IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2009-09-02

DGFT Committee Minutes

Reliability

IN FORCE

In force — no superseding record on file.

Issuer: DGFT
Type: Committee Minutes
Committee / bench: Norms Committee — Pharmaceuticals (NC-III)
Date: 2009-09-02
Topic: Advance Authorisation
Official copy: Download source PDF ↗

Referenced in this document

Tariff

Chapter 29 Organic chemicals

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Chapter 30 Pharmaceutical products

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Policy

Para 4.7 ×4
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Amended 6× , last 2010-07-22.

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Para 4.7.1 ×2
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Parties

Aurobindo Pharma
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Lupin Ltd.
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Shirdi Chemicals
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SPC Life Sciences Pvt. Ltd.
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Document text

Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision

MEETING NUMBER : 20/82‐ALC4/2009 MEETING DATE : 11.08.2009 The Meeting No.20/82 in the year 200910 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200409 pertaining to products falling in Chapter 29 and 30 scheduled to be held on 11.08.2009 was actually held on 02.09.2009 under the Chairmanship of Jt. DGFT, Shri Anil Aggarwal in his chamber. Following members were present: 1. Shri Shaish Kumar, IA, DIPP 2. Shri D.N. Mathur, Dy. IA, Department of Pharmaceuticals 3. Shri Rajinder Pal Singh, Dy. DGFT 4. Shri Shyam Lal, FTDO

Case No. B‐229

M/s SPC Life Sciences Pvt. Ltd. Norms Commiោ�ee Mee៝�ng No. 20/10 File No. 01/83/050/00091/AM07 Mee៝�ng Date 04.08.2009 RAF No. 34/24/040/00020/AM07 Adv. Lic. No. 3410015935 dated 25.04.2006 Committee decided to defer case for 29.09.2009 for comments of Department of Pharmaceuticals.

Case No. B‐230

M/s Shirdi Chemicals Pvt. Ltd. Norms Commiោ�ee Mee៝�ng No. 20/10 File No. 01/83/050/00687/AM07 Mee៝�ng Date 04.08.2009 RAF No. 03/95/040/00639/AM07 Adv. Lic. No. 0310400054 dated 19.09.2006 Committee decided to defer case for 29.09.2009 for comments of Department of Pharmaceuticals.

Case No. B‐231

M/s Lupin Ltd. Norms Commiោ�ee Mee៝�ng No. 20/10 File No. 01/82/050/01721/AM07 Mee៝�ng Date 04.08.2009 RAF No. 03/95/040/01297/AM07 Adv. Lic. No. 0310416716 dated 22.01.2007 Committee decided to defer case for 29.09.2009 for comments of Department of Pharmaceuticals.

Case No. C‐12

M/s Aurobindo Pharma Ltd. Norms Commiោ�ee Mee៝�ng No. 20/10 File No. 01/82/162/00881/AM08 Mee៝�ng Date 04.08.2009 RAF No. 34/24/040/00020/AM07 Committee considered case as per agenda and observed that the firm has submitted application for fixation of

SION for the export product “Piperacillin Sodium Strile and Tazobactam Sodium Strile (8:1) or Premix of Tazobactam Sodium plus Piperacillin Sodium (1:8) Sterile”, while the SION for Piperacillin Sodium Strile and Tazobactam Sodium Sterile have not been fixed. It was, therefore, decided to advise the firm to furnish application first through Pharmexcil alongwith All Industry data for fixation of SION for the bulk drug “Piperacillin Sodium Strile” and “Tazobactam Sodium Sterile” separately. 1

Case No.:23/48/83‐ALC1/2008

Party Name:PRACHI PHARMACEUTICALS PVT LTD Meet No/Date:20/82‐ALC4/2009 11.08.2009 Status:Case Deferred HQ File :01/83/050/01292/AM09/ RLA File :03/95/040/00317/AM09/ Lic.No/Date:0310507250 16.02.2009 Defer Date:29.09.2009 Decision :Commiោ�ee decided to defer case for 29.09.2009 for comments of Department of Pharmaceu៝�cals. 2

Case No.:4/51/82‐ALC4/2008

Party Name:MERIT HEALTHCARE PVT. LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/01690/AM09/ RLA File :03/95/040/00909/AM09/ Lic.No/Date:0310509173 25.02.2009 Defer Date:29.09.2009 Decision : Commiោ�ee decided to defer case for 29.09.2009 for comments of Department of Pharmaceu៝�cals. 3

