DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 11/82‐ALC4/2010 MEETING DATE : 15.06.2010 The MeeƟng No.11/82 in the year 2010‐11 to consider the cases under Duty ExempƟon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 15.06.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Shaish Kumar, IA, DIPP 2. Shri Jasbir Singh, I.A., Department of C&PC 3. Shri D.N. Mathur, Dy. IA, Department of PharmaceuƟcals 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms CommiƩee MeeƟng No. 8/82 dated 25.05.2010 were raƟfied by the CommiƩee.
Case No.B‐109
M/S Blue Circle Speciality Chemicals Pvt. Ltd. Norms CommiƩee MeeƟng No.11/11 F.No.01/83/050/00723/AM08 F.No.01/83/050/00656/AM08 MeeƟng Date:15.06.2010 RA F.No.03/94/040/00116/AM08 RA F.No.03/94/040/00288/AM07 Adv.Lic.No.0310432127 dated 08.06.2007 Adv.Lic.No.0310434322 dated 28.06.2007 CommiƩee considered case as per agenda and in light of earlier decision taken in 7/08 meeƟng held on 23.05.2007 in the case of M/S Blue Circle CorporaƟon, decided to enhance the quanƟty of input namely Isophthalic Acid to the extent of 2.06 kg/kg of export product without any other change in the decision taken in 34/83 meeƟng held on 28.11.2007. RA concerned may take further necessary acƟon as per above decision of NC.
Case No.B‐110
M/S Sudershan Laboratories Ltd. Norms CommiƩee MeeƟng No.11/11 F.No.01/82/050/00545/AM08 F.No.01/82/050/00597/AM08 F.No.01/82/050/00145/AM09 F.No.01/82/050/00464/AM09 F.No.01/82/050/00465/AM09
MeeƟng Date:15.06.2010 RA F.No.09/24/040/00476/AM08 RA F.No.09/24/040/00523/AM08 RA F.No.09/24/040/00549/AM08 RA F.No.09/24/040/00002/AM09 RA F.No.09/24/040/00025/AM09 Adv.Lic.No.0910032726 dated 24.01.2008 Adv.Lic.No.0910033012 dated 19.02.2008 Adv.Lic.No.0910033166 dated 03.03.2008 Adv.Lic.No.0910033607 dated 09.04.2008 Adv.Lic.No.0910033864 dated 12.05.2008 CommiƩee considered case as per agenda and in light of earlier decision taken in 38/82 meeƟng held on 23.02.2010 in the case of M/S Sainor Laboratories Pvt. Ltd and in consultaƟon with technical authority present in meeƟng, 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 N‐Butyl Lithium (15% w/w in n‐ Hexane (100% AcƟve Basis) 1 Kg. 1. Lithium Metal 0.300 kg 2. n‐Butyl Chloride 1.60 kg 3. n‐Hexane 6.66 kg
Case No.B‐111
M/S Anuh Pharma Ltd. Norms CommiƩee MeeƟng No.11/11 F.No.01/82/050/00582/AM09 MeeƟng Date:15.06.2010 RA F.No.03/94/040/00045/AM09 Adv.Lic.No.0310473788 dated 09.06.2008 CommiƩee considered case as per agenda and observed that there was a mistake in recording of minutes and the item Erythromycin Thiocyanate is imported in KGA only. It was, therefore, decided to amend the descripƟon and quanƟty import item to read as “Erythromycin Thiocyanate – 1.55 KGA” without any other change in the decision taken in 18/82 meeƟng held on 29.07.2008.
Case No.B‐112
M/S Alembic Ltd. Norms CommiƩee MeeƟng No.11/11 F.No.01/87/050/01154/AM06 MeeƟng Date:15.06.2010 RA F.No.34/24/040/00215/AM06 Adv.Lic.No.3410015102 dated 30.12.2005
CommiƩee considered case as per agenda and in light of earlier decision taken in 27/81 meeƟng held on 11.10.2006 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Benzyl Penicillin 5 Mega Inj. 1 lakh Vials 1. Benzyl Penicillin Sodium BP Grade 475.58 BOU Benzyl Penicillin 2 Mega Inj 1lakh Vials 1. Benzyl Penicillin Sodium BP Grade 190.33 BOU Benzyl Penicillin 1 Mega Inj 1 lakh Vials 1. Benzyl Penicillin Sodium BP Grade 94.453 BOU
Case No.B‐113
M/S Esteem Industries Pvt. Ltd. Norms CommiƩee MeeƟng No.11/11 F.No.01/82/050/00569/AM08 MeeƟng Date:15.06.2010 RA F.No.17/24/040/00117/AM08 Adv.Lic.No.1710001672 dated 20.06.2007 CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to call for the following informaƟon from the firm:‐ 1. Chemical name of the export product. 2. Details of manufacturing process with Chemical equaƟons, molecular formula and molecular weight. 3. Yield obtained in each stage. 4. ProducƟon and ConsumpƟon data cerƟfied by Chartered Accountant. Accordingly, case was deferred for 10.08.2010.
Case No.B‐114
M/S IPCA Labs Ltd. Norms CommiƩee MeeƟng No.11/11 F.No.01/83/050/00027/AM08 MeeƟng Date:15.06.2010 RA F.No.03/94/040/01455/AM07 Adv.Lic.No.0310425428 dated 02.04.2007 CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng decided to amend the descripƟon of export product to read as “6 Methoxy‐2‐Naphthaldehyde” without any other change in the decision taken in 19/08 meeƟng held on 11.09.2007.
