DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 19/82ALC4/2011 MEETING DATE : 09.08.2011 The Meeting No.19/82 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 09.08.2011 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present: 1. Shri V.K. Tyagi, Dy.I.A, Department of Pharmaceuticals 2. Shri Jasbir Singh, Consultant, Department of C&PC 3. Shri S.S. Bose, Sr. D.O., DIPP 4. Shri Pramod Bharti, Asstt. Director, DC(MSME) 5. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No.18/82 dated 09.08.2011 were ratified by the Committee.
Case No.B202
Suggestions sought by DGFT’ Norms Committee Meeting No.19/12 F.No.01/82/162/0404/AM12/DESIII Meeting Date:09.08.2011 1. Norms Committee3 is entrusted with the responsibility of fixation of norms in respect of Pharmaceuticals and Organic Chemicals. Products under Organic Chemicals being the result of series of chemical processes, the requirement of inputs depends entirely upon the percentage yield or efficiency achieved by the applicant firm for each stage of chemical conversion. Needless to say that where the efficiency is lower, the requirement of input is higher. 2. Norms are to be worked out keeping the benchmark of optimum yield achieved by the firm wherever comparison is available for same or similar compound/export product. In all other cases which are old or where comparison is not available, the exercise of arriving at the quantum of inputs required is advised by the Administrative Ministry/technical Departments by going the technical details provided by firms. Additionally, Committee also calls for production and consumption data certified by Central Excise Authority from the firms in cases so recommended by technical authority and arrives at the norms based on such actual consumption data. 3. A major portion of cases before Norms Committee3, relate to Pharmaceutical products. Pharmaceutical and allied products being complex in nature, very often involve new pathways with the addition of newer molecules. In such instances, no feed back on conversion yields are available in the technical literature provided by the firm. Departments take longer time to determine and recommend suitable technical advice in such cases. In order to obviate delays, the production and consumption data certified by the Central Excise authority is called from the applicant firm to enable the Committee to arrive at the norms. 4. After conducting review meeting of Norms Committee, DG had issued directions indicating steps to be taken to minimize delays in finalizing norms. Accordingly, the issue of cases pending for fixing norms, due to nonavailability of technical comments, was taken up through a DO letter addressed to DDG (Jt.
Secy. Level) in Dept. of Pharmaceuticals. The need to finalise norms within the stipulated period in terms of Foreign Trade Policy Procedures was duly emphasized. 5. Shri V.K. Tyagi, Dy. Industrial Adviser, Department of Pharmaceuticals informed NCIII that technical comments are forwarded only after it is placed before a Departmental Technical Committee. Hence, providing technical comments is subject to completion of the said exercise which takes a longer time. Wherever, technical details on manufacturing process are available, technical authorities are already giving inputs for disposal of cases. 6. It is also proposed to follow up the matter with a personal meeting, to ensure that arrangement for providing technical comments is accorded priority. Meanwhile, Pharmexcil has deputed its expert Shri D.N. Mathur (ExTechnical Adviser, Dept. of Pharmaceuticals) to participate in Norms Committee meetings regularly and provide technical advice. 7. In the light of above position, the Committee has decided to expedite norms in respect of all cases pending for more than 4 months. Wherever a detailed scrutiny of the cases involves delays, the production and consumption data certified by Central Excise Authority will be relied upon for regularization of cases.
Case No.B197
M/S Vins Bioproducts Ltd F.No.01/82/162/00939/AM11/DESIII Committee decided to defer case for 16.08.2011 for comments of Department of Biotechnology.
Case No.B198
M/S Navin Fluorine International Ltd. F.No.01/82/050/01351/AM07/DESIII RA F.No.03/95/040/01412/AM07 Adv.Lic.No.0310423394 dated 15.03.2007 Committee considered case as per agenda and in light of earlier decision taken in 39/06 meeting held on 04.01.2006 and in consultation with technical authorities present in meeting, committee decided to ratify norms under para 4.7 of HBP for regularization purpose as per details below or as applied by the firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed Refrigerant Gas HFC 134a (Mafron 134a) (filled in small Cylinders) 1 Kg. 1. Refrigerant Gas 134a in bulk container 1.010 kg Note: No repeat advance authorization may be issued on the basis of above norms. RA concerned may take further necessary action as per above decision of NC.
Case No.B199
M/S Navin Fluorine International Ltd. F.No.01/82/050/01283/AM07/DESIII
RA F.No.03/95/040/01336/AM07 Adv.Lic.No.0310421068 dated 18.07.2007 Committee considered case as per agenda and in light of earlier decision taken in 25/10 meeting held on 15.09.2009 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 Meta Chloro Benzo Tri Fluoride 1 Kg. 1. Sulphur 0.273 kg 2. Fluorspar 0.910 kg 3. Benzo tri chloride 1.246 kg
Case No.B200
M/S Techno Drugs & Intermediates Pvt. Ltd. F.No.01/83/050/00503/AM07/DESIII RA F.No.03/95/040/00466/AM07 Adv.Lic.No.0310392619 dated 02.08.2006 Committee considered case as per agenda and observed that Department of C&PC vide their letter No.14010/66/2011Ch.II dated 05.08.2011, has called for the following information from the firm: 1. Details of manufacturing process with chemical equations, molecular formula and molecular weight. 2. Yield obtained in each step. 3. Norms approved earlier for import of Pyridine2 Aldehyde against export of Bisphenol. 4. Production of export item Bisphenol and corresponding consumption of each input in past duly certified by Central Excise Authority. It was, therefore, decided to remind the firm to furnish the above information. Accordingly, case was deferred for 06.09.2011.
Case No.B201
M/S Sterling Auxiliaries Pvt. Ltd. F.No.01/82/050/00769/AM09/DESIII RA F.No.03/95/040/00355/AM09 Adv.Lic.No.0310479455 dated 27.07.2008 Committee considered case as per agenda and in light of written comments of Department of C&PC dated 08.08.2011 and in consultation with technical authority present in meeting, decided to amend the description of export product to read as “Stero MDEA (PIP) (Blends of Piperazine and Methyl Di Ethanol Amine)” and “Stero Co 400 (IMP) (Polyoxethylene Ricinoleic Acid)” for regularization purpose only without any other change in the earlier decision taken in 53/82 meeting held on 30.03.2010.
Case No.B203
M/S Jubilant Organosys Ltd.
F.No.01/82/050/00651/AM07/DESIII RA F.No.05/24/040/00330/AM07 Adv.Lic.No.0510187592 dated 27.07.2006 Committee considered case as per agenda and observed that out of eight import items applied by the firm, they have imported only two inputs namely “Methanol” and “Ammonia”. The representative of Department of C&PC informed the Committee that the quantity of these two inputs imported by the firm are reasonable and may be allowed for regularization purpose. After detailed deliberations and in light of written comments of Department of C&PC dated 08.08.2011 and in consultation with technical authority present in the meeting, Committee decided to ratify norms under para 4.7 of HBP as per details below for regularization purpose only: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,3 Lutidine 1 Kg. 1. Methanol 13.20 kg 2. Ammonia 11.32 kg
Case No.B204
M/S Sterling Auxiliaries Pvt. Ltd. F.No.01/82/050/00201/AM12/DESIII RA F.No.03/95/040/00012/AM12 Adv.Lic.No.0310629884 dated 06.05.2011 Committee considered case as per agenda and in light of written comments of Department of C&PC dated 08.08.2011 and in consultation with technical authority present in meeting, decided to allow import of “LABSA” to the extent of 0.756 kg/kg of STEROCARE CABS without any other change in the decision taken in 8/82 meeting held on 24.05.2011.
