IN FORCE Norms Committee — Engineering (Gr B / NC-I) Advance Authorisation 2008-04-08

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 : 2/82‐ALC4/2008 MEETING DATE : 08.04.2008 The Meeting No.02/09 in the year 2008‐09 to consider the cases under Duty Exemption Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to products falling in Chapter 29 and 30 was held on 08.04.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi. Following members were present:‐ 1. Shri Jasbir Singh, IA, Chemical Division, C & PC. 2. Shri D.N. Mathur, Dy. IA, PI Division, C & PC. 3. Shri Rajinder Pal Singh, Dy. DGFT. 4. Shri Shyam Lal, FTDO At the outset minutes of Norms Committee Meeting No.47/08 dated 25.03.2008 and 01/09 meeting held on 01.04.2008 were ratified by the Committee.

Case No.B‐5

M/S Madaus Pharma Pvt. Ltd. Norms Committee Meeting No.2/09 F.No.01/82/50/201/AM08 Meeting Date:08.04.2008 RLA F.No.17/24/40/68/AM08 Adv.Lic.No.1710001775 dated 09.10.2007 Committee considered case as per agenda for enhancement in the quantity of inputs. Committee observed that norms were ratified in its 37/82 meeting held on 15.01.2008 as per details below:‐ Export product: Agiolax (bulk granules laxative formulation)‐‐‐‐‐‐1kg. Import items: 1. Iron Oxide Red E 172‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.0035kg/kg 2. Iron Oxide Yellow E 172‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.00145kg/kg 3. Iron Oxide Black E 172‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.00169kg/kg 4. Caraway Oil Dab Type III‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.00040kg/kg 5. Sage oil type 90745 Dacl‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.00040kg/kg

6. Peppermint oil‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.00110kg/kg 7. ACACIA‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.01570kg/kg 8. Hard Paraffin‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.00127kg/kg 9. Liquid Paraffin‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.00276kg/kg Representative of PI Division present in meeting informed Committee that revised norms have been given in NC Meeting No.1/82 held on 09.05.2007 (copy of decision enclosed with agenda). Committee, therefore, in consultation with representative of PI Division decided to revise norms 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 Agiolax (bulk granules laxative formulation) 1 Kg. 1. Iron Oxide Red E 172 0.0035 kg/kg 2. Iron Oxide Yellow E 172 0.00145 kg/kg 3. Iron Oxide Black E 172 0.00169 kg/kg 4. Caraway Oil Dab Type III 0.00052 kg/kg 5. Sage oil type 90745 Dacl 0.00052 kg/kg 6. Peppermint oil 0.00110 kg/kg 7. ACACIA 0.01570 kg/kg 8. Hard Paraffin 0.00127 kg/kg 9. Liquid Paraffin 0.00276 kg/kg RA concerned may take further necessary action as per above decision of NC.

Case No.B‐6

M/S Pab Organics Pvt. Ltd. F.No.01/82/50/1256/AM07 RLA F.No.34/24/40/259/AM07 Adv.Lic.No.3410018108 dated 19.02.2007 Committee considered case as per agenda for correction in the quantity of inputs. Committee in light of written corrected comments forwarded by PI Division vide their U.O. No.35011/207/2006‐PI‐III dated 21.01.2008 decided to correct norms ratified in its 35/08 meeting held on 08.01.2008 as per details below:‐

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 5‐Bromo Phthalide 1 Kg. 1. Hydrobromic Acid 48% 3.35 kg/kg 2. 5‐Amino Phthalide 0.87 kg/kg

Case No.B‐7

M/S Pab Organics Pvt. Ltd. F.No.01/82/50/799/AM08 RLA F.No.34/24/40/76/AM08 Adv.Lic.No.3410019236 dated 19.07.2007 Committee considered case as per agenda for enhancement in the quantity of inputs. Committee observed that firm vide their letter dated 07.04.2008 have requested for personal hearing before NC to explain their case. Committee, therefore, decided to grant personal hearing on 13.05.2008. Accordingly, case was deferred.

Case No.B‐8

M/S Om Shree Pharma Pvt. Ltd. F.No.01/83/50/1378/AM07 RLA F.No.03/95/40/1605/AM07 Adv.Lic.No.0310424623 dated 27.03.2007 Committee considered case as per agenda for ratification of norms for export product Iso Sorbide‐5‐Mononitrate under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of PI Division.

Case No.B‐9

M/S Om Shree Pharma Pvt. Ltd. F.No.01/83/50/1267/AM07 RLA F.No.03/95/40/1424/AM07 Adv.Lic.No.0310420407 dated 21.02.2007 Committee considered case as per agenda for ratification of norms for export product Iso Sorbide‐5‐Mononitrate under para 4.7 of HBP.

Case No.B‐10

M/S Om Shree Pharma Pvt. Ltd. F.No.01/83/50/725/AM08 RLA F.No.03/95/40/230/AM08 Adv.Lic.No.03104321412 dated 08.06.2007 Committee considered case as per agenda for ratification of norms for export product Iso Sorbide‐5‐Mononitrate under para 4.7 of HBP.

Case No.B‐11

M/S SMS Pharmaceuticals Ltd F.No.01/83/162/424/AM07 RLA F.No.09/24/40/02/AM06 Adv.Lic.No.0910023407 dated 05.07.2005 Committee considered case as per agenda for revision of norms for export product (D‐ erythro.d‐threo)‐2‐Deoxy‐2,2‐difluoro pentafuramos‐1‐ulose‐3,5 dibenzoate para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/15/2006‐PI‐III dated 24.03.2008 decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (D‐erythro.d‐thero)‐2‐ Deoxy‐2,2‐difluoro pentafuranos‐1‐ulose‐3,5 dibenzoate 1kg. 1. 2,2 Dimethoxy Propane 3.34 kg/kg 2. Dimethyl sulfoxide 1.33 kg/kg 3. Sodium meta peraodate 3.06 kg/kg 4. Tetrahydrofuran 2.50 kg/kg 5. Trimethyl silyl chloride 0.100 kg/kg 6. Ethyl bromo difluoro acetate 1.51 kg/kg 7. Trifluoro acetic acid 0.400 kg/kg 8. Dimethyl amino pyridine 0.125 kg/kg 9. Methylene chloride 3.64 kg/kg

Case No.B‐12

M/S SMS Pharmaceuticals Ltd F.No.01/83/162/425/AM07 RLA F.No.09/24/40/377/AM06 Adv.Lic.No.0910025027 dated 28.11.2005 Committee considered case as per agenda for revision of norms for export product (D‐ erythro.d‐threo)‐2‐Deoxy‐2,2‐difluoro pentafuramos‐1‐ulose‐3,5 dibenzoate para 4.7 of HBP. No.35011/15/2006‐PI‐III dated 24.03.2008 decided to revise norms under para 4.7 of HBP as per Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (D‐erythro.d‐thero)‐2‐ Deoxy‐2,2‐difluoro pentafuranos‐1‐ulose‐3,5 dibenzoate 1kg. 1. 2,2 Dimethoxy Propane 3.34 kg/kg 2. Dimethyl sulfoxide 1.33 kg/kg 3. Sodium meta peraodate 3.06 kg/kg 4. Tetrahydrofuran 2.50 kg/kg

Trimethyl silyl chloride 0.100 kg/kg 6. Ethyl bromo difluoro acetate 1.51 kg/kg 7. Trifluoro acetic acid 0.400 kg/kg 8. Dimethyl amino pyridine 0.125 kg/kg 9. Methylene chloride 3.64 kg/kg

Case No.B‐13

M/S Vasudha Pharma Ltd. F.No.01/83/50/1097/AM07 RLA F.No.09/24/40/209/AM08 Adv.Lic.No.0910031382 dated 03.09.2007 Committee considered case as per agenda for revision of norms for export product Amitriptyline Crude under para 4.7 of HBP. No.35011/94/2007‐PI‐III dated 31.03.2008 decided to revise norms under para 4.7 of HBP as per Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Amitriptyline crude 1 Kg. 1. Pthalic Anhydride 0.823 kg/kg 2. Toluene 1.49 kg/kg 3. Methanol 0.423 kg/kg 4. Phosphorus Pentaoxide 0.396 kg/kg 5. Phosphoric Acid 0.297 kg/kg 6. Tetrahydrofuran 0.477 kg/kg 7. 1‐bromo‐3 chloropropane 0.648 kg/kg 8. Carbon 0.043 kg/kg 9. Methylene di chloride 0.288 kg/kg 10. Acetone 0.072 kg/kg

