PartyName:CADILA (Meet No/Date:3/82- —-‘Status:Case 4 | {HEALTHCARE LTD., JALC4/2014 Approved — | 1HQ File oo TIRLAFile SS”S~™~™*CSLiec No /DDate:08 10129091 “Defer Date: | | :01/82/050/00240/AM15/ (:08/24/040/00516/AM14/ ‘(24.02.2014 | | (Decision 3 In the light of earlier decision taken by NC in its 19/82 meeting 02.01.2014, it! | lwas decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as! | ‘applied by the firm, whichever is less: | | | Beoort Product | | Topriamate 25mg SO MG, 100 MG and 200 MG Tablets | | | Import items Norms recoramended for 1 No. Tablets p82. 25 mg Tablets |50 mg Tablets | 100 mg 200mg || Po Tablets Tablets ‘ re MICROCRYSTALLINE 75 15.0 30.0 | 4 CELLULOSE NF (AVICEL | i PH 102 | y 48 MICROCRYSTALLINE 8.25 16.50 33.0 | 44 CELLULOSE NF (AVICEL | 1 4 PHARMATOSE DCL-21 | ES | BOTTLES & CAPS Relevant, As per packing poficy. lL. [RA may take appropriateaction as per the decision of NormsCommittee, [Case No.:237/3/82- —~=—~=~=SParty Name:CADILA (MeetNo/Date:3/82-_—-Status:Case 1 JALC42014 IHEALTHCARE LTD., JALC4/2014 Deferred | ee eea BS| pONB2OSO/00241/AMIS/ HQFile ~~ ——:08/24/040/00523/AMI4/RLAFile ==———S—S~SCS 24.02.2014Lic. No Date0810129092(Date:24,07.2014)[Defer | | Decision :It was decided to deferthe case for 24.07.2014 for comments of Department of) ----- End of picture text -----

==> picture [412 x 602] intentionally omitted <==

----- Start of picture text ----- 98 1[/ [Case4 Nos163/a/@2-ALCa014 “CHEMICALSParty Name:SIRMAXO PVT LTD "MeetJALC42014No/Daies/62-—ApprovedStatus:Case|| || [HO Fite~ - RLAFHe © Lic-No/Date:0310771502 Defer Dates | ROLMS2/050/00167/AMI5/ —:03/95/040/00935/AMI4/ 24.02.2014 | [Decision : Committee considered case as per agenda and in consultation with technical A ‘authority present in meeting decided fo. ratify norms under para 4.7 of HBP as per details given: below or as applied by the firm, whichever is fess~ | :| Export product Export | SLNo. | Importitems | Quantity Allowed | i Qty. | | Povidone lodine 10% Solution | ikg | 1. Povidone 1.02 kgper kg | | (Available lodine NLT 1% w/v) lodine contained in the |! i _ RAconcerned may take further necessary action as per above decisionofNC. 14 |CHINTAN PHARMA CHEM /ALC4/2014 (Approved | THQ File ~~ (RLAFile Lic No/date:34 10039342 (Defer Date: | | -sO1/82/050/000S7/AMI5/ :34/24/040/00277/AMI14/ 24022014 | Decision * In the light of written comments received from Department of Chemicals and) (Petrochemicals vide their U.O No. 14010/37/2014-Ch I dated 21.05.2014, it was, (decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied| ‘ses BY the firm, whichever is less: | 4 Export product Exp. SI.Na. | Import items Qty. | ‘ Oty. allowed | | RCCL CAT- 18 METHYL ike 1 “ALAMINES36 or 0.845 kg || | | TRIOCTYL AMMONIUM TRE Octyl Decy! Amine Tri (C-8, C- | | o|| METHYLCHLORIDE) TRI (C-8, C-10) ALKYL 10) ALKYL AMINE |: | AMMONIUM CHLORIDE CAS No, | || 63393-96-4 ASSAY 88 - 92% | | :IRA may take appropriate action as per the decision of Norms Committee, | |, ALC4/2014(Case'No.:105/3/82-~—~—~—~=S PartySPHARMA-CROName:THINQ. LIMITED {ALC4/2014[Meet NorDatese2- Deferred(Status:Case|4 bs6/HQFile ==———<—~*‘s‘WRLAidle SS~™S~CSCS LicNep/DDate0310771596(Deer | | (Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | ----- End of picture text -----

