DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 46/82ALC4/2011 MEETING DATE : 14.02.2012 The Meeting No.46/82 in the year 201112 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 14.02.2012 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Pramod Bharti, Asstt. Director, DC(MSME) 2. Shri Jasbir Singh, Consultation, Department of C&PC 3. Shri V.K. Tyagi, Dy. Industrial Adviser, Department of Pharmaceuticals 4. Ms.Lalita Maini, FTDO At the outset, minutes of Norms Committee Meeting No.44/82 dated 31.01.2012 were ratified by the Committee.
Case No.B 483
M/s. Jubilant Lifesciences Limited Norms Committee Meeting No.46/AM12 F.No. 01/82/050/01598/AM 11/DES III Meeting Date:14.02.2012 Adv. Lic. No. 0510271327 dated 25.08.2010 R.A F.NO 05/23/040/00129/AM 11 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to call from the production and consumption data duly certified by technical authorities. Accordingly, the case has been deferred for 13.3.2012..
Case No.B 484
M/s. Jubilant Lifesciences Limited Norms Committee Meeting No.46/AM12 F.No. 01/82/050/01593/AM 11/DES III Meeting Date:14.02.2012 Adv. Lic. No. 0510272117 dated 06.09.2010 R.A F.NO 05/23/040/00138/AM 11 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for Comments from Department of Chemicals and Petrochemicals for 13.3.2012..
Case No.B 485
M/s. Jubilant Lifesciences Limited Norms Committee Meeting No.46/AM12 F.No. 01/82/050/01600/AM 11/DES III
Meeting Date:14.02.2012 Adv. Lic. No. 0510267990 dated 13.07.2010 R.A F.NO 05/23/040/00082/AM 11 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for Comments from Department of Chemicals and Petrochemicals for 13.3.2012
Case No.B 486
M/s. Encee Aromatics Pvt. Ltd. Norms Committee Meeting No.46/AM12 F.No. 01/82/050/00020/AM 10/DES III Meeting Date:14.02.2012 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to advice the firm to bring recommendation of the Chemixcil and also call All Industry Data of other manufacturers for this product from Chemxicil. . Accordingly, the case has been deferred tor 10.4.2012.
Case No.B 454
M/s. Laffans Petrochemicals Limited Norms Committee Meeting No.46/AM12 F.No. 01/82/050/00654/AM 12/DES III Meeting Date:14.02.2012 Adv. Lic. No. 0310433500 dated 22.6.2007 R.A File No. 03/95/40/00111/AM 08 Decision: The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to Call from the firm Certificate of Analysis from the foreign supplier. Accordingly, the case has been deferred for 13.3.2012.
Case No.A 57
M/s Camlin Fine Chemicals Limited Norms Committee Meeting No.46/AM12 F.No. 01/82/162/00922/AM 12/DES III Meeting Date:14.02.2012 Adv. Lic. No. 0510267990 dated 13.07.2010 R.A F.NO 05/23/040/00082/AM 11 Decision: The Committee considered the case as per agenda, in the light of written communication from Department of Chemicals and Petrochemicals vide their letter No. 14010/139/2011Ch.II dated 28.12.2011 and in consultation with the technical authorities decided to remind the firm the furnish the following details: Balanced chemical reaction showing all the reactants, product and by product with their molecular formula and molecular weight. Stagewise % yield on molecular weight basis in respect to each reactant alongwith justification. Authentic/technical literature in support of % yield or norms supplied for import. Details of by products recovered in the process in terms of quantity and value for per kg of export item. The case has been deferred for 13.3.2012.
1
Case No.:12/28/82ALC4/2010
Party Name:S M S PHARMACEUTICALS LTD Meet No/Date:46/82ALC4/2011 14.02.2012 Status:Case Approved HQ File :01/82/050/00894/AM11/ RLA File :09/24/040/00278/AM11/ Lic.No/Date:0910043760 30.09.2010 Defer Date: Decision : The Committee considered the case as per agenda and in the light of the written comments received from Department of Pharmaceuticals vide their OM No. 35011/219/2010PI(Norms) dated 25.11.2011 and in consultation with the technical authorities present in the meeting, decided to ratify norms under Para 4.7 of HBP v1 as per details below or as applied by firm whichever is lower: Export Product Exp. Qty. S.No Import Items (in Kgs) Qty. Allowed (Kgs) Efavurenz 1 kg 1 4Chloro2trifluroacetyl aniline hydrochloride hydrate 1.45 2. NPyrrrodinyl norephedrine 0.08 3. 2,2,2trifluoro ethanol 0.447 4. nButyl magnesium chloride 0.537 5. Di Ethyl Zine 0.634 6. Tetrahydrofuran 2.156 7. Citric Acid Mono hydrate 0.788 8. Sodium Chloride Not an importable item 9. Hexane 0.674 10 Cyclo Propyl acetylene 0.510 11. CP HCL Not an importable item 12 EDB Not an importable item 13 Toluene 7.185 14 Methanol 7.185 15 Sodium Hydroxide Flakes 0.41 16. DM Water Not an importable item 17 Sodium Bi Carbonate 0.47 18. Tri Phosgene 0.448 19 Acetic Acid Not shown in process 20. PS 133 Carbon 0.02 21 Liq. Ammonia Not shown in process. RA may take appropriate action as per the decision of Norms Committee. 2
Case No.:12/28/82ALC4/2011
Party Name:CECIL PHARMACEUTICALS PVT. LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/00782/AM12/ RLA File :18/24/040/00004/AM11/ Lic.No/Date:1810003284 18.11.2010 Defer Date:
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v1 as applied by the firm on the basis of SION 412. 3
Case No.:9/22/82ALC4/2011
Party Name:EMCURE PHARMACEUTICALS LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/00652/AM12/ RLA File :31/83/040/00103/AM12/ Lic.No/Date:3110049873 19.08.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals. 4
Case No.:48/46/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01264/AM12/ RLA File :09/24/040/00287/AM12/ Lic.No/Date:0910048912 19.09.2011 Defer Date: Decision : Committee considered case as per agenda for ratification of norms and in light of earlier decision taken in Meeting NO. 8/82 held on 24.5.2011and 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 the firm whichever is lower: Export product Export Qty. Sl. No. Import items Qty. allowed Tetrazole Aldehyde 1kg. 1. Orthotoluyl Benzonitrile 0.95 kg 2. 1,3Dibromo 5,5 Dimethyl Hydantoin 0.57 kg 3. 2N Butyl4Chloro5 Formyl Imidazole 0.62 kg 4. Tributyl Tin Chloride 1.65 kg 5. Methyl Isobutyl Ketone 1.43 kg 6. Acetonitrile 1.43 kg 7. Azobis Isobutyronitrile 0.096 kg RA concerned may take further necessary action as per above decision of Norms Committee. 5
Case No.:9/46/82ALC4/2011
Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01225/AM12/ RLA File :03/94/040/00587/AM12/ Lic.No/Date:0310663315 03.11.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Chemicals and Petrochemicals. 6
Case No.:6/46/82ALC4/2011
Party Name:AGIO PHARMACEUTICALS LTD 14.02.2012 Status:Case Approved HQ File :01/82/050/01222/AM12/ RLA File :03/94/040/00527/AM12/ Lic.No/Date:0310663915 Defer Date:
08.11.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 22/82 dated 31.8.2010 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 Bendaz 600 mg 1 No. 1. Albendazole 612 mg/600 mg Bolus Bendaz 2500 mg 1 No. 1. Albendazole 2550 mg/2500 mg Bolus Bendaz Plus 535 (Albendazole and Oxyclozanide Tablet 360/175 mg) 1 No. 1. Albendazole 367.2 mg/tablet Bendaz Plus 900 (Albendazole and Oxyclozanide Tablets 600/300 mg) 1 No. 1. Albendazole 612 mg/tablet RA concerned may take further necessary action as per above decision of NC. 7
Case No.:3/46/82ALC4/2011
Party Name:CIPLA LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01219/AM12/ RLA File :03/94/040/00716/AM12/ Lic.No/Date:0310664427 11.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting nO. 11/82 held on 15.6.2010 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 Prednisilone Tablets JP 5 mg 1 No. 1. Prednisolone 5.10 mg 2. Gelatin 1.90 mg 3. Lactose Hydrate 72.60 mg 8