Case No.:17/1/83‐ALC1/2009

Party Name:PRACHI PHARMACEUTICALS PVT LTD 11.08.2009 Status:Case Deferred HQ File :01/83/050/01355/AM09/ RLA File :03/95/040/00906/AM09/ Lic.No/Date:0310510030 03.03.2009 Defer Date:29.09.2009 4

Case No.:19/14/82‐ALC4/2009

Party Name:HETERO DRUGS LIMITED, 11.08.2009 Status:Case Deferred HQ File :01/82/050/00189/AM10/ RLA File :09/24/040/00447/AM09/ Lic.No/Date:0910037377 16.03.2009 Defer Date:29.09.2009 5

Case No.:22/14/82‐ALC4/2009

Party Name:INTAS PHARMACEUTICALS LTD., 11.08.2009 Status:Case Deferred HQ File :01/82/050/00192/AM10/ RLA File :08/24/040/00007/AM10/ Lic.No/Date:0810079232 09.04.2009 Defer Date:29.09.2009

Case No.:1/14/82‐ALC4/2009

Party Name:MAKSON INDUSTRIES PVT. LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00171/AM10/ RLA File :03/95/040/01025/AM09/ Lic.No/Date:0310515322 13.04.2009 Defer Date:29.09.2009 Decision : Commiោ�ee decided to defer case for 29.09.2009 for comments of DC(NSME). 7

Case No.:33/14/82‐ALC4/2009

Party Name:RAY CHEMICALS PRIVATE LIMITED, 11.08.2009 Status:Case Deferred HQ File :01/82/050/00203/AM10/ RLA File :07/24/040/00003/AM10/ Lic.No/Date:0710064266 20.04.2009 Defer Date:29.09.09 8

Case No.:34/14/82‐ALC4/2009

Party Name:R L FINE CHEM 11.08.2009 Status:Case Deferred HQ File :01/82/050/00204/AM10/ RLA File :07/24/040/00007/AM10/ Lic.No/Date:0710064267 20.04.2009 Defer Date:29.09.2009 9

Case No.:9/14/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD 11.08.2009 Status:Case Deferred HQ File :01/82/050/00179/AM10/ RLA File :09/24/040/00466/AM09/ Lic.No/Date:0910037701 20.04.2009 Defer Date:29.09.2009 10

Case No.:10/14/82‐ALC4/2009

Party Name:RELIANCE INDUSTRIES LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00180/AM10/ RLA File :03/95/040/00038/AM10/ Lic.No/Date:0310516853 24.04.2009 Defer Date:29.09.2009 Decision : Commiោ�ee decided to defer case for 29.09.2009 for comments of Department of C&PC. 11

Case No.:21/14/82‐ALC4/2009

Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00191/AM10/ RLA File :31/24/040/00019/AM10/ Lic.No/Date:3110038255 28.04.2009 Defer Date:29.09.2009

Case No.:5/14/82‐ALC4/2009

Party Name:UNIMARK REMEDIES LIMITED., 11.08.2009 Status:Case Approved HQ File :01/82/050/00175/AM10/ RLA File :03/95/040/01329/AM07/ Lic.No/Date:0310517616 28.04.2009 Decision : Commiោ�ee considered case as per agenda and in light of earlier decision taken in 41/82 mee៝�ng held on 06.01.2009 and in consulta៝�on with technical authority present in mee៝�ng, decided to ra៝�fy 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 Nemesulide 1kg. 1. Ortho Nitro Chloro Benzene 0.92 kg 2. Phenol 0.55 kg 3. Methane Sulfonyl Chloride 0.52 kg 4. Pyridine 0.19 kg 5. Methylene Dichloride 2.29 kg RA concerned may take further necessary ac៝�on as per above decision of NC. 13

Case No.:11/14/82‐ALC4/2009

Party Name:UNIMARK REMEDIES LIMITED., 11.08.2009 Status:Case Deferred HQ File :01/82/050/00181/AM10/ RLA File :03/95/040/00212/AM08/ Lic.No/Date:0310518138 04.05.2009 Defer Date:29.09.2009 14

Case No.:35/14/82‐ALC4/2009

Party Name:R L FINE CHEM 11.08.2009 Status:Case Deferred HQ File :01/82/050/00205/AM10/ RLA File :07/24/040/00031/AM10/ Lic.No/Date:0710064493 04.05.2009 Defer Date:29.09.2009 15

