DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 20/82‐ALC4/2010 MEETING DATE : 17.08.2010 The MeeƟng No.20/82 in the year 2010‐11 to consider the cases under Duty ExempƟon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 17.08.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Shaish Kumar, IA, DIPP 2. Shri D.N. Mathur, Dy. IA, Department of PharmaceuƟcals 3. Shri Krishan Kumar, Dy. DGFT 4. Shri Shyam Lal, FTDO CommiƩee discussed the issue regarding holding up of clearance of Erythromycin Thiocyanate by ADCGI at Nhava Sheva imported by M/S Unimax Chemicals Pvt. Ltd. Shri M. Mitra, Dy. DCGI present in the meeƟng informed that CommiƩee that the maƩer has been solved out and they have issued the leƩer in this regard. He has been requested to handover/send a copy of the said leƩer to Directorate General of Foreign Trade.
Case No. B‐170
M/s Advy Chemicals Norms CommiƩee MeeƟng No. 20/11 F.No.01/82/162/01094/AM10/DES‐III MeeƟng Date 17.08.2010 RLA F. No. 03/24/040/01518/AM03 Adv. Lic. No.0310174022 dated 23.12.2002 CommiƩee considered case as per agenda and in light of earlier decision taken in 2/09 meeƟng held on 08.04.2008 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 HBsAg Subtypes and Reagent (4000mgs) (HeptaƟƟs‐B surface anƟgen‐subtypes ad) 1000 mg (1gm) 1. HepaƟƟs B PosiƟve 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) RA concerned may take further necessary acƟon as per above decision of NC.
Case No. B‐171
M/s Chemill NutraceuƟcals Pvt. Ltd. F.No.01/85.050/00011/AM10/DES‐III RLA F. No. 03/94/040/01119/AM09 Adv. Lic. No.0310516126 dated 17.04.2009 CommiƩee considered case as per agenda and observed that the firm was requested to furnish technical informaƟon vide leƩer dated 02.07.2010, but the same have not been received and norms can not be fixed in absence of the required technical informaƟon. It was, therefore, decided to reject the case.
Case No. B‐172
M/s Yasho Industries Pvt. Ltd. F.No.01/83/050/00646/AM08/DES‐III F.No.01/83/050/01077/AM07/DES‐III RLA F. No. 03/95/040/00281/AM08 RLA F. No. 03/95/040/01183/AM07 Adv. Lic. No.0310433842 dated 25.06.2007 Adv. Lic. No.0310413968 dated 29.12.2006 CommiƩee considered case as per agenda and in consultaƟon with technical authoriƟes present in meeƟng, decided to amend the descripƟon of export product to read as “AromaƟc DerivaƟve Diphenylamine (ADA)” and to amend the descripƟon of import item to read as “Diphenylamine” without any other change in the decision taken in 20/83 meeƟng held on 29.08.2007 and 48/83 meeƟng held on 14.03.2007.
Case No. B‐173
M/s Global Calcium Pvt. Ltd. F.No.01/82/050/00390/AM08/DES‐III RLA F. No. 07/24/040/00861/AM08 Adv. Lic. No.0710051390 dated 24.04.2007 CommiƩee considered case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by Central Excise and in consultaƟon with technical authoriƟes present in meeƟng, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product QuanƟty Sl.No. Import items QuanƟty allowed Zinc Gluconate 1 kg 1. Glucono Delta Lactone 0.9453 kg Magnesium Gluconate 1 kg 1. 0.91 kg Potassium Gluconate 1 kg 1. 0.91 kg Ferrous Gluconate 1 kg 1. 0.91 kg
Manganese Gluconate 1 kg 1. 0.83 kg Calcium Magnesium Lactate Gluconate 1 kg 1. 0.62 kg Magnesium Lactate Gluconate 1 kg 1. 0.80 kg Cobalt Gluconate 1 kg 1. 1.25 kg Copper Gluconate 1 kg 1. 1.25 kg RA concerned may take further necessary acƟon as per above decision of NC. The earlier decision taken in 15/82 meeƟng held on 08.07.2008 stands withdrawn.
Case No. B‐174
M/s Global Calcium Pvt. Ltd. F.No.01/82/050/00393/AM08/DES‐III RLA F. No. 07/24/040/00053/AM08 Adv. Lic. No.0710051439 dated 26.04.2007 CommiƩee considered case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by Central Excise and in consultaƟon with technical authoriƟes present in meeƟng, decided to revise norms under para Export Product QuanƟty Sl.No. Import items QuanƟty allowed Calcium Gluconate‐ Injectable Grade USP 1 kg 1. Calcium Gluconate (oral grade) 1.09 kg Calcium Lactate Gluconate 1 kg 1. 0.57 kg Calcium Glubionate 1 kg 1. 0.430 kg Calcium Boro Gluconate 1 kg 1. Not fixed as the firm did not provide C.E. cerƟfied data, as was asked for by NC. RA concerned may take further necessary acƟon as per above decision of NC. The earlier decision taken in 15/82 meeƟng held on 08.07.2008 stands withdrawn.
Case No. B‐175
M/s Global Calcium Pvt. Ltd. F.No.01/82/050/00437/AM08/DES‐III RLA F. No. 07/24/040/00454/AM08 Adv. Lic. No.0710053786 dated 12.10.2007 CommiƩee considered case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by Central Excise and in consultaƟon with technical authoriƟes present in meeƟng, decided to revise norms under para
Export Product QuanƟty Sl.No. Import items QuanƟty allowed Ferrous Lactate 1 kg 1. LacƟc Acid (any grade) 1.200 kg Magnesium Lactate (Dihydrate) 1 kg 1. LacƟc Acid (any grade) 1.200 kg Calcium Lactate Gluconate 1 kg 1. LacƟc Acid (any grade) 0.51 kg Magnesium Lactate Gluconate 1 kg 1. LacƟc Acid (any grade) 0.245 kg The norms for the export product Zinc Lactate could not be fixed as the firm has not furnished ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority . as was asked for by NC. RA concerned may take further necessary acƟon as per above decision of NC. The earlier decision taken in 14/82 meeƟng held on 01.07.2008 stands withdrawn.