1
Case No.:2/32/82‐ALC4/2008
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED Meet No/Date:11/82‐ALC4/2010 15.06.2010 Status: Case Approved HQ File :01/82/050/01177/AM09/ RLA File :03/94/040/00998/AM08/ Lic.No/Date:0310491143 20.10.2008 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/39/2009‐Ch.II dated 14.06.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Saccharin 1 Kg. 1. Ortho Toluene Sulphonamide 0.927 kg 2. Sulphur 0.200 kg 2
Case No.:29/41/82‐ALC4/2008
Party Name:ARCH PHARMALABS LTD Meet No/Date:11/82‐ALC4/2010 15.06.2010 Status:Case Deferred HQ File :01/82/050/01469/AM09/ RLA File :03/94/040/00752/AM09/ Lic.No/Date:0310493255 06.11.2008 Defer Date:10.08.2010 Decision :CommiƩee considered case as per agenda. The representaƟves of the firm appeared for personal hearing before the CommiƩee and explained basis. The technical authority present in the meeƟng asked the representaƟve of the firm to indicate TheoraƟcal, pracƟcal and yield obtained on molar basis correctly and the representaƟve of the firm agreed to furnish the same with 15 days. It was, therefore, decided to defer the case for 10.08.2010. 3
Case No.:1/40/82‐ALC4/2008
Party Name:INTAS PHARMACEUTICALS LTD., 15.06.2010 Status:Case Deferred HQ File :01/82/050/01420/AM09/ RLA File :08/24/040/00187/AM09/ Lic.No/Date:0810076754 16.12.2008 Defer Date:10.08.2010 Decision :CommiƩee considered case as per agenda and observed that the firm was requested to furnish the copy of Master Batch Formula, but they have furnished the copy of Master Batch Record. It was, therefore, decided to call for again the copy of Master Batch Formula and defer the case for 10.08.2010. 4
Case No.:27/42/82‐ALC4/2008
15.06.2010 Status: Case Deferred HQ File :01/82/050/01505/AM09/ RLA File :03/94/040/00904/AM09/ Lic.No/Date:0310501134 05.01.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda. The representaƟves of the firm appeared for personal hearing before the CommiƩee and explained basis. The technical authority present in the meeƟng asked the representaƟve of the firm to indicate TheoraƟcal, pracƟcal and yield obtained on molar basis correctly and the representaƟve of the firm agreed to furnish the same with 15 days. It was, therefore, decided to defer the case for 10.08.2010. 5
Case No.:28/42/82‐ALC4/2008
Status: Case
15.06.2010 Deferred HQ File :01/82/050/01506/AM09/ RLA File :03/94/040/00920/AM09/ Lic.No/Date:0310501141 05.01.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda. The representaƟves of the firm appeared for personal hearing before the CommiƩee and explained basis. The technical authority present in the meeƟng asked the representaƟve of the firm to indicate TheoraƟcal, pracƟcal and yield obtained on molar basis correctly and the representaƟve of the firm agreed to furnish the same with 15 days. It was, therefore, decided to defer the case for 10.08.2010. 6
Case No.:55/18/82‐ALC4/2009
15.06.2010 Status: Case Deferred HQ File :01/82/050/00329/AM10/ RLA File :03/94/040/00949/AM09/ Lic.No/Date:0310503316 21.01.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda. The representaƟves of the firm appeared for personal hearing before the CommiƩee and explained basis. The technical authority present in the meeƟng asked the representaƟve of the firm to indicate TheoraƟcal, pracƟcal and yield obtained on molar basis correctly and the representaƟve of the firm agreed to furnish the same with 15 days. It was, therefore, decided to defer the case for 10.08.2010. 7
Case No.:9/2/82‐ALC4/2009
15.06.2010 Status:Case Deferred HQ File :01/82/050/00009/AM10/ RLA File :03/94/040/01131/AM09/ Lic.No/Date:0310514341 02.04.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda. The representaƟves of the firm appeared for personal hearing before the CommiƩee and explained basis. The technical authority present in the meeƟng asked the representaƟve of the firm to indicate TheoraƟcal, pracƟcal and yield obtained on molar basis correctly and the representaƟve of the firm agreed to furnish the same with 15 days. It was, therefore, decided to defer the case for 10.08.2010. 8
Case No.:66/18/82‐ALC4/2009
Party Name:CORVINE CHEMICALS & PHARMACEUTICALS LIMITED, 15.06.2010 Status: Case Deferred HQ File :01/82/050/00340/AM10/ RLA File :07/24/040/00009/AM10/ Lic.No/Date:0710064113 13.04.2009 Defer Date:10.08.2010 Decision :CommiƩee decided to defer case for 10.08.2010 for comments of Department of C&PC. 9
Case No.:14/5/82‐ALC4/2009
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00047/AM10/ RLA File :04/24/040/00002/AM10/ Lic.No/Date:0410104217 24.04.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments of Department of PharmaceuƟcals and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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
GapapenƟn 1 Kg. 1. 1,1‐Cyclohexane DiaceƟc Acid Monamide 1.765 kg 2. Methanol 0.445 kg 3. Toluene 0.890 kg 4. Isopropyl Alcohol 2.165 kg 5. CausƟc Soda Flakes 0.785 kg 10
Case No.:20/18/82‐ALC4/2009
15.06.2010 Status: Case Deferred HQ File :01/82/050/00294/AM10/ RLA File :03/94/040/00087/AM10/ Lic.No/Date:0310524765 18.06.2009 Defer Date:10.08.2010.2010 Decision : CommiƩee considered case as per agenda. The representaƟves of the firm appeared for personal hearing before the CommiƩee and explained basis. The technical authority present in the meeƟng asked the representaƟve of the firm to indicate TheoraƟcal, pracƟcal and yield obtained on molar basis correctly and the representaƟve of the firm agreed to furnish the same with 15 days. It was, therefore, decided to defer the case for 10.08.2010. 11
Case No.:4/17/82‐ALC4/2009
