DGFT Committee Minutes

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

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 39/82-ALC4/2007 MEETING DATE : 29.01.2008 The Meeting No.39/08 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 was held on 31.01.2008 under the Chairmanship of Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No.1/08 dated 09.05.2007, 2/08 dated 16.05.2007, 3/08 dated 23.05.2007, 4/08 dated 30.05.2007, 5/08 dated 06.06.2007 and 38/08 dated 23.01.2008 were ratified by the Committee.

Case No.B-515

M/S Om Shree Pharmachem Pvt. Ltd. Norms Committee Meeting No.39/08 F.No.01/83/50/1378/AM07 Meeting Date: 29.01.2008 RLA F.No.03/95/40/1605/AM07 Adv.Lic.No.0310424623 dated 27.03.2007 Committee considered case as per agenda for ratification of norms for export product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee observed that firm has sought deferment of personal hearing for two weeks. Accordingly, Committee decided to call representative of firm for personal hearing on 12.02.2008. Accordingly, case was deferred for two weeks.

Case No.B-516

M/S Om Shree Pharmachem Pvt. Ltd. F.No.01/83/50/725/AM08 RLA F.No.03/95/40/230/AM08 Adv.Lic.No.0310432141 dated 08.06.2007 product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee observed that firm has sought deferment of personal hearing for two weeks. Accordingly, Committee decided to call representative of firm for personal hearing on 12.02.2008. Accordingly, case was deferred for two weeks.

Case No.B-517

M/S Om Shree Pharmachem Pvt. Ltd. F.No.01/83/50/1267/AM07 RLA F.No.03/95/40/1424/AM07 Adv.Lic.No.0310420407 dated 21.02.2007 product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee observed that firm has sought deferment of personal hearing for two weeks. Accordingly, Committee decided to call representative of firm for personal hearing on 12.02.2008. Accordingly, case was deferred for two weeks.

Case No.B-518

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 Department of Revenue present in the meeting handed over a copy of DO letter No.605/46/2007-DBK dated 15.01.2008 from Revenue Secretary to Secretary, MOC wherein it has been stated that there is no need to add any additional item or change value cap at this stage when DEPB scheme is on its last legs. In view of above, Committee did not fix the value addition in this case and decided to refer the matter to DEPB Committee for their comments as to whether the value addition is to be fixed where data for fixation of DEPB rate or fix value addition norms has been received.

Case No.B-519

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-Amino Penicillanic Acid (SION A-33).

The representative of Department of Revenue present in the meeting handed over a copy of DO letter No.605/46/2007-DBK dated 15.01.2008 from Revenue Secretary to Secretary, MOC wherein it has been stated that there is no need to add any additional item or change value cap at this stage when DEPB scheme is on its last legs. In view of above, Committee did not fix the value addition in this case and decided to refer the matter to DEPB Committee for their comments as to whether the value addition is to be fixed where data for fixation of DEPB rate or fix value addition norms has been received.

Case No.B-520

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 Sapsylate USP (SION A- 175). The representative of Department of Revenue present in the meeting handed over a copy of DO letter No.605/46/2007-DBK dated 15.01.2008 from Revenue Secretary to Secretary, MOC wherein it has been stated that there is no need to add any additional item or change value cap at this stage when DEPB scheme is on its last legs. In view of above, Committee did not fix the value addition in this case and decided to refer the matter to DEPB Committee for their comments as to whether the value addition is to be fixed where data for fixation of DEPB rate or fix value addition norms has been received.

Case No.B-521

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 Department of Revenue present in the meeting handed over a copy of DO letter No.605/46/2007-DBK dated 15.01.2008 from Revenue Secretary to Secretary, MOC wherein it has been stated that there is no need to add any additional item or change value cap at this stage when DEPB scheme is on its last legs.

In view of above, Committee did not fix the value addition in this case and decided to refer the matter to DEPB Committee for their comments as to whether the value addition is to be fixed where data for fixation of DEPB rate or fix value addition norms has been received.

Case No.B-522

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 Department of Revenue present in the meeting handed over a copy of DO letter No.605/46/2007-DBK dated 15.01.2008 from Revenue Secretary to Secretary, MOC wherein it has been stated that there is no need to add any additional item or change value cap at this stage when DEPB scheme is on its last legs. In view of above, Committee did not fix the value addition in this case and decided to refer the matter to DEPB Committee for their comments as to whether the value addition is to be fixed where data for fixation of DEPB rate or fix value addition norms has been received.

Case No.B-523

M/S Shreya Life Science Pvt. Ltd.

RLA F.No.03/95/40/1605/AM07 Adv.Lic.No.0310300924 dated 05.11.2004 Committee considered case as per agenda for regularization of additional marginal waste quantity of 3.124kgs. Committee decided to advise firm to get the matter regularized as per provisions of Foreign Trade Policy & Procedures.

Case No.B-524

M/S Dalas Biotech Ltd. F.No.01/82/50/223/AM08 RLA F.No.05/24/40/1078/AM07 Adv.Lic.No.0510203062 dated

27.04.2007 Committee considered case as per agenda for revision of norms for export product 7 AVCA under para 4.7 of HBP. Committee observed that there is no basis for enhancement of quantity of inputs. Accordingly, Committee decided to maintain status quo.

Case No.B-525

M/S Cipla Ltd. F.No.01/82/50/927/AM06 RLA F.No.03/94/40/904/AM06 Adv.Lic.No.0310355734 dated 17.11.2005 product Doxazosin Mesylate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007-PI-III dated 28.01.2008 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 Import items Quantity allowed per unit of export product Sl.N o. Product Doxazoxin Mesylate 1kg. 1. 6,7-Dimethoxy-2-(1- piperazinyl) 4-amino quinazoline 1.05kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-526

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

product HBsAG Subtypes ad Reagent 4000mgs) (Hepatitis B Surface Antigen- Subtypes ad) under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of DBT.

Case No.B-527

M/S Alkem Laboratories Ltd. F.No.01/87/50/967/AM07 RLA F.No.03/94/40/1200/AM07 Adv.Lic.No.0310418737 dated 07.02.2007 Committee considered case as per agenda for revision of norms for export product Amoxycillin and Clavulanate Potassium Tablet 375mg under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/71/2006-PI-III dated 31.01.2008 decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:- Export product Export Quantity Import items Total Quantity allowed
Sl.No. Product Amoxycillin and Clavulanate Potassium Tablets 375mg. (ITC(HS)No.30041000)

13,00,000Nos . 1) Amoxicillin Trihydrate 377.91kg 2) Clavulanat e Potassium with Avicel (1:1) 394.485k gs. Amoxycillin and Clavulanate Potassium Tablets 625mg. (ITC(HS)No.30041000) 20,00,000Nos . 1) Amoxicillin Trihydrate 1162.80k gs. 2) Clavulanat e Potassium with Avicel (1:1) 606.90kg s. Amoxycillin and Clavulanate Potassium Tablets 1000mg. (ITC(HS)No.30041000) 66,00,000Nos . 1) Amoxicillin Trihydrate 671.52kg s. 2) Clavulanat e Potassium with Avicel (1:1) 200.277k gs.

