IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2008-03-18

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
: 46/82-ALC4/2007 MEETING DATE : 18.03.2008

The Meeting No.46/08 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 18.03.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. At the outset minutes of Norms Committee Meeting No40/08 dated 03.03.2008, 41/08 dated 03.03.2008, 42/08 dated 11.03.2008 and 45/08 dated 11.03.2007 were ratified by the Committee.

Case No.B-580

M/s Aarti Drugs Ltd M.No.46/08 F.No.01/83/50/1064/AM 08 Meeting Date 18.03.2007 RLA F.No. 03/94/40/376/AM08 Adv. Lic. No.0310441411 dt.30.08.2007

The Committee considered the case as per agenda for amendment in description of import items No.1 and 2 under para 4.7 of HBP.

Committee in consultation with representative of PI Division present in meeting decided to allow amendment in the description of import items No1 and 2 to read as “Dichlofenac Sodium” and “Mono Chloro Aniline (MCA)” respectively.

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

Case No.B-581

M/s Alchem International Ltd M.No.46/08 F.No.01/87/50/374/AM 06 RLA F.No. 05/24/40/241/AM06 Adv. Lic. No. 0510160970 dt.29.06.2005

The Committee considered the case as per agenda for revision of norms for the export product
Hyoscine-n-Butyl Bromide under para 4.7 of HBP.

Committee observed that advance authorization was issued in 2005 and norms were ratified by ALC in 2005, while representation of firm for revision of norms has been received on 22.01.2008 i.e. after a gap of more than two years. Committee, therefore, decided to maintain status quo.

Case No.B-582

M/s Alchem International Ltd M.No.46/08 F.No.01/87/50/1413/AM 05 RLA F.No. 05/24/40/543/AM05 Adv. Lic. No. 0510149505 dt. 24.01.2005

The Committee considered the case as per agenda for ratification of norms for the export product
Hyoscine-n-Butyl Bromide or Hyoscine Hydro Bromide under para 4.7 of HBP.

Committee observed that advance authorization was issued in 2005 and norms were ratified by ALC in 2005, while representation of firm for revision of norms has been received on 22.01.2008 i.e. after a gap of more than two years. Committee, therefore, decided to maintain status quo.

Case No.B-583

M/s Aico Lab Ltd M.No.46/08 F.No.01/87/50/517/AM 08 RLA F.No. 08/24/40/62/AM07 Adv. Lic. No. 0810056884 dt. 01.06.06

The Committee considered the case as per agenda for ratification of norms for the export product
Glycine USP under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U,O.35011/90/2005-PI-III dated 18.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export produc Glycine USP 1kg. 1. Amino Acetic Acid Purity NMT98.5% (chloride content NLT 0.5%) 1.05kg/kg 2. Methanol 0.20kg/kg

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

Case No.B-584

M/s Alkem Laboratories Ltd M.No.46/08 F.No.01/83/50/409/AM 08

Adv. Lic. No. 0310430680 dt.25.05.2007

The Committee considered the case as per agenda for ratification of norms for the export product
Sucralose USP under para 4.7 of HBP.

Committee observed that firm was requested to appear for personal hearing, but they have sought postponement of personal hearing for another date. Committee, therefore, decided to call firm for personal hearing before NC in its meeting to be held on 15.04.2008. Accordingly, case was deferred for four weeks.

Case No.B-585

M/s Wockhardt Ltd M.No.46/08 F.No.01/82/162 /548/AM 07

The Committee considered the case as per agenda for fixation of Value addition for DEPB rate for the export product D- Oxyphene Base (Powder) Sl.No. A-166.

Committee observed that Director (DBK) vide letter dated 18.03.2008 has again requested that the value addition norms are not altered/fixed in respect of DEPB items. In view of above, it was decided to seek comments of DEPB Committee regarding action to be taken in such cases.

Case No.B-586

M/s Wockhardt Ltd M.No.46/08 F.No.01/82/162 /215/AM 08

The Committee considered the case as per agenda for fixation of Value addition for DEPB rate for the export product Dextropropoxyphene Napsylate USP Sl.No. A-175. . Committee observed that Director (DBK) vide letter dated 18.03.2008 has again requested that the value addition norms are not altered/fixed in respect of DEPB items. In view of above, it was decided to seek comments of DEPB Committee regarding action to be taken in such cases.

