DGFT Committee Minutes

Directorate General of Foreign Trade Ministry of Commerce & Industry, Maulana Azad Road, Udyog Bhawan New Delhi -110011

Para 4.7 Decision

MEETING NUMBER : 42/82-ALC4/2007 MEETING DATE : 11.03.2008 The Meeting No.42/08 for the licensing year 2007-08 to consider the cases under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2004-09 pertaining to Pharma Products due for 19.02.2008 was actually held on 11.03.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No21/08 dated 25.09.2007, 22/08 dated 04.10.2007, 23/08 dated 09.10.2007 and 24/08 dated 16.10.2007 were ratified by the Committee.

Case No.B-544

M/s Alliance Laboratories Ltd M.No.42/08 F.No.01/82/50/424/AM 08 F.No.01/83/50/1037/AM 08 Meeting Date 19.02.2007 Adv. Lic. No. 0310430399 dt. 23.05.2007 Adv. Lic. No. 0310441279 dt. 30.08.2007 The Committee considered the case as per agenda for ratification of norms for the export product Iso Sorbide –5-Mononitrate under para 4.7 of HBP. Committee decided to withdraw case as case has already been considered in its 44/08 meeting held on 03.03.2008.

Case No.B-545

M/s Glenmark Pharmaceutical Ltd M.No.42/08 F.No.01/82/162/285/AM 08 RLA F.No.03/24/40/1482/AM05 Adv. Lic. No0310295800 dt.7.10.2004 the export product Cilazapril under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.B-546

M/s Glenmark Pharmaceutical Ltd M.No.42/08 F.No.01/82/162/1484/AM 06 RLA F.No.03/94/40/1347/AM06 Adv. Lic. No0310372003 dt. 17.3.2006

the export product Cilazapril under para 4.7 of HBP.

Case No.B-547

M/s Glenmark Pharmaceutical Ltd M.No.42/08 F.No.01/82/50/1159/AM 05 RLA F.No.03/24/40/1482/AM05 Adv. Lic. No0310295800 dt. 7.10.05 the export product Cilazapril under para 4.7 of HBP.

Case No.B-548

M/s Calyx Chemicals & Pharmaceutical Ltd M.No.42/08 F.No.01/82/50/1369/AM 04 RLA F.No.03/24/40/2120/AM04 Adv. Lic. No.0310249192 dt. 22.01.2004 the export product Zopiclone BP/USP under para 4.7 of HBP. Committee observed that Advance Authorisation was issued on 22.01.2004 and the norms were ratified in its meeting held on 28.07.2004 while representation of firm has been received only on 04.10.2007 i.e. after a gap of more than three and half years. Committee, therefore, decided to maintain status quo.

Case No.B-549

M/s Avignon Exim Pvt. Ltd M.No.42/08 F.No.01/87/50/1102/AM 07 RLA F.No.03/94/40/1374/AM07 Adv. Lic. No0310422847 dt. 13.03.2007

the export product Niacinamide BP/USP under para 4.7 of HBP. Committee in light of written comments forwarded by Department of MSME vide their U.O. No.5(9)/2005-Chem dated 05.02.2008 decided to ratify norms under para 4.7 of HBP as per detais below or as applied by firm whichever is lower:- Export product Export Qty. Import item Qty. allowed per unit

of

export product Niacinamide BP/USP 1kg. Mix

Picoline (containing 87.5% +1% Beta Picoline) 1.369kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-550

M/s Om Shri Pharma Pvt. Ltd M.No.42/08 F.No.01/83/50/725/AM 08 RLA F.No.03/95/40/230/AM08 Adv. Lic. No.0310432141 dt. 8.06.2007 the export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee decided to withdraw case as case has already been considered in its 44/08 meeting held on 03.03.2008.

Case No.B-551

M/s Om Shri Pharma Pvt. Ltd M.No.42/08 F.No.01/83/50/1267/AM 07 RLA F.No.03/95/40/1424/AM07 Adv. Lic. No.0310420407 dt. 21.02.2007 the export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee decided to withdraw case as case has already been considered in its 44/08 meeting held on 03.03.2008.

Case No.B-552

M/s Om Shri Pharma Pvt. Ltd M.No.42/08 F.No.01/83/50/1378/AM 07 RLA F.No.03/95/40/1605/AM07 Adv. Lic. No.0310424623 dt. 27.03.2007

the export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee decided to withdraw case as case has already been considered in its 44/08 meeting held on 03.03.2008.

Case No.B-553

M/s SMS Pharmaceutical Ltd M.No.42/08 F.No.01/83/162/425/AM 07 RLA F.No.09/24/40/377/AM06 Adv. Lic. No0910025027 dt. 28.11.2005 The Committee considered the case as per agenda for revision of norms for the export product D-erythro,d-threo-2-Deoxy-2,2-difluoro penta furanos-1 ulose-3,5- dibenzoate under para 4.7 of HBP.

Case No.B-554

M/s SMS Pharmaceutical Ltd M.No.42/08 F.No.01/83/162/424/AM 07 RLA F.No.09/24/40/02/AM06 Adv. Lic. No0910023407 dt. 05.07.2005 The Committee considered the case as per agenda for revision of norms for the export product D-erythro,d-threo-2-Deoxy-2,2-difluoro penta furanos-1 ulose-3,5- dibenzoate under para 4.7 of HBP.

Case No.B-555

M/s Vasudha Pharma Ltd M.No.42/08 F.No.01/83/50/1097/AM 08 Adv. Lic. No.0910031382 dt. 03.09.2007 The Committee considered the case as per agenda for revision of norms for the export product Amitriptyline Crude under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.B-556

M/s Vasudha Pharma Ltd M.No.42/08 F.No.01/83/50/1098/AM 08 Adv. Lic. No.0910031383 dt. 03.09.2007

The Committee considered the case as per agenda for revision of norms for the export product Dibenzosuberone under para 4.7 of HBP.

Case No.B-557

Jt. DGFT, Hyderabad M.No.42/08 F.No.01/82/162/821/AM 08 The Committee considered the case as per agenda for clarification regarding applicability of DEPB for Veterinary Injections/Drugs under Sl.No.40A and 42C of Chemical Products. Committee observed that there is no separate SION for Veterinary Injections/Drugs and therefore, no DEPB rate could be fixed.

Case No.B-558

M/s Smilax Laboratories Ltd M.No.42/08 F.No.01/83/50/1203/AM 07 RLA F.No.09/24/40/466/AM07 Adv. Lic. No.0910029229 dt. 07.02.2007 the export product 5-Methoxy –2-(4-Methoxy-3,5-Dimethyl-2 Pyridinyl)Methyl) Thio-1 Hbenzimidazole under para 4.7 of HBP.

Case No.B-559

M/s Smilax Laboratories Ltd M.No.42/08 F.No.01/82/50/10/AM 08 RLA F.No.09/24/40/555/AM07 Adv. Lic. No.0910029933 dt. 10.04.2007 the export product 2-Chloro methyl-3-methyl-4-(2,2,2-trifluoro ethoxy) pyridine HCL(Lansoprazole-Chlorointermediate) under para 4.7 of HBP.

Case No.A-1073

M/s Emami Ltd M.No.42/08 F.No.01/83/162/1069/AM 08 RLA F.No.02/24/40/183/AM08 Adv. Lic. No.0210106154 dt. 19.11.2007

the export product Himani(Fast Relief) Pain Relief Ointment(Hero) under para 4.7 of HBP. Committee decided to call for a copy of DML from firm. Accordingly, case was deferred for six weeks.

Case No.A-1074

M/s Aurolab
M.No.42/08 F.No.01/85/50/75/AM 08 RLA F.No.35/24/40/29/AM08 Adv. Lic. No.3510021598 dt. 4.09.2007 the export product Aurovisc,Visivisc,Curagel, Rhoto Visc and Supreme Viscoelastic Surgical Fluild Hydroxypropyl Methylcellulose 2% PFS under para 4.7 of HBP. Committee decided to transfer case to DES-VII as export product pertains to Plastic Sector.

Case No.A-1075

M/s Elpee Chemicals Pvt. Ltd. Ltd M.No.42/08 F.No.01/83/50/1371/AM 08 RLA F.No.03/94/40/728/AM08 Adv. Lic. No.0310446807 dt. 17.10.2007 the export product Niclosamide Piperazine Salt under para 4.7 of HBP. Committee in light of its earlier decision taken in its 22/82 meeting held on 04.10.2007 vide Case No.724/24/83 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Niclosamide Piperazine Salt 1kg. 1. Salicylic acid 0.65kg/kg 2. Triethylamine 0.26kg/kg 3. Piperazine Anhydrous 0.13kg/kg 4. Thionyl chloride 0.20kg/kg 5. IPA 0.30kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-1076

M/s Alkaloid Corporation Ltd

M.No.42/08 F.No.01/83/50/1409/AM 08 RLA F.No.02/24/40/155/AM08 Adv. Lic. No.0210103867 dt. 6.09.2007 the export product 1. Noscapine BP/Noscapine Hydrochloride BP 2. Papaverine Hydrochloride BP under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/66/2006-PI-III dated 11.03.2008 decided to ratify 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 Quantity Import items Qty. allowed per unit

of

export product Noscapine BP/Noscapine Hcl BP 0.11kg 1 X Papaverine crude containing Noscapine

not more than 12% and crude Papaverine not more than 40% 1kg/0.11kg Papaverine Hcl BP 0.373kg 1 X Papaverine crude containing Noscapine

not more than 12% and crude Papaverine not more than 40% 1kg/0.373kg The imported Papaverine crude shall not contain any narcotic material like opium, Morphine, Codeine, Thevaine or any other alkaloids. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-1077

M/s Global Calcium Ltd M.No.42/08 F.No.01/83/50/1077/AM 08 RLA F.No.07/24/40/861/AM07 Adv. Lic. No.0710051390 dt. 24.04.2007 the export product 1. Zinc Gluconate 2. Magnesium Gluconate 3. Potassium Gluconate 4. Ferrous Gluconate 5. Manganese Gluconate 6. Calcium Magnesium Lactate Gluconate 7. Magnesium Lactate Gluconate 8. Cobalt Gluconate 9.Copper Gluconate under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of PI/Chem. Division.

Case No.A-1078

M/s Aarti Drugs Ltd M.No.42/08 F.No.01/82/50/341/AM 08 RLA F.No.03/94/40/753/AM08 Adv. Lic. No.0310455126 dt. 26.12.2007 the export product Metoprolol Succinate under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1079

M/s Global Calcium Ltd M.No.42/08 F.No.01/83/162/1033/AM 08 RLA F.No.07/24/40/53/AM08 Adv. Lic. No.0710051439 DT. 26.04.2007 the export product Calcium Gluconate under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of PI/Chem. Division.

Case No.A-1080

M/s Gland Pharma Ltd M.No.42/08 F.No.01/82/50/254/AM 08 RLA F.No.09/24/40/314/AM08 Adv. Lic. No.0910031800 dt. 16.10.2007 the export product Adenosine Injection USP Prefilled Syringe under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1081

M/s Neo Medichem Pvt. Ltd M.No.42/08 F.No.01/82/50/329/AM 08 RLA F.No.09/21/40/288/AM08 Adv. Lic. No.0910031762 dt. 12.10.2008 the export product 1(2-4-Difluoro Phenyl under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1082

M/s Nicholas Piramal (I)Ltd M.No.42/08 F.No.01/83/50/118/AM 05 RLA F.No.03/24/40/367/AM05 Adv. Lic. No.0310270588 dt. 25.05.2004

the export product Halothane BP under para 4.7 of HBP. the export product Halothane BPunder para 4.7 of HBP on the rquest of RA that no norms has been fixed earlier in this case and no decision of Committee is available with them. Committee in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Sl.N o. Import items Qty allowed per unit of export product Halothane BP 1kg. 1. Halothane Technical Grade Nil 1.02kg/kg RA concerned may take further necessary action as per above decision of Norms committee. In case any different decision has been taken contrary to above decision, the onus lies on the RA & firm.

