DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 17/82‐ALC4/2010 MEETING DATE : 27.07.2010 The Meeng No.17/82 in the year 2010‐11 to consider the cases under Duty Exempon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 27.07.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Jasbir Singh, IA, Department of C&PC 2. Shri Shaish Kumar, IA, DIPP 3. Shri D.N. Mathur, Dy. IA, Department of Pharmaceucals 4. Shri M. Mitra, Dy.DCGI, o/o DCGI 5. Shri Krishan Kumar, Dy. DGFT 6. Shri Shyam Lal, FTDO At the outset, minutes of Norms Commi쏧ee Meeng No. 15/82 dated 13.07.2010 were rafied by the Commi쏧ee. O.D.S. included in SIONs The Commi쏧ee also discussed the issue of import of O.D.S. against Advance Authorisaon and decided that Shri Jasbir Singh, Industrial Adviser, Department of C&PC may examine the issue in detail and submit a report in the ma쏧er to NC so that O.D.S. items are not allowed by RAs. It was felt that O.D.S. items should be earmarked in SIONs.
Case No. B‐146
M/s Lupin Ltd. Norms Commi쏧ee Meeng No. 17/11 F.No.01/82/50/1156/AM10/DES‐III Meeng Date 27.07.2010 RLA F. No. 03/95/40/753/AM10 Adv. Lic. No.0310561192 dt. 22.02.2010 Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/168/2009‐PI (Norms) dated 22.02.2010 and in consultaon with technical authority present in meeng, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Quanty Sl.No. Import items Quanty allowed Rifampicin BP/USP 1 kg 1. Sodium Rifa‐S 0.98 kga 2. Chloroform 0.661 kg 3. Acec Acid 0.16 kg 4. Piperzine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg 6. Isopropyl Alcohol 0.51 kg 7. Dimethyl Formamide 0.75 kg
Tert. Butylamine 0.19 kg 9. Acetone 0.832 kg 10. 1‐Amino‐4‐Methyl Piperazine 0.16 kg RA concerned may take further necessary acon as per above decision of NC. The earlier decision taken in 1/82 meeng held on 06.04.2010 may be treated as withdrawn.
Case No. B‐147
M/s RA Chem Pharma Ltd. F.No.01/82/50/1149/AM07/DES‐III RLA F. No. 09/24/40/432/AM09 Adv. Lic. No.0910029095 dt. 19.01.2007 Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng decided to amend the descripon of import item No.3 to read as “1,4‐Dibromo Butane” without any other change in the decision of NC taken in 16/08 meeng held on 21.08.2007.
Case No. B‐148
M/s Alchem Internaonal Ltd. F.No.01/82/162/295/AM10/DES‐III RLA F. No. 05/24/40/543/AM05 Adv. Lic. No.0510149505 dt. 24.01.2005 Adv. Lic. No.0510160970 dt. 29.06.2005 Adv. Lic. No.0510160972 dt. 29.06.2005 Adv. Lic. No.0510161341 dt. 04.07.2005 Commi쏧ee decided to defer case for 21.09.2010 for reply from firm.
Case No. B‐149
M/s Otsuka Chemical (India) Ltd. F.No.01/82/50/1493/AM10/DES‐III RLA F. No. 05/24/40/195/AM10 Adv. Lic. No.0510248081 dt. 21.08.2009 Commi쏧ee considered case as per agenda and in light of Producon and Consumpon data cerfied by Central Excise Authority and in consultaon with technical authority present in meeng decided to enhance the quanty of Penicillin G Potassium Ist Crystal to read as “2.85 kg/kg of export product” without any other change in the decision taken in 44/82 meeng held on 27.01.2010. RA concerned may take further necessary acon as per above decision of NC.
Case No. B‐150
M/s Amines & Plascizers Ltd., F.No.01/82/50/407/AM08/DES‐III RLA F. No. 03/94/40/171/AM08
Adv. Lic. No.0310430655 dt. 25.05.2007 Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng decided to amend the descripon of export product to read as “N‐Formyl Morpholine” without any other change in the decision taken in 19/83 meeng held on 22.08.2007.
Case No. B‐151
M/s Olefine Organic (I) Pvt. Ltd. F.No.01/82/50/277/AM10/DES‐III RLA F. No. 03/95/40/138/AM10 Adv. Lic. No.0310522629 dt. 04.06.2009 Commi쏧ee considered case as per agenda and decided to call for the firm for personal hearing on 24.08.2010. Accordingly, case was deferred for 24.08.2010.
Case No. B‐151‐A
M/s Vivimed Labs.Ltd F.No.01/85/50/00236/AM10/DES‐III RLA F. No. 09/24/040/00504/AM10 Adv. Lic. No.0910041262 dated 11.03.2010 Commi쏧ee considered case as per agenda and decided to forward a copy of applicaon to Department of C&PC for their comments. Accordingly, case was deferred for 21.09.2010.
Case No. B‐152
M/s Punjab chemicals and Crop Producon Ltd. F.No.01/82/162/106/AM10/DES‐III RLA F. No. 03/95/40/1022/AM09 Adv. Lic. No.0310513269 dt. 25.03.2009 Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/76/2005/Ch.II dated 22.07.2010 and in consultaon with technical authority present in meeng, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Quanty Sl.No. Import items Quanty allowed 3,4,5‐Trimethoxy Toluene 1 kg 1. 3,4,5‐Trimethoxy Benzaldeh 1.25 kg 2. Hydrazine Hydrate 4.20 kg 3. PEG‐600 1.00 kg RA concerned may take further necessary acon as per above decision of NC. The earlier decision taken in 12/10 meeng held on 16.06.2009 may be treated as withdrawn.
Case No. B‐153
M/s Hildose Ltd. F.No.01/82/50/497/AM08/DES‐III RLA F. No. 03/94/40/1100/AM08 Adv. Lic. No.0310460275 dt. 06.02.2008 Commi쏧ee considered case as per agenda and observed that the firm has not given the percentage purity of import and exports. In the absence of percentage purity of import and export items, Commi쏧ee in consultaon with technical authority present in meeng decided to rafy norms under para 4.7 of HBP with 2% wastage.
Case No. B‐154
M/s J.S. Chemicals.. F.No.01/82/50/1179/AM09/DES‐III RAF No. 52/24/40/00019/AM09 Adv. Lic. No.5210024577 dt. 21.10.2080 Commi쏧ee considered case as per agenda and observed that Department of C&PC vide their le쏧er dated 26.02.2010 has called for technical informaon from firm which is sll awaited. It was, therefore, decided to remind the firm and defer the case for 21.09.2010.
Case No. B‐155
M/s Global Calcium Ltd. F.No.01/82/50/1492/AM07/DES‐III RLA F. No. 07/24/40/654/AM07 Adv. Lic. No.0710049231 dt. 27.12.2006 Commi쏧ee considered case as per agenda and in light of Producon and Consumpon data cerfied by Central Excise Authority and in consultaon with technical authority present in meeng, decided to revise 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 Calcium Gluconate 1 Kg. 1. Dextrose Monohydrate 1.25 kg RA concerned may take further necessary acon as per above decision of NC. The earlier decision taken in 16/83 meeng held on 25.07.2007 may be treated as withdrawn.
Case No. B‐156
M/s Jubilant Organosys Ltd. F.No.01/82/50/1715/AM09/DES‐III RLA F. No. 50/24/40/744/AM09 Adv. Lic. No.051038238 dt. 18.03.2009
Commi쏧ee decided to defer case for 21.09.2010 for reply from firm.