==> picture [416 x 605] intentionally omitted <==

----- Start of picture text ----- |||CaseNo:1613/82-Party NameUNIMAXMeet No/Date:3/82- Status:Case | JALCa/2014 “CHEMICALS PVT LTD. JALC4/2014 ‘Deferred | bh esnais baugeees 387 ues, 108.05.2014- ee— | HQ File IRLA File - «Lis. No/Date:0310771527 [Defer| 01/82/0S0/00163/AMI5/ FO3/95/040/00889/AMI4/ 24.02.2014 apg HOAUEIZA.07,2014 Decision | :It was decided to defer the case for 24.07.2014 for comments ofDepartment of || (Case No.:233/382- Party}Name:CADILA [Meet NovDate/82- ~~ (StatustCase | ALCA/2014 "HEALTHCARE LTD., IALC4/2014 ‘Deferred | bss HQFile= IRLA File _ Lie No/Date:0810129185 [Defer —— i to 1/82/050/00237/AMIS/ HO824/040/0052G/AMI4/ (25.02.2014 ey, Date24.07.2014 | Decision It was decided to defer the case for 24.07.2014 for comments ofDepartment of | Louw fPharmacetice gto susp csesmmasaaad | [Case No.80/882-ALCHR014 any Name:ONEIRO~~" [Meet No/Date3/82. /Status:Case | fod (CHEMICALS LTD (ALCa?2014 (Approved | eeee sesesigcrgce lOO OSOON | | HOFie “'REAFie Lie. No/Date:3410039346 {Defer Date: | | [O1/82/0S0/000S4/AMIS/ _FB424/0400028/AMI4/ 25.02.2014a ee 4 ‘Decision > In the light of earlier decision taken by NC in its 1/82 meeting date 08.05.2014, it was | (decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the sfirm, | “Wwhichever is tess: | 399) Export product Export Qty. Import items Qty. allowed | [Eeiieoneiss Ake sss’*§ —— i RA may take appropriate action as per the decision of Norms Committee. 4 : ; PHARMA LIMITED jALC4/2014 ‘Deferred ' to] | {08.05.2014 | i 390 | /HO File IRLA File [Lic.No/Date:0910059417 ‘Defer | | :01/82/050/00018/AM15/ ses OS2MOSO/O0SB9/AMI4E (25.02.2014 _ __(Date:24. 07.2014) ‘Decision It was decided to defer the case for 24.07.2014 for comments of Department ofi L_Phammaceuticas a po\Case No.:234/3/82-ALC4/2014 Party NomeTORRENT [Meet No/Date:i/82-StatussCase' B91) (PHARMACEUTICALS LTD. ooanl4 2 Approved ----- End of picture text -----

100

==> picture [429 x 576] intentionally omitted <==

----- Start of picture text ----- | :01/82/0S0/00238/AMIS/ ——_—|:08/24/040/00503/AM14/ 125,02.2014 f | | ‘Decision :Committee considered case as per agenda and in consultation with technical authority | | jpresentjwastage.in meeting decided to ratify norms under para 4.7 of HBP as per SION A-412 with 2%; io _[RAconcemed may take further necessary action as per above decision of NC. ad : PleaseNo.:238/3/62-ALCA/2014 [Pary Name:TORRENT Meet No/Date:3/82- StatusiCase | | | “PHARMACEUTICALS LTD, jALC42014 Approved i | {HQ File . “IRA File ~ je. No/Date:08 10129132 ‘(Defer Date: | A, 92 01 /82/050/00239/AM1 5/ “108/24/040/00502/AM14/ : 25.02.2014 4 | ‘| ‘Decision :Decision ‘Committee considered case as per agenda and in consultation with } technical authority present in meeting dacided to ratify norms under para 4.7 of HBP as per SION! { A412 with 2% wastage. : L. IRA concerned may take further necessaryaction as per above decisionofNC. etessusasagel [ease Noxi397782- ~~ Party NamesHETERO LABS Mest No‘Date3/@3-(StatusiCase ; (ALC4/2014 ‘LIMITED IALC42014 ‘Deferred j B93 HQFile ~RLA File” Lic No/Date:09 10059425 (Defer - | [ ho1/s2/0s0/00133/AMI5/ fOSAAOAOQOGOS/AMIAS 26.02.2014 (Date:07.08.2014 [Decision : It was decided to defer the case for 24.07.2014 for comments of Department; lof Pharmaceuticals 7"fo\Case No78/3/82-ALC4/2014[Party Name:HIPL ADDITIVES Mest No/Date:382-"/StatussCase| | ‘|LIMITED(FORMERLY /ALC4/2014 ‘Approved | || [HQPieete eeREAKNOWNFile HIGH POLYMERSSCS(08.05.2014AesNov/DDate05 10380295 | ‘(Defer Date: | | 101/82/050/00082/AMI5/ _ _:OS/23/040/00477/AMI4/ 26.02.2014ee t 4HDecision ; in the light of written comments received from Department of Chemicals all | . 4 f Petrochemicals vide their U.O No. 14010/7/2011-Ch. | dated 26.03.2013, it was decided to! | ratty norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | iwhichever is less: | 41394: - : - ‘i Export product Export | S.No. | Import items Quantity i | | Quantity Allowed |} || 13.S-TRIMETHYL2,4,6-TRISG,S-DE | 4 ke PHENOL | | || TERT-BUTYL-4-HYDROXYBENZYL) O.172kg | | | BENZENE (KINOX-30) PE) 26% A i... RAmay take appropriate action as perthe decision of Norms Committee, ----- End of picture text -----