Case No.A-1083

M/s Nicholas Piramal (I)Ltd M.No.42/08 F.No.01/83/50/130/AM 06 RLA F.No.03/24/40/2889/AM05 Adv. Lic. No.0310333873 dt. 10.06.2005 the export product Complete Tablets of 54mg under para 4.7 of HBP. Committee decided to forward a copy of application to Department of Bio- technology for their comments. Accordingly, case was deferred for six weeks.

Case No.C-35

M/s Amsal Chem Pvt. Ltd M.No.42/08 F.No.01/87/50/456/AM 08 The Committee considered the case as per agenda for modification of DEPB Sl.No.55. Committee decided to defer case for three weeks for comments of Department of Revenue.

Case No.C-36

M/s Lupin Ltd M.No.42/08 F.No.01/82/162/797/AM 08 The Committee considered the case as per agenda for modification of SION A- 225.

Case No.C-37

M/s NGL Fine Chem Ltd M.No.42/08 F.No.01/82/162/796/AM 08 The Committee considered the case as per agenda for fixation of norms under

para 4.4.2 of HBP.

Committee observed that application for fixation of norms under para 4.4.2 of HBP was filed one and half years back and no norms can be fixed against such an old application. Committee, therefore, decided to close the case. Firm may be advised to apply afresh. 1

Case No.:49/42/82-

ALC4/2007 Party Name:CORAL LABORATORIES LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Closed HQ File : 01/82/050/00385/AM08/ RLA File : 03/24/040/01378/AM02/ Lic.No/Date:03101225 68 01.02.2002

Decision :Committee considered case as per agenda for ratification of norms for export product under para 4.7 of HBP. Committee noticed that advance authorization was issued on 25.01.2002 and norms can not be ratified against such an old licence. Committee, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee. 2

Case No.:6/42/82-

ALC4/2007 Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 Status:Cas e Closed

19.02.2008 HQ File : 01/82/050/00342/AM08/ RLA File : 04/81/040/00249/AM04/ Lic.No/Date:04100533 50 20.02.2004

Decision : Committee considered case as per agenda for ratification of norms for export product Benzarone under para 4.7 of HBP. Committee noticed that advance authorization was issued on 20.02.2004 and norms can not be ratified against such an old licence. Committee, therefore, decided to close the case. of Norms Committee. 3

Case No.:7/42/82-

ALC4/2007 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00343/AM08/ RLA File : 08/24/040/00259/AM06/ Lic.No/Date:08100541 57 22.02.2006 Defer Date: 22.04.2008 norms for export product under para 4.7 of HBP. Committee observed that application alongwith details of import and export has not been received from RA. Committee, therefore, decided to call for application alongwith details of import and export from RA. Accordingly, case was deferred for six weeks. 4

Case No.:8/42/82-

ALC4/2007 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00344/AM08/ RLA File : 03/95/040/00479/AM07/ Lic.No/Date:03103915 84 26.07.2006 Defer Date: 08.04.2008 norms for export product Acephate Technical 97% Min. under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Division of C&PC for their comments. Accordingly, case was deferred for four weeks. 5

Case No.:39/22/83-

ALC1/2006 Party Name:SAI LIFE SCIENCES LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred

HQ File : 01/83/050/00484/AM07/ RLA File : 09/24/040/00152/AM07/ Lic.No/Date:09100270 96 01.08.2006 Defer Date: 15.04.2008 norms for export product Strontium Ranelate under para 4.7 of HBP. Committee decided to obtain case file from DES-IV. Accordingly, case was deferred for five weeks. 6

Case No.:389/24/83-

ALC1/2007 Party Name:PI INDUSTRIES LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status: Deferred HQ File : 01/83/050/01034/AM07/ RLA File : 13/24/040/00024/AM07/ Lic.No/Date:13100234 04 18.12.2006 Defer Date: 08.04.2008 norms for export product 2-Chloro-6-thiomethyl toluene (2C6SMT) under

para 4.7 of HBP.

four weeks. 7

Case No.:9/42/82-

ALC4/2007 Party Name:DORF-KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status: Deferred HQ File : 01/82/050/00345/AM08/ RLA File : 03/94/040/01125/AM07/ Lic.No/Date:03104154 09 11.01.2007 Defer Date: 08.04.2008 norms for export product Chemical-Organic Mixture-Trade Name SR 8103 four weeks. 8

Case No.:10/42/82-

ALC4/2007 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00346/AM08/ RLA File : 03/94/040/00890/AM07/ Lic.No/Date:03104155 22 11.01.2007 Defer Date: 08.04.2008

norms for export product Ethyl Triphenyl Phosphonium Bromide under para 4.7 of HBP. four weeks. 9

Case No.:11/42/82-

ALC4/2007 Party Name:MORAYA GLOBAL LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Case Deferred HQ File : 01/82/050/00347/AM08/ RLA File : 03/95/040/01114/AM07/ Lic.No/Date:03104154 96 11.01.2007 Defer Date: 08.04.2008 norms for export product Ethyl Limalool Pure 99% under para 4.7 of HBP. four weeks. 10

Case No.:12/42/82-

ALC4/2007 Party Name:MERCK LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00348/AM08/ RLA File : 03/95/040/01259/AM07/ Lic.No/Date:03104155 07 11.01.2007

norms for export product DL-Alpha Tocopheryl Acetate USP (Vitamin E Acetate USP) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 31/82 meeting held on 04.12.2007 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Expo rt Qty. Sl.N o. Import items Qty. allowed per unit of export Product DL-Alpha Tocopheryl Acetate

USP (Vitamin E Acetate USP) 1kg 1. Isophytol 0.738kg/kg 2. 2,3,5-Trimethyl Hydroquinone 0.385kg/kg of NC.

11

Case No.:13/42/82-

ALC4/2007 Party Name:MERCK LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00349/AM08/ RLA File : 03/95/040/01258/AM07/ Lic.No/Date:03104155 14 11.01.2007 : norms for export product Thiamine Disulfide under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 8/08 meeting held on 28.06.2007. 12

Case No.:17/42/82-

ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00353/AM08/ RLA File : 03/95/040/01047/AM07/ Lic.No/Date:03104156 51 12.01.2007

norms for export product Ethambutol Hcl under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/107/2006-PI-III dated 11.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Ethambutol Hcl 1kg 1. DL-2 Aminobutanol 1.6014kg/kg 2. Tartaric Acid 0.1977kg/kg 3. Methanol 0.5620kg/kg 4. Iso Propyl Alcohol 0.3436kg/kg 5. Ethylene dichloride 0.490kg/kg 6. Caustic Soda Flakes 0.4264kg/kg 7. Cyclohexane 0.0056kg/kg 8. Calcium Hydroxide 2.4525kg/kg of NC. 13 Case No.:33/42/82- ALC4/2007 Party Name:METROPOLITAN Meet No/Date:42/82- ALC4/2007 Status:Cas e Deferred

EXIMCHEM LTD. 19.02.2008 HQ File : 01/82/050/00369/AM08/ RLA File : 03/95/040/01220/AM07/ Lic.No/Date:03104157 75 12.01.2007 Defer Date: 08.04.2008 norms for export product Potassium Diphenyl Sulphone 3-Sulfonate (KSS) four weeks. 14

Case No.:14/42/82-

ALC4/2007 Party Name:MISSION PHARMACEUTICALS LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00350/AM08/ RLA File : 03/95/040/01249/AM07/ Lic.No/Date:03104158 74 15.01.2007

norms for export product Erithromycin Ethyl Succinate Caps BP 250mg approved in its 16/08 meeting held on 21.08.2007. 15

Case No.:15/42/82-

ALC4/2007 Party Name:MISSION PHARMACEUTICALS LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00351/AM08/ RLA File : 03/95/040/01175/AM07/ Lic.No/Date:03104158 76 15.01.2007

norms for export product Ciprofloxacin Tabs BP 500mg (Proxacin 500) approved in its 4/08 meeting held on 30.05.2007. 16 Case No.:16/42/82- ALC4/2007 Party Name:MORAYA GLOBAL LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00352/AM08/ RLA File : 03/95/040/01287/AM07/ Lic.No/Date:03104159 93 15.01.2007 Defer Date: 08.04.2008

norms for export product Indole Pure 99% under para 4.7 of HBP. four weeks. 17

Case No.:35/42/82-

ALC4/2007 Party Name:BENZOCHEM LIFE SCIENCES PVT. LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00371/AM08/ RLA File : 03/94/040/01169/AM07/ Lic.No/Date:03104162 24 16.01.2007

norms for export product Artemether under para 4.7 of HBP. Committee in light of its earlier decision taken in its 09/08 meeting held on 03.07.2007 vide Case No.A-207 in the case of M/S Vital Healthcare Pvt. Ltd. and in consultation with representative of PI Division present in meeting decided to ratify 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 Quantity Import item Qty. allowed per unit of export product Artemether 1kg. Artemisinin 1.50kg/kg of Norms Committee. 18 Case No.:34/42/82- ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00370/AM08/ RLA File : 03/95/040/01242/AM07/ Lic.No/Date:03104163 58 17.01.2007

norms for export product Ethambutol Hcl under para 4.7 of HBP. their U.O. No.35011/107/2006-PI-III dated 11.03.2008 decided to ratify Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of

export product Ethambutol Hcl 1kg 1. DL-2 Aminobutanol 1.6014kg/kg 2. Tartaric Acid 0.1977kg/kg 3. Methanol 0.5620kg/kg 4. Iso Propyl Alcohol 0.3436kg/kg 5. Ethylene dichloride 0.490kg/kg 6. Caustic Soda Flakes 0.4264kg/kg 7. Cyclohexane 0.0056kg/kg 8. Calcium Hydroxide 2.4525kg/kg of NC. 19

Case No.:36/42/82-

ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00372/AM08/ RLA File : 03/95/040/01254/AM07/ Lic.No/Date:03104163 62 17.01.2007

norms for export product Ethambutol Hcl under para 4.7 of HBP. their U.O. No.35011/107/2006-PI-III dated 11.03.2008 decided to ratify Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Ethambutol Hcl 1kg 1. DL-2 Aminobutanol 1.6014kg/kg 2. Tartaric Acid 0.1977kg/kg 3. Methanol 0.5620kg/kg 4. Iso Propyl Alcohol 0.3436kg/kg 5. Ethylene dichloride 0.490kg/kg 6. Caustic Soda Flakes 0.4264kg/kg 7. Cyclohexane 0.0056kg/kg 8. Calcium Hydroxide 2.4525kg/kg of NC.

20

Case No.:32/42/82-

ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00368/AM08/ RLA File : 03/95/040/01319/AM07/ Lic.No/Date:03104167 17 22.01.2007

norms for export product Ethambutol Hcl under para 4.7 of HBP. their U.O. No.35011/107/2006-PI-III dated 11.03.2008 decided to ratify Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Ethambutol Hcl 1kg 1. DL-2 Aminobutanol 1.6014kg/kg 2. Tartaric Acid 0.1977kg/kg 3. Methanol 0.5620kg/kg 4. Iso Propyl Alcohol 0.3436kg/kg 5. Ethylene dichloride 0.490kg/kg 6. Caustic Soda Flakes 0.4264kg/kg 7. Cyclohexane 0.0056kg/kg 8. Calcium Hydroxide 2.4525kg/kg of NC. 21

Case No.:16/49/82-

ALC1/2006 Party Name:LUPIN LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/01721/AM07/ RLA File : 03/95/040/01297/AM07/ Lic.No/Date:03104167 16 22.01.2007 Defer Date: 08.04.2008 norms for export product Sterile Ceftriazone Sodium Non Infringing under

para 4.7 of HBP.