Case No. A‐20
M/s Matrix Ltd. F.No.01/82/162/879/AM10/DES‐III RLA F. No. 09/24/40/00097/AM08 Adv. Lic. No.0910030541 dt. 13.06.2007 Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/31/2010‐PI (Norms) dated 02.07.2010 and in consultaon with technical authority present in meeng, decided to revise 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 Lopinavir 200 mg + Ritonavir 50 mg Tablets 1 Kg. 1. Lopinavir 204 mg 2. Ritonavir 51.0 mg 3. Copovidone 853.800 mg 4. Sorbitan Monolaurate 83.90 mg 5. Methylene Chloride Not allowed 6. Sodium Stearyl fumarate 12.00 kg7. 7. Bo쏧le Pill Jar As per packing policy 8. Closure
Case No. C‐16
M/s Bliss GVS Pharma Ltd. F.No.01/82/50/1156/AM10/DES‐III Commi쏧ee decided to defer case for 21.09.2010 for comments of Department of Pharmaceucals. 1
Case No.:1007/21/82‐ALC4/2007
Party Name:GRAND ORGANICS PVT.LTD. Meet No/Date:17/82‐ALC4/2010 27.07.2010 Status:Case Approved HQ File :01/82/050/01883/AM07/ RLA File :17/24/040/00090/AM07/ Lic.No/Date:1710001597 27.03.2007 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/114/2007/Ch.II dated 27.07.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Grand AP05 Colourless Clear Liquid containing 50% of 2 Ethyl Hexyl Phosphate and 10% of Propylene Glycol 1 Kg. 1. 2 Ethyl Hexanol 0.372 kg 2. Phosphorous Pentoxide 0.137 kg 3. Propylene Glycol 0.100 kg 2
Case No.:17/46/82‐ALC4/2007
Party Name:ARCH PHARMALABS LTD 27.07.2010 Status:Case Approved HQ File :01/82/050/00571/AM08/ RLA File :03/94/040/01117/AM08/ Lic.No/Date:0310461019 14.02.2008 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide O.M. No.35011/8/2010‐PI (Norms) dated 10.06.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Montelukast Sodium 1 Kg. 1. Triethanol Amine 0.0634 kg 2. Iso propyl alcohol 2.58 kg 3. Toluene 13.77 kg 4. Ethyl Acetate 14.33 kg 5. Heptane 4.75 kg 6. CD X 026 (Ezzyme) 0.12 kg 7. B‐Niconamide‐Adenine Dinucleode Phosphate, Oxidized From Monosodium Salt 0.0019 kg 8. Acvated Carbon Norit 0.100 kg 9. Cerium Chloride Anhydrous 1.19 kg 10. Ortho Xylene 1.34 kg 11. Tetrahydrofuran 6.89 kg 12. Methyl Magnesium Chloride 10.57 kg 13. Acec Acid 3.129 kg 14. Methyl Sulphonyl Chloride 0.41 kg 15. Di Isopropyl Ethyl Amine 0.55 kg 16. Methylene Di Chloride 8.62 kg 17. Acetonitrile 2.32 kg 18. Hexane 2.23 kg 19. 1‐(Mercaptomethyl) Cyclopropane Acec Acid 0.60 kg
(CYTA) 20. Methanol 6.80 kg 3
Case No.:7/41/82‐ALC4/2008
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 27.07.2010 Status:Case Approved HQ File :01/82/050/01447/AM09/ RLA File :04/24/040/00138/AM09/ Lic.No/Date:0410098239 28.08.2008 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/24/2010‐PI (Norms) dated 09.06.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 (E)‐4‐ Dimethylaminocrotomie Acid Hcl 1 kg 1. Methyl Crotonate 2.42 kg 2. Iso Propyl alcohol 1.82 kg 4
Case No.:7/32/82‐ALC4/2008
Party Name:ARCH PHARMALABS LTD 27.07.2010 Status:Case Approved HQ File :01/82/050/01182/AM09/ RLA File :03/94/040/00721/AM09/ Lic.No/Date:0310491254 21.10.2008 Decision :Commi쏧ee decided to close the case as the firm has surrendered the Advance Authorisaon. 5
Case No.:19/35/82‐ALC4/2008
Party Name:VIJAYASRI ORGANICS LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/01275/AM09/ RLA File :09/24/040/00287/AM09/ Lic.No/Date:0910035950 17.11.2008 Defer Date:21.09.2010 Decision :Commi쏧ee considered case as per agenda and decided to remind DC(MSME) through D.O. reminder at the level of Chairman, NC‐III. Accordingly, case was deferred for 21.09.2010. 6
Case No.:13/10/82‐ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00137/AM10/ RLA File :09/24/040/00055/AM10/ Lic.No/Date:0910038020 28.05.2009 Defer Date:21.09.2010
Decision :Commi쏧ee decided to defer case for 21.09.2010 for comments of Department of C&PC. 7
Case No.:9/13/82‐ALC4/2009
Party Name:ENCUBE ETHICALS PVT LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00149/AM10/ RLA File :03/94/040/00063/AM10/ Lic.No/Date:0310522513 03.06.2009 Defer Date:21.09.2010 Decision :Commi쏧ee considered case as per agenda and decided to remind the firm to furnish a copy of DML containing approved list of items. Accordingly, case was deferred for 21.09.2010. 8
Case No.:23/15/82‐ALC4/2009
Party Name:VIVIMED LABS LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00252/AM10/ RLA File :09/24/040/00109/AM10/ Lic.No/Date:0910038369 29.06.2009 Defer Date:21.09.2010 Decision : Commi쏧ee decided to defer case for 21.09.2010 for comments of Department of C&PC. 9
Case No.:21/35/82‐ALC4/2009
Party Name:ASTRIX LABORATORIES LTD., 27.07.2010 Status:Case Approved HQ File :01/82/050/00711/AM10/ RLA File :09/24/040/00127/AM10/ Lic.No/Date:0910038698 24.07.2009 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/393/2009‐PI‐(Norms) dated 07.06.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Lopinavir (TPA Route) 1 Kg. 1. (2S)‐(1‐Tetrahydro Pyrimid‐2‐Only)‐3‐Methyl Butanoic Acid (TPA) 1.161 kg 2. Triphosgene 0.715 kg 3. Tetrahydrofuran 5.25 kg 4. 2,6‐Dimethoxy Phenol 0.618 kg 5. Sodium Borohydride 0.89 kg 6. Dimethyl formamide 2.48 kg 7. Methylene Di Chloride 9.62 kg 8. Methane Sulfonic Acid 2.485 kg 9. Iso Propyl Alcohol 1.07 kg 10. 1,2‐Dimethoxy Ethane 29.38 kg 11. Methyl Terary Butyl Ether 2.86 kg 12. Methanol 7.62 kg 13. (L)‐Pyroglu Tamic Acid 0.57 kg
10
Case No.:26/21/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00453/AM10/ RLA File :09/24/040/00112/AM10/ Lic.No/Date:0910038897 12.08.2009 Defer Date:21.09.2010 Decision :Commi쏧ee considered case as per agenda and decided to remind the firm to furnish the required informaon. Accordingly, case was deferred for 21.09.2010. 11
Case No.:60/5/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00094/AM11/ RLA File :09/24/040/00198/AM10/ Lic.No/Date:0910039255 08.09.2009 Defer Date:21.09.2010 Decision : Commi쏧ee decided to defer case for 21.09.2010 for comments of Department of Pharmaceucals. 12
Case No.:82/5/82‐ALC4/2010
Party Name:BILCARE LIMITED 27.07.2010 Status:Case Approved HQ File :01/82/050/00116/AM11/ RLA File :31/24/040/00106/AM10/ Lic.No/Date:3110039936 16.09.2009 Decision :Withdrawn as the case has already been approved by NC in 16/82 meeng held on 20.07.2010. 13
Case No.:101/5/82‐ALC4/2010