RA concerned may check the quantity of imported input as per record before allowing revised norms and take further necessary action as per above decision of Norms Committee.

Case No.B-528

M/S Alliance Laboratories Ltd. F.No.01/82/50/424/AM08 F.No.01/83/50/1037/AM08 Meeting Date:29.01.2008 RLA F.No.03/94/40/160/AM08 RLA F.No.03/94/40/556/AM08 Adv.Lic.No.0310430399 dated 23.05.2007 Adv. Lic.No.0310441279 dated 30.08.2007 product Iso Sorbide-5-Mononitrate under para 4.7 of HBP. Committee observed that firm has sought deferment of personal hearing for two weeks. Accordingly, Committee decided to call representative of firm for personal hearing on 12.02.2008. Accordingly, case was deferred for two weeks.

Case No.A-989

M/S Matrix Lab. Ltd. F.No.01/82/50/226/AM08 RLA F.No.09/24/40/192/AM08 Adv.Lic.No.0910031252 dated 27.08.2007 product Tenofovir Disoproxil Fumarate 300mg tablets under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-990

F.No.01/82/50/234/AM08 RLA F.No.09/24/40/188/AM08 Adv.Lic.No.0910031126 dated 13.08.2007 product Valsartan Tablets 40mg under para 4.7 of HBP.

Case No.A-991

F.No.01/82/50/227/AM08 RLA F.No.09/24/40/204/AM08 Adv.Lic.No.0910031354 dated 31.08.2007 product Tenofovir Disoproxil Fumarate 300mg and Lamidudine 300mg tablets under

para 4.7 of HBP.

Case No.A-992

F.No.01/82/50/233/AM08 RLA F.No.09/24/40/196/AM08 Adv.Lic.No.0910031321 dated 30.08.2007 product Emtricitabine 200mg and Tenofovir Disoproxil Fumarate 300mg Tablets under para 4.7 of HBP.

Case No.A-993

F.No.01/82/50/231/AM08 RLA F.No.09/24/40/191/AM08 Adv.Lic.No.0910031127 dated 13.08.2007 product Quetiapine Fumarate Tablet 25 mg under para 4.7 of HBP.

Case No.A-994

F.No.01/82/50/229/AM08 RLA F.No.09/24/40/202/AM08 Adv.Lic.No.0910031202 dated 24.08.2007 product Didanosine Delayed Release Capsules-125mg, 200mg, 250mg and 400mg Capsules under para 4.7 of HBP.

Case No.A-995

F.No.01/82/50/232/AM08 RLA F.No.09/24/40/216/AM08 Adv.Lic.No.0910031186 dated 21.08.2007 product Citalopram Tablets-10mg, 20mg, 30mg, 40mg and 60mg under para 4.7 of HBP.

Case No.A-996

F.No.01/82/50/230/AM08 RLA F.No.09/24/40/187/AM08 Adv.Lic.No.0910031251 dated 27.08.2007 product Abacavie Sulfate-300mg tablets under para 4.7 of HBP.

Case No.A-997

M/S Intervet India Pvt. Ltd. F.No.01/82/162/392/AM08 RLA F.No.09/24/40/329/AM03 Adv.Lic.No.0910013828 dated 03.04.2003 product ND Clon 30 Vaccine 2ml under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of DBT.

Case No.A-998

M/S Medreich Ltd. F.No.01/82/50/1790/AM07 Meeting Date:29.01.2008 RLA F.No.07/24/40/718/AM07 Adv.Lic.No.0710049763 dated 24.01.2007

product Paracetamol 450mg + Caffiene Anhydrous 45mg or 50mg or 30mg + Doxylamine Succinate 5mg + Codeine Phosphate 10mg Tablets under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/207/2006-PI-III dated 31.01.2008 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 Quanti ty Import items Quantity allowed per unit of export product Sl.No . Product Paracetamol 450mg + Caffiene Anhydrous 45mg or 50mg or 30mg

• Doxylamine Succinate 5mg + Codeine Phosphate 10mg Tablets (ITC(HS)No.300490 39) 1 Tablet

Paracetamol 459mg/tablet 2. Doxylamine Succinate 5.1mg/tablet 3. Spectracolquinoline yellow 800744 B20 Neither description nor CI No. matches with description given in MBF. Hence not allowed 4. Spectracolquinoline yellow LK 80500 2B10 -d0- RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-999

M/S Lyka BDR Intl. Ltd. F.No.01/82/50/89/AM08 RLA F.No.03/95/40/1309/AM07 Adv.Lic.No.0310419266 dated 12.02.2007 product (1) Clobetasole Propionate Cream 10gm (Dermotyl Cream 10gm), (2) Clobetasole Propionate Cream 15gm (Dermotyl Cream 15gm), (3) Clobetasole Propionate Cream 30gm (Dermotyl Cream 30gm), (4) Clobetasol Propionate Topical Solution 0.05% W/V and (5) Clobetasol Propionate Topical Sodution 0.05% W/V under para 4.7 of HBP. Committee decided to call from the firm calculation sheet showing the wastage. Accordingly case was deferred for six weeks.

Case No.A-1000

M/S Cipla Ltd. F.No.01/82/50/255/AM08 RLA F.No.03/94/40/798/AM08 Adv.Lic.No.0310448930 dated 02.11.2007 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.

Case No.A-1001

M/S Cipla Ltd. F.No.01/82/50/256/AM08 RLA F.No.03/94/40/797/AM08 Adv.Lic.No.0310448512 dated 31.10.2007 product Efavir Capsule 200mg/Efavirenz 200mg Capsules and Efavir 600mg Tablets/Efavirenz 600mg Tablets tablets under para 4.7 of HBP.

Case No.A-1002

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 product (1) Lamivir 150 mg Tablets/Lamivudine Tablet 150mg, (2) Lamivir S-30 Tablets/Lamivudine and Stavudine Tablets, (3) Lamivir S-40 Tablets/Lamivudine and Stavudine Tablets, (4) Lamivir S Junior Tablets Lamivudine and Stavudine Tablets and (5) Lamivir S Baby Tablets lamivudine and Stavudine Tablets under para 4.7 of HBP.

Case No.A-1003

M/S Cipla Ltd. F.No.01/82/50/216/AM08 RLA F.No.03/94/40/688/AM08 Adv.Lic.No.0310445044 dated 03.10.2007 product Nevimune 200mg Tablets/Nevirapine 200mg Tablets and Nevirapine Oral Suspension 50mg/5ml Nevimune under para 4.7 of HBP.

