IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2010-05-04

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision

MEETING NUMBER : 5/82‐ALC4/2010 MEETING DATE : 04.05.2010 The Meeĕng No.5/82 in the year 2010‐11 to consider the cases under Duty Exempĕon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 04.05.2010 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 Pharmaceuĕcals 4. Shri M. Mitra, Dy. Drugs Controller (I), DCGI 5. Shri Krishan Kumar, Dy. DGFT 6. Shri Shyam Lal, FTDO

Case No.B‐45

M/S Benzo Chem Industries P. Ltd Norms Commiĥee Meeĕng No.5/AM11 F.No.01/82/050/00449/AM10 Meeĕng Date: 04.05.2010 RA F.No.03/95/040/00166/AM10 Adv.Lic.No.0310533439 dated 12.08.2009 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/11/2008/Ch.II dated 22.08.2008 and in consultaĕon with technical authority present in meeĕng, decided to revise the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Qty. allowed 2‐Coumaranone 30% in Aceĕc Anhydride 70% 1 kg 1. Ortho Chloro Phenyl Aceĕc Acid 0.653 2. Causĕc Soda Flakes 0.900 kg 3. Toluene 0.266 kg RA concerned may take further necessary acĕon as per above decision of NC. The earlier decision taken in 21/82 meeĕng held on 18.08.2009 may be treated as withdrawn.

Case No.B‐46

M/S Cipla Ltd. F.No.01/82/050/00447/AM08 RA F.No.03/94/040/00860/AM08 Adv.Lic.No.0310450692dated 19.11.2007 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of

Pharmaceuĕcals vide their O.M. No.35011/284/2009‐PI‐(Norms) dated 28.04.2010 and in consultaĕon with technical authority present in meeĕng, 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 item Qty. allowed Irinotecan Hydrochloride Injecĕon 40 mg/2 ml [Irinotecan Hcl = 44.0 mg] 1 No. 1. IRT‐2 (10‐Hydroxy‐7‐Ethyl Camptothecin) 1.035 kg/kg of Irinotecan Hcl 2. 4‐Piperidino Piperidine 0.608 kg/kg of Irinotecan Hcl Irinotecan Hcl Injection 100 mg/5 ml [Irinotecan Hcl = 110.00 mg] 1 No. 1. IRT‐2 (10‐Hydroxy‐7‐Ethyl Camptothecin) 1.035 kg/kg of Irinotecan Hcl 2. 4‐Piperidino Piperidine 0.608 kg/kg of Irinotecan Hcl RA concerned may take further necessary acĕon as per above decision of NC. The earlier decision taken in 23/82 meeĕng held on 02.09.2008 may be treated as withdrawn.

Case No.B‐47

M/S Cipla Ltd. F.No.01/82/050/00446/AM08 RA F.No.03/94/040/00857/AM08 Adv.Lic.No.0310450548 dated 16.11.2007 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/284/2009‐PI‐(Norms) dated 28.04.2010 and in consultaĕon with technical authority present in meeĕng, 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 item Qty. allowed Irinotecan Hydrochloride Injecĕon 40 mg/2 ml [Irinotecan Hcl = 44.0 mg] 1 No. 1. IRT‐2 (10‐Hydroxy‐7‐Ethyl Camptothecin) 1.035 kg/kg of Irinotecan Hcl Irinotecan Hcl Injection 100 mg/5 ml [Irinotecan Hcl = 110.00 mg] 1 No. 1. IRT‐2 (10‐Hydroxy‐7‐Ethyl Camptothecin) 1.035 kg/kg of Irinotecan Hcl RA concerned may take further necessary acĕon as per above decision of NC. The earlier decision taken in 18/82 meeĕng held on 29.07.2008 may be treated as withdrawn.

Case No.B‐48

M/S Laffans Petrochemicals Ltd.

F.No.01/82/050/00669/AM10 RA F.No.03/95/040/00410/AM10 Adv.Lic.No.0310543654 dated 03.11.2009 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/33/2007‐Ch.II dated 07.12.2009 and in consultaĕon with technical authority present in meeĕng, decided to revise 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 Diethylene Glycol Monomethyl Ether (yield 98%) 1 kg 1. Methanol 0.272 kg 2. Ethylene Oxide 0.748 kg RA concerned may take further necessary acĕon as per above decision of NC. The earlier decision taken in 44/82 meeĕng held on 27.01.2010 may be treated as withdrawn.

Case No.B‐49

M/S Hildose Ltd. F.No.01/82/050/00497/AM08 RA F.No.03/94/040/01100/AM08 Adv.Lic.No.0310460275 dated 06.02.2008 Commiĥee considered case as per agenda and decided to call for the following informaĕon from the firm:‐ 1. The purity of export product has been indicated to be more than 98.5%, while the purity of import item has not been indicated. Please indicate the purity of import item also. Accordingly case was deferred for 15.06.2010.

Case No.B‐50

M/S Grand Organics Pvt.Ltd. F.No.01/82/050/01825/AM07 RA F.No.17/24/040/00084/AM07 Adv.Lic.No.1710001580 dated 15.03.2007 Commiĥee decided to defer case for 01.06.2010 for comments of Department of C&PC.

Case No.B‐51

M/S Arch Pharmalabs Ltd. F.No.01/82/050/01213/AM09 RA F.No.05/24/040/00466/AM09 Adv.Lic.No.0510229951 dated 24.10.2008 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/50/2009‐PI‐III dated 30.10.2009 and in consultaĕon with technical

authority present in meeĕng, 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 Zidovudine USP 1 Kg. 1. 5’‐O‐Trityl‐2,3’‐Anhydro Thymidine 2.63 kg RA concerned may take further necessary acĕon as per above decision of NC. The earlier decision taken in 34/82 meeĕng held on 17.11.2009 may be treated as withdrawn.

Case No.B‐52

M/S Goodwill Chemical Industries Ltd. F.No.01/82/050/01344/AM05 RA F.No.03/94/040/02391/AM06 Adv.Lic.No.0310255907 dated 03.03.2004 Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/10/2007/Ch.II dated 21.04.2008 and in consultaĕon with technical authority present in meeĕng, 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 1,2,4 Trichloro Benzene 1 Kg. 1. Mixed Dichloro Benzene 1.40 kg RA concerned may take further necessary acĕon as per above decision of NC. The earlier decision taken in 8/05 meeĕng held on 02.06.2004 may be treated as withdrawn.

Case No.A‐8

M/S Intas Pharma Ltd. F.No.01/82/162/00205/AM10 RA F.No.08/24/040/00007/AM10 Adv.Lic.No.0810079232 dated 09.04.2009 Commiĥee considered case as per agenda and observed that the technical informaĕon called from the firm have been received and sent to Department of Pharmaceuĕcals on 30.04.2010 for their examinaĕon and comments. Accordingly, case was deferred for 15.06.2010.

Case No.A‐9

M/S Shree Ganesh Remedies Pvt. Ltd. F.No.01/82/050/00243/AM08 RA F.No.34/24/040/00166/AM07 Adv.Lic.No.3410018711 dated 03.05.2007 Commiĥee decided to defer case for 01.06.2010 for comments of Department of Pharmaceuĕcals.

Case No.C‐6

M/S Reliance Industries Ltd F.No.01/82/162/00707/AM10 Commiĥee considered case as per agenda and observed that Chemexcil, on the basis of DGCIS data, has cerĕfied that out of total export of 7058.01 MT in respect of export product Propylene during the year 2006‐07, 2007‐ 08 and 2008‐09, M/S Reliance Industries Ltd has exported to the extent of 6996.734 Mt which is 93.13% of the total exports and hence it was decided to accept the data of M/S Reliance Industries Ltd as All Industry data. A├er detailed deliberaĕons and in light of wriĥen comments forwarded by Department of C&PC vide their O.M. No.46011/20/2008‐PC.II dated 21.04.2010 and in consultaĕon with technical authoriĕes present in meeĕng, decided to fix SION for the export product Propylene as per details below:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Propylene 1 MT. 1. Naphtha 1.2359 MT Necessary Public Noĕce may be issued for publicaĕon of above SION a├er approval of DG. 1

Case No.:37/22/83‐ALC1/2007

Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:5/82‐ALC4/2010 04.05.2010 Status:Case Approved HQ File :01/83/050/00732/AM08/ RLA File :03/95/040/00197/AM08/ Lic.No/Date:0310432840 15.06.2007 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/93/2007‐Ch.II dated 03.05.2010 and in consultaĕon with technical authority present in meeĕng, decided to revise norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed ETHOXYKATED TEA (Poly Ethoxylated Tri Ethanol Amine 1 Kg. 1. Ethylene Oxide 0.948 kg RA concerned may take further necessary acĕon as per above decision of NC. 2

Case No.:36/6/83‐ALC1/2008

Party Name:H.K.FINECHEM LIMITED 04.05.2010 Status:Case Deferred HQ File :01/83/050/00146/AM09/ RLA File :08/24/040/00149/AM08/ Lic.No/Date:0810067303 Defer

21.09.2007 Date:01.06.2010 Decision :Commiĥee considered case as per agenda and decided to refer the case to DIPP and deferred the case to 01.06.2010. 3

Case No.:24/23/82‐ALC4/2008

Party Name:ARCH PHARMALABS LTD 04.05.2010 Status:Case Approved HQ File :01/82/050/00928/AM09/ RLA File :03/94/040/00512/AM09/ Lic.No/Date:0310483819 26.08.2008 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/341/2009‐PI‐(Norms) dated 26.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under

para 4.7 of HBP as per details below or as applied by the firm whichever is lower.

Export Product Export Qty. Sl.No. import items Quanĕty allowed Gemcitabin Hydrochloride 1 kg 1. 3,5‐O‐Dibenzoyl‐2‐Deoxy‐2,2‐ Difluorocyĕdine 1.756 kg 2. Methanol 1.312 kg 3. Monoglyme Not allowed 4. Ethyl Acetate Not allowed 4

Case No.:28/28/82‐ALC4/2008

Party Name:METROCHEM API PVT. LTD. 04.05.2010 Status:Case Deferred HQ File :01/82/050/01077/AM09/ RLA File :09/24/040/00204/AM09/ Lic.No/Date:0910035464 29.09.2008 Defer Date:01.06.2010 Decision :Commiĥee decided to defer case for 01.06.2010 for comments of Department of Pharmaceuĕcals. 5

Case No.:50/29/82‐ALC4/2008

04.05.2010 Status:Case Approved HQ File :01/82/050/01132/AM09/ RLA File :03/94/040/00655/AM09/ Lic.No/Date:0310489368 07.10.2008 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/341/2009‐PI‐(Norms) dated 26.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under

para 4.7 of HBP as per details below or as applied by the firm whichever is lower.

