DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 45/82ALC4/2011 MEETING DATE : 07.02.2012 The Meeting No.45/82 in the year 201112 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 scheduled to be held on 7.2.2012 was actually held on 14.2.2012 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Pramod Bharti, Asstt. Director, DC(MSME) 2. Shri Jasbir Singh, Consultation, Department of C&PC 3. Shri D.N. Mathur, Consultation, Department of Pharmaceuticals 4. Ms.Lalita Maini, FTDO At the outset, minutes of Norms Committee Meeting No.41/82 dated 17.01.2012 were ratified by the Committee.
Case No.B 477
M/s. Jubilant Lifesciences Limited Norms Committee Meeting No.45/AM12 dated F.No. 01/82/050/01481/AM 07/DES III F.No 01/82/50/01710/AM 07/DES III Meeting Date:14.02.2012 Advance Authorization No0510196612 dated 21.12.2006 Adv. Lic No. 0510200116 dated 27.2.2007 RLA File No 05/24/040/00782/AM 07 RLA File No.0510200116 dated 27.02.2007 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012for comments of Department of Chemicals and Petrochemicals.
Case No.B 478
M/s. Nandolia Organic Chemicals Pvt. Ltd., Mumbai Norms Committee Meeting No.45/AM12 dated F.No. 01/82/050/00316/AM 10/DES III (pt) Meeting Date:14.02.2012 Advance Authorization No. 0310513643 dated 31.3.2009 RLA File No. 03/95/040/001005/AM 09 Decision: The Committee considered the case as per agenda and in the light of written comments of Department of Chemicals and Petrochemicals communicated on 6.2.2012 decided to to amend the export product from Para Anlayl Alcohol to “Para Anisyl alcohol”. RA may accordingly take appropriate action
Case No.B 479
M/s. Neuland Laboratories Limited
Norms Committee Meeting No.45/AM12 dated F.No. 01/82/162/00480/AM 12/DES III Meeting Date:14.02.2012 Decision: The representative of the firm came for personal hearing on 7.2.2012. They have furnished a copy of technical literature in support of the correct and complete description of Import Item No. 1. Accordingly, the Committee recommended following modification in SION A3504: Item in S,No 1 of SION A3504 is read as 7Chloro1cyclopropyl6fluoro1,4dihydro4 oxo3Quinoline3carboxylic acid Recommended to be 7Chloro1cyclopropyl6fluoro1,4dihydro4oxoQuinoline3 carboxylic acid The above amendment may be notified through Public Notice.
Case No.B 480
M/s. Neogen Chemicals Limited, Mumbai Norms Committee Meeting No.45/AM12 dated F.No. 01/82/050/00269/AM 07/DES III Meeting Date:14.02.2012 Advance Authorization No. 0310384101 dated 12.6.2006 RLA File No. 03/95/040/00263/AM 07 Decision: The Committee considered the case as per agenda and in the light of written comments of Department of Chemicals and Petrochemicals forwarded vide U.O No. 14010/117/2011Ch. II dated 30.12.2011 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1, as per details below or as applied by the firm, whichever is lower: Item of Export Quantity Item of Import Quantity 0.7 Molar Vinyl Magnesium Bromide in THF Solution 0.7 Molar 1 kg Ethylene Dibromoide EDBR 99.9% Tetra Hydro Furan, THF 99.5% 0.190 kg 0.946 kg RA may take appropriate action as per the decision of Norms Committee.
Case No.B 481
M/s. Arch Pharmalabs Limited, Mumbai Norms Committee Meeting No.45/AM12 dated F.No. 01/82/050/00870/AM 09/DES III Meeting Date:14.02.2012 Advance Authorization No. 0310481979 dated 08.08.2008 RLA File No. 03/94/040/00393/AM 09 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Pharmaceuticals.
Case No.B 482
M/s. Sterling Auxiliaries Pvt. Ltd. Norms Committee Meeting No.45/AM12 dated F.No. 01/82/050/01748/AM 09/DES III Meeting Date:14.02.2012 Advance Authorization No. 0310510096 dated RLA File No. 03/95/040/00963/AM 09
03.03.2009 Decision: The Committee considered the case and in the light of written comments of Department of Chemicals and Petrochemicals forwarded vide note dated 14.2.2012 and in consultation with the technical authorities present in the meeting, it has been observed that the firm has indicated “HS CODE 29221300 TriEthanol amine and Its salts” in the shipping bills. Export Product in their application is STERO TEA 85 EX and the same is indicated in the shipping bill also. Hence, the license can be redeemed. RA may accordingly take appropriate action. 1
Case No.:84/5/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:45/82ALC4/2011 07.02.2012 Status:Case Approved HQ File :01/82/050/00118/AM11/ RLA File :22/24/040/00047/AM10/ Lic.No/Date:2210009594 19.01.2010 Defer Date: Decision :The Committee considered the case as per agenda and in consultation with technical authority present in the meeting an in light of earlier decision taken in meeting No. 39/82 dated 27.12.2911, decided to ratify the norms on repeat basis under Para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export Product Exp. Qty. Import Item Qty. allowed Diethy 2Thienyl Methyl Malonate 1 Kg Thiopene2Carboxyaidehyde Synonyms: 2Thienylaldehyde, 2 Thiophenecarboxaldehyde Formula: C5H4OS Purity NLT 99% 0.554 kg Diethyl Malonate Synonyms: ethyl Methane Dicarboxylate, Ethyl Propanedioate Formula CH@ (COOC2H5)2 Purity: NLT 99% 0.791 kg RA may take necessary action as per the decision of the NC. 2
Case No.:17/50/82ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 07.02.2012 Status:Case Approved HQ File :01/82/050/01171/AM10/ RLA File :05/24/040/00486/AM10/ Lic.No/Date:0510259472 25.02.2010 Defer Date: Decision : The committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to ratify norms under Para 4.7 of HBP v1 as per details below HBP as per details below or as applied by the firm whichever is lower: Export Product Exp. Qty. Import Item Qty. allowed kg/kg Meopenem Sterile 1 kg 3R,4R)4ACETOXY3((R)(TERT 5.95
BUTYLDIMETHYLSILYLOXY) ETHYL2AZETIDINONE 1PYRROLIDINECARBOXYLIC ACID, 2 L(DIMETHYLAMINO)CARBONYLL 4MERCAPTO,(4 NITROPHENYL)METHYL ESTER, (2S,4S) 1.69 2Amino2Methyl1Propanol 9.62 Acetone 19.37 Activated Carbon 0.200 Diisopropyl ethylamine 2.04 Dimethyl Aminopyridine 1.316 Diphenyl Chlorophosphate 2.14 Ethyl Acetate 9.03 Imidazole 2.78 Isopropyl Alcohal 2.85 Magnesium Chloride, Anhydrous 1.066 Methanol 2.81 Methyl iso butyl Ketone 1.36 N,NDimethyl Formamide 4.93 NMethyl morpholine 0.634 Palladium Sponge 10.0gm Rhodium Octanoate 0.0038 Toluene 9.91 Triethylamine 8.85 3
Case No.:68/39/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/01149/AM11/ RLA File :09/24/040/00054/AM11/ Lic.No/Date:0910042623 06.07.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and in the light of written comments of Department of Pharmaceuiticals forwarded vide Om No. 35011/227/2010PI (Norms) decided to call from the firm the following information: % Yield on Molar Basis for each step of manufacturing process. Actual past productionconsumption data duly certified by Central Excise Authroity for the above export product. Accordingly, the case has been deferred for 6.3.2012.