Case No. B‐176
M/s Global Calcium Pvt. Ltd. F.No.01/82/050/01313/AM07/DES‐III RLA F. No. 07/24/040/00566/AM07 Adv. Lic. No.0710048576 dated 22.11.2006 CommiƩee considered case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by Central Excise and in consultaƟon with technical authoriƟes present in meeƟng, decided to revise norms under para Export Product QuanƟty Sl.No. Import items QuanƟty allowed Calcium Lactate Gluconate 1 kg 1. Calcium Lactate (any grade) 0.67 kg RA concerned may take further necessary acƟon as per above decision of NC. The earlier decision taken in 11/82 meeƟng held on 17.07.2007 stands withdrawn.
Case No. B‐177
M/s Matrix Laboratories Ltd. F.No.01/82/050/00235/AM089DES‐III RLA F. No. 09/24/040/00187/AM08 Adv. Lic. No.0910031251 dated 27.08.2007 CommiƩee decided to defer case for 14.09.2010 for comments of Department of PharmaceuƟcals.
Case No. A‐27
M/s Encee AromaƟcs (P) Ltd. F.No.01/82/152/00020/AM10/DES‐III
RLA F. No. 32/80/162/00876/AM11 Case under para 4.4.2 of HBP CommiƩee considered case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by Central Excise and in consultaƟon with technical authoriƟes present in meeƟng, decided to fix norms for issue of Advance AuthorisaƟon under para 4.4.2 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product QuanƟty Sl.No. Import items QuanƟty allowed Enamber/Kephalis/Tetrambrone 1 kg 1. Triethyl Orthofomate 1.742 kg 2. Di Acetone Alcohol 5.720 kg
Case No. C‐19
M/s Filtra speciality Catalysts Ltd. F.No.01/82/162/00006/AM10/DES‐III CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC.
Case No. C‐20
M/s Reliance Industries Ltd. F.No.01/82/162/00695/AM10/DES‐III CommiƩee considered case as per agenda and observed that Chemexcil has menƟoned that the request is only for a correcƟon in the descripƟon of the export product under SION A‐3559 and as there is no request for change in the input‐output norms of the product, there is no need to cross check the consumpƟon paƩern across industry in this maƩer. CommiƩee aŌer detailed deliberaƟons and in light of wriƩen comments forwarded by Department of C&PC vide their O.M. No.46011/25/2005‐PC.II dated 17.05.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to amend the descripƟon of export product under SION A‐3559 to read as “1,3‐Butadiene”. Further necessary acƟon may be taken for issue of Public NoƟce for publicaƟon of above amendment with the approval of DG.
1
Case No.:5/42/83‐ALC1/2006
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:20/82‐ALC4/2010 17.08.2010 Status:Case Approved HQ File :01/83/050/01050/AM07/ RLA File :05/24/040/00797/AM07/ Lic.No/Date:0510196616 21.12.2006 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments of Department of PharmaceuƟcals and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Imipenem PH.EUR Sterile 1 kg 1. (3R,4R)‐4‐Acetoxy‐3‐((R)‐(Tert‐ Butyldimethylsilyloxy)‐Ethyl‐2‐AzeƟdinone 7.17 kg 2. Diphenyl Chlorophosphate 3.88 kg 3. N,N‐Diisopropyl Ethylamine 5.58 kg 4. N‐methyl Morholine 0.62 kg 5. P‐Nitrobenzyl Alcohol 4.71 kg 6. Poly (4‐Vinyl Pyridine) Cros Linked with 2% Divinyl Benzene 0.93 kg 7. Rhodium Octanoate (Dimer) 0.011 kg 8. Cysteamine Hydrochloride 1.23 kg 9. 4 Dimethyl Aminopyridine 0.044 kg 10. Methyl Acetoacetate 3.58 kg 11. Triethylamine 5.06 kg 12. Methane Sulfonic Acid 1.22 kg 13. Formic Acid 5.01 kg 14. Toluene 4.01 kg 15. Methylene Chloride 22.68 kg 16. Acetone 17.44 kg 17. Methanol 2.17 kg 18. Acetonitrile 1.22 kg 19. Iso Propyl Alcohol 0.80 kg 20. Tetrahydrofuran 4.40 kg 21. Cyclohexane 22.60 kg 22. Palladium 0.01375 kg 2
Case No.:36/6/83‐ALC1/2008
Party Name:H.K.FINECHEM LIMITED 17.08.2010 Status:Case Deferred HQ File :01/83/050/00146/AM09/ RLA File :08/24/040/00149/AM08/ Lic.No/Date:0810067303 21.09.2007 Defer Date:14.08.2010
Decision :CommiƩee considered case as per agenda and decided to call for the firm for personal hearing on 14.09.2010. Accordingly, the case was deferred for 14.09.2010. 3
Case No.:32/41/82‐ALC4/2008
Party Name:ARCH PHARMALABS LTD 17.08.2010 Status:Case Approved HQ File :01/82/050/01472/AM09/ RLA File :03/94/040/00791/AM09/ Lic.No/Date:0310494617 18.11.2008 Decision : CommiƩee considered this case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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. DescripƟon of import items Qty. allowed L‐Glucose Monohydrate 1 kg 1. L‐Arabinose 2.47 kg RLA concerned may take further necessary acƟon as per above decision of NC. 4
Case No.:10/40/82‐ALC4/2008
Party Name:ARCH PHARMALABS LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/01429/AM09/ RLA File :03/94/040/00871/AM09/ Lic.No/Date:0310498562 17.12.2008 Defer Date:14.09.2010 Decision : CommiƩee considered case as per agenda and decided to call for the firm for personal hearing on 14.09.2010. Accordingly, the case was deferred for 14.09.2010. 5
Case No.:58/18/82‐ALC4/2009