Export Product Export Qty. Sl.No. import items Quanĕty allowed Gemcitabin Hydrochloride 1 kg 1. 3,5‐O‐Dibenzoyl‐2‐Deoxy‐2,2‐ Difluorocyĕdine 1.756 kg 2. Methanol 1.312 kg

Monoglyme Not allowed 4. Ethyl Acetate Not allowed 6

Case No.:7/32/82‐ALC4/2008

04.05.2010 Status:Case Deferred HQ File :01/82/050/01182/AM09/ RLA File :03/94/040/00721/AM09/ Lic.No/Date:0310491254 21.10.2008 Defer Date:01.06.2010 Decision : Commiĥee decided to defer case for 01.06.2010 for comments of Department of Pharmaceuĕcals. 7

Case No.:19/35/82‐ALC4/2008

Party Name:VIJAYASRI ORGANICS LTD 04.05.2010 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:01.06.2010 Decision : Commiĥee decided to defer case for 01.06.2010 for comments of DC(MSME). 8

Case No.:1/40/82‐ALC4/2008

Party Name:INTAS PHARMACEUTICALS LTD., 04.05.2010 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:15.06.2010 9

Case No.:10/40/82‐ALC4/2008

04.05.2010 Status:Case Deferred HQ File :01/82/050/01429/AM09/ RLA File :03/94/040/00871/AM09/ Lic.No/Date:0310498562 17.12.2008 Defer Date:01.06.2010 10

Case No.:102/5/82‐ALC4/2010

Party Name:KUDOS CHEMIE LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/00136/AM11/ RLA File :22/24/040/00063/AM09/ Lic.No/Date:2210008631 10.02.2009 Decision : Commiĥee considered case as per agenda for raĕficaĕon of norms and in light of its earlier decision taken in its 52/09 meeĕng held on 31.12.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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

p p p y p y Caffeine (Syntheĕc Caffeine Anhydrous) 1kg. 1. Crude Theophylline 80% w/w (wet) Loss on Drying NLT 15% 1.15 kg 2. Causĕc Soda (flakes of Lye) 0.24 kg 3. Dimethyl sulphate 0.68 kg 4. Acĕvated Carbon 0.100 kg 11

Case No.:55/5/82‐ALC4/2010

Party Name:GLAND PHARMA LIMITED 04.05.2010 Status:Case Deferred HQ File :01/82/050/00089/AM11/ RLA File :09/24/040/00462/AM09/ Lic.No/Date:0910037899 13.05.2009 Defer Date:25.05.2010 Decision :Commiĥee considered case as per agenda and decided to call for the firm for personal hearing alongwith Producĕon and Consumpĕon data cerĕfied by Central Excise Authority on 25.05.2010. Accordingly case was deferred for 25.05.2010. 12

Case No.:23/22/82‐ALC4/2009

Party Name:HETERO LABS LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/00480/AM10/ RLA File :09/24/040/00058/AM10/ Lic.No/Date:0910037940 19.05.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Efavirenz 1 Kg. 1. 4‐Chloro‐2‐trifluoro Acetylaniline Hydrochloride hydrate 1.49 kg 2. Cyclopropyl Acetylene 0.524 kg 3. (1R,2S)‐N‐Pyrrolidinyl Norephedrine 0.189 kg 4. Diethyl Zinc (20% in toluene) 4.41 kg 5. 2,2,2‐Trifluoro Ethanol 0.642 kg 6. n‐Butyl Chloride Not allowed 7. Citric Acid Monohydrate 0.81 kg 8. Tetrahydrofuran 5.50 kg 9. Triphosgene 0.498 kg 10. Methylene Chloride 7.50 kg 11. Cyclohexane 4.20 kg 13

Case No.:13/10/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD Status:Case

04.05.2010 Deferred HQ File :01/82/050/00137/AM10/ RLA File :09/24/040/00055/AM10/ Lic.No/Date:0910038020 28.05.2009 Defer Date:01.06.2010 Decision :Commiĥee considered case as per agenda and in consultaĕon with technical authoriĕes present in meeĕng decided to call for the following informaĕon from the firm. 1. Specific end use of the export product. 2. The name and address of the buyer of the export product. Accordingly, case was deferred for 01.06.2010. 14

Case No.:9/13/82‐ALC4/2009

Party Name:ENCUBE ETHICALS PVT LTD 04.05.2010 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:01.06.2010 Decision : Commiĥee decided to defer case for 01.06.2010 for comments of DC(MSME). 15

Case No.:23/13/82‐ALC4/2009

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00163/AM10/ RLA File :09/24/040/00018/AM10/ Lic.No/Date:0910038170 10.06.2009 Defer Date:01.06.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/217/2009‐PI‐(Norms) dated 01.02.2010, decided to call for the following informaĕon from the firm. 1. Complete chemical reacĕon indicaĕng molar weight of each import of output material and % yield on molar basis. 2. Material balance for the enĕre process. 3. Requirement and recovery of solvents at each step of manufacturing process. Accordingly, case was deferred for 01.06.2010. 16

Case No.:5/21/82‐ALC4/2009

Party Name:ASTRIX LABORATORIES LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/00432/AM10/ RLA File :09/24/040/00097/AM10/ Lic.No/Date:0910038362 25.06.2009 Defer Date:01.06.2010 17

Case No.:23/15/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 04.05.2010 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:01.06.2010 Decision : Commiĥee decided to defer case for 01.06.2010 for comments of Department of C&PC. 18

Case No.:61/18/82‐ALC4/2009

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/00335/AM10/ RLA File :04/24/040/00057/AM10/ Lic.No/Date:0410106102 14.07.2009 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/227/2009‐PI‐(Norms) dated 30.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Zepufa Capsules 1000 mg 1 No.. 1. Borage Oil 339.66 mg/capsule The norms for the export product Star Flower Oil 500 mg So├ Geleĕn Capsules could not be fixed in absence of copy of Drug Manufacturing Licence. 19

Case No.:34/17/83‐ALC1/2009

Party Name:AJANTA PHARMA LTD., 04.05.2010 Status:Case Deferred HQ File :01/83/050/00316/AM10/ RLA File :03/94/040/00220/AM10/ Lic.No/Date:0310529278 16.07.2009 Defer Date:01.06.2010 Decision :Commiĥee considered case as per agenda and in consultaĕon with technical authoriĕes present in meeĕng, decided to call for the following informaĕon/documents from the firm:‐ 1. Correct ITC(HS) Code of the export product. 2. Copy of Drug Manufacturing licence and other Manufacturing Licences. Accordingly, case was deferred for 01.06.2010. 20

Case No.:15/5/82‐ALC4/2010

Party Name:CIPLA LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00049/AM11/ RLA File :03/94/040/00334/AM10/ Lic.No/Date:0310529947 21.07.2009 Decision : Commiĥee considered case as per agenda. Shri Rahul Phalke, Producĕon Officer of the company had appeared before Commiĥee in similar cases in meeĕng held on 27.04.10 and explained the case. He had informed the Commiĥee that they are imporĕng Inulin extracted from Chicory route which is a natural product. He also informed that the item is processed by way of meshing and repacking in consumer packs.

p y y g p g p A├er detailed deliberaĕons and in consultaĕon of technical authoriĕes present in meeĕng, Commiĥee decided to raĕfy 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 Quanĕty allowed Fibre Clear/Pharmacy Choice Fibre Clear/Terry White Chemists Fibre Clear/Chemmart Pharmacy Clear/Inulin Fibre Supplement (Pack Size 331 gm) contains Inulin (100% Natural Fibre) 331 gm 3000 Packs 1. Inulin (100% Natural Fibre) Extracted from Chicory Route (With 1% wastage) 2005.86 kgs. RLA concerned may take further necessary acĕon as per above decision of NC. 21

Case No.:19/35/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00709/AM10/ RLA File :09/24/040/00133/AM10/ Lic.No/Date:0910038696 24.07.2009 Defer Date:01.06.2010 22

Case No.:21/35/82‐ALC4/2009

Party Name:ASTRIX LABORATORIES LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/00711/AM10/ RLA File :09/24/040/00127/AM10/ Lic.No/Date:0910038698 24.07.2009 Defer Date:01.06.2010 23

Case No.:16/35/82‐ALC4/2009

04.05.2010 Status:Case Approved HQ File :01/82/050/00706/AM10/ RLA File :09/24/040/00158/AM10/ Lic.No/Date:0910038722 29.07.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/375/2009‐PI (Norms) dated 30.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Oseltamivir Phosphate 1 Kg. 1. Ethyl (3R,4R,5S)‐4‐N‐Acetylamino‐5‐N,N‐ Diallylamino‐3‐(1‐Ethylpropoxy)‐1‐Cyclohexane‐1‐ Carboxylate 1.11 kg

1,3‐Dimethylbarbituric Acid 0.64 kg 3. n‐Heptane 1.39 kg 24

Case No.:14/35/82‐ALC4/2009

04.05.2010 Status:Case Deferred HQ File :01/82/050/00704/AM10/ RLA File :09/24/040/00173/AM10/ Lic.No/Date:0910038796 04.08.2009 Defer Date:04.05.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/375/2009‐PI (Norms) dated 30.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Oseltamivir Phosphate 1 Kg. 1. 4‐Acetylamino‐5‐ Diallylamino‐3‐(1‐ Ethylpropoxy)‐1‐Formic Acid Ethylester‐1‐ Cyclohexane 1.111 kg 2. 1,3‐Dimethylbarbituric Acid 0.64 kg 3. n‐Heptane 1.39 kg 25

Case No.:26/21/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 04.05.2010 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:01.06.2010 26

Case No.:27/21/82‐ALC4/2009

Party Name:GITANJALI CHEMICALS PVT LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00454/AM10/ RLA File :03/94/040/00225/AM10/ Lic.No/Date:0310533516 12.08.2009 Defer Date:01.06.2010 27

Case No.:15/35/82‐ALC4/2009

04.05.2010 Status:Case Approved HQ File :01/82/050/00705/AM10/ RLA File :09/24/040/00191/AM10/ Lic.No/Date:0910039017 18.08.2009

Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide O.M. No.35011/375/2009‐PI (Norms) dated 30.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Efavirenz 1 Kg. 1. 4‐Chloro‐2‐trifluoro Acetylaniline Hydrochloride hydrate 1.49 kg 2. Cyclopropyl Acetylene 0.524 kg 3. (1R,2S)‐N‐Pyrrolidinyl Norephedrine 0.189 kg 4. Diethyl Zinc (20% in toluene) 4.41 kg 5. 2,2,2‐Trifluoro Ethanol 0.642 kg 6. n‐Butyl Chloride Not allowed 7. Citric Acid Monohydrate 0.81 kg 8. Tetrahydrofuran 5.50 kg 9. Triphosgene 0.498 kg 10. Methylene Chloride 7.50 kg 11. Cyclohexane 4.20 kg 28