Party Name:IND‐SWIFT LABORATORIES LTD., 27.07.2010 Status:Case Approved HQ File :01/82/050/00135/AM11/ RLA File :22/24/040/00033/AM10/ Lic.No/Date:2210009355 14.10.2009 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/39/2010‐PI‐(Norms) dated 01.07.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Clopidogrel Camphor Sulfonate 1 Kg. 1. 4,5,6,7 Tetrahydro Thieno(3,2‐C) Pyridine Hcl 1.012 kg 2. Alpha‐Bromo‐2‐Chloro Phenyl Acec Acid/Methyl Ester 1.52 kg 3. N,N‐Dimethyl Formamide 1.26 kg 4. Triethylamine 1.265 kg 5. Methylene Chloride 2.20 kg
Acetone 6.34 kg 7. L(‐) Camphor Sulphonic Acid 0.455 kg 14
Case No.:101/9/82‐ALC4/2010
Party Name:KOPRAN LIMITED 27.07.2010 Status:Case Approved HQ File :01/82/050/00316/AM11/ RLA File :03/94/040/00619/AM10/ Lic.No/Date:0310543241 29.10.2009 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/6/2010‐ PI‐(Norms) dated 08.06.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Cefepime for Injecon 1 Kg. 1. Cefepime Hcl (Non‐Sterile) 0.655 kg 2. Methanol 0.742 kg 3. Eno Carbon 0.034 kg 4. Acetone 1.816 kg 5. L‐Arginine (Non‐Sterile) 0.370 kg 6. IPA (Iso Propyl Alcohol) 0.392 kg 15
Case No.:70/48/82‐ALC4/2009
Party Name:CHEMPRO EXPORTS (INDIA) 27.07.2010 Status:Case Deferred HQ File :01/82/050/01133/AM10/ RLA File :03/94/040/00613/AM10/ Lic.No/Date:0310544665 09.11.2009 Defer Date:21.09.2010 16
Case No.:29/5/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00063/AM11/ RLA File :03/94/040/00657/AM10/ Lic.No/Date:0310547230 24.11.2009 Defer Date:21.09.2010 17
Case No.:20/38/82‐ALC4/2009
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 27.07.2010 Status:Case Deferred Lic.No/Date:0910040146
HQ File :01/82/050/00793/AM10/ RLA File :09/24/040/00355/AM10/ 03.12.2009 Defer Date:21.09.2010 Decision :Commi쏧ee considered case as per agenda and decided to remind the firm to furnish the required informaon. Accordingly, case was deferred for 21.09.2010. 18
Case No.:79/9/82‐ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00294/AM11/ RLA File :09/24/040/00350/AM10/ Lic.No/Date:0910040204 14.12.2009 Defer Date:21.09.2010 19
Case No.:82/9/82‐ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00297/AM11/ RLA File :09/24/040/00353/AM10/ Lic.No/Date:0910040205 14.12.2009 Defer Date:21.09.2010 20
Case No.:94/9/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00309/AM11/ RLA File :09/24/040/00342/AM10/ Lic.No/Date:0910040200 14.12.2009 Defer Date:21.09.2010 21
Case No.:67/9/82‐ALC4/2010
Party Name:HETERO LABS LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00282/AM11/ RLA File :09/24/040/00393/AM10/ Lic.No/Date:0910040408 23.12.2009 Defer Date:21.09.2010 22
Case No.:96/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00311/AM11/ RLA File :09/24/040/00391/AM10/ Lic.No/Date:0910040412 23.12.2009 Defer Date:21.09.2010 23
Case No.:84/9/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 27.07.2010 Status:Case Deferred
HQ File :01/82/050/00299/AM11/ RLA File :09/24/040/00318/AM10/ Lic.No/Date:0910040461 30.12.2009 Defer Date:21.09.2010 24
Case No.:85/9/82‐ALC4/2010
Party Name:ANUS LABORATORIES LTD., 27.07.2010 Status:Case Approved HQ File :01/82/050/00300/AM11/ RLA File :09/24/040/00381/AM10/ Lic.No/Date:0910040463 30.12.2009 Defer Date: Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/56/2010‐Ch.II dated 21.06.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Sodium Methoxide Soluon 30% 1 Kg. 1. Methanol 0.622 kg 2. CS Flakes 0.050 kg 25
Case No.:43/9/82‐ALC4/2010
Party Name:HETERO LABS LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00258/AM11/ RLA File :09/24/040/00405/AM10/ Lic.No/Date:0910040496 01.01.2010 Defer Date:21.09.2010 26
Case No.:66/9/82‐ALC4/2010
Party Name:HETERO LABS LTD. 27.07.2010 Status:Deffered and Re‐indexed HQ File :01/82/050/00281/AM11/ RLA File :09/24/040/00404/AM10/ Lic.No/Date:0910040497 01.01.2010 Defer Date:27.07.2010 27
Case No.:107/9/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 27.07.2010 Status:Case Approved HQ File :01/82/050/00322/AM11/ RLA File :03/94/040/00847/AM10/ Lic.No/Date:0310553763 05.01.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/9/2005‐Ch.II dated 22.05.2005 and in consultaon with technical authority present in meeng, decided to rafy 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 Astrolide in Diethyl Phthalate/Isopropyl Myristate/Benzyl Benzoate Main Total Astrokide content: 62.5% minimum 1 Kg. 1. Alpha Methyl Styrene 0.500 kg 2. Isoamylene 0.380 kg 3. Propylene Oxide 0.280 kg 4. Para Formaldehyde 0.088 kg 28
Case No.:34/5/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00068/AM11/ RLA File :03/94/040/00778/AM10/ Lic.No/Date:0310554129 07.01.2010 Defer Date:21.09.2010 29
Case No.:17/9/82‐ALC4/2010
Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 27.07.2010 Status:Case Approved HQ File :01/82/050/00232/AM11/ RLA File :03/94/040/00875/AM10/ Lic.No/Date:0310554935 12.01.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/52/2009‐Ch.II dated 21.06.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 N,N Dialkylamino‐ diphenylmethane/4,4‐bis (sec‐ butylamino) diphenylamethane, UOP No.225/Unlink 4200 1 Kg. 1. 4,4‐Methylenedianline 0.950 kg 2. Methyl Ethyl Ketone 0.639 kg 3. Catalyst‐3% Planum on carbon powder (Dry Basis) 0.0003 kg 30
Case No.:58/9/82‐ALC4/2010
Party Name:CIPLA LIMITED 27.07.2010 Status:Case Approved HQ File :01/82/050/00273/AM11/ RLA File :03/94/040/00873/AM10/ Lic.No/Date:0310554940 12.01.2010 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 7/11 meeng held on 18.05.2010 and in consultaon with technical authority present in meeng, decided to rafy norms on repeat basis 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 Beclate Nasal Spray/Ciplametazon Nasal Spray (50 MCG/200 MD) 1000000 Nos. 1. Beclomethasone Dipropionate 10,000 gms 2. 63 mcl Aerosol Vasve 3. 19 ml Aluminium Can 4. Actuators with Dust Covers/Caps Fi嬀�ng to 19 ml Aluminium Can 31
Case No.:77/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00292/AM11/ RLA File :09/24/040/00401/AM10/ Lic.No/Date:0910040590 12.01.2010 Defer Date:21.09.2010 32
Case No.:97/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00312/AM11/ RLA File :09/24/040/00417/AM10/ Lic.No/Date:0910040596 12.01.2010 Defer Date:21.09.2010 33
Case No.:23/9/82‐ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00238/AM11/ RLA File :03/94/040/00826/AM10/ Lic.No/Date:0310555276 14.01.2010 Defer Date:21.09.2010 34
Case No.:21/5/82‐ALC4/2010
Party Name:LAFFANS PETROCHEMICALS LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00055/AM11/ RLA File :03/95/040/00663/AM10/ Lic.No/Date:0310555780 18.01.2010 Defer Date:21.08.2010 35