4
Case No.:72/39/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/01153/AM11/ RLA File :09/24/040/00146/AM11/ Lic.No/Date:0910042671 12.07.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and in the light of written comments of Department of Pharmaceuiticals forwarded vide Om No. 35011/227/2010PI (Norms) dated 15.12.2012 decided to call from the firm the following information: % Yield on Molar Basis for each step of manufacturing process. Actual past productionconsumption data duly certified by Central Excise Authroity for the above export product Requirement & Recovery of solvent of each step. Accordingly, the case has been deferred for 6.3.2012. 5
Case No.:14/28//82ALC4/2010
Party Name:SATYADEEPTHA PHARMACEUTICALS lIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00896/AM11/ RLA File :09/24/040/00272/AM11/ Lic.No/Date:0910043780 10.12.2010 Defer Date:28.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call the firm for personal hearing on 28.2.2012 along with the following documents: Stepwise complete and balanced chemical reaction showing molecular weight of each input and output product and molar requirement of each reactant. Percentage yield on molar basis for each step. Requirement and recovery of solvent at each step of manufacturing process. Accordingly, the case has been deferred for 28.2.2012. 6
Case No.:3/31/82ALC4/2010
Party Name:EMAMI LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/Am 11 dated 28.9.2010/ Lic.No/Date 0210149202 dated 12.10.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of DC( MSME). 7
Case No.:63/40/82ALC4/2010
Party Name:EMAMI LIMITED Status:Case Deferred
07.02.2012 HQ File :01/82/050/01262/AM11/ dated 20.12.2010 RLA File :02/24/040/00120/Am 11 dated 29.9.2010/ Lic.No/Date 0210149565 dated 25.10.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of DC( MSME). 8
Case No.:24/47/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01614/AM11/ RLA File :09/24/040/00404/AM11/ Lic.No/Date:0910044631 10.12.2010 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals. 9
Case No.:43/3/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00043/AM12/ RLA File :09/24/040/00452/AM11/ Lic.No/Date:0910045290 28.01.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/227/2010PI (Norms) dated 15.12.2011 decided to call from the firm the following information: % yield on Molar Basis for each step of manufacturing process. Actual past productionconsumption data duly certified by Central Excise Authority for the above export product. Accordingly, the case has been deferred for 6.3.2012. 10
Case No.:44/3/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00044/AM12/ RLA File :09/24/040/00422/AM11/ Lic.No/Date:0910045287 28.01.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm the following details: % yield on Molar Basis for each step of manufacturing process. Technical details as per Appendix 33.
Accordingly, the case has been deferred for 6.3.2012. 11
Case No.:32/48/82ALC4/2010
Party Name:DR. SABHARWALS WOUND CARE 07.02.2012 Status:Case Deferred HQ File :01/82/050/01675/AM11/ RLA File :06/24/040/00057/AM11/ Lic.No/Date:0610020786 01.02.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Industrial Policy and Promotion. 12
Case No.:22/3/82ALC4/2010
Party Name:CIPLA LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00022/AM11/ RLA File :03/94/040/00998/am 11/ DATED 7.2.2011 Lic.No/Date:0310615336 DATED 10.02.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals. 13
Case No.:3/52/82ALC4/2010
Party Name:SRINI PHARMACEUTICALS LTD. 07.02.2012 Status:Case Approved HQ File :01/82/050/01772/AM 11/ RLA File :09/24/040/00558/AM 11/dated 4.3.2011 Lic.No/Date:0910045891 dated 11.3.2011 Defer Date: Decision : . Committee considered case as per agenda and in light of earlier decision taken in meeting No. 41/82 held on 10.1.2012 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Trazodone HCL 1 Kg 1. 1(3Chlorophenyl) Piperazine HCL 1.282 2. 1Bromo3Chloro Propane 2.01 3. 2Chloro Pyridine 0.984 4. Semicarbazide HCL 1.968 5. Ethoxy Ethanol 1.829 6. Acetonitrile 4.19 RA may take appropriate action as per the decision of Norms Committee 14
Case No.:9/52/82ALC4/2010
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01778/AM11/ RLA File :09/24/040/00560/AM11/ Lic.No/Date:0910045929 Defer Date:
15.03.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 44/12 dated 31.1.2012 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: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Adenine 1 kg 1 Hypoxanthine 1.33 15
Case No.:2/1/82ALC4/2011
Party Name:KOPRAN LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01790/AM11/ RLA File :03/94/040/01135/AM11/ Lic.No/Date:0310623333 25.03.2011 Defer Date: Decision : : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 44/82 dated 31.1.2012 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: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Meropenem for Injection USP 1 kg 1 Meropenem Trihydrate NonSterile 1.032 16
Case No.:10/2/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01800/AM12/ RLA File :09/24/040/00583/AM 11/dated 18.3.2011 Lic.No/Date:0910046056 dated 25.3.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 41/82 dated 10.1.2012 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 3,4Dihydroxy5 NitroBenzaldehyde 1 Kg 1. 2 3 Vanillin Dichloro Methane Pyridine 1.97 0.93 0.457
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Case No.:7/5/82ALC4/2011
Party Name:NEULAND LABORATORIES LIMITED 07.02.2012 Status:Case Approved HQ File 01/82/050/00109/am 12 / RLA File :09/24/040/00561/AM 11/DATED 8.3.2011 Lic.No/Date0910046412 dated 19.4.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 41/82 held on 10.1.2012and 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Posaconazol 1 Kg 1. 2 3 2[(1S, 2S)1Ethyl2 Bezyloxypropyl]2,4Dihydro4[4[4[4 Hydroxyphenyl)1Piperazinyl] Phenyl]3H1,2,4Triazol3one (5RCIS)5(2,4Difluorophenyl)5 [(1H1,2,4Triazol1YL)Methyl] Tetrahydro3Furanmethanol,4 Toluenesulphonate 10% Palladium on Carbon 1.23 1.27 0.200 RA may take further action as per the decision of Norms Committee 18
Case No.:10/5/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 07.02.2012 Status:Case Approved HQ File :01/82/050/00112/AM12/ RLA File :05/23/040/00007/AM12/ Lic.No/Date:0510288427 20.04.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2011Ch II dated 10.2.2012 2012and 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 2Chloro6 Trichloromethyl Pyridine 1 kg 1 2 Alpha Picoline 1,2,4Trichlorobenzene 0.658 kg 0.220 kg
3 4 5 Heptane Stergene Carbon 0.280 kg 0.006 kg 0.005 kg 19
Case No.:13/5/82ALC4/2011
Party Name:EMBIO LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00115/AM12/ RLA File :03/94/040/00009/AM12/ Lic.No/Date:0310627428 20.04.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 20
Case No.:14/5/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00116/AM12/ RLA File :03/94/040/00008/AM12/ Lic.No/Date:0310627429 20.04.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 21
Case No.:32/6/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00150/am 12/ RLA File :09/24/040/00037/AM12/ DATED 18.4.2011 Lic.No/Date:0910046439 12.05.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of technical authorities. 22
Case No.:33/6/82ALC4/2011
Party Name: AUROBINDO PHARMA LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00151/AM12/ RLA File :09/24/040/00031/AM12/ Lic.No/Date:0910046440 21.04.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of technical authorities.
