DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 12/82ALC4/2013 MEETING DATE : 19.09.2013 The Meeting No. 12/82 in the year 201314 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was scheduled to be held on 19.09..2013 but was actually held on 26.09.2013 under the Chairmanship of, Shri Jaikant Singh, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present: 1. Shri D.N. Mathur. Consultantr, Department of Pharmaceutical 2. . Shri Manoj Kumar, Deputy Director, DC (MSME) 3. Shri R.C. Meena, Deputy Director General of Foreign Trade
Case No. A‐12
M/s Divis Laboratories Ltd, Hyderabad Mee韣�ng No. 12/AM14 dated – 19.09.2013 F.No. 01/82/162/00621/AM13/DES‐III Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals.
Case No. A‐13
M/s Sandoz Pvt Ltd. F.No. 01/82/162/00087/AM14/DES‐III F.No. 01/82/162/00099/AM14/DES‐III Decision :It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals.
Case No. B‐107
M/s Astrix Labs Pvt Ltd F.No. 09/24/50/00165/AM13/DES‐III RLA F. No. 09/24/040/538/AM12 Adv. Lic. No.0910005472 dated 27.07.2012 Decision :It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals.
Case No. B‐108
M/s Intas Pharma Ltd F.No. 01/82/50/711/AM12/DES‐III F.No. 01/82/50/726/AM12/DES‐III RLA F. No. 03/94/040/114/AM12 RLA F. No. 03/94/040/173/AM12 Adv. Lic. No.0810102412 dated 11.08.2011 Adv. Lic. No.0810104691 dated 31.08.2012 Decision : Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo. RA concerned may take further necessary action as per above decision of NC.
Case No. B‐109
M/s IPCA Labs Ltd F.No. 01/82/50/1060/AM10/DES‐III RLA F. No. 03/94/040/949/AM10 Adv. Lic. No.0310558204 dated 02.02.2010 Decision : It was decided to amend the description of Export Product as “Triamcinolone Base instead of “Triamcinolone Acetonide”” . The rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee.
Case No. B‐110
M/s IPCA Labs Ltd F.No. 01/82/162/104/AM14/DES‐III RLA F. No. 03/94/040/183/AM12 Adv. Lic. No.0310644410 dated 26.07.2011 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals and also decided to send the copy of application to TA.
Case No. B‐111
M/s Deccan Nutraceu韣�cals Pvt Ltd, Pune F.No. 01/82/050/08244/AM130/DES‐III RLA F. No. 31/83/040/000117/AM13 Adv. Lic. No.3110056020 dated 09.10.2012 Decision :Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo. RA concerned may take further necessary action as per above decision of NC.
Case No. B‐112
M/s Deccan Nutraceu韣�cals Pvt Ltd, Pune
F.No. 01/82/050/00824/AM13/DES‐III RLA F. No. 31/83/040/00058/AM13 Adv. Lic. No.3110055158 dated 27.07.2012 Decision :Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo. RA concerned may take further necessary action as per above decision of NC.
Case No. B‐113
M/s Lupin Ltd F.No. 01/82/050/00417/AM11/DES‐III RLA F. No. 03/95/040/00127/AM11 Adv. Lic. No.031057576 dated 20.05.2010 Decision : This case was earlier considered and approved in NC meeting no. 30/82 dated 26.10.2010 for export of 5000 kg of 7APCA. The firm exported 999.62 kg of 7APCA, after which the export order got cancelled. The firm now intend to export various formulation of Cefprozil in lieu of balanced quantity of 7APCA due for export. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/696/2012PI(Norms) dated 11.09.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: As per the approved norms for Cefprozil and 7APCA. 1 kg 7APCA is equivalent to 1.2453 kg of Cefprozil Balance quantity of 7APCA for export = 4000.38 kg equivalent to 4981.70 kg of Cefprozil In lieu of the balance 4000.38 kg of 7APCA the firm be advised to export various formulation of Cefprozil for a total quantity of 4981.70 kg of Cefprozil. The firm should thereof be advised to account for 4981.70 kg of Cefprozil. RA may take appropriate action as per the decision f Norms Committee.
Case No. B‐114
M/s Lupin Ltd F.No. 01/82/050/647/AM13/DES‐III RLA F. No. 3/95/040/304/AM13 Adv. Lic. No.0310704078 dated 20.07.2012 Decision :It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals. .
Case No. B‐115
M/s Alembic Ltd F.No. 01/82/050/542/AM13/DES‐III RLA F. No. 34/24/040/00103/AM13 Adv. Lic. No.3410034667 dated 18.07.2012 Decision : :Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to amend the description of Import item Sr. No. 7 and Sr. No. 8 in the minutes of the NC meeting no. 31/AM 13 dated 21.02.2013 as details given below. The rest of the minutes would remain same. S.No Import item For Export of 1 No. of Tablet 250 mg 400 mg 1. Ursodeoxycholic Acid 255.0 mg 408.0 mg 2. Microcrystalline Cellulose (Avicel PH 101) 26.75 42.80 3 Povidone (Kollidon25 ) 6.00 9.60 4. Crospovidone (Polyplasdone XL) 5.00 8.00 5. Microcrystalline Cellulose (Avicel PH 102) 80.25 128.40 6. Magnesium Stearate 4.00 6.40 7. Hypromellose (Methocel E5 Premium LV) / (HPMC 5 CP Methocel E5LV USP/EP Prem) 1.90 2.85 8. Polyethylene Glycol 20000 (Macrogol 20000) / ( Polyglykol 20000 P ) 1.10 1.65 RA may take appropriate action as per the decision f Norms Committee.
Case No. B‐116
M/s Gaurav Pharma Ltd, New Delhi F.No. 01/82/171/00018/AM13/DES‐III Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals.
Case No. B‐117
M/s Medreich Ltd, Bangalore F.No. 01/82/171/00061/AM14/DES‐III RLA F. No. 07/24/040/00796/AM08 Adv. Lic. No.0710056381 dated 13.03.2008 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals.
Case No. B‐118
M/s Mylan Laboratories Ltd, Hyderabad F.No. 01/82/050/00212/AM12/DES‐III RLA F. No. 09/24/040/00485/AM11 Adv. Lic. No.0910045600 dated 18.02.2011 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals.
Case No. B‐119
M/s Arch Pharmalabs Ltd., Mumbai F.No. 01/82/050/00870/AM09/DES‐III(Pt.) RLA F. No. 03/94/040/00393/AM09 Adv. Lic. No.0310481979 dated 08.08.2008 Decision : It was decided to remind the firm to furnish technical details as per Appendix 33. The case was deferred for 17.10.2013.
Case No. B‐120
M/s Pregna Interna韣�onal Ltd., Mumbai
F.No. 01/82/050/00941/AM13/DES‐III RLA F. No. 03/95/040/00635/AM12 Adv. Lic. No.0310665072 dated 15.11.2011 Decision : It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals.
Case No. B‐121
M/s Panacea Biotec Ltd, New Delhi F.No. 01/82/050/00427/AM10/DES‐III F.No. 01/82/050/00927/AM11/DES‐III F.No. 01/82/050/00327/AM12/DES‐III RLA F. No. 05/24/040/00156/AM11 RLA F. No. 05/24/040/00235/AM11 RLA F. No. 05/24/040/00070/AM12 Adv. Lic. No.0510269042 dated 26.07.2010 Adv. Lic. No.0510274701 dated 11.10.2010 Adv. Lic. No.0510292280 dated 31.05.2011 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Biotechnology.
Case No. B‐122
M/s Honest Bio‐Vet Pvt Ltd., Ahmedabad F.No. 01/82/050/714/AM13/DES‐III RLA F. No. 08/24/040/208/AM13 Adv. Lic. No.0810115028 dated 12.09.2012 Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo. RA concerned may take further necessary action as per above decision of NC. 1
Case No.:3/31/82ALC4/2010
Party Name:EMAMI LIMITED, Meet No/Date:12/82ALC4/2013 19.09.2013 Status:Case Approved HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 23/4/2013 Chem‐Ch. II dated 26.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product Export Qty. Sl.No. Import items Qty. allowed ZANDU BALM 10 Gram /2482395 PCS = 24823.950 KGS & 30 Gram / 395550 PCS = 11866.500 KGS. 1 kg 1. Micro Crystalline Wax 0.100 kg 2. Paraffin Wax 0.100 kg 3. Petroleum Jelly 0.500 kg 4. Methyl Salysilate 0.102 kg 5. Menthol 0.204 kg RA may take appropriate ac韣�on as per the decision of Norms Commi埜�ee. 2
Case No.:63/40/82ALC4/2010
Party Name:EMAMI LIMITED, 19.09.2013 Status:Case Approved HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 23/4/2013 Chem‐Ch. II dated 26.09.201s3, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed ZANDU BALM 4 ml / 14590902 pcs., 9 ml /11615748 pcs & 25 ml / 864000 pcs. Total 126141.732 litres 1 kg 1. Micro Crystalline Wax 0.100 kg 2. Paraffin Wax 0.100 kg 3. Petroleum Jelly 0.500 kg 4. Methyl Salysilate 0.102 kg 5. Menthol 0.204 kg 3
Case No.:27/19/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00541/AM12/ RLA File :09/24/040/00086/AM12/ Lic.No/Date:0910046997 06.06.2011 Defer Date:17.10.2013 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Chemicals and Petrochemicals. 4
Case No.:6/22/82ALC4/2012
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00709/AM13/ RLA File :03/95/040/00262/AM13/ Lic.No/Date:0310705888 22.08.2012 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Department of Chemicals and Petrochemicals.