Case No.B-587

M/s Wockhardt Ltd M.No.46/08 F.No.01/82/162 /428/AM 07

The Committee considered the case as per agenda for fixation of Value addition for DEPB rate for the export product Dextromethorphan Hydrobromide at SION Sl.No. A-173. . Committee observed that Director (DBK) vide letter dated 18.03.2008 has again requested that the value addition norms are not altered/fixed in respect of DEPB items. In view of above, it was decided to seek comments of DEPB Committee regarding action to be taken in such cases.

Case No.B-588

M/s Makpar Exports M.No.46/08 F.No.01/82/162/597/AM 08

The Committee considered the case as per agenda for Clarification on applicability of DEPB on export of Lozenges.

Committee observed that Director (DBK) vide letter dated 18.03.2008 has again requested that the value addition norms are not altered/fixed in respect of DEPB items. In view of above, it was decided to seek comments of DEPB Committee regarding action to be taken in such cases.

Case No.B-589

M/s Penam Laboratories Ltd M.No.46/08 F.No.01/82/162/450/AM 08

The Committee considered the case as per agenda for fixation of DEPB rate for 6APA(6-Amino Penicillanic Acid.

Committee observed that Director (DBK) vide letter dated 18.03.2008 has again requested that the value addition norms are not altered/fixed in respect of DEPB items. In view of above, it was decided to seek comments of DEPB Committee regarding action to be taken in such cases.

Case No.B-590

M/s Lupin Ltd M.No.46/08 F.No.01/82/162/285/AM 06

The Committee considered the case as per agenda for fixation of DEPB rate for Export Product 3C7ACCA-SION A-2119.

Committee observed that Director (DBK) vide letter dated 18.03.2008 has again requested that the value addition norms are not altered/fixed in respect of DEPB items. In view of above, it was decided to seek comments of DEPB Committee regarding action to be taken in such cases.

Case No.C-38

M/s Aurobindo Pharma Ltd M.No.46/08 F.No.01/82/162/450/AM 08

The Committee considered the case as per agenda for fixation of SION for Piperacillin sodium Sterile and Tazobactam Sodium Sterile (8.1) or Premix of Tazobactam Sodium Plus Piperacillin sodium (1.8)Sterile.

Committee decided to defer case for six weeks for comments of PI Division.

Case No.C-39

M/s R.L.Fine Chem Ltd M.No.46/08 F.No.01/82/162/47/AM 08

The Committee considered the case as per agenda for fixation of SION for the Export Product Trimipramine Maleate.

Committee decided to defer case for four weeks for comments of PI Division.

Case No.C-40

M/s DCM Shriram Industries Ltd M.No.46/08 F.No.01/82/162/286/AM 08

The Committee considered the case as per agenda for fixation of SION for the export product D(-) Para Hydroxy Phenyl Glycine Methyl Potasium Dane Salt as per SION No. 3011.

Case No.C-41

M/s Aurobindo Pharma Ltd M.No.46/08 F.No.01/82/162/882/AM 08

The Committee considered the case as per agenda for fixation of SION for Cefepime HFCL for Injection of Cefepime HCL Sterile buffered with L- Agrine Sterile .

Case No.C-42

M/s Parabolic Drugs Ltd M.No.46/08 F.No.01/82/162/805/AM 08

The Committee considered the case as per agenda for Modification of SION A-33 for 6 Amino Penicillnic acid (6-APA).

Case No.C-43

M/s Parabolic Drugs Ltd M.No.46/08 F.No.01/82/162/806/AM 08

The Committee considered the case as per agenda for Modification of SION A-152 for Cloxacillin Sodium (Pen G route).

Case No.C-44

M/s Parabolic Drugs Ltd M.No.46/08 F.No.01/82/162/807/AM 08

The Committee considered the case as per agenda for Modification of SION A-58 for Amoxycillin Trihydrate (Pen G route).

Case No.C-45

M/s Parabolic Drugs Ltd M.No.46/08 F.No.01/82/162/808/AM 08

The Committee considered the case as per agenda for Modification of SION A-69 for Ampicillin Trihydrate (Pen G route).

1

Case No.:493/21/82-ALC4/2007 Party Name:DOCTORSORGANIC

CHEMICALS LTD Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00955/AM04/
RLA File :26/80/040/00010/AM04/
Lic.No/Date:2610003194 14.11.2003 Defer Date:29.04.2008 Decision :Committee considered case as per agenda for ratification of norms for export

product 1-Cyano Cyclohexane Ethylester Acetic Acid under para 4.7 of HBP.