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Case No.:28/7/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00194/AM12/ RLA File :03/94/040/01026/AM11/ Lic.No/Date:0310629152 03.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 24
Case No.:29/7/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00195/AM12/ RLA File :03/94/040/01027/AM11/ Lic.No/Date:0310629153 03.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 25
Case No.:19/10/82ALC4/2011
Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of DC(MSME). 26
Case No.:43/8/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00243/AM12/ RLA File :03/94/040/01024/AM11/ Lic.No/Date:0310630508 10.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 27
Case No.:44/8/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00244/AM12/ RLA File :03/94/040/01023/AM11/ Lic.No/Date:0310630510 Defer
10.05.2011 Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 28
Case No.:50/8/82ALC4/2011
Party Name:VIJAYASRI ORGANICS LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00250/AM12/ RLA File :09/24/040/00592/AM11/ Lic.No/Date:0910046744 12.05.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 29
Case No.:17/16/82ALC4/2011
Party Name:SMILAX LABORATORIES LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00475/AM12/ RLA File :09/24/040/00501/AM11/ Lic.No/Date:0910046743 12.05.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 30
Case No.:3/9/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00254/AM12/ RLA File :03/94/040/00120/AM12/ Lic.No/Date:0310631346 16.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 31
Case No.:4/9/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00255/AM12/ RLA File :03/94/040/00121/AM12/ Lic.No/Date:0310631350 16.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower
than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 32
Case No.:2/9/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00253/AM12/ RLA File :09/24/040/00012/AM12/ Lic.No/Date:0910046777 18.05.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals 33
Case No.:1/10/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00260/AM12/ RLA File :03/94/040/00148/AM12/ Lic.No/Date:0310631875 19.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 34
Case No.:2/10/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00261/AM12/ RLA File :03/94/040/00151/AM12/ Lic.No/Date:0310631883 19.05.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 35
Case No.:18/11/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00332/AM12/ RLA File :09/24/040/00080/AM12/ Lic.No/Date:0910046973 02.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 36
Case No.:1/13/82ALC4/2011
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00373/AM12/ RLA File :03/94/040/01111/AM11/ Lic.No/Date:0310635238 09.06.2011 Defer Date:06.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 37
Case No.:4/13/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 07.02.2012 Status:Case Deferred HQ File :01/82/050/00376/AM12/ RLA File :05/24/040/00424/AM11/ Lic.No/Date:0510292794 09.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 38
Case No.:5/13/82ALC4/2011
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 07.02.2012 Status:Case Deferred HQ File :01/82/050/00377/AM12/ RLA File :05/24/040/00442/AM11/ Lic.No/Date:0510292795 09.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 39
Case No.:14/19/82ALC4/2011
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/00528/AM12/ RLA File :09/24/040/00134/AM12/ Lic.No/Date:0910047151 15.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 40
Case No.:22/19/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00536/AM12/ RLA File :09/24/040/00121/AM12/ Lic.No/Date:0910047114 15.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 41
Case No.:49/21/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00631/AM12/ RLA File :05/24/040/00093/AM12/ Lic.No/Date:0510293830 17.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer
42
Case No.:26/21/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/00608/AM12/ RLA File :09/24/040/00147/AM12/ Lic.No/Date:0910047215 21.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, in light of earlier decision taken in meeting No. 41/82 dated 10.1.2012, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 6Bromo3 (Tetrahydro Pyran 4YL Amino) Indazole1 Carboxylic Acid Tert. Butyl Ester 1 kg 1 2 3 4 5 6 7 4Bromo2 Fluoro Benzonitrile Hydrazine Hydrate Tetra Hydro Pyran4One Sodium Triacetoxy Borohydride Tetrahydrofuran BOC Anhydride NMethyl Imidazole 1.01 /kg 1.04/ kg 0.85/ kg 1.51/kg 8.95/kg 1.408/kg 0.50/kg 43
Case No.:34/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00616/AM12/ RLA File :09/24/040/00089/AM12/ Lic.No/Date:0910047213 21.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 44
Case No.:41/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00623/AM12/ RLA File :09/24/040/00040/AM12/ Lic.No/Date:0910047212 21.06.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 45
Case No.:42/21/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/00624/AM12/ RLA File :09/24/040/00142/AM12/ Lic.No/Date:0910047214 Defer Date:
Q 21.06.2011 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 1,2,3,5TetraO AcetylBD Riboduranose 1 kg 1 2 3 DRibose Iso Propyl Alcohol Toluene 1.30 kg 2.43 kg 0.273 kg 46
Case No.:43/21/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/00625/AM12/ RLA File :09/24/040/00150/AM12/ Lic.No/Date:0910047217 21.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 5(4 Methyltetrahydropyran) [1,2,4] Triazolo [1,5 a]2Pyridineamine 1 kg 1 2 3 4 5 6Methyl2Amino Pyridine 2Methyl Tetrahydrofuran Tetrahydrofuran Tetrahydro Pyran4One Acetonitrile 1.64 kg 15.22 kg 8.15 kg 2.80 kg 3.545 kg 47
Case No.:44/21/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/00626/AM12/ RLA File :09/24/040/00141/AM12/ Lic.No/Date:0910047216 21.06.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, based on the Central Excise data provided by the firm, decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 1Tert Butoxycarbonylamino 1 kg 1 Ethyl Cyanoacetate 2.657 kg
y y 1Cyclo Butylcarboxylic Acid 2 3 4 5 13Dibromopropane Acetone Di Tert Butyl Dicarbonate Triethylamine 5.24 kg 3.09 kg 2.085 kg 1.30 kg 48
Case No.:18/21/82ALC4/2011
Party Name:SHREE JAYA LABORATORIES PVT LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00600/AM12/ RLA File :09/24/040/00623/AM11/ Lic.No/Date:0910047446 01.07.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 49
Case No.:16/21/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 07.02.2012 Status:Case Deferred HQ File :01/82/050/00598/AM12/ RLA File :09/24/040/00165/AM12/ Lic.No/Date:0910047474 05.07.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 50
Case No.:17/21/82ALC4/2011
Party Name:MATRIX LABORATORIES LIMITED 07.02.2012 Status:Deffered and Reindexed HQ File :01/82/050/00599/AM12/ RLA File :09/24/040/00153/AM12/ Lic.No/Date:0910047476 05.07.2011 Defer Date:07.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 51
Case No.:60/21/82ALC4/2011
Party Name:INDSWIFT LABORATORIES LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/00642/AM12/ RLA File :22/24/040/00026/AM12/ Lic.No/Date:2210011604 06.07.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 52
Case No.:5/21/82ALC4/2011
07.02.2012 Status:Case Approved
HQ File :01/82/050/00587/AM12/ RLA File :03/94/040/00319/AM12/ Lic.No/Date:0310641299 08.07.2011 Defer Date: Decision : Committee considered case as per agenda and based on comparison of data of the the past cases 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 the firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowedkg/kg Finasteride 1 kg 1 2 3 4 (3oxo4aza5AlphaAndrostane17 Beta1butyl Carboxamide)P7 Compound 1,4 Dioxane Dichloro Dicyano Benzoquinone (DDQ) BisTrimethyl Silyl trifluoro Acetamide (BSTFA) 1.7647 12.50 0.86 1.47 RA may take appropriate action as per the decision of NC. 53
Case No.:3/17/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00498/AM12/ RLA File :05/24/040/00124/AM12/ Lic.No/Date:0510296379 12.07.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 54
Case No.:6/17/82ALC4/2011
(FORMERLY JUBILANT 07.02.2012 Status:Case Approved HQ File :01/82/050/00501/AM12/ RLA File :05/23/040/00137/AM12/ Lic.No/Date:0510296623 14.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2011Ch II dated 10.2.2012 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 2Chloro6 Trichloromethyl Pyridine 1 kg 1 2 Alpha Picoline 1,2,4Trichlorobenzene 0.658 kg 0.220 kg
3 4 5 Heptane Stergene Carbon 0.280 kg 0.006 kg 0.005 kg 55
Case No.:58/21/82ALC4/2011
Party Name:ESSIX BIOSCIENCES LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00640/AM12/ RLA File :22/24/040/00028/AM12/ Lic.No/Date:2210011653 14.07.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm technical information as per Appendix 33. Accordingly, the case has been deferred for 6.3.2012. 56
Case No.:9/17/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00504/AM12/ RLA File :03/94/040/00318/AM12/ Lic.No/Date:0310642597 15.07.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 57