Case No.:20/35/82‐ALC4/2009

Party Name:MATRIX LABORATORIES LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00710/AM10/ RLA File :09/24/040/00194/AM10/ Lic.No/Date:0910039023 18.08.2009 Defer Date:01.06.2010 29

Case No.:33/22/82‐ALC4/2009

Party Name:PRIVI ORGANICS LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00490/AM10/ RLA File :03/95/040/00310/AM10/ Lic.No/Date:0310534394 20.08.2009 Defer Date:01.06.2010 30

Case No.:60/5/82‐ALC4/2010

Party Name:MATRIX LABORATORIES LTD 04.05.2010 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:01.06.2010

Case No.:82/5/82‐ALC4/2010

Party Name:BILCARE LIMITED 04.05.2010 Status:Case Deferred HQ File :01/82/050/00116/AM11/ RLA File :31/24/040/00106/AM10/ Lic.No/Date:3110039936 16.09.2009 Defer Date:01.06.2010 Decision :Commiĥee considered case as per agenda and observed that the item of import and export are same. It was, therefore, decided to call the firm for personal hearing on 01.06.2010. Accordingly, case was deferred for 01.06.2010. 32

Case No.:88/5/82‐ALC4/2010

Party Name:NECTAR LIFESCIENCES LIMITED, 04.05.2010 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:15.06.2010 Decision : Commiĥee decided to defer case for 15.06.2010 for comments of Department of Pharmaceuĕcals. 33

Case No.:89/5/82‐ALC4/2010

04.05.2010 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:15.06.2010 34

Case No.:72/5/82‐ALC4/2010

Party Name:KAMUD DRUGS PVT.LIMITED., 04.05.2010 Status:Case Approved HQ File :01/82/050/00106/AM11/ RLA File :31/24/040/00117/AM10/ Lic.No/Date:3110040069 25.09.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/71/2009‐PI‐III dated 22.10.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Timolol Maleate 1 Kg. 1. S‐(‐)‐Tert‐Butylamino)1,2‐Propanediol 0.81 kg 2. 3‐Morpholino‐4‐chloro‐1,2,5‐Thiadiazole 1.09 kg 35

Case No.:90/5/82‐ALC4/2010

04.05.2010 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:15.06.2010

Case No.:49/34/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 04.05.2010 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:15.06.2010 Decision : Commiĥee decided to defer case for 15.06.2010 for comments of Department of Bio‐technology. 37

Case No.:50/34/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 04.05.2010 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:15.06.2010 Decision : Commiĥee decided to defer case for 15.06.2010 for comments of Department of Bio‐technology. 38

Case No.:47/39/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 04.05.2010 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:15.06.2010 Decision : Commiĥee decided to defer case for 15.06.2010 for comments of Department of Bio‐technology. 39

Case No.:101/5/82‐ALC4/2010

Party Name:IND‐SWIFT LABORATORIES LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/00135/AM11/ RLA File :22/24/040/00033/AM10/ Lic.No/Date:2210009355 14.10.2009 Defer Date:01.06.2010 40

Case No.:74/5/82‐ALC4/2010

Party Name:CHIRAL BIOSCIENCES LTD., 04.05.2010 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:15.06.2010 41

Case No.:37/5/82‐ALC4/2010

Party Name:AUROBINDO PHARMA LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00071/AM11/ RLA File :09/24/040/00264/AM10/ Lic.No/Date:0910039746

28.10.2009 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 2/08 meeĕng held on 16.05.2007 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Cefixime Trihydrate 1 Kg. 1. Acetone 1.205 kg 2. Acĕvated Carbon 0.100 kg 3. Dimethyl Formamide 2.23 kg 4. GCLE 1.555 kg 5. Isopropyl Alcohol 1.97 kg 6. Methanol 6.50 kg 7. Methylene Chloride 7.30 kg 8. MICA (MICA Acid) 0.923 kg 9. Tetrahydrofuran 1.64 kg 10. Triphenyl Phosphine 1.22 kg 42

Case No.:63/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00097/AM11/ RLA File :09/24/040/00296/AM10/ Lic.No/Date:0910039750 28.10.2009 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 46/82 meeĕng held on 09.02.2010 and in consultaĕon with technical authority present in meeĕng decided to raĕfy 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 Tenofovir Disoproxil Fumarate 1 Kg. 1. Adenine 0.914 kg 2. R‐Propylene Carbonate 0.7938 kg 3. Methanol 2.95 kg 4. Diethyl‐Tosyloxymethyl Phosphonate 2.025 kg 5. Tetrahydrofuran 4.28 kg 6. Lithium tert‐Butoxide 0.536 kg 7. Methylene Dichloride 7.84 kg 8. Acetonitrile 2.94 kg 9. Chloromethyl Chloro Formate 2.0867 kg 10. N‐methyl‐2‐Pyrolidone 3.92 kg

Case No.:70/5/82‐ALC4/2010

Party Name:MSN PHARMACHEM PRIVATE LIMITED 04.05.2010 Status:Case Deferred HQ File :01/82/050/00104/AM11/ RLA File :09/24/040/00228/AM10/ Lic.No/Date:0910039743 28.10.2009 Defer Date:15.06.2010 44

Case No.:71/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred HQ File :01/82/050/00105/AM11/ RLA File :09/24/040/00295/AM10/ Lic.No/Date:0910039749 28.10.2009 Defer Date:01.06.2010 45

Case No.:91/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00125/AM11/ RLA File :22/24/040/00034/AM10/ Lic.No/Date:2210009372 28.10.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/212/2009‐PI‐(Norms) dated 16.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 7 AVCA 1 Kg. 1. GCLE 2.672 kg 2. Triphenyl Phosphine 1.26 kg 3. Sodium Iodide 0.828 kg 4. Formaldehyde 2.886 kg 5. DMF 2.00 kg 6. Methanol 7.87 kg 7. Methylene Chloride 10.31 kg 8. N‐Butyl Acetate 3.15 kg 9. Phenol 0.933 kg 10. Penicillin G Amidase Enzyme 1.353 gm 11. Acetone 2.1375 kg 12. Eno Carbon 0.100 kg 13. Hydro Chloric Acid Not allowed and not a importable item 14. Sodium Hydroxide 0.214 kg

Sodium Bicarbonate Not allowed 16. Sodium Chloride Not allowed 17. Sodium Carbonate Not allowed 18. Sodium Thionate (Hydro) Now allowed 19. Aceĕc Acid 0.022 kg 20. EDTA Not allowed 21. Sulphuric Acid Not allowed 46

Case No.:92/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00126/AM11/ RLA File :22/24/040/00035/AM10/ Lic.No/Date:2210009373 28.10.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Ce├riaxone Sodium Sterile 1 Kg. 1. Ce├riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Aceĕc Acid Disodium Salt Dihydrate (EDTA) 0.01 kg 4. Eno Carbon 51.66 gm 47

Case No.:3/34/83‐ALC1/2009

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 04.05.2010 Status:Case Deferred HQ File :01/83/050/00588/AM10/ RLA File :03/95/040/00464/AM10/ Lic.No/Date:0310543184 29.10.2009 Defer Date:15.06.2010 Decision :Commiĥee considered case as per agenda and decided to call for the correct ITC(HS) Code of the export product from firm. Accordingly, case was deferred for 15.06.2010. 48

Case No.:100/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00134/AM11/ RLA File :22/24/040/00036/AM10/ Lic.No/Date:2210009397 04.11.2009 Decision : Commiĥee considered case as per agenda for raĕficaĕon of norms and in light of wriĥen comments forwarded by PI Division vide their U.O.

No.35011/206/2006‐PI‐III dated 12.08.2008 and in consultaĕon with technical authority present in meeĕng decided to raĕfy 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 per unit of export product Nitazoxanide 1 Kg. 1. 2‐Acetyloxy benzoic acid (Asprin) 0.916 kg. 2. 2‐amino‐5‐nitro thiazole 0.59 kg. 3. Triethylamine 0.1288 kg. 4. Methylene Chloride 3.17 kg. 5. N,N Dimethyl formamide 0.069 kg. 6. Acetone 2.00 kg. 7. Thionyl chloride 0.92 kg. 49

Case No.:108/5/82‐ALC4/2010

Party Name:VIVEK PHARMACHEM (INDIA) LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/00142/AM11/ RLA File :13/24/040/00019/AM10/ Lic.No/Date:1310030397 04.11.2009 Defer Date:01.06.2010 Decision : Commiĥee considered case as per agenda and decided to call for DML and deferred the case for 15.06.2010. 50

Case No.:94/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00128/AM11/ RLA File :22/24/040/00037/AM10/ Lic.No/Date:2210009417 11.11.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce├riaxone Sodium Sterile 1 Kg. 1. Ce├riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Aceĕc Acid Disodium Salt Dihydrate (EDTA) 0.01 kg 4. Eno Carbon 51.66 gm

Case No.:99/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred HQ File :01/82/050/00133/AM11/ RLA File :22/24/040/00038/AM10/ Lic.No/Date:2210009406 11.11.2009 Defer Date:15.06.2010 52

Case No.:31/35/82‐ALC4/2009

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00721/AM10/ RLA File :09/24/040/00306/AM10/ Lic.No/Date:0910039891 12.11.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/107/2008‐Ch.II dated 15.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the 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 Salidant DMH Plus Liquid Containing DMDM Hydantoin [1,3‐bis‐(hydroxymethyl)‐5,5‐ dimethylimidazolidine‐2,4‐ dione]:60% 1 kg 1. DMDM Hydantoin [1,3‐bis‐ (hydroxymethyl)‐5,5‐ dimethylimidazolidine‐2,4‐dione]: 0.600 kg 53

Case No.:59/5/82‐ALC4/2010

Party Name:SARNA CHEMICALS PVT.LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/00093/AM11/ RLA File :03/95/040/00463/AM10/ Lic.No/Date:0310546241 18.11.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/77/2006‐Ch.II dated 09.04.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the 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 N‐Hydroxy Methyl 2‐Chloro Acetamide 1 kg 1. 2‐Chloro Acetamide 0.841 kg 54

Case No.:112/5/82‐ALC4/2010

Party Name:CHIRAG ENTERPRISE 04.05.2010 Status:Case Approved

HQ File :01/82/050/00146/AM11/ RLA File :24/24/040/00011/AM10/ Lic.No/Date:2410026542 23.11.2009 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 5/83 meeĕng held on 30.04.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Qty. allowed Crude Methyl Methacrylate Monomer 1 kg 1. Acrylic Plasĕc Strips/Offcuts 1.25 kg 55

