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 : 43/82-ALC4/2007 MEETING DATE : 04.03.2008 The Meeting No.43/08 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 26.02.08 was actually held on 04.03.2008 under the Chairmanship of Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No16/08 dated 21.08.2007, 17/08 dated 28.08.2007, 18/08 dated 06.09.2007, 19/08 dated 11.09.2007 and 20/08 dated 18.09.2007 were ratified by the Committee.

Case No.B-560

M/S Artemis Biotech Norms Committee Meeting No.43/08 F.No.01/87/50/01324/AM05 Meeting Date:26.02.2008 RLA F.No.03/24/41/175/AM05 Adv.Lic.No.03102310813 dated 05.01.2005 Committee considered case as per agenda for ratification of norms for export product Losarton Potassium under para 4.7 of HBP. Committee observed that Advance Authorisation was issued on 05.01.2005 while firm has furnished required information called for vide letter dated 7.9.05 only on 10.01.2008. The information is received after a gap of more than two and half years. Committee, therefore, decided to maintain status quo.

Case No.B-561

M/S Alembic Ltd. F.No.01/82/50/5/AM08 RLA F.No.34/24/40/301/AM07 Adv.Lic.No.3410018454 dated 30.03.2007 Committee considered case as per agenda for revision of norms for export product Azithromycin Step IV under para 4.7 of HBP. Committee observed that firm had applied and obtained Advance Authorisation for export of Azithromycin Crude and not for Azithromycin Step-4 and Azithromycin Crude can not be treated as 100% pure. Committee, therefore, decided to maintain status quo.

Case No.B-562

M/S Alembic Ltd. F.No.01/82/50/149/AM08 RLA F.No.34/24/40/84/AM08 Adv.Lic.No.3410019403 dated 13.08.2007 Committee considered case as per agenda for revision of norms for export product Azithromycin Step 3 under para 4.7 of HBP. Committee observed that firm had obtained Advance Authorisation for export of Azithromycin Step-3 (KGA) while in the decision of NC, same was mentioned “Azithromycin Step 3 (Aza Azithromycin”. Committee, therefore, in consultation with representative of PI Division present in meeting decided to allow amendment in the description of export product to read as “Azithromycin Step-3 (KGA)”. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-563

M/S Alembic Ltd. F.No.01/82/50/150/AM08 RLA F.No.34/24/40/85/AM08 Adv.Lic.No.3410019404 dated 13.08.2007 Committee considered case as per agenda for revision of norms for export product Azithromycin Step IV under para 4.7 of HBP. Committee observed that firm had obtained Advance Authorisation for export of Azithromycin Step-4 (KGA) while in the decision of NC, same was mentioned “Azithromycin Step-IV (Azithromycin Crude Purity NLT 94.5%)”. Committee, therefore, in consultation with representative of PI Division present in meeting decided to allow amendment in the description of export product to read as “Azithromycin Step-IV (KGA)”. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-564

M/S Alembic Ltd. F.No.01/82/50/37/AM08 RLA F.No.34/24/40/290/AM07 Adv.Lic.No.3410018404 dated 23.03.2007 Committee considered case as per agenda for revision of norms for export product Azithromycin Step IV under para 4.7 of HBP.

Committee observed that firm had applied and obtained Advance Authorisation for export of Azithromycin Crude and not for Azithromycin Step-4 and Azithromycin Crude can not be treated as 100% pure. Committee, therefore, decided to maintain status quo.

Case No.B-565

M/S Advy Chemicals F.No.01/87/50/313/AM07 RLA F.No.03/94/40/310/AM07 Adv.Lic.No.0310387468 dated 29.06.2006 Committee considered case as per agenda for ratification of norms for export product HBsAG Subtypes ad Reagent (4000mgs) (Hepatitis B Surface Antigen- Subtypes ad) under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of DBT.

Case No.B-566

M/S Wockhardt Ltd. F.No.01/82/162/548/AM07

Committee considered case as per agenda for fixation of value addition for DEPB rate in respect of export product D-Oxyphene Base (Powder) (SION A-166). The representative of DOR did not attend the meeting and case could not be discussed in his absence. It was decided to defer case for two weeks.

Case No.B-567

M/S Wockhardt Ltd. F.No.01/82/162/215/AM08

Committee considered case as per agenda for fixation of value addition for DEPB rate in respect of export product Dextropropoxyphene Napsylate USP (SION A- 175). The representative of DOR did not attend the meeting and case could not be discussed in his absence. It was decided to defer case for two weeks.