2

Case No.:29/29/82-ALC1/2006

Party Name:INNOVASSYNTH TECHNOLOGIES (INDIA) LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/01010/AM07/
RLA File :03/94/040/00604/AM07/
Lic.No/Date:0310400933 25.09.2006 Defer Date:15.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 5-O-Dimethoxytrityl-2-O-tert—butyldimethylsilyl-N-benzoyl adenosine/DMT- rA(bz)TBDMS Solid under para 4.7 of HBP.

Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly, case was deferred for four weeks.

3

Case No.:28/50/83-ALC1/2006

Party Name:R.K.INDUSTRIES, Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/83/050/01307/AM07/
RLA File :08/24/040/00349/AM07/
Lic.No/Date:0810063342 02.03.2007 Defer Date:15.04.2008 product Ortho Toluidine 5 Sulfonic Acid under para 4.7 of HBP.

4

Case No.:756/24/87-ALC1/2007 Party Name:AVIGNON EXIM

PVT.LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Withdrawn HQ File :01/87/050/01102/AM07/
RLA File :03/94/040/01374/AM07/
Lic.No/Date:0310422847 13.03.2007

product Niacinamide BP/USP under para 4.7 of HBP.

Committee decided to withdraw case as case has already been approved in its 42/08 meeting held on 11.03.2008.

5

Case No.:796/24/87-ALC1/2007 Party Name:ALKALOIDS CORP

Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File RLA File Lic.No/Date:0210099423 Defer

:01/87/050/01145/AM07/
:02/24/040/00366/AM07/
27.03.2007 Date:29.04.2008 product Artesunate Intl. PH3 under para 4.7 of HBP.

Committee decided to call for complete description of import and export items alongwith copy of DML from firm. Accordingly, case was deferred for six weeks.

6

Case No.:18/22/83-ALC1/2007

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/83/050/00496/AM08/
RLA File :04/24/040/00041/AM08/
Lic.No/Date:0410089893 11.06.2007

product Clindamycin Hydrochloride under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/65/2006-PI-III dated 18.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export product Export Qty. Import item
Qty. allowed per unit of export product Clindamycin Hcl An active pharmaceutical ingredient 1kg. Lincomycin Hcl 1.43kg/kg

7

Case No.:20/27/83-ALC1/2007

Party Name:UMA ORGANICS PVT. LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/83/050/01094/AM08/
RLA File :09/24/040/00206/AM08/
Lic.No/Date:0910031379 03.09.2007 Defer Date:15.04.2008 product Ethoxy Nonenone under para 4.7 of HBP.

8

Case No.:65/27/83-ALC1/2007

Party Name:HALCYON LABS PVT. LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred

HQ File :01/83/050/01139/AM08/
RLA File :03/94/040/00315/AM07/
Lic.No/Date:0310442297 10.09.2007 Defer Date:29.04.2008 product Dexamethasone Sodium Phosphate under para 4.7 of HBP.

Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for six weeks.

9

Case No.:101/27/83-ALC1/2007 Party Name:DOCTORSORGANIC

CHEMICALS LTD Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/83/050/01175/AM08/
RLA File :26/24/040/00002/AM08/
Lic.No/Date:2610006381 14.09.2007 Defer Date:15.04.2008 product Sertraline Hydrochloride under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

10

Case No.:189/27/83-ALC1/2007 Party Name:KESHAVA

ORGANICS PVT. LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/83/050/01263/AM08/
RLA File :03/94/040/00595/AM08/
Lic.No/Date:0310444705 01.10.2007 Defer Date:15.04.2008 product Chlorpheniramine Base under para 4.7 of HBP.

Committee decided to defer case four weeks for comments of PI Division.

11

Case No.:81/32/83-ALC1/2007

Party Name:METROCHEM API PVT. LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Withdrawn HQ File :01/83/050/01503/AM08/
RLA File :09/24/040/00240/AM08/
Lic.No/Date:0910031988 05.11.2007 Defer Date: product 2-Chloro Methyl-3-Methyl-4-(2,2.2-Trifloro Ethoxy)-Pyridine Hydrochloride under

para 4.7 of HBP.

