IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2007-09-18

DGFT Committee Minutes

Document text

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

Para 4.7 Decision

MEETING NUMBER : 20/82-ALC4/2007 MEETING DATE : 18.09.2007 1

Case No.:1/6/82-

ALC4/2007 Party Name:DR REDDYS LABORATORIES LTD Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00389/AM04/ RLA File : 09/24/040/00068/AM04/ Lic.No/Date:09100152 88 05.08.2003 Defer Date: 16.10.2007 Decision :Committee considered case as per agenda for ratification of norms for export product N,N-Dimethyl Amino Ethoxy Benzyl Amino (DEBA) under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that case is under examination in his Department and he sought deferment for four weeks. Committee, accordingly, decided to defer case for four weeks. 2

Case No.:2/6/82-

ALC4/2007 Party Name:HINDUSTAN ANTIBIOTICS LTD Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Rejected HQ File : 01/82/050/00432/AM04/ RLA File : 31/80/040/00163/AM04/ Lic.No/Date:31100120 90 08.08.2003

Decision : Committee considered case as per agenda for ratification of norms for export product Tablets i.e. Potassium Phenoxymethyl Pencillin Tablets BP 250mg under para 4.7 of HBP. Committee observed that copy of application alongwith a report was called from RA vide letter dated 25.06.2007, but same has not been received. Due to non-co-operative attitude of RA, Committee decided to reject the case. RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms committee. 3

Case No.:2/35/82-

ALC1/2004 Party Name:MADHUR PHARMA & RESEARCH LABORATORIES PVT.LTD., Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred

HQ File : 01/82/050/01467/AM05/ RLA File : 07/24/040/00492/AM05/ Lic.No/Date:07100342 46 23.11.2004 Defer Date: 16.10.2007 for export product Herpasil Capsules and Stimmune Capsules under para 4.7 of HBP. Committee noted that technical comments were called for from Deptt. of Ayush, but same have not been received. Committee, therefore, decided to remind Deptt. of Ayush demi-officially at the level of DGFT. Accordingly, case was deferred for four weeks. 4

Case No.:5/37/82-

ALC1/2005 Party Name:FDC LTD., Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00946/AM06/ RLA File : 03/94/040/00798/AM06/ Lic.No/Date:03103562 18 22.11.2005 Defer Date: 16.10.2007 for export product Econazole Nitrate BP/JP/USP under para 4.7 of HBP. weeks. Committee, accordingly, decided to defer case for four weeks. 5

Case No.:1/35/83-

ALC1/2006 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Approved HQ File : 01/83/050/00557/AM07/ RLA File : 09/24/040/00190/AM07/ Lic.No/Date:09100272 54 22.08.2006

for export product Bicalutamide under para 4.7 of HBP. Committee in light of its earlier decision taken in its 25/87 meeting held on 28.09.2005 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Bicalutamide-------------------------------1Kg. Import items:

N-[4-Cyano-3-(trifluoromethyl)phenyl]-2-methyloxirane

Carboxamide--- 1.11kg/kg 2. 4-fluorobenzenethiol-------------------------------------------------------------------

0.53kg/kg above decision of Norms Committee. 6

Case No.:17/31/82-

ALC1/2006 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00911/AM07/ RLA File : 03/94/040/00615/AM07/ Lic.No/Date:03103990 69 12.09.2006 Defer Date: 09.10.2007 for export product Terbinafine Hydrochloride under para 4.7 of HBP. Committee decided to call for copy of relevant DML from firm. Accordingly, case was deferred for three weeks. 7

Case No.:11/34/87-

ALC1/2006 Party Name:ALKALOIDS CORP Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/87/050/00566/AM07/ RLA File : 02/24/040/00189/AM07/ Lic.No/Date:02100940 06 25.09.2006 Defer Date: 16.10.2007 for export product Senega Soft Extract under para 4.7 of HBP. Committee noted that technical comments were called for from Deptt. of Ayush, but same have not been received. Committee, therefore, decided to remind Deptt. of Ayush demi-officially at the level of DGFT. Accordingly, case was deferred for four weeks. 8

Case No.:23/32/82-

ALC1/2006 Party Name:EMMELLEN BIOTECH PHARMACEUTICALS LIMITED, Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Rejected HQ File : 01/82/050/01100/AM07/ RLA File : 03/94/040/00702/AM07/ Lic.No/Date:03104028 29 06.10.2006

for export product 1-Phenyl Propanolamine Hcl (L-Norephedrine Hcl) under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details as per Appendix 33 but same has not been received. Committee, therefore, decided

to reject case. RLA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 9

Case No.:24/32/82-

ALC1/2006 Party Name:EMMELLEN BIOTECH PHARMACEUTICALS LIMITED, Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Rejected HQ File : 01/82/050/01101/AM07/ RLA File : 03/94/040/00703/AM07/ Lic.No/Date:03104028 30 06.10.2006

for export product L-Norephedrine Base under para 4.7 of HBP. Committee observed that firm was requested to furnish technical details as per Appendix 33 but same has not been received. Committee, therefore, decided to reject case. per above decision of Norms Committee. 10 Case No.:4/43/83- ALC1/2006 Party Name:SREENIVASA PHRAMA PVT LTD. Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Approved HQ File : 01/83/050/00942/AM07/ RLA File : 09/24/040/00163/AM07/ Lic.No/Date:09100282 92 21.11.2006

for export product Cis-2-Bromo Methyl)-2-(2,4-Dichloro Phenyl)-4-Methane Sulphonyl methyl-1,3-dioxalane (cis-Bromo mesylate) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide U.O. No.35011/68/2007 PI-III dated 19.09.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Cis-2-Bromo Methyl)-2-(2,4-Dichloro Phenyl)-4-Methane Sulphonyl methyl-1,3-dioxalane (Cis-Bromo mesylate)-----------------------------1Kg. Import items:

2,4 Dichloro Acetophenone----------------------------------------------------1.65kg/kg
Benzoyl chloride-------------------------------------------------------------------1.35kg/kg
Toluene------------------------------------------------------------------------------5.28kg/kg
Methanol----------------------------------------------------------------------------2.84kg/kg
Methane Sulfonyl chloride------------------------------------------------------0.42kg/kg