5
Case No.:16/24/82ALC4/2012
Party Name:OGENE SYSTEMS INDIA PVT. LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00820/AM13/ RLA File :09/24/040/00312/AM13/ Lic.No/Date:0910053896 25.09.2012 Defer Date:17.10.2013 6
Case No.:12/12/82ALC4/2013
Party Name:DSM ANTIINFECTIVES INDIA LTD 19.09.2013 Status:Case Approved HQ File :01/82/050/00436/AM14/ RLA File :22/24/040/00013/AM13/ Lic.No/Date:2210013403 21.11.2012 Defer Date: Decision : In the light of earlier decision taken in mee韣�ng no. 1/82 dated 04.04.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through enzymatic route Tech. Spec: ASSY not less than 84% as such or 96% on dry basis 1 kg 1. 6Amino Pencillanic Acide (6APA) 0.568 kg 2. Formidase (Enzyme) 0.005 kg 3. Methanol Not required in the process given by the firm 4. D()PHydroxy Phenyl Glycine Methylester 0.608 kg RA may take appropriate action as per the decision of Norms Committee. 7
Case No.:85/31/82ALC4/2012
Party Name:SANOFI INDIA LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/01125/AM13/ RLA File :03/95/040/00465/AM13/ Lic.No/Date:0310717240 14.12.2012 Defer Date:17.10.2013 Decision :It was decided to put up the case on file . The case was deferred for 17.10.2013 8
Case No.:13/12/82ALC4/2013
Party Name:HETERO DRUGS LIMITED, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00437/AM14/ RLA File :09/24/040/00495/AM13/ Lic.No/Date:0910054735 09.01.2013 Defer Date:17.10.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 17.10.2013
9
Case No.:42/12/82ALC4/2013
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00466/AM14/ RLA File :09/24/040/00454/AM13/ Lic.No/Date:0910054767 11.01.2013 Defer Date:17.10.2013 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals. 10
Case No.:48/4/82ALC4/2013
Party Name:SRINI PHARMACEUTICALS LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00089/AM14/ RLA File :09/24/040/00463/AM13/ Lic.No/Date:0910054762 11.01.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals. 11
Case No.:158/33/82ALC4/2012
Party Name:FERMENTA BIOTECH LTD., 19.09.2013 Status:Case Approved HQ File :01/82/050/01305/AM13/ RLA File :03/94/040/00683/AM13/ Lic.No/Date:0310721893 24.01.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/105/2013PI(Norms) dated 11.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Cholecalciferol (Vitamin D3) BP/USP/EP 1 kg 1. Cholesterol NF 4.14 2. Methyl Formate 4.72 3. Petroleum Ether 6.25 4. 2,4,6 Colidine 0.362 A may take appropriate ac韣�on as per the decision of Norms Commi埜�ee. 12
Case No.:38/33/82ALC4/2012
Party Name:R L FINE CHEM 19.09.2013 Status:Case Approved HQ File :01/82/050/01185/AM13/ RLA File :07/24/040/00449/AM13/ Lic.No/Date:0710093355 28.01.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/373/2013‐PI(Norms) dated 16.09.2013, it was decided to ra韣�fy norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg CHLORPROMAZINE 1 1 BROMO 3 CHLORO 0.95
HCL IP PROPANE 2 2 CHLORO PHENOTHIAZINE 0.90 3 ACETONE 3.33 13
Case No.:197/33/82ALC4/2012
Party Name:FERMENTA BIOTECH LTD., 19.09.2013 Status:Case Approved HQ File :01/82/050/01344/AM13/ RLA File :03/94/040/00917/AM13/ Lic.No/Date:0310722266 29.01.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/105/2013PI(Norms) dated 11.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Cholecalciferol (Vitamin D3) BP/USP/EP 1 kg 1. Cholesterol NF 4.14 2. Methyl Formate 4.72 3. Petroleum Ether 6.25 4. 2,4,6 Colidine 0.362 14
Case No.:14/12/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00438/AM14/ RLA File :03/94/040/00903/AM13/ Lic.No/Date:0310722358 30.01.2013 Defer Date:17.10.2013 15
Case No.:28/4/82ALC4/2013
Party Name:MYLAN LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00069/AM14/ RLA File :09/24/040/00520/AM13/ Lic.No/Date:0910054940 05.02.2013 Defer Date:17.10.2013 16
Case No.:21/10/82ALC4/2013
Party Name:AUCTUS PHARMA LIMITED 19.09.2013 Status:Case Approved
HQ File :01/82/050/00204/AM14/ RLA File :09/24/040/00568/AM13/ Lic.No/Date:0910055280 05.03.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/339/2013PI(Norms) dated 11.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg (2S,5R) FLUOROCYTOSINE1 YL[1,3] OXATHIOLANE2 CARBOXYLIC ACID METHYL ESTER (FCE) 1 kg 1. GLYOXALIC ACID 50% 0.68 2. CYCLOHEXANE 1. 27 3. 2,5DIHYDROXY1,4 DITHIANE 0.28 4. 5FLUOROCYTOSINE 0.531 5. METHYLENE CHLORIDE (MDC) 8.54 17
Case No.:55/4/82ALC4/2013
Party Name:SHREE GANESH REMEDIES PVT.LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00096/AM14/ RLA File :34/24/040/00287/AM13/ Lic.No/Date:3410036329 06.03.2013 Defer Date:17.10.2013 18
Case No.:58/4/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00099/AM14/ RLA File :22/24/040/00077/AM13/ Lic.No/Date:2210013693 06.03.2013 Defer Date:17.10.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/425/2013PI(Norms) dated 26.09.2013, it was decided to request the firm to furnish technical details as per Appendix 33 along with % composition of the export product. 19
Case No.:18/8/82ALC4/2013
Party Name:VIVIMED LABS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00149/AM14/ RLA File :09/24/040/00572/AM13/ Lic.No/Date:0910055306 07.03.2013 Defer Date:17.10.2013 20
Case No.:27/10/82ALC4/2013
Party Name:VIVIMED LABS LIMITED 19.09.2013 Status:Case
Deferred HQ File :01/82/050/00210/AM14/ RLA File :09/24/040/00589/AM13/ Lic.No/Date:0910055307 07.03.2013 Defer Date:17.10.2013 21
Case No.:114/10/82ALC4/2013
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00297/AM14/ RLA File :03/94/040/00991/AM13/ Lic.No/Date:0310727451 08.03.2013 Defer Date:17.10.2013 22
Case No.:30/10/82ALC4/2013
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00213/AM14/ RLA File :09/24/040/00548/AM13/ Lic.No/Date:0910055356 11.03.2013 Defer Date:17.10.2013 23
Case No.:214/10/82ALC4/2013
Party Name:SHREE GANESH REMEDIES PVT.LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00397/AM14/ RLA File :34/24/040/00299/AM13/ Lic.No/Date:3410036377 12.03.2013 Defer Date:17.10.2013 24
Case No.:31/10/82ALC4/2013
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00214/AM14/ RLA File :09/24/040/00593/AM13/ Lic.No/Date:0910055380 13.03.2013 Defer Date:17.10.2013 25
Case No.:35/8/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00166/AM14/ RLA File :09/24/040/00591/AM13/ Lic.No/Date:0910055383 13.03.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/528/2013PI(Norms) dated 13.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg OXACILLIN SODIUM 1 kg 1. 6 Aminopenicillanic acid (6APA ) 0.518 2. Carbon Enoanticromos [ Activated Carbon ] 0.010 3. PMIC Chloride 0.617 4. 2Ethylhexanoic Acid 0.128 5. Methyl isobutylketone (MIBK) 0.050 6. Steam/Thermal Coal As per fule policy 26
Case No.:141/10/82ALC4/2013
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00324/AM14/ RLA File :03/94/040/00982/AM13/ Lic.No/Date:0310728214 14.03.2013 Defer Date:17.10.2013 27
Case No.:59/10/82ALC4/2013
Party Name:MYLAN LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00242/AM14/ RLA File :09/24/040/00585/AM13/ Lic.No/Date:0910055390 14.03.2013 Defer Date:17.10.2013 28
Case No.:10/8/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 19.09.2013 Status:Case Approved HQ File :01/82/050/00141/AM14/ RLA File :08/24/040/00439/AM13/ Lic.No/Date:0810119457 15.03.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/539/2013‐PI(Norms) dated 26.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product VENLAFAXINE 2 5 MG, 37.5 MG, 50MG , 75 MG and 1080 MG TAB S.NO. Import Items For export of 1 No. Tablets
(Quan韣�ty in mg) 25 mg 37.5 mg 50 mg 75 mg 100 mg 1 VENLAFAXINE HCL 28.855 43.283 57.71 86.565 115.42 2 LACTOSE MONOHYDRATE NF 30.0 45.0 60.0 90.0 120.0 3 MICROCRYSTALLINE CELLULOSE NF (AVICEL PH 101) 16.663 24.994 33.325 49.988 66.650 4 MICROCRYSTALLINE CELLULOSE NF (AVICEL PH 102) 16.463 24.694 32.925 49.388 65.850 5 MAGNESIUM STEARATE 1.00 1.50 2.00 3.00 4.00 6 SODIUM STARCH GLYCOLATE 7.50 11.25 15.00 22.50 30.00 7 Import items at Sl. No. 7 to 10 Relevant, As per Packing Policy 29
Case No.:13/10/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00196/AM14/ RLA File :22/24/040/00075/AM13/ Lic.No/Date:2210013720 15.03.2013 Defer Date:17.10.2013 30
Case No.:17/8/82ALC4/2013
Party Name:CADILA PHARMACEUTICALS LTD. 19.09.2013 Status:Case Approved HQ File :01/82/050/00148/AM14/ RLA File :08/24/040/00446/AM13/ Lic.No/Date:0810119459 15.03.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/203/2013‐PI(Norms) dated 26 .09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg NEBIVOLOL HCL 1 kg 1. 4FLUORO ANISOLE 14.97 2. ETHYLENE DI CHLORIDE Not recommended 3. HEXANE 36.5 4. ACETIC ACID 10.88 5. DICHLORO METHANE 47.54 6. METHANOL 38‐80 7. VITRIDE 13.35
TOLUENE 9.89 9. DIMETHYLE SULPHOXIDE 13.13 10. ISOPROPYL ALCOHOL 1.44 11. ACETONITRILE 0.76 12. DISOPROPYL ETHER 1.94 31
Case No.:25/8/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00156/AM14/ RLA File :05/24/040/00469/AM13/ Lic.No/Date:0510349278 15.03.2013 Defer Date:17.10.2013 32
Case No.:135/10/82ALC4/2013
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 19.09.2013 Status:Case Approved HQ File :01/82/050/00318/AM14/ RLA File :03/94/040/01048/AM13/ Lic.No/Date:0310728565 18.03.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2011‐Ch II dated 30.08.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed ASTROLIDE (S) (Astrolide content : 100%) 1 kg 1. ISOAMYLENE 0.580 kg 2. SPROPYLENE OXIDE 0.380 kg 3. ALPHA METHYL STYRENE 0.769 kg 4. PARAFORMALDEHYDE 0.117 kg 33
Case No.:3/8/82ALC4/2013
Party Name:BHARAT PARENTERALS LTD, 19.09.2013 Status:Case Approved HQ File :01/82/050/00134/AM14/ RLA File :34/24/040/00303/AM13/ Lic.No/Date:3410036435 18.03.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/526/2013PI(Norms) dated .09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed
METHYL PREDNISOLONE SODIUM SUCCINATE FOR INJECTION 1 GM USP (EACH VIAL CONTAIN METHYL PREDNISOLONE SODIUM SUCCINATE USP EQ.TO METHYL PREDNISOLONE 1.36 GM) ACTUAL CONTENT OF METHYL PREDNISOLONE SODIUM SUCCINATE USP 25.024 KGS (TOTAL 18400.00 VIALS) kg 1. METHYL PREDNISOLONE SODIUM SUCCINATE USP/BP 1.36 gm/vial 34
Case No.:139/10/82ALC4/2013
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 19.09.2013 Status:Case Approved HQ File :01/82/050/00322/AM14/ RLA File :03/94/040/01097/AM13/ Lic.No/Date:0310728798 19.03.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2011‐Ch II dated 30.08.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed ASTROLIDE (S) (Astrolide content : 100%) 1 kg 1. ISOAMYLENE 0.580 kg 2. SPROPYLENE OXIDE 0.380 kg 3. ALPHA METHYL STYRENE 0.769 kg 4. PARAFORMALDEHYDE 0.117 kg 35
Case No.:140/10/82ALC4/2013
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00323/AM14/ RLA File :03/94/040/00981/AM13/ Lic.No/Date:0310728713 19.03.2013 Defer Date:17.10.2013 36
Case No.:21/8/82ALC4/2013
Party Name:HETERO LABS LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00152/AM14/ RLA File :09/24/040/00597/AM13/ Lic.No/Date:0910055419 19.03.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/534/2013PI(Norms) dated 16.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg SORAFENIB / SORAFENIB TASYLATE 1 kg 1. 4Chloro(2Pyridyl)Nmethyl carboxamide 0.70 2. pAmino phenol 0.44 3. 1,1Carbonyl Diimidazole 0.528 4. Potassium tert. butoxide 0.46 5. 4Chloro3(trifluoro methyl) benzamine 0.64 37
Case No.:32/8/82ALC4/2013
Party Name:BIOLOGICAL E LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00163/AM14/ RLA File :09/24/040/00607/AM13/ Lic.No/Date:0910055421 19.03.2013 Defer Date:17.10.2013 Decision :Department of Biotechnology vide their letter No. BT/IL/05/382/2013PID dated 29.08.2013 has mentioned that the norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type B (HIB) Combined vaccine with vaccine vial monitar (VVM) (5000000.00) against the import inputs mentioned in the application. You are requested to furnish the following information: Drug Manufaturing Licensing of the export product (DML encloased with the application does not mention the export product. To submit QA approved Batch Manufacturing Record. The case was deferred for 17.10.2013 38
Case No.:57/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00240/AM14/ RLA File :09/24/040/00606/AM13/ Lic.No/Date:0910055420 19.03.2013 Defer Date:19.09.2013 Decision :Department of Biotechnology vide their letter No. BT/IL/05/382/2013PID dated 29.08.2013 has mentioned that the norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type B (HIB) Combined vaccine with vaccine vial monitar (VVM) (5000000.00) against the import inputs mentioned in the application. You are requested to furnish the following information: Drug Manufaturing Licensing of the export product (DML encloased with the application does not mention the export product.