Party Name:SUVEN LIFE SCIENCES LIMITED 17.08.2010 Status:Case Approved HQ File :01/82/050/00332/AM10/ RLA File :09/24/040/00431/AM09/ Lic.No/Date:0910037268 03.03.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/57/2010‐PI‐(Norms) dated 29.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 4‐(2‐Chloroethyl)‐1‐Trityl‐1‐H‐ Imidazole 1 Kg. 1. Histamine Dihydrochloride‐Powder 0.853 kg 2. Trityl Chloride‐Powder 0.988 kg 6
Case No.:4/54/82‐ALC4/2008
Party Name:PADMINI AROMATICS PVT. LTD 17.08.2010 Status:Case Deferred
HQ File :01/82/050/01706/AM09/ RLA File :07/24/040/00660/AM09/ Lic.No/Date:0710063727 19.03.2009 Defer Date:14.09.2010 Decision :CommiƩee decided to defer case for 14.09.2010 for comments of Department of C&PC. 7
Case No.:54/1/82‐ALC4/2009
Party Name:RA CHEM PHARMA LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/01774/AM09/ RLA File :09/24/040/00460/AM09/ Lic.No/Date:0910037582 31.03.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of C&PC. 8
Case No.:21/18/82‐ALC4/2009
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/00295/AM10/ RLA File :03/94/040/01082/AM09/ Lic.No/Date:0310515875 16.04.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of C&PC. 9
Case No.:36/18/82‐ALC4/2009
Party Name:CHEMILL NUTRACEUTICALS PVT.LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00310/AM10/ RLA File :03/94/040/00148/AM10/ Lic.No/Date:0310521537 27.05.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of C&PC. 10
Case No.:30/13/82‐ALC4/2009
Party Name:SHILPA MEDICARE LTD., 17.08.2010 Status:Case Deferred HQ File :01/82/050/00170/AM10/ RLA File :07/24/040/00103/AM10/ Lic.No/Date:0710065349 11.06.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of PharmaceuƟcals. 11
Case No.:10/17/82‐ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 17.08.2010 Status:Case Deferred HQ File :01/82/050/00273/AM10/ RLA File :05/24/040/00203/AM10/ Lic.No/Date:0510245516 10.07.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for reply from firm. 12
Case No.:2/21/82‐ALC4/2009
Party Name:METROPOLITAN EXIMCHEM LTD. 17.08.2010 Status:Case
Deferred HQ File :01/82/050/00429/AM10/ RLA File :03/95/040/00224/AM10/ Lic.No/Date:0310532930 07.08.2009 Defer Date:12.10.2010 Decision :CommiƩee considered case as per agenda and in light of leƩer No.14010/75/2008‐Ch.II dated 24.06.2010 issued by Department of C&PC, decided to call for the following informaƟon from the firm:‐ 1. JusƟficaƟon for the yield given at various stages. 2. AuthenƟc/Printed technical literature in support of yield are norms a;;oied for import. 3. ProducƟon of export item for the past two years upto January, 2020 and corresponding consumpƟon of each input duly cerƟfied by the Chartered Accountant. Accordingly, case was deferred for 12.10.2010. 13
Case No.:29/24/82‐ALC4/2009
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/00526/AM10/ RLA File :09/24/040/00208/AM10/ Lic.No/Date:0910039223 01.09.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of PharmaceuƟcals. 14
Case No.:5/28/82‐ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 17.08.2010 Status:Case Deferred HQ File :01/82/050/00565/AM10/ RLA File :05/24/040/00308/AM10/ Lic.No/Date:0510249608 18.09.2009 Defer Date:12.10.2010 Decision :CommiƩee considered case as per agenda and observed that the firm has been requested to clarify that the process details and export product do not match vide our leƩer dated 23.07.2010, but no reply has been received. It was, therefore, decided to remind the firm to furnish the said clarificaƟon immediately. Accordingly, case was deferred for 12.10.2010. 15
Case No.:9/28/82‐ALC4/2009
Party Name:EMCURE PHARMACEUTICALS LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00569/AM10/ RLA File :31/24/040/00110/AM10/ Lic.No/Date:3110040034 23.09.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of PharmaceuƟcals. 16
Case No.:41/46/82‐ALC4/2009
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 17.08.2010 Status:Case Approved HQ File :01/82/050/00957/AM10/ RLA File :07/24/040/00227/AM10/ Lic.No/Date:0710067164 23.09.2009 Decision : CommiƩee considered case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by Central Excise and in consultaƟon with technical
authoriƟes present in meeƟng, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product QuanƟty Sl.No. Import items QuanƟty allowed Calcium Gluconate‐ Injectable Grade USP 1 kg 1. 1.09 kg Calcium Lactate Gluconate 1 kg 1. 0.57 kg Calcium Glubionate 1 kg 1. 0.430 kg Calcium Boro Gluconate 1 kg 1. Not fixed The firm has not furnished Central Excise cerƟfied ProducƟon and ConsumpƟon data for the export product ‘Calcium Boro Gluconate’. Norms for this product will be considered only when C.E. cerƟfied data is furnished by the firm. 17
Case No.:9/30/82‐ALC4/2009
Party Name:EMCURE PHARMACEUTICALS LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00610/AM10/ RLA File :31/24/040/00123/AM10/ Lic.No/Date:3110040264 09.10.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of PharmaceuƟcals. 18
Case No.:35/48/82‐ALC4/2009
