DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 14/82‐ALC4/2010 MEETING DATE : 06.07.2010 The Mee退ng No.14/82 in the year 2010‐11 to consider the cases under Duty Exemp退on Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 06.07.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri D.N. Mathur, Dy. IA, Department of Pharmaceu退cals 2. Shri M. Mitra, Dy.DCGI, o/o DCGI 3. Shri A.K. Sinha, Ass題�. Director, Pharmexcil 4. Shri Krishan Kumar, Dy. DGFT 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms Commi題�ee Mee退ng No. 10/82 dated 08.06.2010 and 13/11 dated 29.06.2010 were ra退fied by the Commi題�ee.
Case No.B‐139
M/S Halcyon Labs Pvt.Ltd. Norms Commi題�ee Mee退ng No.14/11 F.No.01/82/050/00725/AM03 Mee退ng Date:06.07.2010 RA F.No.03/24/040/01314/AM03 Adv.Lic.No.0310171208 dated 09.12.2002 Commi題�ee considered case as per agenda and in consulta退on with technical authority present in mee退ng decided to amend the UOM of export product to read as “KG” without any other change in the decision taken in 46/03 mee退ng held on 05.03.2003. RA concerned may take further necessary ac退on as per above decision of NC.
Case No.B‐140
M/S Esteem Industries Pvt. Ltd. Norms Commi題�ee Mee退ng No.14/11 F.No.01/82/050/01735/AM08 Mee退ng Date:06.07.2010 RA F.No.17/24/040/00117/AM08 Adv.Lic.No.1710001862 dated 12.12.2007 Commi題�ee decided to defer case for 03.08.2010 for comments of Department of C&PC. 1
Case No.:25/15/82‐ALC4/2009
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD Meet No/Date:14/82‐ALC4/2010 06.07.2010 Status:Case Deferred
HQ File :01/82/050/00254/AM10/ RLA File :09/24/040/00087/AM10/ Lic.No/Date:0910038375 29.06.2009 Defer Date:31.08.2010 Decision :Commi題�ee decided to defer case for 31.08.2010 for reply form firm. 2
Case No.:16/20/82‐ALC4/2009
Party Name:PANACEA BIOTEC LTD., 06.07.2010 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:31.08.2010 Decision :Commi題�ee decided to defer case for 31.08.2010 for comments of Department of Bio‐technology. 3
Case No.:18/46/82‐ALC4/2009
Party Name:CIPLA LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00934/AM10/ RLA File :03/94/040/00406/AM10/ Lic.No/Date:0310532726 07.08.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/15/2010‐PI (Norms) dated 08.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退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 Prednisilone Tablets 5 mg 1 No. 1. Prednisolone 5.10 mg 2. Gela退n 1.90 mg 3. Lactose Hydrate 72.60 mg 4
Case No.:9/34/82‐ALC4/2009
Party Name:SURYA PHARMACEUTICAL LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00654/AM10/ RLA File :22/24/040/00021/AM10/ Lic.No/Date:2210009180 20.08.2009 Defer Date:31.08.2010 Decision :Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/300/2009‐PI (Norms) dated 11.05.2010, decided to call for the following informa退on from the firm. 1. Complete & balanced chemical reac退ons for each step of manufacturing process indicate molecular weight of each reactant and output material, % yield on molar basis etc. 2. Material balance for en退re process. 3. Requirement and recovery of solvent at each step. Accordingly, case was deferred for 31.08.2010.
5
Case No.:25/46/82‐ALC4/2009
Party Name:CIPLA LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00941/AM10/ RLA File :03/94/040/00434/AM10/ Lic.No/Date:0310534556 20.08.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/15/2010‐PI (Norms) dated 08.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Prednisilone Tablets 5 mg 1 No. 1. Prednisolone 5.10 mg 2. Gela退n 1.90 mg 3. Lactose Hydrate 72.60 mg 6
Case No.:19/24/82‐ALC4/2009
Party Name:PANACEA BIOTEC LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00516/AM10/ RLA File :05/24/040/00299/AM10/ Lic.No/Date:0510248628 28.08.2009 Defer Date:31.08.2010 Decision :Commi題�ee decided to defer case for 31.08.2010 for comments of Department of Bio‐technology. 7
Case No.:27/24/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 06.07.2010 Status:Case deferred HQ File :01/82/050/00524/AM10/ RLA File :09/24/040/00196/AM10/ Lic.No/Date:0910039221 01.09.2009 Defer Date:31.08.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/392/2009‐PI (Norms) dated 11.06.2010, decided to call for the following informa退on from the firm. 1. End use of the export product. In case this is drug intermediate, name of the bulk drug may be indicated. 2. Stepwise complete chemical reac退ons indica退ng molecular weight, molar requirement and % yield on molar basis. 3. Requirement and recovery of solvent at each step. 4. Material balance for the en退re process. Accordingly, case was deferred for 31.08.2010. 8
Case No.:28/24/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 06.07.2010 Status:Case Deferred
HQ File :01/82/050/00525/AM10/ RLA File :09/24/040/00199/AM10/ Lic.No/Date:0910039222 01.09.2009 Defer Date:31.08.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/392/2009‐PI (Norms) dated 11.06.2010, decided to call for the following informa退on from the firm. 1. End use of the export product. In case this is drug intermediate, name of the bulk drug may be indicated. 2. Stepwise complete chemical reac退ons indica退ng molecular weight, molar requirement and % yield on molar basis. 3. Requirement and recovery of solvent at each step. 4. Material balance for the en退re process. Accordingly, case was deferred for 31.08.2010. 9
Case No.:14/14/82‐ALC4/2010
Party Name:IND‐SWIFT LABORATORIES LTD., 06.07.2010 Status:Case Approved HQ File :01/82/050/00376/AM11/ RLA File :22/24/040/00029/AM10/ Lic.No/Date:2210009284 24.09.2009 Decision : Commi題�ee considered case as per agenda and in light of earlier decision taken in 14/08 mee退ng held on 07.08.2007 and in consulta退on with technical authority present in mee退ng, decided to ra退fy 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 Clarithromycin Granules 33% (Suspension Grade) 1kg. 1. Raw Material of Clarithromycin as per SION A‐2263 on pro‐rata basis 2. Carbopol 0.25 kg 3. HPMC Phthalate 0.44 kg RA concerned may take further necessary ac退on as per above decision of NC. 10
Case No.:15/14/82‐ALC4/2010
Party Name:IND‐SWIFT LABORATORIES LTD., 06.07.2010 Status:Case Approved HQ File :01/82/050/00377/AM11/ RLA File :22/24/040/00028/AM10/ Lic.No/Date:2210009285 24.09.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/246/2009‐PI‐(Norms) dated 20.01.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy 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 Clarithromycin Granules 27.5% 1kg. 1. Clarithromycin 0.2777 KG
(Suspension Grade) 2. Carbopol 0.20 kg 3. HPMC Phthalate 0.54 kg RA concerned may take further necessary ac退on as per above decision of NC. 11
Case No.:30/29/82‐ALC4/2009
Party Name:PROMED EXPORTS PVT.LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00600/AM10/ RLA File :05/24/040/00332/AM10/ Lic.No/Date:0510250305 06.10.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/336/2009‐PI‐(Norms) dated 13.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy 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 Ciprofloxacin 0.3% and Dexamethasone 0.1% Eye ear drops 5 ml pack 1 pack 1. Dexamethasone 5.1 mg/5 ml pack RA concerned may take further necessary ac退on as per above decision of NC. 12
Case No.:75/14/82‐ALC4/2010
Party Name:GULBRANDSEN CHEMICALS PVT LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00437/AM11/ RLA File :34/24/040/00105/AM10/ Lic.No/Date:3410025321 09.10.2009 Defer Date:31.08.2010 Decision :Commi題�ee decided to defer case for 31.08.2010 for comments of Department of C&PC. 13
Case No.:14/33/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00642/AM10/ RLA File :09/24/040/00262/AM10/ Lic.No/Date:0910039756 29.10.2009 Defer Date:31.08.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/392/2009‐PI (Norms) dated 11.06.2010, decided to call for the following informa退on from the firm. 1. End use of the export product. In case this is drug intermediate, name of the bulk drug may be indicated. 2. Stepwise complete chemical reac退ons indica退ng molecular weight, molar requirement and % yield on molar basis. 3. Requirement and recovery of solvent at each step. 4. Material balance for the en退re process.