To submit QA approved Batch Manufacturing Record. The case was deferred for 17.10.2013 39
Case No.:12/10/82ALC4/2013
Party Name:KUDOS CHEMIE LTD., 19.09.2013 Status:Case Approved HQ File :01/82/050/00195/AM14/ RLA File :22/24/040/00082/AM13/ Lic.No/Date:2210013723 20.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 02.05.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Adenine 1 kg 1. Formamide 6.28 kg 40
Case No.:125/10/82ALC4/2013
Party Name:LAXMI ORGANIC INDUSTRIES LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00308/AM14/ RLA File :03/95/040/00911/AM13/ Lic.No/Date:0310728818 20.03.2013 Defer Date:17.10.2013 41
Case No.:24/10/82ALC4/2013
Party Name:KUDOS CHEMIE LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00207/AM14/ RLA File :22/24/040/00083/AM13/ Lic.No/Date:2210013724 20.03.2013 Defer Date:17.10.2013 42
Case No.:52/4/82ALC4/2013
Party Name:CHIRAG ENTERPRISE 19.09.2013 Status:Case Deferred HQ File :01/82/050/00093/AM14/ RLA File :24/24/040/00017/AM13/ Lic.No/Date:2410038507 20.03.2013 Defer Date:17.10.2013 Decision : It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals and again sent a copy of application to TA. 43
Case No.:53/4/82ALC4/2013
Party Name:CHIRAG ENTERPRISE Status:Case
19.09.2013 Deferred HQ File :01/82/050/00094/AM14/ RLA File :24/24/040/00014/AM13/ Lic.No/Date:2410038508 20.03.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 44
Case No.:27/8/82ALC4/2013
Party Name:STERILE INDIA PRIVATE LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00158/AM14/ RLA File :05/24/040/00477/AM13/ Lic.No/Date:0510349855 21.03.2013 Defer Date:17.10.2013 45
Case No.:29/8/82ALC4/2013
19.09.2013 Status:Case Deferred HQ File :01/82/050/00160/AM14/ RLA File :08/24/040/00454/AM13/ Lic.No/Date:0810119673 21.03.2013 Defer Date:17.10.2013 46
Case No.:58/10/82ALC4/2013
Party Name:MYLAN LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00241/AM14/ RLA File :09/24/040/00583/AM13/ Lic.No/Date:0910055475 21.03.2013 Defer Date:17.10.2013 47
Case No.:60/10/82ALC4/2013
Party Name:MYLAN LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00243/AM14/ RLA File :09/24/040/00586/AM13/ Lic.No/Date:0910055474 21.03.2013 Defer Date:17.10.2013 48
Case No.:11/10/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 19.09.2013 Status:Case Approved HQ File :01/82/050/00194/AM14/ RLA File :22/24/040/00085/AM13/ Lic.No/Date:2210013739 22.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 9/82 dated 25.07.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed Tazobactam Sodium+Piperacillin Sodium Sterile (1:8) 1 Kg. 1. Piperacillin Acid 0.9153 kg 2. Tazobactam Acid 0.1130 kg 3. Sodium Bicarbonate 0.174 kg 4. Aluminium Bottle Anodized with Tear off alu cap & chlorobutyl plug Relevant, as per packing policy 49
Case No.:25/10/82ALC4/2013
Party Name:ANUS LABORATORIES LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00208/AM14/ RLA File :09/24/040/00186/AM12/ Lic.No/Date:0910055523 22.03.2013 Defer Date:17.10.2013 Decision :It was decided to request the firm to furnish the technical details as per Appendix 33 . The case was deferred for 17.10.2013 50
Case No.:6/10/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00189/AM14/ RLA File :05/24/040/00480/AM13/ Lic.No/Date:0510350030 22.03.2013 Defer Date:17.10.2013 51
Case No.:61/10/82ALC4/2013
Party Name:GRANULES INDIA LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00244/AM14/ RLA File :09/24/040/00610/AM13/ Lic.No/Date:0910055505 22.03.2013 Defer Date:17.10.2013 52
Case No.:19/10/82ALC4/2013
Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00202/AM14/ RLA File :09/24/040/00601/AM13/ Lic.No/Date:0910055530 25.03.2013 Defer Date:17.10.2013 Decision : Department of Biotechnology vide their letter No. BT/IL/05/390/2013PID dated 29.08.2013 has requested the firm to furnish the following information: 1. Justification for 10% wastage for rubber stoppers and flip of seas.
2. Use/applicaiton of import inputs Nos. 4 to 12 in manufaturing of Revac B (1). 3. In DML aluminium hydroxyl Gel is mentioned as 0.5 mg as Al+++ whereas its impoet quantity is is liters. Please provide information on mgs of Al+++ present in l ml of aluminium hydroxyl Gel. The case was deferred for 17.10.2013 53
Case No.:20/10/82ALC4/2013
Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00203/AM14/ RLA File :09/24/040/00605/AM13/ Lic.No/Date:0910055537 25.03.2013 Defer Date:17.10.2013 Decision :Department of Biotechnology vide their letter No. BT/IL/05/390/2013PID dated 29.08.2013 has requested the firm to furnish the following information: 1. Justification for 10% wastage for rubber stoppers 2. Use/applicaiton of import inputs Nos. 4 ,5 and 712 in manufaturing of Indirab 0.5 ml. 3. Clarification on the import inputs mentioned in Appendix 11 A. the datasheet appears to be a copy of the sheet submitted for Revac B and only name of product has been changed as Indirab. 4. Please submit Q. A apporved Batch Manufacturing Record 5. The DML enclosed with the application does not include brand "Indirab", please clarify. The case was deferred for 17.10.2013 54
Case No.:55/10/82ALC4/2013
Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00238/AM14/ RLA File :09/24/040/00602/AM13/ Lic.No/Date:0910055529 25.03.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Department of Biotechnology. 55
Case No.:7/8/82ALC4/2013
19.09.2013 Status:Case Approved HQ File :01/82/050/00138/AM14/ RLA File :08/24/040/00465/AM13/ Lic.No/Date:0810119781 25.03.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/543/2011‐PI(Norms) dated 26.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product LEUCOVORIN CALCIUM FOR INJECTION 50MG/ VIAL, 100MG/ VIAL, 200MG/ VIAL and 350MG/ VIAL
S.NO. Import Items For export of 1 No. Tablets (Quan韣�ty in mg) 50MG/ VIAL 100MG/ VIAL 200MG/ VIAL 350MG/ VIAL 1 LEUCOVORIN CALCIUM 55.65 mg 110.74 mg 220.96 mg 386.80 mg 2 VIALS (EMPTY GLASS BOTTLES/ VIAL ) (GENERAL NOTE FOR CHEMICAL & ALLIED PRODUCTS POINT NO. 5) Relevant. As per packing policy 3 RUBBER STOPPER GENERAL NOTE FOR CHEMICAL & ALLIED PRODUCTS POINT NO. 5) 56
Case No.:9/8/82ALC4/2013
Party Name:GULBRANDSEN CHEMICALS PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00140/AM14/ RLA File :34/24/040/00311/AM13/ Lic.No/Date:3410036520 25.03.2013 Defer Date:17.10.2013 57
Case No.:119/10/82ALC4/2013
Party Name:MICRO ORGOCHEM 19.09.2013 Status:Case Deferred HQ File :01/82/050/00302/AM14/ RLA File :03/95/040/00672/AM13/ Lic.No/Date:0310729719 26.03.2013 Defer Date:17.10.2013 58
Case No.:14/8/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00145/AM14/ RLA File :09/24/040/00615/AM13/ Lic.No/Date:0910055544 26.03.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals and decided to send the application to TA. 59
Case No.:33/2/82ALC4/2013
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 19.09.2013 Status:Case Deferred
HQ File :01/82/050/01480/AM13/ RLA File :05/24/040/00481/AM13/ Lic.No/Date:0510350279 26.03.2013 Defer Date:17.10.2013 60
Case No.:12/8/82ALC4/2013
Party Name:HETERO LABS LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00143/AM14/ RLA File :09/24/040/00620/AM13/ Lic.No/Date:0910055572 27.03.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/529/2011‐PI(Norms) dated 26.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import item Qty. allowed kg/kg LOPINAVIR 1 kg 1. LValine 0.761 2. Methyl Chloroformate 1.23 3. Acrylonitrile 0.38 4. (2S,3S,5S)2amino3hydroxy5 (tert.butyloxycrbonylamino)1,6 diphenyl hexane 1.35 5. 4Dimethyl amino pyridine 0.0386 6. Imidazole 1.50 61
Case No.:13/8/82ALC4/2013
Party Name:SARACA LABORATORIES LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00144/AM14/ RLA File :09/24/040/00598/AM13/ Lic.No/Date:0910055571 27.03.2013 Defer Date:17.10.2013 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals. 62
Case No.:117/10/82ALC4/2013
Party Name:PRASOL CHEMICALS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00300/AM14/ RLA File :03/95/040/00881/AM13/ Lic.No/Date:0310729886 28.03.2013 Defer Date:17.10.2013 63
Case No.:9/10/82ALC4/2013
Party Name:KUDOS CHEMIE LTD., Status:Case
19.09.2013 Approved HQ File :01/82/050/00192/AM14/ RLA File :22/24/040/00081/AM13/ Lic.No/Date:2210013759 28.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 02.05.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Adenine 1 kg 1. MALONONITRILE 0.95 kg 64
Case No.:146/10/82ALC4/2013
Party Name:GALAXY SURFACTANTS LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00329/AM14/ RLA File :03/94/040/01113/AM13/ Lic.No/Date:0310729942 01.04.2013 Defer Date:17.10.2013 65
Case No.:216/10/82ALC4/2013
Party Name:GULBRANDSEN CHEMICALS PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00399/AM14/ RLA File :34/24/040/00319/AM13/ Lic.No/Date:3410036563 01.04.2013 Defer Date:17.10.2013 66
Case No.:4/8/82ALC4/2013
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00135/AM14/ RLA File :03/95/040/00899/AM13/ Lic.No/Date:0310729960 01.04.2013 Defer Date:17.10.2013 67
Case No.:115/10/82ALC4/2013