Committee decided to examine case on file. 22 Case No.:18/42/82- ALC4/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved

HQ File : 01/82/050/00354/AM08/ RLA File : 22/24/040/00289/AM07/ Lic.No/Date:22100064 25 24.01.2007

norms for export product Ampicillin Trihydrate Pen G Route under para 4.7 of HBP. Committee decided to ratify norms under para 4.7 of HBP as per revised norms A-69 published vide Public Notice No.2 dated 19.04.2007. of NC. 23

Case No.:37/42/82-

ALC4/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00373/AM08/ RLA File : 03/94/040/01101/AM07/ Lic.No/Date:03104170 69 24.01.2007

norms for export product Paroxetine Hcl under para 4.7 of HBP. their U.O. No.35011/128/2006-PI-III dated 11.03.2008 decided to ratify Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Paroxetin Hcl 1kg 1. Trans-(+-)-4-(4-fluoro Phenyl)-3-hydroxy methyl-N-methyl Piperidine[+-carbinol] 2.66kg/kg 2. Di-p-totyl

tartaric acid (DPTTA) 3.10kg/kg 3. Sesamol 0.55kg/kg 4. Acetone 5.22kg/kg 5. Dimethyl sulfoxide 2.50kg/kg 6. Methylene chloride 4.38kg/kg 7. Isopropyl alcohol 0.86kg/kg of NC.

24

Case No.:19/42/82-

ALC4/2007 Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00355/AM08/ RLA File : 22/21/040/00102/AM06/ 30 25.01.2007

norms for export product Ampicillin Trihydrate Pen G Route under para 4.7 of HBP. norms A-69 published vide Public Notice No.2 dated 19.04.2007. of NC. 25

Case No.:20/42/82-

ALC4/2007 Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00356/AM08/ RLA File : 22/21/040/00009/AM06/ 31 25.01.2007

norms for export product Cloxacillin Sodium (From 6APA Route) under para 4.7 of HBP. norms A-151 published vide Public Notice No.45 dated 06.09.2007. of NC. 26 Case No.:21/42/82- ALC4/2007 Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00357/AM08/ RLA File : 22/21/040/00101/AM06/ 32 25.01.2007

norms for export product Ampicillin Trihydrate (Pen G Route) under para 4.7 of HBP.

norms A-69 published vide Public Notice No.2 dated 19.04.2007. of NC. 27

Case No.:22/42/82-

ALC4/2007 Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00358/AM08/ RLA File : 22/21/040/00142/AM06/ 34 25.01.2007

norms for export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. norms A-68 published vide Public Notice No.2 dated 19.04.2007. of NC. 28

Case No.:23/42/82-

ALC4/2007 Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00359/AM08/ RLA File : 22/21/042/00005/AM05/ 46 31.01.2007

norms for export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. of NC. 29 Case No.:24/42/82- ALC4/2007 INFECTIVES INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00360/AM08/ RLA File : 22/21/041/00100/AM05/ 47 31.01.2007 : norms for export product Ampicillin Trihydrate (6APA Route) under para 4.7

of HBP. of NC. 30

Case No.:25/42/82-

ALC4/2007 INFECTIVES INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00361/AM08/ RLA File : 22/21/041/00057/AM05/ 48 31.01.2007

norms for export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. of NC. 31

Case No.:26/42/82-

ALC4/2007 INFECTIVES INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00362/AM08/ RLA File : 22/21/041/00079/AM05/ 49 31.01.2007

norms for export product Cloxacillin Sodium (From 6APA Route) under para 4.7 of HBP. norms A-151 published vide Public Notice No.45 dated 06.09.2007. of NC. 32 Case No.:27/42/82- ALC4/2007 INFECTIVES INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00363/AM08/ RLA File : 22/21/041/00081/AM05/ 50 :

31.01.2007 norms for export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. of NC. 33

Case No.:28/42/82-

ALC4/2007 INFECTIVES INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00364/AM08/ RLA File : 22/21/041/00078/AM05/ 51 31.01.2007

norms for export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. of NC. 34

Case No.:29/42/82-

ALC4/2007 INFECTIVES INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00365/AM08/ RLA File : 22/21/041/00098/AM05/ 52 31.01.2007

norms for export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. of NC. 35 Case No.:30/42/82- ALC4/2007 Meet No/Date:42/82- ALC4/2007 Status:Cas e Approved

19.02.2008 HQ File : 01/82/050/00366/AM08/ RLA File : 22/21/042/00004/AM05/ 54 31.01.2007

norms for export product Cloxacillin Sodium (From 6APA Route) under para 4.7 of HBP. norms A-151 published vide Public Notice No.45 dated 06.09.2007. of NC. 36

Case No.:31/42/82-

ALC4/2007 INFECTIVES INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00367/AM08/ RLA File : 22/21/041/00087/AM05/ 55 31.01.2007

norms for export product Ampicillin Trihydrate (6APA Route) under para 4.7 of HBP. of NC. 37 Case No.:39/42/82- ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00375/AM08/ RLA File : 03/95/040/01341/AM07/ Lic.No/Date:03104176 97 31.01.2007

norms for export product Ethambutol Hcl under para 4.7 of HBP. their U.O. No.35011/107/2006-PI-III dated 11.03.2008 decided to ratify whichever is lower. Export Export Qty. Sl.N Import items Qty. allowed

product o. per unit of export product Ethambutol Hcl 1kg 1. DL-2 Aminobutanol 1.6014kg/kg 2. Tartaric Acid 0.1977kg/kg 3. Methanol 0.5620kg/kg 4. Iso Propyl Alcohol 0.3436kg/kg 5. Ethylene dichloride 0.490kg/kg 6. Caustic Soda Flakes 0.4264kg/kg 7. Cyclohexane 0.0056kg/kg 8. Calcium Hydroxide 2.4525kg/kg of NC. 38

Case No.:38/42/82-

ALC4/2007 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00374/AM08/ RLA File : 34/24/040/00246/AM07/ Lic.No/Date:34100180 35 06.02.2007 Defer Date: 08.04.2008 norms for export product Verdyl Acetate under para 4.7 of HBP. four weeks. 39

Case No.:40/42/82-

ALC4/2007 Party Name:BHARAT DYE CHEM Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00376/AM08/ RLA File : 08/24/040/00327/AM07/ Lic.No/Date:08100628 50 09.02.2007 Defer Date: 08.04.2008 norms for export product under para 4.7 of HBP. four weeks. 40 Case No.:41/42/82- ALC4/2007 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred

HQ File : 01/82/050/00377/AM08/ RLA File : 34/24/040/00247/AM07/ Lic.No/Date:34100180 64 09.02.2007 Defer Date: 08.04.2008 norms for export product Verdyl Acetate under para 4.7 of HBP. four weeks. 41

Case No.:42/42/82-

ALC4/2007 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00378/AM08/ RLA File : 03/94/040/01132/AM07/ Lic.No/Date:03104189 87 09.02.2007 Defer Date: 08.04.2008 norms for export product 5-Hydroxy Isophthalic Acid under para 4.7 of HBP. four weeks. 42

Case No.:43/42/82-

ALC4/2007 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00379/AM08/ RLA File : 03/95/040/01325/AM07/ Lic.No/Date:03104191 95 12.02.2007

norms for export product Chloroquine Sulphate under para 4.7 of HBP. approved in its 2/08 meeting held on 16.05.2007. 43 Case No.:44/42/82- ALC4/2007 Party Name:CAMLIN FINE CHEMICALS LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00380/AM08/ RLA File : 03/94/040/01233/AM07/ Lic.No/Date:03104192 19 12.02.2007 Defer Date: 01.04.2008 norms for export product Butylated Hydroxy Anisole under para 4.7 of HBP. Committee decided to call for application alongwith copy of advance

authorization from RA. Accordingly, case was deferred for three weeks. 44

Case No.:45/42/82-

ALC4/2007 Party Name:BASE METAL CHLORINATIONS (P) LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Case Deferred HQ File : 01/82/050/00381/AM08/ RLA File : 34/24/040/00254/AM07/ Lic.No/Date:34100180 76 12.02.2007 Defer Date: 08.04.2008 norms for export product Calcium Butyrate under para 4.7 of HBP. four weeks. 45

Case No.:47/42/82-

ALC4/2007 Party Name:LYKA BDR INTERNATIONAL LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00383/AM08/ RLA File : 03/95/040/01309/AM07/ Lic.No/Date:03104192 66 12.02.2007

norms for export product Clobetasole Propionate Cream 10gm, 15gm, 30gm and Clobetasole Propionate Topical Solution 15ml and 30ml under

para 4.7 of HBP.

Committee decided to ratify norms under para 4.7 of HBP as per SION at Sl.No.A-1931 for Medicinal Cream/Ointment with 2% wastage. of NC. 46

Case No.:48/42/82-

ALC4/2007 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00384/AM08/ RLA File : 03/94/040/01225/AM07/ Lic.No/Date:03104193 38 12.02.2007 Defer Date: 08.04.2008 norms for export product Astrolide (DEP) under para 4.7 of HBP. four weeks.

47

Case No.:46/42/82-

ALC4/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00382/AM08/ RLA File : 09/24/040/00456/AM07/ Lic.No/Date:09100293 18 13.02.2007

norms for export product Phenazopyridine Hydrochloride DC Grade 68% their U.O. No.35011/63/2007-PI-III dated 11.03.2008 decided to ratify Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Phenazopyrid ine Hcl DC Grade 68% Granules 1kg 1. Phenazopyridine Hcl 0.68kg/kg 2. Starch

pre geletinised 0.083kg/kg 3. Maize starch 0.0928kg/kg 4. Povidone K-30 0.0098kg/kg 5. Cros

Carmellose Sodium 0.0244kg/kg 6. Microcrystalline Cellulose 0.0977kg/kg 7. Magnesium Stearate 0.0049kg/kg of NC. 48

Case No.:879/21/82-

ALC4/2007 Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01714/AM07/ RLA File : 07/24/040/00780/AM07/ Lic.No/Date:07100503 14 27.02.2007

norms for export product Dorzolamide Hcl under para 4.7 of HBP. approved in its 43/08 meeting held on 04.03.2008.