Accordingly, case was deferred for 31.08.2010. 14
Case No.:15/33/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00643/AM10/ RLA File :09/24/040/00240/AM10/ Lic.No/Date:0910039761 29.10.2009 Defer Date:31.08.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/392/2009‐PI (Norms) dated 11.06.2010, decided to call for the following informa退on from the firm. 1. End use of the export product. In case this is drug intermediate, name of the bulk drug may be indicated. 2. Stepwise complete chemical reac退ons indica退ng molecular weight, molar requirement and % yield on molar basis. 3. Requirement and recovery of solvent at each step. 4. Material balance for the en退re process. Accordingly, case was deferred for 31.08.2010. 15
Case No.:21/2/82‐ALC4/2010
Party Name:THERMAX LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/01255/AM10/ RLA File :31/24/040/00138/AM10/ Lic.No/Date:3110040580 10.11.2009 Defer Date:31.08.2010 Decision :Commi題�ee decided to defer case for 31.08.2010 for comments of Department of C&PC, PC Division. 16
Case No.:32/35/82‐ALC4/2009
Party Name:SMILAX LABORATORIES LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00722/AM10/ RLA File :09/24/040/00299/AM10/ Lic.No/Date:0910039896 12.11.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their U.O. No.35011/251/2008‐PI‐III dated 23.04.2009 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 5‐(Difluoromethoxy)‐2‐((3,4‐ Dimethoxypyridin‐2‐ YL)Methylthio)‐1H‐Benzimidazole [Pantoprazole‐Sulphide] 1 Kg. 1. 3‐Hydroxy‐2‐Methyl‐4H‐Pyran‐4‐ One[Maltol] 1.32 kg 2. Toluene 4.60 kg 3. Methanol 2.458 kg 4. Methylene dichloride 2.457 kg 5. Acetone 0.35 kg
5‐Difluoromethoxy‐2‐mercapto 1H‐ Benzimidazole 0.70 kg 17
Case No.:25/2/82‐ALC4/2010
Party Name:THERMAX LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/01259/AM10/ RLA File :31/24/040/00141/AM10/ Lic.No/Date:3110040624 12.11.2009 Defer Date:31.08.2010 Decision : Commi題�ee decided to defer case for 31.08.2010 for comments of Department of C&PC. 18
Case No.:20/2/82‐ALC4/2010
Party Name:THERMAX LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/01254/AM10/ RLA File :31/24/040/00139/AM10/ Lic.No/Date:3110040645 13.11.2009 Defer Date:31.08.2010 19
Case No.:12/36/82‐ALC4/2009
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00737/AM10/ RLA File :04/24/040/00193/AM10/ Lic.No/Date:0410109462 17.11.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/391/2009‐PI (Norms) dated 04.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退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 Phenylepherine Hcl 1 kg 1. Phenylepherine Base 0.912 kg 2. Methanol 0.50 kg 3. Iso Propyl alcohol 0.50 kg 20
Case No.:68/14/82‐ALC4/2010
Party Name:HETERO LABS LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00430/AM11/ RLA File :09/24/040/00344/AM10/ Lic.No/Date:0910039963 18.11.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M.
No.35011/289/2009‐PI‐III dated 29.12.2009 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Oseltamivir Phosphate 1 Kg. 1. Shikimic Acid 4.025 kg 2. 2,2‐Dimethoxy Propane 0.043 kg 3. 3‐Pentanone 14.239 kg 4. Trifluoromethane Sulfonic Acid 0.204 kg 5. Triethyl Silane 3.00 kg 6. Methanol 2.410 kg 7. Methylene Chloride 13.52 kg 8. Tetrahydrofuran 2.77 kg 9. Dimethyl formamide 1.57 kg 21
Case No.:5/37/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00748/AM10/ RLA File :09/24/040/00325/AM10/ Lic.No/Date:0910039975 19.11.2009 Defer Date:31.08.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/392/2009‐PI (Norms) dated 11.06.2010, decided to call for the following informa退on from the firm. 1. End use of the export product. In case this is drug intermediate, name of the bulk drug may be indicated. 2. Stepwise complete chemical reac退ons indica退ng molecular weight, molar requirement and % yield on molar basis. 3. Requirement and recovery of solvent at each step. 4. Material balance for the en退re process. Accordingly, case was deferred for 31.08.2010. 22
Case No.:6/37/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00749/AM10/ RLA File :09/24/040/00326/AM10/ Lic.No/Date:0910039976 19.11.2009 Defer Date:31.08.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/392/2009‐PI (Norms) dated 11.06.2010, decided to call for the following informa退on from the firm. 1. End use of the export product. In case this is drug intermediate, name of the bulk drug may be indicated. 2. Stepwise complete chemical reac退ons indica退ng molecular weight, molar requirement and % yield on molar basis.
3. Requirement and recovery of solvent at each step. 4. Material balance for the en退re process. Accordingly, case was deferred for 31.08.2010. 23
Case No.:9/37/82‐ALC4/2009
Party Name:ARCH PHARMALABS LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00752/AM10/ RLA File :03/94/040/00704/AM10/ Lic.No/Date:0310546649 19.11.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/395/2009‐PI (Norms) dated 04.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Irinotecan Hcl 1 kg 1. 7‐Ethyl‐10‐Hydroxycamptothecin 1.035 kg 2. 1,4‐Bipiperidinyl‐1‐Carbonyl Chloride 0.608 kg 24
Case No.:16/37/82‐ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00759/AM10/ RLA File :09/24/040/00294/AM10/ Lic.No/Date:0910040009 24.11.2009 Defer Date:31.08.2010 Decision : Commi題�ee decided to defer case for 31.08.2010 for comments of Department of Pharmaceu退cals. 25
Case No.:17/37/82‐ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00760/AM10/ RLA File :09/24/040/00244/AM10/ Lic.No/Date:0910040010 24.11.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/397/2009‐PI‐III dated 04.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Losartan Potassium 1 Kg. 1. Valeronitrile 0.738 kg 2. Di methyl formamide 1.10 kg 3. Methanol 2.51 kg 4. Toluene 2.04 kg
Glycine 0.50 kg 6. Phasphorus Oxychloride 1.86 kg 7. Tetra Hydro Furan 0.94 kg 8. Para Chloro Toluene 0.97 kg 9. Ortho Chloro Benzo nitrile 0.85 kg 10. 1,3‐Dibromo‐5,5‐dimethyl Hydatoin 0.205 kg 11. Chloroform 0.94 kg 12. Sodium Boro Hydride 0.048 kg 13. Tri Ethyl amine Hydrochloride 0.30 kg 26
Case No.:5/38/82‐ALC4/2009
Party Name:LIFE LINE INDUSTRIES LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00778/AM10/ RLA File :03/95/040/00553/AM10/ Lic.No/Date:0310548279 30.11.2009 Defer Date:17.08.2010 Decision :Commi題�ee decided to defer case for 17.08.2010 for Central Excise Data to be received from firm. 27
Case No.:6/38/82‐ALC4/2009
Party Name:LIFE LINE INDUSTRIES LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00779/AM10/ RLA File :03/95/040/00541/AM10/ Lic.No/Date:0310548289 30.11.2009 Defer Date:17.08.2010 Decision :Commi題�ee decided to defer case for 17.08.2010 for Central Excise data to be received from firm. 28
Case No.:31/2/82‐ALC4/2010
Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 06.07.2010 Status:Case Approved HQ File :01/82/050/01265/AM10/ RLA File :31/24/040/00187/AM10/ Lic.No/Date:3110041059 14.12.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/11/2009/Ch.II dated 17.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退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 Trigonox‐EHP W50 bis(2‐ ethylhexyl)peroxydicarbonate (50%) 1 Kg. 1. 2‐Ethyl hexyl Chloroformate (2‐EHCF) 0.583 kg 2. Polyvinyl Alcohol 0.030 kg 3. An退‐foaming agent (Dequest) 0.0005 kg
29
Case No.:18/2/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 06.07.2010 HQ File :01/82/050/01252/AM10/ RLA File :03/94/040/00618/AM10/ Lic.No/Date:0310551045 16.12.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007/Ch.II dated 17.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Calcium Disodium EDTA (Calcium content 10+0.5%) 1 Kg. 1. Ethylene Diamine Tetra Ace退c Acid (EDTA) 0.720 kg 30