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 19.09.2013 Status:Case Approved HQ File :01/82/050/00298/AM14/ RLA File :03/95/040/01037/AM13/ Lic.No/Date:0310730058 02.04.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/13/2012‐Ch. II dated 30.08.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed COPPER DISODIUM EDTA (Cu 14%) 1 kg 1. ETHYLENE DIAMINE TETRA ACETIC ACID (EDTA ACID) 0.748 kg 68
Case No.:22/8/82ALC4/2013
Party Name:HETERO DRUGS LIMITED, 19.09.2013 Status:Case Approved HQ File :01/82/050/00153/AM14/ RLA File :09/24/040/00632/AM13/ Lic.No/Date:0910055649 02.04.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/530/2013‐PI(Norms) dated 26.09 .2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg PERINDOPRIL TERT.BUTYLAMINE 1 kg 1. N(S)1 carbethoxy butyl Lalanine 1.012 RA may take further appropriate ac韣�on as per the decision of Norms Commi埜�ee. 69
Case No.:42/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00225/AM14/ RLA File :09/24/040/00635/AM13/ Lic.No/Date:0910055653 02.04.2013 Defer Date:17.10.2013 Decision :Department of Biotechnology vide their letter No. BT/IL/05/382/2013PID dated 29.08.2013 has mentioned that the norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type B (HIB) Combined vaccine with vaccine vial monitar (VVM) (5000000.00) against the import inputs mentioned in the application. You are requested to furnish the following information: Drug Manufaturing Licensing of the export product (DML encloased with the application does not mention the export product. To submit QA approved Batch Manufacturing Record. The case was deferred for 17.10.2013 70
Case No.:85/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 19.09.2013 Status:Case
Deferred HQ File :01/82/050/00268/AM14/ RLA File :09/24/040/00636/AM13/ Lic.No/Date:0910055652 02.04.2013 Defer Date:17.10.2013 Decision :Department of Biotechnology vide their letter No. BT/IL/05/382/2013PID dated 29.08.2013 has mentioned that the norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type B (HIB) Combined vaccine with vaccine vial monitar (VVM) (5000000.00) against the import inputs mentioned in the application. You are requested to furnish the following information: Drug Manufaturing Licensing of the export product (DML encloased with the application does not mention the export product. To submit QA approved Batch Manufacturing Record. The case was deferred for 17.10.2013 71
Case No.:11/8/82ALC4/2013
Party Name:PREMIER INDUSTRIES 19.09.2013 Status:Case Deferred HQ File :01/82/050/00142/AM14/ RLA File :50/24/040/00020/AM13/ Lic.No/Date:5010001635 03.04.2013 Defer Date:17.10.2013 72
Case No.:148/10/82ALC4/2013
Party Name:ANTHEA AROMATICS PVT.LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00331/AM14/ RLA File :03/94/040/00996/AM13/ Lic.No/Date:0310730232 03.04.2013 Defer Date:17.10.2013 73
Case No.:37/10/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00220/AM14/ RLA File :09/24/040/00004/AM14/ Lic.No/Date:0910055673 03.04.2013 Defer Date:17.10.2013 74
Case No.:82/10/82ALC4/2013
Party Name:VEGESNA LABORATORIES PRIVATE LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00265/AM14/ RLA File :09/24/040/00637/AM13/ Lic.No/Date:0910055659 03.04.2013 Defer Date:17.10.2013
75
Case No.:20/8/82ALC4/2013
Party Name:RAY CHEMICALS PRIVATE LIMITED, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00151/AM14/ RLA File :07/24/040/00518/AM13/ Lic.No/Date:0710094644 04.04.2013 Defer Date:17.10.2013 76
Case No.:147/10/82ALC4/2013
Party Name:CONCEPT PHARMACEUTICALS LTD., Meet No/Date:12/82ALC4/2013 19.09.2013 Status:Case Deferred HQ File :01/82/050/00330/AM14/ RLA File :03/94/040/00004/AM14/ Lic.No/Date:0310730523 05.04.2013 Defer Date:17.10.2013 77
Case No.:17/10/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00200/AM14/ RLA File :05/24/040/00478/AM13/ Lic.No/Date:0510350968 08.04.2013 Defer Date:17.10.2013 78
Case No.:4/10/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00187/AM14/ RLA File :17/24/040/00001/AM14/ Lic.No/Date:1710005280 08.04.2013 Defer Date:17.10.2013 79
Case No.:120/10/82ALC4/2013
Party Name:MEHTA API PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00303/AM14/ RLA File :03/95/040/00020/AM14/ Lic.No/Date:0310730905 09.04.2013 Defer Date:17.10.2013 80
Case No.:38/10/82ALC4/2013
Party Name:ARENE LIFE SCIENCES LIMITED. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00221/AM14/ RLA File :09/24/040/00613/AM13/ Lic.No/Date:0910055691 09.04.2013 Defer Date:17.10.2013
81
Case No.:129/10/82ALC4/2013
Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00312/AM14/ RLA File :03/94/040/01061/AM13/ Lic.No/Date:0310730972 10.04.2013 Defer Date:19.09.2013 82
Case No.:168/10/82ALC4/2013
Party Name:AARTI INDUSTRIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00351/AM14/ RLA File :03/94/040/01115/AM13/ Lic.No/Date:0310731080 10.04.2013 Defer Date:17.10.2013 83
Case No.:5/10/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00188/AM14/ RLA File :17/24/040/00004/AM14/ Lic.No/Date:1710005285 10.04.2013 Defer Date:17.10.2013 84
Case No.:36/10/82ALC4/2013
Party Name:EYTAN LABS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00219/AM14/ RLA File :09/24/040/00006/AM14/ Lic.No/Date:0910055745 15.04.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals 85
Case No.:81/10/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00264/AM14/ RLA File :09/24/040/00631/AM13/ Lic.No/Date:0910055730 15.04.2013 Defer Date:17.10.2013 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals. 86
Case No.:150/10/82ALC4/2013
Party Name:KOPRAN LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00333/AM14/ RLA File :03/94/040/00021/AM14/ Lic.No/Date:0310731505 Defer Date:17.10.2013
16.04.2013 87
Case No.:149/10/82ALC4/2013
Party Name:JESONS INDUSTRIES LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00332/AM14/ RLA File :03/94/040/00013/AM14/ Lic.No/Date:0310731609 17.04.2013 Defer Date:17.10.2013 Decision : It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 88
Case No.:160/10/82ALC4/2013
Party Name:RIOCARE INDIA PRIVATE LIMITED. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00343/AM14/ RLA File :03/95/040/00024/AM14/ Lic.No/Date:0310731584 17.04.2013 Defer Date:17.10.2013 89
Case No.:68/4/82ALC4/2013
Party Name:HALDIA PETROCHEMICALS LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00109/AM14/ RLA File :02/24/040/00002/AM14/ Lic.No/Date:0210188734 17.04.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 90
Case No.:80/10/82ALC4/2013
Party Name:PORUS LABORATORIES PVT LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00263/AM14/ RLA File :09/24/040/00010/AM14/ Lic.No/Date:0910055794 17.04.2013 Defer Date:17.10.2013 91
Case No.:92/10/82ALC4/2013
Party Name:CATAPHARMA CHEMICALS PVT. LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00275/AM14/ RLA File :31/83/040/00214/AM13/ Lic.No/Date:3110057970 17.04.2013 Defer Date:17.10.2013 92
Case No.:195/10/82ALC4/2013
Party Name:MALLADI DRUGS & Status:Case
PHARMACEUTICALS LIMITED 19.09.2013 Deferred HQ File :01/82/050/00378/AM14/ RLA File :04/24/040/00292/AM13/ Lic.No/Date:0410145340 18.04.2013 Defer Date:17.10.2013 93
Case No.:51/10/82ALC4/2013
Party Name:PARABOLIC DRUGS LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00234/AM14/ RLA File :05/24/040/00015/AM14/ Lic.No/Date:0510351967 18.04.2013 Defer Date:17.10.2013 94
Case No.:43/10/82ALC4/2013
Party Name:SRINI PHARMACEUTICALS LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00226/AM14/ RLA File :09/24/040/00017/AM14/ Lic.No/Date:0910055800 19.04.2013 Defer Date:17.10.2013 95
Case No.:35/10/82ALC4/2013
Party Name:MYLAN LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00218/AM14/ RLA File :09/24/040/00008/AM14/ Lic.No/Date:0910055819 22.04.2013 Defer Date:17.10.2013 96
Case No.:166/10/82ALC4/2013
Party Name:SANDOZ PRIVATE LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00349/AM14/ RLA File :03/95/040/00978/AM13/ Lic.No/Date:0310732470 25.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 23/12 dated 06.09.2011, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Clopidogrel Hydrochloride Bulk Drug 1 kg 1. L() Camphor Sulphonic Acid Chemical Intermediate 1.00 kg 2. 4,5,6,7 Tetrahydrothieno (3,2,C) Pyridine HCL (Cyclic Amine HCI) 1.75 kg
Chemical Intermediate 97
Case No.:11/12/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00435/AM14/ RLA File :17/24/040/00009/AM14/ Lic.No/Date:1710005298 26.04.2013 Defer Date:17.10.2013 98
Case No.:158/10/82ALC4/2013
Party Name:MEHTA API PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00341/AM14/ RLA File :03/95/040/00035/AM14/ Lic.No/Date:0310732641 26.04.2013 Defer Date:17.10.2013 99
Case No.:173/10/82ALC4/2013
Party Name:KUSUMA PHARMA 19.09.2013 Status:Case Approved HQ File :01/82/050/00356/AM14/ RLA File :03/94/040/00059/AM14/ Lic.No/Date:0310732708 29.04.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/32/2013‐Ch. II dated 30.08.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Sodium Saccharin(Pure Dental Grade) 1 kg 1. Sodium Saccharin(BP)99%Purity 1.02 kg 100
Case No.:174/10/82ALC4/2013
Party Name:JESONS INDUSTRIES LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00357/AM14/ RLA File :03/94/040/00037/AM14/ Lic.No/Date:0310732711 29.04.2013 Defer Date:17.10.2013 Decision : It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals.