Case No.:8/14/82‐ALC4/2009

Party Name:RATNAGIRI CHEMICALS PVT. LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00178/AM10/ RLA File :03/95/040/00061/AM10/ Lic.No/Date:0310518497 05.05.2009 Defer Date:29.09.2009 16

Case No.:36/14/82‐ALC4/2009

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 11.08.2009 Status:Case Deferred

HQ File :01/82/050/00206/AM10/ RLA File :07/24/040/00050/AM10/ Lic.No/Date:0710064616 07.05.2009 Defer Date:29.09.2009 17

Case No.:37/14/82‐ALC4/2009

Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:20/82‐ALC4/2009 11.08.2009 Status:Case Approved HQ File :01/82/050/00207/AM10/ RLA File :07/24/040/00019/AM10/ Lic.No/Date:0710064597 07.05.2009 Decision : Commiោ�ee decided to close the case as Advance Authorisa៝�on has been issued under para 4.7.1 of HBP. 18

Case No.:26/14/82‐ALC4/2009

Party Name:DSM ANTI‐INFECTIVES INDIA LTD 11.08.2009 Status:Case Deferred HQ File :01/82/050/00196/AM10/ RLA File :22/24/040/00003/AM10/ Lic.No/Date:2210008912 11.05.2009 Defer Date:29.09.2009 19

Case No.:12/14/82‐ALC4/2009

Party Name:TORRENT PHARMACEUTICALS LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00182/AM10/ RLA File :08/24/040/00028/AM10/ Lic.No/Date:0810079929 12.05.2009 Defer Date:29.09.2009 20

Case No.:13/14/82‐ALC4/2009

Party Name:AUROBINDO PHARMA LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00183/AM10/ RLA File :09/24/040/00003/AM10/ Lic.No/Date:0910037902 13.05.2009 Defer Date:29.09.2009 21

Case No.:14/14/82‐ALC4/2009

Party Name:AUROBINDO PHARMA LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00184/AM10/ RLA File :09/24/040/00026/AM10/ Lic.No/Date:0910037901 13.05.2009 Defer Date:29.09.2009 22

Case No.:16/14/82‐ALC4/2009

Party Name:HETERO LABS LTD. 11.08.2009 Status:Case

Deferred HQ File :01/82/050/00186/AM10/ RLA File :09/24/040/00050/AM10/ Lic.No/Date:0910037893 13.05.2009 Defer Date:29.09.2009 23

Case No.:17/14/82‐ALC4/2009

Party Name:HETERO LABS LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00187/AM10/ RLA File :09/24/040/00049/AM10/ Lic.No/Date:0910037892 13.05.2009 Defer Date:29.09.2009 24

Case No.:18/14/82‐ALC4/2009

Party Name:HETERO DRUGS LIMITED, 11.08.2009 Status:Case Deferred HQ File :01/82/050/00188/AM10/ RLA File :09/24/040/00047/AM10/ Lic.No/Date:0910037891 13.05.2009 Defer Date:29.09.2009 25

Case No.:23/14/82‐ALC4/2009

Party Name:MANTENA LABORATORIES LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00193/AM10/ RLA File :09/24/040/00019/AM10/ Lic.No/Date:0910037904 13.05.2009 Defer Date:29.09.2009 26

Case No.:27/14/82‐ALC4/2009

Party Name:SURYA PHARMACEUTICAL LTD 11.08.2009 Status:Case Deferred HQ File :01/82/050/00197/AM10/ RLA File :22/24/040/00009/AM10/ Lic.No/Date:2210008926 19.05.2009 Defer Date:29.09.2009 27

Case No.:3/14/82‐ALC4/2009

Party Name:HETERO DRUGS LIMITED, 11.08.2009 Status:Case Deferred HQ File :01/82/050/00173/AM10/ RLA File :09/24/040/00052/AM10/ Lic.No/Date:0910037939 19.05.2009 Defer Date:29.09.2009 28

Case No.:15/14/82‐ALC4/2009

Party Name:AUROBINDO PHARMA LIMITED Status:Case

11.08.2009 Deferred HQ File :01/82/050/00185/AM10/ RLA File :09/24/040/00039/AM10/ Lic.No/Date:0910037981 21.05.2009 Defer Date:29.09.2009 29