Case No.B‐14

M/S Vasudha Pharma Ltd. F.No.01/83/50/1098/AM08 RLA F.No.09/24/40/226/AM08 Adv.Lic.No.0910031383 dated 03.09.2007 Committee considered case as per agenda for revision of norms for export product Dibenzosuberone para 4.7 of HBP. No.35011/94/2007‐PI‐III dated 31.03.2008 decided to revise norms under para 4.7 of HBP as per Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Dibenzosuberone 1 Kg. 1. Pthalic Anhydride 1.17 kg/kg 2. Methanol 0.627 kg/kg 3. Toluene 0.503 kg/kg 4. Phosphorus Pentaoxide 0.758 kg/kg 5. Phosphoric Acid 0.523 kg/kg 6. Tetrahydrofuran 0.250 kg/kg

Case No.B‐15

M/S Smilax Laboratories Ltd. F.No.01/83/50/1203/AM07 RLA F.No.09/24/40/466/AM07 Adv.Lic.No.0910029229 dated 07.02.2007

Committee considered case as per agenda for ratification of norms for export product 5‐ Methoxy‐2‐((4‐Methoxy‐3,5‐Dimethyl‐2Pyridinyl) Methyl] Thio‐iH‐BenzimidaZole under para 4.7 of HBP. No.35011/97/2007‐PI‐III dated 31.03.2008 decided to ratify norms under para 4.7 of HBP as per Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 5‐[[4‐Methoxy‐ 3,5‐Dimethyl‐2 pyridinyl] methyl]thio‐iH‐ Benzimidazole (Omeprazole sulphide) 1 Kg. 1. 3,5 Lutidine 1.456 kg/kg 2. Hydrogen peroxide 1.26 kg/kg 3. Methanol 2.16 kg/kg 4. Ammonium Persulphate 2.00 kg/kg 5. 2‐Mercapto‐5‐Methoxy Benzimidazole 0.70 kg/kg 6. Thionyl chloride 0.75 kg/kg 7. Toluene 3.45 kg/kg

Case No.B‐16

M/S Smilax Laboratories Ltd. F.No.01/82/50/10/AM08 RLA F.No.09/24/40/555/AM07 Adv.Lic.No.0910029933 dated 10.01.2007 Committee considered case as per agenda for ratification of norms for export product 2‐ Chloro methyl‐3‐methyl‐4‐(2,2,2‐trifluoro ethoxy) pyridine Hcl (Lansoprazole‐Chloro intermediate) under para 4.7 of HBP. No.35011/97/2007‐PI‐III dated 31.03.2008 decided to ratify norms under para 4.7 of HBP as per

Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2‐chloro methyl‐ 3‐methyl‐4‐(2,2,2‐ trifluoro ethoxy)pyridine Hcl (Lansoprazole‐ chloro intermediate) 1 Kg. 1. 2,3‐Lutidine 0.79 kg/kg 2. Hydrogen Peroxide 1.25 kg/kg 3. Methylene Dichloride 1.68 kg/kg 4. Isopropyl alcohol 0.18 kg/kg 5. 2,2,2 Trifluoro Ethanol 0.936 kg/kg 6. Potassium Carbonate 0.96 kg/kg 7. Methyl Isobutyl Keton 0.38 kg/kg 8. Toluene 0.80 kg/kg

Case No.B‐17

M/S Shalina Laboratories Pvt. Ltd. F.No.01/82/50/146/AM08 RLA F.No.03/95/40/277/AM08 Adv.Lic.No.0310437531 dated 26.07.2007 Committee considered case as per agenda for revision of norms for export product Epiderm Lotion 30ml under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that quantity of inputs has already been allowed correctly and hence there is no scope for enhancement in the quantity of inputs. Committee, accordingly decided to maintain status quo.

Case No.B‐18

M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/50/1484/AM06 RLA F.No.03/94/40/1347/AM06 Adv.Lic.No.0310372003 dated 17.03.2006

Committee considered case as per agenda for ratification of norms for export product Cilazapril under para 4.7 of HBP.

Case No.B‐19

M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/162/285/AM08 RLA F.No.03/24/40/1485/AM05 Adv.Lic.No.0310295800 dated 07.10.2004 Committee considered case as per agenda for ratification of norms for export product Cilazapril under para 4.7 of HBP.

Case No.B‐20

M/S Glenmark Pharmaceuticals Ltd. F.No.01/82/50/1159/AM05 RLA F.No.03/24/40/1482/AM05 Adv.Lic.No.0310295800 dated 07.10.2004 Committee considered case as per agenda for ratification of norms for export product Cilazapril under para 4.7 of HBP.

Case No.B‐21

M/S Advy Chemical F.No.01/87/50/313/AM07 RLA F.No.03/94/40/310/AM07

Adv.Lic.No.0310387468 dated 29.06.2006 Committee considered case as per agenda for ratification of norms for export product HBsAG Subtypes ad Reagent (4000mgs) (Hepa奱�奱�s B Surface Antigen‐Subtypes ad) under para 4.7 of HBP. Committee in light of written comments forwarded by Department of Bio‐technology vide their O.M. No.BT/IL/05/231/06/2006‐PID dated 03.04.2008 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 HBsAg Subtypes and Reagent (4000mgs) (Hepta奱�奱�s‐B surface antigen‐ subtypes ad) 1000 mg (1gm) 1. Hepa奱�奱�s B Positive Plasma 100,000 m (100 ltrs) (200ml bag X 50)/1000mg (1 gm) 2. Trizma base 24kg/1000 mg (1 gm) 3. Sucrose 10 kg/1000mg (1 gm) 4. Dextran Sulphate 125 gm/1000mg (1 gm) 5. Polyethylene Glycol 18 kg/1000 mg (1 gm)

Case No.B‐22

M/S Shalina Laboratories Ltd. F.No.01/82/50/288/AM08 RLA F.No.03/95/40/841/AM08 Adv.Lic.No.0310452338 dated 03.12.2007 Committee considered case as per agenda for revision of norms for export product Diproson Lotion 30ml under para 4.7 of HBP.

Representative of PI Division present in meeting informed Committee that quantity of inputs has already been allowed correctly and hence there is no scope for enhancement in the quantity of inputs. Committee, accordingly decided to maintain status quo.

Case No.B‐23

M/S Shalina Laboratories Ltd. F.No.01/82/50/31/AM08 RLA F.No.03/95/40/95/AM08 Adv.Lic.No.0310428999 dated 10.05.2007 Committee considered case as per agenda for revision of norms for export product Diproson Lotion under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that quantity of inputs has already been allowed correctly and hence there is no scope for enhancement in the quantity of inputs. Committee, accordingly decided to maintain status quo.

Case No.B‐24

M/S Shalina Laboratories Ltd. F.No.01/82/50/186/AM08 RLA F.No.03/95/40/574/AM08 Adv.Lic.No.0310444049 dated 24.09.2007 Committee considered case as per agenda for revision of norms for export product Diproson Lotion under para 4.7 of HBP. Representative of PI Division present in meeting informed Committee that quantity of inputs has already been allowed correctly and hence there is no scope for enhancement in the quantity of inputs. Committee, accordingly decided to maintain status quo.

Case No.A‐18

M/S Cipla Ltd. F.No.01/82/50/274/AM08

RLA F.No.03/94/40/895/AM08 Adv.Lic.No.0310451841 dated 28.11.2007 Committee considered case as per agenda for ratification of norms for export product Efavir Capsule 200mg/Efavirenz 200mg Capsules and Efavir 600mg Tablets/Efavirenz 600mg Tablets under

para 4.7 of HBP.

