IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2014-07-03

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi -0

Para 4.7 Decision(DRAFT)

MEETING NUMBER _ : 4/82-ALC4/2014 MEETING DATE: 03.07.2014

The Meeting No. 4/82 of 2014-15 to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2009-14 pertaining to Chemical and Allied products and falling under Chapter 29 and 30 was scheduled for 03.07.2014 under the Chairmanship of, Shri Jaikant Singh, Addi. DGFT in Room No.11, Udyog Bhawan, New Delhi.

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 —IIl meeting No. 3/82 dated 08.05.2014 held on 25.06.2014 and approved the same.

The following cases/issues were discussed and the committee took the decision as mentioned against the case.

Case No.B-30 M/s Mehta API Pvt. Ltd. Meeting No.04/AM15 dated — 03.07.2014.2014 | Pt. F.No. 01/82/050/00341/AM14/DES-III RLA F. NO. 03/95/040/00035/AM14 Adv. Lic. No. 0310732641 dt. 26.04.2013 Decision: Committee considered the case as per agenda and in consultation with technical authority present in the meeting it was decided to revise the UOM (Unit of Measurement) of import item as _| “KG Activity” instead of “kg/kg”.Rest of the decision of NC-III meeting No. 20/82 dated 16.01.2014 in respect of this case shall remain unchanged. RA may take appropriate action as per the decision of Norms Committee.

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----- Start of picture text ----- M/s DSM Sinochem Pharmaceuticals PC—(‘isésOOSOCO Ad. Lic, No. 2210005608 [dt.] 08.06.2006 Decision: Committee considered the case as per agenda and in consultation with technical authority present in the meeting it was decided to ratify norms as per SION A-33 and A-58 and as per details given below or as applied by the firm, whichever is less: Export product Gx. | SINo. | Import items exportQty. allowed per kg 6-Amino 1kg Pencillin G Potassium 1° Crystal | 2.92 BOU Penicillanic Acide write to off white powder assy assy not less than not less than 96% 84 as such or 96% Methylene Chloride Clear liquid | 0.83 kg on dry basis%. INN purity not less than 96% FR of PUL Aone ttepasee Neve Ce ity ity Oioeet LIM, er bee geo 4 Leap ace mee ite . ----- End of picture text -----

UR os hs Uayog Shuvwar, Neve Ce ity ity

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----- Start of picture text ----- 3. Pencellin Amedise Brownish fine | 0.852gm beadsin liquid ph-5 to 6 ----- End of picture text -----

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----- Start of picture text ----- RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

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|||||||
|---|---|---|---|---|---|
|Case No. B-32|M/s Drof Ketal|Chemicals|I|Pvt.|Ltd.|
|Meeting No.04/AM15|dated — 03.07.2014.2014|||01/82/171/280/AM14/DES-III|
|Ad.|Licence|No.|03104180237|Dt.|0.12..2006|
|Ad.|Licence|No.|0310478565|Dt.|14.07.2008|
|Ad.|Licence|No.|0310491961|Dt.|24.10.2008|
|Ad.|Licence|No.|0310526499|Dt.|30.06.2009|
|Ad.|Licence|No.|0310541892|Dt.|23.10..2009|
|Ad.|Licence|No.|0310548591|Dt.|01.12.2009|
|Ad.|Licence|No.|0310548598 Dt.|01.12..2009|
|Ad.|Licence|No.|0310560279|Dt.|15.02.2010|
|Ad.|Licence|No.|0310560279|Dt.|15.02.2010|
|Ad.|Licence|No.|0310582532|Dt.|26.07.2010|
|Ad.|Licence|No.|0310594926|Dt.|04.10..2009|

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Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

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||||||||||
|---|---|---|---|---|---|---|---|---|
|Case No.|B-33|M/s Ecological|Chemcials|Ltd.|
|Meeting No.04/AM15|dated — 03.07.2014.2014|F.No.|01/82/050/00932/AM13/DES-III|
|R.A|F. No. 09/24/040/00296/AM13|Adv.|Lic. No. 0910053811|dt.|14.09.2012|
|Decision|:It was|decided|to|defer the|case|for 07.08.2014|for comments|of Department of|
|Pharmaceuticals.|
|Case No.|B-34|M/s Gaurav|Pharma|ttd.,|New|Delhi|
|Meeting No.04/AM15|dated — 03.07.2014.2014|F.No.|01/82/171/00018/AM13/DES-III|

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Decision: It was decided to defer the case for 05.12.2013 for comments of Department of Pharmaceuticals.

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|---|---|---|---|---|---|---|---|---|---|---|
|Case No.|B-35|M/s|Laffans|Petrochemicals|Ltd.|
|Meeting No.04/AM15|dated — 03.07.2014.2014|F.No. 01/83/162/01428/AM08/DES-III|
|RA|F.|No. 03/95/040/01379/AM07|Adv.|Lic.|No. 0310419553|dated|13.02.2007|
|Decision:|withdraw|already|rejected|by|NC|in|its|1/AM15|meeting|dated 21.04.2014|

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----- Start of picture text ----- Case No. B-36 M/s. Galaxy Surfactants Limited ol Meeting No.04/AM15 dated — 01/82/50/00772/AM 14/DES III VL| ----- End of picture text -----

. “pce panes Veeve twist

~ Br

”

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|03.07.2014.2014|01/82/50/00314/AM|14/DES|III|
|710530|3|
|Decision:CommitteeRLA— File No. 03/94/40/000473/A-|consider:|the case|as|per agenv.|da|andLic.|No.in|consultation-|with;|technicalthereical|auwasauthorinoty|
|present|in|the|meeting.|It|was|decided|to|reject|the|request|of|the|firm|as|ther|
|justifications|for enhancement|maintain|status|qua.|
|||Case|No.|B-37|M/s.FORMERLYPRAMAL NICHOLAS HEALTHCARE PIRAMALLTD.|
|i|
|Meeting|[No.04/AM]|.|15|dated — 03.07.2014.2014|||F. No.01/82/50/256/AM13/D|ES-III|
|F, No.01/82/50/261/AM13/DES-III|
|F.|No.01/82/50/260/AM13/DES-III|
|F, No.01/82/50/255/AM13/DES-HI|
|F. No.01/82/50/928/AM12/DES-III|
|adv.|Lic.|No.|0310694731|dated|15.05.2012|
|adv.|Lic.|No.03 10694936|dated|16.05.2012|
|adv.|Lic. No.|0310694925|dated|16.05.2012|
|,|adv.|Lic.|No.|0310694706|dated|15.05.2012|
|Decision:|adv. Lic. No. 0310642739 dated|18.07.2011|
|It|was|decided|to|defer|the|case|for|05.12.2013|for|comments|of|Department|of|
|Pharmaceuticals.|
|Case No.|B-38|M/s Encube|Ethicals Pvt|Ltd.|
|Meeting No.04/AM15 dated — 03.07.2014.2014|F.No. 01/82/50/00345/AM11/ DES-III|
|RA No. 26/02/040/00001/AM11|Adv.|Lic. No. 0310571323|dated|24.06.2010|
|Decision: Committee considered case as per agenda and|in|light of written comments forwarded|by|
|OC(MSME) vide their U.O. No.23(10)2013/Chem|dated 30.06.2014,|decided to allow import item at|
|SI.|Nos. 5|“ Allantoin|“ for|manufacture|of export Product Secura|Protective Cream|(Product Code|
|No.59431100, 59431200, 59431379, 59431379) and Triple Care Cream(Product Code No.59447525)|
|including 2% wastage.|Norms Committee|in|its Meeting|No. 23/82 dated 07.09.2010|has already|
|recommended|six items|except the|import item|Allantoin.|The committee|recommend the|item|
|below:|
|mentioned|at SI.|No. 5|I.e. Allantoin and|its respective|quantity for duty free import as details given|
|itme|at|SI.|
|Import|Name of|the import item|ITCHS Code|Quantity (kg) recommended|per kg|
|No.|of export product with 2% wastage|
|[5.____[Allantoin____T|33029080|0.00204 kg|
|RA concerned may|take further necessary|action as|per above decision of NC.|

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Case No.:11/20/82Party Name:NEULAND Meet No/Date:4/82Status:Case ALC4/2009 LABORATORIES LTD ALC4/2014 Deferred 1 03.07.2014 lH:01/82/050/00422/AM10/File REA:09/24/040/00144/AM]1 Fil maaania, 0/ 06.08.2009Lic.No/Date:09 10038818 [DefDat :07.08.2014 e r Decision :It has been noticed that the firm has furnished production and consumption data in respect of only one import item whereas they have applied for nine import items. Hence, it was HEYee eet hetee won sen TER

decided to remind the firm to furnish production and consumption data certified by Central Excise Authority for all import items.

The case was deferred for 07.08.2014

Case No.:22/6/82-ALC4/2010 {|Party Name:WANBURY Meet No/Date:4/82Status: LIMITED(FORMERLY ALC4/2014 Approved PEARL ORGANICS LTD) 03.07.2014 HQ File RLA File Lic.No/Date:03 10571937 |Defer Date: :01/82/050/00169/AM1 I/ :03/95/040/00396/AM10/ 29.04.2010

Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals and in consultation with technical authority present
2 in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by |firm whichever is lower:-

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----- Start of picture text ----- Qty. kg/kg D.C. GRANULES DICYANODIMIDE 30 RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

||Case No.:38/24/82-|PartyName:AUROBINDO|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|PHARMALIMITED|ALC4/2014|Deferred|
||||03.07.2014||
|3||HQ File|RLA File|Lic.No/Date:0910046104|(Defer|
||°01/82/050/01237/AM14/|:09/24/040/00585/AM11/|28.03.2011|Date:07.08.2014|

Decision :It was decided send a copy of application to Department of Pharmaceuticals for their comments. The case is deferred for 07.08.2014.

||CaseNo.:4/16/82-ALC4/2011||PartyName:BOSTIKINDIA<br>PRIVATELIMITED|(MeetNo/Date:4/82-<br>ALC4/2014|Status:Deffered<br>and Re-indexed|
|---|---|---|---|---|
||||03.07.2014||
|4||HQ File|RLA File|Lic.No/Date:0710079777||Defer|
||:01/82/050/00462/AM12/|:07/24/040/00073/AM12/|13.06.2011|Date:07.08.2014|

Decision :It was decided to remind the Petrochemicals Division of Department of Chemicals and Petrochemicals for their comments.The case is deferred for 07.08.2014.

Case No.:196/10/82Party Name:BOSTIK INDIA {Meet No/Date:4/82Status:Case ALC4/2013 PRIVATE LIMITED ALC4/2014 Deferred 03.07.2014 5 [HQ File RLA File Lic.No/Date:0710085024 |Defer :701/82/050/00379/AM 1 4/ :07/24/040/00380/AM12/ 28.12.2011 Date:07.08.2014 Decision : It was decided to remind the Petrochemicals Division of Department of Chemicals and Petrochemicals for their comments. The case is deferred for 07.08.2014. Case No.:8/4/82-ALC4/2014 |Party Name:OTSUKA Meet No/Date:4/82Status:Case 6 CHEMICAL( INDIA ) ALC4/2014 Approved 7 PRIVATE LIMITED 03.07.2014

ayes Piers | aH Le thivis a co a ces wane”us fede eae haw an, Iswev Ligiiet

| |

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----- Start of picture text ----- a HQ File RLA File Lie.No/Date:0510315363 [Defer Date: :01/82/050/00256/AM15/ :05/24/040/00349/AM 12/ ie 01.2012 | Decision :in the light of earlier decision taken in meeting no. 21/82 dated 06.02.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is lower: ----- End of picture text -----

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----- Start of picture text ----- Item of Export Quantity {tem of Import Quantity Allowed kg/kg 7-Phenylacetamideo-3- | 1kg Penicillin G Potassium ae Chloromethy! 1*Crystals Cephalosporanic Acid [2 [Methanol ParaMethoxybenzyl || 3.|2.00Dimethyl Formamide (38600 —=*d Ester (GCLE) || 4| Methylene Chloride 200 While/Light Yelow|~ «5.__| 2-Mercaptobenzothiazole 0.511 Powder -——T 6. [isopropyl Alcohol RA may take appropriate action as per the decision of Norms Committee. Case No.:21/20/82- Party Name:HETERO DRUGS |Meet No/Date:4/82- Status:Case ALC4/2013 LIMITED, ALC4/2014 Deferred 03.07.2014 7 \HQ File RLA File Lic.No/Date:0910052113 |Defer :01/82/050/01007/AM 14/ :09/24/040/00668/AM12/ 11.04.2012 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

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||||||
|---|---|---|---|---|
|CaseALC4/2013No.:44/20/82-|_|PartyORGOCHEM Name:HIRAN LIMITED|MeetALC4/2014 No/Date:4/82-|DeferredStatus:Case|
|03.07.2014|
|g|[HQ File|RLA File|Lic.No/Date:03 10692029||Defer|
|:01/82/050/01030/AM14/|:03/94/040/008|14/AM12/|25.04.2012|Date:07.08.2014|

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|||||
|---|---|---|---|
|Case No.:25/20/82-ALC4/2013||Party Name:DR REDDYS|Meet No/Date:4/82-|Status:Case|
|LABORATORIES|LIMITED|{ALC4/2014|Approved|
|03.07.2014|
|fe:01/82/050/01011/AM14/ File|RLA:09/24/040/00012/AM13/ File|26.04.2012Lic.No/Date:0910052380||Defer Date:|

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Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals and in consultation with technical authority present g |i meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Valsartan 1 kg N-(2-Cyanobiphenyl-41.267 Methyl)(L) Valine Methyl! Ester HCL RA may take appropriate action as per the decision of Norms Committee.

| | |

— ——

A

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----- Start of picture text ----- Case No.:30/13/82- Party Name:HALDIA Meet No/Date:4/82- Status:Case ALC4/2012 PETROCHEMICALS LTD. ALC4/2014 Deferred 03.07.2014 10 HQ File RLA File Lic.No/Date:0210177518 |Defer |:01/82/050/00365/AM13/ :02/24/040/00029/AM13/ 14.05.2012 Date:07.08.2014 Decision :It was decided to remind the Department of Petrochemicals Division of D/o C&PC to furnish their comments as the case is pending since 13.06.2013. The case was deferred for 07.08.2014 Case No.:28/20/82- Party Name:HETERO LABS [Meet No/Date:4/82- Status:Case ALC4/2013 LIMITED ALC4/2014 Deferred 03.07.2014 11 |HQ File RLA File Lic.No/Date:09 10052608 |Defer :01/82/050/01014/AM14/ :09/24/040/00070/AM 13/ 14.05.2012 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. Case No.:38/20/82- Party Name:HETERO LABS = |Meet No/Date:4/82- Status:Case ALC4/2013 LIMITED ALC4/2014 Deferred 03.07.2014 12 |HQ File RLA File Lic.No/Date:0910052665 |Defer :01/82/050/01024/AM14/ :09/24/040/00069/AM 1 3/ 17.05.2012 Date:07.08.2014 ----- End of picture text -----

Decision :It was decided to remind the Department of Petrochemicals Division of D/o C&PC to furnish their comments as the case is pending since 13.06.2013. The case was deferred for 07.08.2014

Case No.:29/20/82-ALC4/2013 |Party Name:HETERO LABS _ |Meet No/Date:4/82Status:Case LIMITED ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:0910052722 Defer Date: :01/82/050/01015/AM14/ :09/24/040/00090/AM13/ 22.05.2012

Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals and in consultation with technical authority present[meeting,][decided][to][ratify][norms][ under][ para][ 4.7][ of][HBP][as][ per][ details][below][or][ as][ applied][by] B[in] firm whichever is lower:-

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----- Start of picture text ----- Export product Export j SI-No. | Import items Qty. allowed Qty. kg/kg ABACAVIR 1.055 SULPHATE (PURITY ABACAVIR SULPHATE (PURITY 99.5%) RA may take appropriate action as per the decision of Norms Committee. Case No.:39/20/82- Party Name:HETERO LABS _|Meet No/Date:4/82- Status:Case ALC4/2013 LIMITED ALC4/2014 Deferred 14 03.07.2014 HQ File RLA File Lic.No/Date:0910052780 [Defer |... ....| : :01/82/050/01025/AM14/ :09/24/040/00094/AM 13/ 25.05.2012 yeverre 8! Date:07.08.2014 ty ----- End of picture text -----

Gayra = wees

a |

Decision : It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

||CaseNo.:31/20/82-<br>ALC4/2013|PartyName:HETEROLABS_<br>LIMITED|[MeetNo/Date:4/82-<br>ALC4/2014<br>03.07.2014|Status:Case<br>Deferred|
|---|---|---|---|---|
|15||HQ File<br>:01/82/050/01017/AM14/|RLA File<br>:09/24/040/00108/AM13/|Lic.No/Date:0910052814<br>29.05.2012||Defer<br>Date:07.08.2014|

Case No.:20/20/82Party Name:HETERO LABS [Meet No/Date:4/82Status:Case ALC4/2013 LIMITED ALC4/2014 Deferred 03.07.2014
16 |HQ File RLA File Lic.No/Date:09 10052908 |Defer 101/82/050/01006/AM14/ :09/24/040/00127/AM13/ 07.06.2012 Date:07.08.2014.

||Case No.:17/20/82-<br>ALC4/2013|PartyName:CADILA<br>HEALTHCARELTD.,|MeetNo/Date:4/82-<br>IALC4/2014<br>03.07.2014|Status:Case<br>Deferred|
|---|---|---|---|---|
|17||HQ File<br>:01/82/050/01003/AM14/|RLA File<br>:08/24/040/00088/AM13/|Lic.No/Date:0810112512<br>14.06.2012||Defer<br>Date:07.08.2014|

||CaseNo.:18/20/82-|PartyName:CADILA|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|HEALTHCARELTD.,|ALC4/2014|Deferred|
||||03.07.2014||
|18||HQ File<br>101/82/050/01004/AM14/|RLA File<br>:08/24/040/00090/AM 13/|Lic.No/Date:0810112511<br>14.06.2012|;Defer<br>Date:07.08.2014|
||Decision :Itwasdecided|to deferthe case for07.08.2014 forcommentsofDepartment of|||
||Pharmaceuticals.||||
||Case No.:19/20/82-<br>ALC4/2013|PartyName:CADILA<br>HEALTHCARE LTD.,|MeetNo/Date:4/82-<br>ALC4/2014|Status:Case<br>Deferred|
||||03.07.2014||
|19||HQ File|RLA File|Lic.No/Date:0810112510||Defer|
||:01/82/050/01005/AM14/|:08/24/040/00095/AM13/|14.06.2012|Date:07.08.2014|

||CaseNo.:34/20/82-|PartyName:CADILA|MeetNo/Date:4/82-|Status:Case||
|---|---|---|---|---|---|
||ALC4/2013|HEALTHCARE LTD.,|ALC4/2014|Deferred||
|20|||03.07.2014||||
||HQ File<br>PRFieo1020/M14|RLA File<br>:08/24/040/00100/AM13/|Lic.No/Date:0810112516<br>14.06.2012<br>~~—~.||Defer<br>-|Daté:07.08:2014'||

| | | | | | | |

||CaseNo.:2/23/82-ALC4/2012||PartyName:IND-SWIFT|MeetNo/Date:4/82-|Status:|
|---|---|---|---|---|
|||LABORATORIES LTD.,|ALC4/2014|Rejected|
||||03.07.2014||
|21||HQFile<br>:01/82/050/00802/AM13/|RLAFile<br>:22/24/040/00012/AM13/|Lic.No/Date:2210013015<br>14.06.2012|[DeferDate:<br>;|

Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders.

|CaseNo.:5/22/82-<br>ALC4/2012|PartyName:SANOFI INDIA<br>LIMITED||MeetNo/Date:4/82-<br>ALC4/2014<br>03.07.2014|Status:Case<br>Approved|
|---|---|---|---|
|HQFile|RLAFile|Lic.No/Date:0310706473||DeferDate:|
|:01/82/050/00708/AM13/|:03/95/040/00318/AM13/|27.08.2012||

Decision :Committee considered the case as per agenda and in the light of earlier decision taken by NC in its 34/82 meeting dated 21.11.2011 , it was decided to ratify norms under para 4.7 59 of HBP as per details below or as applied by firm whichever is lower:-

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----- Start of picture text ----- Export product Export | SI-No. | Import items Qty. allowed Qty. 4000 ----- End of picture text -----

RA may take appropriate action as per the decision of Norms Committee.

Case No.:4/20/82-ALC4/2012 |Party Name:RANBAXY Meet No/Date:4/82Status:Case LABORATORIES LTD ALC4/2014 Deferred 73 [HQ File RLA File 03.07.2014Lic.No/Date:05 10333154 |Defer . :01/82/050/006 1 5/AM13/ :05/24/040/00323/AM12/ 30.08.2012 Date:07.08.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 07.08.2014

Case No.:40/15/82Party Name:CALYX Meet No/Date:4/82Status:Case ALC4/2013 (CHEMICALS & ALC4/2014 Deferred PHARMACEUTICALS LTD. |03.07.2014 24:/HQ File RLA File Lic.No/Date:03 10707994 |Defer :01/82/050/00802/AM14/ :03/94/040/00199/AM10/ 06.09.2012 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:88/1/82-ALC4/2013 \Party Name:MYLAN Meet No/Date:4/82Status:Case ,; LABORATORIES LIMITED |ALC4/2014 Deferred no 25 03.07.2014 . HQ File RLA File Lic.No/Date:0910054034 |Defer..... i} -4> :01/82/050/01446/AM13/ _|:09/24/040/00287/AM13/ 11.10.2012 ~" JDate;07.08.2014]

uis yew CE Was tetas

a_i

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/403/2013-Pl(Norms) dated 26.09.2013, it was decided to call from the firm

the following technical details:

Complete technical details as per Appendix 33. Copy of technical literature in support of yield envisaged in the process past production vis-a-vis Actual consumption of all inputs duly certified by Central Excise Authorities.

The case was deferred for 07.08.2014.