Case No.:4/14/82‐ALC4/2009

Party Name:MSN PHARMACHEM PRIVATE LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00174/AM10/ RLA File :09/24/040/00054/AM10/ Lic.No/Date:0910037983 21.05.2009 Defer Date:29.09.2009 30

Case No.:38/14/82‐ALC4/2009

Party Name:GLENMARK GENERICS LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00208/AM10/ RLA File :03/94/040/00174/AM10/ Lic.No/Date:0310523789 12.06.2009 Defer Date:29.09.2009 31

Case No.:39/14/82‐ALC4/2009

Party Name:BAYER CROPSCIENCE LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00209/AM10/ RLA File :03/94/040/00190/AM10/ Lic.No/Date:0310523818 12.06.2009 Defer Date:29.09.2009 32

Case No.:42/14/82‐ALC4/2009

Party Name:LUPIN LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00212/AM10/ RLA File :03/95/040/00128/AM10/ Lic.No/Date:0310524133 15.06.2009 Defer Date:29.09.2009 33

Case No.:47/14/82‐ALC4/2009

Party Name:NEON LABORATORIES LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00217/AM10/ RLA File :03/95/040/00165/AM10/ Lic.No/Date:0310524407 16.06.2009 Defer Date:29.09.2009

Case No.:48/14/82‐ALC4/2009

Party Name:NEULAND LABORATORIES LTD 11.08.2009 Status:Case Deferred HQ File :01/82/050/00218/AM10/ RLA File :09/24/040/00077/AM10/ Lic.No/Date:0910038258 17.06.2009 Defer Date:29.09.2009 35

Case No.:1/20/82‐ALC4/2009

Party Name:ATUL LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00412/AM10/ RLA File :08/24/040/00102/AM10/ Lic.No/Date:0810081939 31.07.2009 Defer Date:29.09.2009 36

Case No.:2/20/82‐ALC4/2009

Party Name:GUJARAT ORGANICS LTD., 11.08.2009 Status:Case Deferred HQ File :01/82/050/00413/AM10/ RLA File :03/94/040/00364/AM10/ Lic.No/Date:0310531735 31.07.2009 Defer Date:29.09.2009 37

Case No.:3/20/82‐ALC4/2009

Party Name:AGIO PHARMACEUTICALS LTD 11.08.2009 Status:Case Deferred HQ File :01/82/050/00414/AM10/ RLA File :03/94/040/00154/AM10/ Lic.No/Date:0310531742 31.07.2009 Defer Date:29.09.2009 38

Case No.:4/20/82‐ALC4/2009

Party Name:AGIO PHARMACEUTICALS LTD 11.08.2009 Status:Case Deferred HQ File :01/82/050/00415/AM10/ RLA File :03/94/040/00186/AM10/ Lic.No/Date:0310531751 31.07.2009 Defer Date:29.09.2009 39

Case No.:5/20/82‐ALC4/2009

Party Name:MEDREICH LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00416/AM10/ RLA File :07/24/040/00170/AM10/ Lic.No/Date:0710066306 03.08.2009 Defer Date:29.09.2009

Case No.:6/20/82‐ALC4/2009

Party Name:SARNA CHEMICALS PVT.LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00417/AM10/ RLA File :03/95/040/00244/AM10/ Lic.No/Date:0310531923 03.08.2009 Defer Date:29.09.2009 41

Case No.:7/20/82‐ALC4/2009

Party Name:AVENTIS PHARMA LIMITED 11.08.2009 Status:Case Approved HQ File :01/82/050/00418/AM10/ RLA File :03/94/040/00321/AM10/ Lic.No/Date:0310532006 03.08.2009 Decision :Commiោ�ee decided to close the case as Advance Authorisa៝�on has been issued under para 4.7.1 of HBP. 42