Case No.B205
M/S Prachi Pharmaceuticals Pvt. Ltd. F.No.01/82/050/00790/AM10/DESIII RA F.No.03/95/040/00565/AM10 Adv.Lic.No.0310549028 dated 03.12.2009 Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/72/2005/Ch.II dated 06.08.2011 and in consultation with technical authority present in meeting, decided to reduce the quantity of Methanol to the extent of 0.762 kg/kg of export product and allow import of Potassium Iodide Solution (Iodine content 25%) to the extent of 3.048 kg/kg of export product without any other change in the earlier decision taken in 1/82 meeting held on 06.04.2010.
Case No.B206
M/S J.K. Drugs & Pharma Ltd. F.No.01/82/162/00124/AM12/DESIII
RA F.No.05/88/040/00237/AM99 Adv.Lic.No.P/L/0101298 dated 06.01.1999 Committee considered case as per agenda. The representatives of the company appeared before the Committee for personal hearing and explained the case. They informed that Committee that they have fulfilled the export obligation against the advance licence. They further informed that the company has been closed in 2002 and this is the only advance licence to be closed in RA. The technical authorities present in meeting advised that the norms may be fixed for regularization purpose on the basis of actual imports made by the firm. After detailed deliberations and in consultation with technical authorities present in meeting, Committee decided to ratify norms for regularization purpose under para 4.7 of HBP as per details below: Export product Exp. Qty. Sl.No. Import items Qty. allowed 6OMethylDihydro14 Oxacyclotetra Decan 1 Kg. 1. Erythromycin Base 2.806 kg 2. Methylene Chloride 2.686 kg 3. 2 Methoxy Propene 0.865 kg 4. Pyridine Hydrobromide 0.583 kg 5. Hexamethyl Disilazane 1.336 kg 6. Dimethyl Sulphoxide 1.790 kg 7. Tetrahydrofuran 8.983 kg
Case No.B207
M/S Penem Laboratories Ltd. F.No.01/82/162/00371/AM07/DESIII RA F.No.05/21/040/00160/AM06 Adv.Lic.No. Committee considered case as per agenda and observed that office of DCGI vide their letter No.Z 28020/67/11D dated 30.06.2011 has issued clarification under RTI Act, 2005 clarifying that 6Amino Penicillanic Acid is not a drug and is not registered by their office. The other technical authorities present in the meeting also supported the clarification given by DCGI and confirmed that the above item is not a drug and therefore, the provisions of Policy Circular No.9(RE2004)/200207 dated 30.06.2003, Policy Circular No.15(RE2003)/200207 dated 17.09.2003, Policy Circular No.33(RE2004)/200207 dated 30.04.2004, Policy Circular No.41(RE 2004)/200207 dated 22.07.2004, Public Notice No.73 dated 09.07.2004, Public Notice No.6 dated 17.09.2004 and Policy Circular No.1 dated 17.09.2004 shall not be applicable for import of 6Amino Penicillanic Acid.
Case No.B208
M/S Global Exim. F.No.01/82/162/00395/AM12/DESIII Committee considered case as per agenda. Department of C&PC vide their U.O. No.14010/84/2011 Ch.II dated 09.08.2011 has clarified as under: 1. Various technical reference are there which confirm the use of Coumarin as a stress corrosion inhibitor in industrial application amongst other use.
2. In the book Modern Electroplating 4th Edition by Mordechay Schlesinger, it is mentioned that Coumarin in combination with carrier and auxiliary brighteners produce semibright Nickel deposits having good ductility and leveling characteristics over a wide range of current desities. The brightener added to the plating fills up the fine cavities on the substrate. 3. Similarly, the Kirk Othmer Encyclopedia of Chemical Technology, 3rd Edition also describes Coumarin as stress relieving additives for the fine grain refinement columnar structures which are characterstics of electro deposits from high metal ion concentration solution with high deposition rate or from low metal ion concentration solution of low deposition rate. In view of above clarification given by Department of C&PC and in consultation with technical authorities present in meeting, Committee confirmed the use of Coumarin as a Corrosion Inhibitor in industrial application.
Case No.C38
M/S Emami Ltd. F.No.01/82/162/00638/AM11/DESIII Committee decided to remind the firm to furnish technical information called by DC(MSME). Accordingly, case was deferred for 23.08.2011. 1
Case No.:7/19/82ALC4/2011
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:19/82ALC4/2011 09.08.2011 Status:Case Approved HQ File :01/82/050/00521/AM12/ RLA File :03/95/040/01049/AM08/ Lic.No/Date:0310458672 22.01.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/88/2004 Ch.II dated 07.12.2009 and in consultation with technical authoritiy 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 Octylated Diphenylamine (OCD Powder/Flakes) 1 Kg. 1. Diphenylamine 0.405 kg 2. DiIsobutylene 0.680 kg 2
Case No.:8/15/82ALC4/2011
Party Name:CIPLA LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00448/AM12/ RLA File :03/94/040/00932/AM09/ Lic.No/Date:0310502537 16.01.2009 Defer Date:06.09.2011 Decision :Committee decided to remind Ministry of Environment and Forests for their NOC/comments. Accordingly, case was deferred for 06.09.2011. 3
Case No.:3/29/87ALC1/2009
Party Name:PARABOLIC DRUGS LTD., 09.08.2011 Status:Case Deferred
HQ File :01/87/050/00216/AM10/ RLA File :05/24/040/00302/AM10/ Lic.No/Date:0510250358 06.10.2009 Defer Date:23.08.2011 Decision :Committee decided to call for the firm for personal hearing on 23.08.2011. Accordingly, case was deferred for 23.08.2011. 4
Case No.:14/33/82ALC4/2009
Party Name:VIJAYASRI ORGANICS LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00642/AM10/ RLA File :09/24/040/00262/AM10/ Lic.No/Date:0910039756 29.10.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/71/2008PIIII dated 30.08.2008 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 (1S,4R)4(2Amino6Chloro5 Formamido4Pyrimidinyl) Amino2Cyclopentene1 Methanol (AFC) 1kg. 1. (+)2Azabicyclo (2.2.1) Hept Ene3One (Vancelactam) 100% 2.18 kg kg 2. Methylene Dichloride 5.00 kg 3. Pyridine 3.48 kg 4. Sodium Borohydride (SBH) 0.317 kg 5. Methanol 2.60 kg 6. DTartaric Acid 1.06 kg 7. Dimethyl Formamide (DMF) 0.433 kg 8. 2,5 Diamino 4,6 Dihydroxypyrimidine (DADHP) 1.638 kg 9. Toluene 1.76 kg 10. Propionic Acid 1.35 kg 5
Case No.:27/34/82ALC4/2009
Party Name:VIVIMED LABS LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Decision :Withdrawn as the case has already been approved by NC in its 18/82 meeting held on 02.08.2011. 6
Case No.:2/47/82ALC4/2010
Party Name:MEDREICH LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/01592/AM11/ RLA File :07/21/040/00729/AM10/ Lic.No/Date:0710068320 17.11.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceutical vide their U.O. No.35011/46/2009PIIII dated 21.10.2009 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 Export Qty. Sl.No. Import items Qty. allowed CoAmoxiclav Injection BP, 1200 mg (containing Amoxycillin Sod. Sterile equivalent to 1000 mg of Amoxycillin and Sterile Clavulanate Potassium Equivalent to 200 mg of Clavulanic Acid) 1 Vial 1. Blend of Sterile Amoxycillin Sodium BP and Sterile Potassium Clavulanate BP in 5:1 ratio 1224 mg CoAmoxiclav Injection BP, 600 mg (containing Amoxycillin Sod. Sterile equivalent to 600 mg of Amoxycillin and Sterile Clavulanate Potassium Equivalent to 200 mg of Clavulanic Acid) 1 Vial 1. Blend of Sterile Amoxycillin Sodium BP and Sterile Potassium Clavulanate BP in 5:1 ratio 612 mg 7