101

==> picture [413 x 608] intentionally omitted <==

----- Start of picture text ----- | (Case No.:7/3/82-ALC4/2014 PantyName:MYLAN Moet No/Date:3/82- [Status:Case [~~] i | LABORATORIES LIMITED |ALC4/2014 (Deferred | |b9s| :01/82/050/00011/AM15/HQ File IRLA—_:09/24/040/00604/AM14/ File ~ [Lic.No/Date:091005942726.02.2014 ‘Date:24.07.2014|Defer | | Decision ‘It was decided to defer the case for 24.07.2014 for comments of Department of | ("Case| laucaoi4No.:132/3/82- [REMEDIES——~=~=«SPartyName:VENUS LTD., —~—~(MeetJALC4/2014No/Date:3/82-Status:Case(Deferred | |[396 WO182/050/00136/AMI5/|:22/24/040/00088/AMI4/HO File “IRLA File ~~ "Lie.26.02.2018 ——Date:08.05.2014 [No/Date:2210014635] [Defer | [Decision iit was decided to defer the case for 24.07.2014 for comments of Department of | {Pharmaceuticals , i[caseNo.:5/3/82-ALC4/2014 Party Name:INDO PHYTO [Meet No/Date:3/82- (Status:Case | i ICHEMICALSPVTLTD —-|ALC4/2014 (Deferred | 307| HO File IRA Fille "Lig. NofDate:0510380433 Defer ' HO1/82/0S0/00009/AM15/ —:05/23/040/00494/AMI4/ [27.02.2014 ‘Date:24.07.2014| | (Decision It was decided to defer the case for 24.07.2014 for comments ofDepartment of | Pharmaceuticals | |pojeee Nostra ALcantis [Party(CHEMICALS NameINDO PYTPHYTO LTD (MeetHALCS/2014No/Date:3/82-‘ApprovedSStatus:Case | | [HQ File URLAFIe {Lic.No/Date:05 10380432 — [Defer Date: | | O1/82/050/00081/AMI1S/__1:05/23/040/00490/AM14/ 27.02.2014 sonny sanstbersraapencs | | {Decision : In the light of earlier decision taken by NC in its 16/82 meeting date 21.11.2013, it was} | decided‘iwhichever to isratifyless: nerms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,;| (398) Export Product Export S.No | Import Product Qty. Allowed | | | Quantity ke/ke | ||| Nandrolone ikg Sitolactone Intermediate | | | Phenylpropionate 2. 5-Chloro-2-Pentanone 1.18 | : | Bulk Drug Reagent | | Tetrahydrofuran Solvent 3,157 / ig Pyridine Reagent 0.565 | i TRA may take appropriate action as perthe decision of Norms Committee, | (ICasei No.:227/3/82-ALC4/2014 [Party [Name:TORRENT] (Meet No/Date:3/82- ——‘Status:Case | |PHARMACEUTICALS LTD. jALC4/2014 “Approved — | /HQFile SRA File = S~SC«Sf Lic NoD)ate:0810129230 [Defer Dates hoc: ----- End of picture text -----