Case No.:3/47/80-

ALC2/2006 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Approved HQ File : 01/80/050/01016/AM07/ RLA File : 09/24/040/00324/AM07/ Lic.No/Date:09100285 24 06.12.2006

for export product Benzyl (S)-(-)-1,2,3,4-Tetrahydro-3-Isoquinoline Carboxylate- para-toluene sulfonic acid salt under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/72/2007-PI-III dated 06.09.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Benzyl (S)-(-)-1,2,3,4-Tetrahydro-3-Isoquinoline Carboxylate-para-toluene sulfonic acid salt--------------------------------------1kg. Import item: L-Phenyl Alanine-------------------------------------------------------------------------0.64kg/kg per above decision of norms Committee. 12

Case No.:11/44/82-

ALC1/2006 Party Name:HETERO DRUGS LIMITED, Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/01409/AM07/ RLA File : 09/24/040/00374/AM07/ Lic.No/Date:09100285 36 07.12.2006 Defer Date: 16.10.2007 for export product Lisinopril under para 4.7 of HBP. weeks. Committee, accordingly decided to defer case for four weeks. 13 Case No.:3/47/87- ALC1/2006 Party Name:ASTRIX LABORATORIES LTD., Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Rejected

HQ File : 01/87/050/00826/AM07/ RLA File : 09/24/040/00323/AM07/ Lic.No/Date:09100286 60 18.12.2006

for export product Ritonavir under para 4.7 of HBP. Committee observed that firm was request to furnish certain information, but same has not been received so far. Committee, therefore, decided to reject the case. 14

Case No.:6/50/87-

ALC1/2006 Party Name:ALKEM LABORATORIES LTD., Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/87/050/00967/AM07/ RLA File : 03/94/040/01200/AM07/ Lic.No/Date:03104187 37 07.02.2007 Defer Date: 04.10.2007 for export product Amoxycillin and Clavulanate Potassium Tablets 375mg, 625mg and 1000mg under para 4.7 of HBP. case is under examination in his Department and he sought deferment for two weeks. Committee, accordingly decided to defer case for two weeks. 15

Case No.:3/10/83-

ALC1/2007 Party Name:WANKSONS CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/83/050/01262/AM07/ RLA File : 03/95/040/01284/AM07/ Lic.No/Date:03104202 13 20.02.2007 Defer Date 30.10.2007 : for export product Metachololropropiophenone under para 4.7 of HBP. case is under examination in his Department and he sought deferment for six weeks. Committee, accordingly decided to defer case for six weeks. 16 Case No.:3/9/83- ALC1/2007 Party Name:VITAL HEALTHCARE PVT.LTD. Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : RLA File : Lic.No/Date:03104210 Defer

01/83/050/01284/AM07/ 03/95/040/01405/AM07/ 71 27.02.2007 Date: 16.10.2007 for export product Dihydroartemisinin under para 4.7 of HBP. 17

Case No.:4/10/83-

ALC1/2007 Party Name:VASUDHA PHARMA CHEM LTD Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Apporved HQ File : 01/83/050/01288/AM07/ RLA File : 09/24/040/00448/AM07/ Lic.No/Date:09100294 59 27.02.2007

for export product Dibenzosuberone under para 4.7 of HBP. U.O. No.35011/77/2007-Pi-III dated 06.09.2007 decided to ratify norms under para 4.7 of HBP as per derails below or as applied by firm whichever is lower. Export product: Dibenzosuberone---------------------------------------------------1kg. Import items:

Methanol---------------------------------------------------0.627kg/kg
Acetonitrile------------------------------------------------0.75kg/kg
Phosphorous Pentaoxide------------------------------0.758kg/kg
Phosphoric acid------------------------------------------0.523kg/kg
Tetrahydrofuran-----------------------------------------0.25kg/kg per above decision of Norms Committee. 18 Case No.:1/20/82- ALC4/2007 Party Name:MACRO POLYMERS P. LTD. Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Transferr ed HQ File : 01/82/050/01805/AM07/ RLA File : 08/24/040/00348/AM07/ Lic.No/Date:08100636 07 14.03.2007

for export product
under para 4.7 of HBP.

Committee decided to transfer case to DES-IV as export product pertains to Plastic Sector. 19

Case No.:5/10/82-

ALC4/2007 Party Name:GLAXOSMITHKLINE PHARMACEUTICALS LIMITED, Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/01887/AM07/ RLA File : 03/94/040/00324/AM06/ Lic.No/Date:03104246 28 27.03.2007 Defer Date: 30.10.2007 for export product Betamethasone Di-Sodium Phosphate BP/USP under para 4.7 of HBP. case is under examination in his Department and he sought deferment for six 20 Case No.:8/12/82- ALC4/2007 Party Name:MANTENA LABORATORIES LIMITED Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Approved HQ File : 01/82/050/01898/AM07/ RLA File : 09/24/040/00524/AM07/ Lic.No/Date:09100298 41 29.03.2007

for export product
Methyl(E)-2-[3(S)-[3-[2-[(7-Chloro-2-Quinolinyl)Ethenyl} Phenyl]-3-Hydroxy Propyl]Benzoate under para 4.7 of HBP. U.O. No.35011/72/2007-PI-III dated 06.09.2007 decided to ratify norms under para Export product: Methyl(E)-2-[3(S)-[3-[2-(7-chloro-2-Quinolinyl) Ethenyl]Phenyl]-3-Hydroxypropyl]benzoate--------------------------------1Kg. Import items:

7-chloro quinaldine----------------------------------------1.43kg/kg
Isophthaldehyde--------------------------------------------1.70kg/kg
Vinyl magnesium bromide--------------------------------5.28kg/kg
Methyl-2-Iodobenzoate-----------------------------------1.32kg/kg
Ammonium acetate----------------------------------------1.13kg/kg
Palladium acetate------------------------------------------0.0125kg/kg
Dichloromethane--------------------------------------------14.29kg/kg
(-)Diisopino camphenyl chloro borane-----------------1.47kg/kg per above decision of Norms Committee. 21

Case No.:2/8/83-

ALC1/2007 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Approved HQ File : 01/83/050/00110/AM08/ RLA File : 03/94/040/01210/AM07/ Lic.No/Date:03104266 93 13.04.2007

for export product Budesonide under para 4.7 of HBP. U.O. No.35011/93/2006-PI-III dated 19.09.2007 decided to ratify norms as per details below or as applied by firm whichever is lower. Export product: Budesonide-------------------------------------1Kg. Import items:

Prednisolone---------------------------2.69kg/kg
Triethyl Orthoformate---------------2.61kg/kg 22 Case No.:6/12/83- ALC1/2007 Party Name:AARTI DRUGS LIMITED Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Approved HQ File : 01/83/050/00170/AM08/ RLA File : 03/94/040/00041/AM08/ Lic.No/Date:03104274 32 20.04.2007

for export product Metformin Hcl under para 4.7 of HBP. U.O. No.35011/178/2006-PI-III dated 06.09.2007 decided to ratify norms under

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

Export product: Metformin Hcl-----------------------------------1Kg.