101
Case No.:219/10/82ALC4/2013
Party Name:RENOWN PHARMACEUTICALS PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00402/AM14/ RLA File :34/24/040/00005/AM14/ Lic.No/Date:3410036732 29.04.2013 Defer Date:17.10.2013 102
Case No.:177/10/82ALC4/2013
Party Name:ATLAS FINE CHEMICALS PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00360/AM14/ RLA File :03/94/040/00845/AM13/ Lic.No/Date:0310732910 30.04.2013 Defer Date:17.10.2013 103
Case No.:56/10/82ALC4/2013
Party Name:GOPINATH CHEMTECH LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00239/AM14/ RLA File :08/24/040/00026/AM14/ Lic.No/Date:0810120616 30.04.2013 Defer Date:17.10.2013 104
Case No.:63/10/82ALC4/2013
Party Name:KUDOS CHEMIE LTD., 19.09.2013 Status:Case Approved HQ File :01/82/050/00246/AM14/ RLA File :22/24/040/00084/AM13/ Lic.No/Date:2210013817 30.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 27/82 dated 29.12.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg CYANOACETIC ACID 1 kg 1. CYANOACETIC ACID ‐ 70% (Contains 30% water) 1.587 105
Case No.:164/10/82ALC4/2013
Party Name:PREGNA INTERNATIONAL LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00347/AM14/ RLA File :03/95/040/00071/AM14/ Lic.No/Date:0310733040 01.05.2013 Defer Date:17.10.2013
Decision :It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 106
Case No.:23/8/82ALC4/2013
19.09.2013 Status:Case Approved HQ File :01/82/050/00154/AM14/ RLA File :08/24/040/00036/AM14/ Lic.No/Date:0810120636 01.05.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/540/2013‐PI(Norms) dated 26.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg LEVOFLOXACIN HEMIHYDRATE 1 kg 1. ()9,10DIFLUORO3METHYL7 OXO2, 3 DIHYDRO7HPYRIDO (1,2,3DE)1, 4BENZOXAZIN E6CARBOXYLIC ACID 0.8571 2. DIMETHYL SULFOXIDE 0.2193 3. NMETHYL PIPERAZINE 0.432 4. ISOPROPYL ALCOHOL (IPA) 1.54 RA may take appropriate ac韣�on as per the decision of Norms Commi埜�ee 107
Case No.:34/10/82ALC4/2013
Party Name:MAHESHRAJ CHEMICALS PVT.LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00217/AM14/ RLA File :08/24/040/00024/AM14/ Lic.No/Date:0810120820 07.05.2013 Defer Date:17.10.2013 108
Case No.:170/10/82ALC4/2013
Party Name:AGOG PHARMA LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00353/AM14/ RLA File :03/94/040/00075/AM14/ Lic.No/Date:0310733767 09.05.2013 Defer Date:17.10.2013 109
Case No.:1/5/82ALC4/2013
Party Name:MYLAN LABORATORIES LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00119/AM14/ RLA File :09/24/040/00020/AM14/ Lic.No/Date:0910055978 10.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 7/82 dated 27.06..2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less:
Export product Export Qty. Sl.No. Import items Qty. allowed 4Amino5 fluoro1(2R hydroxy methyl [1,3]oxothiolane 5Syl)1H pyrimidin2one (EMTII) 1 kg 1. (2R, 5S)5(4Amino5fluoro2 oxo2Hpyrimidin1yl) [1,3]oxathiolane2 carboxylicacid2SIsopropyl5R Methyl1Rcyclohexyl ester (FCE) 2.075 kg 2. Sodium Borohydride 0.423 kg 3. Isopropyl Alcohol 1.75 kg 4. Toluene 0.135 kg 5. Methanol 0.271 kg 6. Triethylamine 0.913 kg 7. Methylene Dichloride 1.421 kg RA may take appropriate ac韣�on as per the decision of Norms Commi埜�ee 110
Case No.:217/10/82ALC4/2013
Party Name:BEST VALUE CHEM PVT. LTD. 19.09.2013 Status:Case Approved HQ File :01/82/050/00400/AM14/ RLA File :34/24/040/00029/AM14/ Lic.No/Date:3410036850 13.05.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/58/2013‐Ch. II dated 30.08.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Iso Amyl Salicylate 1 kg 1. Iso Amyl Alcohol 0.470 kg 2. Salicylic Acid 0.737 kg 111
Case No.:153/10/82ALC4/2013
Party Name:PI INDUSTRIES LTD., 19.09.2013 Status:Case Approved HQ File :01/82/050/00336/AM14/ RLA File :13/24/040/00007/AM14/ Lic.No/Date:1310042991 14.05.2013 Defer Date:
Decision :Withdrawn the case has been already approved in its meeting 10/82 dated 22.08.2013. 112
Case No.:142/10/82ALC4/2013
Party Name:WOCKHARDT LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00325/AM14/ RLA File :03/95/040/00101/AM14/ Lic.No/Date:0310734494 15.05.2013 Defer Date:17.10.2013 Decision : It was decided to send a copy of application again to DCGI for their comments particularly in view of with shelf life of the export and Import items. The case was deferred for 17.10.2013. 113
Case No.:77/10/82ALC4/2013
Party Name:GOPINATH CHEMTECH LTD., 19.09.2013 Status:Case Approved HQ File :01/82/050/00260/AM14/ RLA File :08/24/040/00061/AM14/ Lic.No/Date:0810121120 15.05.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2013‐Ch. II dated 03.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed 4 AMINO DIPHENYL AMINE 2 SULPHONIC ACID ( 4 ADAPSA) 1 kg 1. ANILINE OIL 0.525 kg 2. PARA NITRO CHLORO BENZENE 0.927 kg 3. SODA ASH 2.500 kg 114
Case No.:186/10/82ALC4/2013
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00369/AM14/ RLA File :03/94/040/00023/AM13/ Lic.No/Date:0310734610 16.05.2013 Defer Date:17.10.2013 115
Case No.:1/8/82ALC4/2013
19.09.2013 Status:Case Approved HQ File :01/82/050/00132/AM14/ RLA File :08/24/040/00064/AM14/ Lic.No/Date:0810121196 Defer Date:
17.05.2013 Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/544/2011‐PI(Norms) dated 26.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product LEVOFLOXACIN 250 MG TABS 500 MG TAB, 750 MG TAB (ACTIVE INGREDIENT : LEVOFLOXACIN HEMIHYDRATE NT. WT. 10148.23 KGS., GR. WT. 10608.95 KGS.) S.NO. Import Items For export of 1 No. Tablets (Quan韣�ty in mg) 250 mg Tablets 500 mg Tablets 750 mg Tablets 1 LEVOFLOXACIN HEMIHYDRATE 261.35 522.70 784.054 2 HYPROMELLOSE 6 CPS,2910 USP 11.63 23.30 34.95 3 MICROCRYSTALLINE CELLULOSE NF (AVICEL PH 102) 49.65 99.30 148.95 4 CROSPOVIDONE NF 21.65 43.30 64.95 5 MAGNESIUM STEARATE NF 5.00 10.00 15.00 6 Bottle and Caps Relevant, As per Packing Policy [B] Recommended Norms for 1 kg LEVOFLOXACIN LEVOFLOXACIN HEMIHYDRATE S.NO. Import Items Quan韣�ty recommended kg/kg 1 ()9,10DIFLUORO3METHYL7 OXO2, 3 DIHYDRO7HPYRIDO (1,2,3DE)1, 4BENZOXAZIN E6 CARBOXYLIC ACID 0.8571 2 DIMETHYL SULFOXIDE 0.2193 3 NMETHYL PIPERAZINE 0.432 4 ISOPROPYL ALCOHOL (IPA) 1.54 116
Case No.:143/10/82ALC4/2013
Party Name:SALVI CHEMICAL INDUSTRIES Status:Case
LIMITED 19.09.2013 Deferred HQ File :01/82/050/00326/AM14/ RLA File :03/95/040/00009/AM14/ Lic.No/Date:0310734807 17.05.2013 Defer Date:17.10.2013 117
Case No.:161/10/82ALC4/2013
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00344/AM14/ RLA File :03/95/040/00992/AM13/ Lic.No/Date:0310734808 17.05.2013 Defer Date:17.10.2013 118
Case No.:39/10/82ALC4/2013
Party Name:SCOTTEDIL PHARMACIA LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00222/AM14/ RLA File :22/24/040/00015/AM14/ Lic.No/Date:2210013866 17.05.2013 Defer Date:17.10.2013 119
Case No.:171/10/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00354/AM14/ RLA File :03/94/040/00101/AM14/ Lic.No/Date:0310734943 20.05.2013 Defer Date:17.10.2013 120
Case No.:172/10/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00355/AM14/ RLA File :03/94/040/00055/AM14/ Lic.No/Date:0310734945 20.05.2013 Defer Date:17.10.2013 121
Case No.:211/10/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00394/AM14/ RLA File :07/24/040/00037/AM14/ Lic.No/Date:0710095520 22.05.2013 Defer Date:17.10.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 and defer the case for 17.10.2013 for comments of Department of Pharmaceuticals.