Case No.A-1004

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/194/AM 08 Meeting Date 29.01.2008 RLA F. No. 03/94/40/582/AM08 Adv. Lic. No.0310441827 dt.05.09.2007 The Committee considered the case as per agenda for ratification of norms for the export product Nevimune 200 MG Tablets/Nevirapine 200MG Tablets (2) Nevirapine Oral Suspension 50 MG/5 ML/Nevimune under para 4.7 of HBP.

Case No.A-1005

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/210/AM 08 RLA F. No. 03/94/40/578/AM08 Adv. Lic. No.0310441906 dt.21.08.2007 for the export product 62/0 Lamivir 150MG Tablets/Lamivudine Tablets 150 MG under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1006

M/S Cipla Ltd. F.No.01/82/50/212/AM08/DES-III Meeting Date:29.01.2008 RLA F.No.03/94/40/590/AM08 Advance licence No.0310442077 dated 06.09.2007

product Terbinafine Hcl under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/83/2007-PI-III dated 28.01.2008 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 Import items Quantity allowed per unit of export product Sl.No. Product Terbinafine Hcl ITC(HS)No.294200 90) 1kg. 1 . 1-chloro-6,6-dimethyl-2- heptene-4-yne 0.87kg/kg 2 . N-methyl-1-naphthyl methylamine Hcl 1.14kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-1007

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/264/AM 08 RLA F. No. 03/94/40/865/AM08 Adv. Lic. No.0310450789 dt.20.11.2007 for the export product Lamivir under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.A-1008

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/265/AM 08 RLA F. No. 03/94/40/857/AM08 Adv. Lic. No.0310450548 dt.16.11.2007 for the export product 1. Irinotecan Hydrochloride Injection 40mg/2ml (each Vial 2ml) 2. Irinotecan Hydrochloride Injection 100mg/5ml (each Vial 5ml) para 4.7 of HBP. Division.

Case No.A-1009

M/s Cipla Ltd. M.No.39/08 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-1010

M/S Cipla Ltd. F.No.01/82/50/224/AM08/DES-III Meeting Date:29.01.2008 RLA F.No.03/94/40/708/AM08 Advance licence No.0310445737 dated 09.10.2007 product Nevimune 200mg Tablets/Nevirapine 200mg Tablets and Nevirapine Oral Suspension 50mg/5ml Nevimyne under para 4.7 of HBP.

Case No.A-1011

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/251/AM 08 RLA F. No. 03/94/40/747/AM08 Adv. Lic. No.0310447486 dt.23.10.2007 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. Division.

Case No.A-1012

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/214/AM 08 RLA F. No. 03/94/40/674/AM08

Adv. Lic. No.0310445040 dt.03.10.2007 for the export product 62/0 Telmisartan and Amlodipin Tablets under para 4.7 of HBP. Division.

Case No.A-1013

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/155/AM 08 RLA F. No. 03/94/40/473/AM08 Adv. Lic. No.0310438672 dt.07.08.2007 for the export product Nevimune 200 MG Tablets/Nevirapine 200MG Tablets under

para 4.7 of HBP.

Division.

Case No.A-1014

M/S Cipla Ltd. F.No.01/82/50/168/AM08/DES-III Meeting Date:29.01.2008 RLA F.No.03/94/40/17/AM08 Advance licence No.0310426065 dated 10.04.2007 product Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets and Triomune 40/Lamivudine, Stavudine and nevirapine Tablets under para 4.7 of HBP.

Case No.A-1015

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/211/AM 08 RLA F. No. 03/94/40/553/AM08 Adv. Lic. No.0310440694 dt.27.08.2007

for the export product 62/0 Lamivir 150MG Tablets/Lamivudine Tablets 150 MG under para 4.7 of HBP. Division.

Case No.A-1016

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/213/AM 08 RLA F. No. 03/94/40/534/AM08 Adv. Lic. No.0310440647 dt.23.08.2007 for the export product 62/0 Efavir Capsules 200MG/Efavirenz 200 Capsules (2) Efavir 600 MG Tablets/Efavirenz 600MG Tablets under para 4.7 of HBP. Division.

Case No.A-1017

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/270/AM 08 RLA F. No. 03/94/40/860/AM08 Adv. Lic. No.0310450692 dt.19.11.2007 for the export product 1. Irinotecan Hydrochloride Injection 40mg/2ml (each Vial 2ml) 2. Irinotecan Hydrochloride Injection 100mg/5ml (each Vial 5ml) under para 4.7 of HBP. Division.

Case No.A-1018

M/s Cipla Ltd. M.No.39/08 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. Division.

Case No.A-1019

M/s Cipla Ltd. M.No.39/08 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-1020

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/188/AM 08 RLA F. No. 03/94/40/554/AM08 Adv. Lic. No.0310441419 dt.30.08.2007 for the export product 62/0 Lopinavir and Ritonavir Tablets under para 4.7 of HBP. Division.

Case No.A-1021

M/S Cipla Ltd. F.No.01/82/50/223/AM08/DES-III Meeting Date:29.01.2008 RLA F.No.03/94/40/706/AM08 Advance licence No.0310445735 dated 09.10.2007 product Lamivir 150mg Tablets/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 Baby Tablets Lamivudine and Stavudine Tables, Lamivir HBV Tablets 100mg/Lamivudine 100mg Tablets, Lamivudine and Zidovudine Tablets/Duovir/Bivir, Lamivudine, Zidovudine and nevirapine Tablets Duovir-N and Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP.

Case No.A-1022

M/S Cipla Ltd. F.No.01/82/50/136/AM08/DES-III Meeting Date:29.01.2008 RLA F.No.03/94/40/383/AM08 Advance licence No.0310436156 dated 13.07.2007 product Stavir 15mg, 20mg, 30mg, 40 mg Capsules and Lamivir S-30 and S-40 Tablets under para 4.7 of HBP.

Case No.A-1023

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/158/AM 08 RLA F. No. 03/94/40/535/AM08 Adv. Lic. No.0310440429 dt.22.08.2007 for the export product 62/0 Budccort 200 Inhaler (200 MD) Aerobud Inhaler (200 MD)/Budesonide Generis 200 Inhaler (200 MD) under para 4.7 of HBP. Division.

Case No.A-1024

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/193/AM 08 RLA F. No. 03/94/40/540/AM08 Adv. Lic. No.0310440643 dt.23.08.2007 for the export product 62/0 Cyproterone Acetate Tablets 100MG/Cyproterone Acetate Tablets 50 MG under para 4.7 of HBP.

Case No.A-1025

M/s Cipla Ltd. M.No.39/08 F.No.01/82/50/169/AM 08 RLA F. No. 03/94/40/250/AM08

Adv. Lic. No.0310432136 dt.08.06.2007 for the export product Stavir 15 MG Capsules under para 4.7 of HBP. Division.

Case No.A-1026

M/s Cipla Ltd. M.No.39/08 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. Division.