Party Name:SARAF CHEMICALS LTD. 15.06.2010 Status: Case Deferred HQ File :01/82/050/00267/AM10/ RLA File :03/95/040/00207/AM10/ Lic.No/Date:0310527468 06.07.2009 Defer Date:10.08.2010 Decision :CommiƩee considered case as per agenda. The representaƟve of Department of C&PC informed the CommiƩee that the export product is Drug. It was, therefore, decided to forward a copy of applicaƟon to Department of PharmaceuƟcals for their comments. Accordingly, case was deferred for 10.08.2010. 12
Case No.:7/17/82‐ALC4/2009
Party Name:LAKE CHEMICALS PRIVATE LIMITED 15.06.2010 Status: Case Deferred HQ File :01/82/050/00270/AM10/ RLA File :07/24/040/00051/AM10/ Lic.No/Date:0710065810 07.07.2009 Defer Date:10.08.2010.2010 Decision :CommiƩee decided to defer case for 10.08.2010 for comments of Department of PharmaceuƟcals. 13
Case No.:82/18/82‐ALC4/2009
Party Name:LUPIN LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00356/AM10/ RLA File :03/95/040/00079/AM10/ Lic.No/Date:0310529028 16.07.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/296/2009‐PI (Norms) dated 18.05.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. The non‐infringing process has not been taken into consideraƟon in raƟficaƟon of norms:‐
Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefotoxime Sodium (Non‐ Infringing) 1 kg 1. 7‐Amino Cephalosporanic Acid 0.741 kg 2. Ethyl Acetate 5.94 kg 3. Tetra Hydrofuran 2.66 kg 4. Methylene Chloride 6.84 kg 5. Isopropyl Alcohol 0.35 kg 6. Sodium 2‐Ethy Hexanoate 0.40 kg 7. Hexamethyl Disilazane 0.360 kg 8. Methanol 0.83 kg 9. Phosphorous Pentachloride 0.5968 kg 10. Trimethtyl Amine 0.410 kg 11. AcƟvated Carbon 0.100 kg 12. Trimethyl Chlorosilane 0.1796 kg 13. Sodium Hydrosulphite 0.060 kg 14. 4‐Bromo‐2‐Methoxyimino‐3‐oxo Butyric Acid (Bromo Acid) 0.6596 kg 15. Aluminium Containers As per packing policy 14
Case No.:15/29/82‐ALC4/2009
Party Name:AUROBINDO PHARMA LIMITED 15.06.2010 Status:Case Deferred HQ File :01/82/050/00585/AM10/ RLA File :09/24/040/00006/AM10/ Lic.No/Date:0910038659 23.07.2009 Defer Date:10.08.2010 Decision :CommiƩee decided to forward a copy of applicaƟon to Department of PharmaceuƟcals for their comments. Accordingly, the case was deferred for 10.08.2010. 15
Case No.:3/19/82‐ALC4/2009
Party Name:AVENTIS PHARMA LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00381/AM10/ RLA File :03/94/040/00134/AM10/ Lic.No/Date:0310530972 28.07.2009 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Trental 100 mg Film Coated Tablets 60s 1 No. 1. Theobromine 91.8 mg Trental 400 mg Film Coated Tablets 20s 1 No. 1. Theobromine 367.2 mg
16
Case No.:102/46/82‐ALC4/2009
Party Name:MSN LABORATORIES LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/01018/AM10/ RLA File :09/24/040/00211/AM10/ Lic.No/Date:0910039292 11.09.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/16/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Eplerenone 1 kg 1. Pregna‐4,9(11)‐Diene‐7,21‐Dicarboxylic Acid 17‐ Hydroxy‐3‐oxo,G‐Lactone, Methyl Ester, (7A,17A) 1.764 kg 17
Case No.:33/46/82‐ALC4/2009
Party Name:KORES (INDIA) LTD. 15.06.2010 Status:Case Approved HQ File :01/82/050/00949/AM10/ RLA File :03/94/040/00418/AM10/ Lic.No/Date:0310537562 14.09.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/1/2010‐PI (Norms) dated 09.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Caffeine Anhydrous EP/BP 1 kg 1. Crude Theophylline (Wet) NLT 80% W/W 1.15 kg 18
Case No.:46/46/82‐ALC4/2009
Party Name:TADIMETY AROMATICS PVT. LTD 15.06.2010 Status:Case Deferred HQ File :01/82/050/00962/AM10/ RLA File :07/24/040/00221/AM10/ Lic.No/Date:0710067059 17.09.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to call for the following informaƟon from the firm:‐ 1. Chemical name of the export product. 2. Details of manufacturing process with Chemical equaƟons, molecular formula and molecular weight.
3. Yield obtained in each stage. 4. ProducƟon and ConsumpƟon data cerƟfied by Chartered Accountant. Accordingly, case was deferred for 10.08.2010. 19
Case No.:88/5/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 15.06.2010 Status:Case Deferred HQ File :01/82/050/00122/AM11/ RLA File :22/24/040/00025/AM10/ Lic.No/Date:2210009273 17.09.2009 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of PharmaceuƟcals. 20
Case No.:89/5/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 15.06.2010 Status:Case Deferred HQ File :01/82/050/00123/AM11/ RLA File :22/24/040/00027/AM10/ Lic.No/Date:2210009272 17.09.2009 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of PharmaceuƟcals. 21
Case No.:6/28/82‐ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 15.06.2010 Status:Case Deferred HQ File :01/82/050/00566/AM10/ RLA File :05/24/040/00275/AM10/ Lic.No/Date:0510249610 18.09.2009 Defer Date:10.08.2010 Decision :CommiƩee decided to call for a copy of applicaƟon, copy of DML and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 10.08.2010. 22
Case No.:90/5/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 15.06.2010 Status:Case Deferred HQ File :01/82/050/00124/AM11/ RLA File :22/24/040/00030/AM10/ Lic.No/Date:2210009293 25.09.2009 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of PharmaceuƟcals. 23
Case No.:3/29/87‐ALC1/2009
Party Name:PARABOLIC DRUGS LTD., 15.06.2010 Status:Case Deferred HQ File :01/87/050/00216/AM10/ RLA File :05/24/040/00302/AM10/ Lic.No/Date:0510250358 06.10.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/380/2009‐PI (Norms) dated 04.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to call for technical details as per
Appendix 33 from firm. Accordingly, case was deferred for 10.08.2010. 24
Case No.:10/30/82‐ALC4/2009
Party Name:INTAS PHARMACEUTICALS LTD., 15.06.2010 Status:Case Deferred HQ File :01/82/050/00611/AM10/ RLA File :08/24/040/00174/AM10/ Lic.No/Date:0810083512 12.10.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda and observed that the firm was requested to furnish the copy of Master Batch Formula, but they have furnished the copy of Master Batch Record. It was, therefore, decided to call for again the copy of Master Batch Formula and defer the case for 10.08.2010. 25