Committee decided to withdraw case as case has already been considered in its 45/08 meeting held on 11.03.2008.

12 Case No.:107/32/83-ALC1/2007 Party Name:JUBILANT ORGANOSYS LTD (FORMERLY Meet No/Date:46/82- ALC4/2007 Status:Case Deferred

VAM ORGANIC CHEM 18.03.2008 HQ File :01/83/050/01529/AM08/
RLA File :05/24/040/00510/AM08/
Lic.No/Date:0510211736 06.11.2007 Defer Date:15.04.2008 product 2-Fluoro-4-Iodobenzonitrile under para 4.7 of HBP.

13

Case No.:64/39/83-ALC1/2007 Party Name:PUNJAB CHEMICALS

AND CROP PROTECTION LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/83/050/01643/AM08/
RLA File :03/95/040/00839/AM08/
Lic.No/Date:0310451680 27.11.2007 Defer Date:15.04.2008 product 3,5 Dimethoxy,4-Hydroxy Benzonitrile under para 4.7 of HBP.

14

Case No.:141/39/83-ALC1/2007 Party Name:MODEPRO (INDIA)

PRIVATE LIMITED., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/83/050/01720/AM08/
RLA File :03/95/040/00863/AM08/
Lic.No/Date:0310453055 07.12.2007 Defer Date: product 2-Chlorothiophene under para 4.7 of HBP.

Committee perused the written comments forwarded by Department of MSME vide their U.O. No.5(9)/2005-chem dated 08.03.2006 and decided to ratify norms under para 4.7 of HBP as per details below in view of the reasons that in the case of Advance Authorisation No.0310453554 dated 11.02.2007, the firm has applied for less qty. of inputs

Export product Export Qty. Import item Qty. allowed per unit of export product 2-Chlorothiophene 1kg. Thiophene 0.534kg/kg

15 Case No.:149/39/83-ALC1/2007 Party Name:MODEPRO (INDIA) PRIVATE LIMITED., Meet No/Date:46/82- ALC4/2007 Status:Case Approved

18.03.2008 HQ File :01/83/050/01728/AM08/
RLA File :03/95/040/00191/AM07/
Lic.No/Date:0310453554 11.12.2007 Defer Date: product 2-Chlorothiophene under para 4.7 of HBP.

Committee perused the written comments of Department of MSME conveyed vide their U.O. No.5(9)/2005-chem dated 08.03.2006 and decided to ratify norms under para 4.7 of HBP by allowing item of import as applied for.

16

Case No.:164/39/83-ALC1/2007 Party Name:ARCH PHARMALABS

LTD Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Withdrawn HQ File :01/83/050/01743/AM08/
RLA File :03/94/040/00870/AM08/
Lic.No/Date:0310454008 14.12.2007

product Clopidogrel Bisulphate under para 4.7 of HBP.

Committee decided to withdraw case as case has already been approved in its 44/08 meeting held on 04.03.2008.

17

Case No.:159/39/83-ALC1/2007 Party Name:DIVIS

PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/83/050/01738/AM08/
RLA File :09/24/040/00158/AM08/
Lic.No/Date:0910032408 14.12.2007 Defer Date:15.04.2008 product Bromo Ketorolac (or) 5-Benzoyl-7-bromo-1,2 di hydro-3H-pyrrolol (1,2-a)pyrrole-1- carbocylic acid under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

18

Case No.:6/40/83-ALC1/2007

Party Name:KDAC CHEM PVT LTD Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/83/050/01771/AM08/
RLA File :34/24/040/00196/AM08/
Lic.No/Date:3410020422 26.12.2007 Defer Date:15.04.2008 product Phenyl Ethyl alcohol under para 4.7 of HBP.

Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for their comments. Accordingly, case was deferred for six weeks.

19

Case No.:11/46/82-ALC4/2007 Party Name:LAFFANS

PETROCHEMICALS LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00565/AM08/
RLA File :03/95/040/00819/AM08/
Lic.No/Date:0310455622 28.12.2007 Defer Date:29.04.2008 product Laffsolve MEB (Ethylene Glycol Mono Butyl Ether) under para 4.7 of HBP.

Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for their comments. Accordingly, case was deferred for six weeks.