102

==> picture [406 x 601] intentionally omitted <==

----- Start of picture text ----- 4 [Decision Decision :Committee considered case as per agenda and in consultation with | jtechnical authority present in meeting decided to ratify norms under para 4.7 of HBP as per SION | | he with 2% wastage. | | RA concerned may take further necessaryaction as per abovedecisionof NC. ne esc | 14 SINDUSTRIES PVT.LTD. jALCA2014 “Approved f ee ne cS), ee | HQFiie REA File SSSCLie,No/Date:0310772324 [Defer Date: | 1:01/82/050/00230/AM15/ —___ :03/95/040/00966/AMI4/ 702.2014 es eee | ‘Decision ; In the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/95/2011-Ch. 11 dated 26.02.2014, it was decided to! | ‘ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, | | iwhichever is less: | 1400! | | | Export product Export | S.No, {| Importifems Quantity | | 3 Quantity Allowed || i ikg CLOVE LEAF OIL. 1388kg | |, 4 SO BUGENOL 2 RUTHENIUMPENTANEDIONATEGl) 2,4( 0.001 kg i| 1 ACETYLACETONATE | Lo Ieamay tate appropriate action as per the decision of Norms Committee, | ["\Case No.:162/3/82-arty Name:Zibi [Meet No/Date:3/82-—“[Status:Case [ALC4/2014 ‘LABORATORIES LTD. laLcazo14 {Deferred | | | Ceca hie, (0805201 lgorHQFile “IRLAFie ————S~S~S~S~S*«Lic No DDate0310772330 (Defer 4 4:01/82/050/00 166/AM1 5/ 1:03/95/040/00967/AM14/ 127.602.2614 Date:24,07.2014) | Decision sIt was decided to defer the case for 24.07.2014 for comments of Department of | [Pharmaceuticals sue usesusppnppitsigpssssssssss| [Case No.:79/3/82-ALC4/2014 Party Name:GLAND Meet No/Date:3/82- ——‘(Status:Case i { . iH 4 4 ee (PHARMA LIMITED (ALC4/2014 Deferred i “4ov/HQFile =—————<it~=‘“‘s RA WR ~(Lic.No/Date:0910059455 [Defer : { $01/82/050/00083/AMIS/ L09/24/040/G0610/AMI4/ (28.02.2014 (Date:24.07.2014 | [Decision :It was decided to remind the firm to furnish Central Excise Data and also | | [Batch Log Sheet for last 5 batches . The case was deferred for 24.07.2014 | [ [ease No133(/82- Party Name:NECTAR (Meet No/Date:3/82-‘Status:Case | 4 ALC42014 aLIFESCIENCES LIMITED, |ALC42014 “Deferred 4 (403-1 File OT IRLAFile ~~ Lic.No/Date:2210014646. Defer j | -SOUVR2/0S0/00137AMIS/ —(:22/24/04000096/AMI14/ (28.02.2014 (Date:24.07.2014) |_ Decision :1t was decided to defer the case for 24.07.2014 forcommentsof Department of | ----- End of picture text -----

103

==> picture [1 x 1] intentionally omitted <==

----- Start of picture text ----- . ----- End of picture text -----

==> picture [410 x 567] intentionally omitted <==

----- Start of picture text ----- 7"4 [CaseNo.:106/3/83-——~SSSatyNamesPERFECT ‘Meet No/Date:3/82-—(Status:Case ‘ALC42014 ‘VITAMINS PVT.LTD. :/ALC4/2014 Deter | loaHQFile RL File ~(Lic.NofDate:0310772411 [| KOL/82/0S0/00110/AMIS/ :03/9S/040/00960/AMI14/ (28.02.2014 Date:24.07.2014Defer | ‘Decision :It was decided to defer the case for 24.07.2014 for comments of Department of | [Casetog No.1077382-ALC42014 (CHEMICALSParty Name-SUPREET PVT.LTD. MestVALC42014 No/Date82-"/StatusiCase‘Approved | || 1HOROL/B2/0SQ/00LLIVAMISS File ~IRLA——:03/95/040/009S0/AMI4/File (28.02.2014[bie.NovDate:03 10772380 |Defer Date: } | Decision : in the light of written comments received from Department of Chemicals and | | [Petrochemicals vide their U.O No. 14010/81/2012-Ch. [I dated 21.05.2014, it was decided to] |405 (ratify norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, | | whichever is less: | : | Export product Export | $.No. | Import items Quantity i 4; Meta Chioro Aniline 99.9% or 3 Chiore Quantitytk Meta Chlora Aniline 99% or | Allowed1.03 kg /i || Aniline 99.9% (MCA) g 3 Chioro Aniline 99% (MCA) i i-—JALCS/2014(Case No.:184/3/82-PartyLABS PRIVATEName:ARUDAA LIMITED VIS j[ALC4/2014MeetNo/Date:3/82-Status:CaseDeferred | lgo(HOFile| POH82/050/00188/AMI5/===——s~—~«C«RLLAA——_:04/24/040/00266/AM14/ite ~~ 03.03.2014Lig. NofDate:04 10155776 “ D ate:24.07.2014efer | | Decision sit was decided to defer the case for 24.07.2014 for comments of Department of Lo Pharmaceuticgls. papain! ("Case No.:214/3/82-—~S*SiParty NamecEMCURE (MeetNo/Date:3/82-—(Status:Case | JALCano14 ;PHARMACEUTICALS LTD. laLcanota |Approved A 4 i 108,05.2014 if | | THQ File BLA File {Lic.No/Date:3 110062874 [Defer Date: | | SO1/82/050/00218/AMIS/ 3 1/83/040/00224/AMIA! 03.03.2004 Messen | ‘Decision in the fight of earlier decision taken by NC in its 31/82 meeting date 21.02.2013 , it | 407 was decided to ratify norms under Para 4.7 of HBP vi as per details given below or as applied by | | ithe firm, whichever is less::- : || Ciprofloxacin HCL One | 1. Ciprofloxacin HCL =| 555.0 mg/500 mg | | | Tablets USP 500 MG $00 (Relevant Bulk Drug) | Tablets i ----- End of picture text -----