Case No.B-568

M/S Wockhardt Ltd. F.No.01/83/162/428/AM07

Committee considered case as per agenda for fixation of value addition for revision of DEPB rate in respect of export product Dextromethorphan hydrobromide (SION A-173). The representative of DOR did not attend the meeting and case could not be discussed in his absence. It was decided to defer case for two weeks.

Case No.B-569

M/S Lupin Ltd. F.No.01/82/162/285/AM06

Committee considered case as per agenda for fixation of value addition for DEPB rate in respect of export product 3C7ACCA (SION A-2119). The representative of DOR did not attend the meeting and case could not be discussed in his absence. It was decided to defer case for two weeks.

Case No.B-570

M/S Penam laboratories Ltd. F.No.01/82/162/450/AM08

Committee considered case as per agenda for fixation of value addition for DEPB rate in respect of export product 6-APA (SION A-33). The representative of DOR did not attend the meeting and case could not be discussed in his absence. It was decided to defer case for two weeks.

Case No.A-1084

M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/50/267/AM08 RLA F.No. Adv.Lic.No.0310450439 dated 16.11.2007 Committee considered case as per agenda for ratification of norms for export product Cilazapril under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1085

M/S Cadila Healthcare Ltd. F.No.01/82/50/278/AM08 RLA F.No. 08/24/40/203/AM08 Adv.Lic.No.0810068702 dated 28.11.2007 Committee considered case as per agenda for ratification of norms for export product Warfarin Tablets under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division.

Case No.A-1086

M/S Cipla Ltd. F.No.01/82/50/215/AM08 RLA F.No. 03/94/40/621/AM08 Adv.Lic.No.0310443538 dated 18.09.2007 Committee considered case as per agenda for ratification of norms for export product Lamivir Tablets under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1087

M/S Cipla Ltd. F.No.01/82/50/213/AM08 RLA F.No. 03/94/40/534/AM08 Adv.Lic.No.0310440647 dated 23.08.2007 Committee considered case as per agenda for ratification of norms for export product Efavir Capsules 200mg and Efavir 600 mg Tablets under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1088

M/s Cipla Ltd. M.No.43/08 F.No.01/82/50/251/AM 08 Meeting Date 26.02.2008 RLA F. No. 03/94/40/747/AM08 Adv. Lic. No.0310447486 dt.23.10.2007 The Committee considered the case as per agenda for ratification of norms for the export product (1) Nevimune 200 MG Tablets/Nevirapine 200MG Tablets (2) Nevirapine Oral Suspension 50 MG/5 ML/Nevimune under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1089

M/s Cipla Ltd. M.No.43/08 F.No.01/82/50/153/AM 08 RLA F. No. 03/94/40/485/AM08 Adv. Lic. No.0310439033 dt.09.08.2007 for the export product Gemcitabine Okasa Pharma under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1090

M/s Cipla Ltd. M.No.43/08 F.No.01/82/50/160/AM 08 RLA F. No. 03/94/40/524/AM08 Adv. Lic. No.0310440273 dt.21.08.2007 for the export product Irinotecan Hydrochloride Injection 40MG/2ML(each Vial 2ML)/Irinotecan Hydrochloride Injection 100MG/5ML(each Vial 5ML) under para 4.7 of HBP. Division.

Case No.A-1091

M/s Cipla Ltd. M.No.43/08 F.No.01/82/50/152/AM 08 RLA F. No. 03/94/40/437/AM08 Adv. Lic. No.0310437618 dt.27.07.2007 for the export product Triomune 30/Lamivudine Stavudine and Nevirapine Tablets under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1092

M/S Cipla Ltd. F.No.01/82/50/255/AM08 Meeting Date26.02.2008 RLA F.No.03/94/40/798/AM08 Adv.Lic.No.0310448930 dated

02.11.2007 Committee considered case as per agenda for ratification of norms for export product Lamivir 150mg Tablet/Lamivudine Tablet 150mg, Lamivir S-30 Tablets/Lamivudine and Stavudine tablets, Lamivir S-40 Tablets/Lamivudine and Stavudine Tablets, LaMIVIR s Junior Tablets/Lamivudine and Stavudine Tablets, Lamivir S Bany Tablets/Lamivudine and Stavudine Tablets, Lamivir HBV Tablets 100mg/Lamivudine 100mg Tablets, Lamivudine and Zidovudine Tablets/Duovir/Bivir, Lamidudine, Zidovudine and nevirapine Tablets/Duovir-N and Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1093

M/s Cipla Ltd. M.No.43/08 F.No.01/82/50/250/AM 08 RLA F. No. 03/94/40/749/AM08 Adv. Lic. No.0310447493 dt.23.10.2007 for the export product Lamivir under para 4.7 of HBP. Division.