20 Case No.:12/42/83-ALC1/2007 Party Name:PARABOLIC DRUGS Meet No/Date:46/82- Status:Case

LTD., ALC4/2007 18.03.2008 Deferred HQ File :01/83/050/01788/AM08/
RLA File :22/24/040/00053/AM08/
Lic.No/Date:2210007356 04.01.2008 Defer Date:29.04.2008 product 7-AVCA under para 4.7 of HBP.

21

Case No.:9/46/82-ALC4/2007

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00563/AM08/
RLA File :03/95/040/00935/AM08/
Lic.No/Date:0310456686 07.01.2008 Defer Date:15.04.2008 product Fluoro Benzene (99.9%) under para 4.7 of HBP.

22

Case No.:5/46/82-ALC4/2007

Party Name:MERCK LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/82/050/00559/AM08/
RLA File :03/95/040/00971/AM08/
Lic.No/Date:0310457165 09.01.2008

product Thiamine Disulfide under para 4.7 of HBP.

Committee in light of its earlier decision taken in its 35/08 meeting held on 08.01.2008 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 Qty. Sl.No. Import items Qty. allowed per unit of export produc Thiamine Disulfide 1kg. 1. Thiamine Hcl IP/BP/USP (Vitamin B1 Hcl) 1.4199kg/kg 2. Sodium Hydroxide Pellets 0.4634kg/kg 3. Potassium Hexacyanoferate (III) GR 0.0022kg/kg

Hydrochloric Acid fuming 37% 0.3356kg/kg

Hydrogen peroxide solution 35% 0.2157kg/kg

extra pure 6. Acetone 0.8702Ltrs/kg

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

23

Case No.:18/42/83-ALC1/2007

Party Name:AICO LABORATORIES INDIA LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/83/050/01794/AM08/
RLA File :08/24/040/00216/AM08/
Lic.No/Date:0810069556 11.01.2008

product Glycine USP 27 Chemical Formula Nh2Ch2Cooh, Purity (Min) as (C2H5No2) not less than 99.00% Chloride 0.0010% Loss on Drying 0.2%, Sulphate (SO4): 0.0065% under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U,O.35011/90/2005-PI-III dated 18.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export produc Glycine USP 1kg. 1. Amino Acetic Acid Purity NMT98.5% (chloride content NLT 0.5%) 1.05kg/kg 2. Methanol 0.20kg/kg

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

24

Case No.:12/46/82-ALC4/2007

Party Name:NAPROD LIFE SCIENCES PVT. LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/82/050/00566/AM08/
RLA File :03/95/040/00965/AM08/
Lic.No/Date:0310458523 22.01.2008

product Hydrocortisone Sodium Succinateunder para 4.7 of HBP.

Committee in light of its earlier decision taken in its 25/08 meeting held on 23.10.2007 vide

Case No.785 in the case of M/S Symbiotec Pharmalab Ltd 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 Sl.No. Import items Qty. allowed per

Qty. unit of export produc Hydrocortisone Sodium Succinate 1kg. 1. Hydrocortisone Base EP 1.10kg/kg

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

25

Case No.:13/46/82-ALC4/2007

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/82/050/00567/AM08/
RLA File :04/24/040/00329/AM08/
Lic.No/Date:0410093403 23.01.2008

product Carbamazepine under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/259/2004-PI-III dated 18.03.2008 in the case of M/S Bajaj Healthcare Pvt. Ltd decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export produc Carbamazepine 1kg. 1. Iminostilbene Carbonyl Chloride 1.25kg/kg

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

26

Case No.:10/46/82-ALC4/2007 Party Name:J.B. CHEMICALS &

PHARMACEUTICALS LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00564/AM08/
RLA File :03/94/040/01050/AM08/
Lic.No/Date:0310459136 25.01.2008 Defer Date:29.04.2008 product Bio-Kanamycin Injection 1GM/3ml vial under para 4.7 of HBP.

Committee decided to call for a copy of application alongwith copy of Advance Authorisation from RA/firm. Accordingly, case was deferred for six weeks.

27

Case No.:22/46/82-ALC4/2007

Party Name:LUPIN LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/82/050/00576/AM08/
RLA File :03/95/040/01097/AM08/
Lic.No/Date:0310460267 06.02.2008

product Ethambutol Hcl under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/107/2006-PI-III dated 11.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower.