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----- Start of picture text ----- Case No.:3/23/82- Party Name:TITAN Meet No/Date:4/82- Status:Rejected ALC4/2012 LABORATORIES PVT. LTD. |ALC4/2014 03.07.2014 26 [HQ File RLA File Lic.No/Date:03 10713360 |Defer Date: :01/82/050/00803/AM13/ :03/95/040/00544/AM 13/ 22.10.2012 Decision :It was decided to reject the case as the information furnished by the firm is not in order. ----- End of picture text -----

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----- Start of picture text ----- Case No.:16/28/82- Party Name:CADILA Meet No/Date:4/82- Status: Approved ALC4/2012 PHARMACEUTICALS LTD. |ALC4/2014 03.07.2014 . HQ File RLA File Lic.No/Date:0810115897 |Defer Date: :01/82/050/00983/AM 13/ :08/24/040/00259/AM13/ 25.10.2012 ----- End of picture text -----

Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/203/2013-PI(Norms) dated 01.04.2014, 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:

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----- Start of picture text ----- Export product Exp. Qty. allowed Qty. kg/kg NEBIVOLOLHCL [1kg [1.—_ | 4-FLUORO ANISOLE ” [2.[ ETHYLENE DI CHLORIDE [3 | HEXANE }4.| ACETIC ACID |5.| DICHLORO METHANE [é.| METHANOL VITRIDE f&. | TOLUENE |9. _ | DIMETHYLE SULPHOXIDE }14.| ACETONITRILE ----- End of picture text -----

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----- Start of picture text ----- Case No.:112/33/82- Party Name:STERICAT Meet No/Date:4/82- Status:Case ALC4/2012 GUTSTRINGS PVT. LTD. ALC4/2014 Deferred 28 03.07.2014 HQ File RLA File Lic.No/Date:0510340033 |Defer :01/82/050/01259/AM 13/ :05/24/040/00304/AM13/ 04.12.2012, Date:07.08.2014 ----- End of picture text -----

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| [Decision sIt was decided to defer the case for 07.08.2014 for comments of DIPP

: |,

|| DecisionNo. 35011/203/2013-Pl(Norms)in theNo. 35011/203/2013-Pl(Norms)in the 35011/203/2013-Pl(Norms)in thein the the light of writtendatedcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM of writtendatedcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM writtendatedcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMdatedcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMreceivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMof Pharmaceuticals norms under Paravide 4.7 their of HBP OM Pharmaceuticals norms under Paravide 4.7 their of HBP OM norms under Paravide 4.7 their of HBP OM under Paravide 4.7 their of HBP OM Paravide 4.7 their of HBP OMvide 4.7 their of HBP OM 4.7 their of HBP OM their of HBP OM of HBP OM HBP OM OM : v1 as per details given given below or as applied by the firm, the firm, firm, whichever is less: : Export product product Exp. Import items items Qty. allowed allowed

Case No.:43/33/82Party Name:BENZO CHEM _ /Meet No/Date:4/82Status:Case ALC4/2012 INDUSTRIES PRIVATE ALC4/2014 Deferred LIMITED, 03.07.2014 29 |HQ File RLA File Lic.No/Date:03 10716674 |Defer :01/82/050/01190/AM13/ :03/94/040/00727/AM 13/ 07.12.2012 Date:07.08.2014 Decision :It was decided to send the copy of application to Department of Pharmaceuticals. The case is deferred for 07.08.2014. Case No.:172/33/82Party Name:CADILA Meet No/Date:4/82Status:Case ALC4/2012 PHARMACEUTICALS LTD. |ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:0810116727 |Defer Date: :01/82/050/013 19/AM13/ :08/24/040/00303/AM13/ 07.12.2012 DecisionNo. 35011/203/2013-Pl(Norms)in theNo. 35011/203/2013-Pl(Norms)in the 35011/203/2013-Pl(Norms)in thein the the light of writtendatedcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM of writtendatedcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM writtendatedcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMdatedcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMcomments01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM01.04.2014,receivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMreceivedit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMit was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM was from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM from decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM decidedDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMDepartment to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM to ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OM ratifyof Pharmaceuticals norms under Paravide 4.7 their of HBP OMof Pharmaceuticals norms under Paravide 4.7 their of HBP OM Pharmaceuticals norms under Paravide 4.7 their of HBP OM norms under Paravide 4.7 their of HBP OM under Paravide 4.7 their of HBP OM Paravide 4.7 their of HBP OMvide 4.7 their of HBP OM 4.7 their of HBP OM their of HBP OM of HBP OM HBP OM OM v1 as per details given given below or as applied by the firm, the firm, firm, whichever is less: Export product product Exp. Import items items Qty. allowed allowed | Qty. kg/kg NEBIVOLOL HCL /-FLUORO ANISOLE +0 (2. ETHYLENE DI CHLORIDE S|[HEXANE] SC=*dSCS [4| ACETIC ACID [5.___| DICHLORO METHANE [6[METHANOL VITRIDE [| TOLUENE |9.| DIMETHYLE SULPHOXIDE (13.1300 |}10.[11.] | ISOPROPYLACETONITRILEALCOHOL

Case No.:4/27/82-ALC4/2012 |Party Name:PORUS Meet No/Date:4/82Status:Case LABORATORIES PVT LTD. |ALC4/2014 Deferred 03.07.2014 31 |HQ File RLA File Lic.No/Date:0910054464 |Defer :01/82/050/00959/AM13/ :09/24/040/00408/AM 13/ 07.42.2012 Date:07.08.2014 Decision : It was decided to send the copy of application to Department of Pharmaceuticals. The case is deferred for 07.08.2014. Case No.:85/31/82Party Name:SANOFI INDIA _ |Meet No/Date:4/82Status: Deffered 32 ALC4/2012 LIMITED ALC4/2014 and Re-indexed 03.07.2014 [HQ File RLA File [Lic.No/Date:0310717240 [Defer | o>

14.12.2012 (Date: 12.06.2014 12.06.2014

:01/82/050/01125/AM13/ :03/95/040/00465/AM13/ 14.12.2012 (Date: 12.06.2014 12.06.2014 Decision : Jt was decided that RA may call for NOC from Drug Controller of India before discharging EO.

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|---|---|---|---|---|---|
|Case No.:165/33/82-|Party Name:CADILA|Meet No/Date:4/82-|Status:Case|
|ALC4/2012|HEALTHCARE LTD.,|ALC4/2014|Deferred|
|03.07.2014|
|HQ|File|RLA File|Lic.No/Date:0810117317||Defer|
|33||:01/82/050/01312/AM13/|:08/24/040/00257/AM13/|02.01.2013|_|{Date:07.08.2014|

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Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/361/2013-Pl(Norms) dated 11.09.2013, it was decided to call from the firm a copy of Master batch Formula duly certified by Quality —Control In charge. The case was deferred for 07.08.2014

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|---|---|---|---|---|---|
|Case No.:49/4/82-ALC4/2013||Party Name:ALEKHYA|Meet No/Date:4/82-|Status:|
|DRUGS PVT LTD.|ALC4/2014|Rejected|
|03.07.2014|
|34|}HQ File|RLA|File|Lic.No/Date:0910054675||Defer Date:|
|:01/82/050/00090/AM|14/|:09/24/040/00157/AM13/|03.01.2013|

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Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders.

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|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:13/12/82-|Party|Name:|HETERO|DRUGS|[Meet No/Date:4/82-|Status:Case|
|ALC4/2013|LIMITED,|ALC4/2014|Deferred|
|03.07.2014|
|35|[HQ File|RLA|File|Lic.No/Date:0910054735||Defer|
|:01/82/050/00437/AM14/|:09/24/040/00495/AM13/|09.01.2013|Date:07.08.2014|
|Decision|It was|decided|to|defer the|case|for|07.08.2014|for|comments|of Department|of|
|Pharmaceuticals.|

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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:117/33/82-|Party Name:MAHESHRAJ|Meet No/Date:4/82-|Status:|
|ALC4/2012|CHEMICALS PVT.LTD|ALC4/2014|Rejected|
|03.07.2014|
|36:|HQ File|RLA File|Lic.No/Date:0810117495||Defer Date:|
|:01/82/050/01264/AM13/|:08/24/040/00339/AM|13/|10.01.2013|
|Decision|:|It|was|decided|to|reject|the|case|as|the|firm|has|not|furnished|information|
|despite repeated|reminders.|

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Case No.:16/20/82Party Name:ASTRIX Meet No/Date:4/82Status:Case ALC4/2013 LABORATORIES LTD., ALC4/2014 Deferred 03.07.2014 37 |HQ File RLA File Lic.No/Date:0910054794 |Defer :01/82/050/01002/AM14/ :09/24/040/0045 1/AM13/ 17.01.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. 38 Case No.:3/30/82Party Name:MOREPEN Meet No/Date:4/82__ |Status:Deffered_ ALC4/2012 LABORATORIES ALC4/2014 Ss fand Re-indexed:}°

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”

LTD.&MOREPEN 03.07.2014 INTERNATION HQ File RLA File Lic.No/Date:05 10343986 |Defer :01/82/050/01039/AM13/ :05/24/040/00393/AM13/ 23.01.2013 Date:07.08.2014 Decision :It was decided to send again the copy of application to Department of Pharmaceuticals. The case is deferred for 07.08.2014

Case No.:9/4/82-ALC4/2013 |Party Name:GOPALDAS Meet No/Date:4/82Status:Case VISRAM & CO.LTD. ALC4/2014 Deferred 03.07.2014 HQ File RLA File Lic.No/Date:0310722715 |Defer | 39 :01/82/050/00050/AM14/ :03/94/040/00945/AM13/ 01.02.2013 Date:07.08.2014 (Decision :it was decided to give last reminder to the firm to furnish the following technical details: (a) Net weight of the cream in each tube. (b) Detailed working on arriving at the norms applied by the firm. The case was deferred for 07.08.2014.

Case No.:9/9/82Party Meet No/Date:4/82Status: Rejected ALC4/2013 Name:CATAPHARMACHEMICAL |ALC4/2014 S PVT. LTD., 03.07.2014 HQ File RLA File :31/83/040/00177/AM13/ |Lic.No/Date:311005703 |Defer |:01/82/050/00183/AMI 2 Date:07.08.2014 4/ 05.02.2013 . .

Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders. Case No.:7/3/82-ALC4/2013 |Party Name:WOCKHARDT __ |Meet No/Date:4/82Status:Case LIMITED ALC4/2014 Deferred 03.07.2014 ; 41 |HQ File RLA File Lic.No/Date:03 10723636 |Defer :01/82/050/00040/AM 14/ :03/95/040/00886/AM13/ 11.02.2013 Date:07.08.2014 Decision :It was decided to send a copy of application again to DCGI for their comments. The case was deferred for 07.08.2014. Case No.:43/4/82-ALC4/2014 |Party Name:BENZO CHEM Meet No/Date:4/82Status:Case INDUSTRIES PRIVATE ALC4/2014 Approved LIMITED, 03.07.2014 HQ File RLA File Lic.No/Date:0310723791 |Defer Date: :01/82/050/0029 1/AM15/ :03/94/040/00942/AM13/ 12.02.2013

Decision :In the light of written comments received from Department of Chemicals and Petrochemicals 42 vide their U.O No. 14010/29/2011-Ch. II dated 26.05.2012, 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:

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----- Start of picture text ----- Export product Export Import items Quantity Quantity Allowed 2,4,6-TRIMETHYL PHENYL 1 kg 1,3,5-TRIMETHYL BENZENE | 1.490 kg ACETYL CHLORIDE OR MESITYLENE [2 [[PARAFORMALDEHYDE] | O804kg ----- End of picture text -----

°

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----- Start of picture text ----- ~ 18 (Mesitylessigsaure Chloride) [id [soptuM][ CYANIDE] [3 [__|] (O%)——“—Cs‘“‘;;C XSTCSdrtStt:t:ttCd | 4. | CAUSTIC SODA FLAKES 2.290 kg 15.| THIONYL CHLORIDE 0.730 kg ----- End of picture text -----

RA may take appropriate action as per the decision of Norms Committee.

Case No.:26/4/82-ALC4/2013 |Party Name:S MS Meet No/Date:4/82Status: PHARMACEUTICALS LTD _|ALC4/2014 Rejected 03.07.2014 43 |HQ File RLA File Lic.No/Date:0910055023 Defer Date: :01/82/050/00067/AM 14/ :09/24/040/00501/AM13/ 12.02.2013 Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders.

Case No.:4/4/82-ALC4/2013 |Party Name:SABERO Meet No/Date:4/82Status:Case ORGANICS GUJARAT ALC4/2014 Deferred LIMITED 03.07.2014
44 [HQ File RLA File Lic.No/Date:03 10724136 |Defer :01/82/050/00045/AM14/ :03/95/040/00880/AM 13/ 14.02.2013 Date:07.08.2014

Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals.

||CaseNo.:79/1/82-ALC4/2013||PartyName:STERICAT|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
|||GUTSTRINGS PVT. LTD.|ALC4/2014|Deferred|
||||03.07.2014||
|45|THQFile|RLA File|Lic.No/Date:0510346353|{Defer|
||:01/82/050/01437/AM13/|:05/24/040/00420/AM13/|18.02.2013|Date:07.08.2014|

Decision :It was decided to defer the case for 07.08.2014 for comments of DIPP.

Case No.:31/8/82-ALC4/2013 |Party Name:MYLAN Meet No/Date:4/82Status:Case LABORATORIES LIMITED jALC4/2014 Deferred 03.07.2014
HQ File RLA File Lic.No/Date:0910055106 |Defer
46 |:01/82/050/00162/AM14/ :09/24/040/00537/AM 13/ 19.02.2013 Date:07.08.2014

Decision :It was decided to remind the firm to furnish the following technical details: * Complete technical details as per Appendix -33 including % Yield on molar basis for each step and solvent Recovery etc. + Past Production vis-a-vis Actual consumption of raw materials duly certified by Central Excise Authorities. The case was deferred for 07.08.2014.

Case No.:8/10/82-ALC4/2013 |Party Name: VIVIMED LABS |Meet No/Date:4/82Status:Case LIMITED ALC4/2014 Deferred 03.07.2014 47 |HQ File RLA File Lic.No/Date:0910055119 |Defer :01/82/050/00191/AM14/ :09/24/040/00554/AM13/ 21.02.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

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|CaseNo.:39/24/82-ALC4/2013||Party Name: VIRCHOW|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|
||PETROCHEMICAL PVTLTD. |ALC4/2014||Approved|
|||03.07.2014||
|HQ File|RLA File|Lic.No/Date:0910055266|[DeferDate:|
|:01/82/050/01238/AM14/|:09/24/040/00562/AM13/|04.03.2013||

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----- Start of picture text ----- Decision :Committee considered case as per earlier decision taken by NC in its 48/82 meeting dated 01.03.2011 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:- 48] [ Export product Ep. OW. Qy- allowed PHENYLACETAMIDEO- FIRST CRYSTAL 3-CHLOROMETHYL (2. [ACETONE Cd OTK CS OR OXY |3.|ISOPROPYLALCOHOL (| 0.66kg ACIDBENZYL P (4. |DIMETHYLFORMAMIDE| 1.314 kg ESTER (GCLE) [5.___[ [METHYLENE] |6. __ | [2MERCAPTOBENZOTHIAZOLE] CHLORIDE ||0.511kg3.29 kg | 1.971 kg RA concerned may take further necessary action as per above decision of NC. Case No.:141/10/82- Party Meet No/Date:4/82- Status: ALC4/2013 IName:EUROLIFEHEALTHCARE |ALC4/2014 Rejected PVT. LTD. 03.07.2014 49 }HQ File RLA File Lic.No/Date:03 10728214 |Defer Date: :01/82/050/00324/AM14/ :03/94/040/00982/AM13/ 14.03.2013 ----- End of picture text -----

Decision:It was decided to reject the case as the firm has not furnished information despite repeated reminders,

|Case No.:32/8/82-ALC4/2013||PartyName:BIOLOGICAL E||MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|
||LTD|ALC4/2014|Deferred|
|||03.07.2014||
|HQ File|RLA File|Lic.No/Date:0910055421||Defer|
|:01/82/050/00163/AM14/|:09/24/040/00607/AM13/|19.03.2013|Date:07.08.2014|

50 |Decision : Department of Biotechnology vide their letter No. BT/IL/05/382/2013-PID dated 17.04.2014 has informed that the reply received from the firm is incomplete. It was decided to call from the firm copy of Batch production record of complete Manufacturing process (up stream, down stream, formulation, filling etc.) showing quantities and use of import inputs”. The case was deferred for 07.08.2014.

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----- Start of picture text ----- Case No.:57/10/82- Party Name:BIOLOGICAL E {Meet No/Date:4/82- Status:Case ALC4/2013 LTD ALC4/2014 Deferred 03.07.2014 :09/24/040/00606/AM13/ 19.03.2013 Date:07.08.2014 51 lH [|:01/82/050/00240/AM14/] File LA File Lic.No/Date:09 10055420 [Pete Decision : Department of Biotechnology vide their letter No. BT/IL/05/382/2013-PID ; ice etna has informed that the reply received from the firm is incomplete. It was ec €d to call from the firm copy ofBatch production record of complete Manufacturing process (up stream, down stream, formulation, filling etc.) showing quantities and use of ----- End of picture text -----

| t

a | | | )

~ 15 -

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----- Start of picture text ----- import inputs”. ----- End of picture text -----

The case was deferred for 07.08.2014.

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----- Start of picture text ----- Case No.:24/10/82-ALC4/2013 |Party Name:KUDOS CHEMIE [Meet No/Date:4/82- Status: LTD., ALC4/2014 Rejected 03.07.2014 52 |HQ File RLA File Lic.No/Date:2210013724 |Defer Date: :01/82/050/00207/AM14/ :22/24/040/00083/AM13/ 20.03.2013 ----- End of picture text -----

Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders.

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----- Start of picture text ----- Case No.:6/10/82-ALC4/2013 |Party Name:RANBAXY Meet No/Date:4/82- Status:Case LABORATORIES LTD ALC4/2014 Deferred 03.07.2014 53 JHQ File RLA File Lic.No/Date:05 10350030 |Defer :01/82/050/00189/AM14/ :05/24/040/00480/AM13/ 22.03.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:117/10/82- Party Name:PRASOL Meet No/Date:4/82- Status:Case ALC4/2013 CHEMICALS LIMITED ALC4/2014 Deferred 03.07.2014 HQ File RLA File Lic.No/Date:03 10729886 |Defer :01/82/050/00300/AM14/ :03/95/040/0088 1/AM13/ 28.03.2013 Date:07.08.2014 ----- End of picture text -----

Decision :It was decided to remind the firm to furnish the following technical details: 1. Complete set of application
54 |2. Details of Manufacturing process of 3,3,5 Trimethyl Cyclohexanone with Chemical equations, molecular formula, molecular weights.
1. Yield obtained in each step.
2. Authentic technical literature in support of yield obtained.
3. Material balance.
4. CA certificate certifying the production of export item achieved by you for the past three years and corresponding consumption of each input

|7. Detailed calculations, arriving at the norms applied for

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----- Start of picture text ----- Case No.:15/4/82-ALC4/2014 |Party Name:GITANJALI Meet No/Date:4/82- Status:Case CHEMICALS PVT LTD ALC4/2014 Deferred 03.07.2014 55 |HQ File , RLA File Lic.No/Date:03 10729944 |Defer :01/82/050/00263/AM15/ :03/94/040/01017/AM13/ 01.04.2013 Date:07.08.2014 Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals. ----- End of picture text -----

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----- Start of picture text ----- Case No.:17/10/82- Party Name:RANBAXY Meet No/Date:4/82- Status:Case ALC4/2013 LABORATORIES LTD ALC4/2014 Deferred 56 03.07.2014 HQ File RLA File Lic.No/Date:0510350968 |Defer :01/82/050/00200/AM14/ —|:05/24/040/00478/AM13/ [08.04.2013 \y,|Date:07.08.2014|* ----- End of picture text -----

“Ih -

Decision :It was decided to again send the copy of application to Department of Pharmaceuticals for their comments The case is deferred for 07.08.2014.

|CaseNo.:120/10/82-|PartyName:MEHTA APIPVT |MeetNo/Date:4/82-|PartyName:MEHTA APIPVT |MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|
|ALC4/2013|LTD|ALC4/2014|Deferred|
|||03.07.2014||
|HQ File|RLA File|Lic.No/Date:0310730905||Defer|
|:01/82/050/00303/AM14/|:03/95/040/00020/AM14/|(09.04.2013|Date:07.08.2014|

57 |Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/632/2013-PI(Norms) dated 04.03.2014, it was decided to call the following information from the firm : 1. Stepwise yield on molar basis for each step of manufacturing process, 2. Material balance for each step. 3. Copy of Technical Literature in support of yield claimed 4, Requirement of Calrithromycin Oxime per kg of clarithromycin. (ii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 07.08.2014

||CaseNo.:92/10/82-ALC4/2013||PartyName:CATAPHARMA_||MeetNo/Date:4/82-|Status:|
|---|---|---|---|---|
|||CHEMICALSPVT. LTD.,|ALC4/2014|Rejected|
||||03.07.2014||
|58||HQFile|RLA File|Lic.No/Date:3110057970||Defer Date:|
||:01/82/050/00275/AM14/|331/83/040/00214/AM13/|17.04.2013||

Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders.

Case No.:68/4/82-ALC4/2013 |Party Name: HALDIA Meet No/Date:4/82Status:Case PETROCHEMICALS LTD. ALC4/2014 Deferred 03.07.2014 59 |HQ File RLA File Lic.No/Date:0210188734 |Defer :01/82/050/00109/AM14/ :02/24/040/00002/AM14/ 17.04.2013 Date:07.08.2014 Decision : It was decided to remind the Department of Petrochemicals to furnish their comments as the case is pending since 16.05.2013.The case is defer 07.08.2014. ] Case No.:160/10/82Party Name:RIOCARE INDIA [Meet No/Date:4/82Status:Case ALC4/2013 PRIVATE LIMITED. ALC4/2014 Deferred 03.07.2014 HQ File RLA File Lic.No/Date:03 10731584 |Defer :01/82/050/00343/AM14/ :03/95/040/00024/AM14/ 17.04.2013 Date:07.08.2014

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/635/2013-PI(Norms) dated 04.03.2014, it was decided to call[the][ firm][ the][following][technical][details:] 60[from] i) Export Items 1 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

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. iii) 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 07.08.2014.

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a) _i7-

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||||||
|---|---|---|---|---|
|:|
|Case No.:43/10/82-|Party Name:SRINI|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|PHARMACEUTICALS|LTD.,||ALC4/2014|Deferred|
|03.07.2014|
|HQ File|RLA|File|Lic.No/Date:0910055800||Defer|
|61|:01/82/050/00226/AM14/|:09/24/040/00017/AM14/|19.04.2013|Date:07.08.2014|

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

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/676/2013-PI (Norms) dated 21.04.2014, it was decided to call from the firm COA of import item from the foreign supplier. The case was deferred for 07.08.2014

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|||||||
|---|---|---|---|---|---|
|Case|No.:76/14/82-|Party Name:ASTRIX|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|LABORATORIES LTD.,|ALC4/2014|Deferred|
|03.07.2014|
|62||HQ File|RLA|File|Lic.No/Date:0910055845||Defer|
|:01/82/050/0066|1/AM14/|:09/24/040/00611/AM13/|23.04.2013|Date:07.08.2014|

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

Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

==> picture [438 x 106] intentionally omitted <==

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

||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case|No.:219/10/82-|Party Name:RENOWN|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|PHARMACEUTICALS PVT||ALC4/2014|Approved|
|LTD|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:3410036732|[Defer|Date:|
|:01/82/050/00402/AM|1 4/|:34/24/040/00005/AM14/|29.04.2013|
|Decision|:The|Committee|considered|the|case|as|per|agenda|and|3and|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:-|

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

==> picture [438 x 89] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|63|
|Export product|Import|items|Qty.|allowed|
|Qty.|
|COD LIVER OIL|Nos.|1.|liver|Oj|1020 mg/1000 mg|
|1000MGS CAPSULE|Cod|liver Oi|Capsule|
|(Quantity|10,02,000|
|Nos)|

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

Case No.:157/10/82Party Name:LUPIN LIMITED ‘|Meet No/Date:4/82Status:Case ALC4/2013 ALC4/2014 Deferred {03.07.2014 64 |HQ File RLA File Lic.No/Date:03 10733961 |Defer :01/82/050/00340/AM 14/ :03/95/040/00098/AM 14/ 10.05.2013 Date:07.08.2014

Decision : It was decided to ask from the firm whether the export item is non-infringing or ordinary. The case is defer 07.08.2014

Case No.:2/5/82-ALC4/2013 |Party Name: MYLAN Meet No/Date:4/82Status:Case LABORATORIES LIMITED |ALC4/2014 Deferred 65 03.07.2014 HQ File RLA File Lic.No/Date:0910055979 |Defer :01/82/050/00120/AM14/ :09/24/040/00023/AM14/ 10.05.2013 . _|Date:07.08.2014 |}. - -

—|%-

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/708/2013-PI(Norms) dated 10.04.2014, it was decided to call the following information from the firm :

Complete technical details as per Appendix 33
Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities.