Case No.A-1094

M/s Arch Pharma Labs Ltd. M.No.43/08 F.No.01/82/50/268/AM 08 RLA F. No. 03/94/40/715/AM08 Adv. Lic. No.0310451131 dt.22.11.2007 for the export product (1 R2,S,5 R)-Methyl-5S-(Cytosine-I-YL) 1-3-Oxathiolane –2R- Carboxylate/CME Compound under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1095

M/s Arch Pharma Labs Ltd. M.No.43/08 F.No.01/82/50/269/AM 08 RLA F. No. 03/94/40/713/AM08 Adv. Lic. No.0310451128 dt.22.11.2007

for the export product (1 R2,S,5 R)-Methyl-5S-(Cytosine-I-YL) 1-3-Oxathiolane –2R- Carboxylate/CME Compound under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1096

M/s Aurobindo Pharma Ltd. M.No.43/08 F.No.01/82/50/266/AM 08 RLA F. No. 09/24/40/380/AM08 Adv. Lic. No.0910032134 dt.22.11.2007 for the export product Didanosine under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/81/2007-PI-III dated 04.03.2008 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 Quantity Sl.N o. Import items Qty. allowed per unit of export product Didanosine 1kg. 1. 2’,3-Didehydro- 2’,3’- Dideoxyinosine Sodium Salt 2.212kg/kg 2. Acetic Acid 0.534kg/kg 3. 5% Palladium on carbon 0.050kg/kg 4. Activated Carbon 0.100kg/kg 5. Methanol 6.21kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-1097

M/s Glenmark Pharmaceuticals Ltd. M.No.43/08 F.No.01/82/50/339/AM 08 RLA F. No. 03/24/40/405/AM04 Adv. Lic. No.0310209606 dated 23.06.2003

for the export product Glimepride under 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 light of written comments forwarded by PI Division vide their U.O. No.35011/127/2006-PI-III dated 14.08.2006 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 Quantity Sl.N o. Import items Qty allowed per unit of export product Gilimepride 1kg. 1. 4-(2-3-Ethyl-4- Methyl-2-Oxo-3- Pyrroline-1- Carboxamido Ethyl Phenyl Sulfonamide) 0.96kg/kg 2. Trans-4-Methyl Cyclohexyl Isocyanate 0.39kg/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. 1

Case No.:61/24/87-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/87/050/00084/AM06/ RLA File : 34/24/040/00007/AM06/ Lic.No/Date:34100132 61 27.04.2005 Defer Date: 22.04.2008 Decision :Committee considered case as per agenda for ratification of norms for export product Modafinil under para 4.7 of HBP. Committee observed that case was received from DES-VII on 02.01.2008. Committee decided to defer case for six weeks for comments of PI Division. 2

Case No.:2/46/82-

ALC1/2006 Party Name:MATRIX LABORATORIES LTD Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/82/050/01441/AM07/ RLA File : 09/24/040/00390/AM07/ Lic.No/Date:09100286 34 13.12.2006 Defer Date: 08.04.2008

Decision : Committee considered case as per agenda for ratification of norms for export product N-Trifluoro Acetyl-N-Lysine-Prasine (Lyspro (Isolated) under para 4.7 of HBP. Division. 3

Case No.:16/49/82-

ALC1/2006 Party Name:LUPIN LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 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: 22.04.2008 norms for export product Sterile Ceftriaxone Sodium-Non Inringing under

para 4.7 of HBP.