Case No.:41/2/82‐ALC4/2010
Party Name:PI INDUSTRIES LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/01275/AM10/ RLA File :13/24/040/00023/AM10/ Lic.No/Date:1310030771 16.12.2009 Defer Date:31.08.2010 Decision :Commi題�ee decided to defer case for 31.08.2010 for comments of Department of C&PC. 31
Case No.:16/14/82‐ALC4/2010
Party Name:HETERO LABS LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00378/AM11/ RLA File :09/24/040/00379/AM10/ Lic.No/Date:0910040304 16.12.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide O.M. No.35011/375/2009‐PI (Norms) dated 30.04.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退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 Efavirenz 1 Kg. 1. 4‐Chloro‐2‐trifluoro Acetylaniline Hydrochloride hydrate 1.49 kg 2. Cyclopropyl Acetylene 0.524 kg 3. (1R,2S)‐N‐Pyrrolidinyl Norephedrine 0.189 kg 4. Diethyl Zinc (20% in toluene) 4.41 kg 5. 2,2,2‐Trifluoro Ethanol 0.642 kg 6. n‐Butyl Chloride Not allowed 7. Citric Acid Monohydrate 0.81 kg 8. Tetrahydrofuran 5.50 kg
Triphosgene 0.498 kg 10. Methylene Chloride 7.50 kg 11. Cyclohexane 4.20 kg 32
Case No.:9/41/82‐ALC4/2009
Party Name:DHANUKA LABORATORIES LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00844/AM10/ RLA File :05/23/040/00120/AM10/ Lic.No/Date:0510255017 21.12.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide O.M. No.35011/5/2010‐PI (Norms) dated 10.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退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 Tan Endo Powder 1 Kg. 1. Pen‐GK 1.089 kg 2. Dimethyl formamide 4.685 kg 3. Acetone 2.525 kg 4. Methylene Chloride 2.783 kg 5. Para Nitro Benzyl Bromide 0.632 kg 6. Trimethyl Phosphite 0.342 kg 7. Triethyl Amine 0.279 kg 8. Toluene 0.852 kg 33
Case No.:39/2/82‐ALC4/2010
Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 06.07.2010 Status:Case Approved HQ File :01/82/050/01273/AM10/ RLA File :31/24/040/00190/AM10/ Lic.No/Date:3110041176 21.12.2009 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/59/2003/Ch.III dated 20.04.2006 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Trigonox‐25C75 Te退ary butyl peroxy Pivolate 75% in Isododecane 1 Kg. 1. Pivaloyl Chloride 0.546 kg 2. Te退ary butyl hydro peroxide 70% 0.680 kg 3. Isododecane 0.237 kg 4. Magnesium Sulphate 0.036 kg
Container HDPE 30 Ltrs. and Screw Cap R60 are allowed as per packing policy. 34
Case No.:57/2/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/01291/AM10/ RLA File :34/24/040/00169/AM10/ Lic.No/Date:3410025988 24.12.2009 Defer Date:31.08.2010 35
Case No.:2/6/82‐ALC4/2010
06.07.2010 Status:Case Deferred HQ File :01/82/050/00149/AM11/ RLA File :34/24/040/00168/AM10/ Lic.No/Date:3410025987 24.12.2009 Defer Date:31.08.2010 36
Case No.:8/6/82‐ALC4/2010
06.07.2010 Status:Case Deferred HQ File :01/82/050/00155/AM11/ RLA File :34/24/040/00167/AM10/ Lic.No/Date:3410025994 29.12.2009 Defer Date:31.08.2010 37
Case No.:36/2/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/01270/AM10/ RLA File :13/24/040/00025/AM10/ Lic.No/Date:1310030993 31.12.2009 Defer Date:31.08.2010 Decision :Commi題�ee decided to call for a copy of DML from the firm. Accordingly, case was deferred for 31.08.2010. 38
Case No.:117/46/82‐ALC4/2009
Party Name:CIPLA LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/01033/AM10/ RLA File :03/94/040/00865/AM10/ Lic.No/Date:0310554460 08.01.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/284/2009‐PI (Norms) dated 26.04.2010 and in consulta退on with technical authori退es present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as
Export product Exp. Qty. Sl.No. Import items Qty. allowed Entecavir 1 Kg. 1. 2‐Amino‐1,9‐(1S,3R,4S)‐4‐(benzyloxy)‐3‐ (Benzloxymethyl)‐2‐Methylenecyclopentyl)‐6H‐ purin‐6‐one (ECR‐4) 2.0548 kg 39
Case No.:35/2/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 06.07.2010 Status:Case Approved HQ File :01/82/050/01269/AM10/ RLA File :13/24/040/00027/AM10/ Lic.No/Date:1310031092 13.01.2010 Decision : Commi題�ee considered case as per agenda and in consulta退on with technical authority present in mee退ng, decided to ra退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 Cloxacillin for Injec退on BP 250 mg 100% Potency 700000 Vials 1. Cloxacillin 183.75 kg 2. Vials As per packing policy 40
Case No.:6/2/82‐ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00006/AM11/ RLA File :03/95/040/00677/AM10/ Lic.No/Date:0310555187 13.01.2010 Defer Date:31.08.2010 41
Case No.:8/14/82‐ALC4/2010
Party Name:KUSUMA PHARMA 06.07.2010 Status:Case Approved HQ File :01/82/050/00370/AM11/ RLA File :03/94/040/00914/AM10/ Lic.No/Date:0310556411 21.01.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/31/2008.Ch.II dated 21.07.2009, decided to ra退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 Sodium Saccharin (Pure Dental Grade) 100% purity 1 kg 1. Sodium Saccharin (BP) 99% purity 1.02 kg
42
Case No.:5/46/82‐ALC4/2009
Party Name:KALPSUTRA CHEMICALS PVT. LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/00921/AM10/ RLA File :03/94/040/00855/AM10/ Lic.No/Date:0310556797 25.01.2010 Defer Date:31.08.2010 43
Case No.:40/2/82‐ALC4/2010
Party Name:TORRENT PHARMACEUTICALS LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/01274/AM10/ RLA File :08/24/040/00297/AM10/ Lic.No/Date:0810085981 25.01.2010 Decision : Commi題�ee considered case as per agenda and in light of earlier decision taken in 11/82 mee退ng held on 15.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退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 Bisoprolol Fumarate and Hydrochlorothiazide Tablet Comp. Heumann 5/12.5 mg 1 No. 1. Bisoprolol Fumarate 5.1 mg Bisoprolol Fumarate and Hydrochlorothiazide Tablet Comp. Heumann 10/25 mg 1 No. 1. Bisoprolol Fumarate 10.2 mg 44
Case No.:32/2/82‐ALC4/2010
Party Name:POLYGON CHEMICALS 06.07.2010 Status:Case Deferred HQ File :01/82/050/01266/AM10/ RLA File :08/24/040/00293/AM10/ Lic.No/Date:0810086038 27.01.2010 Defer Date:31.08.2010 Decision :Commi題�ee considered case as per agenda and decided to call for Produc退on and Consump退on data cer退fied by Cost Accountant/Chartered Accountant/Juridic退onal Excise Authority from firm. Accordingly, case was deferred for 31.08.2010. 45
Case No.:58/2/82‐ALC4/2010
06.07.2010 Status:Case Deferred HQ File :01/82/050/01292/AM10/ RLA File :34/24/040/00192/AM10/ Lic.No/Date:3410026193 28.01.2010 Defer Date:31.08.2010 46
Case No.:13/14/82‐ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 06.07.2010 Status:Case Approved
HQ File :01/82/050/00375/AM11/ RLA File :09/24/040/00428/AM10/ Lic.No/Date:0910040713 29.01.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/288/2009‐PI (Norms) dated 30.04.2010and in consulta退on with technical authori退es present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed (+)‐Methyl‐Alpha‐(2‐Thienyle Thamino)(2‐Chlorophenyl) Acetate Hydrochloride 1 Kg. 1. DL‐2‐Chlorophenyl Glycine 1.00 kg 2. Methanol 2.56 kg 3. Toluene 0.60 kg 4. Methylene Chloride 1.81 kg 5. Acetone 1.96 kg 6. Thiophene‐2‐Ethanol 0.60 kg 7. Ethyl Acetate 1.81 kg 8. Isopropyl Alcohol 0.60 kg 47
Case No.:71/14/82‐ALC4/2010
Party Name:RELIABLE DYE‐CHEM PVT. LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/00433/AM11/ RLA File :24/24/040/00016/AM10/ Lic.No/Date:2410027269 29.01.2010 Defer Date:31.08.2010 48
Case No.:18/47/82‐ALC4/2009
Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 06.07.2010 Status:Case Approved HQ File :01/82/050/01061/AM10/ RLA File :31/24/040/00226/AM10/ Lic.No/Date:3110041784 02.02.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/11/2009/Ch.II dated 17.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Trigonox‐C Tert.butyl peroxy benzoate 1 Kg. 1. Tert butyl hydro peroxide 70% 0.720 kg 2. Benzoyl Chloride (BOCI) 0.765 kg 3. Magnesium Sulphate 0.026 kg
49
Case No.:20/47/82‐ALC4/2009
Party Name:STERLING BIOTECH LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/01063/AM10/ RLA File :34/24/040/00188/AM10/ Lic.No/Date:3410026245 02.02.2010 Defer Date:31.08.2010 50
Case No.:24/2/82‐ALC4/2010
Party Name:POLYGON CHEMICALS 06.07.2010 Status:Case Deferred HQ File :01/82/050/01258/AM10/ RLA File :08/24/040/00300/AM10/ Lic.No/Date:0810086172 02.02.2010 Defer Date:31.08.2010 Decision : Commi題�ee considered case as per agenda and decided to call for Produc退on and Consump退on data cer退fied by Chartered Accountant/Cost Accountant/Juridic退onal Central Excise Authority from firm. Accordingly, case was deferred for 31.08.2010. 51
Case No.:28/2/82‐ALC4/2010
Party Name:RAY CHEMICALS PRIVATE LIMITED, 06.07.2010 Status:Case Approved HQ File :01/82/050/01262/AM10/ RLA File :07/24/040/00389/AM10/ Lic.No/Date:0710069797 03.02.2010 Decision : Commi題�ee considered case as per agenda in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their U.O. No.35011/207/2004‐ PI‐III dated 10.06.2008 decided to ra退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 Bromazepam BP 1kg. 1. 2‐(2‐Amino‐5‐Bromo)Benzoyl pyridine 1.43 kg/kg 52
Case No.:27/2/82‐ALC4/2010
Party Name:ARJUN CHEMICALS PVT. LTD., 06.07.2010 Status:Case Defered HQ File :01/82/050/01261/AM10/ RLA File :04/24/040/00279/AM10/ Lic.No/Date:0410111329 04.02.2010 Defer Date:17.08.2010 Decision : Commi題�ee decided to defer case for 17.08.2010 for comments of Department of C&PC. 53
Case No.:17/2/82‐ALC4/2010
Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/01251/AM10/ RLA File :03/94/040/01001/AM10/ Lic.No/Date:0310560279 15.02.2010 Defer Date:31.08.2010
54
Case No.:49/2/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/01283/AM10/ RLA File :09/24/040/00474/AM10/ Lic.No/Date:0910041038 22.02.2010 Defer Date:31.08.2010 55
Case No.:48/2/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/01282/AM10/ RLA File :09/24/040/00486/AM10/ Lic.No/Date:0910041063 25.02.2010 Defer Date:31.08.2010 56
Case No.:38/2/82‐ALC4/2010
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/01272/AM10/ RLA File :13/24/040/00030/AM10/ Lic.No/Date:1310031525 02.03.2010 Defer Date:31.08.2010 57
Case No.:10/14/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00372/AM11/ RLA File :09/24/040/00507/AM10/ Lic.No/Date:0910041153 03.03.2010 Defer Date:31.08.2010 58
Case No.:11/14/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00373/AM11/ RLA File :09/24/040/00509/AM10/ Lic.No/Date:0910041154 03.03.2010 Defer Date:31.08.2010 59
Case No.:9/6/82‐ALC4/2010
Party Name:YASHASHVI RASAYAN PVT.LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00156/AM11/ RLA File :52/24/040/00038/AM10/ Lic.No/Date:5210029879 04.03.2010 Defer Date:31.08.2010 Decision :Commi題�ee decided to forward a copy of applica退on to Department of Pharmaceu退cals for their comments. Accordingly, case was deferred for 31.08.2010.
� py pp p g y 60
Case No.:50/2/82‐ALC4/2010
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:14/82‐ALC4/2010 06.07.2010 Status:Case Deferred HQ File :01/82/050/01284/AM10/ RLA File :09/24/040/00483/AM10/ Lic.No/Date:0910041210 08.03.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to forward a copy of applica退on to Department of Pharmaceu退cals for their comments. Accordingly, case was deferred for 31.08.2010. 61
Case No.:51/2/82‐ALC4/2010
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:14/82‐ALC4/2010 06.07.2010 Status:Case Deferred HQ File :01/82/050/01285/AM10/ RLA File :09/24/040/00480/AM10/ Lic.No/Date:0910041209 08.03.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to forward a copy of applica退on to Department of Pharmaceu退cals for their comments. Accordingly, case was deferred for 31.08.2010. 62
Case No.:52/2/82‐ALC4/2010
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:14/82‐ALC4/2010 06.07.2010 Status:Case Deferred HQ File :01/82/050/01286/AM10/ RLA File :09/24/040/00479/AM10/ Lic.No/Date:0910041212 08.03.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to forward a copy of applica退on to Department of Pharmaceu退cals for their comments. Accordingly, case was deferred for 31.08.2010. 63
Case No.:54/2/82‐ALC4/2010
Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:14/82‐ALC4/2010 06.07.2010 Status:Case Deferred HQ File :01/82/050/01288/AM10/ RLA File :09/24/040/00484/AM10/ Lic.No/Date:0910041211 08.03.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to forward a copy of applica退on to Department of Pharmaceu退cals for their comments. Accordingly, case was deferred for 31.08.2010. 64
Case No.:23/14/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00385/AM11/ RLA File :09/24/040/00482/AM10/ Lic.No/Date:0910041256 10.03.2010 Decision :Commi題�ee considered case as per agenda and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as applied by firm. 65
Case No.:6/6/82‐ALC4/2010
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 06.07.2010 Status:Case Deferred
HQ File :01/82/050/00153/AM11/ RLA File :34/24/040/00215/AM10/ Lic.No/Date:3410026599 12.03.2010 Defer Date:31.08.2010 66
Case No.:14/6/82‐ALC4/2010
06.07.2010 Status:Case Deferred HQ File :01/82/050/00161/AM11/ RLA File :34/24/040/00229/AM10/ Lic.No/Date:3410026592 12.03.2010 Defer Date:31.08.2010 67
Case No.:10/6/82‐ALC4/2010
06.07.2010 Status:Case Deferred HQ File :01/82/050/00157/AM11/ RLA File :34/24/040/00234/AM10/ Lic.No/Date:3410026619 17.03.2010 Defer Date:31.08.2010 68
Case No.:11/6/82‐ALC4/2010
06.07.2010 Status:Case Deferred HQ File :01/82/050/00158/AM11/ RLA File :34/24/040/00233/AM10/ Lic.No/Date:3410026618 17.03.2010 Defer Date:31.08.2010 69
Case No.:65/14/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 06.07.2010 Status:Case Deferred HQ File :01/82/050/00427/AM11/ RLA File :03/94/040/01083/AM10/ Lic.No/Date:0310565063 17.03.2010 Defer Date:31.08.2010 70
Case No.:13/6/82‐ALC4/2010
06.07.2010 Status:Case Deferred HQ File :01/82/050/00160/AM11/ RLA File :34/24/040/00235/AM10/ Lic.No/Date:3410026639 18.03.2010 Defer Date:31.08.2010 71
Case No.:34/14/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 06.07.2010 Status:Case
Deferred HQ File :01/82/050/00396/AM11/ RLA File :09/24/040/00527/AM10/ Lic.No/Date:0910041331 18.03.2010 Defer Date:31.08.2010 72
Case No.:18/9/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 06.07.2010 HQ File :01/82/050/00233/AM11/ RLA File :03/94/040/01074/AM10/ Lic.No/Date:0310565586 19.03.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007/Ch.II dated 14.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Disodium Managenese EDTA Mn. content 12.5% (+0.5%) 1 Kg. 1. Ethylene Diamine Tetra Ace退c Acid (EDTA) 0.690 kg 73
Case No.:17/14/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00379/AM11/ RLA File :09/24/040/00517/AM10/ Lic.No/Date:0910041370 19.03.2010 Defer Date:31.08.2010 74
Case No.:21/14/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00383/AM11/ RLA File :09/24/040/00516/AM10/ Lic.No/Date:0910041369 19.03.2010 Defer Date:31.08.2010 75
Case No.:24/14/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00386/AM11/ RLA File :09/24/040/00515/AM10/ Lic.No/Date:0910041368 19.03.2010 Decision : Commi題�ee considered case as per agenda and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as applied by firm.