Case No.:2/46/82ALC4/2011
Party Name:CIPLA LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01218/AM12/ RLA File :03/94/040/00701/AM12/ Lic.No/Date:0310664745 14.11.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting by comparison of data, 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 Esomeprazole Magnesium 1 kg 5Methoxy2{[(4methoxy 3,5Dimethylpyridin 2 yl)Methyl]sulfinyl}1H benzimidazole, Potassium Salt [SMK (N)] 1.20 kg/kg RA may take appropriate action as per the decision of Norms Committee. 9
Case No.:7/46/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01223/AM12/ RLA File :03/94/040/00711/AM12/ Lic.No/Date:0310664716 14.11.2011 Defer Date: Decision : Commi컦�ee considered case as per agenda and in light of earlier decision taken in mee솗ng No. 33/10 dated 10.11.2009 and in consulta솗on with technical authority present in mee솗ng decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Testosterone Undecanoate 1 kg. 1. Androst‐4‐ene‐3, 17 dione (AD) 0.944 kg RA concerned may take further necessary ac솗on as per above decision of NC. 10
Case No.:12/46/82ALC4/2011
Party Name:ENALTEC LABS PVT.LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01228/AM12/ RLA File :03/94/040/00715/AM12/ Lic.No/Date:0310665063 15.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 31/82 held on 2.11.2010 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 Febuxostat 1 Kg. 1. 2(3Cyano4(2Methylpropoxy)Phenyl)4 Methyl5Thiazolecarboxylic Acid ethyl Ester 1.512 kg 11
Case No.:8/46/82ALC4/2011
Party Name:AARTI INDUSTRIES LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01224/AM12/ RLA File :03/94/040/00649/AM12/ Lic.No/Date:0310665291 16.11.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
defer the case for 13.3.2012 for comments of Department of Chemicals and Petrochemicals. 12
Case No.:5/46/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01221/AM12/ RLA File :03/94/040/00712/AM12/ Lic.No/Date:0310665724 17.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meting No. 44/82 held on 31.1.2012 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 kg/kg Methyl Testosterone 1 kg 1 4Androstene3,17Dione 1.00 RA may take appropriate action as per the decision of Norms Committee. 13
Case No.:10/46/82ALC4/2011
Party Name:CIPLA LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01226/AM12/ RLA File :03/94/040/00720/AM12/ Lic.No/Date:0310665712 17.11.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (200 MD) with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms As per packing policy As per packing policy 18.20 gms
Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (200 MD) with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can 0.48 mm OD Actuators with Dus covers/caps 1,1,1,2,Tetrafluoroethane (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can. 1 no of inhaler 1 2 3 4 5 6 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dus covers/caps (HFA 134 A Propellant) Ethanol 0.05gms as per packing policy 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg 1 no of inhaler 1 BECLOMETHASONE DIPROPIONATE 0.06gms
HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can 2 3 4 5 6 63mcl AEROSOL VALVES 19ml ALUMINIUM CAN 0.48 mm OD ACTUATORS WITH DUST COVERS /CAPS (HFA 134A Propellant) ETHANOL As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler (200MD) / Beclocip 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) with 63mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.04 gms 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclocip 250mcg HFA Inhaler (200MD) / Beclometasone Pressurised 250mcg 1 no of inhaler 1 2 3 19ml ALUMINIUM CAN 0.05gms
Inhaler (200MD) Valve and 19ml Aluminium Can 4 5 6 COVERS /CAPS (HFA 134A Propellant) ETHANOL 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) / Budesonide Inhaler 200mcg (200MD) with 58mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 58 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.07gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) / Budesonide Inhaler 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms
Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.50 gms 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 SALMETEROL FLUTICASONE PROPIONATE 14ml ALUMINIUM CAN COVERS /CAPS 0.003 gms 0.015 gms 12.5 gms
6 7 (HFA 134A Propellant) ETHANOL 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 SALMETEROL 14ml ALUMINIUM CAN 0.003 gms 0.006 gms As per packing policy As per packing policy
5 6 7 COVERS /CAPS (HFA 134A Propellant) ETHANOL p y As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.02 gms 0.01 gms 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 14ml ALUMINIUM CAN COVERS /CAPS 0.006 gms 12.5 gms
6 (HFA 134A Propellant) ETHANOL 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.03 gms 12.5 gms
6 ETHANOL 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy
6 (HFA 134A Propellant) 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption RA may take appropriate action as per the decision of Norms Committee 14
Case No.:11/46/82ALC4/2011
Party Name:CIPLA LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01227/AM12/ RLA File :03/94/040/00727/AM12/ Lic.No/Date:0310665703 17.11.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower:
Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (200 MD) with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (200 MD) with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can 0.48 mm OD Actuators with Dus covers/caps (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 1 no of inhaler 1 2 Beclomethasone Dipropionate 63 mcl Aerosol Valves 0.08gms
mcg Inhaler (200 MD)/Beclocip 50 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can. 3 4 5 6 19 ml aluminium Can 0.48 mm OD Actuators with Dus covers/caps (HFA 134 A Propellant) Ethanol 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.09gms As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler (200MD) / Beclocip 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg 1 no of inhaler 1 2 3 19ml ALUMINIUM CAN 0.06 gms
Inhaler (200MD) Valve and 19ml Aluminium Can 4 5 6 COVERS /CAPS (HFA 134A Propellant) ETHANOL 16.37 gms 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclocip (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.07gms 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) / Budesonide Inhaler 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.10gms 18.2 gms
Budespray 100mcg HFA Inhaler (200MD) / Budesonide Inhaler 100mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.02 gms 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.04 gms 12.50 gms 0.256 gms
Flu솗cort Plus ‐ 25mcg HFA Inhaler (120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.015 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms
7 Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.02 gms 0.02 gms 14.04 gms 0.36 gms
7 Flu솗casone Propionate 50mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.006 gms 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms
Flu솗casone Propionate 250mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.03 gms 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms
Formoterol Fumarate and Budesonide Inhaler 100/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.012 gms 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses.