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Ethambutol Hcl 1kg 1. DL-2 Aminobutanol 1.6014kg/kg 2. Tartaric Acid 0.1977kg/kg 3. Methanol 0.5620kg/kg 4. Iso Propyl Alcohol 0.3436kg/kg 5. Ethylene dichloride 0.490kg/kg 6. Caustic Soda Flakes 0.4264kg/kg 7. Cyclohexane 0.0056kg/kg 8. Calcium Hydroxide 2.4525kg/kg

28

Case No.:38/46/82-ALC4/2007 Party Name:TTK LIG LIMITED

Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00592/AM08/
RLA File :04/24/040/00351/AM08/
Lic.No/Date:0410093705 07.02.2008 Defer Date:29.04.2008 product Durex Play Longer-1.0 oz (28.4g) Active Ingredient Benzocaine under para 4.7 of HBP.

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

29

Case No.:36/46/82-ALC4/2007 Party Name:YASHO INDUSTRIES

PVT.LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00590/AM08/
RLA File :03/95/040/01115/AM08/
Lic.No/Date:0310460684 12.02.2008 Defer Date:15.04.2008 product 4&5-Methyl Mercapto Benzimidazole under para 4.7 of HBP.

30

Case No.:33/46/82-ALC4/2007 Party Name:WANBURY

LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00587/AM08/
RLA File :03/95/040/00967/AM08/
Lic.No/Date:0310460760 13.02.2008 Defer Date:15.04.2008 product Metformin Hcl DC Granules 86.6% under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

31

Case No.:17/46/82-ALC4/2007 Party Name:ARCH PHARMALABS

LTD Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00571/AM08/
RLA File :03/94/040/01117/AM08/
Lic.No/Date:0310461019 14.02.2008 Defer Date:29.04.2008 product Montelukast Sodium under para 4.7 of HBP.

32

Case No.:27/46/82-ALC4/2007 Party Name:RELIANCE

INDUSTRIES LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00581/AM08/
RLA File :03/95/040/01105/AM08/
Lic.No/Date:0310460988 14.02.2008 Defer Date:29.04.2008 product Propylene under para 4.7 of HBP.

Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for their comments. Accordingly, case was deferred for Six weeks.

33

Case No.:28/46/82-ALC4/2007 Party Name:SANJAY SALES

CORPORATION Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00582/AM08/
RLA File :03/95/040/01060/AM08/
Lic.No/Date:0310461133 14.02.2008 Defer Date:15.04.2008 product Sodium Salicynate under para 4.7 of HBP.

34

Case No.:16/46/82-ALC4/2007 Party Name:FINE ORGANIC

INDUSTRIES(MUMBAI) PVT. LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00570/AM08/
RLA File :03/94/040/01154/AM08/
Lic.No/Date:0310461283 15.02.2008 Defer Date:29.04.2008 product Ethylene Glycol Stearate under para 4.7 of HBP.

Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for their comments. Accordingly, case was deferred for six weeks.

35

Case No.:7/46/82-ALC4/2007

Party Name:LAFFANS PETROCHEMICALS LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00561/AM08/
RLA File :03/95/040/01122/AM08/
Lic.No/Date:0310461500 18.02.2008 Defer Date:29.04.2008 product Laffsolve MEB (Ethylene Glycol Mono Butyl (Ether) under para 4.7 of HBP.

Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for their comments. Accordingly, case was deferred for six weeks.

36

Case No.:23/46/82-ALC4/2007 Party Name:DELTA FINOCHEM

PVT.LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00577/AM08/
RLA File :03/94/040/01107/AM08/
Lic.No/Date:0310461418 18.02.2008 Defer Date:15.04.2008 product Ethyl Triphenyl Phosphonium Bromide under para 4.7 of HBP.

37

Case No.:24/46/82-ALC4/2007 Party Name:DELTA FINOCHEM

PVT.LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00578/AM08/
RLA File :03/94/040/00951/AM08/
Lic.No/Date:0310461427 18.02.2008 Defer Date:15.04.2008 product Ethyl Tri Phenyl Phosphonium Bromide under para 4.7 of HBP.

38

Case No.:25/46/82-ALC4/2007 Party Name:SARNA CHEMICALS

PVT.LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00579/AM08/
RLA File :03/95/040/01123/AM08/
Lic.No/Date:0310461411 18.02.2008 Defer Date:15.04.2008 product N-Hydroxy Methyl-chloro acetamide under para 4.7 of HBP.