49

Case No.:4/9/83-ALC1/2007 Party Name:ZANDU

CHEMICALS LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01315/AM07/ RLA File : 03/95/040/01260/AM07/ Lic.No/Date:03104220 65 06.03.2007 Defer Date: 08.04.2008 norms for export product 2 Methyl 4,6Bis (Trichloromethyl)1,2,3, Triazine (TAZ) under para 4.7 of HBP. four weeks. 50

Case No.:7/2/82-ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:42/82-

ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/01804/AM07/ RLA File : 03/94/040/01443/AM07/ Lic.No/Date:03104229 72 13.03.2007 Defer Date: 08.04.2008 norms for export product Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets and Triomune 40/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division. 51

Case No.:8/4/83-ALC1/2007 Party Name:SALVI

CHEMICAL INDUSTRIES LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01379/AM07/ RLA File : 03/95/040/01615/AM07/ Lic.No/Date:03104246 38 27.03.2007 Defer Date: 22.04.2008 norms for export product 8-Quinolium under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 52 Case No.:50/42/82- ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00386/AM08/ RLA File : 03/94/040/00017/AM08/ Lic.No/Date:03104260 65 Defer Date:

10.04.2007 08.04.2008 norms for export product Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets and Triomune 40/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. Division. 53

Case No.:9/21/82-

ALC4/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00009/AM08/ RLA File : 09/24/040/00543/AM07/ Lic.No/Date:09100299 31 10.04.2007

norms for export product 7-Amino-3[(Z/E)-1-Propen-1-YL]-3-Cepham-4- Carboxylic Acid (APRA) under para 4.7 of HBP. approved in its 40/08 meeting held on 03.03.2008. 54 Case No.:530/24/83- ALC1/2007 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/83/050/00143/AM08/ RLA File : 34/24/040/00296/AM07/ Lic.No/Date:34100186 01 18.04.2007

norms for export product Betamethasone Valerate BP/USP under para 4.7 of HBP. Committee in light of its earilier decision taken in its 40/82 meeting held on 03.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product Betamethas one Valerate BP/USP 1kg 1. Betamethasone BP/USP 0.915kg/kg

of NC. 55

Case No.:51/42/82-

ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00387/AM08/ RLA File : 05/24/040/00036/AM08/ Lic.No/Date:05102027 74 20.04.2007

norms for export product Ciprofloxacin Tablets USP 250mg, 500mg and 750mg under para 4.7 of HBP. their U.O. No.35011/85/2007-PI-III dated 11.03.2008 decided to ratify Export product Export Qty. Sl.N o. Import items Total

Qty. allowed Ciprofloxacin Tablets 250mg 98040000No s. 1. 7-Chloro-5-1-fluoro-1- cyclopropyl-1,4- dihydro-4- oxoquinoline-3- carboxylic acid (drug intermediate

for Ciprofloxacin) 27650kg 2. Piperazine Anhydrous 23500kg Ciprofloxacin Tablets 500mg 49020000No s. 3. Methanol 25000kg 4. Activated Carbon 1250kg Ciprofloxacin Tablets 750mg 32680000No s. 5. Acetone 3700kg of NC. 56 Case No.:52/42/82- ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00388/AM08/ RLA File : 07/24/040/00005/AM08/ Lic.No/Date:07100513 74 23.04.2007 Defer Date: 01.04.2008 norms for export product Calcium L-Asparate, Magnesium L-Asparate and

Zinc L-Asparate under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of PI/Chem. Division. 57

Case No.:53/42/82-

ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00389/AM08/ RLA File : 07/24/040/00862/AM07/ Lic.No/Date:07100513 89 24.04.2007 Defer Date: 01.04.2008 norms for export product Calcium Lactobionate, Calcium Glubionate and Calcium Bromolactobionate under para 4.7 of HBP. PI/Chem. Division. 58

Case No.:54/42/82-

ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00390/AM08/ RLA File : 07/24/040/00861/AM07/ Lic.No/Date:07100513 90 24.04.2007 Defer Date: 01.04.2008 norms for export product Zinc Gluconate, magnesium Gluconate, Potassium Gluconate, Ferrous Gluconate, Manganese Gluconate, Calcium Magnesium Lactate Gluconate, Magnesium Lactate Gluconate, Cobalt Gluconate and Copper Gluconate under para 4.7 of HBP. PI/Chem. Division. 59

Case No.:55/42/82-

ALC4/2007 Party Name:BELCO PHARMA Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00391/AM08/ RLA File : 05/24/040/00063/AM08/ Lic.No/Date:05102029 27 25.04.2007

norms for export product Hydrocortisone Ointment and Cream under para 4.7 of HBP. their U.O. No.35011/207/2004-PI-III dated 11.03.2008 and in consultation

with representative of PI Division present in meeting decided to ratify Export product Export Qty. Import items Qty. allowed per unit of export product Hydrocortisone Ointment/Cream 1.0% W/W 5gm tube Hydrocortisone 0.051gm/tub e Hydrocortisone Ointment/Cream 1.0% W/W 15gm tube Hydrocortisone 0.153gm/tub e of NC. 60

Case No.:56/42/82-

ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00392/AM08/ RLA File : 07/24/040/00052/AM08/ Lic.No/Date:07100514 38 26.04.2007 Defer Date: 01.04.2008 norms for export product Calcium Gluconate and Calcium Lactate Gluconate under para 4.7 of HBP. PI/Chem. Division. 61

Case No.:57/42/82-

ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00393/AM08/ RLA File : 07/24/040/00053/AM08/ Lic.No/Date:07100514 39 26.04.2007 Defer Date: 01.04.2008 norms for export product Calcium Gluconate-Injectable Grade, Calcium Lactate Gluconate, Calcium Glubionate and Calcium Borogluconate under

para 4.7 of HBP.

PI/Chem. Division.

62

Case No.:58/42/82-

ALC4/2007 Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Case Approved HQ File : 01/82/050/00394/AM08/ RLA File : 09/24/040/00018/AM08/ Lic.No/Date:09100301 94 07.05.2007

norms for export product Bendrofluazide Tablets BP 2.5mg and Bendrofluazide Tablets BP 5mg under para 4.7 of HBP. their U.O. No.35011/209/2005-PI-III dated 11.03.2008 and in consultation with representative of PI Division decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Quantity in Kgs. for 1 lakh tablets Export product Export Qty. Sl.N o. Import items Qty. allowed for 2.5 mg. tablets
Qty. allowe d for 5mg tablet s Bendrofluazi de

Tabs 2.5mg 12,00,00, 000 tablets 1. Bendrofluazide 0.25 0.50 2. Lactose 4.04 8.08 3. Maize Starch 0.682 1.364 4. Pregelatinised Starch 0.328 0.656 Bendrofluazi de Tablets 5mg. 70,00,000 Tablets 5. Sodium

Starch Glycolate 0.1875 0.375 6. Magnesium Stearate 0.0125 0.025 of NC. 63 Case No.:59/42/82- ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00395/AM08/ RLA File : 03/94/040/00102/AM08/ Lic.No/Date:03104288 12 08.05.2007 Defer Date: 08.04.2008 norms for export product Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets and Triomune 40/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP.

Division. 64

Case No.:605/24/83-

ALC1/2007 Party Name:KDL BIOTECH LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/83/050/00348/AM08/ RLA File : 03/94/040/01433/AM07/ Lic.No/Date:03104296 86 17.05.2007

norms for export product Immobilised Penicillin G Amidaxed (Enzyme) Committee in light of its earlier decision taken in its 38/08 meeting held on 22.01.2008 vide Case No.B-504 decided to ratify 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 per unit of export product Immobilized Penicillin G Amidase Enzyme 1kg. 1. Yeast Extract 2.456 kg/kg 2. Malic acid 4.001 kg/kg 3. Sodium Hydroxide 0.600 kg/kg 4. Dipotassium dihydroden Phosphate (k2HPO4) 4.500 kg/kg 5. Potassium dihydrogen Phosphate (KH2PO4) 1.001 kg/kg 6. Acetic acid 0.015 kg/kg 7. P3 Ultracil 0.500 kg/kg 8. Iso Propyl Alcohol 0.422 kg/kg 9. Glycedyl Methacrylate 0.643 kg/kg 10. Acrylonitrile 0.153 kg/kg 11. Divinyl Benzene 0.429 kg/kg 12. Cyclohexanol 1.521 kg/kg 13. Methanol denine Hemi Sulphate Dihydrate 12.857 kg/kg of NC. 65 Case No.:60/42/82- ALC4/2007 Party Name:REDOX PHARMACHEM PVT LTD. Meet No/Date:42/82- ALC4/2007 Status:Cas e Deferred

19.02.2008 HQ File : 01/82/050/00396/AM08/ RLA File : 05/24/040/00092/AM08/ Lic.No/Date:05102038 60 18.05.2007 Defer Date: 08.04.2008 norms for export product Thymol and Para-Cymene 95% under para 4.7 of HBP. four weeks. 66

Case No.:614/24/83-

ALC1/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00369/AM08/ RLA File : 03/95/040/01471/AM07/ Lic.No/Date:03104300 58 21.05.2007

norms for export product Ultrazyme Tablets (7458X) (Contact Lense Cleaning Agent) under para 4.7 of HBP. approved in its 41/08 meeting held on 03.03.2008. 67

Case No.:645/24/83-

ALC1/2007 Party Name:AYURSIDDHA INC. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00438/AM08/ RLA File : 05/24/040/00105/AM08/ Lic.No/Date:05102042 54 30.05.2007 Defer Date: 08.04.2008 norms for export product Blockbuster All Clear Capsules made of Citrolive Representative of Department of MSME informed Committee that he has called technical information from firm, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 68 Case No.:61/42/82- ALC4/2007 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00397/AM08/ RLA File : 34/24/040/00037/AM08/ Lic.No/Date:34100188 72 Defer Date:

01.06.2007 08.04.2008 norms for export product Tetrabutyl Tin, Mono Butyl Tin Trichloride and Di Butyl Tin Oxide under para 4.7 of HBP. four weeks. 69

Case No.:70/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00406/AM08/ RLA File : 03/94/040/00250/AM08/ Lic.No/Date:03104321 36 08.06.2007 Defer Date: 08.04.2008 norms for export product Satvir 15mg, 20mg, 30mg, 40mg Capsules, Lamivir S30 and S40 Tablets under para 4.7 of HBP. Division.

70 Case No.:62/42/82- ALC4/2007 Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Case Approved HQ File : 01/82/050/00398/AM08/ RLA File : 09/24/040/00054/AM08/ Lic.No/Date:0910030 527 13.06.2007

norms for export product Chlorpromazine Hcl Tablets 25, 50mg and 100mg their U.O. No.35011/209/2005-PI-III dated 11.03.2008 and in consultation with representative of PI Division present in meeting decided to ratify Export product Expo rt Qty. Sl.No . Import items Qty. allowed per

1 lakh Tablets of 25mg Qty. allow ed per 1 lakh Tablet s of 50mg Qty. allowed per 1 lakh tablets of 100mg Chlopromazi ne

Hcl Tablets 25mg, 50mg and 100mg 1 lakh table ts 1. Chlorpromazin e hcl. 2.50 Kg. 5.00 kg. 10.0 kg. 2. Lactoser monohydrate 7.48 kg. 22.19 kg. 26.79 kg. 3. Maise starch 0.87 kg. 2.58 kg. 3.11 kg. 4. Povidone (Povidone K25) 0.35 kg. 1.03 kg. 1.25 kg. 5. Sodium starch glycolate 0.60 kg. 1.65 kg. 2.20 kg. 6. Silica colloidal anhydrous 0.04 kg. 0.12 kg. 0.15 kg. 7. Magnesium stearate 0.160 kg. 0.40 kg. 0.50 kg. 8. Hypromellose 5 cps 0.30 kg. 0.60 kg. 0.75 kg. 9. Ethyl cellulose (Ethocel std. 0.080 kg. 0.16 kg. 0.20 kg.

10 premium) 10. Diethyl Phthalate 0.050 kg. 0.10 kg. 0.125 kg. 11. Titanium dioxide 0.080 kg. 0.16 kg. 0.20 kg. of NC. 71

Case No.:63/42/82-

ALC4/2007 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00399/AM08/ RLA File : 08/24/040/00062/AM08/ Lic.No/Date:08100653 64 13.06.2007 Defer Date: 25.03.2008 norms for export product Amlodipine Besylate 2.5mg, 5mg and 10mg Tablets under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 72

Case No.:64/42/82-

ALC4/2007 Party Name:BRAWN LABORATORIES LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00400/AM08/ RLA File : 05/24/040/00163/AM08/ Lic.No/Date:05102048 90 13.06.2007

norms for export product Kanamycin Acid Sulphate Inj BP 1gm and lincomycin Capsule 500mg under para 4.7 of HBP. approved in its 38/08 meeting held on 22.01.2008. 73 Case No.:680/24/83- ALC1/2007 Party Name:DCM SHRIRAM INDUSTRIES LTD, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00524/AM08/ RLA File : 05/24/040/00166/AM08/ Lic.No/Date:05102049 18 14.06.2007 Defer Date: 08.04.2008 norms for export product D(-)Para Hydroxy Phenyl Glycine Dane Salt under

para 4.7 of HBP.