The firm will maintain separate record on HFA 134 A Propellant import and consumption RA may take appropriate action as per the decision of Norms Committee 15
Case No.:18/46/82ALC4/2011
Party Name:MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01234/AM12/ RLA File :03/95/040/00613/AM12/ Lic.No/Date:0310665932 18.11.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 39/82 held on 28.12.2010 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 Hydrocortisone Sodium Succinate for injection 1 Kg. 1. Hydrocortisone Base 1.00 kg 16
Case No.:13/46/82ALC4/2011
Party Name:K.PATEL CHEMO PHARMA PVT LTD 14.02.2012 Status:Case Approved HQ File :01/82/050/01229/AM12/ RLA File :03/94/040/00740/AM12/ Lic.No/Date:0310666288 21.11.2011 Defer Date: Decision : The Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/37/2008Ch. III dated 10.5.2010 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Bromo Cresol Green Purity 90% minimum 1 kg 1 Meta Cresol Purple 0.740 kg. RA may take appropriate action as per the decision of Norms Committee. 17
Case No.:1/46/82ALC4/2011
Party Name:CIPLA LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01217/AM12/ RLA File :03/94/040/00735/AM12/ Lic.No/Date:0310666412 22.11.2011 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 in line with the earlier recommendations, as per details below or as applied by the firm, whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed 1 no. of inhaler
Aerodini 100 mg Inhaler (200 MD)/Bulmol 100 mcg inhaler (200 MD)/Salcross HFA 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (200 MD) with 58 mcl Aerosol Valve and 19 ml Aluminium can. 1 no of inhaler 1 2 3 4 5 Salbutamol 58 mcl Aerosol Valves 19 ml aluminium Can 0.48 mm OD Actuators with Dust Cover/caps 1,1,1,2 Tetrafluoroethane (HFA 134A Propellant) 0.02 gms 18.20 gms Salbutamol 100 mcg Inhaler (200 MD)/Asthalin HFA 100 mcg Inhaler (200 MD)/Salvent HFA 100 mcg Inhaler (200 MD)/Salbutateg 100 mcg Inhaler (200 MD)/Salbutamol Pressurised Inhala솗on BP 100 mcg (200 MD) with 50 mcl Aerosol Valve and 19 ml Aluminium Can 1 no of inhaler 1 2 3 4 5 Salbutamol 50 mcl Aerosol Valves 19 ml aluminium can 0.48 mm OD Actuators with Dus covers/caps (HFA 134 A Propellant) 0.020 gms 14.40 gms Beclometasona Dipropionate 50 mcg Inhaler (200 MD)/Beclocross 50 mcg Inhaler (200 MD)/Beclocip 50 mcg 1 no of inhaler 1 2 3 Beclomethasone Dipropionate 63 mcl Aerosol Valves 19 ml aluminium Can 0.11gms
HFA Inhaler (200 MD)/Beclometasone Pressurised 50 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can. 4 5 6 0.48 mm OD Actuators with Dus covers/caps (HFA 134 A Propellant) Ethanol 17.74 gms 0.456 gms Beclometasona Dipropionate 100 mcg Inhaler (200 MD)/Beclocip 100 mcg HFA Inhaler (200 MD)/Beclometasone Pressurised 100 mcg Inhaler (200 MD) with 63 mcl Aerosol Valve and 19 ml aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.12gms As pr packing policy 17.288 gms 0.912 gms Beclometasona Dipropionate 200mcg Inhaler (200MD) / Beclocip 200mcg HFA Inhaler (200MD) / Beclometasone Pressurised 200mcg Inhaler (200MD) 1 no of inhaler 1 2 3 4 19ml ALUMINIUM CAN COVERS /CAPS 0.08 gms 16.37 gms
Valve and 19ml Aluminium Can 5 6 (HFA 134A Propellant) ETHANOL 1.824 gms Beclometasona Dipropionate 250mcg Inhaler (200MD) / Beclocip (200MD) / Beclometasone Pressurised 250mcg Inhaler (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.09gms 15.90 gms 2.28 gms Budespray 200mcg HFA Inhaler (200MD) / Budesonide Inhaler 200mcg (200MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 BUDESONIDE 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.13gms 18.2 gms Budespray 100mcg HFA Inhaler (200MD) 1 no of inhaler 1 BUDESONIDE 0.02 gms
/ Budesonide Inhaler 100mcg (200MD) Valve and 19ml Aluminium Can 2 3 4 5 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 18.2 gms Salmeterol Inhaler 25mcg (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.05 gms 12.50 gms 0.256 gms Flu솗cort Plus ‐ 25mcg HFA Inhaler 1 no of inhaler 1 SALMETEROL 0.003 gms
(120MD) / Salmeterol 25mg and Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 2 3 4 5 6 7 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms Flu솗cort Plus ‐ (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 250mcg Inhaler (120MD) / Flunacross S ‐ (120MD) with 63mcl Aerosol Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.03 gms 12.5 gms 0.256 gms
Flu솗cort Plus ‐ 50mcg HFA Inhaler (120MD) / Salmeterol 25mcg and Flu솗casone Propionate 50mcg Inhaler (120MD) / Flunacross S ‐ 50mcg HFA Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALMETEROL 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.003 gms 0.006 gms As per packing policy As per packing policy As per packing policy 12.5 gms 0.256 gms Beclomethasone Dipropionate 50mcg and Salbutamol 100mcg Inhaler (200MD) with 50mcl Aerosol Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 SALBUTAMOL 50 mcl AEROSOL VALVES 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.02 gms 0.03 gms 14.04 gms 0.36 gms Flu솗casone Propionate 50mcg 1 no of inhaler 1 0.006 gms
Inhaler (120MD) Valve and 14ml Aluminium Can 2 3 4 5 6 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Flu솗casone Propionate 125mcg Inhaler (120MD) Valve and 14ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 14ml ALUMINIUM CAN 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.015 gms 12.5 gms 0.256 gms Flu솗casone Propionate 250mcg Inhaler (120MD) 1 no of inhaler 1 0.03 gms
Valve and 14ml Aluminium Can 2 3 4 5 6 63 mcl Aerosol vale 14ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 12.5 gms 0.256 gms Formoterol Fumarate Inhaler 12mcg (120MD) with 40mcl Aerosol Valve and 10ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 Formoterol Fumarate 40 mcl AEROSOL VALVES 10ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) ETHANOL 0.0014 gms 7.84 gms 0.16 gms Formoterol Fumarate and Budesonide Inhaler 1 no of inhaler 1 BUDESONIDE 0.012 gms