Case No.:26/9/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 27.07.2010 Status:Case Deferred
HQ File :01/82/050/00241/AM11/ RLA File :03/94/040/00896/AM10/ Lic.No/Date:0310556539 21.01.2010 Defer Date:21.09.2010 36
Case No.:25/9/82‐ALC4/2010
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00240/AM11/ RLA File :03/94/040/00912/AM10/ Lic.No/Date:0310556696 22.01.2010 Defer Date:21.09.2010 37
Case No.:59/9/82‐ALC4/2010
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00274/AM11/ RLA File :03/94/040/00890/AM10/ Lic.No/Date:0310556699 22.01.2010 Defer Date:21.09.2010 38
Case No.:38/5/82‐ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00072/AM11/ RLA File :09/24/040/00359/AM10/ Lic.No/Date:0910040696 28.01.2010 Defer Date:21.09.2010 Decision :Commi쏧ee decided to defer case for 21.09.2010 for comments of Department of Pharmaceucals. 39
Case No.:40/5/82‐ALC4/2010
Party Name:MSN LABORATORIES LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00074/AM11/ RLA File :09/24/040/00427/AM10/ Lic.No/Date:0910040698 28.01.2010 Defer Date:21.09.2010 40
Case No.:81/5/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00115/AM11/ RLA File :09/24/040/00390/AM10/ Lic.No/Date:0910040690 28.01.2010 Defer Date:21.09.2010 41
Case No.:24/9/82‐ALC4/2010
Party Name:CALYX CHEMICALS & 27.07.2010 Status:Case
PHARMACEUTICALS LTD. Deferred HQ File :01/82/050/00239/AM11/ RLA File :03/94/040/00871/AM10/ Lic.No/Date:0310557308 28.01.2010 Defer Date:21.09.2010 42
Case No.:105/9/82‐ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 27.07.2010 Status:Case Approved HQ File :01/82/050/00320/AM11/ RLA File :03/94/040/00887/AM10/ Lic.No/Date:0310557306 28.01.2010 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 12/82 meeng held on 22.06.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 Nabumetone 1 Kg. 1. 6‐Methoxy‐2‐Naphthaldehyde 1.28 kg 2. Acetone 1.26 kg 3. Iso Propyl Alcohol 1.65 kg 43
Case No.:117/9/82‐ALC4/2010
Party Name:CHEMPRO EXPORTS (INDIA) 27.07.2010 Status:Case Deferred HQ File :01/82/050/00332/AM11/ RLA File :03/94/040/00910/AM10/ Lic.No/Date:0310557320 28.01.2010 Defer Date:21.09.2010 44
Case No.:14/9/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00229/AM11/ RLA File :03/94/040/00924/AM10/ Lic.No/Date:0310557720 29.01.2010 Defer Date:21.09.2010 45
Case No.:81/9/82‐ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00296/AM11/ RLA File :09/24/040/00429/AM10/ Lic.No/Date:0910040725 29.01.2010 Defer Date:21.09.2010 46
Case No.:49/5/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD Status:Case
27.07.2010 Deferred HQ File :01/82/050/00083/AM11/ RLA File :09/24/040/00314/AM10/ Lic.No/Date:0910040762 01.02.2010 Defer Date:21.09.2010 47
Case No.:61/5/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 27.07.2010 Status:Case Approved HQ File :01/82/050/00095/AM11/ RLA File :09/24/040/00399/AM10/ Lic.No/Date:0910040760 01.02.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/31/2010‐PI (Norms) dated 02.07.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 1‐(Mercaptomethyl) Cyclopropane Acec Acid 1 Kg. 1. 1‐(Hydroxymethyl)‐Cyclopropane Acetonitrile 1.909 kg 2. Isopropyl Acetate 15.03 kg 3. Methane Sulfonyl Chloride 2.34 kg 4. Potassium Thioacetate 1.97 kg 5. N‐Heptane 12.52 kg 6. Methanol 16.09 kg 48
Case No.:40/9/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 27.07.2010 Status:Case Approved HQ File :01/82/050/00255/AM11/ RLA File :03/94/040/00831/AM10/ Lic.No/Date:0310558191 02.02.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/53/2010‐Ch.II dated 10.06.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 Camphor USP 1 Kg. 1. Alpha Pinene 1.15 kg 49
Case No.:87/9/82‐ALC4/2010
Party Name:SRIDHANADA LABORATORIES 27.07.2010 Status:Case Approved HQ File :01/82/050/00302/AM11/ RLA File :09/24/040/00448/AM10/ Lic.No/Date:0910040859
08.02.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/52/2006‐Ch.II dated 27.07.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Syringaldehyde (Purity Minimum 99.5%) 1 Kg. 1. 3,5‐Dimethoxy‐4‐Hydroxy Benzaldehyde (Purity maximum 95%) 1.05 kg 50
Case No.:41/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00256/AM11/ RLA File :03/94/040/00980/AM10/ Lic.No/Date:0310559358 09.02.2010 Defer Date:21.09.2010 Decision :Commi쏧ee decided to remind Ministry of Environment and Forests for NOC. Accordingly, case was deferred for 21.09.2010. 51
Case No.:75/9/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 27.07.2010 Status:Case Approved HQ File :01/82/050/00290/AM11/ RLA File :09/24/040/00302/AM10/ Lic.No/Date:0910040871 09.02.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/14/2010‐PI (Norms) dated 09.06.2010 and earlier decision taken in 5/82 meeng held on 04.05.2010 for the same export product and in consultaon with technical authories present in meeng, decided to rafy 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 Lamivudine 1 Kg. 1. Cyclohexyl Ester 2.19 kg 2. Sodium Borohydride 0.48 kg 3. Methanol 0.29 kg 4. Toluene 0.35 kg 5. Triethylamine 0.959 kg 6. Iso Propyl Alcohol 2.51 kg 7. Salicylic Acid 0.79 kg 52
Case No.:83/9/82‐ALC4/2010
Party Name:APITHECARY PHARMA PVT LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00298/AM11/ RLA File :09/24/040/00425/AM10/ Lic.No/Date:0910040885 10.02.2010 Defer
Date:21.09.2010 53
Case No.:63/9/82‐ALC4/2010
Party Name:KOPRAN LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00278/AM11/ RLA File :03/94/040/00936/AM10/ Lic.No/Date:0310559797 11.02.2010 Defer Date:21.09.2010 54
Case No.:113/9/82‐ALC4/2010
Party Name:GODAVARI BIOREFINERIES LTD. 27.07.2010 Status:Case Approved HQ File :01/82/050/00328/AM11/ RLA File :03/94/040/00735/AM10/ Lic.No/Date:0310560233 15.02.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/52/2010‐Ch.II dated 14.07.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed 3‐Methyl‐3‐Penten‐2‐one 1 Kg. 1. Methyl Ethyl Ketone 0.816 kg 2. Denatured Ethyl Alcohol 0.540 kg 55
Case No.:68/5/82‐ALC4/2010
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 27.07.2010 Status:Case Deferred HQ File :01/82/050/00102/AM11/ RLA File :07/24/040/00438/AM10/ Lic.No/Date:0710070041 16.02.2010 Defer Date:21.09.2010 Decision :Commi쏧ee decided to defer case for 21.09.2010 for comments of Department of C&PC. 56
Case No.:48/9/82‐ALC4/2010
Party Name:K R R DRUGS & INTERMEDIATES PVT LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00263/AM11/ RLA File :09/24/040/00385/AM10/ Lic.No/Date:0910040985 17.02.2010 Defer Date:21.09.2010 57