Case No.:25/5/82‐ALC4/2010

Party Name:AVA CHEMICALS PVT.LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/00059/AM11/ RLA File :03/94/040/00669/AM10/ Lic.No/Date:0310547222 24.11.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/73/2002‐Ch.III dated 03.08.2006 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Qty. allowed Disodium Zinc EDTA (Zinc content 14‐15%) 1 kg 1. EDTA 0.690 kg 56

Case No.:29/5/82‐ALC4/2010

Party Name:AVA CHEMICALS PVT.LTD., 04.05.2010 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:01.06.2010 57

Case No.:98/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00132/AM11/ RLA File :22/24/040/00041/AM10/ Lic.No/Date:2210009443 27.11.2009 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 16/AM10 meeĕng held on 04.08.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

Export product Export Qty. Sl.No. Import items Qty. allowed Clarithromycin Granules 42% (Suspension Grade) 1kg. 1. Clarithromycin Or Its raw materials as per SION A‐2263 on prorate basis 0.4242 KG 2. Carbopol 0.30 kg 3. HPMC Phthalate 0.30 kg RA concerned may take further necessary acĕon as per above decision of NC. 58

Case No.:19/5/82‐ALC4/2010

Party Name:AVA CHEMICALS PVT.LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/00053/AM11/ RLA File :03/94/040/00658/AM10/ Lic.No/Date:0310549544 07.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007‐Ch.II dated 20.10.2009 and U.O. No.14010/110/2007/Ch.II dated 09.11.09 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the 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 EDTA Diammonium (Liquid) Assay Min. 40% 1 kg 1. EDTA (Ethylene Diamine Tetra Aceĕc Acid) Assay Min. 98% 0.377 kg DTPA Potassium (DTPA K 5‐ Liquid Acĕve Content=40% 1 Kg. 1. DETA (Diethylene Triamine) 0.125 kg 59

Case No.:78/5/82‐ALC4/2010

Party Name:CADILA HEALTHCARE LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/00112/AM11/ RLA File :08/24/040/00244/AM10/ Lic.No/Date:0810084904 15.12.2009 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 44/82 meeĕng held on 27.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Carvvedilol 3.125 mg Tablet 1 Million 1. Carvedilol 3.1875 kg 2. Crospovidone NF 2.75 kg 3. Povidone K30 1.00 kg 4. Magnesium Stearate 0.450 kg

Lactose Monohydrate 37.4875 kg 6. Boĥles and Caps (packing material in finished form a. 60 CC White HDPE Round Boĥle As per packing policy 7. 75 CC White HDPE Round Boĥle ‐do‐ 8. 100 CC White HDPE Round Boĥle ‐do‐ 9. 150 CC White HDPE Round Boĥle ‐do‐ 10. Boĥle 300 CC White HDPE ‐do‐ 11. 33 MM White PP Screw Cap ‐do‐ 12. 38 MM White PP Screw Cap ‐do‐ 13. 53 MM White PP Screw Cap ‐do‐ Carvedilol 6.25 mg Tablet 1 million 1. Carvedilol 6.375 kg 2. Crospovidone NF 5.50 kg 3. Povidone K30 2.00 kg 4. Magnesium Stearate 0.900 kg 5. Lactose Monohydrate 74.975 kg 6. Boĥles and Caps (packing material in finished form a. 60 CC White HDPE Round Boĥle As per packing policy 7. 75 CC White HDPE Round Boĥle ‐do‐ 8. 100 CC White HDPE Round Boĥle ‐do‐ 9. 150 CC White HDPE Round Boĥle ‐do‐ 10. Boĥle 300 CC White HDPE ‐do‐ 11. 33 MM White PP Screw Cap ‐do‐ 12. 38 MM White PP Screw Cap ‐do‐ 13. 53 MM White PP Screw Cap ‐do‐ Carvedilol 12.5 mg Tablet 1 million 1. Carvedilol 12.75 kg 2. Crospovidone NF 11.00 kg 3. Povidone K30 4.22 kg 4. Magnesium Stearate 1.80 kg 5. Lactose Monohydrate 149.95 kg 6. Boĥles and Caps (packing material in finished form a. 60 CC White HDPE Round Boĥle As per packing policy 7. 75 CC White HDPE Round Boĥle ‐do‐ 8. 100 CC White HDPE Round Boĥle ‐do‐ 9. 150 CC White HDPE Round Boĥle ‐do‐ 10. Boĥle 300 CC White HDPE ‐do‐ 11. 33 MM White PP Screw Cap ‐do‐ 12. 38 MM White PP Screw Cap ‐do‐ 13. 53 MM White PP Screw Cap ‐do‐

Carvedilol 25.0 mg Tablet 1 million 1. Carvedilol 25.50 kg 2. Crospovidone NF 22.00 kg 3. Povidone K30 8.00 kg 4. Magnesium Stearate 3.60 kg 5. Lactose Monohydrate 299.90 kg 6. Boĥles and Caps (packing material in finished form a. 60 CC White HDPE Round Boĥle As per packing policy 7. 75 CC White HDPE Round Boĥle ‐do‐ 8. 100 CC White HDPE Round Boĥle ‐do‐ 9. 150 CC White HDPE Round Boĥle ‐do‐ 10. Boĥle 300 CC White HDPE ‐do‐ 11. 33 MM White PP Screw Cap ‐do‐ 12. 38 MM White PP Screw Cap ‐do‐ 13. 53 MM White PP Screw Cap ‐do‐ 60

Case No.:48/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred HQ File :01/82/050/00082/AM11/ RLA File :09/24/040/00377/AM10/ Lic.No/Date:0910040298 16.12.2009 Defer Date:01.06.2010 61

Case No.:50/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred HQ File :01/82/050/00084/AM11/ RLA File :09/24/040/00375/AM10/ Lic.No/Date:0910040302 16.12.2009 Defer Date:01.06.2010 62

Case No.:62/5/82‐ALC4/2010

Party Name:MATRIX LABORATORIES LTD 04.05.2010 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:15.06.2010 63

Case No.:80/5/82‐ALC4/2010

Party Name:HETERO DRUGS LIMITED, 04.05.2010 Status:Case Approved

HQ File :01/82/050/00114/AM11/ RLA File :09/24/040/00374/AM10/ Lic.No/Date:0910040301 16.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/247/2009‐PI‐(Norms) dated 07.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Nebivolol Hcl 1 Kg. 1. Para Fluorophenol 9.01 kg 2. Methanol 23.6 kg 3. n‐Hexane 24.02 kg 4. Acetone 13.031 kg 5. Dimethyl Sulphoxide 11.74 kg 6. Toluene 15.98 kg 7. DIBAL‐H (Diisobutylaluminium Hydrine) 25% in Toluene 27.03 kg 8. Diisopropyl Ether 12.17 kg 9. Methylene Chloride 4.83 kg 64

Case No.:83/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00117/AM11/ RLA File :09/24/040/00388/AM10/ Lic.No/Date:0910040316 17.12.2009 Decision : Commiĥee considered case as per agenda for raĕficaĕon of norms and in light of wriĥen comments forwarded by PI Division vide their U.O. No.35011/87/2007‐PI‐III dated 12.08.2008 and in consultaĕon with technical authority present in meeĕng decided to raĕfy 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 Lamivudine 1 Kg. 1. Glyoxylic acid 50% 1.80 kg. 2. 1,4‐dithiane‐2,5‐dihydroxy 0.739 kg. 3. Cytosine 0.955 kg. 4. Hexamethyl disilazane 1.89 kg. 5. Salicylic acid 0.79 kg. 6. Sodium borohydride 0.48 kg. 7. Dimethyl formamide 0.83 kg. 8. n‐Hexane 3.75 kg. 9. Methylene dichloride 5.75 kg.

Case No.:4/41/82‐ALC4/2009

Party Name:BALAJI AMINES LIMITED 04.05.2010 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:01.06.2010 Decision :Commiĥee decided to defer case for 01.06.2010 for comments of Department of C&PC. 66

Case No.:5/41/82‐ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 04.05.2010 Status:Case Approved HQ File :01/82/050/00840/AM10/ RLA File :31/24/040/00188/AM10/ Lic.No/Date:3110041172 21.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/11/2009‐Ch.II dated 15.11.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Terĕary Butyl peroxy 2 ethyl Hexanoate (TX 21S) 1 kg 1. 2‐Ethyl Hexanoyl Chloride 0.782 kg 2. Tert‐butyl Hydro Peroxide 70% 0.654 kg 3. Magnesium Sulphate 2 acqueous 0.031 kg 4. Container HDPE 30 LTR. Loose, with 2 Lables 30 LTR. CR Cans, with K 60 Opening and Red K29 Screw Cap. 6 Pieces in Plasĕc Bag incluing caps As per packing policy 5. Screwcap K60 As per packing policy 67

Case No.:34/48/82‐ALC4/2009

Party Name:TITAN LABORATORIES PVT. LTD. 04.05.2010 Status:Case Deferred HQ File :01/82/050/01097/AM10/ RLA File :03/95/040/00617/AM10/ Lic.No/Date:0310551871 21.12.2009 Defer Date:01.06.2010 68

Case No.:95/5/82‐ALC4/2010

Party Name:SURYA MEDICARE LTD., 04.05.2010 Status:Case Approved

HQ File :01/82/050/00129/AM11/ RLA File :22/24/040/00043/AM10/ Lic.No/Date:2210009543 29.12.2009 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce├riaxone Sodium Sterile 1 Kg. 1. Ce├riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Aceĕc Acid Disodium Salt Dihydrate (EDTA) 0.01 kg 4. Eno Carbon 51.66 gm 69

Case No.:97/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00131/AM11/ RLA File :22/24/040/00044/AM10/ Lic.No/Date:2210009542 29.12.2009 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 16/AM10 meeĕng held on 04.08.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Clarithromycin Granules 27.5% (Suspension Grade) 1kg. 1. Clarithromycin Or Its raw materials as per SION A‐2263 on pro‐rata basis 0.2778 KG 2. Carbopol 0.20 kg 3. HPMC Phthalate 0.54 kg RA concerned may take further necessary acĕon as per above decision of NC. 70

Case No.:34/5/82‐ALC4/2010

Party Name:AVA CHEMICALS PVT.LTD., 04.05.2010 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:01.06.2010

Case No.:32/5/82‐ALC4/2010

Party Name:R L FINE CHEM 04.05.2010 Status:Case Approved HQ File :01/82/050/00066/AM11/ RLA File :07/24/040/00379/AM10/ Lic.No/Date:0710069417 13.01.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 19/82 meeĕng held on 04.08.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Doxilamine Succinate BP/USP 1 Kg. 1. 2 Acetyl Pyridine 0.58 kg 2. Tetrahydrofuran 1.03 kg 72