Case No.:62/5/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/00096/AM11/ RLA File :09/24/040/00321/AM10/ Lic.No/Date:0910040280 16.12.2009 Defer Date:06.09.2011 Decision :Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 06.09.2011. Accordingly, case was deferred for 06.09.2011. 8
Case No.:14/41/82ALC4/2009
Party Name:RANBAXY LABORATORIES LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00849/AM10/ RLA File :05/24/040/00414/AM10/ Lic.No/Date:0510255098 22.12.2009 Decision : Committee considered case as per agenda and observed that Advance Authorisation is quite old issued on 22.12.2009 and technical comments are not forthcoming from Department of Pharmaceuticals. The technical authorities present in meeting informed the Committee that the quantity of inputs sought by the firm are reasonable and may be allowed for regularization purpose. After detailed deliberations and in consultation with technical authorities present in meeting, Committee decided to ratify norms under para 4.7 of HBP as per details below for regularization purpose only. No repeat licence may be issued on the basis of these norms. Export product Export Qty. Sl.No. Import items Qty. allowed Donepezil 1 kg 1. 5,6 Dimethoxy1Indanone 1.423 kg 2. Pyridine4Aldehyde 0.957 kg 3. Ethyl Acetate 18.272 kg 4. Diisopropyl Ether 27.074 kg 5. Toluene 19.575 kg 6. Acetone 11.341 kg
g 7. Methylene Chloride 52.213 kg 8. Methanol 64.578 kg 9
Case No.:81/9/82ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00296/AM11/ RLA File :09/24/040/00429/AM10/ Lic.No/Date:0910040725 29.01.2010 Decision :Withdrawn as the case has already been approved by NC in 14/82 meeting held on 05.07.2011. 10
Case No.:7/11/82ALC4/2011
Party Name:R L FINE CHEM 09.08.2011 Status:Case Approved HQ File :01/82/050/00321/AM12/ RLA File :07/21/040/00954/AM10/ Lic.No/Date:0710069721 01.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/205/2008PIIII dated 09.04.2009 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 Carbinoxamine Maleate 1 Kg. 1. Pyridine 2aldehyde 0.39 kg 2. Tetra Hydro Furan 0.468 kg 3. Acetone 1.50 kg 11
Case No.:11/5/82ALC4/2010
Party Name:PARABOLIC DRUGS LTD., 09.08.2011 Status:Case Deferred HQ File :01/82/050/00045/AM11/ RLA File :05/24/040/00017/AM11/ Lic.No/Date:0510262860 22.04.2010 Defer Date:23.08.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 23.08.2011. 12
Case No.:6/8/82ALC4/2010
Party Name:SHALINA LABORATORIES PVT. LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/00195/AM11/ RLA File :03/95/040/00074/AM11/ Lic.No/Date:0310573268 07.05.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 10/82 meeting held on 09.06.2009 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 Export Sl.No. Import item Qty. allowed
Qty. Betasol Lotion 30 ml (Clobetasol Propionate Topical Solution 0.05% (w/v) 1 No. 1. Clobetasol Propionate 15.15 mg/30 ml bottle 2. Propylene Glycol BP 18.00 gm/30 ml bottle 3. Purell As per packing policy 13
Case No.:26/19/82ALC4/2011
Party Name:SHREE VINAYAKA LIFE SCIENCES PVT LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/00540/AM12/ RLA File :09/24/040/00106/AM10/ Lic.No/Date:0910042213 02.06.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/112/2010 Ch.II dated 28.02.2011 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 nButyl Magnesium Chloride 24% 1 KG. 1. nButyl Chloride 0.200 kg 2. MagnesiumTurnings 0.052 kg 3. Tetrahydrofuran 1.00 kg 14
Case No.:2/43/82ALC4/2010
09.08.2011 Status:Case Deferred HQ File :01/82/050/01465/AM11/ RLA File :09/24/040/00090/AM11/ Lic.No/Date:0910042511 25.06.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 15
Case No.:18/47/82ALC4/2010
09.08.2011 Status:Case Deferred HQ File :01/82/050/01608/AM11/ RLA File :09/24/040/00505/AM10/ Lic.No/Date:0910042504 25.06.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 16
Case No.:63/39/82ALC4/2010
09.08.2011 Status:Case Deferred
HQ File :01/82/050/01144/AM11/ RLA File :09/24/040/00116/AM11/ Lic.No/Date:0910042624 06.07.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 17
Case No.:68/39/82ALC4/2010
09.08.2011 Status:Case Deferred HQ File :01/82/050/01149/AM11/ RLA File :09/24/040/00054/AM11/ Lic.No/Date:0910042623 06.07.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 18
Case No.:71/39/82ALC4/2010
09.08.2011 Status:Case Deferred HQ File :01/82/050/01152/AM11/ RLA File :09/24/040/00008/AM11/ Lic.No/Date:0910042622 06.07.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 19
Case No.:28/26/82ALC4/2010
Party Name:VASUDHA PHARMA CHEM LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/00846/AM11/ RLA File :09/24/040/00397/AM10/ Lic.No/Date:0910042652 08.07.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 20
Case No.:6/11/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 09.08.2011 Status:Case Deferred HQ File :01/82/050/00320/AM12/ RLA File :22/24/040/00014/AM11/ Lic.No/Date:2210010164 09.07.2010 Defer Date:06.09.2011 Decision :Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 21
Case No.:72/39/82ALC4/2010
Party Name:MATRIX LABORATORIES LTD Meet No/Date:19/82ALC4/2011 09.08.2011 Status:Case Deferred HQ File :01/82/050/01153/AM11/ RLA File :09/24/040/00146/AM11/ Lic.No/Date:0910042671 12.07.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on
22
Case No.:121/40/82ALC4/2010
Party Name:SAURAV CHEMICALS LTD, 09.08.2011 Status:Case Deferred HQ File :01/82/050/01320/AM11/ RLA File :22/24/040/00030/AM11/ Lic.No/Date:2210010307 18.08.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 23
Case No.:17/39/82ALC4/2010
09.08.2011 Status:Case Deferred HQ File :01/82/050/01098/AM11/ RLA File :09/24/040/00151/AM11/ Lic.No/Date:0910043227 24.08.2010 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 24
Case No.:48/41/82ALC4/2010
Party Name:MEDITAB SPECIALITIES PVT. LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/01396/AM11/ RLA File :03/95/040/00356/AM11/ Lic.No/Date:0310589522 25.08.2010 Decision : Committee considered case as per agenda and in light of SION 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 Ampromed 60% Powder/Amprolium Soluble Powder USP 60% w/w 1 KG. 1. Amprolium Hcl 0.606 kg 25
Case No.:9/24/82ALC4/2010
Party Name:RAMPEX LABS PVT. LTD. 09.08.2011 Status:Case Deferred HQ File :01/82/050/00809/AM11/ RLA File :09/24/040/00194/AM11/ Lic.No/Date:0910043391 07.09.2010 Defer Date:23.08.2011 Decision :Committee decided to forward a copy of application to Department of C&PC for their comments. Accordingly, case was deferred for 23.08.2011. 26
Case No.:3/27/82ALC4/2010
09.08.2011 Status:Case Deferred HQ File :01/82/050/00870/AM11/ RLA File :09/24/040/00139/AM11/ Lic.No/Date:0910043602 23.09.2010 Defer Date:30.08.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 30.08.2011. Accordingly, case was deferred for 30.08.2011.