Division. 74

Case No.:65/42/82-

ALC4/2007 Party Name:SALICYLATES & CHEMICALS P.LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00401/AM08/ RLA File : 09/24/040/00078/AM08/ Lic.No/Date:09100305 72 15.06.2007 Defer Date: 08.04.2008 norms for export product Methyl Hydroxy Benzoate BP (Methyl Paraben) and Propyl Hydroxy Benzoate BP (Propyl Paraben) under para 4.7 of HBP. four weeks. 75

Case No.:67/42/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00403/AM08/ RLA File : 03/95/040/00205/AM08/ Lic.No/Date:03104331 27 19.06.2007 Defer Date: 08.04.2008 norms for export product Betasol Cream 15gm and 30gm under para 4.7 of HBP. Division. 76

Case No.:66/42/82-

ALC4/2007 Party Name:VAMSHI CHEMICALS LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00402/AM08/ RLA File : 06/24/040/00007/AM08/ Lic.No/Date:06100120 65 20.06.2007 Defer Date: 08.04.2008 norms for export product Iso-Longifolene and Longifolene Acetate Main four weeks.

77

Case No.:71/42/82-

ALC4/2007 Party Name:RALLIS INDIA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00407/AM08/ RLA File : 03/95/040/00251/AM08/ Lic.No/Date:03104334 12 21.06.2007 Defer Date: 08.04.2008 norms for export product Polyetherketoneketone (PEKK) 60/40 and 70/30 four weeks. 78

Case No.:47/18/83-

ALC1/2007 Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00642/AM08/ RLA File : 03/95/040/00223/AM08/ Lic.No/Date:03104338 36 25.06.2007 Defer Date: 08.04.2008 norms for export product 2[(Chloro Methyl) Mercapto] Benzo Thiazole (CMBT) under para 4.7 of HBP. four weeks. 79

Case No.:83/19/83-

ALC1/2007 Party Name:SUMITOMO CHEMICAL INDIA PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Case Deferred HQ File : 01/83/050/00643/AM08/ RLA File : 03/95/040/01529/AM07/ Lic.No/Date:03104338 38 25.06.2007 Defer Date:01.04.20 08 norms for export product 1,2-Methyl3enedioxybenzene under para 4.7 of HBP. PI/Chem. Division. 80 Case No.:730/24/83- ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : RLA File : Lic.No/Date:09100306

01/83/050/00623/AM08/ 09/24/040/00120/AM08/ 86 29.06.2007 norms for export product (S)-3-Hydroxy-N-Benzyl Pyrrolidine under para 4.7 of HBP. Committee decided to withdraw case as case has been considered and deferred for four weeks in its 40/08 meeting held on 03.03.2008. 81

Case No.:68/42/82-

ALC4/2007 Party Name:SALICYLATES & CHEMICALS P.LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00404/AM08/ RLA File : 09/24/040/00053/AM08/ Lic.No/Date:09100307 19 02.07.2007 Defer Date: 01.04.2008 norms for export product Diazolidinyl Urea and Imidazolidinyl Urea under

para 4.7 of HBP.

PI/Chem. Division. 82

Case No.:19/23/83-

ALC1/2007 Party Name:SEQUENT SCIENTIFIC LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00655/AM08/ RLA File : 07/24/040/00234/AM08/ Lic.No/Date:07100523 01 04.07.2007 Defer Date: 01.04.2008 norms for export product L-(+)-Selenomethionine under para 4.7 of HBP. PI/Chem. Division. 83 Case No.:93/19/83- ALC1/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Approv ed HQ File : 01/83/050/00673/AM08/ RLA File : 05/24/040/00171/AM08/ Lic.No/Date:05102057 92 05.07.2007

norms for export product 1,4-Dihydro-1-ethyl-7-methyl-4-oxo-1,8- naphthyridine-3-carboxylic acid-Crude under para 4.7 of HBP. Committee in light of written coments forwarded by PI Division vide their U.O. No.35011/111/2007-PI-III dated 21.01.2008 decided to ratify Export product Expo rt Qty. Sl.N o. Import items Qty. allowed per unit of export product 1,4 Dihydro-1-Ethyl- 7-Methyl-4-Oxo-1,8 Napthridine-3- Carboxylic

Acid- Crude 1kg. 1. 2-Amino

6-Methyl Pyridine (OR) 0.81kg/kg 1(a) Sodium Metal 0.36kg/kg 1(b) Alumina-Silica Catalyst 0.080kg/kg 1© Denatured

Ethyl Alcohol 4.13kg/kg 2. Triethyl

Ortho formate 1.10kg/kg 3. Para Toluene Sulfonic Acid Monohydrate 0.0027kg/kg 4. Diethyl Malonate 1.20kg/kg 5. Ethyl alcohol 0.180kg/kg 6. Diphenyl DT Not a raw material. Hence not allowed 7. Ethyl bromide 0.520kg/kg 8. Dimethyl Formamide 0.750kg/kg of NC. 84 Case No.:69/42/82- ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00405/AM08/ RLA File : 03/94/040/00335/AM08/ Lic.No/Date:03104356 75 10.07.2007

norms for export product Sulfacox Powder 100gm pack and 1kg pack under

para 4.7 of HBP.

Committee in light of its earlier decision taken in its 30/82 meeting held on 27.11.2007 and in consultation with representative of PI Division present in meeting decided to ratify 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 per unit of export product Sulfacox Powder (Each pack of 1kg Sulfacox Powder containing 860gms Sulphadimerazine and

105gms Diaveridine 1kg. 1. Sulphadimerzine 868.60kg/kg 2. Diaveridine 106.05kg/kg of NC. 85

Case No.:72/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00408/AM08/ RLA File : 03/94/040/00383/AM08/ Lic.No/Date:03104361 56 13.07.2007 Defer Date: 08.04.2008 norms for export product Stavir 15mg,20mg, 30mg, 40mg Capsules and Lamivir S 30 and S 40 Tablets under para 4.7 of HBP. Division. 86 Case No.:797/24/83- ALC1/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00755/AM08/ RLA File : 05/24/040/00286/AM08/ Lic.No/Date:05102063 21 16.07.2007

norms for export product Citalopara Hydrobromide under para 4.7 of HBP.

87

Case No.:73/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00409/AM08/ RLA File : 03/94/040/00391/AM08/ Lic.No/Date:03104367 17 19.07.2007

norms for export product GCS Dog (Powder) and GCS Max Powder under

para 4.7 of HBP.

their U.O. No.35011/83/2007-PI-III dated 23.10.2007 decided to ratify Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product GCS

Dog (Powder) 1 Pack of 150 gram 1. Glucosamine Hcl 82.635gm/p ack 2. Sodium Chondrotin sulphate 27.54gm/pac k 3. Manganese sulphate 0.732gm/pac k 4. Ascorbic

acid (calcium ascorbate) 4.776gm/pac k GCS

Max Powder 1 pack of 500 gram 1. Glucosamine Hcl 275.45gm/p ack 2. Sodium Chondrotin Sulphate 91.80gm/pac k 3. Manganese Sulphate 2.44gm/pack 4. Ascorbic

acid (calcium ascorbate 15.92gm/pac k of NC. 88 Case No.:95/21/82- ALC4/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn

HQ File : 01/82/050/00144/AM08/ RLA File : 03/95/040/00389/AM08/ Lic.No/Date:03104375 08 26.07.2007

norms for export product Hydrocare Tablets (Contact Lens Cleaning Tablets) 89

Case No.:79/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00415/AM08/ RLA File : 03/94/040/00431/AM08/ Lic.No/Date:03104376 33 27.07.2007 Defer Date: 08.04.2008 norms for export product Telmisartan and Ramipril Tabletsunder para 4.7 of HBP. Division. 90

Case No.:74/42/82-

ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Closed HQ File : 01/82/050/00410/AM08/ RLA File : 34/24/040/00070/AM08/ Lic.No/Date:34100193 49 02.08.2007

norms for export product Clarithromycin Coated Granules under para 4.7 of HBP. Committee in consultation with technical authorities present in meeting observed that firm has proposed to export Clarithromycin Coated Granules (28 to 31% and 38 to 44%) while such range of export product is not covered in DML. Committee, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of Norms Committee. 91 Case No.:75/42/82- ALC4/2007 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00411/AM08/ RLA File : 34/24/040/00083/AM08/ Lic.No/Date:34100193 50 Defer Date:

02.08.2007 08.04.2008 norms for export product Tetra Butyl Tin etc. under para 4.7 of HBP. four weeks. 92

Case No.:76/42/82-

ALC4/2007 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00412/AM08/ RLA File : 04/24/040/00151/AM08/ Lic.No/Date:04100904 15 03.08.2007 Defer Date: 22.04.2008 norms for export product Vitaminas Neurotropas Injection 3ml under para 4.7 of HBP. Committee decided to call for application along with copy of advanced authorization from RA. Accordingly, case was deferred for six weeks. 93 Case No.:78/42/82- ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00414/AM08/ RLA File : 05/24/040/00305/AM08/ Lic.No/Date:05102072 01 06.08.2007

norms for export product Simvastatin Tablets 10mg, 20mg and 40mg under

para 4.7 of HBP.

The Committee in light of the written comments of the Deptt. of C&PC forwarded vide their U.O.No.35011/224/2006-PI-III dated 30.5.2007 decided to fix I/O Norms for the export product for the purpose of para 4.7 of HBP only as under or as applied by the firm which ever is lower:- Export product Simvastatin tablets 10/20/40 Mg. Import items For export of Simvastatin 10mg tablets – Simvastatin – 10.20mg/tablet For export of Simvastatin 20mg tablets - Simvastatin – 20.40mg/tablet For export of Simvastatin 40mg tablets - Simvastatin – 40.80mg/tablet Lovastatin---------------1.648 Kg./kg of Simvastatin

Acetone------------------1.042 Kg./kg of Simvastatin Activated Carbon--------0.035 Kg./kg of Simvastatin Cyclohexane-------------1.33 Kg./kg of Simvastatin Cycloproxylamine--------1.23 Kg./kg of Simvastatin Methanol-----------------19.82 Kg./kg of Simvastatin N Butyl Lithium----------2.382 Kg./kg of Simvastatin Pyrrolidine---------------1.53 Kg./kg of Simvastatin Tetrahydrofuran---------6.58 Kg./kg of Simvastatin Caustic flakes------------1.484 Kg./kg of Simvastatin Iodine--------------------0.63 Kg./kg of Simvastatin Ethyl acetate-------------4.49 Kg./kg of Simvastatin RLA concerned may take further necessary action as per above decision of Norms Committee. 94

Case No.:3/18/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00142/AM08/ RLA File : 03/94/040/00455/AM08/ Lic.No/Date:03104384 06 06.08.2007

norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP. 95

Case No.:77/42/82-

ALC4/2007 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00413/AM08/ RLA File : 34/24/040/00087/AM08/ Lic.No/Date:34100193 76 07.08.2007 Defer Date: 08.04.2008 norms for export product Tetra Butyl Tin, Mono Butyl Tin Trichloride and Di Butyl Tin Oxide under para 4.7 of HBP. four weeks. 96 Case No.:81/42/82- ALC4/2007 ALC4/2007 Status:Cas e Deferred

19.02.2008 HQ File : 01/82/050/00417/AM08/ RLA File : 03/94/040/00473/AM08/ Lic.No/Date:03104386 72 07.08.2007 Defer Date: 08.04.2008 norms for export product Nevimune 200mg Tablets/Nevirapine 200mg Tablets and Nevirapine Oral Suspension 50mg/5ml Nevimune under para 4.7 of HBP. Division. 97