Party Name:GALAXY SURFACTANTS LTD., 17.08.2010 Status:Case Rejected HQ File :01/82/050/01098/AM10/ RLA File :03/94/040/00129/AM10/ Lic.No/Date:0310543281 29.10.2009 Decision :CommiƩee considered case as per agenda and observed that Department of C&PC vide their leƩer No.14010/63/2008‐Ch.II dated 17.03.2010 has called for technical informaƟon, but no reply has been received and in absence of the required informaƟon, norms can not be fixed. It was, therefore, decided to reject the case. 19
Case No.:22/34/82‐ALC4/2009
Party Name:SCITECH SPECIALITIES PVT. LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00667/AM10/ RLA File :03/95/040/00470/AM10/ Lic.No/Date:0310543476 30.10.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of C&PC. 20
Case No.:34/34/82‐ALC4/2009
Party Name:PARABOLIC DRUGS LTD., 17.08.2010 Status:Case Deferred
HQ File :01/82/050/00679/AM10/ RLA File :05/24/040/00291/AM10/ Lic.No/Date:0510252005 06.11.2009 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of PharmaceuƟcals. 21
Case No.:14/36/82‐ALC4/2009
Party Name:KAJAY REMEDIES PVT. LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00739/AM10/ RLA File :03/94/040/00571/AM10/ Lic.No/Date:0310545944 17.11.2009 Defer Date:12.10.2010 Decision :CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data from firm duly cerƟfied by CA/ICWA/jurisdicƟonal excise authority. Accordingly, case was deferred for 12.10.2010. 22
Case No.:5/38/82‐ALC4/2009
Party Name:LIFE LINE INDUSTRIES LIMITED 17.08.2010 Status:Case Rejected HQ File :01/82/050/00778/AM10/ RLA File :03/95/040/00553/AM10/ Lic.No/Date:0310548279 30.11.2009 Decision :CommiƩee considered case as per agenda and observed that the firm was requested to furnish ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority, but the same has not been received and norms can not be fixed in absence of required data. It was, therefore, decided to reject the same. 23
Case No.:6/38/82‐ALC4/2009
Party Name:LIFE LINE INDUSTRIES LIMITED 17.08.2010 Status:Case Rejected HQ File :01/82/050/00779/AM10/ RLA File :03/95/040/00541/AM10/ Lic.No/Date:0310548289 30.11.2009 Decision : CommiƩee considered case as per agenda and observed that the firm was requested to furnish ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority, but the same has not been received and norms can not be fixed in absence of required data. It was, therefore, decided to reject the same. 24
Case No.:46/48/82‐ALC4/2009
Party Name:CIPLA LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/01109/AM10/ RLA File :03/94/040/00685/AM10/ Lic.No/Date:0310550099 09.12.2009 Defer Date:12.10.2010 Decision :CommiƩee considered case as per agenda and decided to remind Ministry of Environment and Forests for their NOC/comments. Accordingly, case was deferred for 12.10.2010. 25
Case No.:9/40/82‐ALC4/2009
Party Name:RANBAXY LABORATORIES LTD Status:Case
17.08.2010 Deferred HQ File :01/82/050/00824/AM10/ RLA File :05/24/040/00404/AM10/ Lic.No/Date:0510254651 16.12.2009 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of PharmaceuƟcals. 26
Case No.:4/41/82‐ALC4/2009
Party Name:BALAJI AMINES LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/00839/AM10/ RLA File :31/24/040/00192/AM10/ Lic.No/Date:3110041170 21.12.2009 Defer Date:12.10.2010 Decision :CommiƩee considered case as per agenda and in light of leƩer No.14010/113/2008‐Ch.II dated 15.06.2010 issued from Department of C&PC, decided to remind the firm to furnish the following informaƟon/documents:‐ 1. JusƟficaƟon for the import of 1,4‐Butanediol. The manufacturing process do not indicate the requirement of this item in the manufacturing process with chemical equaƟons. 2. Technical details of Methylamine Catalyst and GBL Catalyst and the role of these items in the manufacturing process. 3. CA cerƟficate cerƟfying producƟon and corresponding consumpƟon of different raw materials for the year 2007‐08, 2008‐09 and 2009‐10. Accordingly, case was deferred for 12.10.2010. 27
Case No.:87/46/82‐ALC4/2009
Party Name:CIPLA LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/01003/AM10/ RLA File :03/94/040/00820/AM10/ Lic.No/Date:0310552364 23.12.2009 Defer Date:12.10.2010 Decision : CommiƩee considered case as per agenda and decided to remind Ministry of Environment and Forests for their NOC/comments. Accordingly, case was deferred for 12.10.2010. 28
Case No.:3/43/82‐ALC4/2009
Party Name:ARCH PHARMALABS LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/00877/AM10/ RLA File :03/94/040/00784/AM10/ Lic.No/Date:0310554371 08.01.2010 Defer Date:12.10.2010 Decision :CommiƩee decided to remind the firm to furnish the required informaƟon. Accordingly, case was deferred for 12.10.2010. 29
Case No.:11/43/82‐ALC4/2009
Party Name:CADILA HEALTHCARE LTD., 17.08.2010 Status:Case Deferred HQ File :01/82/050/00885/AM10/ RLA File :08/24/040/00277/AM10/ Lic.No/Date:0810085697 12.01.2010 Defer Date:14.09.2010 Decision : CommiƩee decided to defer case for 14.09.2010 for comments of Department of PharmaceuƟcals.