Case No.:76/5/82‐ALC4/2010

Party Name:CADILA HEALTHCARE LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/00110/AM11/ RLA File :08/24/040/00255/AM10/ Lic.No/Date:0810085771 13.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments earlier forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/73/2007‐PI‐III dated 14.08.2007 alongwith enclosures and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Benzonatate 100 mg Capsules 1 Million 1. Benzonanate 102 kg 2. Gelaĕn NF 168 kg 3. Glycerin USP 24 kg 4. Noncrystallizing Sorbitol Soluĕon NF 72 kg 5. Triethyl Nitrate NF 75 kg 6. Boĥles and Caps (packing material in finished form a. 60 CC White HDPE Round Boĥle As per packing policy 7. 75 CC White HDPE Round Boĥle ‐do‐ 8. 33 MM White PP Screw Cap ‐do‐ Benzonatate 200 mg Capsules 1 million 1. Benzonanate 204 kg 2. Gelaĕn NF 231 kg 3. Glycerin USP 33 kg 4. Noncrystallizing Sorbitol Soluĕon NF 99 kg 5. Triethyl Nitrate NF 75 kg 6. Boĥles and Caps (packing material in finished form a. 60 CC White HDPE Round Boĥle As per packing policy

75 CC White HDPE Round Boĥle ‐do‐ 8. 33 MM White PP Screw Cap ‐do‐ 73

Case No.:103/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00137/AM11/ RLA File :22/24/040/00045/AM10/ Lic.No/Date:2210009580 14.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce├riaxone Sodium Sterile 1 Kg. 1. Ce├riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Aceĕc Acid Disodium Salt Dihydrate (EDTA) 0.01 kg 4. Eno Carbon 51.66 gm 74

Case No.:1/45/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/00896/AM10/ RLA File :05/24/040/00446/AM10/ Lic.No/Date:0510256458 15.01.2010 Defer Date:25.05.2010 Decision :Commiĥee considered case as per agenda and observed that though the wriĥen comments have been received from Department of Pharmaceuĕcals, the firm has been obtaining advance authorizaĕons from Jt. DGFT, Chandigarh as well as from Zonal Jt. DGFT, CLA, New Delhi. It was, therefore, decided to call the firm for personal hearing before the Chairman, NC to clarify the above point. The firm may fix ĕme with Chairman, NC for telephone. 75

Case No.:10/45/82‐ALC4/2009

Party Name:KDAC CHEM PVT LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00905/AM10/ RLA File :34/24/040/00176/AM10/ Lic.No/Date:3410026153 15.01.2010 Defer Date:01.06.2010 76

Case No.:17/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred

HQ File :01/82/050/00051/AM11/ RLA File :03/94/040/00799/AM10/ Lic.No/Date:0310555541 15.01.2010 Defer Date:15.06.2010 77

Case No.:18/5/82‐ALC4/2010

04.05.2010 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:15.06.2010 Decision :Commiĥee considered case as per agenda and in consultaĕon with technical authority present in meeĕng, decided to call for the following informaĕon/documents from the firm:‐ 1. Cerĕficate of Analysis issued by foreign supplier for import item. 2. Complete specificaĕon of export product from Government approved laboratories. 3. Manufacturing process alongwith wastage claimed on each stage of process. Accordingly, case was deferred for 15.06.2010. 78

Case No.:7/45/82‐ALC4/2009

04.05.2010 Status:Case Approved HQ File :01/82/050/00902/AM10/ RLA File :03/94/040/00888/AM10/ Lic.No/Date:0310555686 18.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/341/2009‐PI‐(Norms) dated 26.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under

para 4.7 of HBP as per details below or as applied by the firm whichever is lower.

Case No.:8/45/82‐ALC4/2009

04.05.2010 Status:Case Deferred HQ File :01/82/050/00903/AM10/ RLA File :03/94/040/00880/AM10/ Lic.No/Date:0310555693 18.01.2010 Defer Date:01.06.2010

Decision :Commiĥee decided to forward a copy of applicaĕon to Department of Pharmaceuĕcals for their comments. Accordingly, case was deferred for 01.06.2010. 80

Case No.:9/45/82‐ALC4/2009

04.05.2010 Status:Case Deferred HQ File :01/82/050/00904/AM10/ RLA File :03/94/040/00879/AM10/ Lic.No/Date:0310555700 18.01.2010 Defer Date:01.06.2010 81

Case No.:20/5/82‐ALC4/2010

Party Name:LAFFANS PETROCHEMICALS LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/00054/AM11/ RLA File :03/95/040/00612/AM10/ Lic.No/Date:0310555771 18.01.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/7/2003‐Ch.II dated 16.06.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Ethylene Glycol Monoethyl Ether 1 kg 1. Denatured Ethyl Alcohol 0.522 kg 2. Ethylene Oxide 0.500 kg 82

Case No.:21/5/82‐ALC4/2010

Party Name:LAFFANS PETROCHEMICALS LTD., 04.05.2010 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:01.06.2010 83

Case No.:75/5/82‐ALC4/2010

Party Name:CADILA HEALTHCARE LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/00109/AM11/ RLA File :08/24/040/00284/AM10/ Lic.No/Date:0810085802 18.01.2010 Defer Date:01.06.2010 Decision : Commiĥee considered case as per agenda. The technical authority from Department of Pharmaceuĕcals referred to earlier decision taken in meeĕng No.45/82 dated 02.02.2009. However, it was noĕced that in the present case, there are two addiĕonal items of import. Hence, it was decided to defer the maĥer for 01.06.2010. 84

Case No.:84/5/82‐ALC4/2010

Party Name:SAURAV CHEMICALS LTD, Status:Case

04.05.2010 Deferred HQ File :01/82/050/00118/AM11/ RLA File :22/24/040/00047/AM10/ Lic.No/Date:2210009594 19.01.2010 Defer Date:15.06.2010 Decision :Commiĥee considered case as per agenda and in consultaĕon with technical authority present in meeĕng, decided to call for (i) specific end use of the export product, (ii) if the export product is drug intermediate, the name of bulk drug from firm. Accordingly, case was deferred for 15.06.2010. 85

Case No.:20/45/82‐ALC4/2009

Party Name:AARTI INDUSTRIES LIMITED 04.05.2010 Status:Case Deferred HQ File :01/82/050/00915/AM10/ RLA File :03/94/040/00919/AM10/ Lic.No/Date:0310556311 20.01.2010 Defer Date:01.06.2010 86

Case No.:21/45/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00916/AM10/ RLA File :52/24/040/00030/AM10/ Lic.No/Date:5210029424 20.01.2010 Defer Date:01.06.2010 87

Case No.:16/5/82‐ALC4/2010

04.05.2010 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:15.06.2010 88

Case No.:51/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00085/AM11/ RLA File :09/24/040/00436/AM10/ Lic.No/Date:0910040652 27.01.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken 15/82 meeĕng held on 12.07.2006 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Quanĕty allowed Zidovudine 1 kg 1. 3‐Azido‐3‐Deoxy Thymidine (total impuriĕes NLT 5%) 1.05 kg 2. Dimethyl Sulfoxide 1.56 kg 3. Methanol 2.19 kg

Case No.:64/5/82‐ALC4/2010

Party Name:BIOLOGICAL E LTD 04.05.2010 Status:Case Rejected HQ File :01/82/050/00098/AM11/ RLA File :09/24/040/00433/AM10/ Lic.No/Date:0910040650 27.01.2010 Decision :Commiĥee considered case as per agenda and observed that the firm has not given the percentage purity of import item and norms can not be fixed in absence of purity of import item. It was, therefore, decided to reject the case. 90

Case No.:65/5/82‐ALC4/2010

Party Name:BIOLOGICAL E LTD 04.05.2010 Status:Case Rejected HQ File :01/82/050/00099/AM11/ RLA File :09/24/040/00442/AM10/ Lic.No/Date:0910040651 27.01.2010 Decision : Commiĥee considered case as per agenda and observed that the firm has not given the percentage purity of import item and norms can not be fixed in absence of purity of import item. It was, therefore, decided to reject the case. 91

Case No.:110/5/82‐ALC4/2010

Party Name:CHIRAG ENTERPRISE 04.05.2010 Status:Case Approved HQ File :01/82/050/00144/AM11/ RLA File :24/24/040/00015/AM10/ Lic.No/Date:2410027234 27.01.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 5/83 meeĕng held on 30.04.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Qty. allowed Crude Methyl Methacrylate Monomer 1 kg 1. Acrylic Plasĕc Strips/Offcuts 1.25 kg 92

Case No.:33/5/82‐ALC4/2010

Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00067/AM11/ RLA File :09/24/040/00424/AM10/ Lic.No/Date:0910040692 28.01.2010 Decision : Commiĥee considered case as per agenda and taking cue from SION A‐1945 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the 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

Ketoprofen Lysine Enteric Coated Pellets 71% w/w 500 kg 1. Ketoprofen Lysine 358.55 kg 93

Case No.:38/5/82‐ALC4/2010

Party Name:MSN PHARMACHEM PRIVATE LIMITED 04.05.2010 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:01.06.2010 94

Case No.:40/5/82‐ALC4/2010

Party Name:MSN LABORATORIES LIMITED 04.05.2010 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:01.06.2010 95

Case No.:81/5/82‐ALC4/2010

Party Name:MATRIX LABORATORIES LTD 04.05.2010 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:01.06.2010 96

Case No.:105/5/82‐ALC4/2010

Party Name:VIVEK PHARMACHEM (INDIA) LTD., 04.05.2010 Status:Case Case Deferred HQ File :01/82/050/00139/AM11/ RLA File :13/24/040/00028/AM10/ Lic.No/Date:1310031256 28.01.2010 Defer Date:15.06.2010 Decision : Commiĥee considered case as per agenda and decided to call for a copy of Drug Manufacturing licence from firm. Accordingly, case was deferred for 15.06.2010. 97

Case No.:47/5/82‐ALC4/2010

Party Name:R L FINE CHEM 04.05.2010 Status:Case Approved HQ File :01/82/050/00081/AM11/ RLA File :07/24/040/00388/AM10/ Lic.No/Date:0710069723 01.02.2010 Decision : Commiĥee considered case as per agenda for raĕficaĕon of norms and in light of wriĥen comments forwarded by Chemical Division vide their U.O. No.35011/85/2007‐PI‐III dated 26.08.2008 and in consultaĕon with technical authority present in meeĕng decided to raĕfy 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 Lorazepam 1 Kg 1. 2 Amino‐2,5‐dichloro benzophenone 1.60 kg 98

Case No.:49/5/82‐ALC4/2010

Party Name:MATRIX LABORATORIES LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00083/AM11/ RLA File :09/24/040/00314/AM10/ Lic.No/Date:0910040762 01.02.2010 Defer Date:01.06.2010 99