122
Case No.:1/6/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00124/AM14/ RLA File :09/24/040/00077/AM14/ Lic.No/Date:0910056114 23.05.2013 Defer Date:17.10.2013 123
Case No.:210/10/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00393/AM14/ RLA File :07/24/040/00034/AM14/ Lic.No/Date:0710095553 23.05.2013 Defer Date:17.10.2013 Decision : It was decided to remind the firm to furnish the technical details as per Appendix 33 and defer the case for 17.10.2013 for comments of Department of Pharmaceuticals. 124
Case No.:206/10/82ALC4/2013
Party Name:CHIRAG ENTERPRISE 19.09.2013 Status:Case Deferred HQ File :01/82/050/00389/AM14/ RLA File :24/24/040/00007/AM14/ Lic.No/Date:2410038997 27.05.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 125
Case No.:207/10/82ALC4/2013
Party Name:CHIRAG ENTERPRISE 19.09.2013 Status:Case Deferred HQ File :01/82/050/00390/AM14/ RLA File :24/24/040/00008/AM14/ Lic.No/Date:2410038996 27.05.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 126
Case No.:3/10/82ALC4/2013
19.09.2013 Status:Case Approved HQ File :01/82/050/00186/AM14/ RLA File :08/24/040/00082/AM14/ Lic.No/Date:0810121433 27.05.2013 Defer Date: Decision : In the light of earlier decision taken in mee韣�ng no. 10/82 dated 22.08.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Benzonatate 100 mg Capsules 1 Million 1. Benzonanate USP 102 kg 2. Gela韣�n NF 168 kg
Glycerin USP 24 kg 4. Noncrystallizing Sorbitol Solu韣�on NF 72 kg 5. Triethyl Nitrate NF 75 kg 6. Bo埜�les and Caps (packing material in finished form a. 60 CC White HDPE Round Bo埜�le As per packing policy 7. 75 CC White HDPE Round Bo埜�le ‐do‐ 8. 33 MM White PP NCRC CAP ‐do‐ Benzonatate 200 mg Capsules 1 million 1. Benzonanate 204 kg 2. Gela韣�n NF 231 kg 3. Glycerin USP 33 kg 4. Noncrystallizing Sorbitol Solu韣�on NF 99 kg 5. Triethyl Nitrate NF 75 kg 6. 225 CC white HDPE CRC Bo埜�le As per packing policy 7. 45 MM white NCRC Cap ‐do‐ 127
Case No.:33/10/82ALC4/2013
Party Name:HESTER BIOSCIENCES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00216/AM14/ RLA File :08/24/040/00081/AM14/ Lic.No/Date:0810121432 27.05.2013 Defer Date:17.10.2013 Decision :Department of Biotechnology vide their letter No. BT/IL/05/391/2013PID dated 29.08.2013 has requested the firm to furnish the following information: 1. Drug Manufaturing Licensing of the export product 2. QA approved Batch Manufacturing Record The case was deferred for 17.10.2013 128
Case No.:71/10/82ALC4/2013
Party Name:SCOTTEDIL PHARMACIA LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00254/AM14/ RLA File :22/24/040/00016/AM14/ Lic.No/Date:2210013890 28.05.2013 Defer Date:17.10.2013 129
Case No.:79/10/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD Status:Case
19.09.2013 Deferred HQ File :01/82/050/00262/AM14/ RLA File :05/23/040/00058/AM14/ Lic.No/Date:0510355497 29.05.2013 Defer Date:17.10.2013 130
Case No.:86/10/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 19.09.2013 Status:Case Approved HQ File :01/82/050/00269/AM14/ RLA File :22/24/040/00017/AM14/ Lic.No/Date:2210013900 29.05.2013 Defer Date: Decision : : In the light of earlier decision taken in mee韣�ng no. 1/82 dated 04.04.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Cefepime for Injection (Cefepime HCL+LArginine in 68:32 ratio) 1 kg 1. Cefepime HCL Non Sterile 0.655 kg 2. LArginine 0.37 kg 3. Acetone (89.6% Rec.) 1.816 kg 4. Methanol 0.742 kg 5. Eno Carbon 0.034 kg 6. Aluminium Bottle Anodized with Tear off alu cap & chlorobuty plug Relevant, as per packing policy RA may take appropriate ac韣�on as per the packing policy. 131
Case No.:209/10/82ALC4/2013
Party Name:R L FINE CHEM 19.09.2013 Status:Case Approved HQ File :01/82/050/00392/AM14/ RLA File :07/24/040/00033/AM14/ Lic.No/Date:0710095687 31.05.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/373/2013‐PI(Norms) dated 11.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg CHLORPROMAZINE HCL 1 kg 1. 1 BROMO 3 CHLORO PROPANE 0.95 3. 2CHLORO PHENOTHIAZINE 0.90 4. ACETONE 3.33 RA may take appropriate ac韣�on as per the decision of Norms Commi埜�ee 132
Case No.:225/10/82ALC4/2013
Party Name:APEX HEALTHCARE LTD Status:Case
19.09.2013 Deferred HQ File :01/82/050/00408/AM14/ RLA File :34/24/040/00035/AM14/ Lic.No/Date:3410037038 31.05.2013 Defer Date:17.10.2013 133
Case No.:3/6/82ALC4/2013
19.09.2013 Status:Case Approved HQ File :01/82/050/00126/AM14/ RLA File :08/24/040/00084/AM14/ Lic.No/Date:0810121574 31.05.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/539/2013‐PI(Norms) dated 26.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed VENLAFAXINE 75 MG TABS (VENLAFAXINA COMBIX 75 MG TABS) (Active ingredient: Venlafaxine Hydrochloride Ph Eur 30.0015 Kgs). 1 No. 1. Venlafaxine Hydrochloride Ph Eur 86.565 mg 134
Case No.:46/12/82ALC4/2013
Party Name:TRIGON CHEMICALS PVT. LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00470/AM14/ RLA File :31/83/040/00019/AM14/ Lic.No/Date:3110058563 31.05.2013 Defer Date:17.10.2013 135
Case No.:96/10/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00279/AM14/ RLA File :08/24/040/00085/AM14/ Lic.No/Date:0810121573 31.05.2013 Defer Date:17.10.2013 136
Case No.:187/10/82ALC4/2013
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 19.09.2013 Status:Case Approved HQ File :01/82/050/00370/AM14/ RLA File :03/94/040/00161/AM14/ Lic.No/Date:0310736386 Defer Date:
03.06.2013 Decision : In the light of earlier decision taken in mee韣�ng no. 11/82 dated 05.09.2012, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quan韣�ty S.No Import Product Quan韣�ty Allowed kg/kg VALSARTAN 1 kg 1. LVALINE 0.708 kg 2. 2CYANO4METHYL BIPHENYL (OTBN) 1.00 kg 137
Case No.:108/10/82ALC4/2013
19.09.2013 Status:Case Deferred HQ File :01/82/050/00291/AM14/ RLA File :08/24/040/00091/AM14/ Lic.No/Date:0810121695 04.06.2013 Defer Date:17.10.2013 138
Case No.:98/10/82ALC4/2013
19.09.2013 Status:Case Deferred HQ File :01/82/050/00281/AM14/ RLA File :08/24/040/00089/AM14/ Lic.No/Date:0810121696 04.06.2013 Defer Date:17.10.2013 139
Case No.:227/10/82ALC4/2013
Party Name:SPAN DIAGNOSTICS LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00410/AM14/ RLA File :52/24/040/00002/AM14/ Lic.No/Date:5210039825 05.06.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Department of IPP. 140
Case No.:6/6/82ALC4/2013
Party Name:HETERO LABS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00129/AM14/ RLA File :09/24/040/00097/AM14/ Lic.No/Date:0910056251 05.06.2013 Defer Date:17.10.2013 141
Case No.:76/10/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, Status:Case
19.09.2013 Approved HQ File :01/82/050/00259/AM14/ RLA File :22/24/040/00021/AM14/ Lic.No/Date:2210013917 05.06.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/440/2013‐PI(Norms) dated 11.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Ceftazidime for Injection "The Export product shall be account for 222 nos. Aluminium Bottle Anodized with Tear of alu & Chlorobutyl plug " 1 kg 1. Ceftazidime Pentahydrate Sterile (Un Buffered) 0.928 2. Sodium Carbonate 0.082 3. Aluminium Bottle Anodized with Tear off alu cap & chlorobuty plug Relevant, as per packing policy RA may take appropriate ac韣�on as per the packing policy. 142
Case No.:68/10/82ALC4/2013
Party Name:ZEE LABORATORIES 19.09.2013 Status:Case Deferred HQ File :01/82/050/00251/AM14/ RLA File :05/24/040/00047/AM14/ Lic.No/Date:0510356364 06.06.2013 Defer Date:17.10.2013 143
Case No.:95/10/82ALC4/2013
Party Name:CONTINENTAL CHEMICALS 19.09.2013 Status:Case Deferred HQ File :01/82/050/00278/AM14/ RLA File :08/24/040/00095/AM14/ Lic.No/Date:0810121745 06.06.2013 Defer Date:17.10.2013 144
Case No.:19/12/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00443/AM14/ RLA File :03/94/040/01070/AM13/ Lic.No/Date:0310737096 07.06.2013 Defer Date:17.10.2013
145
Case No.:184/10/82ALC4/2013
Party Name:ALKALOIDS CORPORATION 19.09.2013 Status:Deffered and Reindexed HQ File :01/82/050/00367/AM14/ RLA File :02/24/040/00030/AM14/ Lic.No/Date:0210190503 10.06.2013 Defer Date:19.09.2013 Decision : In t In the light of earlier decision taken in mee韣�ng no. 11/AM12 dated 05.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Quantity Sl.No. Import items Qty. allowed Noscapine BP/Noscapine Hcl BP 0.049 kg 1 1 X Papaverine (Wet)Crude containing Noscapine not more than 8% and crude Papaverine not more than 25% (on dry basis) Moisture content NLT 32% w/w 1kg Papaverine Hcl BP 0.153 kg 146
Case No.:109/10/82ALC4/2013
Party Name:INDSWIFT LABORATORIES LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00292/AM14/ RLA File :22/24/040/00022/AM14/ Lic.No/Date:2210013931 11.06.2013 Defer Date:17.10.2013 147
Case No.:226/10/82ALC4/2013
Party Name:RUCHI INFRASTRUCTURE LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00409/AM14/ RLA File :56/24/040/00005/AM14/ Lic.No/Date:5610002272 11.06.2013 Defer Date:17.10.2013 148
Case No.:70/10/82ALC4/2013
Party Name:VENUS REMEDIES LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00253/AM14/ RLA File :22/24/040/00023/AM14/ Lic.No/Date:2210013929 11.06.2013 Defer Date:17.10.2013 149
Case No.:72/10/82ALC4/2013
Party Name:KUDOS CHEMIE LTD., Status:Case
19.09.2013 Approved HQ File :01/82/050/00255/AM14/ RLA File :22/24/040/00020/AM14/ Lic.No/Date:2210013927 11.06.2013 Defer Date: Decision : In t In the light of earlier decision taken in mee韣�ng no. 3/AM82 dated 02.05.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Adenine 1 kg 1. Formamide 6.28 kg 150
Case No.:30/12/82ALC4/2013
Party Name:ENCUBE ETHICALS PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00454/AM14/ RLA File :03/94/040/00140/AM14/ Lic.No/Date:0310737624 13.06.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of DC(MSME). 151
Case No.:50/12/82ALC4/2013
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00474/AM14/ RLA File :03/94/040/00222/AM14/ Lic.No/Date:0310737476 13.06.2013 Defer Date:17.10.2013 152
Case No.:7/12/82ALC4/2013
Party Name:GLENMARK GENERICS LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00431/AM14/ RLA File :03/94/040/00082/AM14/ Lic.No/Date:0310737440 13.06.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 18/82 dated 30.08.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Lercanidipine Hydrochloride. 1 kg 1. 3,3 Diphenylpropylamine. 1.19 kg/kg 2. Tetrahydrofuran. 2.90 kg/kg 3. Methylene Dichloride / Methylene Chloride/MDC. 4.88 kg/kg 4. 1Chloro2Methyl2Propanol. 0.507 kg/kg
Isopropyl Acetate. 6.83 kg/kg RA may take appropriate action as per the decision of Norms Committee. 153
Case No.:88/10/82ALC4/2013
Party Name:MAHESHRAJ CHEMICALS PVT.LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00271/AM14/ RLA File :08/24/040/00099/AM14/ Lic.No/Date:0810121913 13.06.2013 Defer Date:17.10.2013 154
Case No.:48/12/82ALC4/2013