Case No.:49/34/83‐ALC1/2009
Party Name:SPAN DIAGNOSTICS LTD 15.06.2010 Status:Case Deferred HQ File :01/83/050/00634/AM10/ RLA File :52/24/040/00014/AM10/ Lic.No/Date:5210028574 13.10.2009 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of Bio‐technology. 26
Case No.:50/34/83‐ALC1/2009
Party Name:SPAN DIAGNOSTICS LTD 15.06.2010 Status:Case Deferred HQ File :01/83/050/00635/AM10/ RLA File :52/24/040/00015/AM10/ Lic.No/Date:5210028575 13.10.2009 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of Bio‐technology. 27
Case No.:47/39/83‐ALC1/2009
Party Name:SPAN DIAGNOSTICS LTD 15.06.2010 Status:Case Deferred HQ File :01/83/050/00754/AM10/ RLA File :52/24/040/00016/AM10/ Lic.No/Date:5210028576 13.10.2009 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of Bio‐technology. 28
Case No.:74/5/82‐ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 15.06.2010 Status:Case Deferred HQ File :01/82/050/00108/AM11/ RLA File :09/24/040/00203/AM10/ Lic.No/Date:0910039636 16.10.2009 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of PharmaceuƟcals. 29
Case No.:70/5/82‐ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 15.06.2010 Status:Case Deferred Lic.No/Date:0910039743
HQ File :01/82/050/00104/AM11/ RLA File :09/24/040/00228/AM10/ 28.10.2009 Defer Date:10.08.2010 Decision :CommiƩee decided to forward a copy of applicaƟon to Department of PharmaceuƟcals for their comments. Accordingly, case was deferred for 10.08.2010. 30
Case No.:44/46/82‐ALC4/2009
Party Name:TORRENT PHARMACEUTICALS LTD. 15.06.2010 Status:Case Approved HQ File :01/82/050/00960/AM10/ RLA File :08/24/040/00186/AM10/ Lic.No/Date:0810083867 04.11.2009 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Bisoprolol Fumarate and Hydrochlorothiazide Tablet Comp. Heumann 5/12.5 mg 1 No. 1. Bisoprolol Fumarate 5.1 mg Bisoprolol Fumarate and Hydrochlorothiazide Tablet Comp. Heumann 10/25 mg 1 No. 1. Bisoprolol Fumarate 10.2 mg 31
Case No.:45/34/82‐ALC4/2009
Party Name:OMKAR SPECIALITY CHEMICALS PVT. LTD. 15.06.2010 Status:Case Deferred HQ File :01/82/050/00690/AM10/ RLA File :03/95/040/00486/AM10/ Lic.No/Date:0310544624 09.11.2009 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of PharmaceuƟcals. 32
Case No.:39/48/82‐ALC4/2009
Party Name:RELIANCE LIFE SCIENCES PVT. LTD. 15.06.2010 Status:Case Approved HQ File :01/82/050/01102/AM10/ RLA File :03/95/040/00475/AM10/ Lic.No/Date:0310544816 10.11.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/18/2010‐PI (Norms) dated 09.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Estradiol Hemehydrate 1 kg 1. Estrone 1.706 kg 33
Case No.:99/5/82‐ALC4/2010
Party Name:IND‐SWIFT LABORATORIES LTD., Status:Case
15.06.2010 Deferred HQ File :01/82/050/00133/AM11/ RLA File :22/24/040/00038/AM10/ Lic.No/Date:2210009406 11.11.2009 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of PharmaceuƟcals. 34
Case No.:96/46/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 15.06.2010 Status:Case Deferred HQ File :01/82/050/01012/AM10/ RLA File :09/24/040/00268/AM10/ Lic.No/Date:0910039892 12.11.2009 Defer Date: Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/324/2009‐PI (Norms) dated 18.05.2010 and in consultaƟon with technical authority present in meeƟng, decided to call for the following informaƟon from the firm:‐ 1. Molecular weight of each input and output product at each step. 2. Percentage yield on molar basis for each step. 3. Material balance for enƟre process for a batch. Accordingly, case was deferred for 35
Case No.:105/46/82‐ALC4/2009
Party Name:AUROBINDO PHARMA LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/01021/AM10/ RLA File :09/24/040/00308/AM10/ Lic.No/Date:0910039941 17.11.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/12/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Lamivudine 1 kg 1. n‐hexane 4.534 kg 2. Acetone 0.309 kg 3. Carbon EnoanƟcromos (AcƟvated Carbon) 0.100 kg 4. Methylene Chloride 10.439 kg 5. 2,5‐dihydroxy,1,4‐dithiane 0.739 kg 6. Cytosine 0.955 kg 7. Methyl Alcohol (Methanol) 1.235 kg 8. Sodium Borohydride 0.480 kg 9. Triethylamine (TEA) 2.00 kg 10. Trimethtyl Chlorosilane (TMCS) 2.74 kg 11. Dimethyl Formamide 0.410 kg
Glyoxalic Acid 50% 1.80 kg 13. Cyclohexane 0.100 kg 14. Steam/Thermal Coal As per Fuel Policy 36
Case No.:62/48/82‐ALC4/2009
Party Name:CIPLA LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/01125/AM10/ RLA File :03/94/040/00698/AM10/ Lic.No/Date:0310546317 18.11.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/15/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Prednisilone Tablets JP 5 mg 1 No. 1. Prednisolone 5.10 mg 2. GelaƟn 1.90 mg 3. Lactose Hydrate 72.60 mg 37
Case No.:39/46/82‐ALC4/2009
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 15.06.2010 Status:Case Deferred HQ File :01/82/050/00955/AM10/ RLA File :07/24/040/00273/AM10/ Lic.No/Date:0710068432 20.11.2009 Defer Date:10.08.2010 Decision :CommiƩee decided to forward a copy of applicaƟon to Department of PharmaceuƟcals for their comments. Accordingly, case was deferred for 10.08.2010. 38
Case No.:79/46/82‐ALC4/2009
Party Name:EXCEL INDUSTRIES LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00995/AM10/ RLA File :03/94/040/00294/AM10/ Lic.No/Date:0310547023 23.11.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/109/2008‐Ch.II dated 15.06.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Diethylene Triamine Pentamethylene Phosphonic Acid (Code 1 Kg. 1. Yellow Phosphorous 0.135 kg 2. Diethylene Triamine 0.087 kg 3. Formaldehyde (37%) 0.395 kg
45031) (AcƟve Acid Content 48%) 39
Case No.:2/38/82‐ALC4/2009