Case No.:1/35/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 07.02.2012 Status:Case Deferred HQ File :01/82/050/00928/AM12/ RLA File :03/95/040/00278/AM12/ Lic.No/Date:0310642739 18.07.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Biotechnology.. 58
Case No.:19/21/82ALC4/2011
Party Name:SAIRAM ORGANICS PVT. LTD., 07.02.2012 Status:Case Approved HQ File :01/82/050/00601/AM12/ RLA File :09/24/040/00174/AM12/ Lic.No/Date:0910047733 19.07.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/160/2011Ch II dated 16.1.2012 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Diethyl (3,5 dimethoxybenzyl) 1 kg 1 3,5Dihydroxy Benzoic Acid 0.560 kg
Phosphonate (ADDP2) 2 3 4 Potassium Carbonate Sodium Boro Hydride Tetra Hydro Furan 1.953 kg 0.232 kg 0.587 kg 59
Case No.:28/21/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 07.02.2012 Status:Case Deferred HQ File :01/82/050/00610/AM12/ RLA File :09/24/040/00178/AM12/ Lic.No/Date:0910047796 21.07.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 60
Case No.:30/31/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00856/AM12/ RLA File :09/24/040/00199/AM12/ Lic.No/Date:0910048014 01.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 61
Case No.:19/20/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/00581/AM12/ RLA File :04/24/040/00363/AM11/ Lic.No/Date:0410126761 03.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 62
Case No.:14/27/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00764/AM12/ RLA File :03/94/040/00395/AM12/ Lic.No/Date:0310646407 04.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/01/2012PI (Norms) dated 6.2.2012 decided to call from the firm details as per Appendix 33. Accordingly, the case has been deferred for 6.3.2012. 63
Case No.:34/31/82ALC4/2011
Party Name:HETERO LABS LIMITED 07.02.2012 Status:Case Approved
HQ File :01/82/050/00860/AM12/ RLA File :09/24/040/00189/AM12/ Lic.No/Date:0910048117 08.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of earlier decision taken in meeting No. 44/82 dated 31.1.2012 and in consultation with the technical authorities present in the meeting, decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Bicalutamide 1 kg 1 2 3 4 2,3EPOXY2METHYLN[4CYANO3 (TRIFLUOROMETHYL)PHENYL]PROPANAMIDE PFLUORO THIO PHENOL DIISOPROPYL ETHER METHYLENE CHLORIDE 1.11 0.50 0.925 2.062 64
Case No.:9/26/82ALC4/2011
07.02.2012 Status:Case Approved HQ File :01/82/050/00692/AM12/ RLA File :03/94/040/00409/AM12/ Lic.No/Date:0310647117 09.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (200 MD) with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms As per packing policy As per packing policy 18.20 gms
Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can 0.48 mm OD Actuators with Dus covers/caps 1,1,1,2,Tetrafluoroethane (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can. 1 no of inhaler 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 0.05gms as per packing policy 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg 1 no of inhaler 1 2 BECLOMETHASONE DIPROPIONATE 63mcl AEROSOL VALVES 0.06gms
Can 3 4 5 6 19ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS (HFA 134A Propellant) ETHANOL As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler (200MD) / Beclocip 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) with 63mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.04 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler 250mcg HFA Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.05gms 15.90 gms 2.28 gms
6 ETHANOL Budespray 200mcg HFA Inhaler (200MD) / Budesonide Inhaler 200mcg (200MD) with 58mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 58 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.07gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 SALMETEROL 0.03 gms
2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.50 gms 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL FLUTICASONE PROPIONATE 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.015 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ 1 no of inhaler 1 SALMETEROL 0.003 gms
(120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 2 3 4 5 6 7 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg 1 no of inhaler 1 SALBUTAMOL 0.02 gms
p p g and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 2 3 4 5 6 7 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.01 gms 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.006 gms 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) 1 no of inhaler 1 2 0.015 gms
Valve and 14ml Aluminium Can 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN 0.0014 gms
4 5 6 COVERS /CAPS (HFA 134A Propellant) ETHANOL 7.84 gms 0.16 gms Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy
6 7 (HFA 134A Propellant) Ethanol 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption 65
Case No.:27/31/82ALC4/2011
Party Name:SAIRAM ORGANICS PVT. LTD., 07.02.2012 Status:Case Approved HQ File :01/82/050/00853/AM12/ RLA File :09/24/040/00217/AM12/ Lic.No/Date:0910048206 10.08.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting NO. 41/82 held on 10.1.2012 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Flavoxate HCL Bp 1 Kg 3Methyl Flavone8Carboxylic Acid 0.883 66
Case No.:41/31/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00867/AM12/ RLA File :09/24/040/00196/AM12/ Lic.No/Date:0910048207 10.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 67
Case No.:45/31/82ALC4/2011
Party Name:GRANULES INDIA LIMITED 07.02.2012 Status:Case Deferred
HQ File :01/82/050/00871/AM12/ RLA File :09/24/040/00220/AM12/ Lic.No/Date:0910048208 10.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 68
Case No.:8/27/82ALC4/2011
Party Name:GLENMARK GENERICS LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/00758/AM12/ RLA File :03/94/040/00397/AM12/ Lic.No/Date:0310648930 17.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting observed that this case was also considered in meeting no. 41/83 held on 10.1.2012 for the same license no. and norms were fixed in consultation with the technical authorities. However, in the minutes the quantity of Export product was mentioned wrongly. The Committee has, therefore, once again ratify the norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Ciclopirox Gel 0.77%, 30 gm 13500 Number Ciclopirox USP 3.181 kg Ciclopirox Gel 0.77%, 45 gm 9100 Number Ciclopirox USP 3.212 kg Ciclopirox Gel 0.77%, 100 gm 4600 Number Ciclopirox USP 3.611 kg RA is, therefore, requested to consider earlier norms sent as cancelled and take appropriate action as per the above decision of Norms Committee. 69
Case No.:11/27/82ALC4/2011
Party Name:INDOFIL INDUSTRIES LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00761/AM12/ RLA File :03/94/040/00465/AM12/ Lic.No/Date:0310650141 24.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 70
Case No.:9/27/82ALC4/2011
Party Name:INDOFIL INDUSTRIES LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00759/AM12/ RLA File :03/94/040/00464/AM12/ Lic.No/Date:0310650335 25.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals
71
Case No.:46/31/82ALC4/2011
Party Name:POSY PHARMACHEM PVT. LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00872/AM12/ RLA File :08/24/040/00084/AM12/ Lic.No/Date:0810102781 25.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and deferred the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 72
Case No.:10/27/82ALC4/2011
07.02.2012 Status:Case Approved HQ File :01/82/050/00760/AM12/ RLA File :03/94/040/00480/AM12/ Lic.No/Date:0310650724 26.08.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 1 no of inhaler 1 2 Salbutamol 50 mcl Aerosol Valves 0.020 gms
mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 3 4 5 19 ml aluminium can (HFA 134 A Propellant) 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Can. 1 no of inhaler 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 0.08gms 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Can 1 no of inhaler 1 2 3 4 5 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.09gms As pr packing policy 17.288 gms 0.912 gms
6 ETHANOL Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.06 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.07gms 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 BUDESONIDE 19ml ALUMINIUM CAN 0.10gms
4 5 COVERS /CAPS (HFA 134A Propellant) 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.04 gms 12.50 gms 0.256 gms
6 ETHANOL Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.015 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS 0.003 gms 0.03 gms 12.5 gms
6 7 (HFA 134A Propellant) ETHANOL 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS 0.02 gms 0.02 gms 14.04 gms
6 7 (HFA 134A Propellant) ETHANOL 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.006 gms 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.015 gms 12.5 gms 0.256 gms
7 ETHANOL Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms
Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses.