Case No.:61/5/82‐ALC4/2010

Party Name:MATRIX LABORATORIES LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00095/AM11/ RLA File :09/24/040/00399/AM10/ Lic.No/Date:0910040760 01.02.2010 Defer Date:01.06.2010 100

Case No.:24/5/82‐ALC4/2010

Party Name:GLENMARK GENERICS LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00058/AM11/ RLA File :03/94/040/00928/AM10/ Lic.No/Date:0310558192 02.02.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 10/08 meeĕng held on 10.07.2007 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Lercanidipine 1 Kg. 1. 3,3‐Diphenyl Propolamine 1.19 kg 2. Tetrahydrofuran 2.90 kg 3. Methylene Chloride 4.88 kg 4. 1‐Chloro‐2 Methyl‐2 Propanol 0.507 kg 5. Isopropyl acetate 6.83 kg 101

Case No.:36/5/82‐ALC4/2010

Party Name:SUNSHIELD CHEMICALS LTD. 04.05.2010 Status:Case Deferred

HQ File :01/82/050/00070/AM11/ RLA File :03/95/040/00662/AM10/ Lic.No/Date:0310558079 02.02.2010 Defer Date:01.06.2010 102

Case No.:79/5/82‐ALC4/2010

Party Name:CHIRAL BIOSCIENCES LTD., 04.05.2010 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:15.06.2010 103

Case No.:56/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred HQ File :01/82/050/00090/AM11/ RLA File :09/24/040/00456/AM10/ Lic.No/Date:0910040810 03.02.2010 Defer Date:15.06.2010 104

Case No.:52/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00086/AM11/ RLA File :09/24/040/00465/AM10/ Lic.No/Date:0910040820 05.02.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken 15/82 meeĕng held on 12.07.2006 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Quanĕty allowed Zidovudine 1 kg 1. 3‐Azido‐3‐Deoxy Thymidine (total impuriĕes NLT 5%) 1.05 kg 2. Dimethyl Sulfoxide 1.56 kg 3. Methanol 2.19 kg 105

Case No.:57/5/82‐ALC4/2010

Party Name:HETERO DRUGS LIMITED, 04.05.2010 Status:Case Approved HQ File :01/82/050/00091/AM11/ RLA File :09/24/040/00464/AM10/ Lic.No/Date:0910040818 05.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/247/2009‐PI‐(Norms) dated 07.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as

Export product Exp. Qty. Sl.No. Import items Qty. allowed Nebivolol Hcl 1 Kg. 1. Para Fluorophenol 9.01 kg 2. Methanol 23.6 kg 3. n‐Hexane 24.02 kg 4. Acetone 13.031 kg 5. Dimethyl Sulphoxide 11.74 kg 6. Toluene 15.98 kg 7. DIBAL‐H (Diisobutylaluminium Hydrine) 25% in Toluene 27.03 kg 8. Diisopropyl Ether 12.17 kg 9. Methylene Chloride 4.83 kg 106

Case No.:39/5/82‐ALC4/2010

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 04.05.2010 Status:Case Deferred HQ File :01/82/050/00073/AM11/ RLA File :03/95/040/00654/AM10/ Lic.No/Date:0310558977 08.02.2010 Defer Date:01.06.2010 Decision : Commiĥee decided to defer case for 01.06.2010 for comments of Department of Bio‐technology. 107

Case No.:54/5/82‐ALC4/2010

Party Name:S.KANT HEALTHCARE LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/00088/AM11/ RLA File :03/95/040/00714/AM10/ Lic.No/Date:0310558971 08.02.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 32/82 meeĕng held on 03.11.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Artemether 1 Kg 1. Artemisinin 1.50 kg Artesunate 1 kg. 1. Artemisinin 0.9259 kg. Dihydro Artemisinin 1 Kg. 1. Artemisinin 1.12 kg 108

Case No.:35/5/82‐ALC4/2010

Party Name:ASTRIX LABORATORIES LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/00069/AM11/ RLA File :09/24/040/00366/AM10/ Lic.No/Date:0910040875

09.02.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 45/82 meeĕng held on 02.02.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Stavudine 1 Kg. 1. 5‐Methyl Uridine 2.597 kg 2. N‐Methyl Morpholine 1.23 kg 3. Methane Sulfonyl Chloride 2.40 kg 4. Aceĕc Acid 0.49 kg 5. N‐Methyl Pyrrolidinone 1.40 kg 6. Dimethyl formamide 1.13 kg 7. Ethyl Acetate 5.87 kg 8. Acetone 2.24 kg 9. Iso Propyl Alcohol 1.75 kg 10. Acĕvated Carbon 0.10 kg 109

Case No.:46/5/82‐ALC4/2010

Party Name:HETERO LABS LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00080/AM11/ RLA File :09/24/040/00467/AM10/ Lic.No/Date:0910040870 09.02.2010 Decision : Commiĥee considered case as per agenda for raĕficaĕon of norms and in light of wriĥen comments forwarded by PI Division vide their U.O. No.35011/87/2007‐PI‐III dated 12.08.2008 and in consultaĕon with technical authority present in meeĕng decided to raĕfy 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 Lamivudine 1 Kg. 1. Glyoxylic acid 50% 1.80 kg. 2. 1,4‐dithiane‐2,5‐dihydroxy 0.739 kg. 3. Cytosine 0.955 kg. 4. Hexamethyl disilazane 1.89 kg. 5. Salicylic acid 0.79 kg. 6. Sodium borohydride 0.48 kg. 7. Dimethyl formamide 0.83 kg. 8. n‐Hexane 3.75 kg. 9. Methylene dichloride 5.75 kg.

110

Case No.:58/5/82‐ALC4/2010

Party Name:LAKE CHEMICALS PRIVATE LIMITED 04.05.2010 Status:Case Deferred HQ File :01/82/050/00092/AM11/ RLA File :07/21/040/01027/AM10/ Lic.No/Date:0710069898 09.02.2010 Defer Date:01.06.2010 111

Case No.:22/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00056/AM11/ RLA File :03/94/040/00992/AM10/ Lic.No/Date:0310560277 15.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/341/2009‐PI‐(Norms) dated 26.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under

para 4.7 of HBP as per details below or as applied by the firm whichever is lower.

Case No.:23/5/82‐ALC4/2010

Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 04.05.2010 Status:Case Approved HQ File :01/82/050/00057/AM11/ RLA File :03/94/040/00991/AM10/ Lic.No/Date:0310560280 15.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/40/2010‐Ch.II dated 27.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Amino‐5‐Chlorobenzophenone (Purity not less than 97%) 1 kg 1. Anthranil/5 Chloro‐3‐ Phenylanthranil 1.16 kg 113

Case No.:43/5/82‐ALC4/2010

Party Name:RATNAGIRI CHEMICALS PVT. LTD. 04.05.2010 Status:Case Approved

HQ File :01/82/050/00077/AM11/ RLA File :03/95/040/00745/AM10/ Lic.No/Date:0310560168 15.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/97/2006‐Ch.II dated 20.11.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Hydroquinone Monomethyl Ether (Purity Min.99%) 1 kg 1. Hydroquinone 1.056 kg 2. Para Benzoquinone 0.10 kg 114

Case No.:68/5/82‐ALC4/2010

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 04.05.2010 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:01.06.2010 Decision : Commiĥee considered case as per agenda. The technical authority from Department of C&PC recommended ad‐hoc norms based on decision taken in meeĕng No.50/AM09. However, it was noĕced that the firm has shown three imported inputs for the export product Calcium Bromolactobionate, while earlier recommendaĕon shows only two import items. Thus, it was decided to defer the case for 01.06.10. 115

Case No.:45/5/82‐ALC4/2010

Party Name:AQUAPHARM CHEMICALS PVT.LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00079/AM11/ RLA File :31/24/040/00223/AM10/ Lic.No/Date:3110042020 18.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/56/2007‐Ch.III dated 17.12.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Aqueous Soluĕon of Polymaleic Acid (Acĕve content 47‐53%) 1 kg 1. Maleic Anhydride 0.355 kg 116

Case No.:66/5/82‐ALC4/2010

Party Name:HETERO LABS LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00100/AM11/ RLA File :09/24/040/00473/AM10/ Lic.No/Date:0910040991 18.02.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 46/82 meeĕng held on 09.02.2010 and in consultaĕon with technical authority present in meeĕng decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

y p g y p p pp y Export Product Export Qty. Sl.No. Import items Qty. allowed Tenofovir Disoproxil Fumarate 1 Kg. 1. Adenine 0.914 kg 2. R‐Propylene Carbonate 0.7938 kg 3. Methanol 2.95 kg 4. Diethyl‐Tosyloxymethyl Phosphonate 2.025 kg 5. Tetrahydrofuran 4.28 kg 6. Lithium tert‐Butoxide 0.536 kg 7. Methylene Dichloride 7.84 kg 8. Acetonitrile 2.94 kg 9. Chloromethyl Chloro Formate 2.0867 kg 10. N‐methyl‐2‐Pyrolidone 3.92 kg 117

Case No.:1/50/82‐ALC4/2009

Party Name:SHIVA PHARMACHEM PVT. LTD, 04.05.2010 Status:Case Deferred HQ File :01/82/050/01155/AM10/ RLA File :34/24/040/00202/AM10/ Lic.No/Date:3410026420 19.02.2010 Defer Date:01.06.2010 118

Case No.:3/50/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/01157/AM10/ RLA File :03/95/040/00760/AM10/ Lic.No/Date:0310561196 22.02.2010 Defer Date:01.06.2010 119

Case No.:4/50/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/01158/AM10/ RLA File :03/95/040/00754/AM10/ Lic.No/Date:0310561197 22.02.2010 Defer Date:01.06.2010 120

Case No.:7/50/82‐ALC4/2009

Party Name:CADILA HEALTHCARE LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/01161/AM10/ RLA File :08/24/040/00326/AM10/ Lic.No/Date:0810086746 Defer

23.02.2010 Date:01.06.2010 121

Case No.:93/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00127/AM11/ RLA File :22/24/040/00052/AM10/ Lic.No/Date:2210009691 23.02.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 16/AM10 meeĕng held on 04.08.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Clarithromycin Granules 42% (Suspension Grade) 1kg. 1. Clarithromycin Or Its raw materials as per SION A‐2263 on prorate basis 0.4242 KG 2. Carbopol 0.30 kg 3. HPMC Phthalate 0.30 kg RA concerned may take further necessary acĕon as per above decision of NC. 122

Case No.:104/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00138/AM11/ RLA File :22/24/040/00053/AM10/ Lic.No/Date:2210009690 23.02.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 16/AM10 meeĕng held on 04.08.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Clarithromycin Granules 27.5% (Suspension Grade) 1kg. 1. Clarithromycin Or Its raw materials as per SION A‐2263 on prorate basis 0.2778 KG 2. Carbopol 0.20 kg 3. HPMC Phthalate 0.54 kg RA concerned may take further necessary acĕon as per above decision of NC.