Party Name:LUPIN LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00775/AM10/ RLA File :03/95/040/00482/AM10/ Lic.No/Date:0310548046 27.11.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/389/2009‐PI (Norms) dated 04.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Benazepril Hcl USP 1 kg 1. 3S‐Amino‐1‐N‐Terbutoxycarbonyl (S Amine) 0.8873 kg 2. Methanol 1.65 kg 3. Methylene Chloride 6.45 kg 4. N‐Methyl Morpholine 0.65 kg 5. R‐Ethyl‐2‐Hydroxy‐4‐Phenyl‐Butanoate 0.762 kg 6. 4‐Nitro Benzene Sulfonyl Chloride 0.893 kg 7. Di Isopropyl Ether 4.30 kg 8. AcƟvated Carbon 0.100 kg 9. Triethylamine 0.48 kg 10. Toluene 0.80 kg 11. Ethyl Acetate 4.34 kg 40
Case No.:15/38/82‐ALC4/2009
Party Name:VIVIMED LABS LIMITED 15.06.2010 Status:Case Deferred HQ File :01/82/050/00788/AM10/ RLA File :09/24/040/00362/AM10/ Lic.No/Date:0910040144 03.12.2009 Defer Date:10.08.2010 Decision :CommiƩee considered case as per agenda and decided to call from the firm ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority. Accordingly, case was deferred for 10.08.2010. 41
Case No.:16/38/82‐ALC4/2009
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 15.06.2010 Status:Case Deferred HQ File :01/82/050/00789/AM10/ RLA File :09/24/040/00352/AM10/ Lic.No/Date:0910040145 03.12.2009 Defer Date:15.06.2010
Decision :CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/10/2010‐PI(Norms) dated 10.06.2010, decided to call for the following informaƟon from the firm:‐ 1. Molecular weight of each reactant and output product of each step. 2. Molar requirement of input alongwith technical jusƟficaƟon. 3. Percentage yield on molar basis for each step of manufacturing process. Accordingly, case was deferred for 42
Case No.:22/38/82‐ALC4/2009
Party Name:LAKE CHEMICALS PRIVATE LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00795/AM10/ RLA File :07/24/040/00339/AM10/ Lic.No/Date:0710068661 03.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/390/2009‐PI (Norms) dated 04.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Di Hcl 1 kg 1. 2‐Amino‐5‐Chloro‐2‐Fluoro Benzophenone 1.71 kg 43
Case No.:63/46/82‐ALC4/2009
Party Name:CADILA HEALTHCARE LTD., 15.06.2010 Status:Case Deferred HQ File :01/82/050/00979/AM10/ RLA File :08/24/040/00215/AM10/ Lic.No/Date:0810084676 03.12.2009 Defer Date:10.08.2010 Decision :CommiƩee decided to forward a copy of applicaƟon to Department of PharmaceuƟcals for their comments. Accordingly, case was deferred for 10.08.2010. 44
Case No.:28/38/82‐ALC4/2009
Party Name:PADMINI AROMATICS PVT. LTD 15.06.2010 Status:Case Deferred HQ File :01/82/050/00801/AM10/ RLA File :07/24/040/00335/AM10/ Lic.No/Date:0710068685 04.12.2009 Defer Date:10.08.2010 Decision :CommiƩee considered case as per agenda and observed that the technical informaƟon called for from the firm have been received and the same has been forwarded to Department of C&PC for their comments. Accordingly, case was deferred for 10.08.2010. 45
Case No.:29/38/82‐ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 15.06.2010 Status:Case Deferred HQ File :01/82/050/00802/AM10/ RLA File :05/24/040/00383/AM10/ Lic.No/Date:0510253942 Defer
04.12.2009 Date:10.08.2010 Decision :CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/396/2009‐PI(Norms) dated 07.06.2010, decided to call for technical details as per Appendix 33 from firm. It was also observed that the firm has not submiƩed technical details as per Appendix 33 in several cases received for raƟficaƟon of norms under para 4.7 of HBP. It was, therefore, decided to advise the firm to furnish technical details as per Appendix 33 in each case. It was also decided to call for the details of Advance licences issued from the office of Jt. DGFT, Chandigarh and its details regarding fulfillment of export obligaƟon from firm. Accordingly, case was deferred for 10.08.2010. 46
Case No.:113/46/82‐ALC4/2009
Party Name:MATRIX LABORATORIES LTD 15.06.2010 Status:Case Deferred HQ File :01/82/050/01029/AM10/ RLA File :09/24/040/00216/AM10/ Lic.No/Date:0910040167 04.12.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/14/2010‐PI(Norms) dated 09.06.2010, decided to call for revised applicaƟon from the firm as they have applied for export of intermediate of Efavirenz and also its raw materials. Accordingly, case was deferred for10.08.2010. 47
Case No.:49/46/82‐ALC4/2009
Party Name:MAHAVIR INTERMEDIATES 15.06.2010 Status:Case Deferred HQ File :01/82/050/00965/AM10/ RLA File :52/24/040/00018/AM10/ Lic.No/Date:5210029042 07.12.2009 Defer Date:10.08.2010 Decision :CommiƩee considered case as per agenda and decided to forward a copy of applicaƟon to Department of C&PC for their comments. Accordingly, case was deferred for 10.08.2010. 48
Case No.:41/48/82‐ALC4/2009
Party Name:AVA CHEMICALS PVT.LTD., 15.06.2010 Status:Case Approved HQ File :01/82/050/01104/AM10/ RLA File :03/94/040/00531/AM10/ Lic.No/Date:0310549545 07.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007/Ch.II dated 14.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Zinc Diammonium EDTA‐ Liquid Zinc content 9%( +1) 1 kg 1. Ethylene Diamine Tetra AceƟc Acid (EDTA) 0.422 kg 49
Case No.:73/46/82‐ALC4/2009
Party Name:YASHO INDUSTRIES PVT.LTD. 15.06.2010 Status:Case Deferred
HQ File :01/82/050/00989/AM10/ RLA File :03/95/040/00575/AM10/ Lic.No/Date:0310550407 11.12.2009 Defer Date:10.08.2010 Decision :CommiƩee decided to call for a copy of applicaƟon from RA/firm. Accordingly, case was deferred for 10.08.2010. 50
Case No.:6/39/82‐ALC4/2009
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 15.06.2010 Status: Case Approved HQ File :01/82/050/00809/AM10/ RLA File :03/95/040/00557/AM10/ Lic.No/Date:0310550660 14.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/43/2007/Ch.II dated 02.06.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 3,4,5‐Trimethoxy Toluene 1 kg 1. 3,4,5‐Trimethoxy Benzaldehyde 1.134 kg 51