76
Case No.:1/6/82‐ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 06.07.2010 Status:Case Deferred HQ File :01/82/050/00148/AM11/ RLA File :52/24/040/00032/AM10/ Lic.No/Date:5210030126 24.03.2010 Defer Date:31.08.2010 Decision :Commi題�ee considered case as per agenda and decided to call for Produc退on and Consump退on data cer退fied by Chartered Accountant/Cost Accountant/Juridic退onal Central Excise Authority from the firm. Accordingly, case was deferred for 31.08.2010. 77
Case No.:18/14/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 06.07.2010 Status:Case Approved HQ File :01/82/050/00380/AM11/ RLA File :09/24/040/00533/AM10/ Lic.No/Date:0910041416 24.03.2010 Decision : Commi題�ee considered the case as per agenda and in light of earlier decision taken in 27/09 mee退ng held on 30.09.2008 and in consulta退on with Technical Authority present in the mee退ng decided to revise the norms as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Cyclopentadecanolide (Recrystallised) 1 Kg. 1. Cyclopentadecanolide (technical grade) (purity NMT 98.5%) 1.075 kg 2. Methanol 2.00 kg RA Concerned may take further necessary ac退on as per above decision of NC. 78
Case No.:22/14/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00384/AM11/ RLA File :09/24/040/00532/AM10/ Lic.No/Date:0910041417 24.03.2010 Defer Date:31.08.2010 79
Case No.:33/14/82‐ALC4/2010
Party Name:DIVIS LABORATORIES LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00395/AM11/ RLA File :09/24/040/00530/AM10/ Lic.No/Date:0910041415 24.03.2010 Defer Date:31.08.2010 80
Case No.:70/14/82‐ALC4/2010
Party Name:ONEIRO CHEMICALS LTD Status:Case
06.07.2010 Approved HQ File :01/82/050/00432/AM11/ RLA File :34/24/040/00244/AM10/ Lic.No/Date:3410026691 25.03.2010 Decision : Commi題�ee considered case as per agenda for ra退fica退on of norms and in light of earlier decision taken in 50/82 mee退ng held on 09.03.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis (NC decision dated 17.11.2009):‐ Export product Export Qty. Sl.No. Import items Qty. allowed 2‐Chloromethyl‐3,5‐Dimethyl‐4‐ Methoxy Pyridine Hydrochloride 1 Kg. 1. 3,5 Lu退dine 1.77 kg 2. Toluene 5.20 kg 3. Methanol 4.14 kg 4. Acetone Not used in process. Hence not allowed. 5. Ac退vated Carbon 0.100 kg 6. Ammonium Persulphates 2.43 kg 81
Case No.:74/14/82‐ALC4/2010
Party Name:KOPRAN LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00436/AM11/ RLA File :03/94/040/01116/AM10/ Lic.No/Date:0310566523 25.03.2010 Decision : Commi題�ee considered case as per agenda and in light of earlier decision taken in 52/10 mee退ng held on 23.03.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms on repeat basis 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 Ce蠋riaxone Sodium Sterile 1 Kg. 1. Ce蠋riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 82
Case No.:14/2/82‐ALC4/2010
Party Name:DEEPAK NITRITE LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/01248/AM10/ RLA File :31/24/040/00239/AM10/ Lic.No/Date:3110042616 26.03.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/66/2007‐Ch.II dated 20.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by
Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Ethyl Hexyl Nitrate 1 Kg. 1. 2‐Hexyl Hexanol 0.765 kg 83
Case No.:15/2/82‐ALC4/2010
Party Name:COMBITIC GLOBAL CAPLET PVT. LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/01249/AM10/ RLA File :33/24/040/00016/AM10/ Lic.No/Date:3310015180 26.03.2010 Defer Date:31.08.2010 84
Case No.:47/2/82‐ALC4/2010
Party Name:MEDREICH LIMITED 06.07.2010 HQ File :01/82/050/01281/AM10/ RLA File :07/24/040/00488/AM10/ Lic.No/Date:0710070729 30.03.2010 Decision :Withdrawn as the case has already been approved by NC in 7/82 mee退ng held on 18.05.2010. 85
Case No.:2/2/82‐ALC4/2010
Party Name:EMCURE PHARMACEUTICALS LTD. 06.07.2010 HQ File :01/82/050/00002/AM11/ RLA File :31/24/040/00253/AM10/ Lic.No/Date:3110042693 31.03.2010 Decision : In view of wri題�en comments furnished by Department of Pharmaceu退cals vide their O.M.. No.35011/33/2010‐PI (Norms) dated 01.07.2010 and in consulta退on with Technical authority present in the mee退ng , the commi題�ee decided to ra退fy the 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 Item Qty. allowed Ropivacin Base (L‐N‐N Propylpipecolin Acid‐2,6 Xylidide) 1 Kg 1 L‐Pipecolic Acid 1.157 kg RA concerned may take further necessary ac退on as per above decision of NC. 86
Case No.:5/6/82‐ALC4/2010
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00152/AM11/ RLA File :52/24/040/00042/AM10/ Lic.No/Date:5210030162 31.03.2010 Defer Date:31.08.2010
Decision : Commi題�ee decided to defer case for 31.08.2010 for comments of Department of C&PC 87
Case No.:64/14/82‐ALC4/2010
Party Name:AARTI DRUGS LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00426/AM11/ RLA File :03/94/040/00974/AM10/ Lic.No/Date:0310567549 31.03.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their U.O. No.35011/57/2009‐PI‐III dated 12.06.2009 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Pioglitazone Hcl 1 Kg. 1. 5‐Ethyl‐Pyridyl‐2‐Ethanol 1.20 kg 2. Tetrahydrofuran 2.62 kg 3. Para Hydroxy Benzaldehyde 0.883 kg 4. Potassium Carbonate 1.00 kg 5. Methylene Dichloride 9.39 kg 6. 2,4‐Thiozolidinenone 1.20 kg 7. Piperidine 0.368 kg 8. Methanol 7.32 kg 9. Sodium Borohydride 0.412 kg 10. Isopropyl Alcohol 1.94 kg 11. Ace退c Acid 0.500 kg 12. Sodium Hydroxide 0.500 kg 88
Case No.:67/14/82‐ALC4/2010
Party Name:EMCURE PHARMACEUTICALS LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00429/AM11/ RLA File :31/24/040/00244/AM10/ Lic.No/Date:3110042694 31.03.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/268/2009‐PI‐III dated 24.12.2009 and in consulta退on with technical authori退es present in mee退ng, decided to revise norms under para 4.7 of HBP as per Export product Export Qty. Sl.No. Import items Qty. allowed Efavirenz Micronized 1 kg. 1. (S)‐5‐Chloro‐(Cyclopropylethynyl)‐2‐ Amino‐(Trifluoromethyl)‐Benzene Methanol 1.0173 kg
89
Case No.:4/2/82‐ALC4/2010
Party Name:HETERO LABS LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00004/AM11/ RLA File :09/24/040/00568/AM10/ Lic.No/Date:0910041513 01.04.2010 Defer Date:31.08.2010 90
Case No.:12/14/82‐ALC4/2010
Party Name:VDH INTERNATIONAL 06.07.2010 Status:Case Deferred HQ File :01/82/050/00374/AM11/ RLA File :05/24/040/00514/AM10/ Lic.No/Date:0510261659 01.04.2010 Defer Date:31.08.2010 91
Case No.:11/2/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00011/AM11/ RLA File :05/24/040/00528/AM10/ Lic.No/Date:0510261872 06.04.2010 Decision : Commi題�ee considered case as per agenda and taking cue from SION A‐1931 and in consulta退on with technical authority present in mee退ng decided to ra退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 Mupirocin Ointment (Mupirax Ointment) 20 mg 45000 No. 1. Mupirocin 13.77 kg 92
Case No.:19/14/82‐ALC4/2010
Party Name:GRANULES INDIA LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00381/AM11/ RLA File :09/24/040/00556/AM10/ Lic.No/Date:0910041593 08.04.2010 Decision : : Commi題�ee considered case as per agenda and in light of wri題�en comments of PI Division vide their O.M. No.35011/71/2008‐PI‐III dated 30.08.2008 and in consulta退on with technical authority present in mee退ng decided to ra退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 Compresso CIP 65 1 Kg. 1. Ciprofloxacin Hydrochloride 0.757 kg 2. Maize Starch 0.159 kg 3. Povidone K‐30 0.005 kg
Sodium Starch Glycollate 0.040 kg 5. Magnesium Stearate 0.009 kg 6. Starch Pregela退nised 0.025 kg 7. Silica, Colloidal Anhydrous 0.005 kg 93
Case No.:32/14/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00394/AM11/ RLA File :09/24/040/00544/AM10/ Lic.No/Date:0910041667 13.04.2010 Decision : Commi題�ee considered case as per agenda and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as applied for by firm. 94
Case No.:36/14/82‐ALC4/2010
Party Name:DR REDDYS LABORATORIES LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00398/AM11/ RLA File :09/24/040/00543/AM10/ Lic.No/Date:0910041666 13.04.2010 Defer Date:31.08.2010 95
Case No.:66/14/82‐ALC4/2010
Party Name:MELZER CHEMICALS PVT. LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00428/AM11/ RLA File :31/24/040/00251/AM10/ Lic.No/Date:3110042864 13.04.2010 Defer Date:31.08.2010 96
Case No.:63/14/82‐ALC4/2010
Party Name:ANUPAM RASAYAN (INDIA) LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00425/AM11/ RLA File :52/24/040/00001/AM11/ Lic.No/Date:5210030320 15.04.2010 Defer Date:31.08.2010 97