The case was deferred for 07.08.2014

==> picture [452 x 557] intentionally omitted <==

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

||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|)|
|Case|No.:14/20/82-|Party Name:DIVIS|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|PHARMACEUTICALS|ALC4/2014|Deferred|
|PRIVATE|LIMITED|03.07.2014|
|66|[HQ File|RLA|File|Lic.No/Date:0910056018||Defer|
|:01/82/050/01000/AM14/|:09/24/040/00016/AM14/|17.05.2013|Date:07.08.2014|
|Decision|:It was|decided|to|defer the|case|for 07.08.2014|for comments of|Department of|
|Pharmaceuticals.|
|Case|No.:52/13/82-|Party Name:STERICON|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|PHARMA PVT.LTD.,|ALC4/2014|Deferred|
|03.07.2014|
|67||HQ File|RLA|File|Lic.No/Date:0710095454||Defer|
|:01/82/050/00528/AM14/|:07/24/040/00039/AM14/|17.05.2013|Date:07.08.2014|
|Decision|:|It was decided to|call from the|firm copy DML|for the export product.|The|case|
|is|defer|07.08.2014|
|Case|No.:91/14/82-ALC4/2013||Party Name:ALKALOIDS|Meet|No/Date:4/82-|Status:Case|
|CORPORATION|ALC4/2014|Approved|
|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:0210189840||Defer|Date:|
|:01/82/050/00676/AM|1 4/|02/2 1/040/00025/AM14/|21.05.2013|
||Decision|:The|Committee|considered|the|case|as|per|agenda|and|in|consultation|with|technical|
|authority|present|in|meeting,|decided|to|ratify|the|norms|as|per|SION|A-263with|details|given|
|68|below or as applied by firm whichever or as applied by firm whichever as applied by firm whichever applied by firm whichever by firm whichever firm whichever whichever|is lower:- lower:-|
|Qty.|
|Hyoscinen|Butyl Bromide|or Hyoscine|Nos.|1.|Duboisia Leaves|85|kgs|
|Hydrobromide|upto Pharmacopoeial|(Dried)|
|Standard|
|RA may|take|appropriate|action|as|per the|decision|of Norms|Committee.|
|Case|No.:136/14/82-|Party Name:CALYX|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|CHEMICALS &|ALC4/2014|Deferred|
|PHARMACEUTICALS|LTD.||03.07.2014|
|69|FQ File|RLA|File|Lic.No/Date:0310735110|[Defer|
|:01/82/050/0072|1/AM14/|:03/94/040/00507/AM13/|21.05.2013|Date:07.08.2014|
|[Decision|:In the light of written comments received from Department|ofPharmaceuticals|

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

|Decision :The Committee considered the case as per agenda and in consultation with technical authority present in meeting, decided to ratify the norms as per SION A-263with details given 68 below or as applied by firm whichever or as applied by firm whichever as applied by firm whichever applied by firm whichever by firm whichever firm whichever whichever is lower:- lower:-

vide their OM No. 35011/734/2013-PI(Norms) dated 21.04.2014, it was decided to call the following information from the firm : 1. Complete technical details as per Appendix 33 2. Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 07.08.2014

==> picture [452 x 60] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Case|No.:10/20/82-|Party Name:DIVIS|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|LABORATORIES|LTD.,|ALC4/2014|Deferred|
|.|03.07.2014|
|70||HQ|File|RLA|File|Lic.No/Date:0910056098||Defer|
|:01/82/050/00996/AM 1 4/|:09/24/040/00057/AM 14/|22.05.2013|Date:07.08.2014|

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

==> picture [452 x 64] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Case No.:13/20/82-|Party Name:HETERO LABS|=||Meet No/Date:4/82-|Status:Case|
|ALC4/2013|LIMITED|ALC4/2014|Deferred|
|03.07.2014|
|71||HQ|File|RLA|File|Lic.No/Date:09 10056096||Defer|
|:01/82/050/00999/AM 14/|:09/24/040/00068/AM14/|22.05.2013|Date:07.08.2014|

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

Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

==> picture [452 x 95] intentionally omitted <==

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

||||||||||
|---|---|---|---|---|---|---|---|---|
|Case|No.:12/20/82-|Party Name:GLAND|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|PHARMA LIMITED|ALC4/2014|Deferred|
|03.07.2014|
|72||HQ|File|RLA|File|Lic.No/Date:0910056108||Defer|
|:01/82/050/00998/AM 14/|:09/24/040/0006 1/AM 14/|23.05.2013|Date:07.08.2014|
|Decision|:It was|decided|to|defer the|case|for 07.08.2014|for comments of Department|of|
|Pharmaceuticals.|.|

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

==> picture [452 x 117] intentionally omitted <==

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

||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Case No.:79/14/82-ALC4/2013||Party Name:AGOG PHARMA|[Meet No/Date:4/82-|Status:Case|
|LTD.|ALC4/2014|Approved|
|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:03 10735570|(Defer|Date:|
|:01/82/050/00664/AM|14/|:03/94/040/00093/AM|14/|24.05.2013|
|Decision|:|The|Committee|considered|the|case|as|per|agenda|and|in|light|of written|comments|
|received|from|Department|of|Pharmaceuticals|vide|their|OM|No.|35011/601/2012-PIl(Norms)|
|73||dated|06.02.2013and|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:-|

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

==> picture [496 x 108] intentionally omitted <==

----- Start of picture text ----- CIPROFLOXACIN Qty. kg/kg555.0 mg/500 mg TABLETS BP 500mg CIPROFLOXACIN HCL BP Tablets RA may take appropriate action as per the decision of Norms Committee. \. 14 Case No.:134/14/82- Party Name:CALYX Meet No/Date:4/82- {Status:Case. | - . ALC4/2013 CHEMICALS ALC4/2014 ~~ [Deferred . ----- End of picture text -----

| | |

||&PHARMACEUTICALS|03.07.2014||
|---|---|---|---|
||LTD.|||
|HQ File<br>:01/82/050/00719/AM14/|RLA File<br>:03/94/040/00508/AM13/|Lic.No/Date:0310735499<br>24.05.2013||Defer<br>Date:07.08.2014|

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/733/2013-PI(Norms) dated 21.04.2014, it was decided to call the following information from the firm : 1. Complete technical details as per Appendix 33 2. Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. The case was deferred for 07.08.2014.

||Case No.:92/14/82-|PartyName:INDOPHYTO|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|CHEMICALSPVTLTD|ALC4/2014<br>03.07.2014|Deferred|
|75||HQ File<br>:01/82/050/00677/AM14/|RLA File<br>:05/23/040/00043/AM14/|Lic.No/Date:0510355138<br>24.05.2013||Defer<br>Date:07.08.2014|

||Case No.:42/15/82-|PartyName:IPCA|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|LABORATORIES LIMITED||ALC4/2014<br>03.07.2014|Deferred|
|76||HQ File<br>:01/82/050/00804/AM14/|RLA File<br>:03/94/040/00071/AM14/|Lic.No/Date:0310735502<br>24.05.2013||Defer<br>Date:07.08.2014|

||Case No.:207/10/82-|PartyName:CHIRAG|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|ENTERPRISE|ALC4/2014<br>03.07.2014|Deferred|
|77||HQFile<br>:01/82/050/00390/AM14/|RLAFile<br>:24/24/040/00008/AM14/|Lic.No/Date:2410038996<br>27.05.2013||Defer<br>Date:07.08.2014|

Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals.

||Case No.:71/10/82-|PartyName:SCOTT-EDIL|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|PHARMACIALTD.,|ALC4/2014<br>03.07.2014|Deferred|
|78||HQ File<br>:01/82/050/00254/AM14/|RLA File<br>:22/24/040/00016/AM14/|Lic.No/Date:2210013890<br>28.05.2013|(Defer<br>Date:07.08.2014|

||‘CaseNo.:225/10/82-|PartyName:APEX|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|HEALTHCARELTD|ALC4/2014|Deferred|
|79|||03.07.2014||
||HQ File|RLA File|Lic.No/Date:3410037038||Defer|
||:01/82/050/00408/AM14/|:34/24/040/00035/AM14/|31.05.2013|Date:07.08.2014|

— 2Yr

Case No.:96/10/82Party Name: TORRENT Meet No/Date:4/82Status:Case ALC4/2013 PHARMACEUTICALS LTD. |ALC4/2014 Deferred 03.07.2014
80 |HQ File RLA File Lic.No/Date:0810121573 |Defer :01/82/050/00279/AM 14/ :08/24/040/00085/AM14/ 31.05.2013 Date:07.08.2014
Case No.:6/6/82-ALC4/2013 |Party Name:HETERO LABS _= [Meet No/Date:4/82Status:Case LIMITED ALC4/2014 Deferred 03.07.2014
81 |HQ File RLA File Lic.No/Date:0910056251 |Defer :01/82/050/00129/AM14/ :09/24/040/00097/AM 1 4/ 05.06.2013 Date:07.08.2014

==> picture [437 x 59] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Case|No.:227/10/82-|Party Name:SPAN|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|DIAGNOSTICS LTD|ALC4/2014|Approved|
|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:5210039825||Defer Date:|
|:01/82/050/00410/AM14/|:52/24/040/00002/AM14/|05.06.2013|

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

Decision :in the light of written comments received from Department of Biotechnology vide their OM

No. BT/IL/05/367/2012-PID dated 14.04.2014, 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:

==> picture [449 x 280] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Item|of Export|Qty.|Item|of import|Quantity|
|allowed|kg/kg|
|ParaHIT-F (Device)|||1 kg|BRU-35|[53.33gm|
|go | (RAPID||3.|||ANTI MOUSE IgG (GOAT)|0.056 gm|
|KIS)|TEST||4.|||BSA PROTEASE FREE POWDER|241.00 gms|
|15.|||MAB TO P. FALCIPARUM FOR NCM.|0.0183 gm|
|MAB FOR P. FALCIPARUM COLLOIDAL|||0.0094 gm|
|GOLD|REA|
|MOUSE|IgG (PURIFIED)|0.0047 gm|
|CONJUGATE RELEASING PAD|21 mm|x|683|
|(2040/2033)PARAHIT.|f|
|21 mm x 500 feet|eet|
|CONJUGATE RELEASING PAD|10MM.|10 mm|x 683|
|(10 mm x|500|feet)|feet|
|22 mm|x|50|mtr|
|||11.|| ABSORBENT PAD FOR RAPID TEST 22|22 mm x 69.0|
|MM X|50 MTR.|
|22 mm x 50 mtr|mtr|
|GOLD CHLORIDE (DUTY PAID)|0.7286.gm|

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

2 2

13."13, || CONTAIN-25,DIS. SAFTYSEALLANCETSPACK12000n0s.—S|2000n0s HEPARINIZED CAPALLARIES PACK 2000 nos CONT.25. DISPOSABLE SWAB PACK EACH CONTAIN-25. RA may take appropriate action as per the decision of Norms Committee’s. Case No.:109/10/82Party Name:IND-SWIFT Meet No/Date:4/82Status:Case ALC4/2013 LABORATORIES LTD., ALC4/2014 Deferred 03.07.2014 83 [HQ File RLA File Lic.No/Date:22 10013931 |Defer :01/82/050/00292/AM 14/ :22/24/040/00022/AM14/ 11.06.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals. .

Case No.:18/13/82Party Name:STERICON Meet No/Date:4/82Status:Case ALC4/2013 PHARMA PVT.LTD., AALC4/2014 Deferred 03.07.2014 84 HQ File RLA File Lic.No/Date:07 10095973 |Defer |:01/82/050/00494/AM14/ :07/24/040/00075/AM14/ 17.06.2013 Date:07.08.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/713/2013-PI(Norms) dated 21.04.2014, it was decided to call from the firm copy DML for the export product. The case is deferred for 07.08.2014.

==> picture [451 x 109] intentionally omitted <==

----- Start of picture text ----- Case No.:23/12/82- Party Name:CIRON DRUGS [Meet No/Date:4/82- Status:Case ALC4/2013 & PHARMACEUTICALS P. |ALC4/2014 Deferred LTD., 03.07.2014 HQ File RLA File Lic.No/Date:03 10738255 |Defer :01/82/050/00447/AM14/ :03/94/040/00094/AM14/ 19.06.2013 Date:07.08.2014 85 Decision : It was decided to remind the firm to furnish the following technical details: 1. Copy of DML for the export product. 2. Detailed working for arriving the import quantity applied by the firm. ----- End of picture text -----

The case was deferred for 07.08.2014.

Case No.:126/14/82Party Name:ZIM Meet No/Date:4/82Status:Case ALC4/2013 LABORATORIES LTD. ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:03 10738604 |Defer Date: :01/82/050/007 1 1/AM14/ :03/95/040/00225/AM14/ 21.06.2013

g6 |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 below or as applied by firm whichever is lower :-

==> picture [394 x 39] intentionally omitted <==

----- Start of picture text ----- Export product Import items Qty. allowed Qty. _| Ke/kg aT ----- End of picture text -----

==> picture [424 x 30] intentionally omitted <==

----- Start of picture text ----- NITROFURANTOINA |1Kg. | eee ~ 103535.” 1 Kg. l. NITROFURANTOIN BP 0.3535 | PELLETS 38% 2011(ANHYDROUS FORM) ----- End of picture text -----

Case No.:19/13/82Party Name:BOSTIK INDIA __/Meet No/Date:4/82Status:Case ALC4/2013 PRIVATE LIMITED ALC4/2014 Deferred 03.07.2014 $7 |HQ File RLA File Lic.No/Date:07 10096186 |Defer :01/82/050/00495/AM14/ :07/24/040/00502/AM 13/ 25.06.2013 Date:07.08.2014

Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals.

|Case No.:203/10/82-|PartyName:SHASUN|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|
|ALC4/2013|PHARMACEUTICALS<br>LIMITED|ALC4/2014<br>03.07.2014|Deferred|
|HQFile|RLA File|Lic.No/Date:0410147556||Defer|
|:01/82/050/00386/AM14/|:04/24/040/00064/AM14/|27.06.2013|Date:07.08.2014|

88 (Decision : In the light of written comments received from Department of Pharmaceuticals vide 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.

The case was deferred for 07.08.2014.

|CaseNo.:204/10/82-<br>ALC4/2013|_ |PartyName:SHASUN<br>PHARMACEUTICALS<br>LIMITED|MeetNo/Date:4/82-<br>ALC4/2014<br>03.07.2014|Status:Case<br>Deferred|
|---|---|---|---|
|HQ File<br>:01/82/050/00387/AM14/|RLA File<br>:04/24/040/00065/AM14/|Lic.No/Date:0410147559<br>27.06.2013||Defer<br>Date:07.08.2014|

89 (Decision : In the light of written comments received from Department of Pharmaceuticals vide 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.

The case was deferred for 07.08.2014.

Case No.:41/8/82-ALC4/2013 |Party Name: UNITED Meet No/Date:4/82Status:Case PHOSPHORUS LTD. ALC4/2014 Deferred 03.07.2014 90 |HQ File RLA File Lic.No/Date:03 10739495 |Defer :01/82/050/00172/AM14/ :03/95/040/01020/AM13/ 28.06.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals

|91|Case No.:64/13/82-<br>ALC4/2013|PartyName:EAGLE<br>CHEMICALWORKS|MeetNo/Date:4/82-<br>ALC4/2014<br>03.07.2014|Status:Case<br>Deferred|
|---|---|---|---|---|
||HQFile<br>:01/82/050/00540/AM14/|RLA File<br>:03/94/040/00019/AM14/|Lic.No/Date:0310740489<br>05.07.2013<br>;||Defer<br>Date:07.08.20 14|

2 Decision :In the light of written comments received from Departmen ofaie s vide their OM No. 3501 1/689/2013-P(Norms) dated[et][ 04.201] » It was ee request the firm to furnish the following technical cetatls: oo, 1. The firm may specify the pharmacopela as per which the export is being made, copy of relevant pharmacopeia may also be furnished 2. Complete technical details as per Appendix 33. The case was deferred for 07.08.2014. Case No.:41/13/82Party Name:JAGSONPAL Meet No/Date:4/82Status:Case ALC4/2013 PHARMACEUTICALS LTD. |ALC4/03.07. 20 1414 Deferred HQ File RLA File Lic.No/Date:0510359156 |Defer :01/82/050/00517/AM14/ -05/23/040/00056/AM 14/ 09.07.2013 Date:07.08.2014 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/698/2013-PI(Norms) dated 21.04.2014, it was decided to call the 92 \following information from the firm : 1. Copy of valid Drug Manufacturing Licence alonwith list ofapproved items showing the composition of export product. 2. The firm has given license for the import of 1000 kg Indomethacin from China. Justification for claiming import of indomethacin Mixed Pellet 53% may be furnished. 3. COA from Foreign Supplier for the import of Indomethacin Mixed Pellet 53%.

The case was deferred for 07.08.2014

Case No.:27/13/82Party Name:ADVY. [Meet No/Dat :4/82. oFue RLA Fil 03.07.2014i - 3s Decision heats Date:07.08.2014 *3 chemical :Departmentand allied productof Biotechnologrou sf fadinformedi that the application—— is made under hemi group and import input mentioned in the applicati chemicals.. nanThe export product is b : . pplication are diagnostic 1s being synthesized through chemical ‘ . of kit. HenceD/o Biotechnology has advised toseek ce rowe and is used in Pharmaceuticals. Accordingl od loseek comments from Department furnished ngly, a copy of application alongwithrep! their comments. by the firm has been sent toDepartment nt ofof PPharmaceuticalsgwithreplyon 19.05.2014of deficiencyfor Case No.:10/4/82-ALC4/2014_|P arty Name:JUBILANT L Fore RARE 03.07.2014 Approved 94 '01/82/0S0/00258/AMI5/ DsAseonousamne — LENeDuRSTORIRGO Defer Date: |Decision :Committee considered the case as pe 07.2013 . “eehnicall members present in the meeting, it was deced o me p gonsulation with the i.[given][below][ or][ as applied][ by][ the][ firm,] ?[ whichever][ is][ less:] a ify norms as per SION A-412 | Spironolac actone Tablets 25mg,50 MG and 100 MG TAB n\n ;

25°

==> picture [404 x 84] intentionally omitted <==

----- Start of picture text ----- S.NO. | Import Items For export of 1 No. Spironolactone Tablets (Quantity in mg) 25mgTablets 50 mgTablets | 100 mgTablets [1. [[Spironolactone] Micronised | 25.5mg_ | 51.0 mg 102.0 mg RA may take appropriate action as per the decision of Norms Committee. — ----- End of picture text -----

CaseNo.:157/14/82-<br>ALC4/2013	PartyName:HETEROLABS<br>LIMITED	‘MeetNo/Date:4/82-<br>ALC4/2014	Status:Case<br>Approved
		03.07.2014
HQFile<br>:01/82/050/00742/AM14/	RLA File<br>:09/24/040/00170/AM14/	Lic.No/Date:0910056762<br>15.07.2013	(DeferDate:

Decision :In the light of earlier decision taken by NC in its 51/82 meeting dated 22.03.2011, 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:

|95|ExportProduct|Exp.<br>Qty.|S.No_ | ImportProduct|_|| Quantity<br>Allowed<br>kg/kg|
|---|---|---|---|---|---|
||TERBINAFINEHCL|lkg|1.<br>N-MethylI-1-naphthalene||1.14 kg|
||||methanamine hydrochloride|||
||||2.<br>1-Chloro-6,6-dimethy!-2-||0.87 kg|
||||hepten-4-yne|||
||||Methylene chloride||2.37 kg|
|||||4.__| DimethylFormamide||}0.85kg|<br>1.17 kg|
||RAmaytakeappropriate|actionasper||6. __|Diisopropylether 1.30 kg<br>perthe decision ofNormsCommittee.|||
||CaseNo.:28/13/82-|Party|MeetNo/Date:4/82-||Status:Case|
||ALC4/2013|IName:RANBAXYLABORA<br>|ALC4/2014|||Deferred|
|||TORIESLTD<br>03.07.2014||||
||HQ File|RLA File|Lic.No/Date:0510360180|||Defer|
|96|1:01/82/050/00504/AM14/|:05/24/040/00114/AM14/<br>18.07.2013|||Date:07.08.2014|

Decision : It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 07.08.2014.

||Case No.:81/13/82-|PartyName:IND-SWIFT|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|LABORATORIES LTD.,|ALC4/2014|Deferred|
||||03.07.2014||
|97||HQ File|RLA File|Lic.No/Date:2210014016||Defer|
||:01/82/050/00557/AM14/|:22/24/040/00032/AM<br>14/|19.07.2013|Date:07.08.2014|

bs Case No.:32/13/82-ALC4/2013 Paty|Party Name:MERCURYName:MER( LIMITED = Meet_|ALC4/2014 No/Date:4/82__|ApprovedStatus:Case _

rb

|||||||(03.07.2014||||
|---|---|---|---|---|---|---|
||HQ File||RLA File|Lic.No/Date:3410037467|||DeferDate:|
||:01/82/050/00508/AM14/||:34/24/040/00077/AM14/|23.07.2013|||

Decision : Committee considered the case as per agenda and in consultation with technical authority present in the meeting , 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.||Import items|Qty. allowed|
|---|---|---|---|---|---|
|||Qty.||||
|Ciprofloxacin TabletUSP250|||1,|Ciprofloxacin Hcl|| 277.5 mg/tabletof|
|mg|||||250mg|

RA concerned may take further necessary action as per above decision of NC.

||Case No.:23/14/82-|PartyName:RACHEM|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|PHARMALIMITED|ALC4/2014|Deferred|
||||03.07.2014||
|99||HQ File<br>:01/82/050/00608/AM14/|RLA File<br>:09/24/040/00191/AM14/|Lic.No/Date:0910056934<br>29.07.2013||Defer<br>Date:07.08.2014|

||CaseNo.:28/19/82-|PartyName:SMILAX|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|LABORATORIESLIMITED||ALC4/2014<br>03.07.2014|Deferred|
|100||HQ File|RLA File|Lic.No/Date:09 10056940||Defer|
||:01/82/050/00973/AM14/|:09/24/040/00181/AM14/|29.07.2013|Date:07.08.2014|

||Case No.:17/13/82-<br>ALC4/2013|PartyName:PABORGANICS <br>PVT.LTD,||MeetNo/Date:4/82-<br>ALC4/2014<br>(03.07.2014|Status:Case<br>Deferred<br>.|
|---|---|---|---|---|
|101||HQ File<br>:01/82/050/00493/AM14/|RLA File<br>:34/24/040/00085/AM14/|Lic.No/Date:3410037541 <br>31.07.2013||Defer<br>Date:07.08.2014|

Decision :It was decided to defer the case for 07.08.2014 for comments of Department of | |Pharmaceuticals.