104

==> picture [414 x 627] intentionally omitted <==

----- Start of picture text ----- r { contains Cipecdl nas sae a aea | | Hydrochloride USP | a equivalent to |Ag|| Ciprofloxacin 500, mg) 4 |.|RAconcerned may takefurther necessary actionas per above decision ofNC. __ wal | (ALC42014 |CHEM-TECH LTD., jALowoi4 (Deferred | l4og HQFile REA FileLic. NoDate:08 10120315 ‘Defer — a | p0182/050/00232/AMi5/ RO8/24/040/00521/AMI4/ (03.03.2014 sss [Date:24.07.2014) | ‘Decision iit was decided to defer the case for 24.07.2014 for comments ofDepartment of | [ [Case No.:762/82-ALC42014 Party Name: MOREPEN Saect Noa [Status:Case i LABORATORIES LTD., [atcarote [Approved i ee ee ee i sssssssl |ao9 HQ Fite 7 feLa File ~— [Lic.No/Date:0$10380667 [Defer Date: | | SOL/82/050/00080/AMI5/ POS/24/040/00453/AMI4/ 03032014 ee | Decision ‘It was decided to defer the case for 24.07.2014 for comments ofDepartment of} | Pharmaceuticals. | [Ke Nogizzs Pay NaneNANDU ~~ Mee Nat. Sitsiase | JALC42614 (CHEMICAL INDUSTRIES |ALC4/2014 ‘Deferred | lao(HQFile = RLAFie ~"{Lie.No/Date:0710102530 [Defer | | :01/82/050/00126/AM15/ EOTAAMAD/ODFOR/AMI4/ 03.03.2014 lpaeagon204 | [Decision ‘It was decided to send a copy of application again to Department of ; |[Pharmaceuticalsfor theircomments.The case was deferredfor24.07.2014 weed a[Case No.:25/3/82-ALC4n2014 [Party Name:CATAPHARMA (Meet No/Date3i83. StatusCase ae \CHEMICALS PVT.LTD., ALC4/2014 (Deferred | 4uHQFile (RLAFile "(Lic No/Date:3 110062928 (Defer —_ | 0 V82/0SO/00029/AMIS/ __|:31/83/040/00207/AM14/ (04.03.2014 __. Date:24.07.2014| |y4‘Decision :It was decided to call from the firm COA ofimPport item from the foreign& ii |... Supplierfor the relevant consignment. The case wasdeferredfor 24.07.2014 | (Cse No.S/800-ALCAR014 a NaneKLy eet NofDae83-~StatusiCase | a4 -PLASTICIZERS LTD., JALC4/2014 Deferred | 1412| HQ File —RLAFile ‘Lic. No/Date:0510380925 (Defer | | #01/82/050/00062/AMI5/ HO5/23/040/00492/AM14/ 05.03.2014 _Date:08.05.2014; ‘Decision it was decided to defer the case for 24.07.2014 for comments of Department of| ee oe ----- End of picture text -----