Case No.:73/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred
HQ File :01/82/050/00288/AM11/ RLA File :03/94/040/01012/AM10/ Lic.No/Date:0310560981 18.02.2010 Defer Date:21.09.2010 58
Case No.:49/9/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 27.07.2010 Status:Case Approved HQ File :01/82/050/00264/AM11/ RLA File :03/94/040/01011/AM10/ Lic.No/Date:0310561133 19.02.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/53/2010‐Ch.II dated 10.06.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Camphor USP 1 Kg. 1. Alpha Pinene 1.15 kg 59
Case No.:95/9/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00310/AM11/ RLA File :09/24/040/00463/AM10/ Lic.No/Date:0910041043 22.02.2010 Defer Date:21.09.2010 60
Case No.:7/50/82‐ALC4/2009
Party Name:CADILA HEALTHCARE LTD., 27.07.2010 Status:Case Approved HQ File :01/82/050/01161/AM10/ RLA File :08/24/040/00326/AM10/ Lic.No/Date:0810086746 23.02.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/38/2010‐PI (Norms) dated 02.07.2010 and in consultaon with technical authority present in meeng decided to rafy 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 Losartan Potassium Tablets 25 mg 1 No. 1. Losartan Potassium USP 25.50 mg 2. Lactose Monohydrate NF 43.0 mg 3. Microcrystalline Cellulose NF (Avicel ph 102) 5.0 mg 4. Low Substuted Hydroxypropyl Cellulose 2.50 mg 5. Magnesium Stearate NF 1.00 mg
60CC White HDPE Round Bo쏧le 7. 33 MM White PP CRC with Pulp Liner 8. 150 CC White HDPE Round Bo쏧le 9. 38 mm White PP Screw Cap 10. 400 CC White HDPE Round Bo쏧le 11. 53 MM White PP Screw Cap 12. 750 CC White HDPE Round Bo쏧le Losartan Potassium 50 mg tablet 1 No. 1. Losartan Potassium USP 51.0 mg 2. Lactose Monohydrate NF 86.0 mg 3. Microcrystalline Cellulose NF (Avicel ph 102) 10.0 mg 4. Low Substuted Hydroxypropyl Cellulose 5.0 mg 5. Magnesium Stearate NF 2.00 mg 6. 60CC White HDPE Round Bo쏧le 7. 33 MM White PP CRC with Pulp Liner 8. 150 CC White HDPE Round Bo쏧le 9. 38 mm White PP Screw Cap 10. 400 CC White HDPE Round Bo쏧le 11. 53 MM White PP Screw Cap 12. 750 CC White HDPE Round Bo쏧le Losartan Potassium 100 mg tablet 1 No. 1. Losartan Potassium USP 102.0 mg 2. Lactose Monohydrate NF 172.0 mg 3. Microcrystalline Cellulose NF (Avicel ph 102) 20.0 mg 4. Low Substuted Hydroxypropyl Cellulose 10.0 mg 5. Magnesium Stearate NF 4.00 mg 6. 60CC White HDPE Round Bo쏧le 7. 33 MM White PP CRC with Pulp Liner 8. 150 CC White HDPE Round Bo쏧le 9. 38 mm White PP Screw Cap 10. 400 CC White HDPE Round Bo쏧le 11. 53 MM White PP Screw Cap 12. 750 CC White HDPE Round Bo쏧le
61
Case No.:41/5/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00075/AM11/ RLA File :09/24/040/00503/AM10/ Lic.No/Date:0910041155 03.03.2010 Defer Date:21.09.2010 62
Case No.:42/5/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00076/AM11/ RLA File :09/24/040/00502/AM10/ Lic.No/Date:0910041152 03.03.2010 Defer Date:21.09.2010 63
Case No.:70/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00285/AM11/ RLA File :03/94/040/01049/AM10/ Lic.No/Date:0310563301 08.03.2010 Defer Date:21.09.2010 64
Case No.:1/52/82‐ALC4/2009
Party Name:RA CHEM PHARMA LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/01194/AM10/ RLA File :09/24/040/00488/AM10/ Lic.No/Date:0910041233 09.03.2010 Defer Date:21.09.2010 Decision :Commi쏧ee considered case as per agenda and decided to call for complete descripon of export product from firm. Accordingly, case was deferred for 21.09.2010. 65
Case No.:96/5/82‐ALC4/2010
Party Name:IND‐SWIFT LABORATORIES LTD., 27.07.2010 Status:Case Approved HQ File :01/82/050/00130/AM11/ RLA File :22/24/040/00055/AM10/ Lic.No/Date:2210009769 10.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/41/2010‐PI (Norms) dated 01.07.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 Clopidogrel Hydrogen Sulphate 1 Kg. 1. DL‐2‐Chlorophenyl Glycine 1.05 kg 2. Methanol 2.375 kg 3. Methylene Chloride 1.185 kg
L(+) Tartaric Acid 0.70 kg 5. Acetone 0.613 kg 6. Thiophene‐2‐Ethanol 1.00 kg 7. Toluene 1.552 kg 8. Iso Propyl Alcohol 4.085 kg 66
Case No.:57/9/82‐ALC4/2010
Party Name:MAKSON INDUSTRIES PVT. LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00272/AM11/ RLA File :03/95/040/00799/AM10/ Lic.No/Date:0310563993 10.03.2010 Defer Date:17.08.2010 Decision :Commi쏧ee considered case as per agenda and observed that the required informaon/documents have been received from the firm. It was, therefore, decided to defer case for 17.08.2010 and to bring the reply received from firm in the meeng to be held on 17.08.2010. 67
Case No.:42/9/82‐ALC4/2010
Party Name:METROPOLITAN EXIMCHEM LTD. 27.07.2010 Status:Case Approved HQ File :01/82/050/00257/AM11/ RLA File :03/95/040/00790/AM10/ Lic.No/Date:0310564129 11.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/60/2010‐Ch.II dated 08.07.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Para Cresidine 4‐Sulfo Methylamide 1 Kg. 1. Para Cresidine 0.763 kg 68
Case No.:56/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00271/AM11/ RLA File :03/94/040/01069/AM10/ Lic.No/Date:0310564080 11.03.2010 Defer Date:21.09.2010 69
Case No.:31/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00246/AM11/ RLA File :03/94/040/01077/AM10/ Lic.No/Date:0310564818 15.03.2010 Defer Date:21.09.2010
70
Case No.:27/5/82‐ALC4/2010
Party Name:SARNA CHEMICALS PVT.LTD. 27.07.2010 Status:Case Approved HQ File :01/82/050/00061/AM11/ RLA File :03/95/040/00832/AM10/ Lic.No/Date:0310565202 18.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/48/2008‐Ch.II dated 27.07.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed 1‐Isopropylamino Anthraquinone/XJ Base 1 Kg. 1. 1‐Nitro Anthraquinone 1.128 kg 2. Isopropylamine(70%) 0.421 kg 71
Case No.:5/9/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00220/AM11/ RLA File :03/94/040/01075/AM10/ Lic.No/Date:0310565589 19.03.2010 Defer Date:21.09.2010 72
Case No.:9/9/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00224/AM11/ RLA File :03/94/040/01087/AM10/ Lic.No/Date:0310565583 19.03.2010 Defer Date:21.09.2010 73
Case No.:20/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00235/AM11/ RLA File :03/94/040/01100/AM10/ Lic.No/Date:0310565614 19.03.2010 Defer Date:21.09.2010 74
Case No.:71/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00286/AM11/ RLA File :03/94/040/01118/AM10/ Lic.No/Date:0310565867 Defer
22.03.2010 Date:21.09.2010 75