Import items:

Dicyandiamide---------------------------0.567kg/kg
Mix Xylene-------------------------------0.40kg/kg
Methanol---------------------------------0.352kg/kg
Dimethylamine Hcl------------------------060kg/kg per above decision of Norms Committee. 23

Case No.:16/12/83-

ALC1/2007 Party Name:HONEST BIO- VET PVT. LTD Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/83/050/00272/AM08/ RLA File : 08/24/040/00032/AM08/ Lic.No/Date:08100646 91 07.05.2007 Defer Date: 16.10.2007 for export product Menadione Dimethyl Pyrimidinol Bisulphite (MPB 50%) under

para 4.7 of HBP.

Case No.:6/4/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00031/AM08/ RLA File : 03/95/040/00095/AM08/ Lic.No/Date:03104289 99 10.05.2007 Defer Date: 16.10.2007 for export product Diproson Lotion 30ml under para 4.7 of HBP. 25 Case No.:9/11/83- ALC1/2007 Party Name:RICHY GOLD INTERNATIONAL Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Approved HQ File : 01/83/050/00341/AM08/ RLA File : 03/95/040/00069/AM08/ Lic.No/Date:03104296 18 16.05.2007

for export product Methyl Dopa Tablets 250mg. under para 4.7 of HBP. The Committee in the light of its earlier decision taken in 10/08 meeting held on 10.07.2007 vide case No.A-287 decided to ratify the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower. Export Product: Methyl Dopa tablets 250 mg. Import item: Methyl Dopa--------------------288.15 kgm/1 million tablets. RLA concerned may take further necessary action under para 4.7 of HBP as per 26

Case No.:3/16/82-

ALC4/2007 Party Name:NIRAYU PRIVATE LIMITED, Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00050/AM08/ RLA File : 34/24/040/00034/AM08/ Lic.No/Date:34100188 53 28.05.2007 Defer Date: 16.10.2007 for export product Azithromycin Dihydrate (Micronised) under para 4.7 of HBP. Committee observed that firm has been requested to furnish complete specification of import and export items and manufacturing activity involved, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 27

Case No.:35/9/82-

ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Withdraw n HQ File : 01/82/050/00051/AM08/ RLA File : 34/24/040/00035/AM08/ Lic.No/Date:34100188 54 28.05.2007

for export product Azithromycin Step-3 under para 4.7 of HBP. Committee decided to withdraw the case as same has already been considered in NC Meeting No.19/08 dated 11.09.2007.

Case No.:11/12/82-

ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Rejected HQ File : 01/82/050/00064/AM08/ RLA File : 34/24/040/00045/AM08/ Lic.No/Date:34100189 32 07.06.2007

for export product Azithromycin Step-4 under para 4.7 of HBP. Committee observed that firm was requested to furnish complete chemical description of export product, but same has not been received. Committee, therefore, decided to reject the case. RA concerned may take further necessary action including cancellation of Advance Authorisation under para 4.7 of HBP as per above decision of Norms Committee. 29

Case No.:12/12/82-

ALC4/2007 Party Name:ALEMBIC LIMITED Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00069/AM08/ RLA File : 34/24/040/00047/AM08/ Lic.No/Date:34100189 88 15.06.2007 Defer Date: 16.10.2007 for export product Azithromycin Dihydrate (Micronized) under para 4.7 of HBP. Committee observed that firm was requested to furnish complete specification of import and export items and manufacturing activity involved, but same has not been received. Committee, therefore, decided to await reply of firm. Accordingly, case was deferred for four weeks. 30

Case No.:2/20/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00081/AM08/ RLA File : 03/95/040/00033/AM08/ Lic.No/Date:03104331 29 19.06.2007 Defer Date: 16.10.2007 for export product Betasol Lotion 30ml under para 4.7 of HBP. 31 Case No.:2/14/82- Party Name:NECTAR Meet No/Date:20/82- Status:Ca

ALC4/2007 LIFESCIENCES LIMITED, ALC4/2007 18.09.2007 se Deferred HQ File : 01/82/050/00116/AM08/ RLA File : 22/24/040/00018/AM08/ Lic.No/Date:22100068 97 17.07.2007 Defer Date: 16.10.2007 for export product Cefdimir under para 4.7 of HBP. 32

Case No.:3/20/82-

ALC4/2007 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00146/AM08/ RLA File : 03/95/040/00277/AM08/ Lic.No/Date:03104375 31 26.07.2007 Defer Date: 16.10.2007 for export product Epiderm Lotion 30ml under para 4.7 of HBP. 33 Case No.:4/20/82- ALC4/2007 Party Name:WOCKHARDT LIMITED Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Approved HQ File : 01/82/050/00148/AM08/ RLA File : 03/95/040/00425/AM08/ Lic.No/Date:03104389 63 09.08.2007

for export product Flu Strength Hot Lemon Powders 5GM Sachet under para 4.7 of HBP. U.O. No.35011/84/2007-PI-III dated 19.09.2007 decided to ratify norms under para Export product: Flu Strength Hot Lemon Powder in 5gm. Sachet (each 5gm. Sachet contain Paracetamol Ph. Eur-1gm) Import item: Paracetamol Ph. EUR-----------------------1.01 gm/5gm Sachet

Case No.:5/20/82-

ALC4/2007 Party Name:RICHY GOLD INTERNATIONAL Meet No/Date:20/82- ALC4/2007 18.09.2007 Status:Ca se Deferred HQ File : 01/82/050/00162/AM08/ RLA File : 03/95/040/00461/AM08/ Lic.No/Date:03104394 44 14.08.2007 Defer Date: 30.10.2007 for export product Oral Rehydration Salt BP under para 4.7 of HBP. case is under examination in his Department and he sought deferment for six Date:14.09.2007 Place:New Delhi Shyam Lal Foreign Trade Development Officer