30
Case No.:4/44/82‐ALC4/2009
Party Name:SARNA CHEMICALS PVT.LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00889/AM10/ RLA File :03/95/040/00601/AM10/ Lic.No/Date:0310555001 13.01.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. 31
Case No.:7/44/82‐ALC4/2009
Party Name:ANUPAM RASAYAN (INDIA) LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/00892/AM10/ RLA File :52/24/040/00027/AM10/ Lic.No/Date:5210029364 13.01.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. 32
Case No.:9/44/82‐ALC4/2009
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 17.08.2010 Status:Case Approved HQ File :01/82/050/00894/AM10/ RLA File :31/24/040/00130/AM10/ Lic.No/Date:3110041489 13.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/111/2008‐Ch.II dated 14.07.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Orthocresyl Glycidyl Ether 1 Kg. 1. Phenol 0.627 kg 2. Methanol 0.214 kg 3. Epichlorohydrin 0.594 kg 33
Case No.:8/44/82‐ALC4/2009
Party Name:EMAMI LIMITED, 17.08.2010 Status:Case Deferred HQ File :01/82/050/00893/AM10/ RLA File :02/24/040/00173/AM10/ Lic.No/Date:0210136503 14.01.2010 Defer Date:14.09.2010 Decision :CommiƩee considered case as per agenda and observed that the wriƩen comments are not forthcoming from DC(MSME) while the case is long pending for fixaƟon of norms. It was, therefore, decided to remind DC(MSME) through D.O. reminder at the level of Chairman, NC‐III. Accordingly, case was deferred for 12.10.2010. 34
Case No.:10/45/82‐ALC4/2009
Party Name:KDAC CHEM PVT LTD 17.08.2010 Status:Case Deferred
HQ File :01/82/050/00905/AM10/ RLA File :34/24/040/00176/AM10/ Lic.No/Date:3410026153 15.01.2010 Defer Date:12.10.2010 Decision CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. 35
Case No.:3/45/82‐ALC4/2009
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 17.08.2010 Status:Case Deferred HQ File :01/82/050/00898/AM10/ RLA File :05/24/040/00410/AM10/ Lic.No/Date:0510256550 18.01.2010 Defer Date:12.10.2010 36
Case No.:16/5/82‐ALC4/2010
Party Name:ARCH PHARMALABS LTD 17.08.2010 Status:Case Approved HQ File :01/82/050/00050/AM11/ RLA File :03/94/040/00940/AM10/ Lic.No/Date:0310557073 27.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/48/2010‐PI‐(Norms) dated 02.07.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms on repeat basis under para Export product Exp. Qty. Sl.No. Import items Qty. allowed (1S,2S,3S)‐1‐(2‐Fluorobenzyl)‐7‐ Methoxy‐3‐(4‐Methoxyphenyl)‐2‐ Methyl‐1,2.3,4‐ Tetrahydronaphtahalene (SCH‐ 900373‐MC) 1 Kg. 1. Desoxyanisoin 2.205 kg 2. 2‐Fluorobenzylzinc Chloride 0.5 m in THF 4.41 kg 3. Ethyl‐2‐bromo Proponiate 2.00 kg 4. 2,6 Di‐tert‐butyl Pyridine 0.933 kg 4. Bis (tri‐tert‐butylphosphone) Palladium 0.034 kg 37
Case No.:17/48/82‐ALC4/2009
Party Name:AMOLI ORGANICS PVT. LTD., 17.08.2010 Status:Case Deferred HQ File :01/82/050/01080/AM10/ RLA File :03/94/040/00025/AM10/ Lic.No/Date:0310558999 08.02.2010 Defer Date:12.10.2010 38
Case No.:18/48/82‐ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/01081/AM10/ RLA File :09/24/040/00435/AM10/ Lic.No/Date:0910040860 Defer
08.02.2010 Date:12.10.2010 39
Case No.:19/48/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/01082/AM10/ RLA File :09/24/040/00454/AM10/ Lic.No/Date:0910040861 08.02.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for reply form firm. 40
Case No.:20/48/82‐ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/01083/AM10/ RLA File :09/24/040/00455/AM10/ Lic.No/Date:0910040862 08.02.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for reply from firm. 41
Case No.:17/2/83‐ALC1/2010
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 17.08.2010 Status:Case Transferred HQ File :01/83/050/00017/AM11/ RLA File :03/95/040/00650/AM10/ Lic.No/Date:0310558976 08.02.2010 Decision :CommiƩee decided to transfer the case to NC‐4 as the export product falls under Chapter 33. 42
Case No.:22/48/82‐ALC4/2009
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 17.08.2010 Status:Case Approved HQ File :01/82/050/01085/AM10/ RLA File :03/95/040/00724/AM10/ Lic.No/Date:0310559152 09.02.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/5/2009‐Ch.II dated 16.08.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Sorbitan Mono Laurate 1 Kg. 1. Palm Kernel FaƩy Acid/Coconut FaƩy Acid 0.660 kg 2. Sorbitol 70% 0.710 kg 43
Case No.:24/48/82‐ALC4/2009
Party Name:TECKBOND LABORATORIES PRIVATE LIMITED 17.08.2010 Status:Case Approved
HQ File :01/82/050/01087/AM10/ RLA File :09/24/040/00450/AM10/ Lic.No/Date:0910040868 09.02.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/53/2010‐PI‐(Norms) dated 29.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms on repeat basis under para Export product Exp. Qty. Sl.No. Import items Qty. allowed N‐((2‐Cyano Biphenyl‐4‐YL)‐ Methyl)‐(L)‐Valine Methyl Ester Hydrochloride 1 Kg. 1. 2‐Cyno‐4‐Methyl Biphenyl 0.84 kg 2. L‐Valine 0.51 kg 3. Catalyst (2,2‐Azo Bis Isobutyronitrile 0.0336 kg 4. Ethyl Acetate 1.653 kg 5. N‐Bromosuccinamide 0.28 kg 6. IPA 1.00 kg 7. Methanol 1.16 kg 44
Case No.:25/48/82‐ALC4/2009
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 17.08.2010 Status:Case Deferred HQ File :01/82/050/01088/AM10/ RLA File :03/95/040/00733/AM10/ Lic.No/Date:0310559189 09.02.2010 Defer Date:12.10.2010 Decision :CommiƩee decided to forward a copy of applicaƟon to Department of PharmaceuƟcals for their comments. Accordingly, case was deferred for 12.10.2010. 45
Case No.:30/48/82‐ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/01093/AM10/ RLA File :05/24/040/00476/AM10/ Lic.No/Date:0510258284 11.02.2010 Defer Date:12.10.2010 46
Case No.:8/49/82‐ALC4/2009
Party Name:SPAN DIAGNOSTICS LTD 17.08.2010 Status:Case Approved HQ File :01/82/050/01143/AM10/ RLA File :52/24/040/00035/AM10/ Lic.No/Date:5210029683 15.02.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of Bio‐technology vide their O.M. No.BT/IL/05/308/2009‐PID dated 21.07.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms under para 4.7 of HBP on net to net basis with accountability clause.