The firm will maintain separate record on HFA 134 A Propellant import and consumption 73
Case No.:19/31/82ALC4/2011
Party Name:MICRO LABS LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00845/AM12/ RLA File :07/24/040/00199/AM12/ Lic.No/Date:0710081875 29.08.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 74
Case No.:37/31/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 07.02.2012 Status:Case Approved HQ File :01/82/050/00863/AM12/ RLA File :22/24/040/00029/AM12/ Lic.No/Date:2210011825 30.08.2011 Defer Date: Decision : Committee considered case as per agenda and observed that this case has already been approved in 41/82 meeting held on 10.1.2012 75
Case No.:39/31/82ALC4/2011
Party Name:SAURAV CHEMICALS LTD, 07.02.2012 Status:Case Deferred HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 76
Case No.:6/27/82ALC4/2011
07.02.2012 Status:Case Approved HQ File :01/82/050/00756/AM12/ RLA File :03/94/040/00489/AM12/ Lic.No/Date:0310651351 02.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 1 no of inhaler 1 2 Salbutamol 58 mcl Aerosol Valves 0.02 gms
MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol with 58 mcl Aerosol Valve and 19 ml Aluminium can. 3 4 5 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg 1 no of inhaler 1 2 3 4 5 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) 0.11gms 17.74 gms 0.456 gms
Can. 6 Ethanol Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.12gms As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.08 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 1 no of inhaler 1 0.09gms
250mcg Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.13gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS 0.02 gms 18.2 gms
5 (HFA 134A Propellant) Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.05 gms 12.50 gms 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 SALMETEROL 14ml ALUMINIUM CAN 0.003 gms 0.015 gms
5 6 7 COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) 1 no of inhaler 1 2 3 4 SALMETEROL 14ml ALUMINIUM CAN 0.003 gms 0.006 gms As per packing policy
Valve and 14ml Aluminium Can 5 6 7 COVERS /CAPS (HFA 134A Propellant) ETHANOL As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.02 gms 0.03 gms 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 14ml ALUMINIUM CAN COVERS /CAPS 0.006 gms 12.5 gms
6 (HFA 134A Propellant) ETHANOL 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms
6 Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol 1 no of 1 BUDESONIDE 0.0007 gms
Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can inhaler 2 3 4 5 6 7 Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption 77
Case No.:11/31/82ALC4/2011
Party Name:ESTEEM INDUSTRIES PVT. LTD, 07.02.2012 Status:Case Deferred HQ File :01/82/050/00837/AM12/ RLA File :17/24/040/00044/AM12/ Lic.No/Date:1710004498 08.09.2011 Defer Date:06.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 78
Case No.:50/31/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00876/AM12/ RLA File :04/24/040/00165/AM12/ Lic.No/Date:0410127861 08.09.2011 Defer Date:06.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. Accordingly, the case has been deferred for 6.3.2012. 79
Case No.:15/31/82ALC4/2011
(FORMERLY JUBILANT 07.02.2012 Status:Case Approved HQ File :01/82/050/00841/AM12/ RLA File :05/23/040/00197/AM12/ Lic.No/Date:0510302069 13.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2011Ch II dated 10.2.2012 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 2Chloro6 Trichloromethyl Pyridine 1 kg 1 2 3 4 5 Alpha Picoline 1,2,4Trichlorobenzene Heptane Stergene Carbon 0.658 kg 0.220 kg 0.280 kg 0.006 kg 0.005 kg 80
Case No.:28/31/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 07.02.2012 Status:Case Deferred HQ File :01/82/050/00854/AM12/ RLA File :22/24/040/00044/AM12/ Lic.No/Date:2210011894 14.09.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals. 81
Case No.:19/27/82ALC4/2011
Party Name:RUSAN PHARMA LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00769/AM12/ RLA File :03/95/040/00407/AM12/ Lic.No/Date:0310654860 20.09.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals 82
Case No.:20/31/82ALC4/2011
(FORMERLY JUBILANT 07.02.2012 Status:Case Deferred
HQ File :01/82/050/00846/AM12/ RLA File :05/23/040/00218/AM12/ Lic.No/Date:0510303152 20.09.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals 83
Case No.:36/31/82ALC4/2011
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/00862/AM12/ RLA File :04/24/040/00177/AM12/ Lic.No/Date:0410128297 20.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and observed that this case has already been approved in meeting no. 41/82 dated 10.1.2012. . 84
Case No.:4/31/82ALC4/2011
07.02.2012 Status:Case Approved HQ File :01/82/050/00830/AM12/ RLA File :03/94/040/00540/AM12/ Lic.No/Date:0310655386 22.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and observed that this case has already been approved in Meeting No. 42/82 dated 17.1.2012. 85
Case No.:49/31/82ALC4/2011
Party Name:ASCENT FINECHEM PVT. LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/00875/AM12/ RLA File :08/24/040/00147/AM12/ Lic.No/Date:0810103865 22.09.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 86
Case No.:7/35/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00934/AM12/ RLA File :03/94/040/00539/AM12/ Lic.No/Date:0310657331 30.09.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals 87
Case No.:15/35/82ALC4/2011
Party Name:HIRAN ORGOCHEM LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00942/AM12/ RLA File :03/94/040/00508/AM12/ Lic.No/Date:0310657262 Defer
30.09.2011 Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals 88
Case No.:16/35/82ALC4/2011
Party Name:HIRAN ORGOCHEM LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00943/AM12/ RLA File :03/94/040/00474/AM12/ Lic.No/Date:0310657248 30.09.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals 89
Case No.:17/35/82ALC4/2011
Party Name:ENALTEC LABS PVT.LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00944/AM12/ RLA File :03/94/040/00574/AM12/ Lic.No/Date:0310657228 30.09.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals 90
Case No.:25/35/82ALC4/2011
07.02.2012 Status:Case Approved HQ File :01/82/050/00952/AM12/ RLA File :03/94/040/00565/AM12/ Lic.No/Date:0310657216 30.09.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms
Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Can. 1 no of inhaler 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 0.14gms 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone 1 no of inhaler 1 0.15gms
) Pressurised 100 mcg Can 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL p p g p y As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.10 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 19ml ALUMINIUM CAN COVERS /CAPS 0.11gms 15.90 gms
5 6 (HFA 134A Propellant) ETHANOL 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.16gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve 1 no of inhaler 1 SALMETEROL 0.06 gms
and 14ml Aluminium Can 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.50 gms 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.015 gms 12.5 gms 0.256 gms
Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms
Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.02 gms 0.04 gms 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.006 gms 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) 1 no of inhaler 1 2 0.015 gms
Valve and 14ml Aluminium Can 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve 1 no of inhaler 1 2 Formoterol Fumarate 40 mcl AEROSOL VALVES 0.0014 gms
and 10ml Aluminium Can 3 4 5 6 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 7.84 gms 0.16 gms Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN 0.0007 gms 0.024 gms As per packing policy As per packing policy
5 6 7 COVERS /CAPS (HFA 134A Propellant) Ethanol As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption 91
Case No.:23/35/82ALC4/2011
Party Name:METROPOLITAN EXIMCHEM LTD. 07.02.2012 Status:Case Approved HQ File :01/82/050/00950/AM12/ RLA File :03/95/040/00521/AM12/ Lic.No/Date:0310657611 03.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2011Ch II dated 23.12.2010 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: Export Product Exp. Qty. S.No Import Item Qty. allowed/kg 1Amino2, 5 Dimethoxy 4 sulphanalide/2,5Dimethoxy Aniline 4 Sulphophenylamide 1 kg Hydroquinone 0.506 kg 92
Case No.:4/35/82ALC4/2011
07.02.2012 Status:Case Approved HQ File :01/82/050/00931/AM12/ RLA File :03/94/040/00583/AM12/ Lic.No/Date:0310657895 04.10.2011 Defer Date:
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 1 no of inhaler 1 2 Beclomethasone Dipropionate 63 mcl Aerosol Valves 0.17gms
MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Can. 3 4 5 6 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.18gms As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) 1 no of inhaler 1 2 3 4 19ml ALUMINIUM CAN 0.12 gms 16.37 gms
Valve and 19ml Aluminium Can 5 6 COVERS /CAPS (HFA 134A Propellant) ETHANOL 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.13gms 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.19gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 1 no of inhaler 1 BUDESONIDE 0.02 gms
100mcg (200MD) Valve and 19ml Aluminium Can 2 3 4 5 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.07 gms 12.50 gms 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler 1 no of inhaler 1 SALMETEROL 0.003 gms
(120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 2 3 4 5 6 7 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ 1 no of 1 SALMETEROL 0.003 gms
50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can inhaler 2 3 4 5 6 7 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.02 gms 0.05 gms 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) 1 no of inhaler 1 2 0.006 gms
Valve and 14ml Aluminium Can 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 63 mcl Aerosol vale 14ml ALUMINIUM CAN 0.03 gms
4 5 6 COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN 0.012 gms 0.0007 gms As per packing policy
5 6 COVERS /CAPS (HFA 134A Propellant) As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption 93
Case No.:2/35/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00929/AM12/ RLA File :03/94/040/00572/AM12/ Lic.No/Date:0310658087 Defer
05.10.2011 Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 94
Case No.:13/35/82ALC4/2011
07.02.2012 Status:Case Approved HQ File :01/82/050/00940/AM12/ RLA File :03/94/040/00603/AM12/ Lic.No/Date:0310658343 07.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 1 no of inhaler 1 2 3 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can 0.020 gms
MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol with 50 mcl Aerosol Valve and 19 ml Aluminium Can 4 5 (HFA 134 A Propellant) 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Can. 1 no of inhaler 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can (HFA 134 A Propellant) Ethanol 0.20gms 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Can 1 no of inhaler 1 2 3 4 5 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.21gms As pr packing policy 17.288 gms 0.912 gms
6 Beclometasona Dipropionate 200mcg Inhaler 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.14 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.15gms 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 BUDESONIDE 19ml ALUMINIUM CAN 0.22gms
4 5 COVERS /CAPS (HFA 134A Propellant) 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.08 gms 12.50 gms 0.256 gms
6 ETHANOL Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.015 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS 0.003 gms 0.03 gms 12.5 gms
6 7 (HFA 134A Propellant) ETHANOL 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 0.06 gms 14.04 gms 0.36 gms
7 ETHANOL Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.006 gms 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms
Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms Formoterol 1 no of 1 BUDESONIDE 0.012 gms
Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can inhaler 2 3 4 5 6 Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption
95
Case No.:24/35/82ALC4/2011
Party Name:LUPIN LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00951/AM12/ RLA File :03/95/040/00562/AM12/ Lic.No/Date:0310658391 07.10.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case 6.3.2012 for comments of Department of Pharmaceuticals. 96
Case No.:9/35/82ALC4/2011
Party Name:UNITED BIOTECH PVT.LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00936/AM12/ RLA File :05/24/040/00226/AM12/ Lic.No/Date:0510304974 11.10.2011 Defer Date:06.03.2012 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012. 97
Case No.:10/35/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00937/AM12/ RLA File :05/24/040/00233/AM12/ Lic.No/Date:0510304887 11.10.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals. 98
Case No.:26/35/82ALC4/2011
Party Name:INDOFIL INDUSTRIES LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00953/AM12/ RLA File :03/94/040/00606/AM12/ Lic.No/Date:0310658741 11.10.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 99
Case No.:28/35/82ALC4/2011
(FORMERLY JUBILANT 07.02.2012 Status:Case Deferred HQ File :01/82/050/00955/AM12/ RLA File :05/23/040/00247/AM12/ Lic.No/Date:0510305029 12.10.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 100 Case No.:6/31/82ALC4/2011 Party Name:SALVI CHEMICAL INDUSTRIES Status:Case
LIMITED 07.02.2012 Rejected HQ File :01/82/050/00832/AM12/ RLA File :03/95/040/00513/AM12/ Lic.No/Date:0310659452 13.10.2011 Defer Date: Decision : The Committee considered the case as per agenda and observed that firm was requested to furnish some technical details in Decemeber 2011. However, no reply has been received. The Committee decided to reject the case. 101
Case No.:7/31/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00833/AM12/ RLA File :03/94/040/00612/AM12/ Lic.No/Date:0310659475 13.10.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 102
Case No.:8/31/82ALC4/2011
07.02.2012 Status:Case Deferred HQ File :01/82/050/00834/AM12/ RLA File :03/94/040/00611/AM12/ Lic.No/Date:0310659491 13.10.2011 Defer Date:06.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 06.3.2012. 103
Case No.:54/31/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/00880/AM12/ RLA File :03/94/040/00647/AM12/ Lic.No/Date:0310660797 19.10.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of DC(MSME). 104 Case No.:124/42/82ALC4/2011 Party Name:DIVIS LABORATORIES LTD., 07.02.2012 Status:Case Approved HQ File :01/82/050/01159/AM12/ RLA File :09/24/040/00371/AM12/ Lic.No/Date:0910049646 09.11.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and in line with the SION A 311 decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed
Naproxen 1 kg 1 2Acetyl6Methoxy Naphthalene 1.38 kg/kg 2. Caustic Potash Flakes 1.32kg/kg 3. Hydroxylammonium Sulphate 0.63 kg/kg 4. NOctylDGlucamine 0.100 kg/kg 5. Methanol 1.87 kg/kg 105
Case No.:3/45/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/01180/AM12/ RLA File :03/94/040/00691/AM12/ Lic.No/Date:0310664617 14.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 106
Case No.:4/45/82ALC4/2011
Party Name:KOPRAN LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01181/AM12/ RLA File :03/94/040/00521/AM12/ Lic.No/Date:0310664771 14.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 107
Case No.:15/45/82ALC4/2011
Party Name:NEULAND LABORATORIES LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/01192/AM12/ RLA File :09/24/040/00360/AM12/ Lic.No/Date:0910049696 14.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 108
Case No.:18/45/82ALC4/2011
Party Name:MSN PHARMACHEM PRIVATE LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01195/AM12/ RLA File :09/24/040/00343/AM12/ Lic.No/Date:0910049675 14.11.2011 Defer Date:06.03.2012 Decision The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 109
Case No.:22/45/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01199/AM12/ RLA File :09/24/040/00341/AM12/ Lic.No/Date:0910049706 Defer
15.11.2011 Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 110
Case No.:14/35/82ALC4/2011