Case No.:7/1/82‐ALC4/2010
Party Name:MEGHMANI ORGANICS LTD 27.07.2010 Status:Case Approved HQ File :01/82/050/01238/AM10/ RLA File :08/24/040/00348/AM10/ Lic.No/Date:0810087615 24.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.15022/16/2010‐Ch.II dated 01.06.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Lambda Cyhalothrin Technical 1 Kg. 1. L.C. Acid (Cyhalothric Acid) 0.743 kg 2. Meta Phenoxy Benzaldehyde 0.557 kg 3. Sodium Cyanide 0.150 kg 4. Thionyl Chloride 0.428 kg 5. Hexane 0.380 kg 6. Iso Propyl Alcohol 0.015 kg 76
Case No.:93/9/82‐ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00308/AM11/ RLA File :03/95/040/00826/AM10/ Lic.No/Date:0310566202 24.03.2010 Defer Date:21.09.2010 77
Case No.:88/9/82‐ALC4/2010
Party Name:GALAXY SURFACTANTS LTD., 27.07.2010 Status:Case Approved HQ File :01/82/050/00303/AM11/ RLA File :03/94/040/00776/AM10/ Lic.No/Date:0310566494 25.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/63/2008‐Ch.II dated 13.07.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Galaxy 610 (Ethylene Glycol Disterate (Assay 98% Minimum) 1 Kg. 1. Stearic Acid 0.941 kg
78
Case No.:90/9/82‐ALC4/2010
Party Name:BHARAT SERUMS & VACCINES LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00305/AM11/ RLA File :03/94/040/01113/AM10/ Lic.No/Date:0310566481 25.03.2010 Defer Date:21.09.2010 79
Case No.:114/9/82‐ALC4/2010
27.07.2010 Status:Case Approved HQ File :01/82/050/00329/AM11/ RLA File :03/94/040/01128/AM10/ Lic.No/Date:0310566470 25.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/284/2009‐PI‐(Norms) dated 28.04.2010 and in consultaon with technical authority present in meeng, decided to revise 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 Telmisartan and Amlodipine Tablet 40/10 mg 1 No. 1. Telmisartan Granules 68.707 mg 2. Amlodipine Besilate 13.864 mg Telmisartan and Amlodipine Tablet 80/10 mg 1 No. 1. Telmisartan Granules 137.414 mg 2. Amlodipine Besilate 13.864 mg Telmisartan and Amlodipine Tablet 40/5 mg 1 No. 1. Telmisartan Granules 68.707 mg 2. Amlodipine Besilate 6.932 mg Telmisartan and Amlodipine Tablet 80/5 mg 1 No. 1. Telmisartan Granules 137.414 mg 2. Amlodipine Besilate 6.932 mg 80
Case No.:10/9/82‐ALC4/2010
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 27.07.2010 Status:Case Approved HQ File :01/82/050/00225/AM11/ RLA File :03/95/040/00822/AM10/ Lic.No/Date:0310566726 26.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/62/2010‐Ch.II dated 15.07.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Trimethylsilyl 1 Kg. 1. Triflic Acid (Trifluoromethane Sulfonic 0.400 kg
Trifluoromethanesulfonate Acid) 81
Case No.:7/9/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00222/AM11/ RLA File :03/94/040/01093/AM10/ Lic.No/Date:0310567048 29.03.2010 Defer Date:21.09.2010 82
Case No.:27/9/82‐ALC4/2010
Party Name:BELCHEM INDS. INDIA PVT. LTD. 27.07.2010 Status:Case Approved HQ File :01/82/050/00242/AM11/ RLA File :03/94/040/01031/AM10/ Lic.No/Date:0310567060 29.03.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/55/2010‐Ch.II dated 22.06.2010 and in consultaon with technical authories present in meeng, decided to rafy norms under para 4.7 of HBP as per details below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Dimethyl Dimethylol Hydantoin (Assay 52‐55% min.) 1 Kg. 1. 5,5‐Dimethyl Hydantoin 0.382 kg 83
Case No.:89/9/82‐ALC4/2010
Party Name:LUPIN LIMITED 27.07.2010 Status:Case Approved HQ File :01/82/050/00304/AM11/ RLA File :03/95/040/00866/AM10/ Lic.No/Date:0310567047 29.03.2010 Decision :Withdrawn as the case has already been approved by NC in 9/82 meeng held on 01.06.2010. 84
Case No.:131/9/82‐ALC4/2010
Party Name:GODAVARI BIOREFINERIES LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00346/AM11/ RLA File :03/94/040/01025/AM10/ Lic.No/Date:0310567684 31.03.2010 Defer Date:21.09.2010 85
Case No.:107/5/82‐ALC4/2010
Party Name:VDH INTERNATIONAL 27.07.2010 Status:Case Deferred
HQ File :01/82/050/00141/AM11/ RLA File :05/24/040/00516/AM10/ Lic.No/Date:0510261663 01.04.2010 Defer Date:21.09.2010 86
Case No.:106/5/82‐ALC4/2010
Party Name:DHANUKA LABORATORIES LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00140/AM11/ RLA File :05/23/040/00169/AM10/ Lic.No/Date:0510261709 05.04.2010 Defer Date:21.09.2010 87
Case No.:53/5/82‐ALC4/2010
Party Name:CADILA PHARMACEUTICALS LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00087/AM11/ RLA File :08/24/040/00004/AM11/ Lic.No/Date:0810088011 07.04.2010 Defer Date:21.09.2010 88
Case No.:98/9/82‐ALC4/2010
Party Name:PAB ORGANICS PVT.LTD, 27.07.2010 Status:Case Approved HQ File :01/82/050/00313/AM11/ RLA File :34/24/040/00238/AM10/ Lic.No/Date:3410026789 08.04.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/51/2010‐PI (Norms) dated 29.06.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Sciff’s Base Hydrazine Carboximidamide 2(Cyano(2,3‐ Dichlorophenyl)Methylene)‐2Z (Cas No.84689 20‐3) or Hydrazine 1 kg 1. 2,3 Dichloro Benzoyl Chloride 1.67 kg 2. Amino Guanidine Bi Carbonate 1.06 kg 89
Case No.:116/9/82‐ALC4/2010
Party Name:CENTAUR PHARMACEUTICALS PVT. LTD., 27.07.2010 Status:Case Approved HQ File :01/82/050/00331/AM11/ RLA File :03/94/040/01146/AM10/ Lic.No/Date:0310569551 15.04.2010
Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No. 14010/58/2009/Ch.II dated 13.10.2009 and in consultaon with technical authority present in meeng, decided to rafy 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‐Chloracetamido‐2‐Chloro‐5‐Nitro Benzaphenone (Chloroacetamido compound) 1 Kg. 1. 2‐Amino‐5‐Nitro 2‐Chloro Benzophenone 0.816 kg 90
Case No.:118/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00333/AM11/ RLA File :03/94/040/00002/AM11/ Lic.No/Date:0310569755 16.04.2010 Defer Date:21.09.2010 91
Case No.:104/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00319/AM11/ RLA File :03/94/040/00073/AM11/ Lic.No/Date:0310570345 20.04.2010 Defer Date:21.09.2010 92
Case No.:1/5/82‐ALC4/2010
Party Name:PORUS LABORATORIES PVT LTD. 27.07.2010 Status:Case Approved HQ File :01/82/050/00035/AM11/ RLA File :09/24/040/00529/AM10/ Lic.No/Date:0910041750 21.04.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/3/2010‐Ch.II dated 17.05.2010 and in consultaon with technical authority present in meeng, decided to rafy 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‐Phenyl‐3,3Bis(4 Hydroxy Phenyl) Phthalimidine (PPPBP) 1 kg. 1. Phthalic Anhydride 0.550 kg 2. Phenol 0.850 kg 3. Zinc Chloride 0.420 kg 4. Aniline 0.420 kg 5. Methanol 1.350 kg