105

==> picture [417 x 598] intentionally omitted <==

----- Start of picture text ----- [7booIcaseNo.:86/3/82-ALC4/2014. Party Name:V.D.H. ~~~ (MeetNo/Date:3/82-—(Status:Case_| ee, JORGANICSee PVT. LTD 2)/ALC4/2014 [Approved || | HQ File REA File Pig. No/Date:05 10381002 [Defer Date: | | ROI/82/050/00060/AMI5/ —205/24/040/00464/AM14/ es | ‘Decision : In the light of written comments received from Department of Chemicals andi | {Petrochemicals vide their U.O No. 14010/58/2010-Ch. li dated 02.04.2013, it was decided to! ns Pt norms under Para 4.7 of HBP vi as per details given below or as applied by the firm, {Whichever is less: | ‘| Export product Export {| S.No. | Import items Quantity | | | Quantity Allowed | |]1 4 THYMOL: CRYSTAL G-HYDROXY-P- Lkg | Meta Cresol (M-Cresol). 0785 kBFi CYMENE) | q t ! |_ [RA may take appropriate action as per the decision of Norms Committee. eeu P"Caseot No.:219/3/82-ALC4/2014“ENDUSTRY[PartyName:TRANSPEK LIMITED jALC4/2014[Meet No/Date:3/83-—(Status:CaseJApproved | | -:01/82/050/00223/AMIS/THQFile ——s—<“—s~=ti‘“‘<s;~*SRLA:34/24/040/00289/AMI4/ WRdle:=SS~*~S~S~S~SCS(06.03.2014Lc NDate 3410039436 ‘Defer Date: | | (Decision : in the light of written comments received from Department of Chemicals and! { 'Petrochemicals vide their U.O No, 14010/6/2011-Ch. I dated 21.05.2014, it was decided to! hae tty norms under Para 4.7 of HBP vi. as per details given below or as applied by the firm, | whichever is less: | | Export product Export | S.No. | Import items Quantity | | 4 Quantity | - Allowed | | WALERYE CHLORIDE tk 1. VALERIC ACID 0973kg |. 1 LIQUID g LIQUID i iZ [RA may take appropriate action asperthe decision of Norms Committee,= }7" i[Case No.:80/3/82-ALC4/2014“LIFESCIENCESParty Name:NECTAR LIMITED,Meet~ALC4/2014No/Date:3/82-—(Status:Case‘Defer { aisHQFile=RLA File = Lic.No/Date:2210014660 | (01/82/050/00084/AMI5/ —:22/24/040/00095/AMI4/ 10.03.2014 Dat[D e fer:24.07.2014,— |{fF Pharmaceuticals.Decisioni : It was® decidedcin to defer the casepssst for 24.07.2014 for commentsetagatsaspisrinasse ofDepartment |i [ [ease No.S/1/82-ALC42014 PantyNameiSD (Meet No/Dares3/82-(Status:Case! 4 : INTERMEDIATES FALCA/2014 iApproved i er0) | HO File "REA File “Lic. No/Date:34 10039464 Defer Date: | FOUS2/0S0/0124T/AMI4) ——[34/24/040/00297/AMI4) 10.03.2014 eottinassna ----- End of picture text -----

106

==> picture [425 x 613] intentionally omitted <==

----- Start of picture text ----- 4 [Decision : In the light of written comments received from Department of Chemicals and, | |Petrochemicals vide their U.O No. 14010/15/2014-Ch. il dated 27.05.2014, it was decided to ‘ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the frm, whichever is fess: | | | Export product Export | S.No. | Import items Quantity | bo Quantity Allowed || | [2 SDICHLOROBENZOIC 9 | |... RAmay take appropriateaction as per [the] decisionof Norms Committee, “este gsc | "Case No.s12/982-—~~S*iParty Name:SAURAV "Meet No/Dates382-"(Status:Case | jALC42014 {CHEMICALS LTD, VALC4H2014 Approved i ee eit 0805204 | sentausnnsssnsssnsel | THQ File —IREA File ~~ Lic.No/Date:221001465 (Defer Date: - | ho 1/82/050/000 16/AM15/ |2224/o¢oroo0s4vant 14/ 19 | 4 a H003,2014 ee | iDecision : Committee considered the case as per agenda and in the light of written | | (comments received from Department of Pharmaceuticals, it was decided to ratify norms. a7 funder Para 4.7 of HBP v1 as per details given below or as applied by the firm,| (whichever is less: | 4 Export product Exp. [ SI.No. | import items Qty. allowed (kg, by Qty. | | DEXKETOPROFEN Tkg KETOPROFEN 1.78 | | | TROMETAMOL 2. |NOCHYLD- Tose _ GLUCAMINE : i _[RA may take appropriate action 3. TROMETHAMINE 0.36 | as per the decisionofNormsCommittee. 4 [Casefo No.:3/3/82-ALC4/2014Party Name:SHASUN [Meet No/Dawe3/@ Status:Case Fe ‘PHARMACEUTICALS —/ALC4/2014 Deferred | | MIMITED 08.05.2018 a | HO Fie ase, (REAFile i ~~ [Lie.No/Date:0410156078 (Defer | (8 SOUS2/0S0/00007/AM15/ _:04/24/040/00258/AMI4/ 11.03.2014 . ssa |DME24 072014) | Decision in the light of written comments received from Department of Pharmaceuticals | i jvide their OM No, 35011/633/2013-PI(Norms) dated 22.01.2014, it was decided to call | , from the firm a copy ofMaster Batch Formula duly certified by Quality Control incharge. | (°°po[Case No.:633/82-ALC42014 [Party‘PHARMACEUTICALS NameSHASUN [Meet——/ALC4/2014No/Dates3/82. ~ ‘(Deferred(SiatussCase | MI LIMITED 0.052014 oe sapssstsssesss| | (HQFie REA File _ Lie.No/Date:0410156076 Defer i | -101/82/050/00010/AM15/ 1:04/24/040/00257/AM14/ 411.038.2014 2 __WDate:24.07.2014 | eee A SSR SS ain RR SN Sea ----- End of picture text -----