47
Case No.:4/50/82‐ALC4/2009
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 17.08.2010 Status:Case Approved HQ File :01/82/050/01158/AM10/ RLA File :03/95/040/00754/AM10/ Lic.No/Date:0310561197 22.02.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/76/2005‐Ch.II dated 20.07.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 p‐(Methyl Mercapto) Benzaldehyde/4‐(Methyl Thio) Benzaldehyde 1 Kg. 1. Para Chloro Benzaldehyde 1.010 kg 2. Sodium Methyl MercapƟde 20% aqueous soluƟon 2.530 kg 3. Toluene 0.141 kg 48
Case No.:10/50/82‐ALC4/2009
Party Name:KOPRAN LIMITED 17.08.2010 Status:Case Approved HQ File :01/82/050/01164/AM10/ RLA File :03/94/040/01019/AM10/ Lic.No/Date:0310561665 24.02.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/35/2010‐PI‐(Norms) dated 01.07.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Cefepime for InjecƟon 1 Kg. 1. 1‐((7‐(2‐Amino‐4‐Thiazolyl) (Methoxyimino)Acetyl)‐2‐Carboxy‐8‐ Oxo‐5‐Thia‐1‐Azabicyclo(4.2.0) Oct‐2‐ EN‐3‐YL)Methyl)‐1‐Methylpyr Rolidinium Chloride Monohydro Chloride 0.655 kg 2. Methanol 0.742 kg 3. Eno Carbon 0.034 kg 4. Acetone 1.816 kg 5. L‐Arginine (Non Sterile) 0.37 kg 6. IPA (Iso Propyl Aclohol) 0.392 kg
49
Case No.:15/50/82‐ALC4/2009
Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 17.08.2010 Status:Case Deferred HQ File :01/82/050/01169/AM10/ RLA File :03/95/040/00779/AM10/ Lic.No/Date:0310561977 25.02.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. 50
Case No.:16/50/82‐ALC4/2009
Party Name:SRINI PHARMACEUTICALS LTD., 17.08.2010 Status:Case Approved HQ File :01/82/050/01170/AM10/ RLA File :09/24/040/00478/AM10/ Lic.No/Date:0910041061 25.02.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/52/2010‐PI‐(Norms) dated 29.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Ramipril 1 Kg. 1. (+)Cis‐endo‐2‐Aza Bicycle(3.3.0)Octane‐3‐ Carboxylic Acid Benzyl Ester Hydrochloride 2.65 kg 2. N‐((1S)‐Ethoxycarbonyl‐3‐Phenylpropyl)‐L‐Alanine 1.23 kg 3. 1,1’‐Carbonyldiimidazole/N,N‐Carbonyldimidazole 1.00 kg 51
Case No.:17/50/82‐ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/01171/AM10/ RLA File :05/24/040/00486/AM10/ Lic.No/Date:0510259472 25.02.2010 Defer Date:12.10.2010 52
Case No.:26/50/82‐ALC4/2009
Party Name:CENTURY PHARMACEUTICALS LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/01180/AM10/ RLA File :34/24/040/00208/AM10/ Lic.No/Date:3410026508 02.03.2010 Defer Date:12.10.2010 Decision :CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/36/2010‐PI (Norms) dated 09.07.2010, decided to call for the following informaƟon from firm:‐ 1. The firm has given different molecular weight of various input and output product in ReacƟons‐Scheme and detailed working. The enƟre working is based on molecular weight of 751 of the export product whereas it is shown as 735 in the reacƟon scheme. Therefore, the firm may be asked to furnish revised chemistry and working based on actual data.