Case No.A-1027

M/s Glenmark Pharmaceuticals Ltd. M.No.39/08 F.No.01/82/50/267/AM 08 RLA F. No. 03/94/40/805/AM08 Adv. Lic. No.0310450439 dt.16.11.2007 for the export product Cilazapril under para 4.7 of HBP. Division.

Case No.A-1028

M/s Arch Pharma Labs Ltd. M.No.39/08 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. Division.

Case No.A-1029

M/s Arch Pharma Labs Ltd. M.No.39/08 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. Division.

Case No.A-1030

M/s Aurobindo Pharma Ltd. M.No.39/08 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. Division.

Case No.A-1031

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 product Warfarin 1mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 6mg, 7.5mg and 10mg tablets under para 4.7 of HBP.

Case No.C-30

M/S DCM Shriram Industries Ltd. Norms Committee Meeting No.35/08 F.No.01/83/162/286/AM08 Meeting Date: 01.01.2008

Committee considered case as per agenda for modification of SION A-3011 in respect of export product D(-) Para Hydroxy Phenyl Glycine Methyl Potassium Dane Salt.

1

Case No.:61/24/87-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 Decision :Committee considered case as per agenda for ratification of norms for export product Modafinil under para 4.7 of HBP. Division. 2

Case No.:303/24/87-

ALC1/2007 Party Name:ASENCE INC Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/87/050/00401/AM06/ RLA File : 34/24/040/00032/AM06/ Lic.No/Date:34100138 08 11.07.2005

Decision : Committee considered case as per agenda for ratification of norms for export product Vitamin C BP/USP (Ascorbic Acid BP) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 36/87 meeting held on 19.01.2005 vide Case No.2/36/87 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. Import items Qty.

allowed per unit of export product Sl.No. Product Vitamin C BP/USP (Ascorbic Acid BP) (ITC(HS)No.30041 000) 1kg. 1. 2 KGA (2 Keto L- Gulonic

Acid) BP/USP
1.476kg/kg
RA concerned may take further necessary action as per above decision of Norms Committee.

3

Case No.:10/20/87-

ALC1/2005 Party Name:ALKALOIDS CORP Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/87/050/00429/AM06/ RLA File : 02/24/040/00081/AM06/ Lic.No/Date:02100800 76 15.07.2005

Decision : Committee considered case as per agenda for ratification of norms for export product Aescin (Horse Chestnut Extract) under para 4.7 of HBP. Committee in light of report forwarded by Department of MSME vide their U.O. No.23(17)/2005-Chem dated 22.01.2008 decided to ratify norms is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product

Aescin (Horse Chestnut Extract) ITC(HS)No.320190 90 1kg. 1. Horse

Chestnut (Aesculus hippocastanum) dried seeds
66.2kgs/kg
RA concerned may take further necessary action as per above decision of Norms Committee. 4

Case No.:31/30/87-

ALC1/2005 Party Name:ALKALOIDS CORP Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Withdrawn HQ File : 01/87/050/00870/AM06/ RLA File : 02/24/040/00154/AM06/ Lic.No/Date:02100827 77 17.10.2005

Decision : Committee considered case as per agenda for ratification of norms for export product Cascara Dry Extract under para 4.7 of HBP. Committee decided to withdraw case as the case has already been approved ny NC in its 38/08 meeting held on 23.01.2008. 5 Case No.:250/24/83- ALC1/2007 Party Name:PHAKT OVERSEAS Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved

HQ File : 01/83/050/00558/AM06/ RLA File : 03/95/040/01006/AM06/ Lic.No/Date:03103604 60 21.12.2005

Decision : Committee considered case as per agenda for ratification of norms for export product Gentamicin Eye/Ear Drops 5ml under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/185/2005-PI-III dated 31.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Gentamycin eye/ear drops, 0.3%W/V in 5ml Vials 1 Vial 1. Gentamycin Sulphate 16.88mg/Vial 2. Relevant glass vials Net to Net 3. Relevant Grey butyl rubber stopper Net to Net 4. Aluminium Seal Net to Net RA concerned may take further necessary action as per above decision of Norms Committee. 6 Case No.:8/10/87- ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/87/050/00096/AM07/ RLA File : 02/24/040/00020/AM07/ Lic.No/Date:02100887 34 28.04.2006

Decision : Committee considered case as per agenda for ratification of norms for export product Aescin (Horse Chestnut Extract) under para 4.7 of HBP. Committee in light of report forwarded by Department of MSME vide their U.O. No.23(17)/2005-Chem dated 22.01.2008 decided to ratify norms is lower. Export product Export Import items Qty. allowed per

Qty. unit of export product Sl.N o. Product

Aescin (Horse Chestnut Extract) ITC(HS)No.320190 90 1kg. 1. Horse

Chestnut (Aesculus hippocastanum) dried seeds
66.2kgs/kg
of Norms Committee. 7

Case No.:1/23/87-

ALC1/2006 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Rejected HQ File : 01/87/050/00336/AM07/ RLA File : 05/24/040/00255/AM07/ Lic.No/Date:05101852 76 21.06.2006

norms for export product Silymarin Extract under para 4.7 of HBP. Committee in consultation with technical authorities present in meeting observed that item of import and export are same and therefore, norms can not be fixed. Accordingly, Committee decided to close the case. of Norms Committee. 8 Case No.:12/20/82- ALC1/2006 Party Name:JUPITER BIOSCIENCE LIMITED, Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/82/050/00502/AM07/ RLA File : 09/24/040/00121/AM07/ Lic.No/Date:09100267 38 05.07.2006

Decision : Committee considered case as per agenda for ratification of norms for export product N-T-Boc-L-Phenylalanine 99% purity under para 4.7 of HBP. their U.O. No.35011/207/2006-PI-III dated 21.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms is lower. Export product Export Import items Qty. allowed

Qty. per unit of export product Sl.No. Product N-T-BOC-L- Phenyl Alanine ITC(HS)No.29374 000 1kg. 1. L-Phenyl Alanine 0.622kg/kg 2. Di-Tertiary-Butyl Dicarbonate Anhydride 0.821kg/kg 3. Isopropyl Alcohol 0.394kg/kg 4. N-Hexane 0.986kg/kg 5. Ethyl Acetate 1.134kg/kg 6. Sodium Hydroxide 0.150kg/kg of Norms Committee. 9

Case No.:16/27/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/87/050/00419/AM07/ RLA File : 02/24/040/00123/AM07/ Lic.No/Date:02100921 25 02.08.2006

Decision : Committee considered case as per agenda for ratification of norms for export product Kola extract under para 4.7 of HBP. Committee in light of report forwarded by Department of MSME vide their U.O. No.23(17)/2005-Chem dated 22.01.2008 decided to ratify norms is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Kola Extract 1kg. 1. Kola Nuts (Cola Nuts)
7.9kgs/kg
of Norms Committee. 10 Case No.:2/46/82- ALC1/2006 Party Name:MATRIX LABORATORIES LTD Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : RLA File : Lic.No/Date:09100286 Defer

01/82/050/01441/AM07/ 09/24/040/00390/AM07/ 34 13.12.2006 Date: 26.02.2008 norms for export product N-Trifluoro Acetyle-N-Lysine-Praline (Lyspro) (Isolated) under para 4.7 of HBP. 11

Case No.:16/49/82-

ALC1/2006 Party Name:LUPIN LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product Sterile Ceftriaxone Sodium – Non Infringing under

para 4.7 of HBP.