Party Name:PREGNA INTERNATIONAL LTD. 07.02.2012 Status:Case Deferred HQ File :01/82/050/00941/AM12/ RLA File :03/95/040/00635/AM12/ Lic.No/Date:0310665072 15.11.2011 Defer Date:06.03.2012 Decision :The Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their letter No. 46011/22/2008.PC II dated 30.1.2012 decided to call from the firm the following information: 1. It is noted that the application includes six different types of intrauterine contraceptive devices. Technical specifications, weight per piece of each type of Intrauterine Contraceptive Devices along with specific end use/application and the copy of export order may be furnished. 2. Separate quantity of raw material applied for import for each type of export product i.e. Intraueterine Contraceptive Devices. The details of indigenous raw material being used for each of the export product may also be furnished. 3. Net quantity of each of the raw material applied for import for each export product, quantity applied for import (net content+ wastages, if any) along with the proper technical justification. 4. Detailed manufacturing process along with justification for wastages at each stage and also on each of the raw material may be furnished. 5. Complete material balance indicating input and output material at each stage of manufacturing process. 6. Details of production of export product under reference and corresponding consumption of raw material in the year 200910 and 201011 duly certified by CA may be furnished if the production has not commenced in the past, the details from commencement of production to be certified by CA. 7. Any other relevant information. 8. Sample of the each of the export product. Accordingly, the case has been deferred for 6.3.2012. 111
Case No.:35/45/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01212/AM12/ RLA File :09/24/040/00374/AM12/ Lic.No/Date:0910049718 16.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer
112
Case No.:39/45/82ALC4/2011
Party Name:AARTI DRUGS LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01216/AM12/ RLA File :03/94/040/00664/AM12/ Lic.No/Date:0310665403 17.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals 113
Case No.:26/45/82ALC4/2011
Party Name:ASTRIX LABORATORIES LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/01203/AM12/ RLA File :09/24/040/00331/AM12/ Lic.No/Date:0910049779 18.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 114
Case No.:27/45/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 07.02.2012 Status:Case Approved HQ File :01/82/050/01204/AM12/ RLA File :09/24/040/00375/AM12/ Lic.No/Date:0910049758 18.11.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1, as per SION A412, as per details given below , as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Clarigen‐250 mg Tablet 1 no. 1 Clarithromycin 255 mg/250 mg tablet Clarigen 500 mg Tablets 1 no. 1 Clarithromycin 510 mg/ 500 mg tablets. 115
Case No.:31/45/82ALC4/2011
Party Name:MYLAN LABORATORIES LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01208/AM12/ RLA File :09/24/040/00348/AM12/ Lic.No/Date:0910049778 18.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 116
Case No.:37/45/82ALC4/2011
Party Name:MSN LABORATORIES LIMITED 07.02.2012 Status:Case Approved
HQ File :01/82/050/01214/AM12/ RLA File :09/24/040/00383/AM12/ Lic.No/Date:0910049788 18.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 45/82 dated 8.2.2011 and in consultation with representative of Department of Pharmaceuticals 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: Export Product Export Qty. Sl.No. Import items Qty. allowed Rosuvastatin Calcium 1 kg 1. (4RCis)6((Acetyloxy)Methyl)2,2 Dimethyl1,3Dioxane4Acetic Acid 1,1Dimethylethyl Ester 1.871 kg 2. 4(4Fluorophenyl)6Isopropyl2[(N MethylN Methylsulphonyl)Amino]Pyrimidine5 YLMethanol 1.871 kg RA concerned may take further necessary action as per above decision of NC. 117
Case No.:19/45/82ALC4/2011
Party Name:DR REDDYS LABORATORIES LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01196/AM12/ RLA File :09/24/040/00368/AM12/ Lic.No/Date:0910049808 22.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 27/82 dated 5.10.2010 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: Export product Exp. Qty. Sl.No. Import items Qty. allowed Finasteride Form III 1 Kg. 1. 3oxo4aza5aandrostane17b Carboxylic Acid 1.90 kg 118
Case No.:32/45/82ALC4/2011
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 07.02.2012 Status:Case Approved HQ File :01/82/050/01209/AM12/ RLA File :07/24/040/00340/AM12/ Lic.No/Date:0710084274 29.11.2011 Defer Date: Decision : The Committee considered the case as per agenda in the light of written comments of Department of Pharmaceuticals forwarded vide OM No. 35011/28/2012PI(Norms) dated 6.2.2012 and in consultation with the technical authorities present in the meeting, it has been observed that one application each from KAPL and SRS Pharmaceuticals Pvt Limited were considered during 2009 for the same export product. In both those cases Cefuroxime Sodium Sterile USP@822.5 mg per vial was allowed. As the quantity applied by the firm in the present case is less than their earlier
application, the Committee decided to ratify the norms as applied by the firm. RA may take appropriate action as per the decision of Norms Committee. 119
Case No.:6/45/82ALC4/2011
Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 07.02.2012 Status:Case Deferred HQ File :01/82/050/01183/AM12/ RLA File :04/24/040/00236/AM12/ Lic.No/Date:0410131109 30.11.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 120
Case No.:7/45/82ALC4/2011
Party Name:SANO MEDICAL KITS PVT. LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/AM12/ Lic.No/Date:0410131205 01.12.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Industrial Policy and Promotion. 121
Case No.:21/45/82ALC4/2011
Party Name:LAKE CHEMICALS PRIVATE LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01198/AM12/ RLA File :07/24/040/00321/AM12/ Lic.No/Date:0710084385 02.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in Meeting no. 48/82 dated 1.3.2011 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: Export product Exp. Qty. Sl.No. Import items Qty. allowed 8Chloro3A, 4Dihydro6(2 Fluorophenyl)1Methyl3H Imidazo(1,5A)(1,4) Benzodiazepine 1 Kg. 1. 2Amino Methyl7Chloro23Dihydro5 (2Flurophenyl) 1H1,4 Benzodiazepine Dimaleate 2.52 kg 2. Triethyl Ortho Acetate 0.90 kg 122
Case No.:24/45/82ALC4/2011
Party Name:LAKE CHEMICALS PRIVATE LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01201/AM12/ RLA File :07/24/040/00319/AM12/ Lic.No/Date:0710084386 02.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 10/82 held on 8.6.2010 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:
Export product Exp. Qty. Sl.No. Import items Qty. allowed Flurazepam Mono Hcl 1 kg 1. 2Amino5Chloro2Fluro Benzophenone 1.795 kg 123
Case No.:28/45/82ALC4/2011
Party Name:LAKE CHEMICALS PRIVATE LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01205/AM12/ RLA File :07/24/040/00320/AM12/ Lic.No/Date:0710084375 02.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 9/82 meeting held on 1.6.2010 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: Export product Exp. Qty. Sl.No. Import items Qty. allowed Midazolam Maleate 1 Kg. 1. 2Aminomethyl7Chloro2,3Dihydro5 (2Flurophenyl)1H1,4Benzodliazepine Dimaleate 2.52 kg 2. Triethyl Ortho Acetate 1.18 kg 124
Case No.:17/45/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01194/AM12/ RLA File :09/24/040/00410/AM12/ Lic.No/Date:0910050063 07.12.2011 Defer Date: Decision : Committee considered case as per agenda for ratification of norms and in light of earlier decision taken in 44/82 meeting held on 27.01.2010 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: Export Product Export Qty. Sl.No. Import items Qty. allowed Drotaverine Hcl 1 Kg. 1. Ortho Diethoxy Benzene 1.86 kg 2. Isopropyl alcohol 1.63 kg 3. Sodium Cyanide 0.48 kg 4. Para formaldehyde 0.30 kg 5. Methanol 3.20 kg
125
Case No.:30/45/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01207/AM12/ RLA File :09/24/040/00363/AM12/ Lic.No/Date:0910050091 08.12.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 126
Case No.:36/45/82ALC4/2011
Party Name:BIOLOGICAL E LTD 07.02.2012 Status:Case Approved HQ File :01/82/050/01213/AM12/ RLA File :09/24/040/00384/AM12/ Lic.No/Date:0910050101 08.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 32/82 meeting held on 8.11.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Heparin Sodium Potency NLT 150 IU/mg 1 Kg. 1. Crude Heparin Sodium Potency: 130 IU/mg to 135 IU/mg 1.10 kg 127
Case No.:8/45/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS LIMITED 07.02.2012 Status:Case Approved HQ File :01/82/050/01185/AM12/ RLA File :04/24/040/00253/AM12/ Lic.No/Date:0410131573 13.12.2011 Defer Date Decision : Committee considered case as per agenda and in light of earlier decision taken in 28/AM12 meeting held on 11.10.2011 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 the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ferrous Fumarate BP 1 Kg. 1. Fumaric Acid (Technical Grade) 0.876 kg 2. Ferrous Sulphate 2.47 kg 3. Soda Ash 0.065 kg 128
Case No.:23/45/82ALC4/2011
Party Name:SUTURES INDIA PRIVATE LIMITED, 07.02.2012 Status:Case Deferred HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Defer Date:06.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Pharmaceuticals.