Case No.A-660

M/S DSM Anti-Infectives India Ltd NC Meeting No.20/08 F.No.01/83/50/912/AM08 Meeting date: 18.09.2007 RLA F.No.22/24/40/27/AM08 Adv.Lic. No.2210006952 dated 07.08.2007 Committee considered case as per agenda for ratification of norms for export product Amoxycillin Trihydrate Pen G Route under para 4.7 of HBP. Committee observed that SION for export product Amoxycillin Trihydrate Pen G Route has already been published at Sl.No.A-58 vide Public Notice No.58 dated 26.09.2006, while RA, Chandigarh has issued Advance Authorisation to the firm for the same export product on 07.08.2007 under para 4.7 of HBP. Committee, therefore, decided to seek clarification from RA, Chandigarh as to why Advance Authorisation has been issued under para 4.7 of HBP when SION for export product has already been published on 26.09.2006. Committee also decided to ratify norms under para 4.7 of HBP as per SION at Sl.No.A-58 published vide Public Notice No.58 dated 26.09.2006. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-661

M/S DSM Anti-Infectives India Ltd NC Meeting No.20/08 F.No.01/83/50/914/AM08 RLA F.No.22/24/40/28/AM08 Adv.Lic. No.2210006954 dated 07.08.2007 product Amoxycillin Trihydrate Pen G Route under para 4.7 of HBP. Committee observed that SION for export product Amoxycillin Trihydrate Pen G Route has already been published at Sl.No.A-58 vide Public Notice No.58 dated 26.09.2006, while RA, Chandigarh has issued Advance Authorisation to the firm for the same export product on 07.08.2007 under para 4.7 of HBP. Committee, therefore, decided to seek clarification from RA, Chandigarh as to why Advance Authorisation has been issued under para 4.7 of HBP when SION for export product has already been published on 26.09.2006. Committee also decided to ratify norms under para 4.7 of HBP as per SION at Sl.No.A-58 published vide Public Notice No.58 dated 26.09.2006.

RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-662

M/S DSM Anti-Infectives India Ltd NC Meeting No.20/08 F.No.01/83/50/913/AM08 RLA F.No.22/24/40/25/AM08 Adv.Lic. No.2210006953 dated 07.08.2007 product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. Committee decided to ratify norms under para 4.7 of HBP as per SION at Sl.No.A-152 published vide Public Notice No.45 dated 06.09.2007.

Case No.A-663

M/S DSM Anti-Infectives India Ltd NC Meeting No.20/08 F.No.01/83/50/869/AM08 RLA F.No.22/24/40/20/AM08 Adv.Lic. No.2210006928 dated 31.07.2007 product Amoxycillin Trihydrate Pen G Route under para 4.7 of HBP. Committee observed that SION for export product Amoxycillin Trihydrate Pen G Route has already been published at Sl.No.A-58 vide Public Notice No.58 dated 26.09.2006, while RA, Chandigarh has issued Advance Authorisation to the firm for the same export product on 07.08.2007 under para 4.7 of HBP. Committee, therefore, decided to seek clarification from RA, Chandigarh as to why Advance Authorisation has been issued under para 4.7 of HBP when SION for export product has already been published on 26.09.2006. Committee also decided to ratify norms under para 4.7 of HBP as per SION at Sl.No.A-58 published vide Public Notice No.58 dated 26.09.2006. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.A-664

M/S Vivin Laboratories Pvt. Ltd. NC Meeting No.20/08 F.No.01/82/50/273/AM08 RLA F.No.09/24/40/444/AM07 Adv.Lic. No.0910030207 dated 08.05.2007 product Menthyl-5S-Cytosine-1YL-1,3-Oxathiolane-2R Carboxalate under para 4.7 of HBP. case is under examination in his Department and he sought deferment for six

Case No.A-665

M/S Vivin Laboratories Pvt. Ltd. NC Meeting No.20/08 F.No.01/82/50/275/AM08 RLA F.No.09/24/40/39/AM08 Adv.Lic. No.0910030209 dated 18.05.2007 product 5-O-Benzoyl-3-Mesyl-2,2 Anhydro-5-Methyl Uridine under para 4.7 of HBP.

Case No.A-666

M/S Vivin Laboratories Pvt. Ltd. NC Meeting No.20/08 F.No.01/82/50/274/AM08 RLA F.No.09/24/40/43/AM08 Adv.Lic. No.0910030208 dated 08.05.2007 product Menthyl-5S-Cytosine-1YL-1,3-Oxathiolane-2R Carboxalate under para 4.7 of HBP.

Case No.A-667

M/S Smilax Laboratories Ltd. NC Meeting No.20/08 F.No.01/82/50/1268/AM08 RLA F.No.09/24/40/478/AM07 Adv.Lic. No.0910039428 dated 22.02.2007 product

{3-5[Bromo-1-(flurophenyl)(1,3-dihydro

isobenzo furanyl)}propyl]dimehylamine oxalate under para 4.7 of HBP.

Case No.A-668

M/S Smilax Laboratories Ltd. NC Meeting No.20/08 F.No.01/82/50/1203/AM07 RLA F.No.09/24/40/466/AM07 Adv.Lic. No.0910029229 dated 07.02.2007 product

5-Methoxy-2-((4-Methoxy-3,5-Dimethyl-2Pyridinyl)

methyl]Thio-1H- Benzimidazole under para 4.7 of HBP.

Case No.A-669

M/S Wockhardt Ltd. NC Meeting No.20/08 F.No.01/82/50/155/AM08 RLA F.No.03/95/40/44/AM08 Adv.Lic. No.0310427335 dated 19.04.2007 product Hydroxocobalamin Acetate/Hcl under para 4.7 of HBP. U.O. No.35011/84/2007-PI-III dated 19.09.2007 decided to ratify norms under para

Export product: Hydroxocobalamin Acetate/Hcl--------------------------------1kg Import item: Cyanocobalamin---------------------------------------------------1.088kg/kg

Case No.A-670

M/S Cadila Healthcare Ltd. NC Meeting No.20/08 F.No.01/82/50/132/AM08 RLA F.No.08/24/40/90/AM08 Adv.Lic. No.0810065759 dated 04.07.2007 product Atenolol 25mg, 50mg and 100mg tablets under para 4.7 of HBP.