Accordingly, case was deferred for 12.10.2010. 53
Case No.:28/50/82‐ALC4/2009
Party Name:SMILAX LABORATORIES LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/01182/AM10/ RLA File :09/24/040/00446/AM10/ Lic.No/Date:0910041147 03.03.2010 Defer Date:12.10.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/56/2010‐PI (Norms) dated 09.07.2010, decided to call for the following informaƟon from firm:‐ 1. The yield shown by the firm in conversion of Cyano Diol to Escitalopram Oxalate appears to be incorrect. 2. The norms applied by the firm do not match with the chemistry and yield shown by the firm. 3. The firm may be requested to give correct and amended yield on molar basis for each step of manufacturing process. 4. Detailed working for applied quanƟƟes of input alongwith technical jusƟficaƟon. Accordingly, case was deferred for 12.10.2010. 54
Case No.:33/50/82‐ALC4/2009
Party Name:VDH INTERNATIONAL 17.08.2010 Status:Case Deferred HQ File :01/82/050/01187/AM10/ RLA File :05/24/040/00456/AM10/ Lic.No/Date:0510259764 03.03.2010 Defer Date:12.10.2010 Decision :CommiƩee considered case as per agenda and observed that the firm has been requested to furnish technical informaƟon vide leƩer dated 02.07.2010, but the same have not been received. It was, therefore, decided to remind the firm and defer the case for 12.10.2010. 55
Case No.:5/52/82‐ALC4/2009
Party Name:VIVIMED LABS LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/01198/AM10/ RLA File :09/24/040/00496/AM10/ Lic.No/Date:0910041237 09.03.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. 56
Case No.:14/52/82‐ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/01207/AM10/ RLA File :05/24/040/00507/AM10/ Lic.No/Date:0510260189 10.03.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of PharmaceuƟcals. A copy of applicaƟon is to be sent to Department of PharmaceuƟcals. 57
Case No.:57/9/82‐ALC4/2010
Party Name:MAKSON INDUSTRIES PVT. LTD. Status:Case
17.08.2010 Deferred HQ File :01/82/050/00272/AM11/ RLA File :03/95/040/00799/AM10/ Lic.No/Date:0310563993 10.03.2010 Defer Date:12.10.2010 Decision : CommiƩee considered case as per agenda and observed that the wriƩen comments are not forthcoming from DC(MSME) while the case is long pending for fixaƟon of norms. It was, therefore, decided to remind DC(MSME) through D.O. reminder at the level of Chairman, NC‐III. Accordingly, case was deferred for 12.10.2010. 58
Case No.:19/52/82‐ALC4/2009
Party Name:ATUL LIMITED, 17.08.2010 Status:Case Approved HQ File :01/82/050/01212/AM10/ RLA File :08/24/040/00288/AM10/ Lic.No/Date:0810087221 11.03.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/40/2006‐Ch.II dated 13.07.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 3,3 Dimethyl 4,4 Diamino Diphenyl Methane 1 Kg. 1. Ortho Ethyl Aniline 1.270 kg 2. Methanol 0.197 kg 59
Case No.:29/52/82‐ALC4/2009
Party Name:AARTI INDUSTRIES LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/01222/AM10/ RLA File :03/94/040/01071/AM10/ Lic.No/Date:0310564649 12.03.2010 Defer Date:12.10.2010 Decision :CommiƩee decided to forward a copy of applicaƟon to Department of PharmaceuƟcals for their comments. Accordingly, case was deferred for 12.10.2010. 60
Case No.:1/1/82‐ALC4/2010
Party Name:PARAMOUNT AROMACHEM PVT.LTD., 17.08.2010 Status:Case Deferred HQ File :01/82/050/01232/AM10/ RLA File :05/24/040/00501/AM10/ Lic.No/Date:0510260909 22.03.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. A copy of applicaƟon is to be sent to Department of C&PC. 61
Case No.:8/2/82‐ALC4/2010
Party Name:AMOLI ORGANICS PVT. LTD., 17.08.2010 Status:Case Approved HQ File :01/82/050/00008/AM11/ RLA File :03/94/040/01029/AM10/ Lic.No/Date:0310568174 06.04.2010
Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Bifonazole Micronised 1 kg 1. Bifonazole Net to Net 62
Case No.:35/2/83‐ALC1/2010
Party Name:ADVY CHEMICAL 17.08.2010 Status:Case Deferred HQ File :01/83/050/00035/AM11/ RLA File :03/94/040/01124/AM10/ Lic.No/Date:0310568188 06.04.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of Bio‐technology. 63
Case No.:2/3/82‐ALC4/2010
Party Name:VIVIMED LABS LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/00013/AM11/ RLA File :09/24/040/00549/AM10/ Lic.No/Date:0910041571 07.04.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. 64
Case No.:8/3/82‐ALC4/2010
Party Name:PROMED EXPORTS PVT.LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00019/AM11/ RLA File :05/24/040/00008/AM11/ Lic.No/Date:0510262191 09.04.2010 Defer Date:12.10.2010 65
Case No.:10/3/82‐ALC4/2010
Party Name:VHB MEDISCIENCES LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00021/AM11/ RLA File :03/95/040/00015/AM11/ Lic.No/Date:0310569153 12.04.2010 Defer Date:12.10.2010 66
Case No.:3/4/82‐ALC4/2010
Party Name:AGIO PHARMACEUTICALS LTD 17.08.2010 Status:Case Approved HQ File :01/82/050/00028/AM11/ RLA File :03/94/040/00048/AM11/ Lic.No/Date:0310569589 15.04.2010
Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/46/2010‐PI‐(Norms) dated 29.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms on repeat basis under para Export product Exp. Qty. Sl.No. Import items Qty. allowed Bendaz 10% Suspension (1000 ml BoƩle) 1 Kg. 1. Albendazole 0.102 kg Bendaz 10% Suspension (200 ml BoƩle) 1 kg 1. Albendazole 0.0204 kg 67
Case No.:6/4/82‐ALC4/2010
Party Name:AGIO PHARMACEUTICALS LTD 17.08.2010 Status:Case Approved HQ File :01/82/050/00031/AM11/ RLA File :03/94/040/01148/AM10/ Lic.No/Date:0310569730 16.04.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/46/2010‐PI‐(Norms) dated 29.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms on repeat basis under para Export product Exp. Qty. Sl.No. Import items Qty. allowed Bendaz 10% Suspension (1000 ml BoƩle) 1 Kg. 1. Albendazole 0.102 kg Bendaz 10% Suspension (200 ml BoƩle) 1 kg 1. Albendazole 0.0204 kg 68