No.35011/83/2007‐PI‐III dated 12.03.2008 decided to ratify norms under para 4.7 of HBP as per Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Efavirenz Capsules 200mg [Efavirenz 204 mg/Capsule] 1No. 1. (S)‐5‐chloro‐alpha‐ (cyclopropyl ethylyl)‐2‐ amino‐alpha‐(trifluoro methyl) benzene methanol 1.092 kg/kg of Efavirenz Efavirenz Tablets 600mg [Efavirenz 612 mg/tablet] 1 No.

Case No.A‐19

M/S Bal Pharma Ltd. F.No.01/82/50/333/AM08 RLA F.No.07/24/40/721/AM08 Adv.Lic.No.0710055464 dated 16.01.2008 Committee considered case as per agenda for ratification of norms for export product Amiloride Hcl under para 4.7 of HBP.

Case No.A‐20

M/S Bal Pharma Ltd. F.No.01/82/50/277/AM08 RLA F.No.07/24/40/617/AM08 Adv.Lic.No.0710054687 dated 28.11.2007 Committee considered case as per agenda for ratification of norms for export product Amiloride Hcl under para 4.7 of HBP.

Case No.A‐21

M/s Codexis Laboratories (I) Ltd M.No.2/09 F.No.01/82/50/332/AM 08 Meeting Date 08.04.2008 RLA F. No. 05/24/40/725/AM08 Adv. Lic. No. 0510214137 dt. 28.12 .2007

The Committee considered the case as per agenda for ratification of norms for the export product (4R‐CIS)‐1‐Dimethylethyl‐6‐Cyanomethyl‐2,2‐Dimethyl‐1‐3‐Dioxane –4‐ Acetate(Pharma Grade)NLT99% under para 4.7 of HBP. No.35011/20/2007‐PI‐III dated 24.03.2008 decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (4‐R‐Cis)‐1,1 dimethyl ethyl‐6‐cyanomethyl‐2,2 dimethyl‐1,3‐dioxane‐4‐ acetate (ATS 8) 1kg. 1. Ethyl ®‐4‐cyno‐3‐Hydroxy Butanoate 1.00 kg/kg 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg/kg 3. Tertiary Butyl Acetate 2.11 kg/kg 4. Tetra Hydro Furan 5.63 kg/kg 5. 2,2‐Dimethoxy propane 2.79 kg/kg 6. Ketroreducatse YDH/KRED 0.013 kg/kg 7. Glucose Dehydrogenase Enzyme GDH 0.0045 kg/kg 8. B‐Nicotinamide‐adenine dinucleotide phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 gm/kg

Case No.A‐22

M/s Aar奱� Drugs Ltd. M.No.2/09 F.No.01/82/50/341/AM 08 RLA F. No. 03/94/40/753/AM08 Adv. Lic. No. 0310455126 dated 26.12.2007

export product Metoprolol Succinate under para 4.7 of HBP.

Case No.A‐23

M/S Global Calcium Pvt. Ltd. M.No.2/09 F.No.01/83/162/1033/AM 08 RLA F. No. 07/24/40/53/AM08 Adv. Lic. No. 0710051439 dated 26.04.2007 export product Calcium Gluconate Injectable Grade, Calcium Lactate Gluconate, Calcium Glubionate and Calcium Borogluconate under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of Chemical Division.

Case No.A‐24

M/s Gland Pharma Ltd. M.No.2/09 F.No.01/82/50/254/AM 08 RLA F. No. 09/24/40/314/AM08 Adv. Lic. No. 0910031800 dated 16.10.2007 export product Adenosine Injection USP Prefilled Syringe 3mg/ml, 2ml in a PFS under para 4.7 of HBP. Committee perused written comments forwarded by PI Division vide their U.O. No.35011/2007/2006‐PI‐III dated 08.04.2008 as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. recommended per unit of export product Adenosine Injection USP prefilled syringes 1 unit of 2ml PFS 1. Adenosine 0.0066 gm/unit 2. Glass barrel syringes 1.25 Nos./unit 3. V‐OVS 10.6 奱�p caps 1.25 Nos./unit 4. Plunger stoppers 1.25 Nos./unit

2ml in a PFS 5. Plunger Rods 1.10 Nos./unit 6. Filter 0.00025 Nos./unit 7. Tubing 0.00025 Nos./unit 8. Reference standard 0.00010 Nos./unit Adenosine Injection USP prefilled syringes 4ml in PFS 1 unit of 4ml PFS 1. Adenosine 0.0132 gm/unit 2. Glass barrel syringes 1.25 Nos./unit 3. V‐OVS 10.6 奱�p caps 1.25 Nos./unit 4. Plunger stoppers 1.25 Nos./unit 5. Plunger Rods 1.10 Nos./unit 6. Filter 0.00025 Nos./unit 7. Tubing 0.00050 Nos./unit 8. Reference standard 0.00020 Nos./unit Committee decided to call for production and consumption data duly certified by Central Excise Authority and to verify the above norms with the Central Excise Data on file. Accordingly, case was deferred for six weeks.

Case No.A‐25

M/S Global Calcium Pvt. Ltd. M.No.2/09 F.No.01/83/50/1077/AM 08 RLA F. No. 07/24/40/861/AM07 Adv. Lic. No. 0710051390 dated 24.04.2007

export product Zinc Gluconate, Magnesium Gluconate, Potassium Gluconate, Ferrous Gluconate, Manganese Gluconate, Calcium Magnesium Lactate Gluconate, Magnesium Lactate Gluconate, Cobalt Gluconate and Copper Gluconate under para 4.7 of HBP. Committee decided to defer case for three weeks for comments of Chemical Division.

Case No.A‐26

M/S Emami Ltd. M.No.2/09 F.No.01/83/162/1069/AM 08 RLA F. No. 02/24/40/183/AM08 Adv. Lic. No. 0210106154 dated 19.11.2007 export product Himani (Fast Relief) Pain Relief Ointment (HFRO) under para 4.7 of HBP. Committee observed that Drug Manufacturing Licence submitted by firm has been issued from Directorate of ISM Drug Control, Kolkata. Committee, therefore, decided to seek the comments from Department Ayush/DC(MSME). Accordingly, case was deferred for four weeks.

Case No.A‐27

M/S Arch Pharma Labs Ltd. M.No.2/09 F.No.01/82/50/269/AM 08 RLA F. No. 03/94/40/713/AM08 Adv. Lic. No. 0310451128 dated 22.11.2007

export product (1’R,2’S,5’R)‐Methyl‐5S‐(Cytosine‐1‐YL)‐1,3‐Oxathiolane‐2R‐Carboxylate under

para 4.7 of HBP.

No.35011/207/2006‐PI‐III dated 07.04.2008 decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (1’R,2’S,5’R)‐Methyl‐5S‐ (Cytosine‐1‐YL)‐1,3‐ Oxathiolane‐2R‐ Carboxylate 1kg. 1. Menthol 0.81 kg/kg 2. 2,5‐Dihydroxy‐1,4‐ Diethane 0.348 kg/kg 3. Cytosine 0.455 kg/kg 4. Cyclohexane 1.535 kg/kg 5. Toluene 3.023 kg/kg 6. N‐Hexane 3.728 kg/kg 7. Ethyl Acetate 0.920 kg/kg

Case No.A‐28

M/s Cipla Ltd. M.No.2/09 F.No.01/82/50/251/AM 08 RLA F. No. 03/94/40/747/AM08 Adv. Lic. No. 0310447486 dated 23.10.2007

export product Nevimune 200mg Tablets/Nevirapine 200mg tablets and Nevirapine Oral Suspension 50mg/5ml Nevimune (per pack 100mg) under para 4.7 of HBP. No.35011/83/2007‐PI‐III dated 12.03.2008 decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Nevirapine 200mg tablet [Nevirapine 204 mg/tablet] 1 No. 1. 3‐(2‐Chloro‐3‐pyridine‐ carbonyl)‐amino‐2‐chloro‐ 4‐methyl pyridine/(NVP(II) compound) 1.428 kg/kg of Nevirapine 2. Cyclopropylamine 0.57 kg/kg of Nevirapine Nevirapine Oral solution 50 mg/5ml, 100ml bottle [Nevirapine 1020 mg/100 ml bottle] 1 No. 3. Diglyme 2.76 kg/kg of Nevirapine

Case No.A‐29

M/s Cipla Ltd. M.No.2/09 F.No.01/82/50/160/AM 08 RLA F. No. 03/94/40/524/AM08 Adv. Lic. No. 0310440273 dated 21.08.2007 export product Irinotecan Hydrochloride Injection 40mg/2ml and Irinotecan Hydrochloride Injection 100mg/5ml under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division.