Party Name:STERLING HEALTHCARE LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00472/AM14/ RLA File :31/83/040/00039/AM14/ Lic.No/Date:3110058904 14.06.2013 Defer Date: Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v1 as per SION A412 with 2 % wastage. Export Product GABAPENTIN 100 MG Caps, 600 MG TABS and 800 MG TAB, S.NO. Import Items For export of 1 No. Tablets (Quan韣�ty in mg) 250 mg Caps 600 mg Tablets 800 mg Tablets 1 GABAPENTIN 102 612 816 RA concerned may take further necessary action as per above decision of NC. 155
Case No.:49/12/82ALC4/2013
Party Name:INDOCO REMEDIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00473/AM14/ RLA File :03/94/040/00155/AM14/ Lic.No/Date:0310737785 14.06.2013 Defer Date:17.10.2013 156
Case No.:15/12/82ALC4/2013
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 19.09.2013 Status:Case Deferred HQ File :01/82/050/00439/AM14/ RLA File :05/24/040/00077/AM14/ Lic.No/Date:0510357304 Defer
17.06.2013 Date:17.10.2013 157
Case No.:199/10/82ALC4/2013
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00382/AM14/ RLA File :04/24/040/00048/AM14/ Lic.No/Date:0410147196 17.06.2013 Defer Date:17.10.2013 158
Case No.:40/12/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00464/AM14/ RLA File :09/24/040/00113/AM14/ Lic.No/Date:0910056355 17.06.2013 Defer Date:17.10.2013 159
Case No.:51/12/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00475/AM14/ RLA File :03/94/040/00240/AM14/ Lic.No/Date:0310737875 17.06.2013 Defer Date:19.09.2013 160
Case No.:89/10/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 19.09.2013 Status:Case Approved HQ File :01/82/050/00272/AM14/ RLA File :05/24/040/00075/AM14/ Lic.No/Date:0510357422 18.06.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/395/2013‐PI(Norms) dated 26.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Sertraline Hydrochloride ( Bulk Drug / Pharmacopeal Grade) 1 kg 1. Activated Carbon 0.029 2. Methanol 2.50 3. Palladium 0.631 mg/kg 4. ( R ) Mandelic Acid 0.392 5. 4(34Dichlorophenyl) 1Tetralone 3.27
Toluene 2.50 RA may take appropriate ac韣�on as per the decision of Norms Commi埜�ee 161
Case No.:17/12/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00441/AM14/ RLA File :03/94/040/00102/AM14/ Lic.No/Date:0310738189 19.06.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/303/2013‐PI(Norms) dated 11.09.2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: Item of Export Quan韣�ty S,No Item of Import Quan韣�ty allowed kg/kg PYRANTEL PAMOATE 1 kg 1. Thiophene 2 Aldehyde 0.30 2. 3Methylamino Propyl Amine 0.35 3. Bon Acid 0.84 4. Methyl Formate 0.28 5. Iso Propyl Alcohol 0.32 6. Aceto Nitrile 0.28 7 Citric Acid 0.45 162
Case No.:183/10/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00366/AM14/ RLA File :13/24/040/00032/AM12/ Lic.No/Date:1310043416 19.06.2013 Defer Date:17.10.2013 163
Case No.:23/12/82ALC4/2013
Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00447/AM14/ RLA File :03/94/040/00094/AM14/ Lic.No/Date:0310738255 19.06.2013 Defer Date:17.10.2013
164
Case No.:28/12/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00452/AM14/ RLA File :03/94/040/00245/AM14/ Lic.No/Date:0310738193 19.06.2013 Defer Date:17.10.2013 165
Case No.:40/8/82ALC4/2013
Party Name:TRANSPEK INDUSTRY LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00171/AM14/ RLA File :34/24/040/00047/AM14/ Lic.No/Date:3410037146 19.06.2013 Defer Date:17.10.2013 166
Case No.:110/10/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00293/AM14/ RLA File :05/23/040/00065/AM14/ Lic.No/Date:0510357630 20.06.2013 Defer Date:17.10.2013 167
Case No.:22/12/82ALC4/2013
Party Name:INDOFIL INDUSTRIES LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00446/AM14/ RLA File :03/94/040/00197/AM14/ Lic.No/Date:0310738404 20.06.2013 Defer Date:17.10.2013 168
Case No.:39/8/82ALC4/2013
Party Name:PORUS LABORATORIES PVT LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00170/AM14/ RLA File :09/24/040/00123/AM14/ Lic.No/Date:0910056393 20.06.2013 Defer Date:17.10.2013 169
Case No.:47/12/82ALC4/2013
Party Name:BALAJI AMINES LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00471/AM14/ RLA File :31/83/040/00030/AM14/ Lic.No/Date:3110059030 20.06.2013 Defer Date:17.10.2013
170
Case No.:29/12/82ALC4/2013
Party Name:FINE ORGANIC INDUSTRIES, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00453/AM14/ RLA File :03/94/040/00190/AM14/ Lic.No/Date:0310738624 21.06.2013 Defer Date:17.10.2013 171
Case No.:45/12/82ALC4/2013
Party Name:BELCHEM INDS. INDIA PVT. LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00469/AM14/ RLA File :03/94/040/00058/AM14/ Lic.No/Date:0310738495 21.06.2013 Defer Date:17.10.2013 172
Case No.:31/12/82ALC4/2013
Party Name:FINE ORGANIC INDUSTRIES, 19.09.2013 Status:Case Deferred HQ File :01/82/050/00455/AM14/ RLA File :03/94/040/00258/AM14/ Lic.No/Date:0310738835 24.06.2013 Defer Date:17.10.2013 173
Case No.:111/10/82ALC4/2013
Party Name:STERICAT GUTSTRINGS PVT. LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00294/AM14/ RLA File :05/24/040/00091/AM14/ Lic.No/Date:0510358000 25.06.2013 Defer Date:17.10.2013 Decision : In the light of wri埜�en comments received from Department of Industrial Policy and Promo韣�on vide their File No. 7/106/2013 dated 18.09.2013, it was decided to call from the firm the following technical details/clarifica韣�ons: (a) An undertaking, clearly showing the export content of each box at S.No. 1 to 8 1. Length of Sterile Surgical sutures USP/ EP ( Monofilament Polydioxanone) with or without Needle packed in 140 Boxes Polyglycolic Acid or PGA+PLA / Monofilament Nylon /Monofilament Polypropylene / Braided Silk / Braided Polyester / Monofilament Poliglecaprone 25 / Catgut Chromic & Plain in meters, in each of the individual boxes at S. No1 to 8 of the export product respectively. 2. Weight of Sterilization paper required for each box at S. No. 1 to 8 3. Weight of triple Craft Paper required for each box at S. No. 1 to 8 4. Weight of Aluminum Foil required for each box at S. No. 1 to 8 5. Weight of Polyester Film required for each box at S. No. 1 to 8
(b) An detailed calcula韣�on sheet may be furnished accoun韣�ng for the total individual item of proposed imports as also to the net content of individual item in the 9 individual consignment of the proposed item of export in 140, 40377, 28675, 3850, 11920, 1718, 900 boxes respec韣�vely. 174
Case No.:18/12/82ALC4/2013
Party Name:CROWN CHEMICALS PVT.LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00442/AM14/ RLA File :03/94/040/00253/AM14/ Lic.No/Date:0310739158 26.06.2013 Defer Date:17.10.2013 175
Case No.:27/12/82ALC4/2013
Party Name:CROWN CHEMICALS PVT.LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00451/AM14/ RLA File :03/94/040/00254/AM14/ Lic.No/Date:0310739161 26.06.2013 Defer Date:17.10.2013 176
Case No.:39/12/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00463/AM14/ RLA File :09/24/040/00138/AM14/ Lic.No/Date:0910056466 26.06.2013 Defer Date:17.10.2013 177
Case No.:101/10/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00284/AM14/ RLA File :09/24/040/00143/AM14/ Lic.No/Date:0910056481 27.06.2013 Defer Date:17.10.2013 178
Case No.:201/10/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00384/AM14/ RLA File :04/24/040/00063/AM14/ Lic.No/Date:0410147551 27.06.2013 Defer Date:17.10.2013 179
Case No.:203/10/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 19.09.2013 Status:Case Deferred
HQ File :01/82/050/00386/AM14/ RLA File :04/24/040/00064/AM14/ Lic.No/Date:0410147556 27.06.2013 Defer Date:17.10.2013 180
Case No.:204/10/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00387/AM14/ RLA File :04/24/040/00065/AM14/ Lic.No/Date:0410147559 27.06.2013 Defer Date:17.10.2013 181
Case No.:202/10/82ALC4/2013
Party Name:ARUDAA VIS LABS PRIVATE LIMITED Meet No/Date:12/82ALC4/2013 19.09.2013 Status:Case Deferred HQ File :01/82/050/00385/AM14/ RLA File :04/24/040/00067/AM14/ Lic.No/Date:0410147616 28.06.2013 Defer Date:17.10.2013 182
Case No.:223/10/82ALC4/2013
Party Name:ANUPAM RASAYAN (INDIA) LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00406/AM14/ RLA File :52/24/040/00011/AM14/ Lic.No/Date:5210039911 28.06.2013 Defer Date:17.10.2013 183
Case No.:224/10/82ALC4/2013
Party Name:ANUPAM RASAYAN (INDIA) LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00407/AM14/ RLA File :52/24/040/00008/AM14/ Lic.No/Date:5210039909 28.06.2013 Defer Date:17.10.2013 184
Case No.:34/12/82ALC4/2013
Party Name:ZIM LABORATORIES LTD. 19.09.2013 Status:Case Approved HQ File :01/82/050/00458/AM14/ RLA File :03/95/040/00255/AM14/ Lic.No/Date:0310739477 28.06.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/395/2013‐PI(Norms) dated 26.09 .2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg AZITHROMYCIN FOR ORAL SUSPENSION (Bulk) (200 MG) NET CONTENT AZITHROMYCIN (USP 34 IP/API) 1 kg 1. AZITHROMYCIN (USP 34 IP/API) 79.415 gm per kg of export product RA may take appropriate ac韣�on as per the decision of Norms Commi埜�ee 185
Case No.:41/8/82ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00172/AM14/ RLA File :03/95/040/01020/AM13/ Lic.No/Date:0310739495 28.06.2013 Defer Date:17.10.2013 186
Case No.:24/12/82ALC4/2013
Party Name:WOCKHARDT LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00448/AM14/ RLA File :03/95/040/00256/AM14/ Lic.No/Date:0310739850 02.07.2013 Defer Date:17.10.2013 Decision :: It was decided to send a copy of application again to DCGI for their comments particularly in view of with shelf life of the export and Import items. The case was deferred for 17.10.2013. 187
Case No.:103/10/82ALC4/2013
Party Name:PORUS LABORATORIES PVT LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00286/AM14/ RLA File :09/24/040/00145/AM14/ Lic.No/Date:0910056663 04.07.2013 Defer Date:17.10.2013 188
Case No.:25/12/82ALC4/2013
Party Name:PREGNA INTERNATIONAL LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00449/AM14/ RLA File :03/95/040/00265/AM14/ Lic.No/Date:0310740293 04.07.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals
189
Case No.:36/12/82ALC4/2013
Party Name:PREGNA INTERNATIONAL LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00460/AM14/ RLA File :03/95/040/00264/AM14/ Lic.No/Date:0310740295 04.07.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 190
Case No.:102/10/82ALC4/2013
Party Name:YELURI FORMULATIONS PRIVATE LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00285/AM14/ RLA File :09/24/040/00149/AM14/ Lic.No/Date:0910056680 05.07.2013 Defer Date:17.10.2013 191
Case No.:33/12/82ALC4/2013
Party Name:THINQ PHARMACRO LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00457/AM14/ RLA File :03/95/040/00207/AM14/ Lic.No/Date:0310740446 05.07.2013 Defer Date:17.10.2013 192
Case No.:37/12/82ALC4/2013
Party Name:DIVIS LABORATORIES LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00461/AM14/ RLA File :09/24/040/00150/AM14/ Lic.No/Date:0910056692 05.07.2013 Defer Date:17.10.2013 193