Case No.:31/4/82-ALC4/2014 |Party Name: UNIVERSAL Meet No/Date:4/82Status:Case BIOFUELS PRIVATE ALC4/2014 Deferred LIMITED 03.07.2014
102 |HQ File RLA File Lic.No/Date:09 10056959 |Defer :01/82/050/00279/AM15/ :09/24/040/00155/AM14/ 31.07.2013 Date:07.08.2014

==> picture [452 x 27] intentionally omitted <==

----- Start of picture text ----- 103 Case No.:61/14/82- Party Name:HETERO Meet No/Date:4/82- Status:Case ALC4/2013 DRUGS LIMITED, ALC4/2014 _,,Deferred” : ----- End of picture text -----

| |

03.07.2014 | HQ File RLA File Lic.No/Date:09 10057007 (Defer 01/82/050/00646/AM14/ :09/24/040/00206/AM14/ 02.08.2013 Date:07.08.2014 Decision : It was decided to call the following information from the firm : i) Stepwise chemical reactions showing correct Molecular weight of each reactant & output product, and % yield on molar basis. ii) Justification for requirement of imported inputs in view of CA certificate furnished by the firm. The case was deferred for 07.08.2014

Case No.:148/14/82Party Name:SUVEN LIFE Meet No/Date:4/82Status:Case ALC4/2013 SCIENCES LIMITED ALC4/2014 Deferred 03.07.2014 104 |HQ File RLA File Lic.No/Date:09 10057006 |Defer :01/82/050/00733/AM14/ :09/24/040/00189/AM14/ 02.08.2013 '|Date:07.08.2014

| ) | | |

==> picture [451 x 109] intentionally omitted <==

----- Start of picture text ----- Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals Case No.:42/14/82- Party Meet No/Date:4/82- Status: Rejected ALC4/2013 IName:A VACHEMICALS ALC4/2014 PVT.LTD., 03.07.2014 105 |HQ File RLA File Lic.No/Date:03 10744155 |Defer :01/82/050/00627/AM 14/ :03/94/040/00220/AM 14/ 05.08.2013 Date:07.08.2014 ----- End of picture text -----

Decision : It was decided to reject the case as the firm has not furnished the information despite repeated reminders.

||CaseNo.:5/4/82-ALC4/2014||PartyName:SANMAR|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
|||SPECIALITY CHEMICALS|jALC4/2014|Deferred|
|||LIMITED,|03.07.2014||
|106||HQ File|RLA File|Lic.No/Date:0410148580||Defer|
||:01/82/050/00253/AM15/|:04/24/040/00046/AM14/|05.08.2013|Date:07.08.2014|

{Decision:]t was decided to defer the case for 07.08.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals.

Case No.:18/14/82Party Name:SUVEN LIFE _— [Meet No/Date:4/82Status: Approved ALC4/2013 SCIENCES LIMITED ALC4/2014 03.07.2014 HQ File RLA File Lic.No/Date:0910057031 |Defer Date: :01/82/050/00603/AM14/ :09/24/040/00207/AM 1 4/ 05.08.2013

Decision : Committee considered the case as per agenda and in the light of earlier decision taken by NC in its 10/82 meeting dated 22.08., it was decided to ratify norms 107 \under para 4.7 of HBP as details given below or as applied by the firm, whichever is less:

==> picture [434 x 78] intentionally omitted <==

----- Start of picture text ----- Export product Export | SIL.No. | Import items Qty. allowed Qty. kg/kg ACETOPHENONE a RA may take appropriate action as per the decision of Norms Committee. Bt ----- End of picture text -----

XE

==> picture [13 x 12] intentionally omitted <==

----- Start of picture text ----- | ----- End of picture text -----

||Case No.:22/13/82-|PartyName:PROMED|MeetNo/Date:4/82-|——-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|EXPORTSPVT.LTD.|ALC4/2014|Deferred|
||||03.07.2014||
|108||HQFile<br>:01/82/050/00498/AM14/|RLA File<br>05/24/040/00171/AM14/|Lic.No/Date:0510362268 <br>07.08.2013||Defer<br>Date:07.08.2014|

||Case No.:20/14/82-<br>ALC4/2013|PartyName:SRIAMLABS<br>PRIVATELIMITED|MeetNo/Date:4/82-<br>Status:Case<br>ALC4/2014<br>Deferred|
|---|---|---|---|
||||03.07.2014|
|109||HQFile<br>:01/82/050/00605/AM14/|RLA File<br>:09/24/040/00177/AM14/|Lic.No/Date:0910057053 {Defer<br>07.08.2013<br>,Date:07.08.2014|
||Decision :Itwasdecided <br>Pharmaceuticals.|todeferthe case for07.08.2014 forcommentsof Department of||

Case No.:11/13/82Party Name:WANBURY Meet No/Date:4/82Status:Case ALC4/2013 LIMITED(FORMERLY ALC4/2014 Deferred PEARL ORGANICS LTD) 03.07.2014 HQ File RLA File Lic.No/Date:03 10744468 |Defer :01/82/050/00487/AM14/ :03/95/040/00134/AM14/ 07.08.2013 Date:07.08.2014

Decision : In the light of written comments received from Department of 110 |Pharmaceuticals vide their OM No. 3501 1/704/2013-PI(Norms) dated 01 04.2014, it was decided to call the following information from the firm : i) Complete technical details as per Appendix 33 for the export product (it) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities.

The case was deferred for 07.08.2014

==> picture [450 x 146] intentionally omitted <==

----- Start of picture text ----- Case No.:73/13/82- Party Name: WANBURY Meet No/Date:4/82- Status:Case ALC4/2013 LIMITED(FORMERLY ALC4/2014 Deferred PEARL ORGANICS LTD) {03.07.2014 HQ File RLA File Lic.No/Date:03 10744832 |Defer :01/82/050/00549/AM14/ :03/95/040/00133/AM14/ 12.08.2013 Date:07.08.2014 111 Decision : Decision :In the light of written comments received from Department of |Pharmaceuticals vide their OM No. 3501 1/705/2013-PI(Norms) dated 01.04.2014, it was decided to call the following information from the firm : i) Complete technical details as per Appendix 33 for the export product (ii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities. ----- End of picture text -----

The case was deferred for 07.08.2014

==> picture [489 x 69] intentionally omitted <==

----- Start of picture text ----- Case No.:76/13/82- Party Name: WANBURY Meet No/Date:4/82- Status:Case 12 ALC4/2013 LIMITED(FORMERLY ALC4/2014 Deferred He [File] RLAPEARL File ORGANICS LTD) {03.07.2014Lic.No/Date:03 10744834 [Defer _ N :01/82/050/00552/AM14/ :03/95/040/00125/AM14/ 12.08.2013 Date:07.08.2014 ----- End of picture text -----

2-4

Decision :Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 3501 1/706/2013-PI(Norms) dated 01.04.2014, it was decided to call the following information from the firm : i) Complete technical details as per Appendix 33 for the export product (ii) Past production vis-a-vis actual consumption of input duly certified by Central Excise Authorities.

The case was deferred for 07.08.2014

||Case No.:75/13/82-|Case No.:75/13/82-|PartyName:WOCKHARDT|[MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|---|
||ALC4/2013||LIMITED|ALC4/2014|Deferred|
|||||03.07.2014||
|113||HQ File||RLA File|Lic.No/Date:0310744861||Defer|
||:01/82/050/00551/AM14/||:03/95/040/00320/AM14/|12.08.2013|Date:07.08.2014|
||Decision<br>:|It was decided to remind DCGI to furnish their comments.|||The case was|
||deferredfor07.08.2014.|07.08.2014.||||

||Case No.:107/13/82-<br>PartyName:DRREDDYS|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|
||ALC4/2013<br>LABORATORIESLIMITED||ALC4/2014|Deferred|
|||03.07.2014||
||HQ File<br>RLA File<br>:01/82/050/00583/AM14/<br>:09/24/040/00222/AM14/|Lic.No/Date:09<br>10057189 <br>14.08.2013|'|Defer<br>Date:07.08.2014|
|114|Decision : Itwasdecided toremindthefirmto furnish the following information :<br>1) Complete details asperAppendix 33.|||
||ii)Copy relevant technical literature in support ofyields envisaged|||
||ili) Pastproduction vis-a-vis actual consumptionofinput|inputduly certifiedby Central Excise||
||Authorities.|||

The case was deferred for 07.08.2014

Case No.:17/14/82-ALC4/2013 |Party Name:IPCA Meet No/Date:4/82Status: LABORATORIES LIMITED |ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:03 10745508 Defer Date: :01/82/050/00602/AM 1 4/ :03/94/040/00978/AM13/ 16.08.2013

Decision :Committee considered the case as per agenda and in consultationwith technical authority present in meeting it was decided to ratify norms under para 4.7 of HBP as per details 115 below or as applied by firm whichever is lower:-

==> picture [65 x 16] intentionally omitted <==

----- Start of picture text ----- Triamcinolone ----- End of picture text -----

==> picture [277 x 47] intentionally omitted <==

----- Start of picture text ----- Qty. 1 kg. 3,20 Dioxopregna-1,4,9(11), 1.00 kg 16 Tetraen-21-Ylacetate (3 - TR ----- End of picture text -----

RA concerned may take further necessary action as per above decision ofNC

==> picture [448 x 34] intentionally omitted <==

----- Start of picture text ----- lie Case No.:16/4/82-ALC4/2014 ery|Party Name:GITANJALIvame:c PVTLTD MeetALC4/2014 No/Date:4/82-___, Approved.Status: ----- End of picture text -----

| | [03.07.2014 HQ File RLA File Lic.No/Date:0310746180 |Defer Date: ; :01/82/050/00264/AM15/ :03/94/040/00355/AM14/ 21.08.2013 Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/41/2011-Ch II dated 25.05.2012, 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:

==> picture [418 x 100] intentionally omitted <==

----- Start of picture text ----- Export product Import items Qty. allowed Qty. BROMO ANSOLE 11 kg 0.820Kg [2.___ | DIMETHYL SULFATE | 0.627 kg RA may take appropriate action as per the[4.___| decision [HYDROGENPEROXIDE] of Norms Committee. = 0.757 kg ----- End of picture text -----

==> picture [450 x 94] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Case No.:20/13/82-|Party|Name: VARUN|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|MEDIMPEX|INC.|ALC4/2014|Deferred|
|03.07.2014|
|117||HQ File|RLA|File|Lic.No/Date:05 10363085||Defer|
|:01/82/050/00496/AM14/|:05/24/040/00134/AM14/|21.08.2013|Date:07.08.2014|
|Decision:It was|decided to|defer the case|for 07.08.2014|for comments|of Petrochemicals|
|Division|of Department|of|Chemicals|and Petrochemicals.|

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

==> picture [447 x 64] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Case No.:90/13/82-ALC4/2013||Party Name:CATAPHARMA|__|Meet No/Date:4/82-|Status:|
|CHEMICALS|PVT. LTD.,|ALC4/2014|Rejected|
|03.07.2014|
|118|HQ|File|RLA|File|Lic.No/Date:3 110060069|(Defer Date:|
|:01/82/050/00566/AM14/|:31/83/040/00054/AM14/|23.08.2013|

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

Decision :It was decided to reject the case as the firm has not furnished information despite repeated reminders

==> picture [429 x 62] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Case No.:4/4/82-ALC4/2014||Party Name:SHASUN|Meet No/Date:4/82-|Status:|
|PHARMACEUTICALS|ALC4/2014|Approved|
|LIMITED|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:0410148932|[Defer Date:|
|:01/82/050/00252/AM15/|:04/24/040/00107/AM14/|23.08.2013|

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

Decision: in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/541/2013-Pl(Norms) dated 26.11 .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: 119:|Export Product

PAROXETINE TABLETS

==> picture [343 x 74] intentionally omitted <==

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

||||||
|---|---|---|---|---|
|Import|Items|For export of 1|No.|Tablets|
|(Quantity|in|mg)|
|10 mg|20 mg|30 mg|
|PAROXETINE|Tablets|Tablets|Tablets|
|HCL|11.33|| 2266|[33.99|

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

HEMIHYDRATE

RA concerned may take further necessary action as per above decision of NC

Case No.:1/15/82-ALC4/2013 |Party Name:CORAL Meet No/Date:4/82Status:Case LABORATORIES LTD., ALC4/2014 Deferred 03.07.2014 .
120 |HQ File RLA File Lic.No/Date:03 10747134 [Defer :01/82/050/00763/AM 14/ :03/94/040/00389/AM14/ 27.08.2013 Date:07.08.2014

Decision :Decision : It was decided to defer the case for 07.08.2014 for comments of Department ofPharmaceuticals.

Case No.:53/4/82-ALC4/2014 |Party Name:GITANJALI Meet No/Date:4/82Status: CHEMICALS PVT LTD ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:03 10747425 :|Defer Date: :01/82/050/00301/AM15/ :03/94/040/004 13/AM14/ 28.08.2013

==> picture [451 x 138] intentionally omitted <==

----- Start of picture text ----- Decision :!n the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/41/2011-Ch It dated 25.05.2012, it was decided to 12] jratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exe.Qty. | SiNo. Qty. allowed 4-CHLORO ANISOLE {ikg |[1.| PHENOL 1.470 kg ||2.3.|| DIMETHYLSODIUM HYDROXIDE SULFATE 0. 48 30 kg RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

Case No.:25/15/82Party Name:IPCA Meet No/Date:4/82Status: Approved ALC4/2013 LABORATORIES LIMITED |ALC4/2014 03.07.2014 HQ File RLA File Lic.No/Date:03 10747414 |Defer Date: :01/82/050/00787/AM 14/ :03/94/040/00992/AM 13/ 28.08.2013

Decision : Committee considered the case as per agenda and in consultationwith technical authority present in meeting it was decided to ratify norms under para 4.7 of HBP as per details 122 [below or as applied by firm whichever is lower:-

Oty. Triamcinolone Acetonide | 1 kg. 3,20 Dioxopregna-1,4,9(11), 1.00 kg 16 Tetraen-21-Ylacetate (3 - TR

RA concerned may take further necessary action as per above decision ofNC

Case No.:25/13/82Party Name:CORPORATE Meet No/Date:4/82Status:Case 123 ALC4/2013 CHANNELS INDIA PVT. ALC4/2014 Deferred LTD., 03.07.2014 [HQ File RLA File Lic.No/Date: 1310044179 |Defer

[:0 1/82/050/00501/AM14/ :13/24/040/00019/AM14/ [29.08.2013 [Date:07.08 2014 Decision :Reply received from the firm and sent to Petrochemical Division of Department of C&PC, on 25.02.2014, for their comments. The case was deferred for 07.08.2014.

|CaseNo.:14/4/82-ALC4/2014|{|PartyName:SUVENLIFE<br>SCIENCESLIMITED|MeetNo/Date:4/82-<br>ALC4/2014<br>03.07.2014|Status:<br>Approved|
|---|---|---|---|
|HQ File<br>:01/82/050/00262/AM15/|RLA File<br>:09/24/040/00256/AM14/|Lic.No/Date:0910057429<br>30.08.2013|iDeferDate:|

||CaseNo.:14/4/82-ALC4/2014<br>{|PartyName:SUVENLIFE<br>MeetNo/Date:4/82-<br>Status:<br>SCIENCESLIMITED<br>ALC4/2014<br>Approved<br>03.07.2014<br>HQ File<br>RLA File<br>Lic.No/Date:0910057429<br>iDeferDate:<br>:01/82/050/00262/AM15/<br>:09/24/040/00256/AM14/<br>30.08.2013|
|---|---|
|124|Decision :In the lightofwrittencomments received fromDepartmentofPharmaceuticals<br>vide theirOMNo. 35011/761/2013-PI(Norms) dated 04.03.2014 itwas decided toratify<br> Norms under Para 4.7 ofHBP v1 as per details given below or as applied by the firm,<br>whichever is less:|
||ExportProduct<br>Export<br>S.No | Import Product<br>Quantity<br>Quanti<br>Allowedkg/kg|
||3,5-<br>1 kg<br>3,5-DIHYDROXY<br>0.89<br>DIACETOXYACETOPHENONE<br>ACETOPHENONE|

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

|CaseNo.:35/14/82-<br>ALC4/2013|PartyName:VIRCHOW<br>PETROCHEMICALPVT<br>LTD.|[MeetNo/Date-4/82-<br>ALC4/2014<br>03.07.2014|_[Status:<br>Approved|
|---|---|---|---|
|HQ File|RLA File|Lic.No/Date:0910057435||DeferDate:|
|:01/82/050/00620/AM14/|09/24/040/00232/AM14/|30.08.2013||

Decision : Committee considered case as per earlier decision taken by NC in its 48/82 meeting dated 01.03.2011 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:-

==> picture [450 x 117] intentionally omitted <==

----- Start of picture text ----- 125| [Export product Qi. allowed PHENYLACETAMIDEO-7. aa PENICILLINFIRST CRYSTAL G-POTASSIUM 2.81 kg 3-CHLOROMETHYL 1.971 kg ACID PAR wR nccy 0.66 kg BENZY'- }4. |DIMETHYLFORMAMIDE| 1.314kg ESTER (GCLE) 3.29 kg |6. __| [2MERCAPTO] BENZO THIAZOLE | 0.511 kg 1.971 kg ----- End of picture text -----

RA concemed may take further necessary action as per above decision ofNC.

	CaseNo.:51/14/82-<br>PartyName:RATNAMANI<br>[MeetNo/Date:4/82-<br>Status:
	ALC4/2013<br>BIOCHEMICALS&<br>ALC4/2014<br>Approved<br>PHARMACEUTICALS PVT. (03.07.2014
	LTD
126	[HQFile<br>RLAFile<br>Lic.No/Date:3410037783 [DeferDate:
	:01/82/050/00636/AM14/<br>:34/24/040/00125/AM14/<br>02.09.2013<br>Decision :Inthelightofwrittencommentsreceivedfrom Departmentof Chemicals and <br>PetrochemicalsvidetheirU.ONo.14010/23/2014-ChIIdated<br>24.06.2014,..itwas;	\,<br>%-

e[)]

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:

==> picture [415 x 122] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Export product|Exp.|||SL.No.|| Import items|Qty. allowed|
|Qty.|
|ee|eeee oa|
|2,3-Dichloro|Tol|.|
|Oba Kg|

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

RA may take appropriate action as per the decision of Norms Committee,

==> picture [450 x 69] intentionally omitted <==

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

|||||||
|---|---|---|---|---|---|
|Case No.:2/12/82-ALC4/2013||Party|Name:|VIVEK|Meet No/Date:4/82-|Status:Case|
|PHARMACHEM (INDIA)|ALC4/2014|Deferred|
|LTD.,|03.07.2014|
|127|[HQ File|RLA File|Lic.No/Date: 1310044274||Defer|
|:01/82/050/00426/AM14/|:13/24/040/00022/AM14/|09.09.2013|Date:07.08.2014|

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

Case No.:16/16/82Party Name:KARNATAKA __|Meet No/Date:4/82Status:Case ALC4/2013 ANTIBIOTICS & ALC4/2014 Deferred PHARMACEUTICALS 03.07.2014 LTD.,
128 THQ File RLA File Lic.No/Date:07 10098183 [Defer :01/82/050/00829/AM14/ :07/24/040/00189/AM14/ 10.09.2013 Date:07.08.2014
Case No.:105/13/82Party Name:RA CHEM Meet No/Date:4/82Status:Case ALC4/2013 PHARMA LIMITED ALC4/2014 Deferred 03.07.2014
129 |HQ File RLA File Lic.No/Date:09 10057516 |Defer :01/82/050/00581/AM14/ :09/24/040/00265/AM14/ 10.09.2013 Date:07.08.2014

Decision : It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:11/15/82Party Name:BENZO CHEM _|Meet No/Date:4/82Status:Case ALC4/2013 INDUSTRIES PRIVATE ALC4/2014 Deferred LIMITED, 03.07.2014 130 |HQ File RLA File Lic.No/Date:03 10749169 |Defer :01/82/050/00773/AM14/ :03/94/040/00352/AM14/ 11.09.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals. ;

a ]

==> picture [424 x 62] intentionally omitted <==

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

||||||
|---|---|---|---|---|
|Case|No.:36/4/82-ALC4/2014||Party Name:CADILA|Meet No/Date:4/82-|Status:|
|HEALTHCARE LTD.,|ALC4/2014|Approved|
|03.07.2014|
|HQ File|RLA|File|Lic.No/Date:0810124685||Defer Date:|
|:01/82/050/00284/AM15/|:08/24/040/00258/AM14/|11.09.2013|

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

Decision :in the light of earlier decision taken by NC in its 12/82 meeting dated 19.09.2013, it was decided to ratify norms under para 4.7 of HBP v | as per details given below or as applied by the firm, whichever is less:

Export Product

LEVOFLOXACIN 250 MG TABS 500 MG TAB, 750 MG TAB (ACTIVE INGREDIENT : LEVOFLOXACIN HEMIHYDRATE NT. WT. 10148.23 KGS., GR. WT. 10608.95 KGS.)