Case No.A-671

M/S Aurobindo Pharma Ltd. NC Meeting No.20/08 F.No.01/87/50/985/AM07 RLA F.No.09/24/40/261/AM07 Adv.Lic. No.0910029298 dated 12.02.2007 product Nelfinavir Mesylate (From PHIQ route) under para 4.7 of HBP. U.O. No.35011/81/2007-PI-III dated 19.09.2007 decided to ratify norms under para Export product: Nelfinavir Mesylate---------------------------------1Kg. Import items: Sl.No. Description of import items Quantity allowed 1. Cis-2-Butene-1,4-Diol 1.061kg/kg 2. 2,2 Dimethoxy Propane 2.507kg/kg

3-Acetoxy-2-Methylbenzoic Acid 0.448kg/kg 4. Acetone 3.14kg/kg 5. Acetonitrile 0.43kg/kg 6. Carbon Enoanticromos (Activated carbon) 0.090kg/kg 7. Isopropyl Alcohol 3.74kg/kg 8. Methane Sulfonyl Chloride 0.649kg/kg 9. Methanol 4.26kg/kg 10. Methylene choride 7.93kg/kg 11. Methyl Isobutyl Ketone 4.58kg/kg 12. (S)-N-T-Butyl Decahydro Iso Quinoline Carboxamide 0.801kg/kg 13. Thiophenol (Benzene Thiol) 0.479kg/kg 14. Toluene 7.57kg/kg per above decision of Norms Committee.

Case No.A-672

M/S Cadila Healthcare Ltd. NC Meeting No.20/08 F.No.01/82/50/133/AM08 RLA F.No.08/24/40/91/AM08 Adv.Lic. No.0810065758 dated 04.07.2007 product Carvedilol 3.125mg, 6.25mg, 12.5mg and 25mg Tablets under para 4.7 of HBP.

Case No.A-673

M/S Acacia Life Sciences Pvt. Ltd. NC Meeting No.20/08 F.No.01/82/50/1086/AM07 RLA F.No.09/24/40/492/AM07 Adv.Lic. No.0910029581 dated 08.03.2007 product (3Z)-4-(Aminomethyl)-3-Pyrrolidinone-O-Methyloxime Hcl under para 4.7 of HBP. Committee perused application of firm and observed that firm has sought different quantities of inputs in their application. Committee, therefore, decided to seek clarification from RA.

U.O. No.35011/76/2007 PI-III dated 06.09.2007 also decided to call for following information from firm. i) Whereas the firm has applied BOC Anhydride @17.85kg/kg and O-Methoxy Hydroxylamine Hcl @1.85kg/kg under Appendix 11-A, the total requirement has been shown as 2000kg and 225kg respectively against the export of 200kg i.e. per unit norms of 10.00 kg/kg and 1.125 kg/kg respectively for the above two inputs. ii) Even the value addition have been shown as 66.7% and 1253% at two places. iii) The firm has neither given complete chemical reaction, molecular weight, molar requirement of inputs nor the percentage yield on molar basis for each step of chemical reactions. Accordingly, case was deferred for six weeks.

Case No.A-674

M/S Astrix Laboratories Ltd NC Meeting No.20/08 F.No.01/82/50/972/AM07 RLA F.No.09/24/40/440/AM07 Adv.Lic. No.0910029251 dated 08.02.2007 product Lamivudine (Cyclohexyl Ester Route) under para 4.7 of HBP.

Case No.A-675

M/S Envee Drugs Pvt. Ltd. NC Meeting No.20/08 F.No.01/82/50/143/AM08 RLA F.No.34/24/40/296/AM07 Adv.Lic. No.3410018601 dated 18.04.2007 product Betamethasone Valerate BP/USP under para 4.7 of HBP.

Case No.A-676

NC Meeting No.20/08 F.No.01/82/50/127/AM08 RLA F.No.09/24/40/469/AM08 Adv.Lic. No.0910030086 dated 24.04.2007 product Sterile Ampicillin Sodium + Sllbactam Sodium (2:1) under para 4.7 of HBP.

Case No.A-677

M/S Medriech Ltd. NC Meeting No.20/08 F.No.01/82/50/1790/AM07 RLA F.No.07/24/40/718/AM07 Adv.Lic. No.0710049763 dated 24.01.2007 product 1. Paracetamol 450mg + Doxylamine Succinate 5mg + Caffeine 45mg +Codeine Phosphate 10mg Tablets, 2. Paracetamol 450mg + Doxylamine Succinate 5mg + Caffeine 50mg + Codeine Phosphate 10mg Tablets and Paracetamol 450mg

Doxylamine Succinate 5mg + Caffeine 30mg + Codeine Phosphate 10mg Tablets under para 4.7 of HBP.

Case No.A-678

M/S Mangalam Drugs & Organics Ltd. NC Meeting No.20/08 F.No.01/83/50/825/AM08 RLA F.No.03/95/40/362/AM08 Adv.Lic. No.0310437194 dated 23.07.2007

product Amodiaquine Base under para 4.7 of HBP. Committee observed that SION for the export product was deleted in 2005. Committee, therefore, decided to call for All Industry Data in respect of export product for revision of norms from Pharmexcil. Accordingly, case was deferred for six weeks.

Case No.A-679

M/S NGL Fine Chem Ltd. NC Meeting No.20/08 F.No.01/83/162/449/AM07 RLA F.No.03/95/40/573/AM07

Para 4.4.2

product Isometamidium Chloride Hcl under para 4.4.2 of HBP. Committee observed that firm was requested vide letter dated 02.08.2007 to furnish consumption data duly certified by Central Excise Authority, but same has not been received. Committee, therefore, decided to reject the case. RLA concerned may take further necessary action including cancellation of licence under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-680

M/S Makson Industries Pvt. Ltd. NC Meeting No.20/08 F.No.01/82/50/744/AM06 RLA F.No.03/95/40/812/AM06 Adv.Lic. No.0310350412 dated 05.10.2005 product Vicks Veporub under para 4.7 of HBP. Committee in light of written comments forwarded by DC(SSI) vide their U.O. No.5(9)/2005-Chem. Dated 06.09.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product: Vicks Veporub----------------------------------------100kg. Import items: Sl.No. Quantity allowed 1. White Petrolactum (White Soft Paradin) 82.29kg/100kg

Camphor USP 5.365kg/100kg 3. Eucalyptus Oil 1.356kg/100kg 4. Nutmeg Oil 0.703kg/100kg 5. Cedar Leaf Oil 0.448kg/100kg 6. Turpentine Oil 4.77kg/100kg 7. Thymol 0.0916kg/100kg per above decision of Norms Committee. The export product is for the limited purpose for Philippines, Malaysia, Thailand, Australia and New Zealand.

Case No.A-681

M/S Prachi Pharmaceuticals Pvt. Ltd. NC Meeting No.20/08 F.No.01/83/50/709/AM08 RLA F.No.03/95/40/308/AM08 Adv.Lic. No.0310435714 dated 11.07.2007 product Thiamine Hcl BP/USP under para 4.7 of HBP.