==> picture [406 x 648] intentionally omitted <==

----- Start of picture text ----- 107 || DecisionIn thelight of written comment recived from Department of Pharmaceuticals | Wide their OM No. 3501 1/633/2013-PI(Norms) dated 22.01.2014, it was decided to call { | from the firm a copy of Master Batch Formula duly certified by Quality Control | Uncharge. fo[Case No.262/3/82-ALC4/2014 PHARMACEUTICALSParty Name:SHASUNMest—ALC4/2014 NovDate:382-/Status:Case(Deferred | | HHO File ~ IRLAFile= Lic.No/Date:0410156077 Defer | OL/82/0S0/00066/AMIS/ :04/244040/00259/AMI4/ (11.03.2014 Dates24.07.2014 (420 ‘Decision In the light of written comments received from Department of Pharmaceuticals | vide their OM No. 35011/633/2013-PI(Norms) dated 22.01.2014, it was decided to call | | ‘from the firm a copy ofMaster Batch Formula duly certified by Quality Control i : a ; — | [7 [caseNo.:51/5/82-ALC4/2014‘PHARMACEUTICALS[Party [Name:ALEMBIC] LTD(Meet/ALC4/2014 No/Dote:3/82-—‘(Status:Case|jAdded Lo HOFle (RLAFiIe ==———~~~~~SCS Le Nate 34100039546 (Defer Date:| |421 | | POWB2/0S0/000SS/AMIS/ :34/24/040/00303/AMI4/ 12.03.2014 J | Decision(Pharmaceuticals.sIt was decided to defer the case for 03.08.2014 for comments ofDepartment of;| [ase No30//83-ALCH2014 [Party Name:BELCO PHARMA (Meet Nofbate:3/82- (Status go Fi SALC4#2014 ‘Deferred | Ce 8020 ssa |(a7HO File “URLAFIe——SS*~~~S:CLc. Nov/Diate:0910381658 Defer Date: | | (DecisionEOL/82/0S0/00034/AMIS/:It was decided to defer05/23/040/00479/AM14/ the case for 07.08.201412.03.2014 for comments of07.08.2014Department of | LAPharmaceutica s,s sss mp asssasnapanuspussnrscisigsinsssssssesss| |“ (Case No.i74/3/82-ALC42014 Party Name:SHREE BANKEY (MeetNo/Date:3/82- | Status:Case| , 3 ; (BEHARI LAL AROMATICS = /ALC4/2014 Approved | De| remnermeri biousicimiicsee 0805204 | HQFile RL File Lic. No/Date:0510381631 [Defer Date: | DecisionEOV82/0S50/00078/AMIS/: In the light of_:05/24/040/00445/AMI4/written comments received 12.03.2014from Department of Chemicals and! 623’Petrochemicals vide their U.O No. 14010/28/2012-Ch. 11 dated 28.05.2014, it was decided to’ ' iratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the fire, | iwhichever is less: 4 | : Export Export | S.No. | Import items Quantity i | | product Quantity Allowed || sernsaniacianteanienseaan ae temrwneHRvEleRNRAnMMAHMneH AaIEHAteM ata CICrns ----- End of picture text -----