Case No.:80/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00416/AM08/ RLA File : 03/94/040/00485/AM08/ Lic.No/Date:03104390 33 09.08.2007 Defer Date: 08.04.2008 norms for export product Gemcitabine Okasa Pharma (Gemcicross) 1g Injection/Gemcitabine Hydrochloride Injection 1000mg/Oncogem 1000 Injection under para 4.7 of HBP. Division. 98

Case No.:84/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00420/AM08/ RLA File : 03/94/040/00510/AM08/ Lic.No/Date:03104395 42 14.08.2007

norms for export product GCS Dog (Powder) and GCS Max Powder under

para 4.7 of HBP.

their U.O. No.35011/83/2007-PI-III dated 23.10.2007 decided to ratify Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product

GCS

Dog (Powder) 1 Pack of 150 gram 1. Glucosamine Hcl 82.635gm/p ack 2. Sodium Chondrotin sulphate 27.54gm/pac k 3. Manganese sulphate 0.732gm/pac k 4. Ascorbic

acid (calcium ascorbate) 4.776gm/pac k GCS

Max Powder 1 pack of 500 gram 1. Glucosamine Hcl 275.45gm/p ack 2. Sodium Chondrotin Sulphate 91.80gm/pac k 3. Manganese Sulphate 2.44gm/pack 4. Ascorbic

acid (calcium ascorbate 15.92gm/pac k of NC. 99

Case No.:962/24/83-

ALC1/2007 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00978/AM08/ RLA File : 03/94/040/00493/AM08/ Lic.No/Date:03104393 77 14.08.2007

norms for export product Phenyl Thio Proline under para 4.7 of HBP. approved in its 40/08 meeting held on 03.03.2008. 10 0

Case No.:16/25/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Case Approved HQ File : 01/83/050/01041/AM08/ RLA File : 03/94/040/00516/AM08/ Lic.No/Date:031043 9736 16.08.2007

norms for export product Losartan potassium under para 4.7 of HBP. their U.O. No.35011/83/2007-PI-III dated 28.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify

Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Losartan Potassium ITC(HS)No.29012 990 1kg 1. 2-Butyl-4-chloro- 1-[{2’- (3-triphenyl methyl-1H- tetrazole-2yl) (1,1’- biphenyl)-4yl)-1H- Imidazole-5- methanol] 2.00kg/kg 2. Tetrahydrofuran 1.80kg/kg of Norms Committee. 10 1

Case No.:14/25/83-

ALC1/2007 Party Name:SANJAY SALES CORPORATION Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01039/AM08/ RLA File : 03/95/040/00475/AM08/ Lic.No/Date:03104397 24 16.08.2007 Defer Date: 08.04.200 8 norms for export product Sodium Salicylate under para 4.7 of HBP. PI/Chem. Division. 10 2

Case No.:82/42/82-

ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00418/AM08/ RLA File : 05/24/040/00401/AM08/ Lic.No/Date:05102076 40 17.08.2007 Defer Date: 08.04.200 8 norms for export product Citaloprom Hydrobromide Tablets 10mg, 20mg and 40mg under para 4.7 of HBP. Committee decided to examine the case on file.

10 3

Case No.:86/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00422/AM08/ RLA File : 03/94/040/00524/AM08/ Lic.No/Date:03104402 73 21.08.2007 Defer Date: 22.04.200 8 norms for export product Irinotecan Hydrochloride Injection 40mg/2ml and 40mg/5ml under para 4.7 of HBP. Division. 10 4

Case No.:87/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00423/AM08/ RLA File : 03/94/040/00535/AM08/ Lic.No/Date:03104404 29 22.08.2007 Defer Date: 22.04.200 8 norms for export product i) Budecort 200 Inhaler (200MD)/Aerobud Inhaler (200MD)/Budesonide Generis 200 Inhaler (200MD) and ii) Budecort 100 Inhaler (200MD)/Budesonida 100mcg Inhaler (200MD) Sycort 100mcg HFA Inhaler (200MD)under para 4.7 of HBP. Division. 10 5

Case No.:83/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00419/AM08/ RLA File : 03/94/040/00540/AM08/ Lic.No/Date:03104406 43 23.08.2007 Defer Date: 22.04.200 8 norms for export product Cyproterone Acetate Tablets 100mg and 50mg Division.

10 6

Case No.:85/42/82-

ALC4/2007 Party Name:MEDREICH LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00421/AM08/ RLA File : 07/24/040/00375/AM08/ Lic.No/Date:07100530 68 27.08.2007

norms for export product Glucosamine 1500mg Sustained Release Tablets and 1000mg under para 4.7 of HBP. Committee in light of its earlier decision taken in its 38/08 meeting held on 22.01.2008 vide Case No.A-987 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product Glucosamine 1500mg Sustained Release Tablet (ITC(HS)No.30049 069) 1 tablet Glucosamine sulphate Sodium Sulphate 1836mg/1500mg tablet Glucosamine 1000mg Sustained Release Tablet (ITC(HS)No.30049 069) 1 tablet Glucosamine sulphate Sodium Sulphate 1358.64mg/1000m g tablet Glucosamine 750mg Sustained Release Tablet (ITC(HS)No.30049 069) 1 tablet Glucosamine sulphate Sodium Sulphate 1018.98mg/750mg tablet RA concerned may take further necessary action as per above decision of Norms Committee. 10 7

Case No.:89/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00425/AM08/ RLA File : 03/94/040/00553/AM08/ Lic.No/Date:03104409 64 27.08.2007 Defer Date: 08.04.200 8 norms for export product Lamivir 150mg tablets/Lamivudine Tablets

150mg, Lamivir S-30 Tablets/Lamivudine and Stavudine Tablets, Lamivir S- 40 Tablets/Lamivudine and Stavudine Tablets, Lamivudine Oral Solution/Lamivir under para 4.7 of HBP. Division. 10 8

Case No.:90/42/82-

ALC4/2007 Party Name:SANDOZ PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00426/AM08/ RLA File : 03/95/040/00488/AM08/ Lic.No/Date:03104411 55 29.08.2007

norms for export product Blistersheet (Pauci-Bacillary) Child, MB- Blistersheet (Multi-Bacillary) Child, MB-Blistersheet (Multi-Bacillary) Adult their U.O. No.35011/207/2006-PI-III dated 30.01.2008 decided to ratify Export product Export Qty. Sl.No. Import items Total Qty. allowed 1.
Blister

Sheet (pauci-bacillary) child Each blister pack contains (a)Rimactane

capsule 150mg

(Rifampicin 150mg)-1No. (b)Rimactane

capsule 300mg

(rifampicin 300mg)-1No. ©Dapsone tablets 50mg- 28 Nos. 1,30,0 00 packs 1. Rafampicin 19.89kgs 2. Rifampicin 39.78kgs 3. Dapsone tablets 50mg 3640000No s. 4. Hard Geletin empty capsule As

per packing policy 2. MB-Blister

Sheet (multi-bacillary) child Each blister pack contains (a)Rimactane

capsule 150mg

(Rifampicin 150mg)-1No. 1,15,0 00 packs 1. Rafampicin 17.59kgs. 2. Rifampicin 35.18kgs. 3. Dapsone tablets 50mg 3220000No s.

(b)Rimactane

capsule 300mg

(rifampicin 300mg)-1No. ©Dapsone tablets 50mg- 28 Nos. (d)Lamprene

capsules 50mg-16Nos. 4. Lamprene Capsules 50mg 18,40,000N os. 5. Hard Geletin empty capsule As

per packing policy

1. MB-Blister

Sheet (multi-bacillary) Adult Each blister pack contains (a)Rimactane

capsule 300mg

(Rifampicin 300mg)-2No. (b)Dapsone

tablets 100mg-28Nos. ©Lamprene

capsules 50mg-27Nos. (d)Lamprene

capsules 100mg-3Nos. 9,80,0 00 packs 1. Rifampicin 599.76kgs. 2. Dapsone tablets 100mg 27440000N os. 3. Lamprene capsules 50mg 26460000N os. 4. Lamprene capsules 100mg 2940000No s. 5. Hard Geletin empty capsule As

per packing policy of NC. 10 9

Case No.:7/25/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01032/AM08/ RLA File : 09/24/040/00231/AM08/ Lic.No/Date:09100313 14 29.08.2007 Defer Date: 08.04.200 8 norms for export product Didanosine under para 4.7 of HBP. Division. 11 0

Case No.:88/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00424/AM08/ RLA File : 03/94/040/00554/AM08/ Lic.No/Date:03104414 19 30.08.2007 Defer Date: 08.04.200

8 norms for export product Lopinavir and Ritonavir Tablets 200/50mg/Lopimune Tablets/Lopinavir and lopinavir and Ritonavir Capsules/Lopimune Capsules/Lopinavir under para 4.7 of HBP. Division. 11 1

Case No.:42/25/83-

ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01067/AM08/ RLA File : 03/94/040/00299/AM08/ Lic.No/Date:03104414 32 30.08.2007

norms for export product Nitazoxanide under para 4.7 of HBP. approved in its 40/08 meeting held on 03.03.2008. 11 2

Case No.:91/42/82-

ALC4/2007 Party Name:ALKALOIDS CORPORATION Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00427/AM08/ RLA File : 02/24/040/00155/AM08/ Lic.No/Date:02101037 80 31.08.2007

norms for export product Noscapine BP/Noscapine hydrochloride BP and Papaverine Hydrochloride BP under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/66/2006-PI-III dated 11.03.2008 decided to ratify 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 Quantity Import items Qty. allowed per unit of export product Noscapine BP/Noscapine Hcl BP 0.11kg 1 X Papaverine crude containing Noscapine

not more than 12% and

crude Papaverine

not more than 40% 1kg/0.11kg

Papaverine Hcl BP 0.373kg 1 X Papaverine crude containing Noscapine

not more than 12% and

crude Papaverine

not more than 40% 1kg/0.373kg The imported Papaverine crude shall not contain any narcotic material like opium, Morphine, Codeine, Thevaine or any other alkaloids. RA concerned may take further necessary action as per above decision of Norms Committee. 11 3

Case No.:6/27/83-

ALC1/2007 Party Name:VANI CHEMICALS & INTERMEDIATES LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01080/AM08/ RLA File : 09/24/040/00009/AM08/ Lic.No/Date:09100313 30 31.08.2007

norms for export product 4-(3,4-Dichlorophenyl)1-Tetralone under para 4.7 of HBP. 11 4

Case No.:9/27/83-

ALC1/2007 Party Name:OM SHREE PHARMACHEM PVT.LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01083/AM08/ RLA File : 03/95/040/00534/AM08/ Lic.No/Date:03104415 37 31.08.2007

norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. 11 5

Case No.:5/22/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00175/AM08/ RLA File : 03/94/040/00571/AM08/ Lic.No/Date:03104415 56 31.08.2007 Defer Date: 08.04.200 8

norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP. Division. 11 6

Case No.:92/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00428/AM08/ RLA File : 03/94/040/00578/AM08/ Lic.No/Date:03104419 06 05.09.2007 Defer Date: 08.04.200 8 norms for export product Lamivir 150mg Tablets/Lamivudine Tablet 150mg, Lamivir S-30 Tablets/Lamivudine and Stavudine Tablets, Lamivir S- 40 Tablets/Lamivudine and Stavudine Tablets and Lamivudine Oral Solution/Lamivir under para 4.7 of HBP. Division. 11 7

Case No.:93/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00429/AM08/ RLA File : 03/94/040/00582/AM08/ Lic.No/Date:03104418 27 05.09.2007 Defer Date 08.04.200 8: norms for export product Nevimune 200mg Tablets/Nevirapine 200mg Tablets, Nevirapine Oral Suspension 50mg/5ml Nevimune under para 4.7 of HBP. Division. 11 8

Case No.:33/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01107/AM08/ RLA File : 09/24/040/00192/AM07/ Lic.No/Date:09100314 03 05.09.2007

norms for export product GCLE-Stage-I under para 4.7 of HBP.