123

Case No.:11/50/82‐ALC4/2009

Party Name:LAFFANS PETROCHEMICALS LTD., 04.05.2010 Status:Case Approved HQ File :01/82/050/01165/AM10/ RLA File :03/95/040/00772/AM10/ Lic.No/Date:0310561666 24.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/7/2003‐Ch.II dated 03.05.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Glycol Mono Ethyl Ether 1 kg 1. Denatured Ethyl Alcohol 0.350 kg 2. Ethylene Oxide 0.670 kg 124

Case No.:14/50/82‐ALC4/2009

Party Name:AMBUJA INTERMEDIATES LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/01168/AM10/ RLA File :03/94/040/01020/AM10/ Lic.No/Date:0310561828 24.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/1/2008‐Ch.II dated 23.02.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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‐Carbethoxyamino‐5‐Naphthol Sulfonic Acid (2‐CNS Acid) 1 kg 1. J Acid 1.322 kg 125

Case No.:15/50/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/01169/AM10/ RLA File :03/95/040/00779/AM10/ Lic.No/Date:0310561977 25.02.2010 Defer Date:01.06.2010 126

Case No.:16/50/82‐ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/01170/AM10/ RLA File :09/24/040/00478/AM10/ Lic.No/Date:0910041061 25.02.2010 Defer Date:01.06.2010 Decision :Commiĥee decided to defer case for 01.06.2010 for comments of Department of Pharmaceuĕcals.

127

Case No.:17/50/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/01171/AM10/ RLA File :05/24/040/00486/AM10/ Lic.No/Date:0510259472 25.02.2010 Defer Date:01.06.2010 128

Case No.:18/50/82‐ALC4/2009

Party Name:STERLING AUXILIARIES PVT LTD 04.05.2010 Status:Case Approved HQ File :01/82/050/01172/AM10/ RLA File :03/95/040/00781/AM10/ Lic.No/Date:0310562269 26.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/93/2007‐Ch.II dated 03.05.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed STERO AEEA (Amino Ethyl Ethanol Amine) 1 kg 1. Ethylene Di Amine 0.588 kg 2. Ethylene Oxide 0.431 kg STERO MPEA (Poly Ethoxylated Methyl Amine) 1 Kg. 1. Mono Methyl Amine 0.194 kg 2. Ethylene Oxide 0.826 kg STERSOLVE ECEL (Ethylene Glycol Mono Ethyl Ether) 1 Kg. 1. Ethanol 0.521 kg 2. Ethylene Oxide 0.498 kg STANOX DSTDP (Di Stearyl Thiodipropionate) 1 Kg. 1. Acryloniĕrle 0.158 kg 2. Stearyl Alcohol 0.807 kg 129

Case No.:20/50/82‐ALC4/2009

Party Name:SHIVA PHARMACHEM PVT. LTD, 04.05.2010 Status:Case Approved HQ File :01/82/050/01174/AM10/ RLA File :34/24/040/00204/AM10/ Lic.No/Date:3410026497 26.02.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/101/2002/Ch.II dated 04.10.2007 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Ethyl Hexanoyl Chloride 1 Kg. 1. 2‐Ethyl Hexanoic Acid 0.925 kg

130

Case No.:41/5/82‐ALC4/2010

04.05.2010 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:01.06.2010 131

Case No.:42/5/82‐ALC4/2010

04.05.2010 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:01.06.2010 132

Case No.:44/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred HQ File :01/82/050/00078/AM11/ RLA File :09/24/040/00494/AM10/ Lic.No/Date:0910041151 03.03.2010 Defer Date:01.06.2010 133

Case No.:86/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00120/AM11/ RLA File :22/24/040/00054/AM10/ Lic.No/Date:2210009749 05.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce├riaxone Sodium Sterile 1 Kg. 1. Ce├riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Aceĕc Acid Disodium Salt Dihydrate (EDTA) 0.01 kg 4. Eno Carbon 51.66 gm 134

Case No.:1/52/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 04.05.2010 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:01.06.2010 Decision :Commiĥee considered case as per agenda and decided to call for the complete descripĕon of export product alongwith the copy of DML from the firm. Accordingly, case was deferred for 01.06.2010. 135

Case No.:96/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred HQ File :01/82/050/00130/AM11/ RLA File :22/24/040/00055/AM10/ Lic.No/Date:2210009769 10.03.2010 Defer Date:01.06.2010 136

Case No.:28/5/82‐ALC4/2010

Party Name:S.KANT HEALTHCARE LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/00062/AM11/ RLA File :03/95/040/00824/AM10/ Lic.No/Date:0310564569 12.03.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 32/82 meeĕng held on 03.11.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Artemether 1 Kg 1. Artemisinin 1.50 kg Artesunate 1 kg. 1. Artemisinin 0.9259 kg. Dihydro Artemisinin 1 Kg. 1. Artemisinin 1.12 kg 137

Case No.:109/5/82‐ALC4/2010

Party Name:KLJ PLASTICIZERS LTD, 04.05.2010 Status:Case Deferred HQ File :01/82/050/00143/AM11/ RLA File :05/23/040/00204/AM10/ Lic.No/Date:0510260377 12.03.2010 Defer Date:01.06.2010 138

Case No.:113/5/82‐ALC4/2010

Party Name:KLJ PLASTICIZERS LTD, 04.05.2010 Status:Case Deferred HQ File :01/82/050/00147/AM11/ RLA File :05/23/040/00203/AM10/ Lic.No/Date:0510260360 12.03.2010 Defer Date:01.06.2010

139

Case No.:31/5/82‐ALC4/2010

Party Name:YASHO INDUSTRIES PVT.LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/00065/AM11/ RLA File :03/95/040/00820/AM10/ Lic.No/Date:0310564712 15.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/120/2007/Ch.III dated 07.07.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Butylated Hydroxy Anisole 1 Kg. 1. Hydroquinone 1.247 kg 2. Terĕary Butanol 0.839 kg 3. Phosphoric Acid 1.00 kg 4. Hexane 1.00 kg 140

Case No.:111/5/82‐ALC4/2010

Party Name:CHIRAG ENTERPRISE 04.05.2010 Status:Case Approved HQ File :01/82/050/00145/AM11/ RLA File :24/24/040/00018/AM10/ Lic.No/Date:2410027698 17.03.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 5/83 meeĕng held on 30.04.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Qty. allowed Crude Methyl Methacrylate Monomer 1 kg 1. Acrylic Plasĕc Strips/Offcuts 1.25 kg 141

Case No.:26/5/82‐ALC4/2010

Party Name:GLENMARK GENERICS LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00060/AM11/ RLA File :03/94/040/01050/AM10/ Lic.No/Date:0310565162 18.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/127/2006‐PI‐III dated 14.08.2006 and in consultaĕon with technical authority present in meeĕng decided to raĕfy 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

Glimepride 1 Kg. 1. 4‐(2‐3‐Ethyl‐4‐Methyl‐2‐Oxo‐3‐Pyrroline‐1‐ Carboxamido Ethyl Phenyl Sulfonamide) 0.96 kg 2. Trans‐4‐Methyl Cyclohexyl Isocyanate 0.39 kg 3. Acetone 2.50 kg 4. Methanol 2.50kg 142

Case No.:27/5/82‐ALC4/2010

Party Name:SARNA CHEMICALS PVT.LTD. 04.05.2010 Status:Case Deferred HQ File :01/82/050/00061/AM11/ RLA File :03/95/040/00832/AM10/ Lic.No/Date:0310565202 18.03.2010 Defer Date:01.06.2010 143

Case No.:1/1/82‐ALC4/2010

Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:5/82‐ALC4/2010 04.05.2010 Status:Case Deferred HQ File :01/82/050/01232/AM10/ RLA File :05/24/040/00501/AM10/ Lic.No/Date:0510260909 22.03.2010 Defer Date:01.06.2010 144

Case No.:2/1/82‐ALC4/2010

Party Name:NAPROD LIFE SCIENCES PVT. LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/01233/AM10/ RLA File :03/95/040/00834/AM10/ Lic.No/Date:0310565691 22.03.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/96/2009‐PI‐III dated 17.03.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Hydrocorĕsone Sodium Succinate for injecĕon (hydrocorĕsone sodium succinate buffered 5% strile) organic chemicals 1 Kg. 1. Hydrocorĕsone Base 1.00 kg 145

Case No.:3/1/82‐ALC4/2010

Party Name:STERLING AUXILIARIES PVT LTD 04.05.2010 Status:Case Approved HQ File :01/82/050/01234/AM10/ RLA File :03/95/040/00853/AM10/ Lic.No/Date:0310565697

22.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/93/2007‐Ch.II dated 03.05.2010 and in consultaĕon with technical authority present in meeĕng, decided to revise norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed STERO MDEA EX (Monomethyl Amine Ethoxylate) 1 Kg. 1. Mono Ethyl Amine 0.265 kg 2. Ethylene Oxide 0.754 kg 146

Case No.:7/1/82‐ALC4/2010

Party Name:MEGHMANI ORGANICS LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/01238/AM10/ RLA File :08/24/040/00348/AM10/ Lic.No/Date:0810087615 24.03.2010 Defer Date:01.06.2010 147

Case No.:30/5/82‐ALC4/2010

Party Name:SHIRDI CHEMICALS PVT. LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/00064/AM11/ RLA File :03/95/040/00869/AM10/ Lic.No/Date:0310567154 30.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/154/2004‐Ch.III dated 16.01.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Dimethyl Bisphenol Cyclohexane 1 kg 1. Ortho Cresol 1.05 kg 2. Dodecyl Benzene Sulphonic Acid 0.53 kg 3. 3‐Mercaptopropionic Acid 0.026 kg 148

Case No.:85/5/82‐ALC4/2010

Party Name:SAURAV CHEMICALS LTD, 04.05.2010 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:15.06.2010

149

Case No.:87/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00121/AM11/ RLA File :22/24/040/00058/AM10/ Lic.No/Date:2210009839 31.03.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/182/2009‐PI‐(Norms) and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Cefpodoxime Proxeĕl 1 Kg. 1. 7‐ACA 0.998 kg 2. Sulfolane 1.29 kg 3. Methanol 1.17 kg 4. Methylene Chloride 5.82 kg 5. Trimethylamine 0.562 kg 6. Tetrahydrofuran 0.92 kg 7. MAEM 0.998 kg 8. Chloroiethyl Isopropyl Carbonate 0.558 kg 9. Sodium Iodide 0.390 kg 10. 18‐Crown‐6‐Ether 0.023 kg 11. Cyclohexene 2.09 k 12. Acetone 0.53 kg 13. 1,8‐Diazabicyclo (DBU) 0.341 kg 14. Dimethyl Acetamide 0.58 kg 15. Eno Carbon 0.100 kg 16. Toluene 0.39 kg 150