Case No.A‐30

M/S Cipla Ltd. M.No.2/09 F.No.01/82/50/255/AM 08 RLA F. No. 03/94/40/798/AM08 Adv. Lic. No. 0310448930 dated 02.11.2007 The Committee considered the case as per agenda for ratification of norms for the export product Lamivir 150mg Tablets/Lamivudine Tablets 150mg, Lamivir S‐30 Tablets/Lamivudine and Stavudine Tablets, Lamivir S‐40 Tablets/Lamivudine and Stavudine Tablets, Lamivir S Junior Tablets/Lamivudine and Stavudine Tablets, Lamivir S Baby Tablets/Lamivudine and Stavudine Tablets, Lamivir HBV Tablets 100mh/Lamivudine 100mg Tablets, Lamivudine and Zidovudine Tablets/Duovir/Bivir, Lamivudine, Zidovudine and Nevirapine Tablets/Duovir‐N and Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. No.35011/83/2007‐PI‐III dated 12.03.2008 decided to ratify norms under para 4.7 of HBP as per Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Lamivudine 150mg tablet [Lamivudine 153.0 mg/tablet] 1 No. 1. (1’R,2’S,5’R)‐ Menthyl‐5S‐ (Cytosine‐1”‐ YL)‐1,3Oxathiolane‐ 2R‐ carboxylate/CME compound 2.19 kg/kg of Lamivudine Lamivudine 150mg + Stavudine 30mg tablet 1 No. Lamivudine 150mg + Stavudine 40mg tablet 1 No. 2. Sodium Borohydride 0.48 kg/kg of Lamivudine Lamivudine 60mg + Stavudine 12mg tablet [Lamivudine 61.2 mg/tablet] 1 No. Lamivudine 30mg + Stavudine 3mg Tables 1 No.

[Lamivudine 30.6 mg/tablet Not allowed Lamivudine 100mg tablet [Lamivudine 102.0 mg/tablet] 1 No. Lamivudine 150mg + Zidovudine 300mg tablet 1 No. Lamivudine 150mg + Zidovudine 300mg + Nevirapine 200mg tablet 1 No. Triomune 30/Lamivudine, Stavudine and Nevirapine Tablet [DML not given] Hence not allowed. 1 No.

Case No.A‐31

M/S Cipla Ltd. M.No.2/09 F.No.01/82/50/152/AM 08 RLA F. No. 03/94/40/437/AM08 Adv. Lic. No. 0310437618 dated 27.07.2007 export product Triomune30/Lamivudine, Stavudine and Nevirapine Tablets and Triomune 40/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. Committee decided to call for a copy of Drug Manufacturing Licence from firm. Accordingly, case was deferred for six weeks.

Case No.A‐32

M/S Cipla Ltd. M.No.2/09 F.No.01/82/50/153/AM 08

RLA F. No. 03/94/40/485/AM08 Adv. Lic. No. 0310439033 dated 09.08.2007 export product Gemcitabine Okasa Pharma (Gemcicross) 1g Injection/Gemcitabine Hydrochloride Injection 1000mg/Oncogem 100mg Injection and Gemcitabnine 200mg Injection/Gemcitabine Hydrochloride Injection 200mg/Oncogem 200 Injection under para 4.7 of HBP. No.35011/83/2007‐PI‐III dated 12.03.2008 decided to ratify norms under para 4.7 of HBP as Export Product Export Qty. Sl.No. Import items Quantity allowed per unit of export product Gemcitabine 1 gm. Injection, 50ml Vial [Gencitanine Hcl 1.05 gm/Vial] 1 No. 1. 2‐Deoxy‐3,5‐Dibenzoyl‐ 2,2‐Difluoro‐D‐ Erythropento Furano‐1‐ Ulose 8.10 kg/kg of Gencitabine Hcl 2. Sodium Dihydro Bil (2‐ Methoxy Ethoxy Aluminate‐70% Active in Toluene) [Vitride] 3.05 kg/kg of Gemcitabine Hcl 3. Tetrahydrofuran 14.175 kg/kg of Gemcitabine Hcl Gemcitabine 200 mg Injection, 10 ml Vial [Gemcitabine Hcl 210 mg/Vial 1 No. 4. 4‐amino 2‐ hydroxypyrimidine [Cytosine] 5.10 kg/kg of Gemcitabine Hcl

Case No.A‐33

M/S Cipla Ltd.

M.No.2/09 F.No.01/82/50/213/AM 08 RLA F. No. 03/94/40/534/AM08 Adv. Lic. No. 0310440647 dated 23.08.2007 export product Efavir Capsule 200mg/Efavirenz 200mg Capsules and Efavir 600mg Tablets/Efavirenz 600 mg tahlets under para 4.7 of HBP. No.35011/83/2007‐PI‐III dated 12.03.2008 decided to ratify norms under para 4.7 of HBP as Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Efavirenz Capsules 200mg [Efavirenz 204 mg/Capsule] 1No. 1. (S)‐5‐chloro‐alpha‐ (cyclopropyl ethylyl)‐2‐ amino‐alpha‐(trifluoro methyl) benzene methanol 1.092 kg/kg of Efavirenz Efavirenz Tablets 600mg [Efavirenz 612 mg/tablet] 1 No.

Case No.A‐34

M/S Cipla Ltd. M.No.2/09 F.No.01/82/50/250/AM 08 RLA F. No. 03/94/40/749/AM08 Adv. Lic. No. 0310447493 dated 23.10.2007 The Committee considered the case as per agenda for ratification of norms for the export product Lamivir 150mg Tablets/Lamivudine Tablets 150mg, Lamivir S‐30 Tablets/Lamivudine and Stavudine Tablets, Lamivir S‐40 Tablets/Lamivudine and Stavudine Tablets, Lamivir S Junior Tablets/Lamivudine and Stavudine Tablets, Lamivir S Baby Tablets/Lamivudine and Stavudine Tablets, Lamivir HBV Tablets 100mh/Lamivudine 100mg Tablets, Lamivudine and Zidovudine

Tablets/Duovir/Bivir, Lamivudine, Zidovudine and Nevirapine Tablets/Duovir‐N and Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. No.35011/83/2007‐PI‐III dated 12.03.2008 decided to ratify norms under para 4.7 of HBP as per Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Lamivudine 150mg tablet 1 No. 1. (1’R,2’S,5’R)‐ Menthyl‐5S‐ (Cytosine‐1”‐ YL)‐1,3Oxathiolane‐ 2R‐carboxylate/CME compound 2.19 kg/kg of Lamivudine Lamivudine 150mg + Stavudine 30mg tablet [Lamivudine 153.0 mg/tablet 1 No. Lamivudine 150mg + Stavudine 40mg tablet 1 No. 2. Sodium Borohydride Not allowed 0.48 kg/kg of Lamivudine Lamivudine 60mg + Stavudine 12mg tablet [Lamivudine 61.2 mg/tablet] 1 No. Lamivudine 30mg + Stavudine 3mg tablets [Lamivudine 30.6mg/tablet] Lamivudine 100mg tablet [Lamivudine 102.0 mg/tablet] 1 No. Lamivudine 150mg + Zidovudine 300mg tablet 1 No. Lamivudine 150mg + Zidovudine 300mg + Nevirapine 200mg tablet 1 No. Triomune 30/Lamivudine, Stavudine and Nevirapine Tablet 1 No.