==> picture [448 x 386] intentionally omitted <==

----- Start of picture text ----- For export of 1 No. Tablets (Quantity in mg) 250 mg 300 mg 730 mg Tablets Tablets Tablets LEVOFLOXACIN HEMIHYDRATE | 261.35 522.70 784.054 131 MICROCRYSTALLINE 148.95 CELLULOSE NF (AVICEL PH 102) a] CROSPOVIDONE NF 21.65 43.30 6495 16 ‘| Bottle and Caps Relevant, As per Packing Policy [B] Recommended Norms for 1 kg LEVOFLOXACIN HEMIHYDRATE SN Import Items Quantity recommended kg/kg 1 (-)-9, 10-DIFLUORO-3-METHYL-7- 0.8571 OXO-2, 3- DIHYDRO-7H-PYRIDO (1,2,3-DE)-1, 4-BENZOXAZIN E-6- CARBOXYLIC ACID DIMETHYL SULFOXIDE 0.2193 PB | N-METHYL PIPERAZINE 0.432 [4 [ISOPROPYL ALCOHOL GPA) [| [__15sa.—Ss~—~SS] ----- End of picture text -----

)

==> picture [478 x 98] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Case|No.:33/15/82-|Party Name:KOPRAN|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|LIMITED|ALC4/2014|Deferred|
|03.07.2014|
|132||HQ|File|RLA|File|Lic.No/Date:031074915||Defer|
|:01/82/050/00795/AM14/|:03/94/040/0049 1/AM14/|1|Date:07.08.2014|
|11.09.2013|i_o|
|Decision|:|It was decided|to defer the case for 07.08.2014|for comments of Department|

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

| i |

| of Pharmaceuticals.

||ofPharmaceuticals.||||
|---|---|---|---|---|
||Case No.:47/16/82-|PartyName:SHASUN|MeetNo/Date:4/82-|Status:Case|
||ALC4/2013|PHARMACEUTICALS|ALC4/2014|Deferred|
|||LIMITED|03.07.2014||
|133||HQ File<br>:01/82/050/00860/AM14/|RLA File<br>:04/24/040/00130/AM14/|Lic.No/Date:0410149741 <br>11.09.2013||Defer<br>Date:07.08.2014|

Decision : It was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control In charge. The case was deferred for 07.08.2014.

|Case No.:33/16/82-|PartyName:HETERO|Meet No/Date:4/82-|Status:Case|
|---|---|---|---|
|ALC4/2013|DRUGSLIMITED,|ALC4/2014|Deferred|
|||03.07.2014||
|HQ File|RLA File|Lic.No/Date:0910057537||Defer|
|:01/82/050/00846/AM14/|:09/24/040/00278/AM14/|12.09.2013|Date:07.08.2014|

134 Decision : It was decided to remind the firm to furnish the following information : i) Stepwise chemical reactions showing correct Molecular weight of each reactant & output product, and % yield on molar basis. i) Justification for requirement of imported inputs in view of CA certificate furnished by the firm.

The case was deferred for 07.08.2014

|Case No.:32/15/82-|PartyName:KOPRAN|MeetNo/Date:4/82-|Status:|
|---|---|---|---|
|ALC42013|LIMITED|ALC4/2014|Approved|
|||03.07.2014||
|HQ File|RLA File|Lic.No/Date:031074929||DeferDate:|
|:01/82/050/00794/AM14/|:03/94/040/00487/AM14/|6||
|||12.09.2013||

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/617/2012-PI(Norms) dated 6.2.2013, 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:

==> picture [453 x 155] intentionally omitted <==

----- Start of picture text ----- | Export product Exp. SI.No. | Import items Qty. allowed 135 Qty. kg/kg Cefepime for injection | 1 kg a Cefepime HCL (Non Sterile) | 0.655 a Isopropyl Alcohol 0.392 ----- End of picture text -----

==> picture [353 x 14] intentionally omitted <==

----- Start of picture text ----- RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

==> picture [24 x 32] intentionally omitted <==

----- Start of picture text ----- » ----- End of picture text -----

: No/Date:4/82Status:Case Case : ~ALC4/2014 [Party Name:NECTAR Meet No.SSI4/82 LIFESCIENCES LIMITED, |ALC4/2014 Deferred 03.07.2014 ; ic. No/Date:2210014211 Defer F 13° HO File RLA File [Nae20H Pagans #1782/050/00303/AM15/ -22/24/040/00044/AM14/ 12.09.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals

Case No.:35/15/82Party Name:KOPRAN Meet No/Date:4/82Status:Case ALC4/2013 LIMITED ALC4/201403.07.2014 Deferred 137 |HQ File RLA File er eee Defer :01/82/050/00797/AM 14/ :03/94/040/00472/AM14/ 13.09.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals

Case No.:26/4/82Party Name:RANBAXY Meet No/Date:4/82Status: Approved ALC4/2014 LABORATORIES LTD ALC4/2014 03.07.2014 HQ File RLA File Lic.No/Date:05 10365650 |Defer :01/82/050/00274/AM15/ :05/24/040/00212/AM14/ 16.09.2013 Date:07.08.2014 Decision : Committee considered the case as per agenda and in consultation with technical authority present in the meeting, it was decided to ratify norms as per SION A-1931 as details given below or as applied by the firm, whichever is less:

138

Export product SI.No. | Import items Qty. allowed per unit of export product = Volini Gel 30 gm 1 No. Racementhol 1.53 gm/30 gm (Each tube contains 1.5 gm tube Racementhol

‘Case No.:9/4/82-ALC4/2014 |Party Name:AUROBINDO _ |Meet No/Date:4/82Status: Approved PHARMA LIMITED ALC4/2014 03.07.2014 eer Date: lee:01/82/050/00257/AM15/ File RLA:09/24/040/00276/AM File 14/~~ [Lic.No/Date:091005761319.09.2013 [Defer Date: 139 forwarded:05.10.2010Decision by::. and DepartmentCommitteein consultation ofconsidered Pharmaceuticalswith technicalcase as videauthorityper theiragenda O.M.No.3501presentand ininin 169/201meeting,lightli of 0-PIwrittendecidedi (Norms)commentto datedratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:Export Product an‘ Import items AllowedQty. — penn kg/ka 2 | iphenyt PhosphingSH| 8

a 3s | Dimethyl Formamide {DMF | [ime ata)} 5786 . igen Conde 00 | Sad8 Can (Gabon maniomes) _L 1 —— 3 Reegl This Ester a 9. Triethylamine 1255 | Poasum efbont ros77 | 40. | Tetrahydrofuran (THF) RA concerned may take further necessary action as per above decision of NCCase ; 4 |Party Name:RA CHEM Meet No/Date:4/82: a Status::Case No.:30/4/82-ALC4/201 Party ATED ALC4/2014 Deferred 03.07.2014 ; i -0910057629 |Defer “0 o/g2/050/00278/AM15/a -09/24/040/001; 19/AM14/ 19.09.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. Case No.118/4/82-ALC4/2014 Party Name:SHASUN Meet No/Date:4/82Status:Case PHARMACEUTICALS ALC4/2014 Deferred LIMITED ; 03.07.2014 ; 141 |HQ File RLA File Lic.No/Date:0410150092 |Defer -01/82/050/00266/AM15/ -04/24/040/00137/AM14/ 19.09.2013 Date:07.08.2014 Decision :It was decided to call from the firm a copy ofMaster Batch Formula duly certified by Quality Control In charge. The case was deferred for 07.08.2014.

Case No.:48/16/82Party Name:SOFTGEL Meet No/Date:4/82Status:Case ALC4/2013 HEALTH CARE PVT. LTD., |ALC4/2014 Deferred 03.07.2014 142 Re:01/82/050/0086 File 1/AM14/ RLA:04/24/040/00099/AM File 14/ 20.09.2013Lic.No/Date:0410150142 Date:07.08.2014|Defer Decision :It was decided to defer the case for 07.08.2014.08. for comments of Department of Pharmaceuticals

CaseALC4/2013 No.:48/15/82PHARMACEUTICALSParty Name:SHASUN MeetALC4/2014 No/Date:4/82 Daterred LIMITED 03.07.2014 HQ File RLA File Li : 143 |.01/8 | ic.No/Date:0410150198 |Defer i Seecision : It was decided to:04/24/040/00128/AM14/call from the firm a copy23.09.2013of Master B.atch FormulaDate:07.08.2014duly certified by Quality5 Control In charge. The case was deferred for 07.08.2014 .

Case No.:47/15/82P ; "3 ALC4/2014 Deferred 144 ALC4/2013 Ib Name:PI INDUSTRIES |Meet No/Date:4/82Status:Case ile RLA File Lic. No/D 0444 ) re:01/82/050/00809/AM14/a :13/24/040/0 03.07.2014se Nomate:1310044452 Defer 10026/AM14/ 24.09.2013) - a ate:07.08.2014 ft

Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals.

Case No.:41/4/82-ALC4/2014 |Party Name:SATYA Meet No/Date:4/82Status:Case DEEPTHA ALC4/2014 Deferred PHARMACEUTICALS LTD 03.07.2014
145 [HQ File RLA File Lic.No/Date:09 10057666 [Defer :01/82/050/00289/AM15/ :09/24/040/00297/AM 14/ 24.09.2013 Date:07.08.2014
Case No.:36/16/82Party Name:CADILA Meet No/Date:4/82_[Status:Case ALC4/2013 HEALTHCARE LTD., ALC4/2014 Deferred 103.07.2014
146 [HQ File RLA File Lic.No/Date:0810125075 [Defer :01/82/050/00849/AM 14/ :08/24/040/00259/AM14/ 25.09.2013 Date:07.08.2014

Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. .

Case No.:38/15/82Party Name:FDC LTD Meet No/Date:4/82Status:Case ALC4/2013 ALC4/2014 Deferred 03.07.2014
147 |HQ File RLA File Lic.No/Date:03 10751024 |Defer :01/82/050/00800/AM14/ :03/94/040/00256/AM 14/ 25.09.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:49/15/82Party Name:SOFTGEL Meet No/Date:4/82Status: ALC4/2013 HEALTH CARE PVT. LTD., |ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:04 10150375 |Defer :01/82/050/00811/AM14/ |:04/24/040/00101/AM14/ 26.09.2013 Date:07.08.2014

==> picture [451 x 145] 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 as per details below or as applied by firm whichever is lower:- 148 F Export Product Export Qty. Qty. Allowed ISOCAP-10 ka/ka | ISOTRETINOIN USP 10 MG SOFT 1kg | 1 ISOTRETINION BP/USP mg10.2 capsule mg/10 TISOCAP-20GELATIN CAPSULES 1 20.4 mg/20 ISOTRETINOIN USP 20 MG SOFT ISOTRETINION BP/USP mg capsule GELATIN CAPSULES ----- End of picture text -----

RA concerned may take further necessary action as per above decision of NC.

==> picture [448 x 36] intentionally omitted <==

----- Start of picture text ----- 149 |ALC4/2013Case No.:7/17/82- CHINTANParty Name: PHARMATATVA MeetALC4/2014 No/Date:4/82- Status: Approv CHEM PVT LTD 03.07.2014 re ----- End of picture text -----

HQ File RLA File Lic.No/Date:34 10038104 |Defer :01/82/050/00869/AM14/ :34/24/040/00159/AM14/ 03.10.2013 __Date:08.05.2014

Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/37/2011-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:

==> picture [417 x 85] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Export product|Exp.|import|items|Qty.|allowed|
|Oty.|
|TCPC|- CAT -|18 (METHYL|1kg|1|ALAMINE336|0.845 kg|
|TRIOCTYL AMMONIUM CHLORIDE)|TRI|(C-8,|C-10) ALKYL|
|||AMMONIUMMETHYL TRI CHLORIDE (C-8, C-10) ALKYLCAS|No.|AMINE CAS NO:|1116-76-3|
|63393-96-4 ASSAY|88|- 92%|

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

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

||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
|Case|No.:107/23/82-|Party Name:ESTEEM|Meet No/Date:4/82-|Status:Deffered|
|ALC4/2013|INDUSTRIES|PVT. LTD,|ALC4/2014|and Re-indexed|
|03.07.2014|
|HQ File|RLA|File|Lic.No/Date: 1710005529||Defer|Date:|
|:701/82/050/01154/AM14/|:17/24/040/00070/AM14/|04.10.2013|
|Decision|:In|the|light|of written|comments|received|from|Department|of Chemicals|and|
|Petrochemicals|vide|their|U.O|No.|14010/78/2012-Ch|II|dated|20.05.2014,|it|was|
|decided|to|ratify norms under Para 4.7 of HBP v1|as per details|given below or as|applied|
|150|by the|firm, whichever|is|less:|

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

||||||||
|---|---|---|---|---|---|---|
|Export|product|Exp.|Import items|Qty.|allowed|
|Aty.|
|PRODUCT-OHEI (OLEYL|OLEIC ACID|0.805|kg|
|HYDROXYETHYL|IMIDAZOLINE)|(Appearance|at 50 Deg|C:|
|(Appearance @25 Deg C:|Yellowish|to|Yellow to|red|oily|liquid|
|amber coloured liquid)|AMINO ETHYL ETHANOL ||0.297|kg|
|AMINE|
|(Appearance|at 25|Deg C:|
|Clear|liquid|

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

==> picture [451 x 91] intentionally omitted <==

----- Start of picture text ----- Case No.:26/17/82- Party Name:MYLAN Meet No/Date:4/82- Status:Case ALC4/2013 LABORATORIES LIMITED |ALC4/2014 Deferred 03.07.2014 151 Hie File RLA File Lic.No/Date:09 10057816 |Defer :01/82/050/00888/AM14/ :09/24/040/00302/AM14/ 04.10.2013 Date:07.08.2014 Decision “It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

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

||||||
|---|---|---|---|---|
|Case No.:34/19/82-|Party Name:ELPPE|Meet No/Date:4/82-|Status:Case|
|152|ALC4/2013|CHEMICALS PRIVATE|ALC4/2014|Deferred|
|LIMITED|03.07.2014|
|.|
|:01/82/050/00979/AM14/|.|:|4|(Defer|
|HQ File|RLA:03/94/040/00552/AM14/ File|Li[07.10.2013 No/Date:031075248||Date:07.08.2014|

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

Y 0

es |

Decision:It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:2/24/82Party Name:SAINOR Meet No/Date:4/82Status: Approved ALC4/2013 LABORATORIES PVT LTD |ALC4/2014 03.07.2014 HQ File RLA File Lic.No/Date:09 10057861 |Defer Date: :01/82/050/01201/AM14/ :09/24/040/00147/AM14/ 08.10.2013

Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/112/2010-Ch II dated 11.06.2013, it was 153 |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. Import items Qty. allowed Qty. [2 [TETRAHYDROFURAN[100% | RA may take appropriate action as per the decision of Norms Committee.

Case No.:17/4/82-ALC4/2014 |Party Name:NAPROD LIFE |Meet No/Date:4/82Status:Case SCIENCES PVT. LTD. ALC4/2014 Deferred 03.07.2014 154 |HQ File RLA File Lic.No/Date:03 10754049 |Defer :01/82/050/00265/AM15/ :03/95/040/00563/AM14/ 17.10.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

Case No.:19/4/82-ALC4/2014 |Party Name:SAVLA Meet No/Date:4/82Status:Case CHEMICALS LIMITED ALC4/2014 Deferred 03.07.2014 155 [HQ File RLA File Lic.No/Date:03 10754070 |Defer :01/82/050/00267/AM15/ :03/95/040/00566/AM14/ 17.10.2013 Date:07.08.2014 Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals

Case No.:174/14/82Party Name:JAINEX Meet No/Date:4/82Status:Approved ALC4/2013 SPECIALITY CHEMICAL |ALC4/2014 03.07.2014 HQ File RLA File Lic.No/Date:34 10038226 |Defer Date: :01/82/050/00759/AM14/ :34/24/040/00170/AM14/ 18.10.2013 Decision :In the light of written comments received from Department of Chemicals and 156 |Petrochemicals vide their U.O No. 14010/16/2014-Ch II 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, whichever is less:

| so || | [CPECRTRERABUTYRABUTYRA TE ke a1 a11 | RA may take appropriate may take appropriate take appropriate appropriate action as per the decision of per the decision of decision of Norms Committee. | Case No.:5/17/82- No.:5/17/82Party Name: TIDE TIDE ALC4/2013 INDUSTRIES |

==> picture [432 x 34] intentionally omitted <==

----- Start of picture text ----- ; [CPECRTRERABUTYRABUTYRA TE ke a1 a11 Ic ACID [eee ----- End of picture text -----

RA may take appropriate may take appropriate take appropriate appropriate action as per the decision of per the decision of decision of Norms Committee.

| Case No.:5/17/82- No.:5/17/82Party Name: TIDE TIDE Meet No/Date:4/82Status: Approved ALC4/2013 INDUSTRIES ALC4/2014 | 03.07.2014 HQ File RLA File Lic.No/Date:34 10038223 |Defer Date: | :01/82/050/00867/AM14/ 334/24/040/00177/AM14/ 18.10.2013 | Decision :In the light of written comments received from Department of Chemicals and | Petrochemicals vide their U.O No. 14010/40/2011-Ch II dated 05.06.2014, it was | 157 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. Import items Qty. allowed | Aty. RA may take appropriate action as per the decision of Norms Committee. Case No.:13/4/82Party Name:MACLEODS Meet No/Date:4/82Status: Deffered ALC4/2014 PHARMACEUTICALS LTD. |ALC4/2014 and Re-indexed 03.07.2014 HQ File RLA File Lic.No/Date:031075453 |Defer :01/82/050/00261/AM15/ :03/95/040/00585/AM14/ 4 Date:07.08.2014 21.10.2013

==> picture [429 x 168] intentionally omitted <==

----- Start of picture text ----- Decision :In the light of earlier decision taken by NC in its 23/82 meeting dated 06.03.2014, it was decided to ratify norms under para 4.7 of HBPv 1 as per details given below or as applied by the firm, whichever is Jess: aty. ke/kg | 1. (S) -9,10-DIFLUORO-3- 492.8 mg/ eee oom 1K METHYL-7-OXO-4 500 mg 2,3DIHYDRO-7-H- Tablets PYRIDO(1,2,3-DE)-1,4- BENZOXAZINE-6- CARBOXYLIC ACID ETHYL ESTER ----- End of picture text -----

158

A may take appropriate action as per the decision of Norms Committee.

Case No.:73/17/82Party Name:RELIANCE Meet No/Date:4/82Status:Deffered ALC4/2013 INDUSTRIES LTD. ALC4/2014 and Re-indexed 03.07.2014 159 |HQ File RLA File Lic.No/Date:03 10754530 |Defer :01/82/050/00935/AM14/ :03/95/040/005 15/AM14/ 21.10.2013 Date:07.08.2014 Decision : It was decided to defer the case for 07.08.2014 for comments of Petrochemical Division of Department of C&PC. .

ve )

|||||||
|---|---|---|---|---|
||CaseNo.:6/20/82-ALC4/2013||PartyName:ZIM|MeetNo/Date:4/82-|Status:Case|
|||LABORATORIESLTD.|'ALC4/2014|Deferred|
||||03.07.2014||
|||||.|
|160|HQFile<br> |:01/82/050/00992/AM14/|RLAFile<br>_—|:03/95/040/00S91/AMI4/_|Lic.No/Date:0310754588 <br>{21.10.2013||DeferDate:<br>Defer|
|||||Date:07.08.2014|

||CaseNo.:28/4/82-<br>ALC4/2014|Party<br>IName:S.R.S.PHARMACEUTICAL<br>S PVT.LTD.|MeetNo/Date:4/82-<br>|ALC4/2014<br>03.07.2014|Status:Case<br>Deferred|
|---|---|---|---|---|
|16<br>1|HQFile<br>|:91/82/050/00276/AM15<br>y|RLA File:03/95/040/00575/AM14/_||Lic.No/Date:031075484<br>8<br>22.10.2013||DeferDate:<br>Defer<br>Date:07.08.201|
|||||4|

Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

Case No.:46/4/82Party Name:ZIM Meet No/Date:4/82Status:Case 03.07.2014
ALC4/2014 LABORATORIES LTD. ALC4/2014 Deferred
162 |HQ File RLA File Lic.No/Date:03 10754827 |Defer :01/82/050/00294/AM15/ :03/95/040/00595/AM14/ 22.10.2013 Date:07.08..2014
Case No.:17/24/82Party Name:EYTAN LABS _ [Meet No/Date:4/82Status:Case ALC4/2013 LIMITED ALC4/2014 Deferred 03.07.2014
163 |HQ File RLA File Lic.No/Date:09 10057998 |Defer :01/82/050/01216/AM14/ :09/24/040/00355/AM14/ 24.10.2013 Date:07.08.2014

Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

Case No.:48/4/82-ALC4/2014 |Party Name: MANGALAM Meet No/Date:4/82Status:Case DRUGS & ORGANICS ALC4/2014 Deferred LIMITED 03.07.2014
164 |HQ File RLA File Lic.No/Date:03 10755274 |Defer :01/82/050/00296/AM15/ :03/95/040/0057 1/AM14/ 24.10.2013 Date:03.08.2014

Case No.:29/4/82-ALC4/2014 |Party Name:MANGALAM Meet No/Date:4/82Status: DRUGS & ORGANICS ALC4/2014 Approved 165 LIMITED 03.07.2014 HQ File RLA File Lic.No/Date:03 10755452 |Defer Date: :01/82/050/00277/AM15/ :03/95/040/00586/AM 14/ 25.10.2013

ie |

Decision :In the light of earlier decision taken by NC in its 23/82 meeting dated 06.03.2014, it was 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 xQty. [SEO Import items Qty.kg/kg allowed ARTEMETHER = agg «= [* [ARTEMIS 285 0.188 aa TRIMETHYL ORTHO ACETATE processNot shown in A may take appropriate action as per the decision of Norms Committee.

Case No.:3/24/82-ALC4/2013 |Party Name:SANZYME LTD [Meet No/Date:4/82Status:Deffered ALC4/2014 and Re-indexed . 03.07.2014 of. 166 |HQ File RLA File Lic.No/Date:09 10058014 |Defer :01/82/050/01202/AM14/ :09/24/040/00295/AM14/ 25.10.2013 Date:07.08.2014 ofDecision Biotechnology.: It was decided to defer the case for 07.08.2014 for comments of Department . Case No.:35/24/82Party Name:AUROBINDO Meet No/Date:4/82Status:Case ALC4/2013 PHARMA LIMITED ALC4/2014 Deferred 03.07.2014 167 |HQ File RLA File Lic.No/Date:09 10058043 |Defer :01/82/050/01234/AM14/ :09/24/040/00346/AM14/ 28.10.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

‘Case No.:7/20/82-ALC4/2013 |Party Name:HONEST BIO[Meet No/Date:4/82Status:Case : VET PVT. LTD ALC4/2014 Deferred 03.07.2014 168 |HQ File RLA File Lic.No/Date:08 10126094 |Defer :01/82/050/00993/AM14/ :08/24/040/00339/AM14/ 29.10.2013 Date:07.08.2014

Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

Case No.:51/15/82Party Name:SAURAV Meet No/Date:4/82Status:Deffered ALC4/2013 CHEMICALS LTD, ALC4/2014 and Re-indexed 03.07.2014 HQ File RLA File Lic.No/Date:221001434 |Defer :01/82/050/008 13/AM14/ :22/24/040/00049/AM 14/ ] Date:07.08.2014 29.10.2013 ® [Decision :In the light of earlier decision taken in meeting No. 3/82 dated 08.05.2014, i 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. |Sl.No.| Import items Qty. allowed (kg"

==> picture [42 x 30] intentionally omitted <==

----- Start of picture text ----- We ----- End of picture text -----

==> picture [502 x 108] intentionally omitted <==

----- Start of picture text ----- e ) a ee | TROMETAMOL ca GLUCAMINEN-OCTYL-D- 0.36 a | TROMETHAMINE 0.36 | RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

Case No.:21/24/82Party Name:SIFLON DRUGS j|Meet No/Date:4/82Status:Case ALC4/2013 ALC4/2014 Deferred 03.07.2014
170.|HQ File RLA File Lic.No/Date:09 10058067 |Defer :01/82/050/01220/AM14/ :09/24/040/00338/AM14/ 29.10.2013 _ |Date:07.08.2014
- Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.
Case No.:31/24/82Party Name:SIFLON DRUGS [Meet No/Date:4/82Status:Case ALC4/2013 ALC4/2014 Deferred 03.07.2014
171 [HQ File RLA File Lic.No/Date:09 10058070 |Defer :01/82/050/01230/AM 14/ :09/24/040/00335/AM14/ 29.10.2013 Date:07.08.2014
| |Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

Case No.:37/24/82Party Name:SIFLON DRUGS |Meet No/Date:4/82Status:Case ALC4/2013 ALC4/2014 Deferred . 03.07.2014
1. [HQ File RLA File Lic.No/Date:0910058069 [Defer :01/82/050/01236/AM14/ :09/24/040/00336/AM14/ 29.10.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:6/19/82-ALC4/2013 |Party Name:IPCA Meet No/Date:4/82Status: Deffered LABORATORIES LIMITED |ALC4/2014 and Re-indexed 03.07.2014 . HQ File RLA File Lic.No/Date:03 10756255 |Defer :01/82/050/0095 1/AM14/ :03/94/040/00632/AM14/ 30.10.2013 Date:07.08.2014

Decision :Committee considered the case as per agenda and in consultationwith technical authority present in meeting it was decided to ratify norms under para 4.7 of HBP as per details 173 |below or as applied by firm whichever is lower:-

Oty. Triamcinolone 1. 3,20 Dioxopregna-1 ,4,9(1 1), 1.00 kg 16 Tetraen-21-Ylacetate (3 - TR RA concerned may take further necessary action as per above decision of NC.