Committee decided to examine case on file as the application for firm is based on non-fringing process. 12

Case No.:3/19/82-

ALC4/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Withdrawn HQ File : 01/82/050/01663/AM07/ RLA File : 05/24/040/00951/AM07/ Lic.No/Date:05101998 28 21.02.2007

norms for export product Nalidixic Acid under para 4.7 of HBP. Committee decided to withdraw case as same has already been approved in its 38/08 meeting held on 22.01.2008. 13 Case No.:852/21/82- ALC4/2007 Party Name:METROCHEM API PVT. LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/82/050/01678/AM07/ RLA File : 09/24/040/00436/AM07/ Lic.No/Date:09100294 25 22.02.2007 Defer Date: 11.03.2008 norms for export product Lansoprazole Pellets 11.2% under para 4.7 of HBP.

Committee decided to call for a copy of DML from firm. Accordingly, case was deferred for six weeks. 14

Case No.:879/21/82-

ALC4/2007 Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/82/050/01714/AM07/ RLA File : 07/24/040/00780/AM07/ Lic.No/Date:07100503 14 27.02.2007 Defer Date: 26.02.2008 norms for export product Dorzolamide HCL under para 4.7 of HBP. 15

Case No.:7/2/82-ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82-

ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product (1) Triomune 30/ Lamivudine, Stavudine and Nevirapine Tablets. Each uncoated tablet contains: Stavudine 30mg, Lamivudine 150mg, Nevirapine 200mg. and (2) Triomune 40/ Lamivudine, Stavudine and Nevirapine Tablets. Each uncoated tablet contains: Stavudine 40mg, Lamivudine 150mg, Nevirapine 200mg. under para 4.7 of HBP. 16

Case No.:17/9/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status: Case Deferred HQ File : 01/82/050/01837/AM07/ RLA File : 03/94/040/01468/AM07/ Lic.No/Date:03104237 77 21.03.2007 Defer Date: 26.02.2008 norms for export product Exemestane under para 4.7 of HBP. Committee observed that technical information has been called for from firm which has not been received. It was, therefore, decided to await reply of firm and to defer case for four weeks. 17 Case No.:25/14/83- ALC1/2007 Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:39/82- ALC4/2007 Status:Cas e Deferred

29.01.2008 HQ File : 01/83/050/00016/AM08/ RLA File : 04/24/040/00501/AM07/ Lic.No/Date:04100887 27 02.04.2007 Defer Date: 26.02.2008 norms for export product Allylestrenol under para 4.7 of HBP. 18

Case No.:19/19/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product Naproxen Granules DC Grade 80% (Compresso NAP 80) under para 4.7 of HBP. 19

Case No.:566/24/83-

ALC1/2007 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Withdrawn HQ File : 01/83/050/00239/AM08/ RLA File : 05/24/040/00080/AM08/ Lic.No/Date:05102032 07 03.05.2007

norms for export product Montelukast Sodium Min Assay 97% under para 4.7 of HBP. Committee decided to withdraw case as case has been approved by NC in its 38/08 meeting held on 23.01.2008. 20

Case No.:27/19/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/00232/AM08/ RLA File : 09/24/040/00024/AM08/ Lic.No/Date:09100301 58 03.05.2007 Defer Date: 11.03.2008 norms for export product PhenazopyridineHydrochloride under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

21

Case No.:20/21/82-

ALC4/2007 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:39/82- ALC4/2007 29.01.2008 Status: Case Deferred HQ File : 01/82/050/00028/AM08/ RLA File : 05/24/040/00097/AM08/ Lic.No/Date:05102033 44 07.05.2007 Defer Date: 26.02.2008 norms for export product Clarithromycin Carbomer Granules 44% (Bulk Drug/ Pharmacopeal Grade) under para 4.7 of HBP. Committee observed that RA concerned was requested to furnish a copy of application, but same has not been received. Accordingly, it was decided to remind RA and to defer case for four weeks. 22

Case No.:29/9/82-

ALC4/2007 Party Name:S.M. HERBALS PVT.LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/82/050/00039/AM08/ RLA File : 05/24/040/01075/AM07/ Lic.No/Date:0510203 751 16.05.2007

norms for export product Camptothecin under para 4.7 of HBP. Committee in light of written comments forwarded by Deptt. Of MSME vide their U.O. No.5(9)/2005-Chem dated 21.01.2008 and in consultation with representative of D/O MSME 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 Sl.N o. Product Camptothecin purity Minimum 99% ITC(HS)No.1302 1919 1kg. 1.
Mappia

foetida (containing Camptothecin 0.14%

• 0.02% 952kg/kg of Norms Committee. 23 Case No.:614/24/83- Party Name:NICHOLAS Meet No/Date:39/82- Status:Cas

ALC1/2007 PIRAMAL INDIA LTD. ALC4/2007 29.01.2008 e Deferred HQ File : 01/83/050/00369/AM08/ RLA File : 03/95/040/01471/AM07/ Lic.No/Date:03104300 58 21.05.2007 Defer Date: 26.02.2008 norms for export product Ultrazyme Tablets (7458X)[Contact lens cleaning tablets] under para 4.7 of HBP. Committee observed that Department of Bio-technology have given NOC for export of Ultrazyme tablets 7458X. As regards technical comments for ratification of norms under para 4.7 of HBP, Department of Bio- technology vide their letter No.BT/IL/05/228/2006-PID dated 26.07.2007 has indicated that the item sought to be exported/imported duty free are chemical products and no biotech product component is involved. Committee, therefore, decided to write to Department of Bio- technology as to how the item of import and export are chemical product when they have issued NOC for import/export of Bio-technology items. Accordingly, case was deferred for four weeks. 24

Case No.:622/24/83-

ALC1/2007 Party Name:SHODHANA LABORATORIES LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/00388/AM08/ RLA File : 09/24/040/00048/AM08/ Lic.No/Date:09100303 34 24.05.2007 Defer Date: 11.03.2008 norms for export product 2-(2-Methoxy Phenoxy) Ethylamine under para 4.7 of HBP. Committee observed that RA has furnished copy of Advance Authorisation for export product 2-(2-Methoxy Phenoxy) Ethylamine while the application has been forwarded for export product 4-(2,3-Epoxy Propoxy) Carbazole. Committee decided to call for a copy of relevant application form concerned RA. Accordingly, case was deferred for six weeks. 25 Case No.:712/24/83- ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status: Case Approved HQ File : 01/83/050/00584/AM08/ RLA File : 03/94/040/00192/AM08/ Lic.No/Date:0310432 914 18.06.2007

norms for export product Testosterone under para 4.7 of HBP. their U.O. No.35011/88/2007-PI-III dated 28.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify whichever is lower. Export product Export Qty. Import items Qty.