==> picture [406 x 624] intentionally omitted <==

----- Start of picture text ----- 108 Pog & D-~-LIMONENE (LIMONENE CITRUS TERPENB, a _ ORANGE TERPENE, BRAZILIAN CITRUS TERPENE, | tog STANDARD CITRUS TERPENE, ORANGE OIL) | i JRA may take appropriate action as per the decision of Norms Committee. : | (Case No.:75/3/82-ALC8/2014 "Party Name:SHREE BANKEY‘(Meet No/Date:3/82-—--Status:Case_ |re| |BEHARIoe LAL AROMATICS (2,jALC4/2014 [Approvedre| | {HQ File ‘RLAFie ‘Lic.No/Date:0510381588 (Defer Date: | | HOW/82/0S0/00079/AMIS/ __:05/24/040/00446/AM14) 12.03.2014ee esses | (Decision : 3 In the light of written comments received from Department of Chemicals and| Petrochemicals vide their U.O No. 14010/28/2012-Ch. 1] dated 21.05.2014, it was decided to! | ‘ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm,; whichever is less: : | 424 ‘ | | Export product | Export | S.No. | Import items Quantity | ; Quantity a Allowed |; |) SL-CARVNONE 1. 2.50kg |, Loa tk D-LIMONENE (LIMONENE CITRUS H fo 8 TERPENE, ORANGE TERPENE, | fo BRAZILIAN CITRUS TERPENE, | Lo STANDARD CITRUS TERPENE, | fo ORANGE OIL) | ___RAmay take appropriate action asper the decisionof Norms Committee, | ("Case| |ALC4/2014 No.:2313/82- ——==—SParty4EXPORTS Name:SWISS PYT. LTD. —~=«(MeetHALC42014No/Date:3/82-—(Status:Case(Deferred || lo5 HQ File IRLA File ~~ |Lic.No/Date:0810129646 [Defer | | -201/82/050/00235/AMIS/ -O8/24/040/00537/AMI4/ 13.03.2014 Date:24.07.2014) | ‘Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | bo Piarmacenticgts. psi 1 LABORATORIES LTD, —ALC4/2014- ‘(Deferred : ee Se lga6HQFile ~ RLA File a Lic.No/Date:2210014693 [Defer | ROL/82/050/00017/AM15/ __:22/24/040/00101/AMI4/ 14032014. __[Date:24.07.2014 | Decision :It was decided to defer the case for 24.07.2014 for comments ofDepartment of | Pharmaceuticals, | (Case No.:57/3/82-ALC4/2014 Party Name:JUBILANT LIFE (Meet No/Date:3/82- ~ StatussCase 1427) ISCIENCES LIMITED IALCan014 “Deferred | ----- End of picture text -----

109

==> picture [406 x 465] intentionally omitted <==

----- Start of picture text ----- | HOL/82/050/00061/AMIS/ __:05/23/040/00S06/AMI4/ 18.03.2014 Date:24.07.2014 | Decision :It was decided to defer the case for 24.07.2014 for comments of Department of |["lGase\ALC4/2014No.123/3/82-ISCIENCESParty Name:JUBILANT LIMITED LIFE 1ALC4/2014[MeetNoibaie:3/82-—— Status:Case(Deferred | {gag {HQ File - “IRLAFile [Lic No/Date:0510382292 [Defer | | HOW/S2/0S0M0127/AMIS/ —_:05/23/040/00S08/AMI4/ 20.03.2014 ———Date:24.07.2014 | (Decision sit was decided to defer the case for 24.07.2014 for comments ofDepartment of (Pharmaceuticals, eee ese i | (" (Case No.:4/1/82-ALC42014 Party Name:AUROBINDO (Meet No/Date:3/82- ~[Status:Case’ i | “PHARMA LIMITED JALC4/2014 ‘Approved | | (HQFite REA File Lie, No/Date:0910059673 [Defer Date: 5 | pOVPR2/0S0/01246/AMI4/ :09/24/040/00649/AMI14/ 28.03.2014 | | Decisioncomments : receivedCommitteefromconsideredDepartment ofthe case Pharmaceuticals,as per agendait wasand indecided the llightto ratifyof written norms! | i funder Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever. 14294is less: 3 j | Export product Export | SINo. | Import items Oty. allowed ; |; (| CEPAZOLINSODIUM [1Kg Ti.| Cefuzolin Free Acid 0.989 ; fo7 STERILE 2. Oeater Lids (withani e aque!es nes ConPlugs/Caps,' Relevant. as per. fi5 i 20 Lirs.(10Ke Capacity) /14 Lis | Packing policy i 4fog {5kg Capacity}/ 12.5 Lirs (Ske | |.|RA Capacity} : may take appropriate actionas per the decision of NormsCommittee. spate | [ (Case Now243/3/82- (Party Name:POLYGON [Meet No/Date:3/83-—(Status:Case | / JALC42014 "CHEM CALS {ALC4/2014 [Deferred i (01H| -901/82/050/00247/AMI15/ Fite :08/24/040/00043/AMIS/IRLA File 29.04.2014~~ {Lic.No/Date:0810130958Date:07.08.2014)[Defer | |[}owas decidedto defer the casefor 07.08.2014 forcomments ofDepartmentofC&PC. | ----- End of picture text -----

Date:17.07.2014 Nirmal Kumar Place:New Delhi Dy. Director General of Foreign Trade

fotse SSHRC Shepard Get CSaecisicgss Testeter Risiyeaty, “Mgavceet, Pde Dashed

Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.