Case No.:4/40/82‐ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 15.06.2010 Status:Case Approved HQ File :01/82/050/00819/AM10/ RLA File :09/24/040/00257/AM10/ Lic.No/Date:0910040253 16.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/3/2010‐PI (Norms) dated 09.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Pantoprazole (OR) Pantoprazole Sodium 1 kg 1. Methanol 4.39 kg 2. Acetonitrile 0.60 kg 3. Maltol 1.46 kg 4. Phosphorus Oxychloride 2.23 kg 5. Hydrogen Peroxide (NMT 60%) 1.40 kg 6. Toluene 0.089 kg 7. Sodium Methoxide 0.45 kg 8. Thionyl Chloride 0.89 kg 9. Methylene Di Chloride 2.80 kg 10. Chloroform 4.90 kg
52
Case No.:14/40/82‐ALC4/2009
15.06.2010 Status:Deffered and Re‐indexed HQ File :01/82/050/00829/AM10/ RLA File :03/94/040/00513/AM10/ Lic.No/Date:0310551191 16.12.2009 Defer Date:15.06.2010 Decision : CommiƩee considered case as per agenda. The representaƟves of the firm appeared for personal hearing before the CommiƩee and explained basis. The technical authority present in the meeƟng asked the representaƟve of the firm to indicate TheoraƟcal, pracƟcal and yield obtained on molar basis correctly and the representaƟve of the firm agreed to furnish the same with 15 days. It was, therefore, decided to defer the case for 10.08.2010. 53
Case No.:58/48/82‐ALC4/2009
Party Name:CIPLA LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/01121/AM10/ RLA File :03/94/040/00782/AM10/ Lic.No/Date:0310551036 16.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/15/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Neobact Powder Spray 150 ml pack 1. Neomycin Sulphate 241.353 mg 2. Bacitracin 315.50 mg Raxenal Powder Spray 150 ml pack 1. Neomycin Sulphate 241.353 mg Bacitracin 315.50 mg 54
Case No.:62/5/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 15.06.2010 Status:Case Deferred HQ File :01/82/050/00096/AM11/ RLA File :09/24/040/00321/AM10/ Lic.No/Date:0910040280 16.12.2009 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of PharmaceuƟcals. 55
Case No.:17/40/82‐ALC4/2009
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00832/AM10/ RLA File :09/24/040/00382/AM10/ Lic.No/Date:0910040331 17.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/107/2008/Ch.II dated 27.04.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Octyl Salicylate 1 kg 1. 2‐Ethyl Hexanol 0.558 kg 56
Case No.:4/41/82‐ALC4/2009
Party Name:BALAJI AMINES LIMITED 15.06.2010 Status:Case Deferred HQ File :01/82/050/00839/AM10/ RLA File :31/24/040/00192/AM10/ Lic.No/Date:3110041170 21.12.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda and observed that Department of C&PC vide their leƩer No.14010/113/2008‐Ch.II dated 15.06.2010 has called for technical informaƟon. It was, therefore, decided to defer the case for 10.08.2010 for reply from firm. 57
Case No.:5/41/82‐ALC4/2009
Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 15.06.2010 Status:Case Deferred HQ File :01/82/050/00840/AM10/ RLA File :31/24/040/00188/AM10/ Lic.No/Date:3110041172 21.12.2009 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of C&PC. 58
Case No.:6/41/82‐ALC4/2009
Party Name:CADILA HEALTHCARE LTD., 15.06.2010 Status:Case Approved HQ File :01/82/050/00841/AM10/ RLA File :08/24/040/00213/AM10/ Lic.No/Date:0810085114 21.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments of Department of PharmaceuƟcals dated 15.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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. allowed for 25 mg Tablets Qty. allowed for 50 mg Tablets Qty. allowed for 100 mg Tablets Qty. allowed for 200 mg Tablets Topiramate Tablets 1 lakh Nos. each 1. Topiramate 2.55 kg 5.10 kg 10.20 kg 20.40 kg 2. Microcrystalline Cellulose PH 102 0.75 kg 1.50 kg 3.00 kg 6.00 kg 3. Avicel PH 101 0.83 kg 1.65 kg 3.30 kg 6.60 kg 4. Lactose Anhydrous 2.75 kg 5.50 kg 11.00 kg 22.00 kg 5. 500 CC White HDPE Round As per packing policy As per packing policy As per packing policy As per packing policy
BoƩle 6. 225 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy 7. 150 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy 8. 75 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy 9. 60 CC WHITE HDPE ROUND BOTTLE As per packing policy As per packing policy As per packing policy As per packing policy 10. 33 MM WHITE PP SCRC with Pulp Liner As per packing policy As per packing policy As per packing policy As per packing policy 11. 33 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy 12. 38 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy 13. 45 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy 14. 53 MM WHITE PP SCREW CAP As per packing policy As per packing policy As per packing policy As per packing policy RA concerned may take further necessary acƟon as per above decision of Norms CommiƩee. 59
Case No.:36/46/82‐ALC4/2009
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 15.06.2010 Status:Case Deferred HQ File :01/82/050/00952/AM10/ RLA File :07/24/040/00356/AM10/ Lic.No/Date:0710069013 21.12.2009 Defer Date:10.08.2010 Decision :CommiƩee considered case as per agenda and decided to call from firm ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority. Accordingly, case was deferred for 10.08.2010. 60
Case No.:83/46/82‐ALC4/2009
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 15.06.2010 Status:Case Deferred HQ File :01/82/050/00999/AM10/ RLA File :03/94/040/00805/AM10/ Lic.No/Date:0310552288 23.12.2009 Defer Date:10.08.2010 Decision : CommiƩee considered case as per agenda and observed that the firm has sought import of Gentamicin Sulphate equivalent to Gentamicin Base and it is not clear whether the quanƟty of 264.810 kgs claimed by the firm is for Gentamicin Sulphate or Gentamicin Base. It was, therefore, decided to seek clarificaƟon from firm.