27
Case No.:16/39/82ALC4/2010
Party Name:CTX LIFESCIENCES PVT LTD, 09.08.2011 Status:Case Deferred HQ File :01/82/050/01097/AM11/ RLA File :03/94/040/00500/AM11/ Lic.No/Date:0310595131 04.10.2010 Defer Date:30.08.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 30.08.2011. Accordingly, case was deferred for 30.08.2011. 28
Case No.:3/31/82ALC4/2010
Party Name:EMAMI LIMITED, 09.08.2011 Status:Case Deferred HQ File :01/82/050/00928/AM11/ RLA File :02/24/040/00119/AM11/ Lic.No/Date:0210149202 12.10.2010 Defer Date:23.08.2011 Decision :Committee decided to defer case for 23.08.2011 for comments of DC(MSME). 29
Case No.:116/40/82ALC4/2010
Party Name:DSM ANTIINFECTIVES INDIA LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/01315/AM11/ RLA File :22/24/040/00017/AM10/ Lic.No/Date:2210010540 19.10.2010 Defer Date:06.09.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 06.09.2011. 30
Case No.:63/40/82ALC4/2010
Party Name:EMAMI LIMITED, 09.08.2011 Status:Case Deferred HQ File :01/82/050/01262/AM11/ RLA File :02/24/040/00120/AM11/ Lic.No/Date:0210149565 25.10.2010 Defer Date:23.08.2011 Decision :Committee decided to defer case for 23.08.2011 for comments of DC(MSME). 31
Case No.:19/35/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/01035/AM11/ RLA File :09/24/040/00319/AM11/ Lic.No/Date:0910044382 22.11.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/203/2010PI (Norms) dated 03.08.2011 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 Clopidogrel Bisulphate 1 KG. 1. Acetone 3.09 kg kg 2. (1 R)()(10)Camphor Sulfonic Acid 0.70 kg 3. Methanol 0.46 kg 4. Methylene Dichloride 2.580 kg
Triethylamine 1.265 kg 32
Case No.:20/35/82ALC4/2010
09.08.2011 Status:Case Approved HQ File :01/82/050/01036/AM11/ RLA File :09/24/040/00333/AM11/ Lic.No/Date:0910044383 22.11.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/203/2010PI (Norms) dated 03.08.2011 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 2CFT Ceftiofur Intermediate 1 KG. 1. Mercapto Benzo Thiazole4YL2(2 Aminothiazolyl) Methoxy Imino Acetate (MAEM) 0.833 kg 2. Triethylamine 0.6517 kg 3. 7Amino Cephalosporanic Acid 0.8098 kg 4. Carbon Enoanticromes (Activated Carbon) 0.100 kg 5. Acetone 7.88 kg 6. N,NDimethyl Acetamide 0.395 kg 7. Methylene Chloride 3.62 kg 8. Tetra Hydrofuran 4.32 kg 33
Case No.:91/39/82ALC4/2010
Party Name:FRESENIUS KABI ONCOLOGY LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01172/AM11/ RLA File :05/23/040/00176/AM11/ Lic.No/Date:0510278093 29.11.2010 Defer Date:06.09.2011 Decision :Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 34
Case No.:93/39/82ALC4/2010
Party Name:FRESENIUS KABI ONCOLOGY LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01174/AM11/ RLA File :05/23/040/00175/AM11/ Lic.No/Date:0510278092 29.11.2010 Defer Date:06.09.2011 Decision : Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 35
Case No.:97/39/82ALC4/2010
Party Name:FRESENIUS KABI ONCOLOGY LIMITED 09.08.2011 Status:Case Approved
HQ File :01/82/050/01178/AM11/ RLA File :05/23/040/00010/AM11/ Lic.No/Date:0510278091 29.11.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 48/82 meeting held on 01.03.2011 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. S.No. Import items Qty. allowed Gemcitabine Hcl 1 kg 1. 2Deoxy2,2DifluoroDErythro Pentafuranous1Ulose3,5Dibenzoate (GN9) 5.14 kg 2. N4Acetyl Cytosine 7.46 kg 3. Trimethyl Silyl Trifluoromethane Sulfonate 8.358 kg 36
Case No.:28/46/82ALC4/2010
09.08.2011 Status:Case Deferred HQ File :01/82/050/01583/AM11/ RLA File :09/24/040/00295/AM11/ Lic.No/Date:0910044520 01.12.2010 Defer Date:30.08.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 30.08.2011. Accordingly, case was deferred for 30.08.2011. 37
Case No.:19/51/82ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01736/AM11/ RLA File :09/24/040/00372/AM11/ Lic.No/Date:0910044623 09.12.2010 Defer Date:06.09.2011 Decision : Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 30.08.2011. 38
Case No.:8/40/82ALC4/2010
Party Name:RA CHEM PHARMA LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01207/AM11/ RLA File :09/24/040/00413/AM11/ Lic.No/Date:0910044684 15.12.2010 Defer Date:23.08.2011 Decision :Committee decided to defer case for 23.08.2011 for comments of Department of Pharmaceuticals. 39
Case No.:20/47/82ALC4/2010
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01610/AM11/ RLA File :09/24/040/00230/AM11/ Lic.No/Date:0910044835 Defer
21.12.2010 Date:13.09.2011 Decision :Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceudticals. 40
Case No.:28/43/82ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01491/AM11/ RLA File :03/94/040/00850/AM11/ Lic.No/Date:0310607789 24.12.2010 Defer Date:06.09.2011 Decision :Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 41
Case No.:10/46/82ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01565/AM11/ RLA File :09/24/040/00427/AM11/ Lic.No/Date:0910044877 24.12.2010 Defer Date:06.09.2011 Decision : Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 42
Case No.:16/44/82ALC4/2010
Party Name:GLENMARK GENERICS LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01515/AM11/ RLA File :03/94/040/00851/AM11/ Lic.No/Date:0310608261 28.12.2010 Defer Date:06.09.2011 Decision : Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 43
Case No.:33/41/82ALC4/2010
09.08.2011 Status:Case Deferred HQ File :01/82/050/01381/AM11/ RLA File :09/24/040/00447/AM11/ Lic.No/Date:0910044965 31.12.2010 Defer Date:06.09.2011 Decision : Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 44
Case No.:1/42/82ALC4/2010
Party Name:SHAMROCK PHARMACHEMI PRIVATE LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01448/AM11/ RLA File :03/95/040/00825/AM11/ Lic.No/Date:0310609520 05.01.2011 Defer Date:30.08.2011 Decision : Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 45
Case No.:14/51/82ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 09.08.2011 Status:Case Deferred HQ File :01/82/050/01731/AM11/ RLA File :03/95/040/00694/AM11/ Lic.No/Date:0310609837 06.01.2011 Defer Date:06.09.2011 Decision : Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals.