Committee decided to examine the case on file. 4

Case No.:879/21/82-

ALC4/2007 Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Approved 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. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/30/2007-PI-III dated 04.03.2008 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 Quantity Sl.N o. Import items Qty. allowed per unit of export product Dorzolamide 1kg. 1. Methyl-R-hydroxy Butyrate 4.78kg/kg 2. Thiophene 2.70kg/kg 3. Boron trifluoride itehrate 2.78kg/kg 4. Tetrahydrofuran 18.00kg/kg 5. Sodium Borohydride 0.60kg/kg

Synhydride 7.96kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 5

Case No.:7/2/82-ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:43/82-

ALC4/2007 26.02.2008 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. Division. 6

Case No.:951/21/82-

ALC4/2007 Party Name:MAHAVIR DYE CHEM Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/82/050/01813/AM07/ RLA File : 52/24/040/00006/AM07/ Lic.No/Date:52100212 88 15.03.2007 Defer Date: 22.04.2008 norms for export product 2(3-Amino Phenyl Sulfonamide)Naptalene 6.8 Di Sulfonic Acid 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 six weeks. 7

Case No.:17/9/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Rejected HQ File : 01/82/050/01837/AM07/ RLA File : 03/94/040/01468/AM07/ Lic.No/Date:03104237 77 21.03.2007

norms for export product Exemestane under para 4.7 of HBP. Committee decided to withdraw case as case has already been rejected in its 40/08 meeting held on 03.03.2008.

8

Case No.:25/14/83-

ALC1/2007 Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00016/AM08/ RLA File : 04/24/040/00501/AM07/ Lic.No/Date:04100887 27 02.04.2007 Defer Date: 22.04.2008 norms for export product Allylestrenol under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 9

Case No.:19/19/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00029/AM08/ RLA File : 09/24/040/00534/AM07/ Lic.No/Date:09100298 86 04.04.2007 Defer Date: 22.04.2008 norms for export product Naproxen Granules DC Grade 80% (Compresso NAP 80) under para 4.7 of HBP. Division. 10

Case No.:14/14/83-

ALC1/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00127/AM08/ RLA File : 05/24/040/00041/AM08/ Lic.No/Date:05102026 22 17.04.2007 Defer Date: 22.04.2008 norms

for

export

product

3,4-Dihydro-4-oxo-6-acetyloxy-7- methoxyquinazoline under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Div. of C&PC for their comments. Accordingly, case was deferred for six weeks. 11 Case No.:730/24/83- ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00623/AM08/ RLA File : 09/24/040/00120/AM08/ Lic.No/Date:09100306 86 29.06.2007 Defer Date: 08.04.2008

norms for export product (S)-3-Hydroxy-N-Benzyl Pyrrolidine under para 4.7 of HBP. Division. 12

Case No.:80/19/83-

ALC1/2007 Party Name:MDB CHEMICALS (INDIA) PVT.LTD. Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/00636/AM08/ RLA File : 31/21/040/00084/AM08/ Lic.No/Date:31100297 17 02.07.2007 Defer Date: 22.04.2008 norms for export product 1,2-Methylenedioxybenzene under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical Div. of C&PC for their comments. Accordingly, case was deferred for six weeks. 13

Case No.:113/21/82-

ALC4/2007 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:43/82- ALC4/2007 26.02.2008 Status: Case
HQ File : 01/82/050/00157/AM08/ RLA File : 22/24/040/00030/AM08/ Lic.No/Date:22100069 84 20.08.2007

norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. Committee decided to withdraw case as case has been considered in its 41/82 meeting held on 03.03.2008. 14

Case No.:7/25/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 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: 22.04.2008 norms for export product Didanosine under para 4.7 of HBP. Division.

15

Case No.:12/27/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01086/AM08/ RLA File : 03/94/040/00555/AM08/ Lic.No/Date:03104415 61 31.08.2007 Defer Date: 08.04.2008 norms for export product Saquinavir 200mg Capsules Saqvir 200mg Capsules under para 4.7 of HBP. Division. 16

Case No.:54/27/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01128/AM08/ RLA File : 03/94/040/00525/AM08/ Lic.No/Date:03104419 78 06.09.2007 Defer Date: 08.04.2008 norms for export product Aprepitant under para 4.7 of HBP. Division. 17

Case No.:69/27/83-

ALC1/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01143/AM08/ RLA File : 05/24/040/00396/AM08/ Lic.No/Date:05102087 76 10.09.2007 Defer Date: 08.04.2008 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. 18 Case No.:10/22/82- ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00180/AM08/ RLA File : 03/94/040/00615/AM08/ Lic.No/Date:03104428 78 12.09.2007 Defer Date: 08.04.2008

norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. Division. 19

Case No.:2/25/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00196/AM08/ RLA File : 03/94/040/00664/AM08/ Lic.No/Date:03104450 42 03.10.2007 Defer Date: 08.04.2008 norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. Division. 20