allowed per unit of export product Sl.N o. Product Testosterone ITC(HS)No.29379 000 1kg. 1. Androst-4-ene-3,17 dione 1.33kg/kg 2. Triethyl

Ortho Formate 0.36kg/kg of Norms Committee. 26

Case No.:715/24/83-

ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/83/050/00590/AM08/ RLA File : 03/94/040/00243/AM08/ Lic.No/Date:0310432 929 18.06.2007

norms for export product Norethisterone under para 4.7 of HBP. their U.O. No.35011/88/2007-PI-III dated 28.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify whichever is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Norethisterone ITC(HS)No.2937 9000 1kg. 1 .
19 Nor-4-Androstene- 3,17 dione 1.066kg/kg

of Norms Committee. 27

Case No.:731/24/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/00624/AM08/ RLA File : 09/24/040/00425/AM07/ Lic.No/Date:09100306 91 29.06.2007 Defer Date: 12.02.2008 norms for export product Sertraline Mandelate under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 28

Case No.:730/24/83-

ALC1/2007 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product (S) – 3 – Hydroxy – N – Bensyle Pyrrolidine under

para 4.7 of HBP.

29 Case No.:95/21/82- ALC4/2007 Party Name:NICHOLAS PIRAMAL INDIA LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/82/050/00144/AM08/ RLA File : 03/95/040/00389/AM08/ Lic.No/Date:03104375 08 26.07.2007 Defer Date: 26.02.2008 norms for export product Hydrocare Tablets (Contact Lens Cleaning Tablets) under para 4.7 of HBP. Committee observed that Department of Bio-technology have given NOC for export of Hydrocare Tablets (Contact Lens Cleaning Tablet). As regards technical comments for ratification of norms under para 4.7 of HBP, Department of Bio-technology vide their letter No.BT/IL/05/228/2006- PID dated 26.07.2007 has indicated that the item sought to be exported/imported duty free are chemical products and no biotech product component is involved.

Committee, therefore, decided to write to Department of Bio- technology as to how the item of import and export are chemical product when they have issued NOC for import/export of Bio-technology items. Accordingly, case was deferred for four weeks. 30

Case No.:875/24/83-

ALC1/2007 Party Name:GRANULES INDIA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/83/050/00879/AM08/ RLA File : 09/24/040/00177/AM08/ Lic.No/Date:0910031 050 06.08.2007

norms for export product Iso Metheptene Mucate under para 4.7 of HBP. their U.O. No.35011/63/2007-PI-III dated 28.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify whichever is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Sl.No . Product Iso Metheptene Mucate ITC(HS)No.290942 00 1kg. 1. Lactose 1.29kg/kg 2. Citral 1.34kg/kg 3. Formic Acid 1.77kg/kg 4. Benzene 1.46kg/kg 5. Iso

Propyl Alcohol 1.17kg/kg 6. Ethyl Acetate 2.75kg/kg 7. Methanol 0.82kg/kg of Norms Committee. 31 Case No.:3/18/82- ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/82/050/00142/AM08/ RLA File : 03/94/040/00455/AM08/ Lic.No/Date:0310438 406 06.08.2007

norms for export product Lamivudine and Sidovudine Tablets/ Duovit/ Bivit/ Arved Tablets (Each film coated Tablets contains Lamivudine 150mg and Zidovudine USP 300mg) 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 whichever is lower. Export product Export Qty. Import items Qty.

allowed per unit of export product Sl.N o. Product Lamivudine 150mg

and Stavudine 300mg Tablets ITC(HS)No.300490 99 1000 Tablets 1. 3’-Azido-3’-5-o-trityl thimidine 0.728kg/1000 Tablets of Norms Committee. 32

Case No.:113/21/82-

ALC4/2007 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/82/050/00157/AM08/ RLA File : 22/24/040/00030/AM08/ Lic.No/Date:22100069 84 20.08.2007 Defer Date: 26.02.2008 norms for export product Cefpodoxime Proxetil (off white to pale yellow powder) under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details as per Appendix 33 vide letter dated 21.01.2008, but information has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 33 Case No.:7/25/83- ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/01032/AM08/ RLA File : 09/24/040/00231/AM08/ Lic.No/Date:09100313 14 Defer Date:

29.08.2007 26.02.2008 norms for export product Didanosine under para 4.7 of HBP. 34

Case No.:42/25/83-

ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/01067/AM08/ RLA File : 03/94/040/00299/AM08/ Lic.No/Date:03104414 32 30.08.2007 Defer Date: 12.02.2008 norms for export product Nitazoxanide under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 35 Case No.:5/22/82- ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/82/050/00175/AM08/ RLA File : 03/94/040/00571/AM08/ Lic.No/Date:0310441 556 31.08.2007

norms for export product Lamivudine and Zidovudine Tablets/ Duovit/Bivit/ Arved Tablets (Each Film coated Tablets contains Lamivudine 150mg and Zidovudine USP 300mg) 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 whichever is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Lamivudine 150mg

and Stavudine 300mg Tablets 1000 Tablets 1. 3’-Azido-3’-5-o- trityl thimidine 0.728kg/1000 Tablets

ITC(HS)No. of Norms Committee. 36

Case No.:12/27/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product Saquinavit 200mg Capsules/ Saqvir 200mg Capsules under para 4.7 of HBP. 37

Case No.:5/27/83-

ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/01079/AM08/ RLA File : 09/24/040/00234/AM08/ Lic.No/Date:09100313 29 31.08.2007 Defer Date: 12.02.2008 norms for export product Florefenicol under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 38

Case No.:9/27/83-

ALC1/2007 Party Name:OM SHREE PHARMACHEM PVT.LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/01083/AM08/ RLA File : 03/95/040/00534/AM08/ Lic.No/Date:03104415 37 31.08.2007 Defer Date: 12.02.2008 norms for export product Iso Sorbide - 5 - Mononitrate under para 4.7 of HBP. Committee observed that the firm was called for personal hearing, but they have sought deferment for two weeks. Committee, therefore, decided to call firm for personal hearing on 12.02.2008. Accordingly, case was deferred for two weeks. 39 Case No.:33/27/83- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:39/82- ALC4/2007 Status:Cas e Deferred

29.01.2008 HQ File : 01/83/050/01107/AM08/ RLA File : 09/24/040/00192/AM07/ Lic.No/Date:09100314 03 05.09.2007 Defer Date: 12.02.2008 norms for export product GCLE – Stage – 1 under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 40

Case No.:54/27/83-

ALC1/2007 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product Aprepitant under para 4.7 of HBP. 41

Case No.:69/27/83-

ALC1/2007 Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product (4R–CIS)–1, 1–Dimethylethyl–6–Cyanomethyl–2, 2–Dimethyl–1–3–Dioxane–4- Acetate (ATS-8) NLT 99% under para 4.7 of HBP. 42

Case No.:72/27/83-

ALC1/2007 Party Name:LUPIN LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/01146/AM08/ RLA File : 03/95/040/00570/AM08/ Lic.No/Date:03104424 36 11.09.2007 DeferDate: 26.02.2008 norms for export product Sterile Ceftriaxone Sodium-Non Infringing under

para 4.7 of HBP.