Accordingly, case was deferred for 10.08.2010. 61
Case No.:1/42/82‐ALC4/2009
Party Name:METROPOLITAN EXIMCHEM LTD. 15.06.2010 Status:Case Approved HQ File :01/82/050/00850/AM10/ RLA File :03/95/040/00517/AM10/ Lic.No/Date:0310552790 29.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/65/2006/Ch.II dated 13.09.2007 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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‐N Carbethoxy Amino 5 Naphthol 7 Sulfonic Acid 1 kg 1. J Acid 0.889 kg 62
Case No.:4/42/82‐ALC4/2009
Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 15.06.2010 Status:Case Deferred HQ File :01/82/050/00853/AM10/ RLA File :31/24/040/00205/AM10/ Lic.No/Date:3110041272 30.12.2009 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of C&PC. 63
Case No.:5/42/82‐ALC4/2009
15.06.2010 Status:Case Approved HQ File :01/82/050/00854/AM10/ RLA File :03/94/040/00772/AM10/ Lic.No/Date:0310552999 30.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/8/2010‐PI (Norms) dated 10.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Docetaxel 1 kg 1. Zinc 0.48 kg 2. AceƟc Acid 0.96 kg 3. BaccaƟn III‐(2S,3S)‐3‐Phenylisoserine‐N‐Benzoyl Ester 1.92 kg 64
Case No.:59/48/82‐ALC4/2009
Party Name:CIPLA LIMITED Status:Case
15.06.2010 Approved HQ File :01/82/050/01122/AM10/ RLA File :03/94/040/00837/AM10/ Lic.No/Date:0310553012 30.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/15/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxicillin & Clavulanate Potassium for Suspension USP 75 ml pack 1. Amoxycillin Trihydrate 4.200 gm 2. Clavulanate Potassium Syloid 2.3444 gm 3. Silicon Dioxide (Syloid AL‐1FP)NF 1.500 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) As per packing policy 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M‐1 Amoxicillin & Clavulanate Potassium for Suspension USP 100 ml pack 1. Amoxycillin Trihydrate 5.649 gm 2. Clavulanate Potassium Syloid 3.126 gm 3. Silicon Dioxide (Syloid AL‐1FP)NF 2.00 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M‐1 Amoxicillin & Clavulanate Potassium for Suspension USP 150 ml pack 1. Amoxycillin Trihydrate 8.274 gm 2. Clavulanate Potassium Syloid 4.6888 gm 3. Silicon Dioxide (Syloid AL‐1FP)NF 3.00 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M‐1
65
Case No.:8/42/82‐ALC4/2009
Party Name:GEMINI EXPORTS., 15.06.2010 Status:Case Approved HQ File :01/82/050/00857/AM10/ RLA File :03/94/040/00785/AM10/ Lic.No/Date:0310553150 31.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/20/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Metoprolol Base Min. 98% (Metoprolol Base) 1 kg 1. 4‐Methoxy Ethyl Phenol 0.665 kg 2. Epichlorohydrin 0.520 kg 3. Methyl Isopropyl Amine 0.509 kg 66
Case No.:9/42/82‐ALC4/2009
Party Name:KOPRAN LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00858/AM10/ RLA File :03/94/040/00843/AM10/ Lic.No/Date:0310553154 31.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/6/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefepime for InjecƟon 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 67
Case No.:53/46/82‐ALC4/2009
Party Name:POLYGON CHEMICALS 15.06.2010 Status:Case Approved HQ File :01/82/050/00969/AM10/ RLA File :08/24/040/00266/AM10/ Lic.No/Date:0810085444 31.12.2009 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 14/83 meeƟng held on 11.07.2007 and in consultaƟon with technical
authority present in meeƟng, decided to raƟfy 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 3 Methyl‐5‐Pyrazolone 1 kg 1. AceƟc Acid Methyl Ester 1.287 kg 2. Hydrazine Hydrate (Purity 80%) 0.692 kg 68
Case No.:21/42/82‐ALC4/2009
Party Name:SHIRDI CHEMICALS PVT. LTD. 15.06.2010 Status:Case Approved HQ File :01/82/050/00870/AM10/ RLA File :03/95/040/00661/AM10/ Lic.No/Date:0310553782 05.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/3/2010/Ch.II dated 17.05.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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‐3,3 Bis(4 Hydroxy Phenyl) Phthalimidine (PPPBP) 1 kg 1. Phthalic Anhydride 0.550 kg 2. Phenol 0.850 kg 3. Zinc Chloride 0.350 kg 4. Aniline 0.420 kg 5. Methanol 1.350 kg 69
Case No.:67/46/82‐ALC4/2009
Party Name:GLENMARK GENERICS LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00983/AM10/ RLA File :03/94/040/00812/AM10/ Lic.No/Date:0310553944 06.01.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 41/82 meeƟng held on 24.01.2007 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Linezolid 1 kg 1. ThioaceƟc Acid 1.77 kg 2. Methylene Chloride/Methylene Dichloride/MDC 10.30 kg 3. R Glycidyl Butyrate 1.07 kg 4. Dimethyl Formamide 4.275 kg 5. Tetrahydrofuran 5.44 kg 6. 3,4‐Difluoronitrobenzene 1.76 kg
Methanol 7.75 kg 70
Case No.:10/44/82‐ALC4/2009
Party Name:SANDOZ PRIVATE LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00895/AM10/ RLA File :03/95/040/00667/AM10/ Lic.No/Date:0310555381 14.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/13/2010‐PI (Norms) dated 09.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Clopidogrel Hcl Bulk Drug 1 kg 1. L(‐) Camphor Sulphonic Acid 0.828 kg 2. 4,5,6,7‐Tetrahydrothieno(3,2,C) Pyridine Hcl (Cyclic Amine Hcl) 1.483 kg 71