Case No.:7/29/83-

ALC1/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01272/AM08/ RLA File : 05/24/040/00518/AM08/ Lic.No/Date:05102098 61 03.10.2007 Defer Date: 08.04.2008 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. 21

Case No.:24/30/83-

ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01393/AM08/ RLA File : 09/24/040/00319/AM08/ Lic.No/Date:09100318 43 23.10.2007 Defer Date: 08.04.2008 norms for export product Rifaximin under para 4.7 of HBP. Division.

22

Case No.:53/30/83-

ALC1/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01422/AM08/ RLA File : 09/24/040/00560/AM07/ Lic.No/Date:09100318 81 24.10.2007 Defer Date: 22.04.2008 norms for export product Cyclopropyl Diol Cyclic Sulfite under para 4.7 of HBP. Division. 23

Case No.:51/30/83-

ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01420/AM08/ RLA File : 09/24/040/00276/AM08/ Lic.No/Date:09100318 79 24.10.2007

norms for export product Indinavir Sulphate under para 4.7 of HBP. Committee decided to withdraw case as case has been considered in its 40/82 meeting held on 03.03.2008. 24

Case No.:82/32/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01504/AM08/ RLA File : 09/24/040/00051/AM08/ Lic.No/Date:09100319 91 05.11.2007

norms for export product Cefepime Hcl for Injection under para 4.7 of HBP. Committee decided to withdraw case as case has been approved in its 40/82 meeting held on 03.03.2008. 25 Case No.:92/32/83- ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Case Deferred HQ File : 01/83/050/01514/AM08/ RLA File : 03/94/040/00814/AM08/ Lic.No/Date:03104494 95 06.11.2007 Defer Date: 22.04.2008 norms for export product Pantoprazole Sodium Sesquihydrate under para

4.7 of HBP. Division. 26

Case No.:32/33/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01561/AM08/ RLA File : 09/24/040/00256/AM08/ Lic.No/Date:09100320 90 14.11.2007 Defer Date: 22.04.2008 norms for export product Cyclohexyl Ester under para 4.7 of HBP. Division. 27

Case No.:60/39/83-

ALC1/2007 Party Name:SANJAY SALES CORPORATION Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01639/AM08/ RLA File : 03/95/040/00792/AM08/ Lic.No/Date:03104516 62 27.11.2007 Defer Date: 22.04.2008 norms for export product Sodium Salicylate under para 4.7 of HBP. Committee decided to forward a copy of application to Chemical div. of C&PC for their comments. Accordingly, case was deferred for six weeks. 28

Case No.:34/39/83-

ALC1/2007 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01613/AM08/ RLA File : 09/24/040/00385/AM08/ Lic.No/Date:09100322 45 28.11.2007 Defer Date: 08.04.2008 norms for export product (s)Alpha-Ethyl-2-Oxo-1-Pyrrolidineacetic Acid (LVA-40) under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for four weeks. 29 Case No.:95/39/83- ALC1/2007 Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Approved

HQ File : 01/83/050/01674/AM08/ RLA File : 11/24/040/00048/AM08/ Lic.No/Date:11100164 77 03.12.2007

norms for export product Hydrocortisone Sodium Succinate Buffered 5% Sterile under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/209/2006-PI-III dated 04.03.2008 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 Quantity Sl.N o. Import item Quantity allowed per unit of export product Hydrocortisone sodium

succinate buffered 5% sterile 1kg. 1. Hydrocortisone BP/USP 1.10kg/k g RA concerned may take further necessary action as per above decision of Norms Committee. 30

Case No.:161/39/83-

ALC1/2007 Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Withdrawn HQ File : 01/83/050/01740/AM08/ RLA File : 11/24/040/00050/AM08/ Lic.No/Date:11100165 15 11.12.2007

norms for export product Hydrocortisone Acetate BP (Micronised) under

para 4.7 of HBP.