Committee decided to examine the case on file as the application is based on non-infrining process.

43

Case No.:10/22/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. 44 Case No.:111/27/83- ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/83/050/01185/AM08/ RLA File : 03/94/040/00622/AM08/ Lic.No/Date:0310443 342 17.09.2007

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 whichever is lower. 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. 45

Case No.:154/27/83-

ALC1/2007 Party Name:ALEMBIC LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Rejected HQ File : 01/83/050/01228/AM08/ RLA File : 34/24/040/00140/AM08/ Lic.No/Date:34100196 98 25.09.2007

norms for export product Venlafaxine Hydrochloride Extended Release Pellets Stage1 under para 4.7 of HBP. Committee observed that firm was requested to furnish a copy of DML vide letter dated 12.12.2007, but same has not been received. Committee, therefore, decided to close the case as no norms can be fixed in absence of DML. of Norms Committee. 46

Case No.:1/25/82-

ALC4/2007 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/82/050/00195/AM08/ RLA File : 13/24/040/00019/AM08/ Lic.No/Date:13100250 71 01.10.2007 Defer Date: 12.02.2008 norms for export product Alpha Lipoic Acid Granules 95% under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 47

Case No.:2/25/82-

ALC4/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. 48 Case No.:7/29/83- Party Name:CODEXIS Meet No/Date:39/82- Status:Cas

ALC1/2007 LABORATORIES INDIA PVT.LTD, ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product (4R-CIS)-1, 1-Dimethylethyl-6-Cyanomethyl-2, 2- Dimethyl-1-3-Dioxane-4-Acetate (ATS-8) NLT 99% under para 4.7 of HBP. 49

Case No.:95/29/83-

ALC1/2007 Party Name:IPCA LABORATORIES LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : 01/83/050/01360/AM08/ RLA File : 03/94/040/00673/AM08/ Lic.No/Date:03104465 03 16.10.2007

norms for export product Hydrochlorothiazide under para 4.7 of HBP. their U.O. No.35011/88/2007-PI-III dated 28.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify whichever is lower. Export product Export Qty. Import items Qty.

allowed per unit of export product Sl.N o. Product Hydrochlorothiaz ide ITC(HS)No.293500 90 1kg. 1. 2,4-Disulfonamide-5- chloroaniline (Chloraminophenami de)
1.194kg/kg 2. Methanol 3.79kg/kg of Norms Committee. 50 Case No.:2/26/82- ALC4/2007 Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : RLA File : Lic.No/Date:03104473

01/82/050/00220/AM08/ 03/94/040/00755/AM08/ 19 22.10.2007 norms for export product Drugs Formulations Drops Namely Fecistil Drops Containing Dimetindene Maleate BP 1 mg/ml (10 ml Bottle) under para 4.7 of HBP. 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 Qty. Import items Total

Qty. allowed
Sl.N o. Product

Drug Formulations Drops namely Fecistil

Drops containing Dimetindene Maleate

BP 1mg/ml (10ml Bottle) ITC(HS)No.300490 11 95200N os. 1. Dimetindene Maleate BP 0.971kg. of Norms Committee. 51

Case No.:3/30/85-

ALC3/2007 Party Name:PREGNA INTERNATIONAL LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Transferred HQ File : 01/85/050/00107/AM08/ RLA File : 31/24/040/00238/AM08/ Lic.No/Date:31100312 57 23.10.2007

norms for export product Intrauterine Contraceptive Device Copper 380A with Silver Core under para 4.7 of HBP. Committee decided to transfer case to DES-VII as export product pertains to Plastic Sector. 52 Case No.:24/30/83- ALC1/2007 Party Name:AUCTUS PHARMA PRIVATE LIMITED Meet No/Date:39/82- ALC4/2007 Status:Cas e Deferred

29.01.2008 HQ File : 01/83/050/01393/AM08/ RLA File : 09/24/040/00319/AM08/ Lic.No/Date:09100318 43 23.10.2007 Defer Date: 26.02.2008 norms for export product Rifaximin under para 4.7 of HBP. 53

Case No.:53/30/83-

ALC1/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product Cyclopropyl Diol Cyclic Sulfite under para 4.7 of HBP. 54

Case No.:51/30/83-

ALC1/2007 Party Name:HETERO DRUGS LIMITED, Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/01420/AM08/ RLA File : 09/24/040/00276/AM08/ Lic.No/Date:09100318 79 24.10.2007 Defer Date: 26.02.2008 norms for export product Indinavir Sulphate under para 4.7 of HBP. 55

Case No.:24/32/83-

ALC1/2007 Party Name:ANUH PHARMA LTD. Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : 01/83/050/01446/AM08/ RLA File : 03/94/040/00456/AM08/ Lic.No/Date:03104481 95 29.10.2007

norms for export product Aceclofenac under para 4.7 of HBP. their U.O. No.35011/264/2006-PI-III dated 31.01.2008 in the case of M/S IPCA Laboratories Ltd 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 Sl.N o. Product Aceclofenac BP ITC(HS)No.294200 90 1kg. 1. Diclofenec Sodium 1.11kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 56

Case No.:69/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : 01/83/050/01491/AM08/ RLA File : 03/94/040/00803/AM08/ Lic.No/Date:03104489 36 02.11.2007

norms for export product Simvastatin 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 whichever is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Simvastatin ITC(HS)No.290129 90 1kg. 1 . Simvastatin Ammonium Salt 1.20kg/kg 2. Acetonitrile 4.05kg/kg 3. N-Heptane 1.33kg/kg of Norms Committee. 57 Case No.:82/32/83- ALC1/2007 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:39/82- ALC4/2007 Status:Cas e Deferred

29.01.2008 HQ File : 01/83/050/01504/AM08/ RLA File : 09/24/040/00051/AM08/ Lic.No/Date:09100319 91 05.11.2007 Defer Date: 12.02.2008 norms for export product Cefepime HCL for injection (Cefepime HCL Sterile Buffered with L-Arginine Sterile) under para 4.7 of HBP. Committee decided to defer case for two weeks for comments of PI Division. 58