Case No.A-682

M/S Neuland Laboratories Ltd. NC Meeting No.20/08 F.No.01/83/50/1047/AM07 RLA F.No.09/24/40/361/AM07 Adv.Lic. No.0910028737 dated 21.12.2006 product Levetiracetam under para 4.7 of HBP. case is under examination in his Department and he sought deferment for two weeks. Committee, accordingly decided to defer case for two weeks.

Case No.A-683

M/S Lupin Ltd. NC Meeting No.20/08 F.No.01/82/50/119/AM08

RLA F.No.03/95/40/293/AM08 Adv.Lic. No.0310433980 dated 26.06.2007 product Sterile Ceftriaxone Sodium 1mg/2mg/250mg Injection under para 4.7 of HBP.

Case No.A-684

M/S Lupin Ltd. NC Meeting No.20/08 F.No.01/83/50/742/AM08 RLA F.No.03/95/40/276/AM08 Adv.Lic. No.0310433502 dated 22.06.2007 product Levetiracetam under para 4.7 of HBP.

Case No.A-685

M/S Matrix Ltd. NC Meeting No.20/08 F.No.01/82/50/125/AM08 RLA F.No.09/24/40/445/AM08 Adv.Lic. No.0910030195 dated 07.05.2007 product Nelfinavir Mesylate under para 4.7 of HBP.

Case No.A-686

M/S Nicholas Piramal India Ltd. NC Meeting No.20/08 F.No.01/82/61/2/AM08 RLA F.No.03/95/40/244/AM08

Case under para 4.4.2 of HBP product Oxysept Tablets under para 4.7 of HBP. Committee observed that firm has given wrong declaration that the application does not involve export and/or import of Biotechnology items and hence there is no need to submit NOC from Department of Biotechnology. Technical comments have been received from Department of Biotechnology according to which Export Product is a Biotechnology item. As such the declaration given by them is wrong and Committee decided to reject the case. RA concerned may take further necessary action including cancellation of licence as per above decision of Norms Committee.

Case No.A-687

NC Meeting No.20/08 F.No.01/83/50/520/AM08 RLA F.No.09/24/40/96/AM08 Adv.Lic. No.0910030542 dated 13.06.2007 product Finasteride under para 4.7 of HBP. U.O. No.35011/81/2007-PI-III dated 19.09.2007 decided to ratify norms under para Export product: Finasteride----------------------------------1kg. Import items: Sl.No . Quantity allowed 1. Azandrostane

Carboxamide

(Androst-4-aza-3-one- 17Beta-N-Tert. Butyl Carboxamide) 2.20kg/kg 2. 4-Dimethylaminopyridine (DMAP) 1.00kg/kg 3. 2,3-Dichloro-5,6-Dicyano-1,4-Benzoquinone (DDQ) 0.86kg/kg 4. Bis-(Trimethylsilyl) Trifluoro-Acetamide (BSTFA) 1.47kg/kg 5. Acetic Acid 13.31kg/kg 6. Methanol 7.23kg/kg 7. Methylene chloride 7.95kg/kg 8. Tetrahydroduran 4.82kg/kg

Case No.A-688

NC Meeting No.20/08 F.No.01/83/50/878/AM08 RLA F.No.09/24/40/182/AM08 Adv.Lic. No.0910031049 dated 06.08.2007 product Benazepril Hcl under para 4.7 of HBP. U.O. No.35011/81/2007-PI-III dated 19.09.2007 decided to ratify norms under para Export product: Benazepril Hcl----------------------------------1kg. Import items: Sl.No . Quantity allowed 1. Tert-buty(S)-3-Aminocaprolactam 0.8873kg/kg 2. ®-2-Hydroxy-4-Phenyl butanoic acid ethyl ester (HDPE) 0.9091kg/kg 3. Methylene chloride 17.54kg/kg 4. Trifluoro methansulphonic anhydride (Trifilic Anhydride) 1.43kg/kg 5. Activated carbon 0.100kg/kg 6. Potassium Carbonate 0.0909kg/kg

Case No.A-689

NC Meeting No.20/08 F.No.01/83/50/831/AM08 RLA F.No.09/24/40/446/AM07 Adv.Lic. No.0910030991 dated 24.07.2007 product Didanosine under para 4.7 of HBP. U.O. No.35011/81/2007-PI-III dated 19.09.2007 decided to ratify norms under para Export product: Didanosine----------------------------------1kg.

Import items: Sl.No . Quantity allowed 1. Inosine 3.82kg/kg 2. 2-Acetoxy Isobutyryl Bromide 7.84kg/kg 3. Ethylene Diamine Tetra Acetic Acid Disodium Salt Dihydrate 4.20kg/kg 4. Activated Carbon 0.100kg/kg 5. N,N Dimethyl Formamide 2.14kg/kg 6. Methylene chloride 4.49kg/kg 7. Acetonitrile 7.68kg/kg 8. Methanol 6.21kg/kg

Case No.A-690

NC Meeting No.20/08 F.No.01/83/50/823/AM08 RLA F.No.09/24/40/159/AM08 Adv.Lic. No.0910030974 dated 23.07.2007 product Efavirenz under para 4.7 of HBP. U.O. No.35011/81/2007-PI-III dated 19.09.2007 decided to ratify norms under para Export product: Efavirenz----------------------------------1kg. Import items: Sl.No . Quantity allowed 1. Isopropyl Alcohol 6.00kg/kg 2. Trifloroethanol (2,2,2-Trifluoro Ethanol) 0.642kg/kg 3. Tetra Hydro Furan 6.00kg/kg 4. 2-Trifluoromethylcarbonyl-4-Chloroaniline

(Ketoaniline Free Base) 1.19kg/kg 5. Cyclopropyl Acetylene 0.524kg/kg 6. Triphosgene 0.498kg/kg 7. Diethyl Zinc (60% in Hexane) 1.47kg/kg 8. Potassium Carbonate 0.428kg/kg 9. n-Hexane 6.03kg/kg 10. (1R,2S)-Pyrrilidinyl Norephedrine (L phenyl proferol 0.185kg/kg

amine Hcl)

Case No.A-691

M/S Astrix Laboratories Ltd. NC Meeting No.20/08 F.No.01/83/50/717/AM08 RLA F.No.09/24/40/119/AM09 Adv.Lic. No.0910030868 dated 12.07.2007 product Ritonavir under para 4.7 of HBP. Committee noted that firm was requested to furnish certain technical details vide letter dated 14.08.2007, but same has not been received. Committee, therefore, decided to reject case. RLA concerned may take further necessary action including cancellation of licence under para 4.7 of HBP as per above decision of Norms Committee.