Case No.:7/4/82‐ALC4/2010
Party Name:AGIO PHARMACEUTICALS LTD 17.08.2010 Status:Case Approved HQ File :01/82/050/00032/AM11/ RLA File :03/94/040/00060/AM11/ Lic.No/Date:0310569747 16.04.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/46/2010‐PI‐(Norms) dated 29.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms on repeat basis under para Export product Exp. Qty. Sl.No. Import items Qty. allowed Bendaz 600 mg Bolus 1 No. 1. Albendazole 612 mg Bendaz 1500 mg Bolus 1 kg 1. Albendazole 1530 mg Bendaz 2500 mg Bolus 1 No. 1. Albendazole 2550 mg Bendaz 10% Suspension (1000 ml) 1 No. 1. Albendazole 102 gm
BoƩle 69
Case No.:36/19/82‐ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/00621/AM11/ RLA File :09/24/040/00160/AM11/ Lic.No/Date:0910042936 29.07.2010 Defer Date:05.10.2010 Decision : CommiƩee decided to defer case for 05.10.2010 for comments of Department of PharmaceuƟcals. 70
Case No.:1/20/82‐ALC4/2010
Party Name:PROMED EXPORTS PVT.LTD. 17.08.2010 Status:Case Deferred HQ File :01/82/050/00627/AM11/ RLA File :05/24/040/00155/AM11/ Lic.No/Date:0510269603 03.08.2010 Defer Date:12.10.2010 71
Case No.:4/20/82‐ALC4/2010
Party Name:ANUH PHARMA LTD. 17.08.2010 Status:Case Approved HQ File :01/82/050/00630/AM11/ RLA File :03/94/040/00376/AM11/ Lic.No/Date:0310586163 05.08.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 6/82 meeƟng held on 11.05.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Clobetasol Propionate BP 1 kg. 1. Betamethasone Base BP 1.04 kg 72
Case No.:2/20/82‐ALC4/2010
Party Name:THEMIS PHARMACEUTICALS(PROP.CHEMOSYN LTD.) 17.08.2010 Status:Case Deferred HQ File :01/82/050/00628/AM11/ RLA File :08/24/040/00147/AM11/ Lic.No/Date:0810090990 06.08.2010 Defer Date:12.10.2010 Decision :CommiƩee decided to call for a copy of applicaƟon, copy of DML and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 12.10.2010. 73
Case No.:3/20/82‐ALC4/2010
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 17.08.2010 Status:Case Deferred
HQ File :01/82/050/00629/AM11/ RLA File :05/24/040/00164/AM11/ Lic.No/Date:0510269870 06.08.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. 74
Case No.:5/20/82‐ALC4/2010
Party Name:INDO AMINES LIMITED 17.08.2010 Status:Case Deferred HQ File :01/82/050/00631/AM11/ RLA File :03/94/040/00360/AM11/ Lic.No/Date:0310586286 06.08.2010 Defer Date:12.10.2010 Decision : CommiƩee decided to defer case for 12.10.2010 for comments of Department of C&PC. 75
Case No.:8/20/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/00634/AM11/ RLA File :05/24/040/00167/AM11/ Lic.No/Date:0510270032 09.08.2010 Defer Date:12.10.2010 76
Case No.:6/20/82‐ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 17.08.2010 Status:Case Deferred HQ File :01/82/050/00632/AM11/ RLA File :09/24/040/00167/AM11/ Lic.No/Date:0910043026 10.08.2010 Defer Date:12.10.2010 77
Case No.:7/20/82‐ALC4/2010
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 17.08.2010 Status:Case Approved HQ File :01/82/050/00633/AM11/ RLA File :09/24/040/00175/AM11/ Lic.No/Date:0910043027 10.08.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 1/82 meeƟng held on 06.04.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 1,1‐Cyclohexane DiaceƟc Anhydride 1 Kg. 1. 1,1 Cyclohexane DiaceƟc Acid 1.20 kg 78
Case No.:9/20/82‐ALC4/2010
Party Name:TORRENT PHARMACEUTICALS LTD. 17.08.2010 Status:Case
Approved HQ File :01/82/050/00635/AM11/ RLA File :08/24/040/00145/AM11/ Lic.No/Date:0810091055 10.08.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 2/82 meeƟng held on 13.04.2010 and in consultaƟon with technical authority present in meeƟng decided to raƟfy 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 Metoprolol Tartrate Tablets 50 mg Metoprolol 50 Heumann 1 No. 1. Metoprolol Tartrate EP 51 mg/tablet Metoprolol Tartrate Tablets 100 mg Metoprolol 50 Heumann 1 No. 1. Metoprolol Tartrate EP 102 mg/tablet 79
Case No.:10/20/82‐ALC4/2010
Party Name:UNIMARK REMEDIES LIMITED., 17.08.2010 Status:Case Approved HQ File :01/82/050/00636/AM11/ RLA File :03/95/040/00145/AM10/ Lic.No/Date:0310586672 10.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/262/2009‐PI‐(Norms) dated 08.03.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Minocycline Hydrochloride 1 Kg. 1. Demeclocycline Gcl 6.487 kg 2. 5% Rodhium on Carbon (50% Wet) 0.097 kg 3. Methanol 22.833 kg 4. Dimethyl formamide 16.20 kg 5. N‐Chlorosuccinimide 0.624 kg 6. Acetone 5.26 kg 80
Case No.:11/20/82‐ALC4/2010
Party Name:SARNA CHEMICALS PVT.LTD. 17.08.2010 Status:Case Approved HQ File :01/82/050/00637/AM11/ RLA File :03/95/040/00329/AM11/ Lic.No/Date:0310586797 10.08.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/48/2008‐Ch.II
dated 20.05.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 4(2‐Chloro Ethylsulfonyl) Butyric Acid (XAZ Base) 1 Kg. 1. Butyrolactone (Gamma Butyrolactone) 0665 kg 2. Isopropyl Alcohol 0.695 kg 3. 2‐Mercapto Ethanol 0.691 kg 81
Case No.:12/20/82‐ALC4/2010
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED Meet No/Date:20/82‐ALC4/2010 17.08.2010 Status:Case Approved HQ File :01/82/050/00638/AM11/ RLA File :03/95/040/00342/AM11/ Lic.No/Date:0310586806 10.08.2010 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy 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 Powder (40‐80 Mesh) 1 Kg. 1. Sodium Saccharin Granular (8‐16) (20‐40 Mesh) 1.01 kg
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