Committee decided to withdraw case as case has been approved in its 40/08 meeting held on 03.03.2008. 31

Case No.:160/39/83-

ALC1/2007 Party Name:SYMBIOTEC PHARMALAB LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Approved HQ File : 01/83/050/01739/AM08/ RLA File : 11/24/040/00046/AM08/ Lic.No/Date:11100165 26 12.12.2007

norms for export product Hydrocortisone Sodium Succinate for Injection

USP under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/209/2006-PI-III dated 04.03.2008 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 Quantity Sl.N o. Import item Quantity allowed per unit of export product Hydrocortisone sodium

succinate buffered 5% sterile 1kg. 1. Hydrocortisone BP/USP 1.10kg/k g RA concerned may take further necessary action as per above decision of Norms Committee. 32

Case No.:9/40/83-

ALC1/2007 Party Name:KUDOES CHEMIE LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/83/050/01774/AM08/ RLA File : 22/24/040/00059/AM08/ Lic.No/Date:22100073 29 27.12.2007 Defer Date: 22.04.2008 norms for export product Caffeine under para 4.7 of HBP. Division. 33

Case No.:1/43/82-

ALC4/2007 Party Name:KUDOES CHEMIE LTD., Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Deferred HQ File : 01/82/050/00459/AM08/ RLA File : 22/24/040/00065/AM08/ Lic.No/Date:22100074 51 13.02.2008 Defer Date: 22.04.2008 norms for export product Synthetic Caffeine under para 4.7 of HBP. Division. 34 Case No.:2/43/82- ALC4/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:43/82- ALC4/2007 Status:Cas e Approved

26.02.2008 HQ File : 01/82/050/00460/AM08/ RLA File : 22/24/040/00063/AM08/ Lic.No/Date:22100074 55 14.02.2008

norms for export product Amoxycillin Trihydrate Through Enzymatic Route under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 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 the firm whichever is lower:- Export product Export Qty. Sl.No . Import items Qty. allowed per unit of export product

Amoxycillin Trihydrate enzymatic route

1kg. 1. Penicillin G Pot. 1st crystal 1.664 BOU/Kg 2. D(-) Para hydroxy phenyl

glycine methyl ester 0.608kg/k g 3. Oxilasa enzyme 5.0gm/kg 4. Penicillin G Amidase enzyme 0.852kg/k g 5. Methanol 0.0215kg/ kg 6. Butyl Acetate 0.122kg/k g 7. Boric acid 0.032kg/k g RA concerned may take further necessary action as per above decision of Norms Committee. 35 Case No.:3/43/82- ALC4/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Approved HQ File : 01/82/050/00461/AM08/ RLA File : 22/24/040/00064/AM08/ Lic.No/Date:22100074 57 14.02.2008

norms for export product Amoxycillin Trihydrate through Enzymatic Route under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 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 the firm whichever is lower:- Export product Export Qty. Sl.No . Import items Qty. allowed per unit of export product

Amoxycillin Trihydrate enzymatic route

1kg. 1. Penicillin G Pot. 1st crystal 1.664 BOU/Kg 2. D(-) Para hydroxy phenyl

glycine methyl ester 0.608kg/k g 3. Oxilasa enzyme 5.0gm/kg 4. Penicillin G Amidase enzyme 0.852kg/k g 5. Methanol 0.0215kg/ kg 6. Butyl Acetate 0.122kg/k g 7. Boric acid 0.032kg/k g RA concerned may take further necessary action as per above decision of Norms Committee. 36

Case No.:4/43/82-

ALC4/2007 Party Name:DSM ANTI- INFECTIVES INDIA LTD Meet No/Date:43/82- ALC4/2007 26.02.2008 Status:Cas e Approved HQ File : 01/82/050/00462/AM08/ RLA File : 22/24/040/00061/AM08/ Lic.No/Date:22100074 58 14.02.2008

norms for export product 6-Amino Penicillin Acid through Pen G Route under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide

their U.O. No.35011/165/2006-PI-III dated 09.03.2007 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 Quantity Sl.N o. Import items Qty.

allowed per unit of export procduct 6-Amino Penicillin Acid (6 APA) 1kg. 1. Penicillin G Pot. 1st crystal 2.92BOU/kg 2. Penicillin

G Amidase Enzyme 0.096gm/kg 3. Boric Acid 0.055kg/kg 4. Methanol- 0.04kg/kg 5. Butyl Acetate 0.214kg/kg 6. P.T. Resin 0.004ltd/kg RA concerned may take further necessary action as per above decision of Norms Committee.