;

||CaseNo.:78/23/82-<br>ALC4/2013|PartyName:AMIORGANICS <br>PVTLTD.||MeetNo/Date:4/82-<br>Status:Case<br>ALC4/2014<br>Deferred|
|---|---|---|---|
||||03.07.2014|
|174||HQ File<br>:01/82/050/01125/AM14/|RLA File<br>:52/24/040/00031/AM14/|Lic.No/Date:5210040368 |Defer<br>31.10.2013<br>Date:07.08.2014|
||Decision :Itwasdecidedto<br>Pharmaceuticals.|to defer thecase for07.08.2014 forcommentsofDepartment of||

Case No.:33/24/82Party Name:PORUS Meet No/Date:4/82Status:Case ALC4/2013 LABORATORIES PVT LTD. |ALC4/2014 Deferred 03.07.2014
175 |HQ File RLA File Lic.No/Date:09 10058093 [Defer :01/82/050/01232/AM14/ :09/24/040/00375/AM14/ 31.10.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of C&PC.

|CaseNo.:12/4/82-<br>ALC4/2014|PartyName:BALAJI<br>AMINESLIMITED|MeetNo/Date:4/82-<br>ALC4/2014|Status:Approved|
|---|---|---|---|
|||03.07.2014||
|HQ File|RLA File|Lic.No/Date:3110060975||DeferDate:|
|:01/82/050/00260/AM15/|:31/83/040/00138/AM14/|01.11.2013||

==> picture [451 x 165] intentionally omitted <==

----- Start of picture text ----- Decision :in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011/Ch Il dated 13.02.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: 176 Export Product Export Import Product Quantity . Quantity Allowed N-ETHYL-2-PYRROLIDONE 14 BUTANEDIOL AMMONIA 0.167 kg ANHYDROUS f ETHYL ALCOHOL (95% | 0.504 kg MINIMUM) (denatured ETHYLAMINE 0.001 kg CATALYST ----- End of picture text -----

Case No.:12/24/82Party Name:ASTRIX Meet No/Date:4/82Status:Case ALC4/2013 LABORATORIES LTD., ALC4/2014 Deferred 03.07.2014
177 |HQ File RLA File Lic.No/Date:09 10058146 |Defer :01/82/050/01211/AM14/ :09/24/040/00359/AM14/ 05.11.2013 Date:07.08.2014

Case No.:34/24/82Party Name:HETERO LABS [Meet No/Date:4/82Status:Case ALC4/2013 LIMITED ALC4/2014 Deferred 178 03.07.2014 HQ File RLA File Lic.No/Date:09 10058148 |Defer :01/82/050/01233/AM14/ :09/24/040/00378/AM14/ 05.11.2013, - |Date:07.08.2014

Decision :It was decided to deferthe case for 07.08.2014 for comments ofDepartment of Pharmaceuticals. CaseNo22/19/82-ALC4/2015 PartyGENERICSName:GLENMARKLIMITED MeetALC4/201403.07.2014No/Date:4/82Status:Approved RLA File [Lic No/Date:0310756884 [Defer Date: HQ File 01/82/050/00947/AM14/ "03/94/040/00668/AM14/ 06.11.2013 Decision +n the light of earlier decision taken by NCin its meeting No. 4/82 meeting dated 04.04.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or35 applied by the firm, whichever is less: Tancbutyl-2-((4R,6S)-2,2drvethyl-6-{(methylcarbony!oxy) Rosuvastatin Calcium methy!]-1 3-dioxan-4-yl}acetate KSM, Side Chain *-d-fivorophenyl)-6-isopropy!-?(N-methyl-NA thanesulfonyl)amino)pyrimidine5~y|-Methanol

RA may take appropriate action as perthe decision of Norms Committee. Case No.:4/22/82-ALC4/2013 PartyORGANICS PVT LTDName: VINDHYA MeetALC4/201403.07.2014HorDate:4/82Status:CaseDeferred T . . | 10 [HQ* File AT nana Tic No/Date:0910058161 /Defe FS mw 01/82/050/01047/AN .09/24/040/00279/ AM 14/ 06.11.2013 _ Date:07.08.2014 Decision “It was decided to deferthe case 07.08.2014 for comments ofDepartment of Chemicals and Petrochemicals tatus:Case Meet No/Date:4/82S : : Case No.:22/24/82Party Name:DIVIS 03.07.2014 ALC4/2013 LABO! ca RATORIESLTD., — |ALC4/2014. ate: Deferred ee 181 ree: RL yrsAM Lic No/Date:0910058 (08.2014 for comments of Department of #2/050/01221/AMI4 -09/24/040/00376/AM14/ [07.11.2013 Dateo7 DecisionPharmaceuticals. :It was decided to defer the case for 07.08 2014“| f === 7—arty Name:RA CHEM Case No.:18/24/82P Deferred PHARMA LIMITED veal ora ALC4 03.07.2014 _ : ialaial aes Set ‘MeetNo/Date:09100581. 58173 Defer 182 [HQ File RLAhyFi -09/24/040/00388/AM14/ 08.11.2013= Date:07.08.2014 .01/82/050/01217/AM14/ Decisc i onsion :Itzi was decided to defer th "se r cofaments of Department of! uticals. = —= - | Case No.: 183 0.:19/24/82TORIES LIMITED JALC42014" 32—'[Btatus:Case

| | , | | , | | |

a

(03.07.2014 HQ File RLA File Lic.No/Date:0910058170 |Defer :01/82/050/01218/AM14/ :09/24/040/00382/AM 1 4/ 08.11.2013 ___ |Date:07.08.2014

Case No.:40/3/82Party Name:ADCOCK Meet No/Date:4/82Status:Case ALC4/2014 INGRAM LTD, * JALC4/2014 Approved 03.07.2014 } HQ File RLA File Lic.No/Date:0710099539 |Defer Date: :01/82/050/00044/AM15/ :07/24/040/00222/AM14/ 11.11.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/600/2012-PI(Norms) dated 6.2.2013, 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: 184 | Export product Exp. SI.No. Import items Qty. allowed Qty. Norfllex(Orphenadrine100 mg100 tablets mg+ | | tablet1 aa Orphenadrine Citrate 102.0 mg mg_Aerosol 200-8 mg Ehty! Cellulose 20.0 mg

||Case No.:27/24/82-|PartyName:DIVIS|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
||ALC4/2013|PHARMACEUTICALS|ALC4/2014|Deferred|
|||PRIVATELIMITED|03.07.2014||
|185||HQFile|RLAFile|Lic.No/Date:0910058176||Defer|
||:01/82/050/01226/AM14/|:09/24/040/00379/AM14/|11.11.2013|Date:07.08.2014|

Case No.:39/3/82-ALC4/2014 |Party Name:ADCOCK Meet No/Date:4/82Status:Case INGRAM LTD, ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:0710099547 |Defer Date: :01/82/050/00043/AM15/ :07/24/040/00223/AM 14/ 12.11.2013 Decision in the the light of written of written written comments received from from Department of Pharmaceuticals Pharmaceuticals vide their OM OM 35011/511/2011-Pl(Norms) dated 21.11.2013., it was was decided to ratify norms under under Para 4.7 of HBP HBP v1 as per details details given below or as applied by the the firm, whichever is less: Export ProductAdvy ProductAdvy 1. Neulin 125mg tablets - Theophylline 125 Mg +Guar gum 4.375 Mg 2. Neulin 200mg tablets - Theophylline 200 Mg + Guar gum 7.00 Mg oe 3. Neulin 250mg tablets - Theophylline 250 Mg + Guar gum 8.750 Mg “ - yo 4, Neulin 300mg tablets - Theophylline 300 Mg + Guar gum 10.5 Mg “~ fon

Decision in the the light of written of written written comments received from from Department of Pharmaceuticals Pharmaceuticals vide their OM OM 186.|No. 35011/511/2011-Pl(Norms) dated 21.11.2013., it was was decided to ratify norms under under Para 4.7 of HBP HBP v1 as per details details given below or as applied by the the firm, whichever is less: Export ProductAdvy ProductAdvy

==> picture [432 x 95] intentionally omitted <==

----- Start of picture text ----- pc peer ms re a Import Items For export of 1 No. NeulinTablets (Quantity in mg) |425mg|200mg [250mg | [300me] Theophylline BP / EP / USP / 127.5mg | 204.0 mg 306.0 mg a PH.EUR Anhydrous powder i Guar Gum IH (BP / EP / USP / 4.375 7.00 8.75 10.5 PH.EUR} ----- End of picture text -----

RA may take appropriate action as per the decision of Norms Committee.

| |

Case No.:42/24/82Party Name:AHLCON Meet No/Date:4/82Status:Case ALC4/2013 PARENTERALS INDIA ALC4/2014 Deferred LTD. 03.07.2014
187 |HQ File RLA File Lic.No/Date:05 10371021 |Defer :01/82/050/01241/AM14/ :05/23/040/00330/AM14/ 13.11.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:29/24/82Party Name:ATGC Meet No/Date:4/82Status:CaseDeferred ALC4/2013 BIOTECH PVT LTD ALC4/2014 03.07.2014 188 |HQ File RLA File Lic.No/Date:09 10058222 |Defer :01/82/050/01228/AM14/ —_|:09/24/040/00275/AMI14/ _|13.11.2013 Date:07.08.2014

| |Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:11/4/82-ALC4/2014 {Party Name:BALAJI AMINES |Meet No/Date:4/82Status:Case LIMITED ALC4/2014 Approved 03.07.2014
HQ File RLA File Lic.No/Date:3110061053 |Defer Date: :01/82/050/00259/AM15/ :31/83/040/00136/AM14/ 13.11.2013

Decision :in the light of written comments received from Department of Chemicals and Petrochemicals 189 vide their U.O No. 14010/122/2011/Ch It dated 13.02.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [381 x 44] intentionally omitted <==

----- Start of picture text ----- Export Product Export Import Product Quantity Quantity Allowed GAMMA [BUTYROLACTONE] 1 [1 [ispuranepion1,4 BUTANEDIOL ——[116ke1.16 ke ----- End of picture text -----

, Case No.:30/24/82Party Name:DIVIS Meet No/Date:4/82Status:Case ALC4/2013 LABORATORIES LTD., ALC4/2014 Deferred 03.07.2014 | 190 |HQ File RLA File Lic.No/Date:09 10058223 |Defer :01/82/050/01229/AM14/ :09/24/040/0039 1/AM14/ 13.11.2013 Date:07.08.2014 | Decision :It was decided to defer the case for 07.08.2014 for comments of Department of | Pharmaceuticals.

|. ’ . . at . 1 oes a =“[oe]

||CaseNo.:16/24/82-<br>ALC4/2013|PartyName:GLAND<br>PHARMALIMITED|MeetNo/Date:4/82-<br>Status:Case<br>ALC4/2014<br>Deferred||
|---|---|---|---|---|
||||03.07.2014||
|19]||HQ File|RLAFile|Lic.No/Date:0910058218 |Defer||
||:01/82/050/01215/AM14/|:09/24/040/00385/AM14/|13.11.2013<br>Date:07.08.2014||
||Decision :Itwasdecidedto<br>Pharmaceuticals.|todeferthecasefor07.08.2014 forcommentsofDepartmentof|||-|

||Case No.:26/24/82-<br>ALC4/2013|PartyName:GLAND<br>PHARMALIMITED|MeetNo/Date:4/82-<br>ALC4/2014|Status:Case<br>{Deferred|
|---|---|---|---|---|
||||03.07.2014||
|192||HQFile<br>:01/82/050/01225/AM14/|RLAFile<br>:09/24/040/00392/AM14/|Lic.No/Date:0910058221 <br>13.11.2013||Defer<br>Date:07.08.2014|

Case No.:3/19/82Party Name:SIRMAXO Meet No/Date:4/82Status:Case ALC4/2013 CHEMICALS PVT LTD ALC4/2014 Deferred 03.07.2014 193 |HQ File RLA File Lic.No/Date:03 10757730. [Defer :01/82/050/00948/AM14/ :03/95/040/00625/AM14/ 13.11.2013 Date:07.08.2014 Decision : It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

||CaseNo.:25/4/82-ALC4/2014||PartyName:S<br>VCHEM<br>INTERMEDIATESPLTD|MeetNo/Date:4/82-<br>ALC4/2014|Status:Case<br>Deferred|
|---|---|---|---|---|
||||03.07.2014||
|194|[HQFile<br>:01/82/050/00273/AM15/|RLAFile<br>:04/24/040/00176/AM14/|Lic.No/Date:0410151914 <br>14.11.2013|[Defer<br>Date:07.08.2014|

Decision : It was decided to defer the case for 07.08.2014 for comments of Department: of C&PC.

Case No.:10/20/85-ALC3/2013 |Party Name: METRO Meet No/Date:4/82Status: EXPORTERS PRIVATE ALC4/2014 Approved LIMITED 03.07.2014 HQ File IRLA File Lic.No/Date:0310758099 |Defer Date: :01/85/050/00129/AM14/ :03/95/040/00596/AM 14/ 18.11.2013

| ||

Decision :Committee considered the case as per agenda and in light of written comments received from Department of Pharmaceuticals vide their OM No. 35021/01/2014-PI(Norms) 19 dated 04.03.2014and in consultation with technical authority present in meeting, decided to 5 ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:Export product Import items Qty. allowed [HALQUINGL 6% [1Qty. Kg | 1.___|[@HYDROXVQUINOLNE] | 0.462kg/kg RA may take appropriate action as per the decision of Norms Committee.

==> picture [21 x 17] intentionally omitted <==

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

‘e

§0

Case No.:28/24/82Party Name:PORUS Meet No/Date:4/82Status:Case ALC4/2013 LABORATORIES PVT LTD. |ALC4/2014 Deferred 03.07.2014 196 |HQ File RLA File Lic.No/Date:09 10058239 |Defer :01/82/050/01227/AM14/ :09/24/040/00396/AM14/ 18.11.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of C&PC.

==> picture [433 x 64] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Case No.:111/23/82-|Party|Name:|TATVA|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|CHINTAN PHARMA CHEM||ALC4/2014|Approved|
|PVT LTD|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:34|10038488||Defer|
|:01/82/050/01158/AM14/|:34/24/040/00202/AM 14/|20.11.2013|Date:08.05.2014|

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

==> picture [457 x 320] intentionally omitted <==

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

||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Decision|:In|the|light|of written|comments|received|from|Department|of Chemicals|and|
|Petrochemicals|vide|their|U.O|No.|14010/37/2012-Ch|II|dated|11.06.2014,|it|was|
|||__|decided|to|ratify norms under Para 4.7|of|HBP|v1|as|per|details|given below or as|applied|
|197|by the|firm, whichever|is|less:|
|Export product|Import|items|Qty.|allowed|
|Qty.|
|Methyl!|Tributyl Ammonium|Chloride|lkg|||1|Tributyl amine|0.619 kg|
|CAS No.|56375-79-2|Assay 75%|(+/-|
|2%)|
|RA may take appropriate|action|as per the decision ofNorms Committee.|
|Case|No.:119/23/82-|Party Name:RATNAMANI|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|BIO CHEMICALS &|ALC4/2014|Approved|
|PHARMACEUTICALS|PVT.|(03.07.2014|
|LTD|
|HQ|File|RLA|File|Lic.No/Date:3410038507||Defer Date:|
|:01/82/050/01166/AM14/|:34/24/040/00207/AM|14/|21.11.2013|
|Decision|:|In|the|light|of written|comments|received|from|Department|of Chemicals|and|
|Petrochemicals|vide|their|U.O|No.|14010/23/2014-Ch|II|dated|24.06.2014,|it|was|
|decided to|ratify norms under Para 4.7|of HBP v1|as per details|given below or as applied|
|by the|firm, whichever|is|less:|

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

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

|||||
|---|---|---|---|
|198|:|
|Export product|SI.No. | Import items|Qty.|allowed|
|Qty.|

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

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----- Start of picture text ----- 0890s aeons | \). co ----- End of picture text -----

||CaseNo.:13/24/82-<br>ALC4/2013|PartyName:SATYA<br>DEEPTHA<br>PHARMACEUTICALS LTD|MeetNo/Date:4/82-<br>ALC4/2014<br>(03.07.2014|Status:Case<br>Deferred|
|---|---|---|---|---|
|199||HQFile<br>:01/82/050/01212/AM14/|RLAFile<br>:09/24/040/00408/AM14/|Lic.No/Date:0910058278<br>21.11.2013||Defer<br>Date:07.08.2014|
||Decision :Itwas decided|to deferthecase for07.08.2014 forcomments ofDepartment of||Department of|
||Pharmaceuticals.||||

	CaseNo.:74/23/82-	PartyName:SWISS	MeetNo/Date:4/82-	Status:Case
	ALC4/2013	EXPORTSPVT.LTD.	ALC4/2014	Deferred
			_-J03.07.2014
200	[HQFile<br>:01/82/050/01121/AM14/	RLAFile<br>:08/24/040/00351/AM14/	Lic.No/Date:0810126591 <br>21.11.2013	[Defer<br>Date:07.08.2014

||CaseNo.:149/23/82-<br>ALC4/2013|Party Name: YASHO<br>INDUSTRIESPVT.LTD.|MeetNo/Date:4/82-<br>ALC4/2014<br>03.07.2014|Status:Case<br>Deferred|
|---|---|---|---|---|
|201||HQ File<br>:01/82/050/01196/AM14/|RLA File<br>:03/95/040/00658/AM14/|Lic.No/Date:03 10758646<br>21.11.2013||Defer<br>Date:07.08.2014|

||Case No.:37/4/82-ALC4/2014 |PartyName:EMCURE|MeetNo/Date:4/82-<br>Status:Case|
|---|---|---|
||PHARMACEUTICALS LTD.||ALC4/2014<br>Deferred|
|||03.07.2014|
|202||HQ File<br>RLA File<br>:01/82/050/00285/AM15/<br>:31/83/040/00141/AM14/|Lic.No/Date:3110061152 |Defer<br>25.11.2013<br>Date:07.08.2014|
||Decision :Itwasdecidedtodeferthecase for07.08.2014 forcommentsofDepartmentof<br>Pharmaceuticals.||

||Case No.:20/24/82-|PartyName:GLAND|MeetNo/Date:4/82-<br>Status:Case|
|---|---|---|---|
||ALC4/2013|PHARMALIMITED|ALC4/2014<br>Deferred<br>03.07.2014|
|203|[HQ File<br>:01/82/050/01219/AM14/|RLA File<br>:09/24/040/00405/AM14/|Lic.No/Date:0910058310 |Defer<br>25.11.2013<br>|Date:07.08.2014.|
||Decision :Itwas decided|to deferthe case for07.08.2014 forcommentsofDepartmentof||
||Pharmaceuticals.|||

||Case No.:139/23/82-<br>ALC4/2013|PartyName:<br>Y ASHO<br>INDUSTRIESPVT.LTD.|MeetNo/Date:4/82-<br>Status:Case<br>ALC4/2014<br>Deferred<br>03.07.2014|
|---|---|---|---|
|204||HQ File|RLA File|Lic.No/Date:0310758995 |Defer|
||:01/82/050/01186/AM14/|:03/95/040/00673/AM14/|25.11.2013<br>Date:07.08.2014|
||Decision :Itwasdecided|to deferthe case 07.08.2014|forcommentsofDepartmentof|
||Chemicals and Petrochemicals.||OB<br>,|

Ling a ersey Be NE

Sr

==> picture [433 x 60] intentionally omitted <==

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||||||
|---|---|---|---|---|
|Case No.:10/24/82-ALC4/2013||Party Name:DR REDDYS|Meet No/Date:4/82-|Status:Case|
|LABORATORIES|LIMITED||ALC4/2014|Approved|
|03.07.2014|
|HQ File|RLA|File|Lic.No/Date:0910058343||Defer Date:|
|:01/82/050/01209/AM14/|:09/24/040/00380/AM 14/|26.11.2013|

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==> picture [453 x 417] intentionally omitted <==

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|||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Decision|:Committee|considered|the|case|as|per|agenda|and|in|light|of|written|comments|
|received|from|Department|of|Pharmaceuticals|vide|their|OM|No.|35011/731/2013-PI(Norms)|
|dated|04.03.2014|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|
|205||lower:-|
|NAPROXEN|Qty.1|Kg.|D,L-2-{6-Methoxy-2-|kg/kg1.17|
|Naphthyl)|Propionic|Acid|
|DL-Acid|
|N-Octyl-D-Glucamine|10.100|
|RA may take appropriate|action|as|per the|decision ofNorms|Committee.|
|Case|No.:14/24/82-|Party Name:DR REDDYS|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|LABORATORIES LIMITED||ALC4/2014|Deferred|
|03.07.2014|
|||
|206||HQ|File|RLA|File|Lic.No/Date:09|10058344||Defer|
|:01/82/050/01213/AM14/|:09/24/040/0038 1/AM14/|26.11.2013|Date:07.08.2014|
|Decision|:It was|decided|to|defer the|case|for 07.08.2014|for comments of Department of|
|Pharmaceuticals.|
|Case No.:11/24/82-|Party Name:GLAND|)|Meet No/Date:4/82-|Status:Case|
|ALC4/2013|PHARMA LIMITED|ALC4/2014|Deferred|
|03.07.2014|
|907.|HQ|File|RLA|File|Lic.No/Date:09 10058351 10058351||Defer|
|:01/82/050/01210/AM14/|:09/24/040/00420/AM14/|26.11.2013|Date:07.08.2014|
|Decision|:It was was|decided|to|defer the case case|for 07.08.2014 07.08.2014|for comments of Department comments of Department of Department Department|of|
|Pharmaceuticals.|