11 9

Case No.:32/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01106/AM08/ RLA File : 09/24/040/00388/AM07/ Lic.No/Date:09100314 02 05.09.2007

norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. 12 0

Case No.:31/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01105/AM08/ RLA File : 09/24/040/00470/AM07/ Lic.No/Date:09100314 01 05.09.2007

norms for export product Pivmecillinam hydrochloride under para 4.7 of HBP. 12 1

Case No.:94/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00430/AM08/ RLA File : 03/94/040/00597/AM08/ Lic.No/Date:03104420 74 06.09.2007

norms for export product GCS Dog (Powder) and GCS Max powder under

para 4.7 of HBP.

their U.O. No.35011/83/2007-PI-III dated 23.10.2007 decided to ratify

Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product GCS

Dog (Powder) 1 Pack of 150 gram 1. Glucosamine Hcl 82.635gm/p ack 2. Sodium Chondrotin sulphate 27.54gm/pac k 3. Manganese sulphate 0.732gm/pac k 4. Ascorbic

acid (calcium ascorbate) 4.776gm/pac k GCS

Max Powder 1 pack of 500 gram 1. Glucosamine Hcl 275.45gm/p ack 2. Sodium Chondrotin Sulphate 91.80gm/pac k 3. Manganese Sulphate 2.44gm/pack 4. Ascorbic

acid (calcium ascorbate 15.92gm/pac k of NC. 12 2

Case No.:62/27/83-

ALC1/2007 Party Name:APITHECARY PHARMA PVT LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01136/AM08/ RLA File : 09/24/040/00146/AM08/ Lic.No/Date:09100314 44 07.09.2007 Defer Date: 08.04.200 8 norms for export product Lansoprazole Sulphide or (2-(4-)(2,2,2-Trifluoro Ethoxy)-3-Methyl-2-Pyridinyl(-2-Methyl(Thio/Ih-Benamidazole under para 4.7 of HBP. Division. 12 3

Case No.:64/27/83-

ALC1/2007 Party Name:KARNATAKA CHEMSYN LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01138/AM08/ RLA File : 07/24/040/00408/AM08/ Lic.No/Date:07100532 51 10.09.2007 Defer Date: 08.04.200 8

norms for export product 5-Hydroxy Methyl 4-Methyl Imidazole 99.0% Purity under para 4.7 of HBP. four weeks. 12 4

Case No.:10/22/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00180/AM08/ RLA File : 03/94/040/00615/AM08/ Lic.No/Date:03104428 78 12.09.2007

norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. 12 5

Case No.:84/27/83-

ALC1/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01158/AM08/ RLA File : 05/24/040/00426/AM08/ Lic.No/Date:05102088 79 12.09.2007 Defer Date: 08.04.200 8 norms for export product (4R-Cis)-1,1-Dimethylethyl-6-Cyuanomethyl-2,2- Dimethyl-1-3-Dioxane-4-Acetate (ATS-8) NLT 99% under para 4.7 of HBP. Division. 12 6

Case No.:94/27/83-

ALC1/2007 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01168/AM08/ RLA File : 34/24/040/00082/AM08/ Lic.No/Date:34100196 47 14.09.2007

norms for export product Betamethasone Valerate BP/USP under para 4.7 of HBP.

approved in its 40/08 meeting held on 03.03.2008. 12 7

Case No.:98/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01172/AM08/ RLA File : 09/24/040/00258/AM08/ Lic.No/Date:09100315 11 14.09.2007

norms for export product Tenofovir Disoproxil Fumerate under para 4.7 of HBP. approved in its 40/08 meeting held on 03.03.2008. 12 8

Case No.:115/27/83-

ALC1/2007 Party Name:WANKSONS CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01189/AM08/ RLA File : 03/95/040/00562/AM08/ Lic.No/Date:03104433 64 17.09.2007 Defer Date: 08.04.200 8 norms for export product Meta Chloropropiophenone under para 4.7 of HBP. Division. 12 9

Case No.:134/27/83-

ALC1/2007 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/83/050/01208/AM08/ RLA File : 03/94/040/00607/AM08/ Lic.No/Date:03104436 95 19.09.2007

norms for export product Fluticasone Propionate under para 4.7 of HBP. their U.O. No.35011/150/2005-PI-III dated 11.03.2008 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export Export Sl.N Import items Qty. allowed

product Qty. o. per unit of export product Fluticasone Propionate 1kg. 1. Flumethasone 2.50kg/kg 2. Bromo Fluro Methane 0.68kg/kg 3. N,N-carboxyl Di-imidazole 1.62kg/kg of NC. 13 0

Case No.:139/27/83-

ALC1/2007 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01213/AM08/ RLA File : 03/95/040/00596/AM08/ Lic.No/Date:03104437 34 20.09.2007 Defer Date: 22.04.200 8 norms for export product Flonicamid under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical six weeks. 13 1

Case No.:95/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00431/AM08/ RLA File : 03/94/040/00674/AM08/ Lic.No/Date:03104450 40 03.10.2007 Defer Date: 08.04.200 8 norms for export product Telmisartan and Amlodipin Tablets 40/10mg, 80/10mg, 40/5mg, 80/5mg under para 4.7 of HBP. Division. 13 2

Case No.:96/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00432/AM08/ RLA File : 03/94/040/00688/AM08/ Lic.No/Date:03104450 44 03.10.2007 Defer Date: 08.04.200 8

norms for export product Nevimune 200 mg Tablets/Nevirapine 200mg Tablets and nevirapine oral Suspension 50mg/5ml Nevimune under para 4.7 of HBP. Division. 13 3

Case No.:97/42/82-

ALC4/2007 Party Name:MISSION PHARMACEUTICALS LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00433/AM08/ RLA File : 03/95/040/00563/AM08/ Lic.No/Date:03104453 07 05.10.2007

norms for export product Levamisole Hydrochloride Tabs USP 40mg (Kymorm) and Levamisole Syrup (Kymorm) 15ml Bottle under para 4.7 of HBP. approved in its 37/08 meeting held on 05.10.2007. 13 4

Case No.:39/29/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01304/AM08/ RLA File : 03/94/040/00643/AM08/ Lic.No/Date:03104453 99 08.10.2007 Defer Date: 08.04.200 8 norms for export product Appepitant under para 4.7 of HBP. Division. 13 5

Case No.:98/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00434/AM08/ RLA File : 03/94/040/00706/AM08/ Lic.No/Date:03104457 35 09.10.2007 Defer Date: 08.04.200 8 norms for export product Lamivir 150mg Tablets etc. under para 4.7 of HBP.

Division. 13 6

Case No.:99/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00435/AM08/ RLA File : 03/94/040/00708/AM08/ Lic.No/Date:03104457 37 09.10.2007 Defer Date: 08.04.200 8 norms for export product Nevimune 200mg Tablets and Nevirapine Oral Suspension under para 4.7 of HBP. Division. 13 7

Case No.:100/42/82-

ALC4/2007 Party Name:SCITECH HEALTHCARE PVT.LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00436/AM08/ RLA File : 03/95/040/00466/AM08/ Lic.No/Date:03104457 58 09.10.2007 Defer Date: 22.04.200 8 norms for export product CoQ10 Softgel Capsules (30mg) and CoQ10 Softgel Capsules (120mg) under para 4.7 of HBP. Committee decided to defer case for six for comments of PI Division. 13 8

Case No.:101/42/82-

ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00437/AM08/ RLA File : 07/24/040/00454/AM08/ Lic.No/Date:07100537 86 12.10.2007 Defer Date: 01.04.200 8 norms for export product Ferrous Lactate, Magnesium Lactate, Zinc Lactate, Calcium Lactate Gluconate and Magnesium Lactate Gluconate PI/Chem. Division.

13 9

Case No.:102/42/82-

ALC4/2007 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00438/AM08/ RLA File : 07/24/040/00455/AM08/ Lic.No/Date:07100537 87 12.10.2007 Defer Date: 01.04.200 8 norms for export product Magnesium Orotate (Dihydrate), Calcium Orotate (Dihydrate), Potassium Orotate and Zinc Orotate (Dihydrate) under para 4.7 of HBP. PI/Chem. Division. 14 0

Case No.:84/29/83-

ALC1/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01349/AM08/ RLA File : 03/94/040/00712/AM08/ Lic.No/Date:03104462 40 12.10.2007 Defer Date: 08.04.200 8 norms for export product Gentadox Powder under para 4.7 of HBP. Division. 14 1

Case No.:103/42/82-

ALC4/2007 Party Name:GLAND PHARMA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00439/AM08/ RLA File : 09/24/040/00314/AM08/ Lic.No/Date:09100318 00 16.10.2007 Defer Date: 08.04.200 8 norms for export product Adenosine Injection USPunder para 4.7 of HBP. Division. 14 2

Case No.:104/42/82-

ALC4/2007 Party Name:REDOX PHARMACHEM PVT LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : RLA File : Lic.No/Date:05102107 Defer

01/82/050/00440/AM08/ 05/24/040/00500/AM08/ 70 18.10.2007 Date: 01.04.200 8 norms for export product Thymol 98% Purity and P-Cymene 95% Purity Chem. Division. 14 3

Case No.:105/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00441/AM08/ RLA File : 03/94/040/00750/AM08/ Lic.No/Date:03104473 27 22.10.2007 Defer Date: 08.04.200 8 norms for export product GCS Dog Powder and GCS Max powder under

para 4.7 of HBP.

Division. 14 4

Case No.:28/30/83-

ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01397/AM08/ RLA File : 09/24/040/00291/AM08/ Lic.No/Date:09100318 44 23.10.2007

norms for export product {1’R,2’S,5’R}-Methyl-5S(Cytosine-1’-YL)-1-3- Oxathiolane-2R-Carboxylate/CME Compound under para 4.7 of HBP. 14 5

Case No.:106/42/82-

ALC4/2007 Party Name:LUPIN LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00442/AM08/ RLA File : 03/95/040/00604/AM08/ Lic.No/Date:03104477 71 25.10.2007 Defer Date: 22.04.200 8

norms for export product Rifampicin 450mg Caps etc. under para 4.7 of HBP. Division. 14 6

Case No.:7/28/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00241/AM08/ RLA File : 03/94/040/00783/AM08/ Lic.No/Date:03104481 15 26.10.2007

norms for export product Toltrazuril Oral Solution 2.5%/Cipcox 2.5% Solution under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 35/82 meeting held on 08.01.2008. 14 7

Case No.:107/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00443/AM08/ RLA File : 03/94/040/00797/AM08/ Lic.No/Date:03104485 12 31.10.2007 Defer Date: 08.04.200 8 norms for export product Efavir Capsule 200mg/Efavirenz 200mg Capsules and Efavir 600mg Tablets/Efavirenz 600mg Tablets under para 4.7 of HBP. Division. 14 8

Case No.:4/28/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00238/AM08/ RLA File : 03/94/040/00792/AM08/ Lic.No/Date:03104485 19 31.10.2007 Defer Date: 08.04.200 8 norms

for

export

product

Lamivudine

and

Zidovudine Tablets/Duovir/Bivir/Arved Tablets under para 4.7 of HBP.