46
Case No.:48/10/82ALC4/2011
Party Name:RELIANCE INDUSTRIES LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/00307/AM12/ RLA File :03/95/040/00813/AM11/ Lic.No/Date:0310610013 07.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC (PC Div.) vide their O.M. No.46011/113/2009PCII dated 11.01.2010 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 Orthoxylene 1 MT. 1. Reformate 1.2565 MT 2. Relevant Catalyst and Chemicals used in manufacture of Orthoxylene CIF value limited to 0.90% of FOB value of exports 47
Case No.:10/42/82ALC4/2010
Party Name:TRIGON CHEMICALS PVT. LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/01457/AM11/ RLA File :31/24/040/00179/AM11/ Lic.No/Date:3110046350 10.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/113/2011 Ch.II dated 09.08.2011 and in consultation with technical authorities 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 3,5 Dimethyl Pyrozol 1 Kg. 1. Acetyl Acetone 1.157 kg 2. Hydrazine Hydrate (80%) 0.758 kg 48
Case No.:15/51/82ALC4/2010
Party Name:TITAN LABORATORIES PVT. LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/01732/AM11/ RLA File :03/95/040/00845/AM11/ Lic.No/Date:0310611821 19.01.2011 Decision : Committee considered case as per agenda and in consultation with technical authorities 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 Flurbiprofen SR Pellets 88.9% 1 Kg. 1. Flurbiprofen 0.898 kg
49
Case No.:37/3/82ALC4/2011
Party Name:DIVIS LABORATORIES LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00037/AM12/ RLA File :09/24/040/00471/AM11/ Lic.No/Date:0910045209 19.01.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 1/82 meeting held on 08.04.2009 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 Cyclocytidine Hcl 1 Kg. 1. Cytidine 2.93 kg 2. Acetonitrile 6.01 kg 3. Methanol 4.36 kg 50
Case No.:7/45/82ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/01547/AM11/ RLA File :03/95/040/00836/AM11/ Lic.No/Date:0310612992 28.01.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/81/2005 Ch.II dated 01.07.2011 and in consultation with technical authorities 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 4 Flurobenzyl Amine (Assay 99%) 1 Kg. 1. 4 Fluoro Toluene (PFT) 1.10 kg 2. 4 Fluoro Benzaldehyde (ALD4) 1.24 kg 51
Case No.:43/3/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00043/AM12/ RLA File :09/24/040/00452/AM11/ Lic.No/Date:0910045290 28.01.2011 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 52
Case No.:44/3/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00044/AM12/ RLA File :09/24/040/00422/AM11/ Lic.No/Date:0910045287 28.01.2011 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on
53
Case No.:48/3/82ALC4/2011
09.08.2011 Status:Case Approved HQ File :01/82/050/00048/AM12/ RLA File :09/24/040/00408/AM11/ Lic.No/Date:0910045288 28.01.2011 Defer Date: Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 54
Case No.:51/3/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00051/AM12/ RLA File :09/24/040/00483/AM11/ Lic.No/Date:0910045289 28.01.2011 Defer Date:06.09.2011 Decision : Committee decided to call for the firm for personal hearing alongwith production and consumption data certified by Central Excise Authority on 55
Case No.:8/46/82ALC4/2010
Party Name:VARUN MEDIMPEX INC. 09.08.2011 Status:Case Approved HQ File :01/82/050/01563/AM11/ RLA File :05/24/040/00363/AM11/ Lic.No/Date:0510283385 08.02.2011 Decision :Withdrawn as the case has already been approved by NC in 12/82 meeting held on 21.06.2011. 56
Case No.:7/51/82ALC4/2010
Party Name:LUPIN LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01724/AM11/ RLA File :03/95/040/00869/AM11/ Lic.No/Date:0310614766 08.02.2011 Defer Date:06.09.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. According, case was deferred for 06.09.2011. 57
Case No.:22/3/82ALC4/2011
Party Name:CIPLA LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00022/AM12/ RLA File :03/94/040/00998/AM11/ Lic.No/Date:0310615336 10.02.2011 Defer Date:06.09.2011 Decision :Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 58
Case No.:28/3/82ALC4/2011
Party Name:LUPIN LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00028/AM12/ RLA File :03/95/040/00900/AM11/ Lic.No/Date:0310615412 10.02.2011 Defer Date:06.09.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for
06.09.2011. 59
Case No.:4/3/82ALC4/2011
Party Name:JINDAL DRUGS LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00004/AM12/ RLA File :03/94/040/01005/AM11/ Lic.No/Date:0310616177 15.02.2011 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of C&PC. 60
Case No.:38/3/82ALC4/2011
Party Name:DIVIS LABORATORIES LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00038/AM12/ RLA File :09/24/040/00497/AM11/ Lic.No/Date:0910045589 18.02.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 26/82 meeting held on 28.09.2010 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 Nateglinide 1 kg 1. D Phenylanine 0.70 kg 2. Trans4Isopropyl Cyclohaexane Carboxylic Acid 0.69 kg 3. N Heptane 2.18 kg 61
Case No.:20/3/82ALC4/2011
Party Name:AVENTIS PHARMA LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00020/AM12/ RLA File :03/94/040/00929/AM11/ Lic.No/Date:0310616987 21.02.2011 Defer Date:30.08.2011 Decision :Committee considered case as per agenda and decided to call from the firm percentage of Granules alongwith copy of DML. Accordingly, case was deferred for 38.08.2011. 62
Case No.:27/3/82ALC4/2011
Party Name:IPCA LABORATORIES LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00027/AM12/ RLA File :03/94/040/01009/AM11/ Lic.No/Date:0310616955 21.02.2011 Defer Date:30.08.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 30.08.2011. 63
Case No.:57/48/82ALC4/2010
Party Name:LAFFANS PETROCHEMICALS LTD., 09.08.2011 Status:Case Deferred HQ File :01/82/050/01700/AM11/ RLA File :03/95/040/00368/AM11/ Lic.No/Date:0310617217 Defer
22.02.2011 Date:30.08.2011 Decision :Committee decided to remind the firm to furnish the required information. Accordingly, case was deferred for 30.08.2011. 64
Case No.:12/6/82ALC4/2011
Party Name:VIHITA CHEM PVT.LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/00130/AM12/ RLA File :34/24/040/00281/AM11/ Lic.No/Date:3410029404 22.02.2011 Decision :Withdrawn as the case has already been approved by NC in its 13/82 meeting held on 28.06.2011. 65
Case No.:59/48/82ALC4/2010
Party Name:TINA ORGANICS PRIVATE LIMITED 09.08.2011 Status:Case Rejected HQ File :01/82/050/01702/AM11/ RLA File :05/24/040/00360/AM11/ Lic.No/Date:0510284536 23.02.2011 Decision :Committee considered case as per agenda and observed that the firm was requested to furnish technical information vide letter dated 27.06.2011, but the same has not been received and norms can not be fixed in absence of required information. Accordingly, it was decided to reject the case. 66
Case No.:64/48/82ALC4/2010
Party Name:MEDREICH LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01707/AM11/ RLA File :07/24/040/00482/AM11/ Lic.No/Date:0710077562 24.02.2011 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 67
Case No.:65/48/82ALC4/2010
Party Name:EMAMI LIMITED, 09.08.2011 Status:Case Approved HQ File :01/82/050/01708/AM11/ RLA File :02/24/040/00202/AM11/ Lic.No/Date:0210155350 24.02.2011 Decision :Withdrawn as the case has already been approved by NC in its 18/82 meeting held on 02.08.2011. 68
Case No.:68/48/82ALC4/2010
Party Name:VIHITA CHEM PVT.LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/01711/AM11/ RLA File :34/24/040/00294/AM11/ Lic.No/Date:3410029428 24.02.2011 Defer Date: Decision : Withdrawn as the case has already been approved by NC in its 13/82 meeting held on 28.06.2011. 69
Case No.:10/3/82ALC4/2011
Party Name:LUPIN LIMITED 09.08.2011 Status:Case Deferred
HQ File :01/82/050/00010/AM12/ RLA File :03/95/040/00936/AM11/ Lic.No/Date:0310617943 25.02.2011 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 70
Case No.:11/51/82ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01728/AM11/ RLA File :03/94/040/01049/AM11/ Lic.No/Date:0310619151 03.03.2011 Defer Date:30.08.2011 Decision :Committee decided to call from the firm production and consumption data certified by Central Excise Authority. Accordingly, case was deferred for 30.08.2011. 71
Case No.:36/3/82ALC4/2011
Party Name:MEDREICH LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00036/AM12/ RLA File :07/24/040/00474/AM11/ Lic.No/Date:0710077816 03.03.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/94/2009PIIII dated 26.10.2009 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 Clindamycin Capsules 150 mg 1 No. 1. Clindamycin Hcl BP 173.53 mg 72
Case No.:31/3/82ALC4/2011
Party Name:BAL PHARMA LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/00031/AM12/ RLA File :07/24/040/00484/AM11/ Lic.No/Date:0710077827 04.03.2011 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 73
Case No.:8/6/82ALC4/2011
Party Name:ENCUBE ETHICALS PVT LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/00126/AM12/ RLA File :03/94/040/01004/AM11/ Lic.No/Date:0310619361 04.03.2011 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of DC(MSME). 74
Case No.:16/3/82ALC4/2011
Party Name:PARABOLIC DRUGS LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00016/AM12/ RLA File :05/24/040/00263/AM11/ Lic.No/Date:0510285254 07.03.2011
Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/262/2009PI(Norms) dated 08.03.2010 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 7AVCA 1 Kg. 1. 7Phenylacetamideo3Chloromethyl Cephalosporanic Acid Para methoxybenzyl Ester (GCLE) 2.672 kg 2. Methylene Chloride 5.488 kg 3. Triphenyl Phosphite 1.260 kg 4. Sodium Iodide 0.828 kg 5. Methanol 13.156 kg 6. Activated Carbon 0.100 kg 7. Acetone 2.726 kg 75
Case No.:1/52/82ALC4/2010
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/01770/AM11/ RLA File :03/94/040/01044/AM11/ Lic.No/Date:0310620978 14.03.2011 Defer Date:30.08.2011 Decision :Committee decided to call from the firm Production and consumption data certified by Central Excise Authority for the period 201011. Accordingly, case was deferred for 30.08.2011. 76
Case No.:22/7/82ALC4/2011
Party Name:TRIGON ANTIOXIDANTS PVT. LTD, 09.08.2011 Status:Case Approved HQ File :01/82/050/00188/AM12/ RLA File :03/95/040/01027/AM11/ Lic.No/Date:0310623197 24.03.2011 Decision :Withdrawn as the case has already been approved by NC in its 17/82 meeting held on 26.07.2011. 77
Case No.:3/3/82ALC4/2011
Party Name:ALKYL AMINES CHEMICALS LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00003/AM12/ RLA File :03/94/040/00515/AM11/ Lic.No/Date:0310624109 29.03.2011 Decision : Withdrawn as the case has already been approved by NC in its 15/82 meeting held on 12.07.2011. 78
Case No.:15/19/82ALC4/2011
Party Name:HETERO LABS LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00529/AM12/ RLA File :09/24/040/00597/AM11/ Lic.No/Date:0910046128 29.03.2011 Defer Date:13.09.2011 Decision :Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceuticals.