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==> picture [537 x 246] intentionally omitted <==

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||||||||||
|---|---|---|---|---|---|---|---|---|
|||907.|HQ|File|RLA|File|Lic.No/Date:09 10058351 10058351||Defer|
|:01/82/050/01210/AM14/|:09/24/040/00420/AM14/|26.11.2013|Date:07.08.2014|
|||Decision|:It was was|decided|to|defer the case case|for 07.08.2014 07.08.2014|for comments of Department comments of Department of Department Department|of|
|:|Pharmaceuticals.|
|||
|/|Case No.:24/24/82-|Party Name:GLAND|Meet No/Date:4/82-|Status:Case|
|||ALC4/2013|PHARMA LIMITED|ALC4/2014|Deferred|
|||03.07.2014|
|||208||HQ|File|RLA|File|Lic.No/Date:09|10058352||Defer|
|||:01/82/050/01223/AM14/|:09/24/040/004 19/AM14/|26.11.2013|Date:07.08.2014|
|||Decision|:It was decided|to|defer the case|for 07.08.2014|for comments of Department of|
|||Pharmaceuticals.|
|Case No.:32/24/82-|Party Name:GLAND|Meet No/Date:4/82-|Status:Case|
|209|ALC4/2013|PHARMA LIMITED|ALC4/2014|Deferred|
|03.07.2014|
|[HQ File|IRLA File|[Lic.No/Date:09|10058353|Defer|i|:|

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

| | | | | || | | | | |

|:01/82/050/0123 1/AM14/ [:09/24/040/00417/AM14/ [26.1 1.2013 [Date:07.08.2014 Decision : It was decided to request the firm to furnish Batch Log Sheet for last 5 consecutive batches . The case was deferred for 07.08.2014. . Case No.:5/24/82-ALC4/2013 (Party Name:SUVEN LIFE Meet No/Date:4/82Status:Case SCIENCES LIMITED ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:0910058355 |Defer. Date: :01/82/050/01204/AM14/ :09/24/040/00343/AM14/ 26.11.2013

Decision :in the light of earlier decision taken in meeting No. 21/82 dated 06.02.2014. it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [452 x 511] intentionally omitted <==

----- Start of picture text ----- 210: Qty. kg/kg MET (ee | 0.957 CHLOROMETHYLPHENYL)-3- }2. foxvene4 METHOXYACRYLATE SODIUM METHOXIDE 0.416 POWDER fume RA may take appropriate action as per the decision of Norms Committee. Case No.:54/4/82-ALC4/2014 |Party Name:NECTAR Meet No/Date:4/82- Status:Case LIFESCIENCES LIMITED, |ALC4/2014 Deferred 03.07.2014 211 |HQ File RLA File Lic.No/Date:22 10014403 |Defer :01/82/050/00302/AM15/ _-|:22/24/040/00062/AM14/ 27.11.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals. Case No.:141/23/82- Party Name:NOCIL LIMITED |Meet No/Date:4/82- Status:Case ALC4/2013 ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:0310759810 {Defer Date: :01/82/050/01188/AM14/ 103/95/040/00684/AM14/ 29.11.2013 Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/32/20112/Ch II dated 11.04.2014, it was decided to ratify norms under Para 4.7 of HBP HBP v1 as per details given below or as applied by the firm, whichever is less: 212 Export Product Export | S.No | Import Product Quantity Quanti Allowed N-(Cyclohexylthio-)phthalimide | PhthalicPAN Anyhdride 0.614 kg Brand Name :- PILGARD {1 kg 2. DICYCLOHEXYL 0.488 kg PVI DISULPHIDE (DCDS 3. CAUSTIC POTASH 0.233 kg FLAKES (Potassium Hydroxide) (KOH ft ----- End of picture text -----

Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/32/20112/Ch II dated 11.04.2014, it was decided to ratify norms under Para 4.7 of HBP HBP v1 as per details given below or as applied by the firm, whichever is less: 212

: . | |

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

|||RA may take appropriate action as per the decision ofNorms Committee.may take appropriate action as per the decision ofNorms Committee.take appropriate action as per the decision ofNorms Committee.appropriate action as per the decision ofNorms Committee.action as per the decision ofNorms Committee.|RA may take appropriate action as per the decision ofNorms Committee.may take appropriate action as per the decision ofNorms Committee.take appropriate action as per the decision ofNorms Committee.appropriate action as per the decision ofNorms Committee.action as per the decision ofNorms Committee.as per the decision ofNorms Committee.per the decision ofNorms Committee.the decision ofNorms Committee.ofNorms Committee.Norms Committee.Committee.|RA may take appropriate action as per the decision ofNorms Committee.may take appropriate action as per the decision ofNorms Committee.take appropriate action as per the decision ofNorms Committee.appropriate action as per the decision ofNorms Committee.action as per the decision ofNorms Committee.as per the decision ofNorms Committee.per the decision ofNorms Committee.the decision ofNorms Committee.ofNorms Committee.Norms Committee.Committee.||||
|---|---|---|---|---|---|
||CaseNo.:104/23/82-<br>ALC4/2013|PartyName:PCLOIL&<br>SOLVENTS LTD.,|MeetNo/Date:4/82-<br>ALC4/2014|Status:Case<br>Deferred||
||||03.07.2014|||
|213|[HQFile<br>:01/82/050/01151/AM14/|RLA File<br>:05/24/040/00201/AM14/|Lic.No/Date:0510372321 <br>29.11.2013||Defer<br>Date:07.08.2014||

Decision :It was decided to defer the case 07.08.2014 for comments of Department of {Chemicals and Petrochemicals.

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----- Start of picture text ----- _ ----- End of picture text -----

||CaseNo.:8/24/82-ALC4/2013|[PartyName:SUVENLIFE|[MeetNo/Date:4/82-|(Status:Deffered|
|---|---|---|---|---|
|||SCIENCES LIMITED|ALC4/2014|and Re-indexed|
||||03.07.2014||
|214||HQFile|RLAFile|Lic.No/Date:0910058405 [Defer||
||:01/82/050/01207/AM14/|:09/24/040/00356/AM14/|29.11.2013|Date:07.08.2014|
||Decision :Itwasdecidedto deferthe case for07.08.2014 forcommentsofDepartment of<br>Pharmaceuticals.|||ofDepartment of|

||CaseNo.:150/23/82-<br>ALC4/2013|PartyName:AGIO<br>PHARMACEUTICALS LTD|MeetNo/Date:4/82-<br>jALC4/2014|Status:Case<br>Deferred|
|---|---|---|---|---|
||||03.07.2014||
|215||HQFile<br>:01/82/050/01197/AM14/|RLAFile<br>:03/94/040/00706/AM14/|Lic.No/Date:03 10760378 <br>03.12.2013||Defer<br>Date:07.08.2014|

Case No.:146/23/82Party Name:CHIRAG Meet No/Date:4/82Status:Case ALC4/2013 ENTERPRISE ALC4/2014 Deferred : 03.07.2014 216 |HQ File RLA File Lic.No/Date:24 10040396 |Defer :01/82/050/01193/AM14/ :24/24/040/00022/AM14/ 06.12.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Petrochemicals Division ofDepartment of Chemicals and Petrochemicals

Case No.:47/4/82-ALC4/2014 |Party Name: VISION DRUGS |Meet No/Date:4/82Status:Case PVT LTD ALC4/2014 Deferred 03.07.2014
1217 |HQ File RLA File Lic.No/Date:0910058477 |Defer :01/82/050/00295/AM15/ :09/24/040/00433/AM14/ 06.12.2013 Date:07.08.2014

Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals

Case No.:10/23/82Party Name: YASHO Meet No/Date:4/82Status:Case ALC4/2013 INDUSTRIES PVT.LTD. ALC4/2014 Deferred 218 03.07.2014 HQ File RLA File Lic.No/Date:03 10761106 |Defer :01/82/050/01057/AM14/ :03/95/040/00720/AM14/ 09.12.2013 {Date:07.08.2014.

| | | |

A

Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals.

==> picture [454 x 415] intentionally omitted <==

----- Start of picture text ----- Case No.:9/23/82-ALC4/2013 |Party Name:‘NAWAL Meet No/Date:4/82- Status:Case PRAKASH AVIKEM ALC4/2014 Deferred PVT.LTD., 03.07.2014 HQ File RLA File Lic.No/Date:03 10761637 |Defer :01/82/050/01056/AM14/ :03/95/040/00434/AM14/ 12.12.2013 Date:07.08.2014 Decision : Decision :Department of Chemicals and Petrochemicals vide their letter no. 46011/59/2009- PC li dated 12.05.2024 has requested the firm to furnish following information: 1. Separate weight of Di Ethylene Glycol, Fibres Glass String / Rope and Aluminium can in one number of final one number of export product i.e. AL cans with components may be furnished along with the copy of the export order. 2. Details and quantity of other indigenous inputs to be used in the manufacture of the export product may be indicated. 3. Detailed manufacturing process along with justification for wastages at each Stage and also on each of the raw material may be furnished. 4. Complete material balance indicating input and output material at each stage of manufacturing 219 process. 5. Standard /Authentic technical literature in support of the raw material requirement formulation for the manufacture of export product. 6. You have applied for the import of aluminium foil/sheets as 1.30 kg/kg content in the Aluminium can which seems t be on gross weight basis and not on net content basis. The details of ; Production of Aluminium cans and corresponding consumption of Aluminium foil/sheets may be furnished for the year 2012-13 and 2013-14. 7. The commercial sale value of the aluminium sheets scrap generated in the process may be furnished along with the documentary evidence. In addition, earlier NC decision for the import of Aluminium foil/sheets against the export of Aluminium can for your similar export product may also be furnished. 8. Details of production of export product under reference and corresponding consumption of raw material in the year 2011-12 and 2012-13 {April to December) duly certified by CA may be furnished. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA. 9. Any other relevant information. The case was deferred for 07.08.2014. ----- End of picture text -----

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----- Start of picture text ----- Case No.:7/18/82-ALC4/2013 |Party Name:SWISS Meet No/Date:4/82- Status:Case EXPORTS PVT. LTD. - |ALC4/2014 Deferred 03.07.2014 220 JHQ File RLA File Lic.No/Date:0810127123 (Defer :01/82/050/00942/AM14/ :08/24/040/00400/AM14/ 16.12.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. Case No.:8/18/82-ALC4/2013 |Party Name: TITAN Meet No/Date:4/82- Status: LABORATORIES PVT. LTD. |ALC4/2014 Rejected 221 03.07.2014 THQ File RLA File Lic.No/Date:0310761921 [Defer :01/82/050/00943/AM14/ :03/95/040/00637/AM14/ 16.12.2013 Date:07.08.2014 Decision : It was decided to reject thes case as the firm has not furnished information \ ----- End of picture text -----

S&L

| | | | | | | | | : | : | ,

| {despite repeated reminders. repeated reminders. reminders.

{despite repeated reminders. repeated reminders. reminders. | Case No.:87/23/82Party Name:INDO PHYTO {Meet No/Date:4/82Status:Case ALC4/2013 CHEMICALS PVT LTD ALC4/2014 Deferred 03.07.2014
222.|HQ File RLA File Lic.No/Date:05 10373925 |Defer . :01/82/050/01134/AM14/ :05/23/040/00385/AM14/ 18.12.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:125/23/82Party Name:EMCURE Meet No/Date:4/82Status:Case ALC4/2013 PHARMACEUTICALS LTD. j|ALC4/2014 Deferred 03.07.2014 223 |HQ File RLA File Lic.No/Date:3 110061658 |Defer :01/82/050/01172/AM14/ :31/83/040/00170/AM14/ 19.12.2013 Date:07.08.2014

Case No,:39/4/82-ALC4/2014 |Party Name:ALKYL AMINES [Meet No/Date:4/82Status:Case CHEMICALS LTD ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:03 10763372 :\Defer Date: :01/82/050/00287/AM15/ :03/94/040/0061 1/AM14/ 26.12.2013 Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012-Ch II dated 12.11.2013, it was 224 |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:

Qty. ACETONE kg [TL ACEC a ee RA may take appropriate action as per the decision ofNorms Committee. Case No.:38/4/82-ALC4/2014 |Party Name:ALTA Meet No/Date:4/82Status:Case LABORATORIES LTD. ALC4/2014 Deferred 03.07.2014 225 |HQ File RLA File Lic.No/Date:03 10763559 |Defer :01/82/050/00286/AM15/ :03/94/040/00796/AM 14/ 27.12.2013 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.

Case No.:2/2/82-ALC4/2014 LIFESCIENCES|Party Name:SAFECON MeetALC4/2014 No/Date:4/82Status:CaseDeferred 226 03.07.2014 HQ[File] RLA Filei Lic.No/Date:i :6110001120 |Defer Fre s/00004/AMIS :61/24/040/00033/AM14/ fF 12.2013 _ Dao7982014

S U

Decision :It was decided to defer the case for 07.08.2014 for comments of Department of | Pharmaceuticals.

Case No.:2/22/82-ALC4/2013 |Party Name:METROCHEM _ |Meet No/Date:4/82-. Status:Case API PVT. LTD. ALC4/2014 Deferred 03.07.2014
227 {HQ File RLA File Lic.No/Date:09 10058842 [Defer :01/82/050/01045/AM14/ :09/24/040/00503/AM14/ 07.01.2014 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals.
Case No.:25/23/82Party Name:GLENMARK Meet No/Date:4/82Status:A pproved ALC4/2013 GENERICS LIMITED ALC4/2014 |03.07.2014
228 |HQ File RLA File Lic.No/Date:03 10766291 |Defer Date: :01/82/050/01072/AM14/ :03/94/040/00885/AM14/ 15.01.2014

Decision : It was decided to withdraw the case as it is already approved in 3/82 meeting dated 03.07.2014.

| |

Case No.:40/4/82-ALC4/2014 |Party Name:NEW Meet No/Date:4/82Status:Case ALLIANCE DYE-CHEM ALC4/2014 Deferred PVT. LTD., 03.07.2014
229 |HQ File RLA File Lic.No/Date:03 1076643 1 |Defer :01/82/050/00288/AM15/ :03/95/040/00805/AM14/ 16.01.2014 Date:07.08.2014

Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

|
Case No.:171/3/82ALC4/2014 GENERICSParty Name:GLENMARKLIMITED __ ALC4/2014{Meet No/Date:4/82Status: Approved 03.07.2014
230 |HQ File RLA File Lic.No/Date:03 10766693 |Defer Date: :01/82/050/00175/AM15/ :03/94/040/00789/AM 14/ 17.01.2014
- Decision : It was decided to withdraw the case as it is already approved in 3/82 meeting dated 03.07.2014.

Case No.:72/3/82Party Name:ADCOCK Meet No/Date:4/82Status: Approve ALC4/2014 INGRAM LTD, ALC4/2014 d . 03.07.2014 HQ File RLA File Lic.No/Date:0710101398 |Defer :01/82/050/00076/AM15/ :07/24/040/00363/AM14/ = |20.01.2014 Date:08.05.2014

Decision :In the light of earlier decision taken by NC in its 31/82 meeting dated
231 |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:

Qty. Acurate Tabs-Paracetamol 1 no. Doxylamine Succinate 5.10 mg 450 mg+Doxylamine of USP/Ph. Eur Grade ; 7a

==> picture [39 x 7] intentionally omitted <==

----- Start of picture text ----- V ----- End of picture text -----

—~S58é7

==> picture [451 x 195] intentionally omitted <==

----- Start of picture text ----- Succinate 5 mg+Caffeine 30 tablet | 2. CaffeineAnhydrous BP 30.6 mg mg+Codeine Phosphate 10 2010/USP/EP/PH. EUR/BP mg+Colour quinolone Yellow Codiene Phsophate 10.2 mg 2 mg Tablets BP/USP/EP/PH. EUR Color Quinoline Yellow Ct 47005 RA may take appropriate action as per the decision ofNorms Committee. Case No.:7/4/82-ALC4/2014 |Party Name:NEOGEN Meet No/Date:4/82- Status:Case CHEMICALS LIMITED ALC4/2014 Deferred 03.07.2014 232 |HQ File RLA File Lic.No/Date:03 10767056 |Defer :01/82/050/00255/AM15/ :03/95/040/00756/AM14/ 21.01.2014 Date:07.08.2014 ----- End of picture text -----

Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals

Case No.:51/4/82-ALC4/2014 |Party Name:SHILPA [Meet No/Date:4/82Status:Case MEDICARE LTD., ALC4/2014 Deferred 03.07.2014 933 |HQ File RLA File Lic.No/Date:07 10101518 |Defer 01/82/050/00299/AM15/ :07/24/040/00375/AM 1 4/ 22.01.2014 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

Case No.:6/4/82-ALC4/2014 |Party Name:NEOGEN Meet No/Date:4/82Status:Case CHEMICALS LIMITED ALC4/2014 Deferred 03.07.2014 234 |HQ File RLA File Lic.No/Date:03 10767490 |Defer :01/82/050/00254/AM15/ :03/95/040/00757/AM 14/ 23.01.2014 Date:07.08.2014 Decision :It was decided to defer the case 07.08.2014 for comments of Department of Chemicals and Petrochemicals.

Case No.:24/4/82-ALC4/2014 |Party Name:BALAJI AMINES |Meet No/Date:4/82Status:Case LIMITED ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:3 110062311 |Defer Date: :01/82/050/00272/AM15/ :31/83/040/00201/AM14/ 27.01.2014

Decision :in the light of written comments received from Department of Chemicals and Petrochemicals 235 vide their U.O No. 14010/122/2011/Ch II dated 13.02.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

==> picture [432 x 65] intentionally omitted <==

----- Start of picture text ----- Export Product Export Import Product Quantity Quantity Allowed GAMMA BUTYROLACTONE 1 jtTaBUTANE1,4 BUTANE DIO LL [146K6 ke | RA may take appropriate action as per the decision of Norms Committee. ----- End of picture text -----

54—

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

||||||||
|---|---|---|---|---|---|---|
|Case No.:50/4/82-ALC4/2014||Party Name:BALAJI AMINES|[Meet No/Date:4/82-|Status:Case|
|LIMITED|ALC4/2014|Approved|
|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:3|110062303|{Defer Date:|
|:01/82/050/00298/AM15/|:31/83/040/001 87/AM14/|27.01.2014|
|Decision:|in the light of written comments received from|Department of Chemicals and|Petrochemicals|
|236|vide their U.O No, 14010/122/2011/Ch|li dated 24.12.2013,|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:|

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

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

||||||
|---|---|---|---|---|
|Export Product|Export|Import|Product|Quantity|
|Quantit|Allowed|
|DIETHYL|AMINO ETHANOL|
|RA|[3.||ETHYLENEOXIDE[0.395kg|
|may take appropriate|action|as|per the|decision of Norms Committee.|

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

Case No.:49/4/82-ALC4/2014 |Party Name:EMCURE Meet No/Date:4/82Status:Case PHARMACEUTICALS LTD. |ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:3 110062302 |Defer Date: :01/82/050/00297/AM 15/ :31/83/040/00197/AM14/ 27.01.2014

Decision :in the light of earlier decision taken by NC in its 31/82 meeting date 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::-

237 | Export product | Exp. Qty. [SINo. [Import items __| Qty. allowed _ Ciprofloxacin HCL One 500 mg Ciprofloxacin HCL 555.0 mg/500 Tablets USP 500 MG tablet (Relevant Bulk Drug) | mg Tablets (Each film coated tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 500 mg

==> picture [382 x 16] intentionally omitted <==

----- Start of picture text ----- RA concernedmay take further necessary action as per above decision of NC. ----- End of picture text -----

Case No.:173/3/82Party Meet No/Date:4/82Status: ALC4/2014 IName:GLENMARKGENERIC_ !ALC4/2014 Approved S LIMITED 03.07.2014 238 |HQ File RLA File Lic.No/Date:03 10767985 |Defer Date: :01/82/050/00177/AM15/ :03/94/040/00893/AM14/ 27.01.2014

Decision : It was decided to withdraw the case as it is already approved in 3/82 meeting dated 03.07.2014.