[DML not given. Hence not allowed.]

Case No.A‐35

M/S Cipla Ltd. M.No.2/09 F.No.01/82/50/215/AM 08 RLA F. No. 03/94/40/621/AM08 Adv. Lic. No. 0310443538 dated 18.09.2007 The Committee considered the case as per agenda for ratification of norms for the export product Lamivir 150mg Tablets/Lamivudine Tablets 150mg, Lamivir S‐30 Tablets/Lamivudine and Stavudine Tablets, Lamivir S‐40 Tablets/Lamivudine and Stavudine Tablets, Lamivir S Junior Tablets/Lamivudine and Stavudine Tablets, Lamivir S Baby Tablets/Lamivudine and Stavudine Tablets, Lamivir HBV Tablets 100mh/Lamivudine 100mg Tablets, Lamivudine and Zidovudine Tablets/Duovir/Bivir, Lamivudine, Zidovudine and Nevirapine Tablets/Duovir‐N and Triomune 30/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. No.35011/83/2007‐PI‐III dated 12.03.2008 decided to ratify norms under para 4.7 of HBP as per Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Lamivudine 150mg tablet 1 No. 1. (1’R,2’S,5’R)‐ Menthyl‐5S‐ (Cytosine‐1”‐ YL)‐1,3Oxathiolane‐ 2R‐ carboxylate/CME compound 2.19 kg/kg of Lamivudine Lamivudine 150mg + Stavudine 30mg tablet [Lamivudine 153.0 mg/tablet 1 No. Lamivudine 150mg + Stavudine 40mg tablet 1 No. 2. Sodium Borohydride 0.48 kg/kg of Lamivudine Lamivudine 60mg + Stavudine 12mg 1 No.

tablet [Lamivudine 61.2 mg/tablet] Not allowed Lamivudine 30mg + Stavudine 3mg tablets [Lamivudine 30.6 mg/tablet] Lamivudine 100mg tablet [Lamivudine 102.0 mg/tablet] 1 No. Lamivudine 150mg + Zidovudine 300mg tablet 1 No. Lamivudine 150mg + Zidovudine 300mg + Nevirapine 200mg tablet 1 No. Triomune 30/Lamivudine, Stavudine and Nevirapine Tablet [DML not given. Hence not allowed] 1 No.

Case No.A‐36

M/S Cadila Healthcare Ltd. M.No.2/09 F.No.01/82/50/278/AM 08 RLA F. No. 08/24/40/203/AM08 Adv. Lic. No. 0810068702 dated 28.11.2007 export product Warfarin 1mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 6mg,, 7.5mg and 10mg tablets under para 4.7 of HBP. No.35011/73/2007‐PI‐III dated 17.03.2008 decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Items of import Qty. allowed per unit of export product Warfarin tablets 1 1 million 1. Warfarin Sodium Clathrate 1.09 kg/million

mg. USP tablets 2. Hydroxypropyl Cellulose 3.67 kg/million tablets 3. Lactose monohydrate 168.08 kg/million tablets 4. Magnesium Stearate 1.37 kg/million tablets 5. Bottle 60CC Bottle 400CC Closure 33mm CR Closure 53mm NCR As per packing policy Warfarin tablets 2 mg. 1 million 1. Warfarin Sodium Clathrate USP 2.18 kg/million tablets 2. 3.66 kg/million tablets 3. Lactose monohydrate 167.12 kg/million tablets 4. Magnesium Stearate 1.38 kg/million tablets 5. Bottle 60CC Bottle 400CC Closure 33mm CR Closure 53mm NCR As per packing policy Warfarin tablets 2.5 mg. 1 million 1. Warfarin Sodium Clathrate USP 2.725 kg/million tablets 2. 3.68 kg/million tablets 3. Lactose monohydrate 166.98 kg/million tablets 4. Magnesium Stearate 1.38 kg/million tablets 5. Bottle 60CC Bottle 400CC Closure 33mm CR Closure 53mm NCR As per packing policy Warfarin tablets 3.0 1 million 1. Warfarin Sodium 3.27 kg/million

mg. Clathrate USP tablets 2. 3.66 kg/million tablets 3. Lactose monohydrate 165.53 kg/million tablets 4. Magnesium Stearate 1.37 kg/million tablets 5. Bottle 60CC Bottle 400CC Closure 33mm CR Closure 53mm NCR As per packing policy Warfarin tablets 4.0 mg. 1 million 1. Warfarin Sodium Clathrate USP 4.36 kg/million tablets 2. 3.67 kg/million tablets 3. Lactose monohydrate 165.12 kg/million tablets 4. Magnesium Stearate 1.38 kg/million tablets 5. Bottle 60CC Bottle 400CC Closure 33mm CR Closure 53mm NCR As per packing policy Warfarin tablets 5.0 mg. 1 million 1. Warfarin Sodium Clathrate USP 5.45 kg/million tablets 2. 3.67 kg/million tablets 3. Lactose monohydrate 159.50 kg/million tablets 4. Magnesium Stearate 1.38 kg/million tablets 5. Bottle 60CC Bottle 400CC Closure 33mm CR Closure 53mm NCR As per packing policy

Warfarin tablets 6.0 mg. 1 million 1. Warfarin Sodium Clathrate USP 6.54 kg/million tablets 2. 3.66 kg/million tablets 3. Lactose monohydrate 156.07 kg/million tablets 4. Magnesium Stearate 1.37 kg/million tablets 5. Bottle 60CC Bottle 400CC Closure 33mm CR Closure 53mm NCR As per packing policy Warfarin tablets 7.5 mg. 1 million 1. Warfarin Sodium Clathrate USP 8.175 kg/million tablets 2. 3.66 kg/million tablets 3. Lactose monohydrate 156.87 kg/million tablets 4. Magnesium Stearate 1.37 kg/million tablets 5. Bottle 60CC Bottle 400CC Closure 33mm CR Closure 53mm NCR As per packing policy Warfarin tablets 10 mg. 1 million 1. Warfarin Sodium Clathrate USP 10.90 kg/million tablets 2. 3.66 kg/million tablets 3. Lactose monohydrate 154.67 kg/million tablets 4. Magnesium Stearate 1.37 kg/million tablets 5. Bottle 60CC Bottle 400CC As per packing policy

Closure 33mm CR Closure 53mm NCR

Case No.A‐37

M/S Glenmark Pharmaceuticals Ltd. M.No.2/09 F.No.01/82/50/267/AM 08 RLA F. No. 03/94/40/805/AM08 Adv. Lic. No0310450439 dated 16.11.2007 export product Cilazapril under para 4.7 of HBP.

Case No.A‐38

M/S Arch Pharma Labs Ltd. M.No.2/09 F.No.01/82/50/268/AM 08 RLA F. No. 03/94/40/715/AM08 Adv. Lic. No. 0310451131 dated 22.11.2007

export product (1’R,2’S,5’R)‐Methyl‐5S‐(Cytosine‐1#YL)‐1,3‐Oxathiolane‐2R‐Carboxylate under

para 4.7 of HBP.

No.35011/207/2006‐PI‐III dated 07.04.2008 decided to ratify norms under para 4.7 of HBP as Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (1’R,2’S,5’R)‐Methyl‐5S‐ (Cytosine‐1#YL)‐1,3‐ Oxathiolane‐2R‐ Carboxylate 1kg. 1. Menthol 0.81 kg/kg 2. 2,5‐Dihydroxy‐1,4‐ Diethane 0.348 kg/kg 3. Cytosine 0.455 kg/kg 4. Cyclohexane 1.535 kg/kg 5. Toluene 3.023 kg/kg 6. N‐Hexane 3.728 kg/kg 7. Ethyl Acetate 0.920 kg/kg

Case No.C‐6

M/S Benzo Chem Industries Pvt. Ltd. M.No.2/09 F.No.01/83/162/901/AM 08 The Committee considered the case as per agenda for modification of SION for export product ‘Para Chloro Phenyl Acetic Acid A‐2468. Committee observed that firm has not produced export product by this route in the past and it is premature to fix SION. It was, therefore, decided to close the case.