79
Case No.:16/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00530/AM12/ RLA File :09/24/040/00314/AM11/ Lic.No/Date:0910046126 29.03.2011 Defer Date:13.09.2011 Decision : Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceuticals. 80
Case No.:1/3/82ALC4/2011
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00001/AM12/ RLA File :04/24/040/00342/AM11/ Lic.No/Date:0410123152 01.04.2011 Defer Date:06.09.2011 Decision : Committee decided to defer case for 06.09.2011 for comments of Department of Pharmaceuticals. 81
Case No.:2/3/82ALC4/2011
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00002/AM12/ RLA File :04/24/040/00358/AM11/ Lic.No/Date:0410123153 01.04.2011 Defer Date:30.08.2011 Decision : Committee decided to defer case for 30.08.2011 for comments of Department of Pharmaceuticals. 82
Case No.:49/3/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00049/AM12/ RLA File :31/24/040/00292/AM11/ Lic.No/Date:3110047691 01.04.2011 Decision :Withdrawn as the case has already been approved by NC in 17/82 meeting held on 26.07.2011. 83
Case No.:8/11/82ALC4/2011
Party Name:ARIHANTANAM LIFECARE PVT. LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/00322/AM12/ RLA File :52/24/040/00057/AM11/ Lic.No/Date:5210034768 04.04.2011 Defer Date: Decision : Withdrawn as the case has already been approved by NC in 16/82 meeting held on 19.07.2011. 84
Case No.:2/11/82ALC4/2011
Party Name:ADCOCK INGRAM LTD, 09.08.2011 Status:Case Approved HQ File :01/82/050/00316/AM12/ RLA File :07/24/040/00007/AM12/ Lic.No/Date:0710078580 13.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/82/2009PIIII dated 26.10.2009 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 Paracetamol 450 mg + Caffeine 30mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Colour Yellow Amstead 14037 1.632 mg 3. Codiene Phosphate BP/PH.EUR 10.02 mg Paracetamol 450 mg + Caffeine 45mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Codiene Phosphate BP/PH.EUR 10.20mg 3. Colour quilolin yellow lake 4.56 mg 4. Colour quilolin yellow WS 2.43 mg Paracetamol 450 mg + Caffeine 50mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Codiene Phosphate BP/PH.EUR 10.20mg 3. Colour Yellow Amstead 14037 Do not tally with master batch formula and hence not allowed. Paracetamol 450 mg + Caffeine 50mg + Doxylamine Succinate 5 mg + Codeine Phosphate 10 mg tablet 1 No. 1. Doxylamine Succinate 5.10 mg 2. Codiene Phosphate BP/PH.EUR 10.20mg 3. Colour Green Appble deep F 1569 200 mg 85
Case No.:3/11/82ALC4/2011
Party Name:MEDREICH LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00317/AM12/ RLA File :07/24/040/00010/AM12/ Lic.No/Date:0710078687 20.04.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/94/2009PIIII dated 26.10.2009 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 Clindamycin Capsules 150 mg 1 No. 1. Clindamycin Hcl BP 173.53 mg 86
Case No.:11/19/82ALC4/2011
Party Name:PORUS LABORATORIES PVT Status:Case
LTD. 09.08.2011 Deferred HQ File :01/82/050/00525/AM12/ RLA File :09/24/040/00019/AM12/ Lic.No/Date:0910046428 21.04.2011 Defer Date:13.09.2011 Decision :Committee considered case as per agenda and decided to call the firm for personal hearing alongwith specification of import and export items and certificate of Analysis on 13.09.2011. Accordingly, case was deferred for 13.09.2011. 87
Case No.:26/10/82ALC4/2011
Party Name:CADILA HEALTHCARE LTD., 09.08.2011 Status:Case Deferred HQ File :01/82/050/00285/AM12/ RLA File :08/24/040/00025/AM12/ Lic.No/Date:0810098807 29.04.2011 Defer Date:23.08.2011 Decision :Committee decided to defer case for 23.08.2011 for comments of Department of Pharmaceuticals. 88
Case No.:5/7/82ALC4/2011
Party Name:PAYAL POLYPLAST PVT.LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00171/AM12/ RLA File :05/24/040/00026/AM12/ Lic.No/Date:0510289321 02.05.2011 Decision :Withdrawn as the case has already been approved by NC in its 15/82 meeting held on 12.07.2011. 89
Case No.:13/10/82ALC4/2011
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00272/AM12/ RLA File :13/24/040/00004/AM12/ Lic.No/Date:1310035288 02.05.2011 Decision : Withdrawn as the case has already been approved by NC in its 18/82 meeting held on 02.08.2011. 90
Case No.:11/11/82ALC4/2011
Party Name:RA CHEM PHARMA LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00325/AM12/ RLA File :09/24/040/00112/AM12/ Lic.No/Date:0910046941 30.05.2011 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms with 1% wastage 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 Flurbiprofen Pellets 60% 1 KG. 1. Flurobiprofen 0.606 kg 91
Case No.:12/11/82ALC4/2011
Party Name:SHASUN PHARMACEUTICALS LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00326/AM12/ RLA File :04/24/040/00048/AM12/ Lic.No/Date:0410124486
30.05.2011 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 as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed Metoprolol Tartrate Tablet 50 mg 86000 Nos. 1. Metoprolol Tartrate 4386 kg 2. Magnesium Stearate/SLS 180.600 kg 3. 400 CC Bottle As per packing Policy 4. 33 MM Closure As per packing Policy 92
Case No.:10/15/82ALC4/2011
Party Name:K V AROCHEM PVT. LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00450/AM12/ RLA File :03/94/040/00161/AM12/ Lic.No/Date:0310633517 30.05.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/76/2011 Ch.II dated 21.07.2011 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 7Acetyl1,1,3,4,4,6Hexamethyl 1,2,3,4Tetrahydro Naphthalene (KEVOLID) 1 KG. 1. HMTCrude (Hexamethyl Tetralene) (85%) 1.180 kg 2. Aluminium Chloride (Purity Min. 98%) 0.720 kg 3. Acetyl Chloride (Purity Min.98%) 0.420 kg 93
Case No.:30/19/82ALC4/2011
Party Name:HETERO LABS LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00544/AM12/ RLA File :09/24/040/00613/AM11/ Lic.No/Date:0910046945 30.05.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 49/82 meeting held on 08.03.2011 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 Losartan Potassium 1 KG. 1. 2Butyl4Chloro5Formyl Imidazole 0.62 kg 2. 4Bromomethyl2Cyano Biphenyl 1.117 kg
Sodium Borohydride 0.048 kg 4. Toluene 3.42 kg 5. Methanol 2.00 kg 6. NMethyl Pyrrolidone 1.20 kg 94
Case No.:13/11/82ALC4/2011
Party Name:PANACEA BIOTEC LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00327/AM12/ RLA File :05/24/040/00070/AM12/ Lic.No/Date:0510292280 31.05.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 17/12 meeting held on 26.07.2011 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 DTwPHepBHib Pentavalent Vaccine (Easyfive) 1 Unit (One unit dose Vial) 1. Diphtheria Bulk 29 Lf (includes label claim, overfill & overages 2. Tetanus Bulk 11 Lf (includes label claim, overfill & overages 3. Pertussis Bulk 17.5 OU (includes label claim, overfill & overages 95