39

Case No.:26/46/82-ALC4/2007 Party Name:SCITECH

SPECIALITIES PVT. LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00580/AM08/
RLA File :03/95/040/01130/AM08/
Lic.No/Date:0310461460 18.02.2008 Defer Date:29.04.2008 product Cevamune Tablets Chlorine Neutralzer under para 4.7 of HBP.

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

40

Case No.:29/46/82-ALC4/2007 Party Name:DELTA FINOCHEM

PVT.LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00583/AM08/
RLA File :03/94/040/00950/AM08/
Lic.No/Date:0310461422 18.02.2008 Defer Date:15.04.2008 product Ethyl Tri Phenyl Phosphonium Bromide under para 4.7 of HBP.

41

Case No.:6/46/82-ALC4/2007

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00560/AM08/
RLA File :03/95/040/01119/AM08/
Lic.No/Date:0310461636 19.02.2008 Defer Date:15.04.2008

product Amino Benzo Trifluoride (ortho)/Ortho amino Benzo Trifluoride under para 4.7 of HBP.

42

Case No.:18/46/82-ALC4/2007 Party Name:GITANJALI

CHEMICALS PVT LTD Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00572/AM08/
RLA File :03/94/040/01120/AM08/
Lic.No/Date:0310461653 19.02.2008 Defer Date:15.04.2008 product 2-Methyl Anisole under para 4.7 of HBP.

43

Case No.:30/46/82-ALC4/2007 Party Name:SPAK ORGOCHEM

(INDIA) PVT. LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00584/AM08/
RLA File :03/95/040/01127/AM08/
Lic.No/Date:0310461638 19.02.2008 Defer Date:15.04.2008 product Sorbitan Mono Oleate under para 4.7 of HBP.

44

Case No.:4/46/82-ALC4/2007

Party Name:INDO GERMAN ALKALOIDS Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/82/050/00558/AM08/
RLA File :03/94/040/01122/AM08/
Lic.No/Date:0310461784 20.02.2008

product Podophyllum Resin BP/USP under para 4.7 of HBP.

Committee in light of its earlier decision taken in its 2/82 meeting held on 16.05.2007 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower.

Export product Export Qty. Sl.No. Import items Qty. allowed

per unit of export product Podophyllum Resin 1kg 1. Poduphyllum root (Podophyllum Resin 5+10%) 19.71kg/kg

45

Case No.:8/46/82-ALC4/2007

Party Name:LAFFANS PETROCHEMICALS LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00562/AM08/
RLA File :03/95/040/00733/AM08/
Lic.No/Date:0310461861 20.02.2008 Defer Date:29.04.2008 product Laffsolve EG under para 4.7 of HBP.

Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for their comments. Accordingly, case was deferred for six weeks.

46

Case No.:15/46/82-ALC4/2007

Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/82/050/00569/AM08/
RLA File :03/94/040/01116/AM08/
Lic.No/Date:0310461787 20.02.2008

product Amiodarone Hcl under para 4.7 of HBP.

Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/102/2006-PI-III dated 18.04.2007 decided to ratify norms on repeat basis under

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

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Amiodarone Hcl 1kg 1. 2-Butyl-3-(3,5-Diiodo-4- Hydroxybenzoyl) Benzofuran 1.04kg/kg 2. Iso Propyl Alcohol 0.75kg/kg 3. Toluene 1.95kg/kg

47

Case No.:37/46/82-ALC4/2007 Party Name:SHASUN

CHEMICALS & DRUGS LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00591/AM08/
RLA File :04/24/040/00376/AM08/
Lic.No/Date:0410093956 21.02.2008 Defer Date:15.04.2008 product 1,4-Dithia 7-Azaspiro (4,4) Nonane-8(S)-Carboxylicacid Hydrobromide (Proti Br)under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

48

Case No.:3/46/82-ALC4/2007

Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00557/AM08/
RLA File :03/94/040/01161/AM08/
Lic.No/Date:0310462185 22.02.2008 Defer Date:29.04.2008 product Bio-Cimetidine 200mg Tablets (Pack of 150) under para 4.7 of HBP.

Committee decided to call for a copy of application alongwith copy of Advance Authorisation from RA/firm. Accordingly, case was deferred for six weeks.

49

Case No.:14/46/82-ALC4/2007 Party Name:CENTAUR

CHEMICALS PVT. LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00568/AM08/
RLA File :03/94/040/01193/AM08/
Lic.No/Date:0310462282 22.02.2008 Defer Date:15.04.2008 product Rivastigmine Hydrogen Tartrate under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of PI Division.