Case No.:23/4/82-ALC4/2014 |Party Name:BALAJI AMINES |Meet No/Date:4/82Status:Case LIMITED ALC4/2014 Approved 03.07.2014 239 THQ File RLA File Lic.No/Date:3110062386 [Defer Date: :01/82/050/0027 1/AM15/ :31/83/040/00193/AM14/ 30.01.2014 [Decision :In the light of written comments received from Department of Chemicals and Petrochemicals|

==> picture [25 x 33] intentionally omitted <==

----- Start of picture text ----- IY) ----- End of picture text -----

| | i

==> picture [68 x 27] intentionally omitted <==

----- Start of picture text ----- “Go = ----- End of picture text -----

vide their U.O No. 14010/122/2011/Ch I! dated 13.02.2014, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

|Export Product||Export<br>Quantity|Import Product|Quantity<br>Allowed|
|---|---|---|---|---|
||||[a [74BUTANEDIOL||
|N-ETHYL-2-PYRROLIDONE|1||ANHYDROUS<br>ETHYLALCOHOL(95%| 0.504kg<br>MINIMUM)<br>(denatured||
||||ETHYLAMINE|0.001 kg|
||||CATALYST||

| : | |

||CaseNo.:44/4/82-ALC4/2014 |PartyName:CATAPHARMA||MeetNo/Date:4/82-<br>Status:Case|
|---|---|---|
||CHEMICALSPVT. LTD.,|ALC4/2014<br>Deferred|
|240||HQFile<br>RLAFile|03.07.2014<br>Lic.No/Date:3110062387 |Defer|
||:01/82/050/00292/AM15/<br>:31/83/040/00199/AM14/|30.01.2014<br>Date:07.08.2014|
||Decision : Itwasdecidedto callfromthe firmCOAof<br>supplier fortherelevant consignment . Thecase wasdeferred|ofimport itemfromthe foreign<br>deferred for 07.08.2014|
||CaseNo.:35/4/82-ALC4/2014 |PartyName:CHIRAG<br>ENTERPRISE|MeetNo/Date:4/82-<br>[Status:Case<br>ALC4/2014<br>Deferred<br>03.07.2014|
|241||HQFile<br>RLAFile<br>:01/82/050/00283/AM15/<br>:24/24/040/00028/AM14/|Lic.No/Date:24 10040726 |Defer<br>30.01.2014<br>Date:07.08.2014|
||Decision :Itwasdecidedto deferthe case07.08.2014 forcomments ofDepartmentof<br>Chemicals and Petrochemicals.||
||CaseNo.:2/4/82-ALC4/2014<br>|PartyName:INDOGERMAN|/|Meet No/Date:4/82-<br>Status:Case|
||ALKALOIDS|ALC4/2014<br>Approved|
|||03.07.2014|
||HQ File<br>RLA File|Lic.No/Date:0310769858 |Defer Date:|
||:01/82/050/00250/AM15/<br>:03/94/040/01019/AM14/|10.02.2014|

Decision : In the light of earlier decision taken in meeting no. 15/82 dated 31.10.2013, it was 242 |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 less:

==> picture [436 x 163] intentionally omitted <==

----- Start of picture text ----- Export product Import items Qty. allowed IPECACUANHA EXTRACT 1. IPECACUANHA ROOTS 4kg BP. / USP. RA concerned may take further necessary action as per above decision of NC. Case No.:21/4/82-ALC4/2014 |Party Name:KREATIVE Meet No/Date:4/82- Status:Case ORGANICS (P) LTD., ALC4/2014 Deferred 243 03.07.2014 . HQ File RLA File Lic.No/Date:09 10059237 |Defer :01/82/050/00269/AM15/ :09/24/040/00577/AM 14/ 11.02.2014 ----- End of picture text -----

==> picture [108 x 34] intentionally omitted <==

----- Start of picture text ----- Date:07.08.2014 IY ----- End of picture text -----

| |

Decision :It was decided to defer the case for 07.08.2014 for comments of Petrochemicals Division ofDepartment of Chemicals and Petrochemicals

==> picture [466 x 656] intentionally omitted <==

----- Start of picture text ----- ) (Case No.:22/4/82-ALC4/2014 |Party Name:ADCOCK Meet No/Date:4/82- Status:Case INGRAM LTD, ALC4/2014 Approved 03.07.2014 HQQ File RLA File Lic.No/Date:0710102144 {Defer Date: :01/82/050/00270/AM15/ :07/24/040/004 16/AM14/ 13.02.2014 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: Export Produ 2. Neulin 200mg tablets - Theophylline 200 Mg + Guar gum 7.00 Mg D44 1. Neulin 125mg tablets - Theophylline 125 Mg +Guar gum 4.375 Mg 3. Neulin 250mg tablets - Theophylline 250 Mg + Guar gum 8.750 Mg 4. Neulin 300mg tablets - Theophylline 300 Mg + Guar gum 10.5 Mg For export of 1 No. NeulinTablets (Quantity in mg) Theophylline BP / EP / USP/ 125mg127.5mg || [200mg] 204.0 mg [[250mg] [300mg306.0 mg_—i| PH.EUR Anhydrous powder PH.EUR)Guar Gum IH (BP / EP / USP/ 4.375 7.00 8.75 10.5 RA may take appropriate action as per the decision of Norms Committee. Ccase No.:52/4/82-ALC4/2014.2 - |Party Name:SWATI: Meet No/Date:4/82- Status:Case MENTHOL & ALLIED ALC4/2014 Deferred CHEMICALS LTD., 03.07.2014 245 iOile RLA File ; 701 :01/82/050/00300/AM15/.s :29/24/040/00011/AM14/ ; 6020Ve. PeteDate:07.08.2014 Decision :It was decided t ; : © defer the case for 07.0 Petrochemicals Divisi : Te v82014 for comments of vision of Department of Chemicals and Petrochemicals Case No.:132/3/82- Party Ni siceoe REMEDIESame: LTD.,VENUS ALC4/2014M : Dans Case= 246 - 03.07.2014 >|HQ:01/82/ File — 36/AM15/ :22/24/040/00088/AMRLA File 14/ 26.02.2014"Lic.Nic.No/Date: 7210014635 Dee07 08.2014 Pharmaceuticals,ecision :It: was decided to defer the case ftor 07.08.20142. for comments of Department of_ Case No.:34/4/82-ALC4/2014 P : 047[renestemiatcansia LABOR AT OREPEN Meet No/Date:4/82-__[Status:c ESLTD, —|ALC472014 Deferres HO eferred 20 File RAH 03.07.2014 1/82/050/00282/AM15/ :05/24/040/00455/4M14/ne Lic.No/Date:05i 10380668 |Defer 03.03.2014 Date:07.08.2014 ----- End of picture text -----

, | | ||

/ |

||Case No.:58/3/82-ALC4/2014 |PartyName:KLJ|MeetNo/Date:4/82-||Status:Case||
|---|---|---|---|---|---|
||PLASTICIZERS LTD.,|ALC4/2014||Deferred||
|||03.07.2014||||
|248|[HQFile<br>RLAFile<br>:01/82/050/00062/AM15/<br>:05/23/040/00492/AM14/|Lic.No/Date:0510380925 <br>05.03.2014||[Defer<br>Date:07.08.2014||
||Decision<br>:It<br>was<br>decided<br>to<br>defer<br>the<br>case|for<br>07.08.2014|for|comments|of|
||Petrochemicals DivisionofDepartmentofChemicals and Petrochemicals|||||
||CaseNo.:45/4/82-ALC4/2014 |Party Name: TRITECH|MeetNo/Date:4/82-||Status:Case||
||CATALYSTAND|ALC4/2014||Deferred||
||INTERMEDIATE (P)LTD.|[03.07.2014||||
||249|[HQFile<br>RLA File<br>:01/82/050/00293/AM15/<br>:31/83/040/00230/AM14/|Lic.No/Date:3110062950 <br>06.03.2014||[Defer<br>Date:07.08.2014||
||Decision<br>:It<br>was<br>decided<br>to<br>defer<br>the<br>case|for<br>07.08.2014|for|comments|of|
||Petrochemicals DivisionofDepartment ofChemicals and Petrochemicals|||||
||CaseNo.:56/4/82-ALC4/2014 |PartyName:IND-SWIFT<br>LABORATORIES LTD.,|MeetNo/Date:4/82-<br>ALC4/2014||Status:Case<br>Deferred||
|||03.07.2014||||
|1250:|/HQFile<br>RLA File<br>:01/82/050/00304/AM15/<br>:22/24/040/00102/AM14/|Lic.No/Date:2210014691 <br>14.03.2014|||Defer<br>Date:07.08.2014||
||Decision :Itwasdecided to deferthecasefor07.08.2014 forcomments ofDepartment of|||Department of|Department of|
||Pharmaceuticals.|||||

||Case No.:57/4/82-ALC4/2014||PartyName:IND-SWIFT|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
|||LABORATORIES LTD.,|ALC4/2014|Deferred|
||||03.07.2014||
|251|JHQ File<br>:01/82/050/00305/AM15/|RLA File<br>:22/24/040/00103/AM14/|Lic.No/Date:2210014692 |Defer<br>14.03.2014<br>Date:07.08.2014||
||Decision :Itwas decidedto deferthe case for07.08.2014 forcommentsofDepartment of||||
||Pharmaceuticals.||||

||Case No.:58/4/82-ALC4/2014||PartyName:IND-SWIFT|MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
|||LABORATORIES LTD.,|ALC4/2014|Deferred|
||||03.07.2014||
|252||HQ File|IRLA File|Lic.No/Date:2210014694 |Defer||
||:01/82/050/00306/AM 15/|:22/24/040/00100/AM14/|14.03.2014|Date:07.08.2014|
||Decision :Itwasdecidedto deferthe case for07.08.2014 forcommentsofDepartment of||||
||Pharmaceuticals.||||

||CaseNo.:1/4/82-ALC4/2014||PartyName:DORF-KETAL _||MeetNo/Date:4/82-|Status:Case|
|---|---|---|---|---|
|||CHEMICALS INDIA|ALC4/2014|Deferred|
|253|fueFile<br>:01/82/050/00249/AM15/|PVT.LTD.<br>RLAFile<br>:03/94/040/00999/AM14/|03.07.2014<br>Lic.No/Date:0310774824 <br>18.03.2014||Defer<br>Date:07.08.2014.|

==> picture [23 x 32] intentionally omitted <==

----- Start of picture text ----- NY ----- End of picture text -----

Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Chemicals and Petrochemicals

||CaseNo.:42/4/82-ALC4/2014|CaseNo.:42/4/82-ALC4/2014||PartyName:RECKITT||PartyName:RECKITT||MeetNo/Date:4/82-|Status:Case||
|---|---|---|---|---|---|---|---|---|
||||BENCKISER|||ALC4/2014|Deferred||
||||HEALTHCARE|INDIA||03.07.2014|||
||||LIMITED||||||
|254|[HQFile<br>:01/82/050/00290/AM 15/|5/|RLA File<br>:05/24/040/00480/AM14/|||Lic.No/Date:0510382032 (Defer<br>18.03.2014<br>Date:07.08.2014|||
||Decision<br>:It<br>was|decided<br>to<br>defer||the|case|for<br>07.08.2014|for comments|of|
||Pharmaceuticals||||||||
||Case No.:43/24/82-||PartyName:THINQ|||MeetNo/Date:4/82-|Status:Case||
||ALC4/2013||PHARMA-CROLIMITED|LIMITED||ALC4/2014|Deferred||
|||||||03.07.2014|||
|255||HQFile<br>:01/82/050/01242/AM14/||RLAFile<br>:03/95/040/00987/AM14/|||Lic.No/Date:03 10774773 |Defer<br>18.03.2014<br>Date:07.08.2014|||

Decision :It was decided call from the firm technical details as per Appendix 33. The case is deferred for 07.08.2014.

||CaseNo.:45/24/82-<br>ALC4/2013|Party Name: VIVIMED LABS<br>(ALATHUR)PRIVATE||MeetNo/Date:4/82-<br>Status:Case<br>ALC4/2014<br>Deferred|
|---|---|---|---|
|||LIMITED|03.07.2014|
|256||HQ File<br>:01/82/050/01244/AM14/|RLA File<br>:04/24/040/00264/AM14/|Lic.No/Date:04 10156358 |Defer<br>19.03.2014<br>Date:07.08.2014|
||Decision<br>: It was decided to send a copy of application again to DCGI for their|||
||commentson 8%watercontent inimport items. The||case was deferred for07.082014.|
||CaseNo.:20/4/82-ALC4/2014||PartyName:DIVIS<br>LABORATORIES LTD.,|MeetNo/Date:4/82-<br>Status:Case<br>ALC4/2014<br>Approved|
||||03.07.2014|
||HQ File|RLA File|Lic.No/Date:0910059675<br>|Defer Date:|
||:°0:1/82/050/00268/AM15/|:09/24/040/00647/AM14/|28.03.2014|

Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/646/2013-Pi(Norms) dated 04.03.2014, 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:

==> picture [445 x 155] intentionally omitted <==

----- Start of picture text ----- 257} Item of Export | Quantity Item of Import Quantity allowed kg/kg TECH [2 | ACETOXY PROPIONYL CHLORIDE [048i [3 [DIMEnavL FORMAMIDE __——~[ 0.702 3.[fa [isoprorveavconor———S~=*d [[MerwanonSSS~=«*di] Sa —*d [| wnonveravi acerape ——«dz Se [7[emmomermane «if ----- End of picture text -----

)

| IRA may take appropriate action as per the decision of Norms Committee.

Case No.:33/4/82-ALC4/2014 |Party Name:JAGSONPAL Meet No/Date:4/82Status:Case PHARMACEUTICALS LTD. |ALC4/2014 Deferred 03.07.2014 258 |HQ File RLA File Lic.No/Date:05 10383280 |Defer :01/82/050/00281/AM15/ :05/23/040/00522/AM14/ 01.04.2014 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

==> picture [455 x 94] intentionally omitted <==

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

||||||||||
|---|---|---|---|---|---|---|---|---|
|Case|No.:32/4/82-ALC4/2014||Party Name:KLJ|Meet No/Date:4/82-|Status:Case|
|PLASTICIZERS|LTD.,|ALC4/2014|Deferred|
|03.07.2014|‘|
|259||HQ|File|RLA|File|Lic.No/Date:05 10383274||Defer|
|:01/82/050/00280/AM15/|:05/23/040/00536/AM14/|01.04.2014|Date:07.08.2014|
|Decision|:It was|decided|to|defer the|case|for|07.08.2014|for comments of|
|Petrochemicals|Division ofDepartment|of|Chemicals|and|Petrochemicals|

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

Case No.:27/4/82-ALC4/2014 |Party Name:SHASUN Meet No/Date:4/82Status:Case PHARMACEUTICALS ALC4/2014 Approved LIMITED 03.07.2014 HQ File RLA File Lic.No/Date:0410157036 |Defer Date: :01/82/050/00275/AM15/ :04/24/040/00303/AM14/ 10.04.2014

Decision :in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/541/2013-PI(Norms) dated 26.11 .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:

Export Product

260 [PAROXETINE TABLETS

==> picture [452 x 223] intentionally omitted <==

----- Start of picture text ----- import Items For export of 1 No. Tablets (Quantity in mg) 10 mg 20 mg 30 mg 40 mg Tablets Tablets Tablets Tablets PAROXETINE HCL 11.33 HEMIHYDRATE RA concerned may take further necessary action as per above decision of NC Case No.:1/2/82-ALC4/2014 iParty Name:CADILA Meet No/Date:4/82- Status:Case HEALTHCARE LTD., ALC4/2014 Deferred 03.07.2014 261 |HQ File RLA File Lic.No/Date:0810130534 |Defer :01/82/050/00003/AM15/ :08/24/040/00008/AM15/ 11.04.2014 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

Case No.:3/4/82-ALC4/2014 |Party Name:CADILA Meet No/Date:4/82Status: 262 HEALTHCARE LTD., ALC4/2014 . (Approved 03.07.2014

ES7

HQ File RLA File Lic.No/Date:0810131315 |Defer Date: :01/82/050/0025 1/AM15/ :08/24/040/00069/AM15/ 13.05.2014

Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/566/2013-PI(Norms) dated 24.12 .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:

==> picture [433 x 221] intentionally omitted <==

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

||||||||
|---|---|---|---|---|---|---|
|Export Product|Export|Import|Product|Quantity|
|Quantity|Allowed|
|IRON|SUCROSE|IRON SUCROSE|2.0 gm /Sml|
|INJECTION USP 20MG/ML|vial|
|(5 ML VIAL)|2.|VIALS (EMPTY GLASS|Relevant|as|
|MG ELEMENTAL IRON &|policys|
|EACH|5 ML VIAL|RUBBER STOPPER|13|
|CONTAIN|100 MG|MM|
|ELEMENTAL IRON)|
|RA may take appropriate|action|as per the decision|of Norms Committee.|
|Case|No.:59/4/82-ALC4/2014||Party Name:NIFTY|LABS PVT||Meet|No/Date:4/82-|Status:Case|
|LTD.,|ALC4/2014|Approved|
|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:0910060256||Defer|Date:|
|:01/82/050/00307/AM15/|:09/24/040/00111/AM15/|28.05.2014|

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

==> picture [452 x 153] intentionally omitted <==

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

||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|Decision|:Committee considered|the case|as per agenda andin the|light of earlier decision|
|taken|by NC|in|its|11/82|meeting|05.09.2013,|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:|
|263|Export product|Exp.|Qty.|
|Qty.|allowed|
|kg/kg|
|HederHydrochloride|eyeitine|}2.|[22,2-Triftuoro2,2,2-Trifluoro EthanolEthanol|0.65|||
|RA|a|
|may take|appropriate|action|as|per the decision|of Norms Committee.|

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

==> picture [470 x 197] intentionally omitted <==

----- Start of picture text ----- Case No.:60/4/82-ALC4/2014 |Party Name:CADILA Meet No/Date:4/82- Status: Case PHARMACEUTICALS LTD. |ALC4/2014 Approved 03.07.2014 HQ File RLA File Lic.No/Date:0810132253 |Defer Date: HHO Fie 00208/AM5) :08/24/040/00108/AM15/ 10.06.2014 D64 Decision35011/203/2013-PI{Norms):in the light of writ da te nd comments26 .09.2013, receivedit was from Department decided to ratify norms of Pharmac und e ruticals Para 4.7 vide of their HBP v1OM as No. per details given below or as applied by the firm, whichever is less: Export product Ea Import items Qty. allowed NEBIVOLOL Qty. kg/kg HCL | 1 kg 4-FLUORO ANISOLE Pe | ETHYLENE DI CHLORIDE Not i] } recommended | ----- End of picture text -----

==> picture [466 x 309] intentionally omitted <==

----- Start of picture text ----- 3. HEXANE 36.5 [ACETIC AGID [.[ DICHLORO METHANE : (6. | METHANOL &_| VITRIDE [TOLUENE] 335] |9. _| DIMETHYLE SULPHOXIDE (4. ACETONITRILE RA may take appropriate action as per the decision of Norms Committee. Case No.:61/4/82-ALC4/2014 |Party Name:V& V PHARMA /|Meet No/Date:4/82- Status:Case INDUSTRIES ALC4/2014 Deferred 03.07.2014 265 [HQ File RLA File Lic.No/Date:03 10785305 [Defer :01/82/050/00309/AM15/ :03/95/040/00190/AM15/ 13.06.2014 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. ----- End of picture text -----

==> picture [434 x 60] intentionally omitted <==

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

|||||||||
|---|---|---|---|---|---|---|---|
|Case|No.:62/4/82-|Party Name:CADILA|Meet No/Date:4/82-|Status:|
|ALC4/2014|HEALTHCARE|LTD.,|ALC4/2014|Approved|
|03.07.2014|
|266|-||HQ|File|RLA|File|Lic.No/Date:0810132355|{Defer Date:|
|:01/82/050/003 10/AM15/|:08/24/040/001|14/AM15/|17.06.2014|

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

: | | | | |

. Decision : It was decided to withdraw the case as advance authorization has been issued on repeat basis under para 4.7.1 HBP v1.

==> picture [480 x 269] intentionally omitted <==

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

||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|.|
|Case No.:63/4/82-|Party|Meet No/Date:4/82-|Status:|CaseDeferred|
|ALC4/2014|IName:SALICYLATES&|j|ALC4/2014|
|CHEMICALS|PRIVATE||03.07.2014|
|LIMITED|
|267|[HQ|File|RLA|File|Lic.No/Date:09 10060484|Defer Date:07.08.2014|
|:01/82/050/00311/AM15/||:09/24/040/00125/AM15/|18.06.2014|
|Decision|:It|was|decided|to|defer|the|case|for|07.08.2014|for|comments|of|Petrochemicals|
|Division|of Department|of Chemicals|and Petrochemicals|.|
|Case|No.:66/4/82-|Party Name:ALEMBIC|Meet|No/Date:4/82-|Status:|
|ALC4/2014|PHARMACEUTICALS|LTD||ALC4/2014|Approved|
|03.07.2014|
|HQ|File|RLA|File|Lic.No/Date:341004030||Defer Date:|
|268||:01/82/050/003 14/AM15/|734/24/040/00060/AM|15/|0|
|23.06.2014|
|Decision|:Committee|considered|the|case|as|per|earlier|decision|taken|by|NC|in|its|33/82|
|meeting|date|31.03.2013|it|was|decided|to|ratify|norms|under|Para|4.7|of HBP|yi.as|per|
|details|given below|or as|applied by|the|firm,|whichever|is|less:|||

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

||1|Export product||||Exp.|Exp.||Import items||Qty.|
|---|---|---|---|---|---|---|---|---|---|---|---|
||||||||Qty.|||||allowed|
||||||||||||||
||| <br>| <br>||Theophylline<br>Extended | 1 no. of<br>Release Tablets 300 mg| tablet<br> (Net<br>content<br>of<br>active<br> ingredients—2160.66 kgs)|||||||TheophyllineAnhydrousPowder| 306.0mg<br>200M(Theophylline Anhydrous<br>USP)|||
|||||||||||MethocelK 100PremiumLV|||
|||||||||||CRLH(Hydroxypropyl|||
|||||||||||Methylcellulose )|||
|||||||||||HPMC-MethocelK100LV-CR|||
|||||||||||Premium|||
||||||||||LactoseMonohydrate||120.40 mg|
||||||||||(Impalpable)|||
||||||||||Povidone K-30 (PlasdoneK-||16.60mg|
|||||||||||29/32)|||
||||||||||fe ||EthylAlcoholAnhydrousUSP [318.6|||
||||Theophylline|Extended | 1||||no. of|| 1.|Theophylline Anhydrous||459.0mg|
||1|Release Tablets 450 mg| <br> (Net<br>Content<br>of<br>active<br>ingredients-67.50kgs)||||tablet|||AnhydrousPowder200M<br>.<br>(TheophyllineAnhydrousUSP)|||
|||||||||||MethocelK 100PremiumLV<br>CRLH(Hydroxypropyl||201.0mg|
|||<br>|||||||||Methylcellulose)<br>HPMC-MethocelK 100LV-CR| 79.50mg|||
|||||||||||Premium|||
|||||||||||LactoseMonohydrate||180.60mg|
||||||||||(Impalpable)<br>;|||
|||||||||||Povidone K-30 (Plasdone K-||24.90mg|
||||||||||29/32)|||
|||||||||fe|EthylAlcoholAnhydrousUSP|||
|||RAmaytakeappropriate action|||appropriate actionasperthedecision ofNormsCommittee.|||||||
||CaseNo.:64/4/82-ALC4/2014|||||PartyName:AUROBINDO||Name:AUROBINDO<br>[MeetNo/Date:4/82-|||Status:Case||
|269|||||PHARMALIMITED||||ALC4/2014<br>03.07.2014|Deferred||
||HQFile||||RLA||File||Lic.No/Date:0910060520||Defer||

| |

:01/82/050/003 12/AM15/ :09/24/040/00154/AM15/ 23.06.2014. [Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comsments of Petrochemicals Division of Department of Chemicals and Petrochemicals

Case No.:65/4/82-ALC4/2014 |Party Name:AUROBINDO [Meet No/Date:4/82Status:Case PHARMA LIMITED ALC4/2014 Deferred 03.07.2014 270 |HQ File RLA File Lic.No/Date:0910060521 |Defer :01/82/050/003 13/AM15/ :09/24/040/00162/AMI15/ 23.06.2014 Date:07.08.2014

Decision :]t was decided to defer the case for 07.08.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals

Case No.:67/4/82-ALC4/2014 |Party Name:DIVIS Meet No/Date:4/82Status:Case LABORATORIES LTD., ALC4/2014 Deferred 03.07.2014 1971 |HQ File RLA File Lic.No/Date:09 10060535 |Defer :01/82/050/003 15/AM15/ :09/24/040/00165/AM15/ 25.06.2014 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments ofDepartment of Pharmaceuticals.

Case No.:68/4/82-ALC4/2014 |Party Name:MICRO LABS Meet No/Date:4/82Status:Case LTD ALC4/2014 Deferred 03.07.2014
272 |HQ File RLA File Lic.No/Date:07 10105379 {Defer :01/82/050/003 16/AM15/ :07/24/040/00106/AM15/ 25.06.2014 Date:07.08.2014 Decision :It was decided to defer the case for 07.08.2014 for comments of Department of Pharmaceuticals. .

Case No.:69/4/82-ALC4/2014 |Party Name:RA CHEM Meet No/Date:4/82Status:Case PHARMA LIMITED ALC4/2014 Deferred 03.07.2014 273 |HQ File RLA File Lic.No/Date:09 10060550 |Defer :01/82/050/003 17/AM15/ :09/24/040/00175/AM15/ 27.06.2014 Date:07.08.2014

Date:02.08.2014 Nirmal Kumar Place:New Delhi Dy. Director General of Foreign Trade Pera par KUMAR Dy. Director Game al Een e faen “eo 7. oe tie 'n rade eines Ta 4 cepa ent ut Cunmnerce vasesgw Delhi

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