Case No.:14/11/82ALC4/2011
Party Name:HETERO DRUGS LIMITED, 09.08.2011 Status:Case Deferred HQ File :01/82/050/00328/AM12/ RLA File :09/24/040/00106/AM12/ Lic.No/Date:0910046965 01.06.2011 Defer Date:13.09.2011 Decision :Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceuticals. 96
Case No.:17/15/82ALC4/2011
Party Name:AVA CHEMICALS PVT.LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00457/AM12/ RLA File :03/94/040/00132/AM12/ Lic.No/Date:0310634100 01.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/67/2011 Ch.II dated 26.07.2011 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 EDTA Tetra Sodium – Liquid (Min.38%) 1 KG. 1. EDTA (Ethylene Diamine Tetra Acetic) (Assay Min.98%) 0.302 kg
y y p 97
Case No.:4/19/82ALC4/2011
Party Name:CIPLA LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00518/AM12/ RLA File :03/94/040/00217/AM12/ Lic.No/Date:0310634431 03.06.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/82 meeting held on 22.02.2011 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 Exemestane 1 KG. 1. Androstenedione 2.38 kg 2. Dichloro Dicyano Benzoquinone (DDQ) 1.70 kg 98
Case No.:25/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00539/AM12/ RLA File :09/24/040/00085/AM12/ Lic.No/Date:0910046996 06.06.2011 Defer Date:30.08.2011 Decision :Committee decided to defer case for 30.08.2011 for comments of Department of C&PC. 99
Case No.:27/19/82ALC4/2011
09.08.2011 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:30.08.2011 Decision : Committee decided to defer case for 30.08.2011 for comments of Department of C&PC. 100
Case No.:10/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00524/AM12/ RLA File :09/24/040/00128/AM12/ Lic.No/Date:0910047036 07.06.2011 Defer Date:13.09.2011 101
Case No.:19/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00533/AM12/ RLA File :09/24/040/00107/AM12/ Lic.No/Date:0910047035 07.06.2011 Defer Date:13.09.2011
102 Case No.:3/19/82ALC4/2011 Party Name:MEHK CHEMICALS PVT. LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/00517/AM12/ RLA File :03/95/040/00189/AM12/ Lic.No/Date:0310635471 10.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/112/2010 Ch.II dated 28.02.2011 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 nButyl Magnesium Chloride 24% 1 KG. 1. nButyl Chloride 0.200 kg 2. MagnesiumTurnings 0.052 kg 3. Tetrahydrofuran 1.00 kg 103
Case No.:6/19/82ALC4/2011
Party Name:ANUH PHARMA LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/00520/AM12/ RLA File :03/94/040/00200/AM12/ Lic.No/Date:0310635393 10.06.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 48/82 meeting held on 23.02.2010 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 Erythromycin Propionate 1 Kg. 1. Erythromycin Thiocyanate 0.900 KGA 104
Case No.:9/19/82ALC4/2011
Party Name:SARACA LABORATORIES LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00523/AM12/ RLA File :09/24/040/00063/AM12/ Lic.No/Date:0910047096 10.06.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 46/82 meeting held on 15.02.2011 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 Gabapentin Hcl (Technical Powder) 1 Kg. 1. 1,1 Cyclohexane Di Acetic Acid Monoamide (CAM) 0.988 kg 2. Bromine 0.923 kg 105 Case No.:18/19/82ALC4/2011 Party Name:COVALENT LABORATORIES Status:Case
PRIVATE LIMITED 09.08.2011 Deferred HQ File :01/82/050/00532/AM12/ RLA File :09/24/040/00527/AM11/ Lic.No/Date:0910047090 10.06.2011 Defer Date:13.09.2011 Decision :Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceuticals. 106
Case No.:31/19/82ALC4/2011
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00545/AM12/ RLA File :09/24/040/00575/AM11/ Lic.No/Date:0910047086 10.06.2011 Defer Date:13.09.2011 107
Case No.:34/19/82ALC4/2011
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00548/AM12/ RLA File :09/24/040/00616/AM11/ Lic.No/Date:0910047091 10.06.2011 Defer Date:13.09.2011 108
Case No.:21/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00535/AM12/ RLA File :09/24/040/00138/AM12/ Lic.No/Date:0910047112 14.06.2011 Defer Date:13.09.2011 Decision : Committee decided to defer case for 13.09.2011 for comments of Department of C&PC. 109
Case No.:12/19/82ALC4/2011
Party Name:BALAJI AMINES LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00526/AM12/ RLA File :31/83/040/00047/AM12/ Lic.No/Date:3110048658 15.06.2011 Defer Date:06.09.2011 Decision : Committee decided to defer case for 06.09.2011 for comments of Department of C&PC. 110
Case No.:14/19/82ALC4/2011
Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 09.08.2011 Status:Case Deferred HQ File :01/82/050/00528/AM12/ RLA File :09/24/040/00134/AM12/ Lic.No/Date:0910047151 15.06.2011 Defer Date:13.09.2011 111
Case No.:20/19/82ALC4/2011
Party Name:AVON ORGANICS LTD., 09.08.2011 Status:Case Deferred HQ File :01/82/050/00534/AM12/ RLA File :09/24/040/00136/AM12/ Lic.No/Date:0910047133 Defer
15.06.2011 Date:13.09.2011 112
Case No.:22/19/82ALC4/2011
Party Name:RAMPEX LABS PVT. LTD. 09.08.2011 Status:Case Deferred HQ File :01/82/050/00536/AM12/ RLA File :09/24/040/00121/AM12/ Lic.No/Date:0910047114 15.06.2011 Defer Date:13.09.2011 Decision :Committee decided to forward a copy of application to Department of C&PC for their comments. Accordingly, case was deferred for 13.09.2011. 113
Case No.:23/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00537/AM12/ RLA File :09/24/040/00105/AM12/ Lic.No/Date:0910047123 15.06.2011 Defer Date:13.09.2011 114
Case No.:24/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00538/AM12/ RLA File :09/24/040/00125/AM12/ Lic.No/Date:0910047121 15.06.2011 Defer Date:13.09.2011 115
Case No.:33/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00547/AM12/ RLA File :09/24/040/00130/AM12/ Lic.No/Date:0910047113 15.06.2011 Defer Date:30.08.2011 Decision : Committee decided to defer case for 30.08.2011 for comments of Department of C&PC. 116
Case No.:4/15/82ALC4/2011
Party Name:STERLING AUXILIARIES PVT LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00444/AM12/ RLA File :03/95/040/00176/AM12/ Lic.No/Date:0310636625 16.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/69/2009 Ch.II dated 09.08.2011 and in consultation with technical authoritiy 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 STERO MDEA EX (Mono Methyl Amine Ethoxylate) 1 Kg. 1. Mono Methyl Amine 0.265 kg 2. Ethylene Oxide 0.754 kg STERO NC 4070 (Nonyl 1 Kg. 1. Nonyl Phenol 0.0945 kg