Case No.A-692

M/Astrix Laboratories Ltd. NC Meeting No.20/08 F.No.01/83/50/718/AM08 RLA F.No.09/24/40/118/AM08 Adv.Lic. No.0910030869 dated 12.07.2007 product Lopinavir under para 4.7 of HBP. Committee observed that in another case of firm for same export product, firm was requested to furnish certain technical information vide letter dated 07.08.2007, but same has not been received. That case has been considered in NC Meeting No.19/08 dated 11.09.2007 and it has been decided to await reply of firm and defer case to be re-listed on 04.10.2007. Committee, therefore, decided to defer this case and to re-list on 04.10.2007 alongwith the other similar case.

Case No.A-693

M/S Arvee Chem Pharma Pvt. Ltd. NC Meeting No.20/08 F.No.01/82/50/297/AM08 RLA F.No.07/24/40/84/AM08 Adv.Lic. No.0710051589 dated

10.05.2007 product Dibenzosuberone Chemical Product under para 4.7 of HBP. U.O. No.35011/77/2007-PI-III dated 06.09.2007 decided to ratify norms under para Export product: Dibenzosuberone-------------------------------------1kg. Import item: Tetrahydroduran--------------------------------------1.627kg/kg per above decision of Norms committee.

Case No.A-694

M/S Wockhardt Ltd. NC Meeting No.20/08 F.No.01/83/50/995/AM08 RLA F.No.03/95/40/239/AM08 Adv.Lic. No.0310439955 dated 17.08.2007 product Vitamin B12 (Cyanocabalamin) USP under para 4.7 of HBP. The Committee in light of earlier decision taken in its 13/08 meeting held on 31.07.2007 vide Case No.A-359 decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export product: Vitamin B12 (Cyanocobalamin) USP Micronised-----1Kg. As per particle size A) Minimum 80% Less than 125 Microns B) Minimum 98% Less than 150 Microns Import item: Vitamin B12 (Cyanocobalamin)-----------------------1.01Kg/Kg As per particle size A) Not more than 66% less than 125 Microns B) Not more than 77% less than 150 Microns per above decision of Norms Committee.

Case No.A-695

M/S Ranbaxy Laboratories Ltd. NC Meeting No.20/08 F.No.01/82/50/107/AM08 RLA F.No.05/24/40/17/AM08 Adv.Lic. No.0510202504 dated 13.04.2007 product Isotretinoin under para 4.7 of HBP.

Case No.A-696

M/S Vijay Perfumes Pvt. Ltd NC Meeting No.20/08 F.No.01/83/50/854/AM08 RLA F.No.03/95/40/422/AM08 Adv.Lic. No.0310437769 dated 30.07.2007 product N-Methyl Benzothiazene Methyl Ester under para 4.7 of HBP. U.O. No.35011/52/2006-PI-III dated 19.09.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower; Export product: N-Methyl Benzothiazene Methyl Ester-------------------------------1kg. Import items: Sl.No. Quantity allowed 1. Sodium Saccarine 1.29kg/kg 2. Dimethyl Formamide 0.50kg/kg 3. Sodium Metal 0.337kg/kg 4. Methyl Alcohol 1.55kg/kg 5. Acetone 0.645kg/kg 6. Xylene 0.645kg/kg 7. Methyl Chloro Acetate 0.98kg/kg

Case No.A-697

M/S DSM Anti-Infectives India Ltd. NC Meeting No.20/08 F.No.01/83/50/984/AM08 RLA F.No.22/24/40/35/AM08 Adv.Lic. No.2210006969 dated 17.08.2007 product Cloxacillin Sodium Pen G Route under para 4.7 of HBP. Committee decided to ratify norms under para 4.7 of HBP as per SION at Sl.No.A-152 published vide Public Notice No.45 dated 06.09.2007.

Case No.A-698

M/S Ranbaxy Laboratories Ltd. NC Meeting No.20/08 F.No.01/82/50/758/AM08 RLA F.No.05/24/40/285/AM08 Adv.Lic. No.0910030869 dated 12.07.2007 product Atorvastatin Calcium under para 4.7 of HBP.

Case No.A-699

M/S Surya Pharmaceutical Ltd. NC Meeting No.20/08 F.No.01/83/50/1007/AM08 RLA F.No.22/24/40/34/AM08 Adv.Lic. No.2210006991 dated 21.08.2007 product Cefprozil under para 4.7 of HBP.

Case No.B-277

M/S Alchem International Ltd. NC Meeting No.20/08 F.No.01/87/50/1374/AM05 RLA F.No.05/24/40/542/AM05 Adv.Lic. No.0510148830 dated 17.01.2005 product Hyocine-n-Butyl Bromide under para 4.7 of HBP. Committee observed that there are several cases of firm for same export product. Committee, therefore, decided to re-list all the cases of firm on 04.10.2007.

Case No.B-278

M/S Cipla Ltd NC Meeting No.20/08 F.No.01/82/50/124/AM08 RLA F.No.03/94/40/263/AM08 Adv.Lic. No.0310432617 dated 14.06.2007 Committee considered case as per agenda for amendment in the description of import items under para 4.7 of HBP. Committee in consultation with technical authorities present in meeting decided to amend description of import items No. 2 to 4 as per details below; Sl.No. Description of import item as per earlier decision of NC Description amended 2. Vials 10ml amber coloured glass (component) 63mcl Aerolol Valves 3. Pump Vol.0.05ml 20mm crimp (component) 19ml Aluminium Can 4. Applicator

Nasal

Spray

EGS (Component) Actuators

with

Dust Covers/Caps Fitting to 19ml Aluminium Can

Case No.B-279

M/S Anuh Pharma Ltd. NC Meeting No.20/08 F.No.01/82/50/1430/AM08 RLA F.No.03/81/39/3/AM07 Adv.Lic. No.0310404537 dated 17.10.2006

Committee considered case as per agenda for amendment in the description of export product under para 4.7 of HBP. Committee in consultation with technical authorities present in meeting decided to allow amendment in description of export product to read as “Erythromycin Propionate”. RLA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-280

M/S Glenmark Pharmaceuticals Ltd NC Meeting No.20/08 F.No.01/82/50/574/AM06 RLA F.No.03/94/40/509/AM06 Adv.Lic. No.0310345199 dated 30.08.2005 Committee considered case as per agenda for amendment in the description of export product under para 4.7 of HBP. Committee in consultation with technical authorities present in meeting decided to allow amendment in description of export product to read as “Glimepiride’. RA concerned may take further necessary action as a per above decision of Norms Committee.