100/6mcg (120MD) Valve and 19ml Aluminium Can 2 3 4 5 6 Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) 0.0007 gms As per packing policy As per packing policy As per packing policy 12.2 gms Formoterol Fumarate and Budesonide Inhaler 200/6mcg (120MD) Valve and 19ml Aluminium Can 1 no of inhaler 1 2 3 4 5 6 7 BUDESONIDE Formoterol Fumarate 19ml ALUMINIUM CAN COVERS /CAPS (HFA 134A Propellant) Ethanol 0.0007 gms 0.024 gms As per packing policy As per packing policy As per packing policy 12.2 gms Nil The above norms are applicable subject to the condition that: Import of HFA 134 A Propellant and its quantity is subject to NOC from Ministry of Environment and Forests. Requirement of HFA 134 A Propellant is inclusive of allowances for permissible loss in weight on storage and primary losses. The firm will maintain separate record on HFA 134 A Propellant import and consumption
RA may take appropriate action as per the decision of Norms Committee 18
Case No.:63/46/82ALC4/2011
Party Name:ANDHRA ORGANICS LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01279/AM12/ RLA File :09/24/040/00387/AM12/ Lic.No/Date:0910049937 29.11.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals. 19
Case No.:54/46/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01270/AM12/ RLA File :09/24/040/00398/AM12/ Lic.No/Date:0910050048 05.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals. 20
Case No.:16/46/82ALC4/2011
Party Name:LAKELAND CHEMICALS (INDIA) LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01232/AM12/ RLA File :03/95/040/00688/AM12/ Lic.No/Date:0310669173 07.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 7/82 held on 17.5.2011 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 Lakpol EI 250 (Sorbitan Mono Oleate) 1kg. 1. Oleic Acid 0.658 kg 2. Sorbitol (70%) 0.425 kg 21
Case No.:60/46/82ALC4/2011
Party Name:LAKELAND CHEMICALS (INDIA) LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01276/AM12/ RLA File :03/95/040/00666/AM12/ Lic.No/Date:0310669166 07.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 7/82 held on 17.5.2011 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 Lakpol EI 250 (Sorbitan Mono Oleate) 1kg. 1. Oleic Acid 0.658 kg 2. Sorbitol (70%) 0.425 kg RA concerned may take further necessary action as per above decision of NC 22
Case No.:76/46/82ALC4/2011
Party Name:VASUDHA PHARMA CHEM LTD 14.02.2012 Status:Case Deferred HQ File :01/82/050/01292/AM12/ RLA File :09/24/040/00367/AM12/ Lic.No/Date:0910050061 07.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 23
Case No.:62/46/82ALC4/2011
Party Name:WINTAC LIMITED, 14.02.2012 Status:Case Deferred HQ File :01/82/050/01278/AM12/ RLA File :07/24/040/00349/AM12/ Lic.No/Date:0710084493 08.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 24
Case No.:82/46/82ALC4/2011
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01298/AM12/ RLA File :09/24/040/00127/AM12/ Lic.No/Date:0910050138 09.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 25
Case No.:22/46/82ALC4/2011
Party Name:PRIVI ORGANICS LTD 14.02.2012 Status:Case Approved HQ File :01/82/050/01238/AM12/ RLA File :03/95/040/00727/AM12/ Lic.No/Date:0310669973 12.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 34/82 meeting held on 22.11.2011 and in consultation with technical authority present in meeting, decided to ratify the norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower: Export Product Export Qty. Sl. No. Import Item Qty. allowed Amber Fleur (2,3,8,8 Tetramethyl 1,2,3,4,5,6,7,8 Octahydro2Napthalenyl Methyl Ketone 1 Kg 1 Myrcene 80% 1.00 kg 2 Methyl ethyl Ketone 0.600 kg 3 Toluene 0.02 kg 4. Phosphoric Acid 0.150 kg
RA concerned may take further necessary action as per above decision of NC 26
Case No.:20/46/82ALC4/2011
Party Name:MAKSON INDUSTRIES PVT. LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01236/AM12/ RLA File :03/95/040/00661/AM12/ Lic.No/Date:0310670334 13.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of its earlier decision taken in 20/82meeting held on 16.8.2011 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Vicks Vaporub 100 kg 1. White Petrolatum (White Soft Parafin) 82.30 kg 2. DLCamphor 5.365 kg 3. Eucalpytus Oil 1.356 kg 4. Nutmeg Oil 0.697 kg 5. Cedar Leaf Oil 0.448 kg 6. Turpentine Oil 4.77 kg 7. Thymol 0.0918kg *Note: norms for different pack sizes may be worked out by RLA on pro‐rata basis. 27
Case No.:21/46/82ALC4/2011
Party Name:MAKSON INDUSTRIES PVT. LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01237/AM12/ RLA File :03/95/040/00662/AM12/ Lic.No/Date:0310670339 13.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of its earlier decision taken in 20/82meeting held on 16.8.2011 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Sl.No. Import items Qty. allowed Vicks Vaporub 100 kg on prorata basis for different pack sizes 1. White Petrolatum (White Soft Parafin) 82.30 kg 2. DLCamphor 5.365 kg 3. Eucalpytus Oil 1.356 kg 4. Nutmeg Oil 0.697 kg 5. Cedar Leaf Oil 0.448 kg 6. Turpentine Oil 4.77 kg 7. Thymol 0.0918kg
Note: Norms for different pack sizes may be worked out by RLA on pro‐rata basis. 28
Case No.:23/46/82ALC4/2011
Party Name:ROYAL PHARMA 14.02.2012 Status:Case Deferred HQ File :01/82/050/01239/AM12/ RLA File :03/95/040/00738/AM12/ Lic.No/Date:0310670268 13.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 29
Case No.:26/46/82ALC4/2011
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 14.02.2012 Status:Case Deferred HQ File :01/82/050/01242/AM12/ RLA File :03/94/040/00751/AM12/ Lic.No/Date:0310670327 13.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Chemicals and Petrochemicals 30
Case No.:24/46/82ALC4/2011