Case No.:28/14/82‐ALC4/2010
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 06.07.2010 Status:Case Deferred HQ File :01/82/050/00390/AM11/ RLA File :07/24/040/00005/AM11/ Lic.No/Date:0710070972 Defer
16.04.2010 Date:31.08.2010 98
Case No.:37/14/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 06.07.2010 Status:Case Approved HQ File :01/82/050/00399/AM11/ RLA File :03/94/040/00040/AM11/ Lic.No/Date:0310570081 19.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007/Ch.II dated 17.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Calcium Disodium EDTA (Calcium content 10+0.5%) 1 Kg. 1. Ethylene Diamine Tetra Ace退c Acid (EDTA) 0.720 kg 99
Case No.:38/14/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 06.07.2010 Status:Case Approved HQ File :01/82/050/00400/AM11/ RLA File :03/94/040/00036/AM11/ Lic.No/Date:0310570080 19.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007/Ch.II dated 17.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Manganese Acetate 1 Kg. 1. Manganese Metal 0.236 kg 100
Case No.:44/14/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00406/AM11/ RLA File :03/94/040/00043/AM11/ Lic.No/Date:0310570074 19.04.2010 Defer Date:17.08.2010 Decision : Commi題�ee decided to defer case for 17.08.2010 for comments of Department of C&PC. 101
Case No.:52/14/82‐ALC4/2010
Party Name:AVA CHEMICALS PVT.LTD., 06.07.2010 Status:Case Approved
HQ File :01/82/050/00414/AM11/ RLA File :03/94/040/00041/AM11/ Lic.No/Date:0310570077 19.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/110/2007/Ch.II dated 17.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Disodium Magnesium EDTA (Magnesium content 6%) 1 Kg. 1. Ethylene Diamine Tetra Ace退c Acid (EDTA) 0.750 kg 102
Case No.:53/14/82‐ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00415/AM11/ RLA File :09/24/040/00557/AM10/ Lic.No/Date:0910041709 19.04.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to defer case for 31.08.2010 for comments of Department of Pharmaceu退cals and to send applica退on to them. 103
Case No.:48/14/82‐ALC4/2010
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/00410/AM11/ RLA File :03/94/040/00933/AM10/ Lic.No/Date:0310570355 20.04.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to defer case for 31.08.2010 for comments of Department of Pharmaceu退cals and to send applica退on to them. 104
Case No.:47/14/82‐ALC4/2010
Party Name:CHEMPRO EXPORTS (INDIA) 06.07.2010 Status:Case Deferred HQ File :01/82/050/00409/AM11/ RLA File :03/94/040/00028/AM11/ Lic.No/Date:0310570620 21.04.2010 Defer Date:31.08.2010 105
Case No.:49/14/82‐ALC4/2010
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00411/AM11/ RLA File :03/94/040/01005/AM10/ Lic.No/Date:0310570535 21.04.2010 Decision : Commi題�ee considered case as per agenda for ra退fica退on of norms and in light of its earlier decision taken in its 44/82 mee退ng held on 27.01.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy 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 Artemether 1 Kg. 1. Artemisinin 1.50 kg 2. Sodium Borohydride 0.188 kg 106
Case No.:10/5/82‐ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00044/AM11/ RLA File :05/24/040/00003/AM11/ Lic.No/Date:0510262859 22.04.2010 Defer Date:31.08.2010 Decision :Commi題�ee considered case as per agenda and in consulta退on with technical authority present in mee退ng, decided to call for percentage of Cefepine Hcl (Non Sterile) and L‐Arginine in the export product from the firm. Accordingly, case was deferred for 31.08.2010. 107
Case No.:41/14/82‐ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 06.07.2010 Status:Case Approved HQ File :01/82/050/00403/AM11/ RLA File :05/24/040/00549/AM10/ Lic.No/Date:0510262863 22.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/205/2009‐PI‐(Norms) dated 20.01.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Ce蠋riaxone Sodium Sterile 1 Kg. 1. Ce蠋riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Eno Carbon 51.66 gm 108
Case No.:46/14/82‐ALC4/2010
Party Name:ENCUBE ETHICALS PVT LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00408/AM11/ RLA File :03/94/040/00061/AM11/ Lic.No/Date:0310570695 22.04.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to call for the copy of DML showing the composi退on of export product from firm. Accoringly, case was deferred for 31.08.2010. 109
Case No.:50/14/82‐ALC4/2010
Party Name:ENCUBE ETHICALS PVT LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00412/AM11/ RLA File :03/94/040/00056/AM11/ Lic.No/Date:0310570694 22.04.2010
Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by DC(MSME) vide their U.O. No.23(1)2009/Chem Vol‐3/113 dated 18.02.2010, decided to ra退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 Secura Extra Protec退ve Cream (Product Code No.59432479) 1 Kg. 1. Petrolatum (White Fonoline Petrolatum) 0.4164 kg 2. Methyl Glucose (Glucate Do) 0.0520 kg 3. Mineral Oil Kyadol 0.0418 kg 4. Cetearyl Alcohol Lane題�e O 0.0624 kg 5. Cellulose Gum (Akucell AF 2781) 0.0312 kg 6. Karaya Gum Gum Karaya MK 200 (Pharma Grade) 0.0728 kg 7. Diazolidinyl Urea Germal II 0.00204 kg 110
Case No.:20/14/82‐ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00382/AM11/ RLA File :09/24/040/00014/AM11/ Lic.No/Date:0910041796 23.04.2010 Defer Date:31.08.2010 111
Case No.:39/14/82‐ALC4/2010
Party Name:HEMA DYE CHEM PVT. LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00401/AM11/ RLA File :03/94/040/00045/AM11/ Lic.No/Date:0310571035 23.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/50/2007/Ch.II dated 22.09.2009 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export product Exp. Qty. Sl. No. Import items Qty. allowed 2‐Chloro‐1‐4‐dimethoxy benzene (clhqdme) 1kg. 1. 1,4‐Dihydroxy Benzene 0.692 kg RA concerned may take further necessary ac退on as per above decision of Norms Commi題�ee. 112
Case No.:4/14/82‐ALC4/2010
Party Name:AARTI DRUGS LIMITED 06.07.2010 Status:Case Approved
HQ File :01/82/050/00366/AM11/ RLA File :03/94/040/00010/AM11/ Lic.No/Date:0310571227 26.04.2010 Decision : Commi題�ee considered this case as per agenda and in light of earlier decision taken in 13/08 mee退ng held on 31.07.2007 and in consulta退on with technical authority present in mee退ng, decided to ra退fy the 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. Descrip退on of import items Qty. allowed Ticlopidine Hcl 1 kg 1. Thiophene‐2‐ethanol 0.72 kg 2. Toluene 1.61 kg 3. Tri ethyl amine 0.25 kg 4. Benzene Sulphonyl chloride 0.99 kg 5. Sodium hydroxide flakes 0.747 kg 6. Ortho chloro benzyl amine 0.80 kg 7. Acetone 0.22 kg 8. IPA 0.85 kg 9. Methanol 0.90 kg 10. Paraformaldehyde o.300 kg RLA concerned may take further necessary ac退on as per above decision of NC. 113
Case No.:6/14/82‐ALC4/2010
Party Name:AARTI DRUGS LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00368/AM11/ RLA File :03/94/040/00003/AM11/ Lic.No/Date:0310571261 26.04.2010 Decision : Commi題�ee considered this case as per agenda and in consulta退on with technical authority present in mee退ng, decided to ra退fy the 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. Descrip退on of import items Qty. allowed Hydrocor退sone Acetate 1 kg 1. Hydrocor退sone 1.00 kg 2. Acetate 1.00 kg RLA concerned may take further necessary ac退on as per above decision of NC. 114
Case No.:7/14/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00369/AM11/ RLA File :03/94/040/01082/AM10/ Lic.No/Date:0310571324 26.04.2010 Defer Date:31.08.2010
115
Case No.:27/14/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00389/AM11/ RLA File :07/24/040/00016/AM11/ Lic.No/Date:0710071197 26.04.2010 Defer Date:31.08.2010 116
Case No.:45/14/82‐ALC4/2010
Party Name:ENCUBE ETHICALS PVT LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00407/AM11/ RLA File :03/94/040/00044/AM11/ Lic.No/Date:0310571319 26.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by DC(MSME) vide their U.O. No.23(1)2009/Chem Vol‐3/113 dated 18.02.2010, decided to ra退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 Secura Moisturizing Cream (Product Code No.59432000 and 59431900) 1 Kg. 1. Petrolatum Super White Propet (SWP) 0.1258 kg 2. White Mineral Oil Kyadol 0.0204 kg 3. Crill 43 Sorbitan Sequiolete 0.0306 kg 4. Fragrance M744 0.00051 kg 117
Case No.:42/14/82‐ALC4/2010