Case No.C‐7

M/S Amsal Chem Pvt. Ltd. M.No.2/09 F.No.01/87/50/456/AM08

The Committee considered the case as per agenda for modification of DEPB Sl.No.55. Committee observed that firm was requested to furnish Central Excise Data and Pharmexcil was requested to furnish All Industry Data vide letter dated 22.01.2008, but no reply has been received. Committee, therefore, decided to close the case. 1

Case No.:31/21/82‐ALC4/2007

Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:2/82‐ALC4/2008 08.04.2008 Status:Case Rejected HQ File :01/82/050/00057/AM06/ RLA File :07/24/040/00013/AM06/ Lic.No/Date:0710037427 21.04.2005 Decision :Committee considered case as per agenda for ratification of norms for export product Minoxidil under para 4.7 of HBP. Committee observed that RA/firm was requested to furnish application vide letter dated 05.03.2008, but application has not been received. Committee, therefore, decided o close the case. 2

Case No.:135/24/87‐ALC1/2007

Party Name:SUDEEP PHARMA LTD., 08.04.2008 Status:Case Approved HQ File :01/87/050/00174/AM06/ RLA File :34/24/040/00021/AM06/ Lic.No/Date:3410013421 18.05.2005 Decision : Committee considered case as per agenda for ratification of norms for export product Di Calcium Phosphate Anhydrous USP or Di Calcium Phosphate Anhydreous (D.C.) under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/24/2004/Ch.III signed on 08.04.2008 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 Di Calcium Phosphate Anhydrous 1kg. 1. Phosphoric Acid 85% 0.890 kg/kg

Case No.:205/21/82‐ALC4/2007

Party Name:IGOR PHARMACHEM LIMITED 08.04.2008 Status:Case Approved HQ File :01/82/050/00268/AM06/ RLA File :09/24/040/00086/AM06/ Lic.No/Date:0910023219 21.06.2005 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Aminomethyl‐7‐Chloro‐2,3‐Dihydro‐5‐(2‐ Fluorophenyl)‐1H‐1,4‐Benzodiazepine Dimaleate under para 4.7 of HBP. Committee in consultation with the representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as applied by firm. 4

Case No.:579/21/82‐ALC4/2007

Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:2/82‐ALC4/2008 08.04.2008 Status:Case Deferred HQ File :01/82/050/01174/AM07/ RLA File :07/24/040/00449/AM07/ Lic.No/Date:0710047985 19.10.2006 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Zinc Pyrithione under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Chemical Division. 5

Case No.:1/42/83‐ALC1/2006

Party Name:RA CHEM PHARMA LIMITED. 08.04.2008 Status:Case Approved HQ File :01/83/050/00936/AM07/ RLA File :09/24/040/00218/AM07/ Lic.No/Date:0910028286 21.11.2006 Decision : Committee considered case as per agenda for ratification of norms for export product 1,2‐Benzisoxazole‐3‐methane Sulfonic acid sodium salt under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/274/2006‐PI‐III dated 08.04.2008 decided to Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 1,2‐Benzisoxazole‐3‐ 1kg. 1. 4‐Hydroxy coumarin 2.34 kg/kg

methane sulfonic acid Sodium Salt 2. Hydroxylamine hcl 1.00 kg/kg 3. Bromine 1.73 kg/kg 4. Dichloro methane 0.87 kg/kg 5. IPA 1.00 kg/kg 6. Sodium sulphite 1.01 kg/kg 7. Pyridine 1.765 kg/kg 8. Methanol 3.28 kg/kg 6

Case No.:2/46/82‐ALC1/2006

Party Name:MATRIX LABORATORIES LTD 08.04.2008 Status: Case Withdrawn HQ File :01/82/050/01441/AM07/ RLA File :09/24/040/00390/AM07/ Lic.No/Date:0910028634 13.12.2006 Decision : Committee considered case as per agenda for ratification of norms for export product N‐Trifluoro Acetyl‐N‐Lysine‐Praline (Lyspro(Isolated)under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 1/09 meeting held on 01.04.2008. 7

Case No.:7/2/82‐ALC4/2007

Party Name:CIPLA LIMITED 08.04.2008 Status: Case Deferred HQ File :01/82/050/01804/AM07/ RLA File :03/94/040/01443/AM07/ Lic.No/Date:0310422972 13.03.2007 Defer Date: 21.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Triomune 30/Lamivudine, Stavudine and nevirapine Tablets and Triomune 40/Lamivudine, Stavudine and Nevirapine Tablets under para 4.7 of HBP. Committee decided to call for a copy of Drug Manufacturing Licence from firm. Accordingly, case was deferred for six weeks. 8

Case No.:665/24/83‐ALC1/2007

Party Name:SIBRA PHARMACEUTICALS LTD. 08.04.2008 Status:Case Deferred HQ File :01/83/050/00497/AM08/ RLA File :09/24/040/00370/AM07/ Lic.No/Date:0910030503 11.06.2007 Defer Date: 21.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product (1R,2S,5R)‐Methyl‐5(S)‐Cytosin‐1,YL‐1,3‐ Oxathiolane‐2R‐Carboxylate under para 4.7 of HBP.

Committee decided to defer case for six weeks for comments of PI Division. 9

Case No.:670/24/83‐ALC1/2007

Party Name:ISHITA DRUGS & INDUSTRIES LTD 08.04.2008 Status:Case Deferred HQ File :01/83/050/00503/AM08/ RLA File :08/24/040/00049/AM08/ Lic.No/Date:0810065340 12.06.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Sulfanilamide 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. 10

Case No.:682/24/83‐ALC1/2007

Party Name:SALICYLATES & CHEMICALS P.LTD. 08.04.2008 Status:Case Deferred HQ File :01/83/050/00526/AM08/ RLA File :09/24/040/00074/AM08/ Lic.No/Date:0910030570 15.06.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Saligerm G‐2 under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Chemical Division. 11

Case No.:82/19/83‐ALC1/2007

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 08.04.2008 Status:Case Deferred HQ File :01/83/050/00641/AM08/ RLA File :03/95/040/00229/AM08/ Lic.No/Date:0310433835 25.06.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 3,5‐Di Methoxy‐4‐Hydroxy Benzamide (Syringamide) under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Chemical Division. 12

Case No.:730/24/83‐ALC1/2007

Party Name:SUVEN LIFE SCIENCES LIMITED 08.04.2008 Status:Case Withdrawn HQ File :01/83/050/00623/AM08/ RLA File :09/24/040/00120/AM08/ Lic.No/Date:0910030686 29.06.2007 Decision : Committee considered case as per agenda for ratification of norms for export product (S)‐3‐Hydroxy‐N‐Benzyl Pyrrolidine under

para 4.7 of HBP.

Committee decided to withdraw case as case has already been approved in its 1/09 meeting held on 01.04.2008. 13

Case No.:755/24/83‐ALC1/2007

Party Name:VIVIMED LABS LIMITED 08.04.2008 Status:Case Deferred HQ File :01/83/050/00685/AM08/ RLA File :09/24/040/00111/AM08/ Lic.No/Date:0910030800 06.07.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Octyne‐B/Octocrylene/2‐Ethylhexyl‐2‐Cyano‐ 3,3‐Diphenylacrylate under para 4.7 of HBP. Committee decided to defer case for four weeks for comments of Chemical Division. 14

Case No.:784/24/83‐ALC1/2007

Party Name:KAIVAL CHEMICALS P LTD 08.04.2008 Status:Case Deferred HQ File :01/83/050/00733/AM08/ RLA File :34/24/040/00073/AM08/ Lic.No/Date:3410019192 13.07.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product L(‐)‐Di‐P‐Toluoyl Tartaric Acid 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. 15