93
Case No.:3/5/82‐ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00037/AM11/ RLA File :03/94/040/01130/AM10/ Lic.No/Date:0310570607 21.04.2010 Defer Date:21.09.2010 94
Case No.:4/5/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 27.07.2010 Status:Case Approved HQ File :01/82/050/00038/AM11/ RLA File :09/24/040/00554/AM10/ Lic.No/Date:0910041759 22.04.2010 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 35/82 meeng held on 01.01.2008 and in consultaon with technical authority present in meeng, decided to rafy 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 Benzhydryl Thioacetamide 1 kg. 1. Hydro Bromic Acid Powder 1.87 kg 2. Thio Urea 0.45 kg 3. Benzhydrol 0.99 kg 4. Methanol 0.30 kg 5. 2‐Chloro Acetamide 0.50 kg 95
Case No.:6/5/82‐ALC4/2010
Party Name:INTAS PHARMACEUTICALS LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00040/AM11/ RLA File :08/24/040/00024/AM11/ Lic.No/Date:0810088431 22.04.2010 Defer Date:21.09.2010 96
Case No.:7/5/82‐ALC4/2010
27.07.2010 Status:Case Approved HQ File :01/82/050/00041/AM11/ RLA File :09/24/040/00013/AM11/ Lic.No/Date:0910041764 22.04.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/47/2010‐PI (Norms) dated 29.06.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 Cephalothin Sodium 1 Kg. 1. 7‐ACA 0.825 kg
p Sterile USP/BP g g 2. 2‐Ethyl Hexanoic Acid 0.536 kg 3. Triethylamine 0.36 kg 4. 2‐Thiophene Acetyl Chloride (Thiophene‐2‐ acetyl Chloride) 0.54 kg 5. Carbon Enoancromos (Acvated Carbon) 0.100 kg 6. Acetone 0.83 kg 7. Methylene Chloride 5.05 kg 8. Aluminium Canisters As per packing Policy 97
Case No.:8/5/82‐ALC4/2010
27.07.2010 Status:Case Approved HQ File :01/82/050/00042/AM11/ RLA File :09/24/040/00016/AM11/ Lic.No/Date:0910041765 22.04.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of Pharmaceucals vide their O.M. No.35011/47/2010‐PI (Norms) dated 29.06.2010 and in consultaon with technical authories present in meeng, decided to rafy 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 Pivmecillinam Hydrochloride 1 Kg. 1. 6‐APA 1.09 kg 2. Carbon Enoancromos (Acvated Carbon) 0.020 kg 3. Di‐isopropyl Ether (Iso Propyl Ether) 2.85 kg 4. Dimethyl Formamide 0.86 kg 5. Hexmethyleneimine 0.42 kg 6. Iso Propyl Alcohol 1.75 kg 7. Methanol 2.34 kg 8. Methylene Chloride 4.38 kg 9. Pivaloyl Chloride 0.69 kg 10. Potassium Carbonate 0.116 kg 11. Triethylamine 1.32 kg 98
Case No.:121/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00336/AM11/ RLA File :03/94/040/00082/AM11/ Lic.No/Date:0310570681 22.04.2010 Defer Date:21.09.2010
99
Case No.:12/5/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 27.07.2010 Status:Case Approved HQ File :01/82/050/00046/AM11/ RLA File :09/24/040/00563/AM10/ Lic.No/Date:0910041793 23.04.2010 Decision :Commi쏧ee considered case as per agenda and in consultaon with technical authority present in meeng decided to rafy norms under para 4.7 of HBP as applied by the firm with nil wastage. 100
Case No.:13/5/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00047/AM11/ RLA File :09/24/040/00003/AM11/ Lic.No/Date:0910041794 23.04.2010 Defer Date:21.09.2010 101
Case No.:102/9/82‐ALC4/2010
Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 27.07.2010 Status:Case Deferred HQ File :01/82/050/00317/AM11/ RLA File :05/23/040/00011/AM11/ Lic.No/Date:0510263007 26.04.2010 Defer Date:21.09.2010 102
Case No.:127/9/82‐ALC4/2010
Party Name:ENCUBE ETHICALS PVT LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00342/AM11/ RLA File :03/94/040/00039/AM11/ Lic.No/Date:0310571312 26.04.2010 Defer Date:21.09.2010 Decision :Commi쏧ee decided to remind the firm to furnish copy of DML containing list of approved items. Accordingly, case was deferred for 21.09.2010. 103
Case No.:123/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00338/AM11/ RLA File :03/94/040/00094/AM11/ Lic.No/Date:0310571485 27.04.2010 Defer Date:21.09.2010 104
Case No.:120/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred
HQ File :01/82/050/00335/AM11/ RLA File :03/94/040/00103/AM11/ Lic.No/Date:0310572042 29.04.2010 Defer Date:21.09.2010 105
Case No.:122/9/82‐ALC4/2010
27.07.2010 Status:Case Deferred HQ File :01/82/050/00337/AM11/ RLA File :03/94/040/00110/AM11/ Lic.No/Date:0310572497 03.05.2010 Defer Date:21.09.2010 106
Case No.:30/9/82‐ALC4/2010
Party Name:RA CHEM PHARMA LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00245/AM11/ RLA File :09/24/040/00007/AM11/ Lic.No/Date:0910042036 14.05.2010 Defer Date:21.09.2010 107
Case No.:137/9/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 27.07.2010 Status:Case Deferred HQ File :01/82/050/00352/AM11/ RLA File :05/24/040/00048/AM11/ Lic.No/Date:0510264575 19.05.2010 Defer Date:21.09.2010 108
Case No.:138/9/82‐ALC4/2010
Party Name:PROMED EXPORTS PVT.LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00353/AM11/ RLA File :05/24/040/00062/AM11/ Lic.No/Date:0510264578 19.05.2010 Defer Date:21.09.2010 Decision : Commi쏧ee considered case as per agenda and observed that the firm had obtained Advance Authorisaon for export of two export product viz. Tropicamide Eye Drops 0.5% and Tropicamide Eye Drops 1%, while they have sought combined quanty of input viz. Tropicamide USP. It was, therefore, decided to ask the firm to bifurcate the quanty of export product and also to bifurcate the quanty of input applied by them against each export product. Accordingly, case was deferred for 21.09.2010. 109
Case No.:1/17/82‐ALC4/2010
Party Name:PROMED EXPORTS PVT.LTD. 27.07.2010 Status:Case Deferred HQ File :01/82/050/00535/AM11/ RLA File :05/24/040/00137/AM11/ Lic.No/Date:0510267953 12.07.2010 Defer Date:21.09.2010 Decision : Commi쏧ee considered case as per agenda and observed that the firm had obtained Advance Authorisaon for export of two export product viz. Tropicamide
Eye Drops 0.5% and Tropicamide Eye Drops 1%, while they have sought combined quanty of input viz. Tropicamide USP. It was, therefore, decided to ask the firm to bifurcate the quanty of export product and also to bifurcate the quanty of input applied by them against each export product. Accordingly, case was deferred for 21.09.2010. 110
Case No.:2/17/82‐ALC4/2010
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 27.07.2010 Status:Case Deferred HQ File :01/82/050/00536/AM11/ RLA File :07/24/040/00101/AM11/ Lic.No/Date:0710072862 13.07.2010 Defer Date:21.09.2010 111