129
Case No.:1/39/82ALC4/2011
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00993/AM12/ RLA File :03/95/040/00718/AM12/ Lic.No/Date:0310670262 13.12.2011 Defer Date: 06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 130
Case No.:2/39/82ALC4/2011
Party Name:BILCARE LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00994/AM12/ RLA File :31/83/040/00167/AM12/ Lic.No/Date:3110051868 13.12.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Industrial Policy and Promotion. 131
Case No.:4/39/82ALC4/2011
Party Name:HIKAL LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/00996/AM12/ RLA File :03/94/040/00745/AM12/ Lic.No/Date:0310671352 16.12.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemcials. 132
Case No.:16/45/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/01193/AM12/ RLA File :05/24/040/00272/AM12/ Lic.No/Date:0510311571 19.12.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 133
Case No.:9/45/82ALC4/2011
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 07.02.2012 Status:Case Deferred HQ File :01/82/050/01186/AM12/ RLA File :07/24/040/00373/AM12/ Lic.No/Date:0710084836 20.12.2011 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 134
Case No.:10/45/82ALC4/2011
(FORMERLY JUBILANT 07.02.2012 Status:Case Deferred HQ File :01/82/050/01187/AM12/ RLA File :05/23/040/00354/AM12/ Lic.No/Date:0510312171 Defer
22.12.2011 Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals. 135
Case No.:33/45/82ALC4/2011
(FORMERLY JUBILANT 07.02.2012 Status:Case Approved HQ File :01/82/050/01210/AM12/ RLA File :05/23/040/00353/AM12/ Lic.No/Date:0510312170 22.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in Meeting No. 44/82 held on 31.01.2012 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: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,3Difluro5 Chloro Pyridine 1 kg. 1. Potassium Fluoride 1.180 kg 2. Sulpholane 0.320 kg 3. Toluene 0.318 kg 4. Tetraglyme 0.023 kg 5. Denatured Ethyl Alcohol 3.776 kg 6. Methanol 2.270 kg 7. Alumino Silicate Catalyst 0.0310 kg 8. Toluene 0.199 kg 9. Sodium Nitrite 0.894 kg 10. Thionyl Chloride 1.517 kg 11. DMF (Di Methyl Formamide) 0.553 kg 12. Stergene 0.002 kg 13. Caustic 3.160 kg RA concerned may take further necessary action as per above decision of NC 136
Case No.:13/45/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 07.02.2012 Status:Case Approved HQ File :01/82/050/01190/AM12/ RLA File :05/24/040/00333/AM12/ Lic.No/Date:0510312195 23.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 38/82 dated 20.12.2011, 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: Export Product Export Qty S.No Import Item Qty. Recommended kg/kg VALSARTAN 15000 Kg 1. 2CYANO4BROMOMETHYL BIPHENYL 1.274 2. ACETONE 3.94 3. ACTIVATED CARBON 0.100 4. DIISOPROPYL ETHER 2.66
LVALINE 0.708 6. METHANOL 3.15 7. METHYLENE CHLORIDE 3.60 8. NPENTANE 5.12 9. PALLADIUM SPONGE 3.16 GM/KG 10. TOLUENE 4.03 KG/KG 137
Case No.:25/45/82ALC4/2011
Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 07.02.2012 Status:Case Approved HQ File :01/82/050/01202/AM12/ RLA File :08/24/040/00110/AM12/ Lic.No/Date:0810107258 30.12.2011 Defer Date: Decision : The Committee considered the case as per agenda and in light of earlier decision taken in meeting No. 41/82 dated 10.1.2012 has ratified the norms under Para 4.7 of HBP v1, as applied by the firm, as per details below: Export Product Export Qty S.No Import Item Qty. Recommended kg/kg Ethyl Triphenyl Phosphonium Bormide 1 kg 1 2 Triphenyl Phospine Ethyl Bromide 0.787 kg 0.23 kg RA may take appropriate action as per the decisions of Norms Committee. 138
Case No.:5/45/82ALC4/2011
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01182/AM12/ RLA File :03/94/040/00755/AM12/ Lic.No/Date:0310674056 02.01.2012 Defer Date:06.03.2012 Decision : : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals 139
Case No.:38/45/82ALC4/2011
(FORMERLY JUBILANT 07.02.2012 Status:Case Deferred HQ File :01/82/050/01215/AM12/ RLA File :05/23/040/00371/AM12/ Lic.No/Date:0510313080 02.01.2012 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and decided to call from the firm the following details: Complete description of export production showing percentage content of API Copy of Drug Manufacturing License. Accordingly, the case has been deferred for 6.3.2012.
140
Case No.:20/45/82ALC4/2011
Party Name:ADCOCK INGRAM LTD, 07.02.2012 Status:Case Approved HQ File :01/82/050/01197/AM12/ RLA File :07/24/040/00405/AM12/ Lic.No/Date:0710085288 05.01.2012 Defer Date: Decision : The Committee considered the case as per agenda and in light of earlier decision taken in Meeting No. 35/82 held on 29.11.2011 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Paracetamol 450 mg + Caffeine 30mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Colour Quinoline Yellow CI 47005 (Spectracol) 1.632 mg 3. Codiene Phosphate BP/PH.EUR 10.02 mg 4. Caffeine Anhydrous BP 2010/USP/EP/PH.EUR/BP 30.06 mg 141
Case No.:12/45/82ALC4/2011
Party Name:DIVIS LABORATORIES LTD., 07.02.2012 Status:Case Approved HQ File :01/82/050/01189/AM12/ RLA File :09/24/040/00465/AM12/ Lic.No/Date:0910050662 06.01.2012 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting and in line with the SION A 311 decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Naproxen 1 kg 1 2Acetyl6Methoxy Naphthalene 1.38 kg/kg 2. Caustic Potash Flakes 1.32kg/kg 3. Hydroxylammonium Sulphate 0.63 kg/kg 4. NOctylDGlucamine 0.100 kg/kg 5. Methanol 1.87 kg/kg 142
Case No.:14/45/82ALC4/2011
Party Name:DIVIS LABORATORIES LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/01191/AM12/ RLA File :09/24/040/00468/AM12/ Lic.No/Date:0910050661 06.01.2012 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer
143
Case No.:34/45/82ALC4/2011
Party Name:PARAGON INDUSTRIES 07.02.2012 Status:Case Deferred HQ File :01/82/050/01211/AM12/ RLA File :08/24/040/00233/AM12/ Lic.No/Date:0810107536 09.01.2012 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the firm the following details: Purity of import and export item. Analysis report of import and export item. Details of manufacturing firms. Accordingly, the case has been deferred for 6.3.2012. 144
Case No.:11/45/82ALC4/2011
Party Name:MEDREICH LIMITED 07.02.2012 Status:Case Deferred HQ File :01/82/050/01188/AM12/ RLA File :07/24/040/00406/AM12/ Lic.No/Date:0710085440 12.01.2012 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals 145
Case No.:29/45/82ALC4/2011
Party Name:ASCENT FINECHEM PVT. LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/01206/AM12/ RLA File :08/24/040/00243/AM12/ Lic.No/Date:0810107956 19.01.2012 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer 146
Case No.:1/45/82ALC4/2011
Party Name:GUJARAT ORGANICS LTD., 07.02.2012 Status:Case Deferred HQ File :01/82/050/01178/AM12/ RLA File :03/94/040/00926/AM12/ Lic.No/Date:0310678746 25.01.2012 Defer Date:06.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 6.3.2012 for comments of Department of Chemicals and Petrochemicals 147
Case No.:2/45/82ALC4/2011
Party Name:FDC LTD 07.02.2012 Status:Case Deferred HQ File :01/82/050/01179/AM12/ RLA File :03/94/040/00938/AM12/ Lic.No/Date:0310678976 27.01.2012 Defer Date:06.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer Date:16.02.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer
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