Party Name:GEM AROMATICS PVT.LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/00404/AM11/ RLA File :03/94/040/00072/AM11/ Lic.No/Date:0310571328 27.04.2010 Defer Date:31.08.2010 118
Case No.:20/6/82‐ALC4/2010
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00167/AM11/ RLA File :07/24/040/00002/AM11/ Lic.No/Date:0710071273 28.04.2010 Defer Date:31.08.2010 119
Case No.:43/14/82‐ALC4/2010
Party Name:EXCEL INDUSTRIES LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00405/AM11/ RLA File :03/94/040/01078/AM10/ Lic.No/Date:0310571888
28.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/109/2008/Ch.III dated 09.02.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export product Exp. Qty. Sl. No. Import items Qty. allowed Styrene Phosphonic Acid 1kg. 1. Styrene 0.830 kg 2. Yellow Phosphorous 0.257 kg 3. Toluene 0.400 kg RA concerned may take further necessary ac退on as per above decision of Norms Commi題�ee. 120
Case No.:72/14/82‐ALC4/2010
Party Name:SURYA PHARMACEUTICAL LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00434/AM11/ RLA File :22/24/040/00005/AM11/ Lic.No/Date:2210009922 28.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/206/2009‐PI‐(Norms) dated 19.01.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Fexofinadine Hcl 1 Kg. 1. 4‐Chloro Butyryl Chloride 1.216 kg 2. Isonepeco退c Acid 0.725 kg 3. Chlorobenzene 1.60 kg 4. Magmegioum 0.879 kg 5. Tetrahydrofuran 1.00 kg 6. Toluene 1.09 kg 7. Potassium Iodide 0.009 kg 8. Potassium Bicarbonate 0.300 kg 9. Dimethyl Sulfoxide 1.12 kg 10. Toluene Already covered 11. Monoethylene Glycol 1.24 kg 12. Methanol 4.00 kg 13. 1,2 Dimethoxy Ethane 1.12 kg 14. Sodium Borohydride 0.332 kg 15. Hexane 1.00 kg 16. Methylene Dichloride 3.00 kg 17. Acetone 2.20 kg 18. Methyl Iso Butylketone 3.00 kg
Isopropyl Alcohol 1.90 kg 20. Ethyl Acetate 2.50 kg 121
Case No.:22/6/82‐ALC4/2010
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 06.07.2010 Status:Case Deferred HQ File :01/82/050/00169/AM11/ RLA File :03/95/040/00396/AM10/ Lic.No/Date:0310571937 29.04.2010 Defer Date:31.08.2010 122
Case No.:25/6/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 06.07.2010 HQ File :01/82/050/00172/AM11/ RLA File :03/94/040/00065/AM11/ Lic.No/Date:0310572034 29.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/8/2010‐PI (Norms) dated 10.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Docetaxel 1 kg 1. Zinc 0.48 kg 2. Ace退c Acid 0.96 kg 3. Bacca退n III‐(2S,3S)‐3‐Phenylisoserine‐N‐Benzoyl Ester 1.92 kg 123
Case No.:27/6/82‐ALC4/2010
Party Name:AARTI DRUGS LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00174/AM11/ RLA File :03/94/040/00075/AM11/ Lic.No/Date:0310572146 29.04.2010 Decision : Commi題�ee considered case as per agenda and in light of earlier decision taken in 40/82 mee退ng held on 05.02.2008 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Quan退ty Sl.No. Import items Quan退ty allowed Nitazoxanide 1 Kg. 1. 2‐Acetyloxy benzoic acid (Asprin) 0.916 kg 2. 2‐amino‐5‐nitro thiazole 0.590 kg 3. Triethylamine 0.716 kg
Methylene Chloride 1.35 kg 5. Dimethyl formamide 0.70 kg 6. Methanol 3.20 kg 7. Charcoal 0.100 kg RA concerned may take further necessary ac退on as per above decision of Norms Commi題�ee. 124
Case No.:30/6/82‐ALC4/2010
06.07.2010 Status:Case Deferred HQ File :01/82/050/00177/AM11/ RLA File :34/24/040/00020/AM11/ Lic.No/Date:3410026932 29.04.2010 Defer Date:31.08.2010 125
Case No.:40/14/82‐ALC4/2010
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00402/AM11/ RLA File :03/94/040/00098/AM11/ Lic.No/Date:0310572124 29.04.2010 Defer Date:31.08.2010 126
Case No.:31/6/82‐ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 06.07.2010 HQ File :01/82/050/00178/AM11/ RLA File :03/95/040/00075/AM11/ Lic.No/Date:0310572320 30.04.2010 Decision : Commi題�ee considered case as per agenda and in light of earlier decision taken in 9/82 mee退ng held on 01.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退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 Flurbiprofen SR Pellets 88.9% 1 Kg. 1. Flurbiprofen 1.01 kg/kg content in the export product Commi題�ee also decided to revise the norms as per details above against Advance Authorisa退on No.0310551871 dated 21.12.2009 issued from file No.03/95/040/00671/AM10 approved in mee退ng No.9/82 dated 01.06.2010. The decision taken in mee退ng dated 01.06.2010 may be treated as withdrawn. 127
Case No.:32/6/82‐ALC4/2010
Party Name:VARUN MEDIMPEX INC. 06.07.2010 Status:Case Deferred HQ File :01/82/050/00179/AM11/ RLA File :05/24/040/00016/AM11/ Lic.No/Date:0510263372 Defer Date:31.08.2010
30.04.2010 Decision : Commi題�ee decided to defer case for 31.08.2010 for comments of Department of DIPP. 128
Case No.:33/6/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00180/AM11/ RLA File :03/94/040/00030/AM11/ Lic.No/Date:0310572376 30.04.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to defer case for 31.08.2010 for reply from firm. 129
Case No.:34/6/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 06.07.2010 HQ File :01/82/050/00181/AM11/ RLA File :03/94/040/00042/AM11/ Lic.No/Date:0310572378 30.04.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/49/2010‐PI‐(Norms) dated 29.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed 2’‐Deoxy‐2’,2’‐Difluoro‐N‐1‐ Acetyl Cy退dine‐3’,5‐ Dibenzoate 1 Kg. 1. 2‐Deoxy‐2,2‐Difluoro‐D‐Erythro‐ Pentofuranose‐3,5‐Dibenzoate‐1‐ Methanesulfonate 1.10 kg 2. N‐Acetyl Cytosine 1.10 kg 3. Trimethyl Silyl Trifluoromethane Sulfonate (Triflate) 1.95 kg 130
Case No.:35/14/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/00397/AM11/ RLA File :03/94/040/00074/AM11/ Lic.No/Date:0310572397 30.04.2010 Defer Date:31.08.2010 131
Case No.:29/14/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/00391/AM11/ RLA File :03/94/040/00078/AM11/ Lic.No/Date:0310572393 30.04.2010 Defer Date:31.08.2010
132
Case No.:35/6/82‐ALC4/2010
Party Name:BALAJI AMINES LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00182/AM11/ RLA File :31/24/040/00011/AM11/ Lic.No/Date:3110043098 30.04.2010 Defer Date:31.08.2010 133
Case No.:36/6/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00183/AM11/ RLA File :09/24/040/00033/AM11/ Lic.No/Date:0910041861 03.05.2010 Defer Date:13.07.2010 Decision : Commi題�ee decided to defer case for 13.07.2010 for comments of Department of C&PC. 134
Case No.:51/14/82‐ALC4/2010
Party Name:CIPLA LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00413/AM11/ RLA File :03/94/040/00115/AM11/ Lic.No/Date:0310572500 03.05.2010 Defer Date:31.08.2010 135
Case No.:73/14/82‐ALC4/2010
Party Name:DEEPAK NITRITE LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00435/AM11/ RLA File :31/24/040/00161/AM10/ Lic.No/Date:3110043136 05.05.2010 Defer Date:31.08.2010 136
Case No.:25/14/82‐ALC4/2010
Party Name:R L FINE CHEM 06.07.2010 Status:Case Approved HQ File :01/82/050/00387/AM11/ RLA File :07/24/040/00026/AM11/ Lic.No/Date:0710071472 06.05.2010 Decision : Commi題�ee considered case as per agenda and in light of its earlier decision taken in its 2/82 mee退ng held on 13.04.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy 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 Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg
137
Case No.:26/14/82‐ALC4/2010
Party Name:R L FINE CHEM 06.07.2010 Status:Case Approved HQ File :01/82/050/00388/AM11/ RLA File :07/24/040/00027/AM11/ Lic.No/Date:0710071473 06.05.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/297/2009‐PI (Norms) dated 18.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Cyclobenzaprine Hcl 1 kg 1. 1 Bromo 3 Chloro Propane 0.95 kg 2. Tetra Hydro Furan 1.00 kg 3. Acetone Not allowed as not shown in process 138
Case No.:2/14/82‐ALC4/2010
Party Name:AMINES & PLASTICIZERS LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00364/AM11/ RLA File :03/94/040/00066/AM11/ Lic.No/Date:0310573855 12.05.2010 Defer Date:31.08.2010 139
Case No.:5/14/82‐ALC4/2010
Party Name:BHARAT SERUMS & VACCINES LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00367/AM11/ RLA File :03/94/040/00144/AM11/ Lic.No/Date:0310573866 12.05.2010 Defer Date:31.08.2010 140
Case No.:56/14/82‐ALC4/2010
Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00418/AM11/ RLA File :03/95/040/00081/AM11/ Lic.No/Date:0310573993 12.05.2010 Defer Date:31.08.2010 Decision :Commi題�ee decided to call for a copy of DML from the firm. Accordingly, case was deferred for 31.08.2010.