Party Name:ASHISH LIFE SCIENCE PVT.LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and observed that description of their export product is vague. It has been decided to advise the firm to give specific export products along with relevant Drug Manufacturing License. Accordingly, the case has been deferred for 13.3.2012. 31
Case No.:55/46/82ALC4/2011
Party Name:VIVIMED LABS LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01271/AM12/ RLA File :09/24/040/00414/AM12/ Lic.No/Date:0910050211 14.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 4/82 held on 26.4.2011 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 EHT (Ethyl Hexyl Triazone)/Etone 1 kg 1. 2. 3. 4. Para Nitro Benzoic Acid (PNBA) Perchloro Ethylene (PCE) Methanol 2 Ethyl Hexanol 2.510 0.606 3.324 2.150
Aceto Nitrile 2.636 RA concerned may take further necessary action as per above decision of NC 32
Case No.:74/46/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 14.02.2012 Status:Case Deferred HQ File :01/82/050/01290/AM12/ RLA File :09/24/040/00421/AM12/ Lic.No/Date:0910050231 14.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 33
Case No.:81/46/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 14.02.2012 Status:Case Deferred HQ File :01/82/050/01297/AM12/ RLA File :09/24/040/00422/AM12/ Lic.No/Date:0910050232 14.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals 34
Case No.:31/46/82ALC4/2011
Party Name:KDAC CHEM PVT LTD 14.02.2012 Status:Case Deferred HQ File :01/82/050/01247/AM12/ RLA File :34/24/040/00187/AM12/ Lic.No/Date:3410032578 15.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals 35
Case No.:59/46/82ALC4/2011
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01275/AM12/ RLA File :09/24/040/00413/AM12/ Lic.No/Date:0910050238 15.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 36
Case No.:29/46/82ALC4/2011
Party Name:INDSWIFT LABORATORIES LTD., 14.02.2012 Status:Case Approved HQ File :01/82/050/01245/AM12/ RLA File :22/24/040/00075/AM12/ Lic.No/Date:2210012333 Defer Date:
20.12.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 28/82 meeting held on 11.10.2011and 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 Clarithromycin Granules 27.5% (Suspension Grade) 1kg. 1. Clarithromycin (OR) 0.2777 kg Its raw material as per SION A 2263 on prorata basis 2. Carbopol 0.20 kg 3. HPMC Phthalate 0.54 kg 37
Case No.:56/46/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01272/AM12/ RLA File :09/24/040/00416/AM12/ Lic.No/Date:0910050319 20.12.2011 Defer Date: Decision : Commi컦�ee considered case as per agenda and in consulta솗on with the technical authori솗es present in the mee솗ng, on the basis of comparison of data available, decided to ra솗fy 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 kg/kg Finasteride 1 Kg. 1. Azaandrostane Carboxamide (Androst‐4‐aza‐3‐one‐17 Beta‐N‐tert.Butyl carboxamide) 1.7647 2. 4‐dimethylaminopyridine 1.00 k 3. 2,3‐Dichloro‐5,6‐Dicyano‐1,4‐Benzoquinone 0.86 4. Bis‐(Trimethylsilyl) Trifluoro‐Acetamide 1.47 5 Ac솗vated Carbon 0.012 6. Methanol 7.23 7. Methylene Chloride 7.50 8. Tetrahydrofuran 4.82 RA concerned may take further necessary ac솗on as per above decision of NC. 38
Case No.:57/46/82ALC4/2011
Party Name:AUROBINDO PHARMA LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01273/AM12/ RLA File :09/24/040/00411/AM12/ Lic.No/Date:0910050318 20.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals
39
Case No.:68/46/82ALC4/2011
Party Name:SUVEN LIFE SCIENCES LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01284/AM12/ RLA File :09/24/040/00430/AM12/ Lic.No/Date:0910050304 20.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to write to firm to clarify whether the export product is Penicillamine or DPencillamine. It has also been decided to call from the firm production and consumption data duly certified by Central Excise authority.. The case has accordingly been deferred for 13.3.2012. 40
Case No.:19/46/82ALC4/2011
Party Name:ARIHANTANAM LIFECARE PVT. LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01235/AM12/ RLA File :52/24/040/00041/AM12/ Lic.No/Date:5210037486 21.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 5/82 meeting held on 4.5.2010 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Artesunate 1 kg. 1. Artemisinin 0.9259 kg. 41
Case No.:25/46/82ALC4/2011
Party Name:ANUH PHARMA LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01241/AM12/ RLA File :03/94/040/00841/AM12/ Lic.No/Date:0310672115 21.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 34/82 meeting held on 17.11.2009 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 Betamethasone Acetate 1 Kg. 1. Betamethasone Base 1.00 kg 42
Case No.:69/46/82ALC4/2011
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01285/AM12/ RLA File :31/83/040/00193/AM12/ Lic.No/Date:3110052023 21.12.2011 Defer Date:13.03.2012
Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 43
Case No.:30/46/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD Meet No/Date:46/82ALC4/2011 14.02.2012 Status:Case Deferred HQ File :01/82/050/01246/AM12/ RLA File :22/24/040/00076/AM12/ Lic.No/Date:2210012341 22.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 44
Case No.:34/46/82ALC4/2011
Party Name:PERSTORP CHEMICALS INDIA PVT. LIMITED. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01250/AM12/ RLA File :03/95/040/00622/AM12/ Lic.No/Date:0310672312 22.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 45
Case No.:41/46/82ALC4/2011
Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01257/AM12/ RLA File :03/94/040/00845/AM12/ Lic.No/Date:0310672404 22.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Chemicals and Petrochemicals 46
Case No.:42/46/82ALC4/2011
Party Name:AARTI INDUSTRIES LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01258/AM12/ RLA File :03/94/040/00839/AM12/ Lic.No/Date:0310672624 23.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 47