Case No.:107/5/82‐ALC4/2010

Party Name:VDH INTERNATIONAL 04.05.2010 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:01.06.2010 151

Case No.:106/5/82‐ALC4/2010

Party Name:DHANUKA LABORATORIES LTD. 04.05.2010 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:01.06.2010

152

Case No.:53/5/82‐ALC4/2010

Party Name:CADILA PHARMACEUTICALS LTD. 04.05.2010 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:01.06.2010 153

Case No.:1/5/82‐ALC4/2010

Party Name:PORUS LABORATORIES PVT LTD. 04.05.2010 Status:Case Deferred HQ File :01/82/050/00035/AM11/ RLA File :09/24/040/00529/AM10/ Lic.No/Date:0910041750 21.04.2010 Defer Date:01.06.2010 154

Case No.:2/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00036/AM11/ RLA File :03/94/040/01055/AM10/ Lic.No/Date:0310570549 21.04.2010 Decision : Commiĥee considered case as per agenda and in light of earlier decision taken in 2/82 meeĕng held on 16.05.2007 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Quanĕty allowed PMIC Chloride 1 kg 1. Benzaldehyde 0.85 kg 2. Hydroxylamine Sulphate 0.73 kg 3. Methyl aceto Acetate 0.92 kg 4. Phosphorous Pentachloride 1.12 kg 5. Causĕc Soda Flakes 1.17 kg 6. Triethylamine 0.11 kg 7. Chloroform 0.39 kg 8. Toluene 0.50 kg 9. Methanol 2.85 kg RLA concerned may take further necessary acĕon as per above decision of NC. 155

Case No.:3/5/82‐ALC4/2010

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 04.05.2010 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:01.06.2010 156

Case No.:4/5/82‐ALC4/2010

Party Name:SUVEN LIFE SCIENCES LIMITED 04.05.2010 Status:Case Deferred HQ File :01/82/050/00038/AM11/ RLA File :09/24/040/00554/AM10/ Lic.No/Date:0910041759 22.04.2010 Defer Date:01.06.2010 157

Case No.:5/5/82‐ALC4/2010

Party Name:ATUL LIMITED, 04.05.2010 Status:Case Approved HQ File :01/82/050/00039/AM11/ RLA File :08/24/040/00015/AM11/ Lic.No/Date:0810088411 22.04.2010 Decision : Commiĥee considered case as per agenda for raĕficaĕon of norms and in light of wriĥen comments forwarded by PC Division vide their O.M. No.46011/105/2005‐PC.II dated 23.06.2008 decided to raĕfy 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 Reacĕve Diluent Lapox 1 Kg. 1. Epichlorohydrin 0.920 kg 2. Phenol 0.941 kg 158

Case No.:6/5/82‐ALC4/2010

Party Name:INTAS PHARMACEUTICALS LTD., 04.05.2010 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:01.06.2010 159

Case No.:7/5/82‐ALC4/2010

04.05.2010 Status:Case Deferred HQ File :01/82/050/00041/AM11/ RLA File :09/24/040/00013/AM11/ Lic.No/Date:0910041764 22.04.2010 Defer Date:01.06.2010 160

Case No.:8/5/82‐ALC4/2010

Status:Case

04.05.2010 Deferred HQ File :01/82/050/00042/AM11/ RLA File :09/24/040/00016/AM11/ Lic.No/Date:0910041765 22.04.2010 Defer Date:01.06.2010 161

Case No.:9/5/82‐ALC4/2010

04.05.2010 Status:Case Approved HQ File :01/82/050/00043/AM11/ RLA File :09/24/040/00001/AM11/ Lic.No/Date:0910041766 22.04.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/155/2009‐PI‐III dated 03.11.2009 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Cefuroxime Axeĕl DC Grade Grannules 1 Kg. 1. 7‐ACA 0.70 kg 2. Chlorosulfonyl Isocyanate 0.369 kg 3. Triethylamine 0.546 kg 4. Ammonium Salt 0.581 kg 5. Tetrain 0.482 kg 6. Carbon Enoanĕcromos 0.070 kg 7. Acetone 1.756 kg 8. Acetonitrile 0.984 kg 9. Cyclohexane 2.587 kg 10. N,N‐Dimethyl Acetamide 0.583 kg 11. Methanol 2.10 kg 12. MIBK 1.64 kg 13. Methylene Chloride 3.82 kg 162

Case No.:10/5/82‐ALC4/2010

Party Name:PARABOLIC DRUGS LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/00044/AM11/ RLA File :05/24/040/00003/AM11/ Lic.No/Date:0510262859 22.04.2010 Defer Date:25.05.2010 Decision :Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their U.O. No.35011/273/2009‐PI (Norms) dated 30.04.2010 decided to call for the firm alongwith the following informaĕon for personal hearing before the Commiĥee on 25.05.2010. 1. Percentage content of Cefepime Hcl (Sterile) and L‐Arginine (Sterile) in the export product.

2. Process of manufactur showing wastage in sterilizaĕon and in further processing. Accordingly, case was deferred for 25.05.2010. 163

Case No.:11/5/82‐ALC4/2010

Party Name:PARABOLIC DRUGS LTD., 04.05.2010 Status:Case Deferred HQ File :01/82/050/00045/AM11/ RLA File :05/24/040/00017/AM11/ Lic.No/Date:0510262860 22.04.2010 Defer Date:25.05.2010 Decision :Commiĥee decided to call the firm for personal hearing before the Commiĥee on 25.05.2010 alongwith the copy of RCMC, copy of DML and other relevant documents. Accordingly, case was deferred for 25.05.2010. 164

Case No.:67/5/82‐ALC4/2010

Party Name:NEON LABORATORIES LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/00101/AM11/ RLA File :03/95/040/00051/AM11/ Lic.No/Date:0310570715 22.04.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/282/2009‐PI (Norms) dated 28.04.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy 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 Pethidine Injecĕon 50 mg/ml 1 Ampule 1. Pethidine Hcl BP 55.0 mg/Ampule 165

Case No.:12/5/82‐ALC4/2010

Party Name:DR REDDYS LABORATORIES LTD 04.05.2010 Status:Case Deferred HQ File :01/82/050/00046/AM11/ RLA File :09/24/040/00563/AM10/ Lic.No/Date:0910041793 23.04.2010 Defer Date:01.06.2010 166

Case No.:13/5/82‐ALC4/2010

Party Name:DR REDDYS LABORATORIES LTD 04.05.2010 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:01.06.2010 167

Case No.:14/5/82‐ALC4/2010

Party Name:MSN LABORATORIES LIMITED Status:Case

04.05.2010 Approved HQ File :01/82/050/00048/AM11/ RLA File :09/24/040/00020/AM11/ Lic.No/Date:0910041795 23.04.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/159/2009‐PI‐(Norms) dated 18.01.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Rosuvastaĕn Calcium 1 Kg. 1. S‐4‐Chloro‐3‐Hydroxybutanenitrile 2.47 kg 2. Sodium Borohydride 1.11 kg 3. Diethylmethoxy Borane 1.922 kg 4. Methyl Isobutyl Acetate 2.11 kg 5. Diisobutyl Aluminium Hydride 2.79 kg 6. 2,2‐Dimethoxy Propane 4.141 kg 7. Tert. Butyl Bromoacetate 11.20 kg 8. Para Toluene Sulfonyl Chloride 2.77 kg 9. Para Fluoro Benzaldehide 1.95 kg 168

Case No.:69/5/82‐ALC4/2010

Party Name:ALEMBIC LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00103/AM11/ RLA File :34/24/040/00016/AM11/ Lic.No/Date:3410026878 23.04.2010 Decision :Commiĥee decided to close the case as Advance Authorisaĕon has been issued under para 4.7.1 of HBP. 169

Case No.:73/5/82‐ALC4/2010

Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 04.05.2010 Status:Case Approved HQ File :01/82/050/00107/AM11/ RLA File :03/94/040/00064/AM11/ Lic.No/Date:0310570983 23.04.2010 Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of C&PC vide their U.O. No.14010/98/2007‐Ch.II dated 20.11.2008 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Ethylene Glycol Stearate 1 kg 1. Monoethylene Glycol 0.118 kg 2. Stearic Acid 1.027 kg

170

Case No.:77/5/82‐ALC4/2010

Party Name:LUPIN LIMITED 04.05.2010 Status:Case Approved HQ File :01/82/050/00111/AM11/ RLA File :03/95/040/00031/AM11/ Lic.No/Date:0310571221 26.04.2010 Defer Date: Decision : Commiĥee considered case as per agenda and in light of wriĥen comments forwarded by Department of Pharmaceuĕcals vide their O.M. No.35011/168/2009‐PI (Norms) dated 22.02.2010 and in consultaĕon with technical authority present in meeĕng, decided to raĕfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Quantity Sl.No. Import items Quantity allowed Ethambutol 1 Kg. 1. DL2 Amino Butanol 1.6014 kg 2. Tartaric Acid 0.153 kg 3. Methanol 0.562 kg 4. Isopropyl Alcohol 0.278 kg 5. Ethylene Dichloride 0.490 kg 6. Caustic Soda Flakes 0.424 kg 7. Cyclohexane 0.0056 kg 8. Calcium Hydroxide 1.4239 kg Outside Agenda Case No.‐ Indian Drug Manufacturers Associaĕon F.No.01/82/162/127/AM10 Meeĕng Date:04.05.2010 Indian Drug Manufacturers Associaĕon (IDMA) in its representaĕon dated 22.04.2010 has menĕoned that Metronidazole is a life saving drug. This drug is manufactured by only M/S Aarĕ Drugs Ltd, Valsad and their plant is currently shut down due to Court Orders. They have further menĕoned that some of manufacturers are holding advance licence shich allows import of Metronidazole from registered sources. However, applicaĕon of many suppliers are pending with Drugs Controller General of India for registraĕon. In these circumstances menĕoned above, IDMA has requested that some of manufacturers holding advance licences which allow import of Metronidazole from registered resources, may be allowed to import Metronisazole from suppliers whose applicaĕons are pending in DCGI’s office for re‐registraĕon. This issue was placed before NC in its meeĕng held on 4th May, 2010. NC handed over a copy of this registraĕon to Sh. M. Mitra, Dy. Drugs Controller (I) in the office of DCGI for examinaĕon and their comments . It was decided to defer the case for 2 weeks and to re‐list it on 18.05.2010.

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