Case No.:920/24/83‐ALC1/2007

Party Name:METROPOLITAN OVERSEAS LIMITED, 08.04.2008 Status:Case Deferred HQ File :01/83/050/00933/AM08/ RLA File :03/95/040/00301/AM08/ Lic.No/Date:0310438008 01.08.2007 Defer Date: 21.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product N‐[1‐(S)‐Ethoxy Carbonyl‐3‐Phenyl Propyl]‐L‐ Alanine (ECPP‐Alanina Ale) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/193/2006‐PI‐III dated 08.04.2008 observed that norms applied by firm are not as per the chemistry furnished by them. Committee, therefore, decided to call for technical justification along with calculations for working out the quantative requirement from firm. Accordingly, case was deferred for six weeks. 16

Case No.:12/27/83‐ALC1/2007

Party Name:CIPLA LIMITED 08.04.2008 Status: Case Withdrawn HQ File :01/83/050/01086/AM08/ RLA File :03/94/040/00555/AM08/ Lic.No/Date:0310441561 :

31.08.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Saquinavir 200mg Capsules/Saqvir 200mg Capsules under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 1/09 meeting held on 01.04.2008. 17

Case No.:54/27/83‐ALC1/2007

Party Name:GLENMARK PHARMACEUTICALS LTD., 08.04.2008 Status:Case Deferred HQ File :01/83/050/01128/AM08/ RLA File :03/94/040/00525/AM08/ Lic.No/Date:0310441978 06.09.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Aprepitant under para 4.7 of HBP. 18

Case No.:69/27/83‐ALC1/2007

Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 08.04.2008 Status:Case Approved HQ File :01/83/050/01143/AM08/ RLA File :05/24/040/00396/AM08/ Lic.No/Date:0510208776 10.09.2007 Decision : Committee considered case as per agenda for ratification of norms for export product (4R‐CIS)‐1,1‐Dimethylethyl‐6‐Cyanomethyl‐ 2,2‐Dimethyl‐1‐3‐Dioxane‐4‐Acetate (ATS‐8) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/20/2007‐PI‐III dated 24.03.2008 decided to Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (4‐R‐Cis)‐1,1 dimethyl ethyl‐6‐ cyanomethyl‐2,2 dimethyl‐ 1,3‐dioxane‐4‐acetate (ATS 8) 1kg. 1. Ethyl ®‐4‐cyno‐3‐Hydroxy Butanoate 1.00 kg/kg 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg/kg 3. Tertiary Butyl Acetate 2.11 kg/kg 4. Tetra Hydro Furan 5.63 kg/kg 5. 2,2‐Dimethoxy propane 2.79 kg/kg 6. Ketroreducatse YDH/KRED 0.013 kg/kg 7. Glucose Dehydrogenase 0.0045 kg/kg

Enzyme GDH 8. B‐Nicotinamide‐adenine dinucleotide phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 gm/kg 19

Case No.:10/22/82‐ALC4/2007

Party Name:CIPLA LIMITED 08.04.2008 Status:Case Withdrawn HQ File :01/82/050/00180/AM08/ RLA File :03/94/040/00615/AM08/ Lic.No/Date:0310442878 12.09.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Abacavir Sulphate Tablets 300mg under para 4.7 of HBP. Committee decided to withdraw case as case has already been approved in its 1/09 meeting held on 01.04.2008. 20

Case No.:2/25/82‐ALC4/2007

Party Name:CIPLA LIMITED 08.04.2008 Status:Case Approved HQ File :01/82/050/00196/AM08/ RLA File :03/94/040/00664/AM08/ Lic.No/Date:0310445042 03.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Abacavir Sulphate Tablets 300mg 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 Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Abacavir Sulphate tablets 300mg Abacavir sulphate 306mg/tablet 1 No. 1. Triethyl orthoformate 0.69 kg/kg of Abacavir sulphate 2. Cyclopropylamine 0.19kg/kg of Abacavir sulphate

Case No.:7/29/83‐ALC1/2007

Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 08.04.2008 Status:Case Approved HQ File :01/83/050/01272/AM08/ RLA File :05/24/040/00518/AM08/ Lic.No/Date:0510209861 03.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product (4R‐CIS)‐1,1‐Dimethylethyl‐6‐ Cyanomethyl‐2,2‐Dimethyl‐1‐3‐Dioxane‐4‐Acetate (ATS‐8) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/20/2007‐PI‐III dated 24.03.2008 decided to Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (4‐R‐Cis)‐1,1 dimethyl ethyl‐6‐ cyanomethyl‐2,2 dimethyl‐ 1,3‐dioxane‐4‐acetate (ATS 8) 1kg. 1. Ethyl ®‐4‐cyno‐3‐Hydroxy Butanoate 1.00 kg/kg 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg/kg 3. Tertiary Butyl Acetate 2.11 kg/kg 4. Tetra Hydro Furan 5.63 kg/kg 5. 2,2‐Dimethoxy propane 2.79 kg/kg 6. Ketroreducatse YDH/KRED 0.013 kg/kg 7. Glucose Dehydrogenase Enzyme GDH 0.0045 kg/kg 8. B‐Nicotinamide‐adenine dinucleotide phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 gm/kg 22

Case No.:30/29/83‐ALC1/2007

Party Name:OMKAR SPECIALITY CHEMICALS PVT. LTD. 08.04.2008 Status:Case Deferred HQ File :01/83/050/01295/AM08/ RLA File :03/95/040/00611/AM08/ Lic.No/Date:0310445277 05.10.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Benzene Seleninic Anhydride 99.0% purity minimum (on dry basis) under para 4.7 of HBP.

Committee decided to defer case for four weeks for comments of Chemical Division. 23

Case No.:24/30/83‐ALC1/2007

Party Name:AUCTUS PHARMA PRIVATE LIMITED 08.04.2008 Status:Case Approved HQ File :01/83/050/01393/AM08/ RLA File :09/24/040/00319/AM08/ Lic.No/Date:0910031843 23.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Refaximin under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/123/2007‐PI‐III dated 24.03.2008 decided to Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Rifaximin 1kg. 1. Rifamycin‐O 1.52 kg/kg 2. 2‐Amino‐4‐Picoline 0.43 kg/kg 3. Methanol 2.56 kg/kg 24

Case No.:19/32/83‐ALC1/2007

Party Name:IND‐SWIFT LABORATORIES LTD., 08.04.2008 Status:Case Approved HQ File :01/83/050/01441/AM08/ RLA File :22/24/040/00046/AM08/ Lic.No/Date:2210007184 25.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Clarithromycin Granules 42% (Suspension Grade) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/159/2005‐PI‐III dated 08.04.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Clarithromycin Granules 1kg. 1. Clarithromycin (OR) 0.4242 kg/kg

42% (Suspension Grade) Its raw material as per SION A‐2263 on pro‐rata basis 2. Carbopol 0.30 kg/kg 3. HPMC Phthalate 0.30 kg/kg 25

Case No.:20/32/83‐ALC1/2007

Party Name:IND‐SWIFT LABORATORIES LTD., 08.04.2008 Status:Case Approved HQ File :01/83/050/01442/AM08/ RLA File :22/24/040/00045/AM08/ Lic.No/Date:2210007185 25.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Clarithromycin Granules 27.5% (Suspension Grade) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/159/2005‐PI‐III dated 08.04.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Clarithromycin Granules 27.5% (Suspension Grade) 1kg. 1. Clarithromycin (OR) 0.2777 kg/kg Its raw material as per SION A‐2263 on pro‐rata basis 2. Carbopol 0.20 kg/kg 3. HPMC Phthalate 0.54 kg/kg 26

Case No.:80/32/83‐ALC1/2007

Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 08.04.2008 Status:Case Approved HQ File :01/83/050/01502/AM08/ RLA File :05/24/040/00562/AM08/ Lic.No/Date:0510211568 05.11.2007