Division. 14 9

Case No.:10/28/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00244/AM08/ RLA File : 13/24/040/00020/AM08/ Lic.No/Date:13100252 80 01.11.2007

norms for export product Ascorbyl Palmitate Granules 95% under para 4.7 of HBP. 15 0

Case No.:75/32/83-

ALC1/2007 Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01497/AM08/ RLA File : 09/24/040/00253/AM08/ Lic.No/Date:09100319 42 02.11.2007 Defer Date: 22.04.200 8 norms for export product (S)-5-Chloro-1-(Cyclopropylethynyl)-2-Amino-1- (Trifluoromethyl) Benzenemethanol (Amino Carbinol) (Efavirenz Inter) Division. 15 1

Case No.:89/32/83-

ALC1/2007 Party Name:VITAL LABORATORIES PVT. LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01511/AM08/ RLA File : 03/95/040/00691/AM08/ Lic.No/Date:03104494 48 06.11.2007 Defer Date: 08.04.200 8 norms for export product Digoxin BP/EP/USP under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of MSME. 15 2

Case No.:101/32/83-

ALC1/2007 Party Name:JUBILANT ORGANOSYS LTD Meet No/Date:42/82- ALC4/2007 Status:Cas e Deferred

(FORMERLY VAM ORGANIC CHEM 19.02.2008 HQ File : 01/83/050/01523/AM08/ RLA File : 05/24/040/00477/AM08/ Lic.No/Date:05102117 02 06.11.2007 Defer Date: 01.04.200 8 norms for export product 5-Methylnicotinic Acid Hcl under para 4.7 of HBP. Chem. Division. 15 3

Case No.:4/33/83-

ALC1/2007 Party Name:ALKALOIDS CORPORATION Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01533/AM08/ RLA File : 02/24/040/00216/AM08/ Lic.No/Date:02101058 67 07.11.2007

norms for export product Noscapine BP/Noscapine Hydrochloride BP under

para 4.7 of HBP.

15 4

Case No.:108/42/82-

ALC4/2007 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00444/AM08/ RLA File : 34/24/040/00167/AM08/ Lic.No/Date:34100200 48 08.11.2007 Defer Date: 01.04.200 8 norms for export product Dibutyl Tin Oxide and Monobutyl Tin Trichloride Chem. Division. 15 5

Case No.:23/33/83-

ALC1/2007 Party Name:VIVIMED LABS LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01552/AM08/ RLA File : 09/24/040/00311/AM08/ Lic.No/Date:09100320 56 12.11.2007 Defer Date: 22.04.200 8

norms for export product Liquid Triclosan/2,4,4-Trichloro-2 Hydroxy Diphenyl Ester/VIV-1.50% (Triclosan Solution) under para 4.7 of HBP. Committee decided to call for a copy of DML from firm. Accordingly, case was deferred for six weeks. 15 6

Case No.:109/42/82-

ALC4/2007 Party Name:GLAND PHARMA LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00445/AM08/ RLA File : 09/24/040/00356/AM08/ Lic.No/Date:09100320 89 14.11.2007 Defer Date: 08.04.200 8 norms for export product Adenosine Injection under para 4.7 of HBP. Division. 15 7

Case No.:110/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00446/AM08/ RLA File : 03/94/040/00857/AM08/ Lic.No/Date:03104505 48 16.11.2007 Defer Date: 22.04.200 8 norms for export product Irinotecan hydrochloride Injection 40mg/2ml and 100mg/5ml under para 4.7 of HBP. Division. 15 8

Case No.:111/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00447/AM08/ RLA File : 03/94/040/00860/AM08/ Lic.No/Date:03104506 92 19.11.2007 Defer Date: 22.04.200 8 norms for export product Irinotecan hydrochloride Injection 40mg/2ml and 100mg/5ml under para 4.7 of HBP.

Division. 15 9

Case No.:112/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/82/050/00448/AM08/ RLA File : 03/94/040/00859/AM08/ Lic.No/Date:03104506 94 19.11.2007

norms for export product GCS Dog Powder and GCS Max powder under

para 4.7 of HBP.

their U.O. No.35011/83/2007-PI-III dated 23.10.2007 decided to ratify whichever is lower. Export product Export Qty. Sl.N o. Import items Qty. allowed per unit of export product GCS

Dog (Powder) 1 Pack of 150 gram 1. Glucosamine Hcl 82.635gm/p ack 2. Sodium Chondrotin sulphate 27.54gm/pac k 3. Manganese sulphate 0.732gm/pac k 4. Ascorbic

acid (calcium ascorbate) 4.776gm/pac k GCS

Max Powder 1 pack of 500 gram 1. Glucosamine Hcl 275.45gm/p ack 2. Sodium Chondrotin Sulphate 91.80gm/pac k 3. Manganese Sulphate 2.44gm/pack 4. Ascorbic

acid (calcium ascorbate 15.92gm/pac k of NC. 16 0

Case No.:113/42/82-

ALC4/2007 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : RLA File : Lic.No/Date:03104507 Defer

01/82/050/00449/AM08/ 03/95/040/00634/AM08/ 51 20.11.2007 Date: 01.04.200 8 norms for export product Stero Tipa 85 (Triisopropanolamine), Stero Deipa 85 [N,N-bis-(2-hydroxyethyl)-2-propanolamine] and Stero Co 360 (Polyoxyethylene Ricinoleic Acid) under para 4.7 of HBP. Chem. Division. 16 1

Case No.:114/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00450/AM08/ RLA File : 03/94/040/00865/AM08/ Lic.No/Date:03104507 89 20.11.2007 Defer Date: 08.04.200 8 norms for export product Lamivir 150mg Tablets etc. under para 4.7 of HBP. Division. 16 2

Case No.:115/42/82-

ALC4/2007 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00451/AM08/ RLA File : 09/24/040/00349/AM08/ Lic.No/Date:09100321 35 23.11.2007 Defer Date: 01.04.200 8 norms for export product Methyl hydroxyl Benzoate BP/Methyl Paraben USP/NF/Saligin MP and Propyl hydroxyl Benzoate BP/Propyl Paraben USP/NF/Saligin PP under para 4.7 of HBP. Chem. Division. 16 3

Case No.:116/42/82-

ALC4/2007 Party Name:ESTELLE CHEMICALS PVT LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00452/AM08/ RLA File : 31/24/040/00284/AM08/ Lic.No/Date:31100316 71 23.11.2007 Defer Date: 01.04.200

8 norms for export product Sorbitan Monostearate, Glyceryl Monostearate and Sorbitan Tristearate under para 4.7 of HBP. Chem. Division. 16 4

Case No.:117/42/82-

ALC4/2007 ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00453/AM08/ RLA File : 03/94/040/00871/AM08/ Lic.No/Date:03104513 37 23.11.2007

norms for export product Levacip 10% Powder/levamisole Hcl Veterinary Oral Powder and Levacip 10% powder/levamisole Hcl Vererinary Oral Powder under para 4.7 of HBP. approved in its 35/08 meeting held on 08.01.2008. 16 5

Case No.:118/42/82-

ALC4/2007 Party Name:AKRY ORGANICS PVT. LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00454/AM08/ RLA File : 03/94/040/00902/AM08/ Lic.No/Date:03104522 57 30.11.2007 Defer Date: 01.04.200 8 norms for export product Diethylene Glycol (DEG) and Tri Ethylene Glycol Chem. Division. 16 6

Case No.:119/42/82-

ALC4/2007 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Withdrawn HQ File : 01/82/050/00455/AM08/ RLA File : 04/24/040/00271/AM08/ Lic.No/Date:04100924 73 04.12.2007

norms for export product Vitamin A&D Capsules BP, Vitamin A Capsules USP and Vitamin A Capsules USP under para 4.7 of HBP.

approved in its 40/08 meeting held on 03.03.2008. 16 7

Case No.:120/42/82-

ALC4/2007 Party Name:ALKEM LABORATORIES LTD., Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00456/AM08/ RLA File : 03/94/040/00930/AM08/ Lic.No/Date:03104539 92 13.12.2007 Defer Date: 08.04.200 8 norms for export product Meropenem for Injection under para 4.7 of HBP. Division. 16 8

Case No.:5/40/83-

ALC1/2007 Party Name:SODIUM METAL (P) LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/83/050/01770/AM08/ RLA File : 34/24/040/00170/AM08/ Lic.No/Date:34100204 17 24.12.2007 : norms for export product 1,1Cyclohexane Diacetic Acid Monoamide under

para 4.7 of HBP.

Committee in consultation with representative of PI Division present in meeting decided to ratify 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. Import item Qty. allowed per unit of export product 1,1cyclohexane Diacetic

Acid Monoamide 1kg. 1,1Cyclohexane Diacetic Acid 1.12kg/kg of NC. 16 9

Case No.:7/42/83-

ALC1/2007 Party Name:ROHAN DYES AND INTERMEDIATES LTD. Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : RLA File : Lic.No/Date:08100693 Defer

01/83/050/01783/AM08/ 08/24/040/00222/AM08/ 21 02.01.2008 Date: 01.04.200 8 norms for export product under para 4.7 of HBP. Chem. Division. 17 0

Case No.:11/42/83-

ALC1/2007 Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Approved HQ File : 01/83/050/01787/AM08/ RLA File : 22/24/040/00057/AM08/ Lic.No/Date:22100073 53 03.01.2008

norms for export product Amoxycillin Trihtydrate through Enzymatic Route Committee in light of its earlier decision taken in its 38/82 meeting held on 22.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:- Export product Export Qty. Import items Qty. allowed per unit of export product

Amoxycillin Trihydrate enzymatic route (ITC(HS)No.29411 030) 1kg. 1.Penicillin G Pot. 1st crystal 1.664 BOU/Kg 2.D(-) Para hydroxy phenyl glycine methyl ester 0.608kg/kg 3.Oxilasa enzyme 5.0gm/kg 4.Penicillin G Amidase enzyme 0.852kg/kg 5.Methanol 0.0215kg/kg 6.Butyl Acetate 0.122kg/kg 7.Boric acid 0.032kg/kg of Norms Committee. 17 1

Case No.:1/42/82-

ALC4/2007 Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred

HQ File : 01/82/050/00334/AM08/ RLA File : 08/24/040/00205/AM07/ Lic.No/Date:08100698 35 28.01.2008 Defer Date: 01.04.200 8 norms for export product Tetra-N-Octyl Ammonium Bromide under para 4.7 of HBP. Chem. Division. 17 2

Case No.:2/42/82-

ALC4/2007 Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00335/AM08/ RLA File : 08/24/040/00229/AM07/ Lic.No/Date:08100698 36 28.01.2008 Defer Date: 01.04.200 8 norms for export product Methyl Tri Phenyl Phosphonium Chloride under

para 4.7 of HBP.

Chem. Division. 17 3

Case No.:3/42/82-

ALC4/2007 Party Name:R.K.INDUSTRIES, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00336/AM08/ RLA File : 08/24/040/00247/AM08/ Lic.No/Date:08100698 37 28.01.2008 Defer Date: 01.04.200 8 norms for export product Ortho Toluidine 5 Sulfonic Acid under para 4.7 of HBP. Chem. Division. 17 4

Case No.:4/42/82-

ALC4/2007 Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00337/AM08/ RLA File : 08/24/040/00180/AM07/ Lic.No/Date:08100698 62 30.01.2008 Defer Date: 01.04.200 8

norms for export product Methyl Tri Butyl Ammonium Chloride 75% solution in water under para 4.7 of HBP. Chem. Division. 17 5

Case No.:5/42/82-

ALC4/2007 Party Name:R.K.INDUSTRIES, Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00338/AM08/ RLA File : 08/24/040/00252/AM08/ Lic.No/Date:08100699 20 04.02.2008 Defer Date: 01.04.200 8 norms for export product under para 4.7 of HBP. Chem. Division. 17 6

Case No.:121/42/82-

ALC4/2007 Party Name:BODAL CHEMICALS LTD Meet No/Date:42/82- ALC4/2007 19.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00457/AM08/ RLA File : 08/24/040/00251/AM08/ Lic.No/Date:08100699 63 06.02.2008 Defer Date: 01.04.200 8 norms for export product under para 4.7 of HBP. Chem. Division.