Case No.:3/17/82‐ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 27.07.2010 Status:Case Deferred HQ File :01/82/050/00537/AM11/ RLA File :05/24/040/00142/AM11/ Lic.No/Date:0510268095 13.07.2010 Defer Date:21.09.2010 112
Case No.:4/17/82‐ALC4/2010
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 27.07.2010 Status:Case Deferred HQ File :01/82/050/00538/AM11/ RLA File :05/24/040/00144/AM11/ Lic.No/Date:0510268096 13.07.2010 Defer Date:21.09.2010 113
Case No.:5/17/82‐ALC4/2010
Party Name:PI INDUSTRIES LTD., 27.07.2010 Status:Case Deferred HQ File :01/82/050/00539/AM11/ RLA File :13/24/040/00017/AM11/ Lic.No/Date:1310032717 13.07.2010 Defer Date:21.09.2010 114
Case No.:7/17/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 27.07.2010 Status:Case Approved HQ File :01/82/050/00541/AM11/ RLA File :34/24/040/00085/AM11/ Lic.No/Date:3410027502 13.07.2010 Decision : Commi쏧ee considered case as per agenda and in light of earlier decision taken in 50/82 meeng held on 09.03.2010 and in consultaon with technical authority present in meeng, decided to rafy 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
Alendronate Tablets 70 mg 1 No. 1. Alendronate Sodium 91.3626 mg/tablet 115
Case No.:6/17/82‐ALC4/2010
Party Name:ANUS LABORATORIES LTD., 27.07.2010 Status:Case Approved HQ File :01/82/050/00540/AM11/ RLA File :09/24/040/00055/AM11/ Lic.No/Date:0910042682 14.07.2010 Decision : Commi쏧ee considered case as per agenda and in light of wri쏧en comments forwarded by Department of C&PC vide their U.O. No.14010/56/2010‐Ch.II dated 21.06.2010 and in consultaon with technical authority present in meeng, decided to rafy 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 Sodium Methoxide Soluon 30% 1 Kg. 1. Methanol 0.622 kg 2. CS Flakes 0.050 kg 116
Case No.:8/17/82‐ALC4/2010
Party Name:HETERO LABS LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00542/AM11/ RLA File :09/24/040/00148/AM11/ Lic.No/Date:0910042685 14.07.2010 Defer Date:21.09.2010 117
Case No.:9/17/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 27.07.2010 Status:Case Deferred HQ File :01/82/050/00543/AM11/ RLA File :34/24/040/00087/AM11/ Lic.No/Date:3410027529 16.07.2010 Defer Date:21.09.2010 Issue of Non‐Infringing Process: The Commi쏧ee discussed the issue of non‐infringing process wrt DO le쏧er dt.23.7.2010 from Shri Rajeev Kher, Jt. Secretary, Department of Commerce. The Commerce Secretary had convened a meeng with PHARMEXCIL and Pharma Industry representaves on July 1, 2010. During the discussion, it had been argued that the DGFT could use the declaraons made by the applicant producer in the Drug Master File(DMF)submi쏧ed to US FDA or FDAs of other regulated markets in respect of actual consumpon of inputs for fixaon of input‐output Norms. DGFT has been asked to examine the Industry’s proposal for using DMF data construcvely so that a large number of pending cases could be disposed of on priority.
2. The Commi쏧ee felt that India is not exploing its full potenal especially in developed market like USA. These markets are not only highly regulated but have addional barriers of product patent and processes for the product process with life of a longer period. In order to enter these markets upon expiry of the basic patent, it is necessary to develop innovave process which may not be cost effecve and therefore results in less yields and higher raw‐material consumpon. Therefore, higher norms are required for export of such products. However, because of regulatory controls and significant R&D capability required, only a few large scale pharma companies in the Country are equipped to use non‐infringing process and that too for some of the pharma products only. It was felt that entry for these products in USA would enhance goodwill and technical capabilies of such companies and promote India Brand. 3. In the meeng, the representave of Department of Pharmaceucal raised their concerns on the issue. The concern raised by Member, Pharma in brief are as under:‐ (a) Whereas the norms nofied under SION were based on the most compeve data and opmum norms derived by comparison of data from other manufacturers/exporters, the process through non‐infringing process has no comparison and there are no SIONs for this category. (b) There is also no way to verify the veracity of claim of non‐infringing process with the tools at our disposal. (c) Monitoring of such exports as claimed by firms by way of a non‐infringing process will be difficult and out of scope of this office. (d) If the request for higher norms for non‐infringing process is granted, then there will be different norms for each company using same or different non‐infringing process for the same export product for different countries for the same export. (e) Country of export and value addion (other than now nofied a minimum 15% in FTP 2009) have no bearing on the quantave requirement of inputs in the FTP. 4. A챦er taking into consideraon concerns of members, the Commi쏧ee decided to made following recommendaons to DGFT for giving thrust to exports of Pharma to regulated markets. (a) The Commi쏧ee has recommended that the applicant company will have to produce a Chartered Engineer’s cerficate about the minimum requirement of essenal inputs on the basis of DMF in each applicaon for authorizaon. (b) Monitoring of exports is required to be done by a Regional Authority of DGFT for which the procedures are already in place including submission of Appendix 23 at the me of discharge of Export Obligaon. (c) Commi쏧ee will consider case of non‐infringing process of Star Export Houses or in respect of units with minimum investment of 100 crores. (d) Commi쏧ee will be free to relax any of the above condions and/or prescribe condion a챦er stang reason with a view to facilitate genuine export & prevent misuse. (e) The Commi쏧ee will clear each case only a챦er sasfying itself about export product, the Country of export, Chartered Engineer Cerficate showing essenal raw‐ materials required as per DMF in each case. 5. As regards pending cases of M/s. Lupin Ltd. referred to in the D.O. le쏧er, the Commi쏧ee felt that we will need excise cerfied producon and consumpon data and chartered engineer’s cerficates cerfying essenality of consumpon of raw materials as per DMF. The minutes in this case would be submi쏧ed to DGFT for his approval.
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