Case No.:33/46/82ALC4/2011
Party Name:ENALTEC LABS PVT.LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01249/AM12/ RLA File :03/94/040/00849/AM12/ Lic.No/Date:0310672816 26.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 31/82 held on 2.11.2010 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 Febuxostat 1 Kg. 1. 2(3Cyano4(2Methylpropoxy)Phenyl)4 Methyl5Thiazolecarboxylic Acid ethyl Ester 1.512 kg 48
Case No.:46/46/82ALC4/2011
Party Name:GLENMARK GENERICS LIMITED 14.02.2012 Status:Case Approved HQ File :01/82/050/01262/AM12/ RLA File :03/94/040/00810/AM12/ Lic.No/Date:0310672825 26.12.2011 Defer Date:14.02.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting, decided to ratify the norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower Export Product Exp. Qty. S.No Import Item Qty. allowed/kg Ciclopirox Gel 0.77%, 30 gm 40000 Numbers Ciclopirox USP 9.44 kg Ciclopirox Gel 0.77%, 45 gm 22000 Numbers Ciclopirox USP 7.76 kg Ciclopirox Gel 0.77%, 100 gm 10000 Numbers Ciclopirox USP 7.85 kg RA may take appropriate action as per the decision of Norms Committee. 49
Case No.:4/46/82ALC4/2011
Party Name:AMI LIFESCIENCES P LTD 14.02.2012 Status:Case Deferred HQ File :01/82/050/01220/AM12/ RLA File :34/24/040/00189/AM12/ Lic.No/Date:3410032719 27.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda in consultation with the technical authorities present in the meeting and decided to call from the firm Certificate of Analysis from the foreign suppliers for import items and testing report for the export items. Accordingly, the case has been deferred for 13.3.2012. 50
Case No.:14/46/82ALC4/2011
Party Name:STAR DRUGS & RESEARCH LABS LTD 14.02.2012 Status:Case Deferred HQ File :01/82/050/01230/AM12/ RLA File :04/24/040/00242/AM12/ Lic.No/Date:0410132171 27.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
51
Case No.:15/46/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 14.02.2012 Status:Case Deferred HQ File :01/82/050/01231/AM12/ RLA File :04/24/040/00259/AM12/ Lic.No/Date:0410132173 27.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 52
Case No.:17/46/82ALC4/2011
Party Name:SHREE GANESH REMEDIES PVT.LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01233/AM12/ RLA File :34/24/040/00199/AM12/ Lic.No/Date:3410032733 27.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 52/82 dated 23.3.2010 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 Di Methyl Amino Propyl Chloride Hcl 65% Sodium in water 1 Kg. 1. 1Bromo3Chloro Propane 0.684 kg 53
Case No.:38/46/82ALC4/2011
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 14.02.2012 Status:Case Deferred HQ File :01/82/050/01254/AM12/ RLA File :03/94/040/00817/AM12/ Lic.No/Date:0310673330 28.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Chemicals and Petrochemicals. 54
Case No.:27/46/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD Meet No/Date:46/82ALC4/2011 14.02.2012 Status:Case Approved HQ File :01/82/050/01243/AM12/ RLA File :22/24/040/00078/AM12/ Lic.No/Date:2210012376 29.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 42/82 meeting held on 17.01.2012 and in consultation with technical authority present in meeting, decided to ratify norms as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate 1 kg. 1. 6Amino Penicillinic Acid (6APA) 0.568 kg
Through 6APA Through Enzymatic Route 2. Formidase (Enzyme 5 gm 3. Methanol 0.020 kg 4. D()PHydroxy Phenyl Glycine Methylester (BBH) 0.608 kg 55
Case No.:28/46/82ALC4/2011
Party Name:DSM ANTIINFECTIVES INDIA LTD Meet No/Date:46/82ALC4/2011 14.02.2012 Status:Case Approved HQ File :01/82/050/01244/AM12/ RLA File :22/24/040/00071/AM12/ Lic.No/Date:2210012378 29.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 40/82 dated 4.1.2011 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 Ampicillin Trihydrate through 6APA through Enzyme Route 1 Kg. 1. 6Amino Pencillanice Acid 0.596 kg 2. Oxilase (HL) spherical balls in suspensionof brown colour 5.25 gram 3. D() Alpha Phenyl Glycine Base Colourless to Greyishwhite Crystalline Powder 0.417 kg 4. Methanol Transparent 0.400 kg 56
Case No.:35/46/82ALC4/2011
Party Name:MOHINI ORGANICS PVT. LTD., 14.02.2012 Status:Case Deferred HQ File :01/82/050/01251/AM12/ RLA File :03/95/040/00707/AM12/ Lic.No/Date:0310673481 29.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals. 57
Case No.:39/46/82ALC4/2011
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 14.02.2012 Status:Case Deferred HQ File :01/82/050/01255/AM12/ RLA File :03/94/040/00856/AM12/ Lic.No/Date:0310673730 30.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 58
Case No.:40/46/82ALC4/2011
Party Name:CIPLA LIMITED Status:Case
14.02.2012 Approved HQ File :01/82/050/01256/AM12/ RLA File :03/94/040/00881/AM12/ Lic.No/Date:0310673753 30.12.2011 Defer Date: Decision : Committee considered case as per agenda and in light of written decision taken in meeting No. 29/82 dated 19.10.2010 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 Praziquantel USP 1 kg 1. (RS2)Benzoyl1,2,3,6,7,11,B Hexahydro4HPyrazino(2,1,a) Isoquinoline4one(Praziquantel StageII) 1.703 kg 2. Cyclohexane Cabonyl Chloride 0.753 kg 59
Case No.:43/46/82ALC4/2011
Party Name:AARTI INDUSTRIES LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01259/AM12/ RLA File :03/94/040/00872/AM12/ Lic.No/Date:0310673641 30.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 60
Case No.:61/46/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01277/AM12/ RLA File :03/94/040/00854/AM12/ Lic.No/Date:0310673707 30.12.2011 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 61
Case No.:36/46/82ALC4/2011
Party Name:ALTA LABORATORIES LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01252/AM12/ RLA File :03/94/040/00826/AM12/ Lic.No/Date:0310675431 09.01.2012 Defer Date: 13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