50

Case No.:19/46/82-ALC4/2007 Party Name:CIPLA LIMITED

Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00573/AM08/
RLA File :03/94/040/01202/AM08/
Lic.No/Date:0310462533 25.02.2008 Defer Date:29.04.2008 product Stavir 15mg, 20mg, 30mg, 40mg Capsules, Lamivir S30 and S-40 tablets under para 4.7 of HBP.

51

Case No.:20/46/82-ALC4/2007 Party Name:AMINES &

PLASTICIZERS LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00574/AM08/
RLA File :03/94/040/01195/AM08/
Lic.No/Date:0310462526 25.02.2008 Defer Date:15.04.2008 product 2-Piperidinoethanol under para 4.7 of HBP.

52

Case No.:21/46/82-ALC4/2007

Party Name:CIPLA LIMITED Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Approved HQ File :01/82/050/00575/AM08/
RLA File :03/94/040/01199/AM08/
Lic.No/Date:0310462759 26.02.2008

product Gentadox Powder 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 12.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:-

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Gentadox Powder 100gm gm pack 5000 Nos. 1 pack of 100gram 1. Gentamycin sulphate 10.1gm/100gm pack 2. Doxycycline Hcl 10.1gm/100gm pack

53

Case No.:31/46/82-ALC4/2007 Party Name:YASHO INDUSTRIES

PVT.LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00585/AM08/
RLA File :03/95/040/01141/AM08/
Lic.No/Date:0310462797 26.02.2008 Defer Date:15.04.2008 product Yantq 2020 (20% Solution of Tertiary Butyl Hydroquinone under para 4.7 of HBP.

54

Case No.:34/46/82-ALC4/2007 Party Name:YASHO INDUSTRIES

PVT.LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00588/AM08/
RLA File :03/95/040/01140/AM08/
Lic.No/Date:0310462556 26.02.2008 Defer Date:15.04.2008 product Zinc Salt of 4-And-5 Methyl Mercaptobenzimidazole (Qureantizmmb) under para 4.7 of HBP.

55

Case No.:35/46/82-ALC4/2007 Party Name:YASHO INDUSTRIES

PVT.LTD. Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00589/AM08/
RLA File :03/95/040/01138/AM08/
Lic.No/Date:0310462555 26.02.2008 Defer Date:15.04.2008 product Octylated Diphenylamine (OCD Powder/Flakes)under para 4.7 of HBP.

56

Case No.:32/46/82-ALC4/2007 Party Name:DUJODWALA PAPER

CHEMICALS LTD Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00586/AM08/
RLA File :03/94/040/01210/AM08/
Lic.No/Date:0310462982 27.02.2008 Defer Date:29.04.2008 product Polyamide Resin under para 4.7 of HBP.

Committee decided to forward a copy of application to Shri A.K. Agarwal, Dy. IA, C&PC for their comments. Accordingly, case was deferred for six weeks.

57

Case No.:39/46/82-ALC4/2007 Party Name:SHIVA

PHARMACHEM PVT. LTD, Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00593/AM08/
RLA File :34/24/040/00232/AM08/
Lic.No/Date:3410020968 03.03.2008 Defer Date:15.04.2008

product Isophthaloyl chloride under para 4.7 of HBP.

58

Case No.:1/46/82-ALC4/2007

Party Name:SKYLEAD CHEMICALS LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00555/AM08/
RLA File :24/80/040/00009/AM08/
Lic.No/Date:2410020710 05.03.2008 Defer Date:15.04.2008 product 40Amino Pyridine under para 4.7 of HBP.

59

Case No.:2/46/82-ALC4/2007

Party Name:KUDOES CHEMIE LTD., Meet No/Date:46/82- ALC4/2007 18.03.2008 Status:Case Deferred HQ File :01/82/050/00556/AM08/
RLA File :22/24/040/00076/AM08/
Lic.No/Date:2210007544 10.03.2008 Defer Date:15.04.2008 product under para 4.7 of HBP.

Committee decided to call for a copy of application alongwith a copy of Advance Authorisation from RA/firm. Accordingly, case was deferred for four weeks.

Date:18.03.2008 Place:New Delhi
Shyam Lal
Foreign Trade Development Officer

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