141
Case No.:60/14/82‐ALC4/2010
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 06.07.2010 Status:Case Deferred HQ File :01/82/050/00422/AM11/ RLA File :03/94/040/00108/AM11/ Lic.No/Date:0310573861 12.05.2010 Defer Date:31.08.2010 142
Case No.:61/14/82‐ALC4/2010
Party Name:JAYANT AGRO ORGANICS LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00423/AM11/ RLA File :03/94/040/00059/AM11/ Lic.No/Date:0310573847 12.05.2010 Defer Date:31.08.2010 143
Case No.:3/14/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00365/AM11/ RLA File :03/94/040/00151/AM11/ Lic.No/Date:0310574397 14.05.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/373/2009‐PI‐(Norms) dated 04.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as Export product Exp. Qty. Sl.No. Import items Qty. allowed Pedrindopril Erbumine 1 Kg. 1. (2as,3as,7as) Octahydro Indole‐2‐Carboxylic Acid 1.00 kg 2. L‐Norvaline 1.60 kg 144
Case No.:2/10/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 06.07.2010 Status:Case Deferred HQ File :01/82/050/00355/AM11/ RLA File :08/24/040/00054/AM11/ Lic.No/Date:0810089022 17.05.2010 Defer Date:31.08.2010 Decision : Commi題�ee decided to call for a copy of applica退on, copy of DML and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 31.08.2010. 145
Case No.:54/14/82‐ALC4/2010
Party Name:NAPROD LIFE SCIENCES PVT. LTD. 06.07.2010 Status:Case Deferred HQ File :01/82/050/00416/AM11/ RLA File :03/95/040/00098/AM11/ Lic.No/Date:0310574607 Defer
17.05.2010 Date:31.08.2010 146
Case No.:57/14/82‐ALC4/2010
Party Name:SARNA CHEMICALS PVT.LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00419/AM11/ RLA File :03/95/040/00110/AM11/ Lic.No/Date:0310574835 18.05.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/48/2008‐Ch.II dated 20.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed 4(2‐Chloro Ethylsulfonyl) Butyric Acid (XAZ Base) 1 Kg. 1. Butyrolactone (Gamma Butyrolactone) 0.665 kg 2. Isopropyl alcohol 0.695 kg 3. 2‐Mercapto Ethanol 0.691 kg 147
Case No.:58/14/82‐ALC4/2010
Party Name:SARNA CHEMICALS PVT.LTD. 06.07.2010 Status:Case Approved HQ File :01/82/050/00420/AM11/ RLA File :03/95/040/00096/AM11/ Lic.No/Date:0310574827 18.05.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of C&PC vide their U.O. No.14010/77/2006‐Ch.II dated 09.04.2008 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed N‐Hydroxy Methyl 2‐Chloro Acetamide 1 Kg. 1. 2‐Chloro Acetamide 0.841 kg 148
Case No.:62/14/82‐ALC4/2010
Party Name:CIPLA LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00424/AM11/ RLA File :03/94/040/00182/AM11/ Lic.No/Date:0310575076 19.05.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by Department of Pharmaceu退cals vide their O.M. No.35011/15/2010‐PI (Norms) dated 08.06.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy norms under para 4.7 of HBP as per
Export product Exp. Qty. Sl.No. Import items Qty. allowed Prednisilone Tablets JP 5 mg 1 No. 1. Prednisolone 5.10 mg 2. Gela退n 1.90 mg 3. Lactose Hydrate 72.60 mg 149
Case No.:55/14/82‐ALC4/2010
Party Name:LUPIN LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00417/AM11/ RLA File :03/95/040/00127/AM11/ Lic.No/Date:0310575276 20.05.2010 Defer Date:31.08.2010 150
Case No.:59/14/82‐ALC4/2010
Party Name:CIPLA LIMITED 06.07.2010 Status:Case Deferred HQ File :01/82/050/00421/AM11/ RLA File :03/94/040/00186/AM11/ Lic.No/Date:0310575233 20.05.2010 Defer Date:31.08.2010 Decision :Commi題�ee decided to call for comments/NOC from Ministry of Environment and Forests. Accordingly, case was deferred for 31.08.2010. 151
Case No.:69/14/82‐ALC4/2010
Party Name:CIPLA LIMITED 06.07.2010 Status:Case Approved HQ File :01/82/050/00431/AM11/ RLA File :03/94/040/00183/AM11/ Lic.No/Date:0310575234 20.05.2010 Decision : Commi題�ee considered case as per agenda and in light of wri題�en comments forwarded by DOP vide their U.O. No.35011/168/2008‐PI‐III dated 24.11.2008 and in consulta退on with technical authority present in mee退ng 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 kg of Budesonide Budecort 200 Inhaler (200MD) [Budesonide = 0.04 gms/Inhaler] 1 No. 1. 16alpha‐Hydroxy Prednisolone 1.093 kg. 2. Butyraldehyde 0.350 kg Budecort 100 Inhaler (200MD) [Buesonide = 0.02 gms/Inhaler] 1 No. 1. 16alpha‐Hydroxy Prednisolone 1.093 kg. 2. Butyraldehyde 0.350 kg
152
Case No.:9/14/82‐ALC4/2010
Party Name:PRIVI ORGANICS LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00371/AM11/ RLA File :03/95/040/00100/AM11/ Lic.No/Date:0310575665 24.05.2010 Defer Date:31.08.2010 153
Case No.:1/14/82‐ALC4/2010
Party Name:FDC LTD 06.07.2010 Status:Case Approved HQ File :01/82/050/00363/AM11/ RLA File :03/94/040/01076/AM10/ Lic.No/Date:0310575824 25.05.2010 Decision : Commi題�ee considered case as per agenda and in light of earlier decision taken in 7/82 mee退ng held on 18.05.2010 and in consulta退on with technical authority present in mee退ng, decided to ra退fy the norms on repeat basis 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 Chloramphenicol Eye Drops 0.5% w/v 10 ml Vial made out of LDPE 1 No. 1. Chloramphenicol 0.05 gram 2. LDPE Granules As per packing policy 154
Case No.:30/14/82‐ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00392/AM11/ RLA File :07/24/040/00037/AM11/ Lic.No/Date:0710071792 26.05.2010 Defer Date:31.08.2010 155
Case No.:31/14/82‐ALC4/2010
Party Name:PADMINI AROMATICS PVT. LTD 06.07.2010 Status:Case Deferred HQ File :01/82/050/00393/AM11/ RLA File :07/24/040/00035/AM11/ Lic.No/Date:0710071909 31.05.2010 Defer Date:31.08.2010
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