Case No.:44/12/82ALC4/2013
Party Name:ENCUBE ETHICALS PVT LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00468/AM14/ RLA File :03/94/040/00306/AM14/ Lic.No/Date:0310740922 10.07.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of DC (MSME). 194
Case No.:26/12/82ALC4/2013
Party Name:SANOFI INDIA LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00450/AM14/ RLA File :03/95/040/00227/AM14/ Lic.No/Date:0310741158 11.07.2013 Defer Date:17.10.2013
195
Case No.:32/12/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00456/AM14/ RLA File :03/95/040/00299/AM14/ Lic.No/Date:0310741860 17.07.2013 Defer Date:17.10.2013 196
Case No.:16/12/82ALC4/2013
Party Name:MICRO INKS LTD. 19.09.2013 Status:Case Approved HQ File :01/82/050/00440/AM14/ RLA File :03/95/040/00308/AM14/ Lic.No/Date:0310742012 18.07.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 9/82 dated 31.05.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Epoxy Acrylate (80% Resin content in GTPA (Glyceryl Propoxy Triacrylate/ Propoxylated Glyceryl Triacrylate) 1 kg. 1. Acrylic Acid 0.2217 kg 2. Epoxy Resins 0.5827 kg 3. Mono Ethyl Hydro Quinone 0.0061 kg 4. Benzyl Dimethyl Amine 0.0040 kg 5. Glyceryl Propoxy Triacrylate /Propoxylated Glyceryl Triacrylate 0.1920 kg RA concerned may take further necessary action as per above decision of NC. 197
Case No.:21/12/82ALC4/2013
Party Name:WOCKHARDT LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00445/AM14/ RLA File :03/95/040/00306/AM14/ Lic.No/Date:0310741992 18.07.2013 Defer Date:17.10.2013 Decision : It was decided to send a copy of application again to DCGI for their comments particularly in view of with shelf life of the export and Import items. The case was deferred for 17.10.2013. 198
Case No.:35/12/82ALC4/2013
Party Name:PIRAMAL ENTERPRISES LIMITED Status:Case Approved
19.09.2013 HQ File :01/82/050/00459/AM14/ RLA File :03/95/040/00948/AM13/ Lic.No/Date:0310742181 19.07.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/386/2013‐PI(Norms) dated 26.09 .2013, it was decided to ra韣�fy norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less: : S. No Import Item For export of 1 no. tablet 3.125 mg 6.25 mg 12.5 mg 25 mg 1. Carvedilol USP 3.125 mg 6.25 mg 12.5 mg 25.0 mg 2. Lactose Monohydrate NF/BP (200 Mesh) Teva 10.0 mg 20.0 mg 40.0 mg 80.0 mg 3. Povidone USP (PVP K 30) 1.50 3.0 6.0 12.0 4. Crospovidone NF 1.50 3.0 6.0 12.0 5. Lactose Monohydrate (pray dried) 32.75 65.5 131.0 262.0 6 to 15 Paking Materials Relevant, as per packing policy RA may take appropriate action as per the decision of Norms Committee. 199
Case No.:20/12/82ALC4/2013
Party Name:PIRAMAL ENTERPRISES LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00444/AM14/ RLA File :03/95/040/00941/AM13/ Lic.No/Date:0310742484 23.07.2013 Defer Date: Decision : In the light of wri埜�en comments received from Department of Pharmaceu韣�cals vide their OM No. 35011/612/2013‐PI(Norms) dated 07.02.2013, it was decided to ra韣�fy norms under
Para 4.7 of HBP v 1 as per details given below or as applied by the firm whichever is less:
Export Item: Diltiazem HCL Tablets 30 mg, 60 mg, 90 mg and 120 mg S.No Import item For Export of 1 no. of Tablets 30 mg 60 mg 90 mg 120 mg 1. Diltiazem Hydrochloride USP 30 mg 60 mg 90 mg 120 mg 2. Lactose Monohydrate NF/BP (200 Mesh) 139.0 mg 278.0 mg 417.0 mg 556.0 mg
Hypromellose USP .35.0 70.0 105.0 140.0 4. Povidone USP (PVP K 90) 3.50 7.0 10.5 14.0 5 to 14 Paking Materials Relevant, as per packing policy RA may take appropriate action as per the decision of Norms Committee. 200
Case No.:38/12/82ALC4/2013
Party Name:DIVIS LABORATORIES LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00462/AM14/ RLA File :09/24/040/00175/AM14/ Lic.No/Date:0910056887 23.07.2013 Defer Date:17.10.2013 201
Case No.:52/12/82ALC4/2013
Party Name:UNIJULES LIFE SCIENCES LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00476/AM14/ RLA File :03/95/040/00305/AM14/ Lic.No/Date:0310742481 23.07.2013 Defer Date:17.10.2013 202
Case No.:9/12/82ALC4/2013
Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00433/AM14/ RLA File :05/24/040/00129/AM14/ Lic.No/Date:0510360635 23.07.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 11/82 dated 19.06.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S.No Item of Import Quantity Allowed kg/kg 7Phenylacetamideo3 Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) While/Light Yellow Powder 1 kg 1. Penicillin G Potassium 1st Crystals 2.85 2. Methanol 2.00 3. Dimethyl Formamide 3.86 4. Methylene Chloride 2.09 5. 2Mercaptobenzothiazole 0.511 6. Isopropyl Alcohol 1.25 203
Case No.:10/12/82ALC4/2013
Party Name:OTSUKA CHEMICAL ( INDIA ) Status:Case
PRIVATE LIMITED 19.09.2013 Deferred HQ File :01/82/050/00434/AM14/ RLA File :05/24/040/00137/AM14/ Lic.No/Date:0510360662 24.07.2013 Defer Date:17.10.2013 204
Case No.:1/10/82ALC4/2013
Party Name:MICRO LABS LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00184/AM14/ RLA File :07/24/040/00111/AM14/ Lic.No/Date:0710097180 30.07.2013 Defer Date:17.10.2013 205
Case No.:2/10/82ALC4/2013
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00185/AM14/ RLA File :09/24/040/00184/AM14/ Lic.No/Date:0910056944 30.07.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.05.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ractopamine HCL for veterinary usage 1 kg 1 (RS) 4(2 Amino1Hydroxy Ethyl) Phenol HCL 1.063 kg 2. 4(4Hydroxy Phenyl)2 Butanone 0.978 kg RA may take appropriate action as per the decision of Norms Committee 206
Case No.:43/12/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00467/AM14/ RLA File :52/24/040/00015/AM14/ Lic.No/Date:5210040038 30.07.2013 Defer Date:17.10.2013 207
Case No.:229/10/82ALC4/2013
Party Name:DHANUKA LABORATORIES LTD. 19.09.2013 Status:Case Approved HQ File :01/82/050/00412/AM14/ RLA File :05/23/040/00183/AM14/ Lic.No/Date:0510361478 01.08.2013 Defer Date: Decision : In the light of earlier decision taken in mee韣�ng no. 26/82 dated 13.12.2012, it was decided to ra韣�fy norms under Para 4.7 of HBP v1 as per details given
below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Cefixime USP/IP/BP 1 kg 1. 7Phenylacetamideo3 Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 1.555 2. Tri Phenyl Phosphine 1.20 3. Acetone 1.18 4. N,N Dimethyl Formamide 4.00 5. Dichloromethane 4.98 6. Phenol 1.12 7. Methanol 6.16 8. Activated Carbon 0.100 9. Triethyl amine 0.34 10 Mica Ester 1.112 11 Tetra Hydrofuran 2.40 208
Case No.:228/10/82ALC4/2013
19.09.2013 Status:Case Approved HQ File :01/82/050/00411/AM14/ RLA File :08/24/040/00198/AM14/ Lic.No/Date:0810123477 05.08.2013 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 49/82 dated 06.03.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Acebutolol Tablet/Capsule 200 mg 1 No. 1. Acebutolol Hcl 221.698 mg Acetbutolol Tablet/Capsule 400 mg 1 No. 1 Acebutolol HCL 443.396 mg RA concerned may take further necessary action as per above decision of NC
209
Case No.:41/12/82ALC4/2013
Party Name:FORACE POLYMERS (P) LTD. 19.09.2013 Status:Case Deferred HQ File :01/82/050/00465/AM14/ RLA File :05/23/040/00147/AM14/ Lic.No/Date:0510362099 06.08.2013 Defer Date:17.10.2013 Decision :It was decided to defer the case for 17.10.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 210
Case No.:230/10/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 19.09.2013 Status:Case Approved HQ File :01/82/050/00413/AM14/ RLA File :08/24/040/00171/AM14/ Lic.No/Date:0810123618 07.08.2013 Defer Date: Decision :It was decided to withdraw the case . As per on lince agenda the advance authorization was issued on repeat basis under para 4.7.1 HBP v1. 211
Case No.:6/12/82ALC4/2013
Party Name:GLENMARK GENERICS LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00430/AM14/ RLA File :03/94/040/00337/AM14/ Lic.No/Date:0310746307 21.08.2013 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 4/82 dated 16.05.2013 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Cilostazol 1 kg 1. [5(4Chlorobutyl)1Cyclohexyl1H Tetrazole] {CBT Cilostazol} 0.88 2. 6Hydroxy3,4Dihydroquinolinone [HCS Cilostazol] 0.59 RA may take appropriate action as per the decision of Norms Committee. 212
Case No.:3/12/82ALC4/2013
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 19.09.2013 Status:Case Deferred HQ File :01/82/050/00427/AM14/ RLA File :04/24/040/00095/AM14/ Lic.No/Date:0410148864 22.08.2013 Defer Date:17.10.2013 Decision : It was decided to again send a copy of application to DCGI for their comments. The case was deferred for 17.10.2013 213
Case No.:8/12/82ALC4/2013
Party Name:JUBILANT LIFE SCIENCES LIMITED 19.09.2013 Status:Case Approved HQ File :01/82/050/00432/AM14/ RLA File :05/23/040/00194/AM14/ Lic.No/Date:0510363392 Defer Date:
23.08.2013 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting and decided to ratify norms under Para 4.7 of HBP v1 as per SION A412 with 2 % wastage. Export Product Levetiracetam Tablets 500mg and Levetiracetam Tablets 1000 MG , S.NO. Import Items For export of 1 No. Tablets (Quan韣�ty in mg) 1 Levetiracetam Ph. Eur 510 tab/ 500 tab 2 Levetiracetam Ph. Eur 1020 tab/ 1000 tab RA may take appropriate action as per the decision of Norms Committee. 214
Case No.:1/12/82ALC4/2013
Party Name:SHIVA PHARMACHEM LTD, 19.09.2013 Status:Case Approved HQ File :01/82/050/00425/AM14/ RLA File :34/24/040/00129/AM14/ Lic.No/Date:3410037815 04.09.2013 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 25/82 dated 29.11.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Iso Butyryl Chloride/Butyryl Chloride Appearance: Clear colourless liquid 1 kg 1. Iso Butyric Acid Appearance: Clear colourless liquid 0.870 kg RA may take appropriate action as per the decision of Norms Committee. 215
Case No.:2/12/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 19.09.2013 Status:Case Deferred HQ File :01/82/050/00426/AM14/ RLA File :13/24/040/00022/AM14/ Lic.No/Date:1310044274 09.09.2013 Defer Date:17.10.2013 216
Case No.:4/12/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 19.09.2013 Status:Case Approved HQ File :01/82/050/00428/AM14/ RLA File :08/24/040/00254/AM14/ Lic.No/Date:0810124777 13.09.2013 Defer Date:
Decision :It was decided to withdraw the case . As per on lince agenda the advance authorization was issued on repeat basis under para 4.7.1 HBP v1. 217
Case No.:5/12/82ALC4/2013
Party Name:AUCTUS PHARMA LIMITED 19.09.2013 Status:Case Deferred HQ File :01/82/050/00429/AM14/ RLA File :09/24/040/00277/AM14/ Lic.No/Date:0910057572 13.09.2013 Defer Date:17.10.2013 Decision : It was decided to defer the case for 17.10.2013 for comments of Department of Pharmaceuticals. Date: 28.09.2013 Place:New Delhi R.C. Meena Deputy Director General of Foreign Trade
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