Case No.B-281

NC Meeting No.20/08 F.No.01/87/50/421/AM07 RLA F.No.09/21/40/85/AM06 Adv.Lic. No.0910023252 dated 23.06.2005 Committee considered case as per agenda for carry forward the export obligation under Advance licence to 100% EOU. Committee decided to advise firm to approach Regional Authority in terms of

para 6.37.1 of HBP (Vol.I).

Case No.B-282

M/S Alkem Laboratories Ltd. NC Meeting No.20/08 F.No.01/83/50/409/AM08

RLA F.No.03/94/40/187/AM08 Adv.Lic. No.0310430680 dated 25.05.2007 product Sucralose USP under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division and defer case for four weeks.

Case No.B-283

NC Meeting No.20/08 F.No.01/87/50/917/AM08 RLA F.No.03/94/40/263/AM06 Adv.Lic. No.0910024429 dated 26.10.2005 Committee considered case as per agenda for modification of norms fixed in its meeting No.37/05 dated 04.01.2006 for export product 7-Amino-3-Vinyl Cephalosporanic Acid under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to modify import items as per details below; Export product: 7-Amino-3-Vinyl Cephalosporanic Acid ---------------------------1kg. Import items: Sl.No. Quantity allowed 1. GCLE

(7-Phenyl

Acetamide-3-Chloro

methyl Cephalosporanic) 3.808kg/kg 2. Butyl Acetate/DMF 4.06kg/kg 3. Methylene Chloride/Methanol 10.70kg/kg 4. Activated Carbon 0.100kg/kg 5. Phenol 6.1347kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-284

M/S Glenmark Pharmaceuticals Ltd. NC Meeting No.20/08 F.No.01/82/162/207/AM08 RLA F.No.03/24/40/789/AM04 Adv.Lic. No.0310217859 dated 11.08.2003

product Cilostazol under para 4.7 of HBP. Committee observed that advance authorization was issued on 11.08.2003 and firm has made representation now for ratification of norms. Committee decided to reject case as it appears to be time barred. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-285

M/S Glenmark Pharmaceuticals Ltd. NC Meeting No.20/08 F.No.01/82/162/154/AM08 RLA F.No.03/24/40/1857/AM04 Adv.Lic. No.0310241497 dated 11.12.2003 product Amiodrone under para 4.7 of HBP. Committee observed that advance authorization was issued on 11.12.2003 and firm has made representation now for ratification of norms Committee decided to reject case as it appears to be time barred. RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-286

M/S Ind Swift Laboratories Ltd. NC Meeting No.20/08 F.No.01/82/50/1131/AM07 RLA F.No.22/24/40/261/AM07 Adv.Lic. No.2210006123 dated 11.10.2006 Committee considered case as per agenda for allowing import of L(+)Tartaric Acid under para 4.7 of HBP. U.O. No.35011/192/2006 PI-III dated 24.04.2007 in case of M/S Arch Pharmababs Ltd

decided to allow import of additional item as per details below. Import item: L+Tartaric acid----------------------------0.70kg/kg RA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-287

M/S Lupin Ltd. NC Meeting No.20/08 F.No.01/82/50/1604/AM07 RLA F.No.03/95/40/1237/AM07 Adv.Lic. No.0310415404 dated 10.01.2007 Committee considered case as per agenda for amendment in the description of import item under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to allow amendment in description of import item No.2 to read as “E.D.T.A. disodium” and import item No.9 to read as “Dimethyl Aniline” without any change in quantity. RLA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-288

M/S Ind-Swift Laboratories Ltd. NC Meeting No.20/08 F.No.01/82/50/179/AM07 RLA F.No.22/24/40/18/AM07 Adv.Lic. No.2210005501 dated 04.05.2006 Committee considered case as per agenda for modification of norms for export product Clopidogrel Hydrogen Sulphate under para 4.7 of HBP. Committee decided to defer case for four weeks for want of comments of PI Division.

Case No.B-289

M/S Lupin Ltd. NC Meeting No.20/08 F.No.01/82/50/1458/AM07 RLA F.No.03/95/40/1145/AM07 Adv.Lic. No.0310412637 dated

19.12.2006 Committee considered case as per agenda for amendment in the description of import item under para 4.7 of HBP. U.O. No.35011/46/2007-PI-III dated 24.04.2007 decided to allow amendment in the description of import item No.12 to read as “Dimethyl Aniline”. RLA concerned may take further necessary action as per above decision of Norms Committee.

Case No.B-290

M/S Shalina Laboratories Pvt. Ltd. NC Meeting No.20/08 F.No.01/83/50/1083/AM07 RLA F.No.03/95/40/1164/AM07 Adv.Lic. No.0310414237 dated 02.01.2007 product Epiderm Lotion 30ml under para 4.7 of HBP.

Case No.B-291

M/S Shalina Laboratories Pvt. Ltd. NC Meeting No.20/08 F.No.01/83/50/1084/AM07 RLA F.No.03/95/40/1163/AM07 Adv.Lic. No.0310414239 dated 02.01.2007 product Betasol Lotion 30ml under para 4.7 of HBP.

Case No.B-292

M/S Wockhardt Ltd. NC Meeting No.20/08 F.No.01/82/162/549/AM’07 Meeting date: 19.09.2007

Committee considered case as per agenda for fixation of value addition for revision of DEPB rate in respect of export product ‘Dextromethorphan Hydrobromide’. Committee observed that there are five inputs allowed under SION at Sl.No.A- 173 out of which, firm has given data for four items. As regards 5th item namely Cyclohexenyl Ethyl Amino”, firm has furnished International data wherein it has been mentioned that Zeeland, USA the sole manufacturer in the world have stopped manufacturing of this product since 2002. The item is being manufactured in India by 02 Manufacturers. Hence no imports done for this item and no import price available since 2002. Committee decided to call for All Industry Data for above input from Pharmexcil. Case was accordingly deferred for four weeks.

Case No.C-11

M/S IPCA Labs. Ltd. NC Meeting No.20/08 F.No.01/82/50/1004/AM07/DES-III Meeting date 19.09.2007 Committee considered case as per agenda for amendment in description of export product in SION at Sl.No.A-373. Committee in consultation with technical authorities present in meeting decided to allow amendment in description of export product in SION A-373 to read as “Propranolol Hydrochloride” instead of “Propanolol Hydrochloride”. Necessary steps may be taken to amend the description of export product through Public Notice.

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