Case No.:17/5/82‐ALC4/2010
15.06.2010 Status:Case Approved HQ File :01/82/050/00051/AM11/ RLA File :03/94/040/00799/AM10/ Lic.No/Date:0310555541 15.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/8/2010‐PI (Norms) dated 10.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Hydroxynitrile 1 kg 1. Lyophilised Enzyme Powder (CDX403) 0.012 kg 2. Ethyl 4 Chloro Aceto Acetate 1.039 kg 3. D‐Glucose (Dextrose) 0.451 kg 4. Lyophilised Enzyme Powder (CDX014) 0.005 kg 5. Lyophilised Enzyme Powder (CDX‐901) 0.004 kg 6. NADP‐SP B‐BicoƟnamide‐Adenine DinucleoƟde Phosphate Oxidized Form, Monosodium Salt (B‐ NADP+,B‐Tan+,Coenzyme‐II) 0.001 kg
72
Case No.:18/5/82‐ALC4/2010
15.06.2010 Status:Case Deferred HQ File :01/82/050/00052/AM11/ RLA File :03/94/040/00795/AM10/ Lic.No/Date:0310555546 15.01.2010 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of PharmaceuƟcals. 73
Case No.:3/45/82‐ALC4/2009
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 15.06.2010 Status:Case Deferred HQ File :01/82/050/00898/AM10/ RLA File :05/24/040/00410/AM10/ Lic.No/Date:0510256550 18.01.2010 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of PharmaceuƟcals. 74
Case No.:84/5/82‐ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 15.06.2010 Status:Case Deferred HQ File :01/82/050/00118/AM11/ RLA File :22/24/040/00047/AM10/ Lic.No/Date:2210009594 19.01.2010 Defer Date:10.08.2010 Decision :CommiƩee considered case as per agenda and decided to call for end use of export product from firm. Accordingly, case was deferred for 10.08.2010. 75
Case No.:9/46/82‐ALC4/2009
15.06.2010 Status:Case Approved HQ File :01/82/050/00925/AM10/ RLA File :03/94/040/00899/AM10/ Lic.No/Date:0310557203 27.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/395/2009‐PI (Norms) dated 04.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Paclitaxel 1 gram 1. 10‐Deacety BaccaƟn 1.50 gram 2. Pyridine 0.87 gram 3. Triethyl Silyl Chloride 1.67 gram 4. (3R,4S)‐3‐Triethylsilanyloxy‐4‐Phenyl‐N‐Benzoyl‐2‐ AzeƟdinone 1.12 gram 76
Case No.:16/5/82‐ALC4/2010
15.06.2010 Status:Case Deferred
HQ File :01/82/050/00050/AM11/ RLA File :03/94/040/00940/AM10/ Lic.No/Date:0310557073 27.01.2010 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of PharmaceuƟcals. 77
Case No.:11/46/82‐ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 15.06.2010 Status:Case Deferred HQ File :01/82/050/00927/AM10/ RLA File :09/24/040/00407/AM10/ Lic.No/Date:0910040660 28.01.2010 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of PharmaceuƟcals. 78
Case No.:105/5/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 15.06.2010 Status:Case Approved HQ File :01/82/050/00139/AM11/ RLA File :13/24/040/00028/AM10/ Lic.No/Date:1310031256 28.01.2010 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Ampicillin for InjecƟon BP 250 mg 100% Potency 1 No. 1. Ampicillin Sodium Sterile 262.50 mg 2. Vials 79
Case No.:79/5/82‐ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 15.06.2010 Status:Case Deferred HQ File :01/82/050/00113/AM11/ RLA File :09/24/040/00413/AM10/ Lic.No/Date:0910040795 02.02.2010 Defer Date:13.07.2010 Decision : CommiƩee decided to defer case for 13.07.2010 for comments of Department of PharmaceuƟcals. 80
Case No.:56/5/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 15.06.2010 Status:Case Approved HQ File :01/82/050/00090/AM11/ RLA File :09/24/040/00456/AM10/ Lic.No/Date:0910040810 03.02.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/29/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed
Cefpodoxime ProxeƟl 1 kg 1. 7‐Aminocephalosporanic Acid (7 ACA) 0.956 kg 2. 1,8‐Diazabicyclo (5,4,0)‐undec‐7‐ece (dbu) 0.319 kg 3. 18‐Crown‐6‐ether 0.022 kg 4. 4‐Dimethyl Amino Pyridine 0.005 kg 5. Acetone 1.10 kg 6. Carbon EnoanƟcromos (AcƟvated Carbon) 0.100 kg 7. Isopropyl Alcohol 0.15 kg 8. Mercapto Benzo Thiazole‐4‐yl‐2‐(2‐Amino Thiazolyl)‐Methoxyimino Acetate (MAEM) 0.956 kg 9. Methanol 3.85 kg 10. Methylene Chloride 2.65 kg 11. N,N‐Dimethyl Acetamide 1.95 kg 12. Iodine 0.448 kg 13. Sulfolane 1.29 kg 14. Tetrahydrofuran 0.52 kg 15. Triphosgene 0.614 kg 16. Triethylamine 0.562 kg 81
Case No.:14/52/82‐ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 15.06.2010 Status:Case Deferred HQ File :01/82/050/01207/AM10/ RLA File :05/24/040/00507/AM10/ Lic.No/Date:0510260189 10.03.2010 Defer Date:10.08.2010 Decision : CommiƩee decided to defer case for 10.08.2010 for comments of Department of PharmaceuƟcals. 82
Case No.:85/5/82‐ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 15.06.2010 Status:Case Deferred HQ File :01/82/050/00119/AM11/ RLA File :22/24/040/00057/AM10/ Lic.No/Date:2210009830 30.03.2010 Defer Date:10.08.2010 Decision : CommiƩee decided to forward a copy of applicaƟon to Department of PharmaceuƟcals for their comments. Accordingly, case was deferred for 10.08.2010.
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