p g p g 62
Case No.:37/46/82ALC4/2011
Party Name:ALTA LABORATORIES LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01253/AM12/ RLA File :03/94/040/00825/AM12/ Lic.No/Date:0310675410 09.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 63
Case No.:44/46/82ALC4/2011
Party Name:AARTI DRUGS LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01260/AM12/ RLA File :03/94/040/00724/AM12/ Lic.No/Date:0310675459 09.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 64
Case No.:45/46/82ALC4/2011
Party Name:AARTI DRUGS LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01261/AM12/ RLA File :03/94/040/00665/AM12/ Lic.No/Date:0310675446 09.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 65
Case No.:71/46/82ALC4/2011
Party Name:MICRO INKS LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01287/AM12/ RLA File :03/95/040/00747/AM12/ Lic.No/Date:0310675514 09.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 9/82 meeting held on 31.5.2011 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 Adhesion Promoter containing 62 + 1% Tetra Isopropyl Titanate and 27 + 1% Butanol 1 MT. 1. Butanol 0.2786 MT 2. Tetra Isopropyl Titanate 0.6302 MT 3. Isopropanol 0.1100 MT 66
Case No.:72/46/82ALC4/2011
Party Name:NEW ALLIANCE DYECHEM PVT. Status:Case
LTD., 14.02.2012 Approved HQ File :01/82/050/01288/AM12/ RLA File :03/95/040/00830/AM12/ Lic.No/Date:0310675523 09.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/83/2010/Ch. II dated 29.11.2010 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 Disodium EDTA Zinc (Zn Content 15% (+/0,5%) 1 kg Ethylene Diamine Tetra Acetic Acid (EDTA) 0.690 kg RA may take appropriate action as per the decision of Norms Committee. 67
Case No.:83/46/82ALC4/2011
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 14.02.2012 Status:Case Approved HQ File :01/82/050/01299/AM12/ RLA File :03/95/040/00829/AM12/ Lic.No/Date:0310675517 09.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/83/2010/Ch. II dated 29.11.2010 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 Zinc Diammonium EDTALiquid Zinc content 9%(+/1)Disodium EDTA Zinc (Zn Content 15% (+/0,5%) 1 kg 1 Ethylene Diamine Tetra Acetic Acid (EDTA) 0.422 kg RA may take appropriate action as per the decision of Norms Committee 68
Case No.:53/46/82ALC4/2011
Party Name:DIVIS LABORATORIES LTD., 14.02.2012 Status:Case Approved HQ File :01/82/050/01269/AM12/ RLA File :09/24/040/00476/AM12/ Lic.No/Date:0910050677 10.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting No. 3/82 dated 19.4.2011 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 BWing(LValine Cyclic Urea) 1 Kg. 1. LValine 1.837 kg 2. Acrylonitrile 0.95 kg 3. Methyl Chloro Formate 2.25 kg
69
Case No.:70/46/82ALC4/2011
Party Name:LUPIN LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01286/AM12/ RLA File :03/95/040/00827/AM12/ Lic.No/Date:0310675771 10.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals. 70
Case No.:58/46/82ALC4/2011
Party Name:LAKELAND CHEMICALS (INDIA) LTD. 14.02.2012 Status:Case Approved HQ File :01/82/050/01274/AM12/ RLA File :03/95/040/00710/AM12/ Lic.No/Date:0310676568 13.01.2012 Defer Date: Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 71
Case No.:64/46/82ALC4/2011
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 14.02.2012 Status:Case Approved HQ File :01/82/050/01280/AM12/ RLA File :05/23/040/00387/AM12/ Lic.No/Date:0510314502 13.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in Meeting No. 6/82 dated 10.5.2011 and in consultation with technical authority present in meeting, decided to revise norms as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl. No. Import items Qty. allowed 1,3,5Trimethyl2,4,6Tris (3,5DiTertButyl4 Hydroxybenzyl) Benzene KINOX 30 1kg. 1. 2,6 Ditertiary Butyl Phenol 1.10 kg 2. Paraformaldehyde 96% 0.200 kg 3. Mesitylene 0.189 kg 4. Methylenedichloride 1.00 kg 5. Methanol 1.00 kg RA concerned may take further necessary action as per above decision of Norms Committee. 72
Case No.:65/46/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 14.02.2012 Status:Case Deferred HQ File :01/82/050/01281/AM12/ RLA File :05/23/040/00390/AM12/ Lic.No/Date:0510314514 13.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to
73
Case No.:66/46/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 14.02.2012 Status:Case Deferred HQ File :01/82/050/01282/AM12/ RLA File :05/23/040/00394/AM12/ Lic.No/Date:0510314512 13.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda in consultation with the technical authorities present in the meeting decided to call from the firm Drug Manufacturing License. Accordingly, the case has been deferred for 13.3.2012. 74
Case No.:67/46/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 14.02.2012 Status:Case Deferred HQ File :01/82/050/01283/AM12/ RLA File :05/23/040/00393/AM12/ Lic.No/Date:0510314507 13.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda in consultation with the technical authorities present in the meeting decided to call from the firm Drug Manufacturing License. Accordingly, the case has been deferred for 13.3.2012. 75
Case No.:73/46/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 14.02.2012 Status:Case Deferred HQ File :01/82/050/01289/AM12/ RLA File :05/23/040/00392/AM12/ Lic.No/Date:0510314520 13.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Pharmaceuticals. 76
Case No.:75/46/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 14.02.2012 Status:Case Deferred HQ File :01/82/050/01291/AM12/ RLA File :05/23/040/00382/AM12/ Lic.No/Date:0510314518 13.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 77
Case No.:80/46/82ALC4/2011