Decision : Committee considered case as per agenda for ratification of norms for export product (4R‐CIS)‐1,1‐Dimethylethyl‐6‐ Cyanomethyl‐2,2‐Dimethyl‐1‐3‐Dioxane‐4‐Acetate (ATS‐8) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/20/2007‐PI‐III dated 24.03.2008 decided to Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (4‐R‐Cis)‐1,1 dimethyl ethyl‐6‐ cyanomethyl‐2,2 dimethyl‐ 1,3‐dioxane‐4‐acetate (ATS 8) 1kg. 1. Ethyl ®‐4‐cyno‐3‐Hydroxy Butanoate 1.00 kg/kg 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg/kg 3. Tertiary Butyl Acetate 2.11 kg/kg 4. Tetra Hydro Furan 5.63 kg/kg 5. 2,2‐Dimethoxy propane 2.79 kg/kg 6. Ketroreducatse YDH/KRED 0.013 kg/kg 7. Glucose Dehydrogenase Enzyme GDH 0.0045 kg/kg 8. B‐Nicotinamide‐adenine dinucleotide phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 gm/kg 27

Case No.:21/33/83‐ALC1/2007

Party Name:SHODHANA LABORATORIES LTD. 08.04.2008 Status:Case Approved HQ File :01/83/050/01550/AM08/ RLA File :09/24/040/00328/AM08/ Lic.No/Date:0910032054 12.11.2007 Decision : Committee considered case as per agenda for ratification of norms for export product 4‐(2,3‐Epoxy Propoxy) Carbazole under para 4.7 of HBP. Committee in light of its earlier decision taken in its 35/08 meeting held on 01.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Sl.No. Import items Qty. allowed per

Qty. unit of export product 4‐(2,3‐Epoxy Propoxy) Carbazole 1kg. 1. 4‐Hydroxy Carbazole 1.14 kg/kg 2. Epichlorophdrin 2.02kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee. 28

Case No.:22/33/83‐ALC1/2007

Party Name:SHODHANA LABORATORIES LTD. 08.04.2008 Status:Case Deferred HQ File :01/83/050/01551/AM08/ RLA File :09/24/040/00332/AM08/ Lic.No/Date:0910032055 12.11.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐(2‐Methoxy Phenoxy) Ethylamine under

para 4.7 of HBP.

Case No.:26/33/83‐ALC1/2007

Party Name:SHODHANA LABORATORIES LTD. 08.04.2008 Status:Case Approved HQ File :01/83/050/01555/AM08/ RLA File :09/24/040/00359/AM08/ Lic.No/Date:0910032060 13.11.2007 Decision : Committee considered case as per agenda for ratification of norms for export product 4‐(2,3‐Epoxy Propoxy) Carbazole under para 4.7 of HBP. Committee in light of its earlier decision taken in its 35/08 meeting held on 01.01.2008 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 4‐(2,3‐Epoxy Propoxy) Carbazole 1kg. 1. 4‐Hydroxy Carbazole 1.14 kg/kg 2. Epichlorophdrin 2.02kg/kg RA concerned may take further necessary action under para 4.7 of HBP as per above decision of Norms Committee.

Case No.:27/33/83‐ALC1/2007

Party Name:SHODHANA LABORATORIES LTD. 08.04.2008 Status:Case Deferred HQ File :01/83/050/01556/AM08/ RLA File :09/24/040/00358/AM08/ Lic.No/Date:0910032061 13.11.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐(2‐Methoxy Phenoxy) Ethylamine under

para 4.7 of HBP.

Case No.:1/38/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 08.04.2008 Status:Case Deferred HQ File :01/83/050/01563/AM08/ RLA File :04/24/040/00281/AM08/ Lic.No/Date:0410092096 15.11.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product (6‐methoxy‐1‐oxoisoindolin‐2‐yl)methyl pivalate under para 4.7 of HBP. 32

Case No.:34/39/83‐ALC1/2007

Party Name:SRINI PHARMACEUTICALS LTD., 08.04.2008 Status:Case Approved HQ File :01/83/050/01613/AM08/ RLA File :09/24/040/00385/AM08/ Lic.No/Date:0910032245 28.11.2007 Decision : Committee considered case as per agenda for ratification of norms for export product (s)Alpha‐Ethyl‐2‐Oxo‐1‐Pyrrolidineacetic Acid (LVA‐40) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/112/2007‐PI‐III dated 31.03.2008 decided to Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (S) Alpha‐ethyl‐2‐oxo‐1‐ pyrrolidineacetic acid 1kg. 1. 2‐Pyrrolidone 1.41 kg/kg 2. Methyl‐2‐bromobutyrate 3.00 kg/kg 3. ®‐(+)‐ alphamethylbenzylamine 0.474 kg/kg

Methyl iso butyl ketone 2.11 kg/kg 33

Case No.:68/39/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 08.04.2008 Status:Case Deferred HQ File :01/83/050/01647/AM08/ RLA File :04/24/040/00289/AM08/ Lic.No/Date:0410092451 30.11.2007 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Fluoro Adenosin Triacetate (2‐FAT) under

para 4.7 of HBP.

Case No.:170/39/83‐ALC1/2007

Party Name:MAHAVIR DYE CHEM 08.04.2008 Status:Case Rejected HQ File :01/83/050/01749/AM08/ RLA File :52/24/040/00023/AM08/ Lic.No/Date:5210022614 14.12.2007 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐(3‐Aminophenyl Sulfonamide)Naphthalene‐ 6.8‐Disulfonic Acid under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.14010/48/2004‐Ch.II signed on 08.04.2008 observed that firm has started their manufacturing process from Nitro Benzene and Amino G Acid and import item Beta Napthol is not consumed in the process. Committee, therefore, decided to close the case. 35

Case No.:10/42/83‐ALC1/2007

Party Name:IND‐SWIFT LABORATORIES LTD., 08.04.2008 Status:Case Approved HQ File :01/83/050/01786/AM08/ RLA File :22/24/040/00060/AM08/ Lic.No/Date:2210007348 01.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Atorvastatin Calcium under para 4.7 of HBP. Committee in light of its earlier decision taken in its 23/82 meeting held on 09.10.2007 and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐

Export product Export Qty. SL.No. Import items Qty. allowed per unit of export product Atorvastatin Calcium 1kg. 1. Methyl Isobutyl Acetate 1.76 kg/kg 2. Betaalanine 0.100 kg/kg 3. 3‐Ethyl‐5‐0(2‐hydroxyethyl)‐4‐ Methyl Thiozolium Bromide 0.30 kg/kg 4. 4R‐cis)‐1,1‐dimethyl ethyl‐6‐ cyanomethyl‐2, 2‐dimethyl‐1,3‐ dioxane‐4‐acetate(ATS‐8) 1.08 kg/kg 5. Sodium Metabisulphide 0.037 kg/kg 6. Parafluoro benzaldehyde 0.85 Kg/Kg 7. IPA 8.375 kg/kg 8. Tertiary Butyl Methyl Ether 4.37 kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 36

Case No.:12/42/83‐ALC1/2007

Party Name:PARABOLIC DRUGS LTD., 08.04.2008 Status:Case Deferred HQ File :01/83/050/01788/AM08/ RLA File :22/24/040/00053/AM08/ Lic.No/Date:2210007356 04.01.2008 Defer Date: 21.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 7‐AVCA under para 4.7 of HBP. Committee decided to defer case for six weeks for comments of PI Division. 37

Case No.:2/2/82‐ALC4/2008

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 08.04.2008 Status:Case Approved HQ File :01/82/050/00617/AM08/ RLA File :08/24/040/00277/AM07/ Lic.No/Date:0810069798 24.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Benzyl Tri Butyl Ammonium Chloride under

para 4.7 of HBP.

Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/84/2002‐CH‐III signed on 08.04.2008 and in consultation with representative of Chemical Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Benzyl Tributyl Ammonium Chloride 1kg. 1. Tributyl Amine 0.693 kg/kg 2. Methyl Isobutyl Ketone 0.230 kg/kg 3. Methyl Ethyl Ketone 0.380 kg/kg 4. Activated Carbon 0.010 kg/kg 38

Case No.:1/2/82‐ALC4/2008

Party Name:KUDOES CHEMIE LTD., 08.04.2008 Status:Case Deferred HQ File :01/82/050/00616/AM08/ RLA File :22/24/040/00080/AM08/ Lic.No/Date:2210007593 20.03.2008 Defer Date: 06.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Caffeine under para 4.7 of HBP.

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