Case No.:106/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/83/050/01528/AM08/ RLA File : 03/94/040/00804/AM08/ Lic.No/Date:0310449 208 05.11.2007

norms for export product Lamivudine 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 whichever is lower. Export product Expor t Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Lamivudine ITC(HS)No.29349 000 1kg. 1.
(2R.5S)-5-[4-Aceta,odp- 2- Pxp-1(2H)- Pyrimidinyl]-1,3- Oxathiolan-2-YL, Methyl Methyl Carbonate 2.63kg/kg of Norms Committee. 59 Case No.:101/32/83- ALC1/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Transferred HQ File : 01/83/050/01523/AM08/ RLA File : 05/24/040/00477/AM08/ Lic.No/Date:05102117 02

06.11.2007 norms for export product 5-Methylnicotinic Acid HCL under para 4.7 of HBP. Committee observed that firm has indicated end use of export product for manufacture of Fine Chemicals. Accordingly, Committee decided to transfer the case to DES-IV. 60

Case No.:93/32/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Case Approved HQ File : 01/83/050/01515/AM08/ RLA File : 03/94/040/00815/AM08/ Lic.No/Date:0310449 498 06.11.2007

norms for export product Efavirenz 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 whichever is lower. Export product Export Qty. Import items Qty. allowed per unit of export product Sl.N o. Product Efavirenz ITC(HS)No.294190 90 1kg. 1. (S)-5-chloro-alpha- (Cycloproptylethyln yl)-2- Amino-alpha- (Trifluoromethyl) Benzenemethanol (EV-1 compound) 1.092kg/kg of Norms Committee. 61

Case No.:7/33/83-

ALC1/2007 Party Name:CIPLA LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : 01/83/050/01536/AM08/ RLA File : 03/94/040/00822/AM08/ Lic.No/Date:03104496 80

07.11.2007 norms for export product Fluticasone Propionate 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 whichever is lower. Export product Expo rt Qty. Import items Qty. allowed per unit of export product Sl.No. Product Fluticasone Propionate ITC(HS)No.2901 2990 1kg. 1. Androsta-1,4-Diene-3- OXO-17β-Caroxylicacid- 16a-Methyl

11β,17a- Dihydroxy-6,9-Difluoro (Fluticasone Stage 1) 2.415kg/ kg 2. Chloride 1.45kg/k g 3. Tetrahydrofuran 2.25kg/k g of Norms Committee. 62

Case No.:32/33/83-

ALC1/2007 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product Cyclohexyl Ester under para 4.7 of HBP. 63 Case No.:60/39/83- ALC1/2007 Party Name:SANJAY SALES CORPORATION Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Transferred HQ File : RLA File : Lic.No/Date:03104516 :

01/83/050/01639/AM08/ 03/95/040/00792/AM08/ 62 27.11.2007 norms for export product Sodium Salicylate under para 4.7 of HBP. Committee decided to transfer case to DES-IV as export product pertains to Chemical Sector. 64

Case No.:34/39/83-

ALC1/2007 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:39/82- ALC4/2007 29.01.2008 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: 26.02.2008 norms for export product (s)Alpha-Ethyl-2-Oxo-1-Pyrrolidineacetic Acid (LVA-40) under para 4.7 of HBP. 65 Case No.:123/39/83- ALC1/2007 Party Name:G AMPHRAY LABORATORIES, Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : 01/83/050/01702/AM08/ RLA File : 03/94/040/00817/AM08/ Lic.No/Date:03104529 97 07.12.2007

norms for export product Piperazine Adipate BP/USP under para 4.7 of HBP. Committee in light of its earlier decision taken in its 10/08 meeting held on 10.07.2007 vide case No.A-264 and in consultation with representative of PI Division present in meeting decided to ratify norms is lower. Export product Export Qty. Import items Qty.

allowed per unit of export product Sl.No. Product Piperazine Adipate BP/USP ITC(HS)No.29333 200 1kg. 1 . Diethyl Diamine Piperazine 0.380kg/kg 2. Adipic Acid 0.675kg/kg

of Norms Committee. 66

Case No.:169/39/83-

ALC1/2007 Party Name:THEMIS MEDICARE LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : 01/83/050/01748/AM08/ RLA File : 03/95/040/01108/AM07/ Lic.No/Date:03104537 20 12.12.2007

norms for export product Lovastatin under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as applied by firm. of Norms Committee. 67

Case No.:167/39/83-

ALC1/2007 Party Name:THEMIS MEDICARE LIMITED Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : 01/83/050/01746/AM08/ RLA File : 03/95/040/01109/AM07/ Lic.No/Date:03104537 02 12.12.2007

norms for export product Lovastatin under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as applied by firm. of Norms committee. 68 Case No.:1/40/83- ALC1/2007 Party Name:PARABOLIC DRUGS LTD., Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Deferred HQ File : 01/83/050/01766/AM08/ RLA File : 22/24/040/00050/AM08/ Lic.No/Date:22100073 08 19.12.2007 Defer Date: 11.03.2008 norms for export product Ampicillin Sodium + Cloxacillin Sodium Sterile Crystalline (1:1 Blend) (A white or almost white crystalline powder) under

para 4.7 of HBP.

Committee observed that firm has been permitted to export 1500kgs. of export product under DML, while they have sought export of 10,000kgs.

of export product. Committee, therefore, decided to advise firm to get the DML amended from DCGI. Accordingly Committee decided to close the case. 69

Case No.:10/40/83-

ALC1/2007 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:39/82- ALC4/2007 29.01.2008 Status:Cas e Approved HQ File : 01/83/050/01775/AM08/ RLA File : 22/24/040/00058/AM08/ Lic.No/Date:22100073 30 27.12.2007

norms for export product Clopidogrel Hydrogen Sulphate under para 4.7 of HBP. Committee in light of its earlier decision taken in its 26/82 meeting held on 30.10.2007 vide Case No.8/12/83 and in consultation with representative of PI Division present in meeting decided to ratify norms is lower. Export product Export Qty. Import items Qty.

allowed per unit of export product Sl.No. Product Clopidogrel Hydrogen Sulphate ITC(HS)No.29415 000 1kg. 1 . Alpha Bromo (2- chloro Phenyl)

Acetic Acid 1.18kg/kg 2. Methylene chloride 2.41kg/kg 3. Dimethyl formamide 3.39kg/kg 4. Acetone 3.91kg/kg 5. Thiophene-2- Ethanol 1.00kg/kg 6 . L(-)Camphor Sulphonic Acid 0.70kg/kg of Norms Committee. 70 Case No.:9/40/83- ALC1/2007 Party Name:KUDOES CHEMIE LTD., Meet No/Date:39/82- ALC4/2007 Status:Cas e Deferred

29.01.2008 HQ File : 01/83/050/01774/AM08/ RLA File : 22/24/040/00059/AM08/ Lic.No/Date:22100073 29 27.12.2007 Defer Date: 26.02.2008 norms for export product Caffeine under para 4.7 of HBP.