Party Name:JUBILANT LIFE SCIENCES LIMITED (FORMERLY JUBILANT 14.02.2012 Status:Case Deferred HQ File :01/82/050/01296/AM12/ RLA File :05/23/040/00389/AM12/ Lic.No/Date:0510314505 13.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 78
Case No.:78/46/82ALC4/2011
Party Name:SOMU ORGANO CHEM PVT.LTD., Status:Case
14.02.2012 Deferred HQ File :01/82/050/01294/AM12/ RLA File :07/24/040/00411/AM12/ Lic.No/Date:0710085576 17.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 79
Case No.:84/46/82ALC4/2011
Party Name:TRANSPEK INDUSTRY LIMITED 14.02.2012 Status:Case Deferred HQ File :01/82/050/01300/AM12/ RLA File :34/24/040/00220/AM12/ Lic.No/Date:3410032968 17.01.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 80
Case No.:79/46/82ALC4/2011
Party Name:R L FINE CHEM 14.02.2012 Status:Case Approved HQ File :01/82/050/01295/AM12/ RLA File :07/24/040/00415/AM12/ Lic.No/Date:0710085696 19.01.2012 Defer Date: Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 42/82 meeting held on 10.1.2012 and in consultation with technical authority present in meeting, decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg RA concerned may take further necessary action as per above decision of NC 81
Case No.:32/46/82ALC4/2011
Party Name:EMBIO LTD 14.02.2012 Status:Case Deferred HQ File :01/82/050/01248/AM12/ RLA File :03/94/040/00942/AM12/ Lic.No/Date:0310679417 31.01.2012 Defer Date:13.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 13.3.2012. 82
Case No.:47/46/82ALC4/2011
Party Name:EMBIO LTD 14.02.2012 Status:Case Deferred
HQ File :01/82/050/01263/AM12/ RLA File :03/94/040/00943/AM12/ Lic.No/Date:0310679893 02.02.2012 Defer Date:13.03.2012 Decision : The representative of the firm came for personal hearing on 07.02.2012 and stated that the quantity applied by them was incorrect as some data is wrongly pasted in their application. They brought with them Central Excise data to show that quantity applied by them was by mistake lower than their actual. The firm has agreed to give a revised application and other details in a month’s time. Accordingly, the case has been deferred for 13.3.2012. 83
Case No.:49/46/82ALC4/2011
Party Name:SV PLASTOCHEM PVT.LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01265/AM12/ RLA File :31/24/040/00030/AM11/ Lic.No/Date:3110052741 06.02.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 84
Case No.:50/46/82ALC4/2011
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01266/AM12/ RLA File :31/83/040/00208/AM12/ Lic.No/Date:3110052844 07.02.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to 85
Case No.:51/46/82ALC4/2011
Party Name:RELIANCE INDUSTRIES LTD. 14.02.2012 Status:Case Deferred HQ File :01/82/050/01267/AM12/ RLA File :03/95/040/00867/AM12/ Lic.No/Date:0310680799 08.02.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with the technical authorities present in the meeting decided to defer the case for 13.3.2012 for comments of Department of Biotechnology. 86
Case No.:52/46/82ALC4/2011
Party Name:ROSSARI BIOTECH LTD 14.02.2012 Status:Case Approved HQ File :01/82/050/01268/AM12/ RLA File :03/95/040/00911/AM12/ Lic.No/Date:0310680801 08.02.2012 Defer Date: Decision : The Committee considered the case as per agenda and in light of the written comments forwarded by Department of Chemicals and Petrochemicals vide their U.O No. 14010/32/2007/Ch.II dated 17.5.2010 and in consultation with the technical authorities present in the meeting decided to ratify norms under Para 4.7 of HBP v 1 as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Textile Auxilliaries: 1 kg 1 Saturated Acyclic Organic Acid 0.503 kg
Roassacid – N/Rossacid PD/C/ShaqF/Glitter Liquid/ECO Acid 2 (Methane Carboxylic Acid) Mono Carboxylic Acid (Methanoic Acid) 0.200 kg 87
Case No.:77/46/82ALC4/2011
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 14.02.2012 Status:Case Deferred HQ File :01/82/050/01293/AM12/ RLA File :03/95/040/00880/AM12/ Lic.No/Date:0310681190 09.02.2012 Defer Date:13.03.2012 Decision : The Committee considered the case as per agenda and in consultation with technical authorities present in the meeting decided to call from the firm Composition of their Export product and its Drug Manufacturing License. Accordingly, the case has been deferred for 13.3.2012. Outside Agenda No. 1 M/s. Shiva Pharma Chem. Pvt. Limited Norms Committee Meeting No.46/AM12 dated F.No. 01/82/050/01507/AM 09/DES III F.No. 01/82/050/01528/AM 09/DES III F.No. 01/82/050/00539/AM 09/DES III F.No. 01/82/050/00457/AM 09/DES III F.No. 01/82/050/00822/AM 09/DES III F.No. 01/82/050/00863/AM 09/DES III F.No. 01/82/050/01769/AM 08/DES III F.No. 01/82/050/01769/AM 09/DES III Meeting Date:14.02.2012 Adv. Lic. No 3410020012 dated 6.11.2007 3410020410 dated 20.12.2007 3410020568 dated 12.01.2008 3410020968 dated 3.3.2008 3410021213 dated 6/11/2007 3410021263 dated 28.4.2008 3410021978 dated 31.7.2008 3410022054 dated 08.08.2008 3410023162 dated 7.1.2009 Decision: The Committee considered the case as per agenda and observed that the norms were fixed in various meetings held in 2007, 2008 and 2009 and were conveyed to RA and to the firm immediately The case is pending with RA on a matter of doubt raised by RA whether Condition No. 2 of General Note for Chemicals and Allied Product Group is applicable in the case of the firm for the
purpose of allowing EODC. The Committee noticed that this is for the first time that such doubt has been raised by any Regional Authority. If RA had doubt, they should have sought clarification immediately. The Committee reconsidered the case and observed that the norms were fixed on the basis of application. The Committee, therefore, reiterated its decision as inputs were correctly allowed after comparison of available data by technical authority. Date:14.02.2012 Place:New Delhi Lalita Maini Foreign Trade Development Officer
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