Case No.:8/20/82‐ALC4/2009

Party Name:CIPLA LIMITED 11.08.2009 Status:Case Approved HQ File :01/82/050/00419/AM10/ RLA File :03/94/040/00385/AM10/ Lic.No/Date:0310532040 04.08.2009 Decision : Commiោ�ee considered case as per agenda and in light of its earlier decision taken in its 6/82 mee៝�ng held on 12.05.2009 and in consulta៝�on with technical authority present in mee៝�ng, decided to ra៝�fy 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 GCS Dog (Powder) 1 Pack of 150 gram 1. Glucosamine Hcl 82.635gm/pack 2. Sodium Chondro៝�n sulphate 27.54gm/pack 3. Manganese sulphate 0.732gm/pack 4. Ascorbic acid (calcium ascorbate) 4.776gm/pack GCS Dog Powder 1 pack of 500 gram 1. Glucosamine Hcl 0.2754 kg/pack 2. Sodium Chondro៝�n Sulphate 0.0918 kg/pack 3. Manganese Sulphate 0.00244 kg/pack 4. Ascorbic acid (calcium ascorbate 0.01592 kg/pack GCS Dog Powder 1 Pack of 4.54 kgs 1. Glucosamine Hcl 2.501 kg/pack 2. Sodium Chondro៝�n Sulphate 0.833 kg/pack 3. Manganese Sulphate 0.022 kg/pack 4. Ascorbic acid (calcium ascorbate 0.144 kg/pack RA concerned may take further necessary ac៝�on as per above decision of NC.

Case No.:10/20/82‐ALC4/2009

Party Name:AMBUJA INTERMEDIATES LIMITED 11.08.2009 Status:Case Deferred HQ File :01/82/050/00421/AM10/ RLA File :03/94/040/00386/AM10/ Lic.No/Date:0310532467 05.08.2009 Defer Date:29.09.2009 44

Case No.:9/20/82‐ALC4/2009

Party Name:VITAL HEALTHCARE PVT.LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00420/AM10/ RLA File :03/95/040/01036/AM09/ Lic.No/Date:0310532437 05.08.2009 Defer Date:29.09.2009 45

Case No.:11/20/82‐ALC4/2009

Party Name:NEULAND LABORATORIES LTD 11.08.2009 Status:Case Deferred HQ File :01/82/050/00422/AM10/ RLA File :09/24/040/00144/AM10/ Lic.No/Date:0910038818 06.08.2009 Defer Date:29.09.2009 46

Case No.:12/20/82‐ALC4/2009

Party Name:SOLVAY SPECIALITIES INDIA PVT.LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00423/AM10/ RLA File :03/95/040/00241/AM10/ Lic.No/Date:0310532546 06.08.2009 Defer Date:29.09.2009 47

Case No.:13/20/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 11.08.2009 Status:Case Deferred HQ File :01/82/050/00424/AM10/ RLA File :03/95/040/00251/AM10/ Lic.No/Date:0310532642 06.08.2009 Defer Date:29.09.2009 48

Case No.:14/20/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 11.08.2009 Status:Case Approved HQ File :01/82/050/00425/AM10/ RLA File :09/24/040/00159/AM10/ Lic.No/Date:0910038841 06.08.2009 Decision : Commiោ�ee considered case as per agenda and in light of wriោ�en comments forwarded by Department of Pharmaceu៝�cals vide their U.O. No.35011/199/2008‐ PI‐III dated 25.02.2009 and in consulta៝�on with technical authority present in mee៝�ng, decided to ra៝�fy norms under para 4.7 of HBP as per details below or as applied by

firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Tetrazol Aldehyde 1 Kg. 1. Orthotoluyl Benzonitrile 0.95 kg 2. 1,3‐Dibromo 5,5‐Dimethyl Hydantoin 0.57 kg 3. 2‐N‐Butyl‐4‐Chloro‐5‐formyl imidazole 0.62 kg 4. Tributyl Tin Chloride 1.65 kg 5. Methyl Isobutyl Ketone 1.43 kg 6. Acetonitrile 1.43 kg 7. Azobis Isobutyronitrile 0.076 kg RA concerned may take further necessary ac៝�on as per above decision of NC. 49

Case No.:15/20/82‐ALC4/2009

Party Name:AQUAPHARM CHEMICALS PVT.LIMITED Meet No/Date:20/82‐ALC4/2009 11.08.2009 Status:Case Deferred HQ File :01/82/050/00426/AM10/ RLA File :31/24/040/00068/AM10/ Lic.No/Date:3110039516 06.08.2009 Defer Date:29.09.2009 50

Case No.:16/20/82‐ALC4/2009

Party Name:PANACEA BIOTEC LTD., 11.08.2009 Status:Case Deferred HQ File :01/82/050/00427/AM10/ RLA File :05/24/040/00262/AM10/ Lic.No/Date:0510247323 06.08.2009 Defer Date:29.09.2009 Decision : Commiោ�ee decided to defer case for 29.09.2009 for comments of Department of Bio‐technology. *******************************************

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