Phenol Polyglycol Ether/Nonyl Phenol 32 Mole Ethoxylated) 2. Ethylene Oxide 0.605 kg 117
Case No.:13/19/82ALC4/2011
Party Name:NIFTY LABS PVT LTD., 09.08.2011 Status:Case Deferred HQ File :01/82/050/00527/AM12/ RLA File :09/24/040/00148/AM12/ Lic.No/Date:0910047160 16.06.2011 Defer Date:13.09.2011 Decision :Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceuticals. 118
Case No.:32/19/82ALC4/2011
Party Name:MAITHRI LABORATORIES (P) LTD., 09.08.2011 Status:Case Deferred HQ File :01/82/050/00546/AM12/ RLA File :09/24/040/00139/AM12/ Lic.No/Date:0910047161 16.06.2011 Defer Date:13.09.2011 119
Case No.:5/19/82ALC4/2011
Party Name:CIPLA LIMITED 09.08.2011 Status:Case Deferred HQ File :01/82/050/00519/AM12/ RLA File :03/94/040/00258/AM12/ Lic.No/Date:0310636879 17.06.2011 Defer Date:13.09.2011 120
Case No.:17/19/82ALC4/2011
09.08.2011 Status:Case Deferred HQ File :01/82/050/00531/AM12/ RLA File :09/24/040/00137/AM12/ Lic.No/Date:0910047175 20.06.2011 Defer Date:30.08.2011 Decision : Committee decided to defer case for 30.08.2011 for comments of Department of C&PC. 121
Case No.:36/19/82ALC4/2011
Party Name:CENTURY PHARMACEUTICALS LTD. 09.08.2011 Status:Case Deferred HQ File :01/82/050/00550/AM12/ RLA File :34/24/040/00020/AM12/ Lic.No/Date:3410030669 22.06.2011 Defer Date:13.09.2011 122 Case No.:38/19/82ALC4/2011 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 09.08.2011 Status:Case Approved HQ File :01/82/050/00552/AM12/ RLA File :52/24/040/00012/AM12/ Lic.No/Date:5210035669 23.06.2011
23.06.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/45/2010 Ch.II dated 27.09.2010 and in consultation with technical authorities 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 Sulpho Gamma Acid (7Amino1 Naphthol3,6Disulfonic Acid 1 Kg. 1. K Acid 2.500 kg 123
Case No.:37/19/82ALC4/2011
Party Name:ALEMBIC PHARMACEUTICALS LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00551/AM12/ RLA File :34/24/040/00040/AM12/ Lic.No/Date:3410030714 27.06.2011 Decision : Committee considered case as per agenda and in light of written comments of Department of Pharmaceuticals dated 07.06.2011 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 Azithromycin Tablet 250 mg 1 No.. 1. Azithromycin Dihydrate 259.50 mg 2. Pregelatinized Starch (Starch 1500) 26.21 mg 3. Calcium Phosphate Dibasic Anhydrous 134.80 mg 4. Croscarmellose Sodium (AC Di Sol) 8.74 mg 5. Magnesium Stearate 3.628 mg 6. Sodium Lauryl Sulphate 0.900 mg Azithromycin Tablet 500 mg 1 No. 1. Azithromycin Dihydrate 519.02 mg 2. Pregelatinized Starch (Starch 1500) 52.42 mg 3. Calcium Phosphate Dibasic Anhydrous 269.58 mg 4. Croscarmellose Sodium (AC Di Sol) 17.48 mg 5. Magnesium Stearate 7.348 mg 6. Sodium Lauryl Sulphate 1.80 mg Azithromycin Tablet 600 mg 1 No. 1. Azithromycin Dihydrate 622.82 mg 2. Pregelatinized Starch (Starch 1500) 62.91 mg 3. Calcium Phosphate Dibasic Anhydrous 323.50 mg 4. Croscarmellose Sodium (AC Di Sol) 20.97 mg 5. Magnesium Stearate 8.80 mg 6. Sodium Lauryl Sulphate 2.16 mg 124 Case No.:35/19/82ALC4/2011 Party Name:NECTAR LIFESCIENCES LIMITED, 09.08.2011 Status:Case Deferred HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer
28.06.2011 Date:13.09.2011 Decision :Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceuticals. 125
Case No.:29/19/82ALC4/2011
Party Name:CHIRAG ENTERPRISE 09.08.2011 Status:Case Deferred HQ File :01/82/050/00543/AM12/ RLA File :24/24/040/00001/AM12/ Lic.No/Date:2410032571 29.06.2011 Defer Date:06.09.2011 Decision :Committee decided to defer case for 06.09.2011 for comments of Department of C&PC. 126
Case No.:28/19/82ALC4/2011
Party Name:R L FINE CHEM 09.08.2011 Status:Case Deferred HQ File :01/82/050/00542/AM12/ RLA File :07/24/040/00109/AM12/ Lic.No/Date:0710080465 07.07.2011 Defer Date:13.09.2011 Decision :Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceuticals. 127
Case No.:2/19/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/00516/AM12/ RLA File :03/94/040/00014/AM12/ Lic.No/Date:0310643597 21.07.2011 Defer Date:13.09.2011 128
Case No.:1/19/82ALC4/2011
Party Name:POLYDRUG LABORATORIES PVT.LTD. 09.08.2011 Status:Case Approved HQ File :01/82/050/00515/AM12/ RLA File :03/95/040/00299/AM12/ Lic.No/Date:0310643921 22.07.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 14/82 meeting held on 05.07.2011 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 Ferrous Fumarate 1 Kg. 1. Fumaric Acid 0.769 kg 129
Case No.:8/19/82ALC4/2011
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 09.08.2011 Status:Case Deferred HQ File :01/82/050/00522/AM12/ RLA File :03/94/040/00334/AM12/ Lic.No/Date:0310643958 22.07.2011 Defer Date:06.09.2011 Decision :Committee decided to defer case for 06.09.2011 for comments of Department of C&PC.
130 Case No.:39/19/82ALC4/2011 Party Name:MASS DYECHEM PVT LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00553/AM12/ RLA File :31/83/040/00011/AM12/ Lic.No/Date:3110049405 25.07.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O.14010/55/2004/Ch.III dated 04.10.2005 and in consultation with technical authority present in meeting, decided to revise norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed 3,4,5,6Tetrahydro Phthalimide 1 kg 1. 1,2,3,6Tetrahydro Phthalic Anhydride 1.80 kg RA concerned may take further necessary action as per above decision of NC.: 131
Case No.:40/19/82ALC4/2011
Party Name:ARCH PHARMALABS LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00554/AM12/ RLA File :03/94/040/00356/AM12/ Lic.No/Date:0310644383 26.07.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/395/2009PI (Norms) dated 04.06.2010 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 Irinotecan Hcl 1 kg 1. 7Ethyl10Hydroxycamptothecin 1.035 kg 2. 1,4Bipiperidinyl1Carbonyl Chloride 0.608 kg 132 Case No.:41/19/82ALC4/2011 Party Name:ARCH PHARMALABS LTD 09.08.2011 Status:Case Approved HQ File :01/82/050/00555/AM12/ RLA File :03/94/040/00342/AM12/ Lic.No/Date:0310644401 26.07.2011 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/395/2009PI(Norms) dated 04.06.2010 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 Paclitaxel 1 gm 1. 10Deacety Baccatin III(2S,3S)3 PhenylisoseringNBox Ester 150gm 2. Pyridine 0.87 gm 3. Trithyl Silyl Chloride 1.67 gm 4. (3R,4S)3Triethylsilanyloxy4PhenylN Benzoyl2Azetidinone 1.12 gm
133
Case No.:42/19/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/00556/AM12/ RLA File :31/83/040/00080/AM12/ Lic.No/Date:3110049430 26.07.2011 Defer Date:06.09.2011 Decision :Committee decided to defer case for 06.09.2011 for comments of Department of C&PC. 134
Case No.:43/19/82ALC4/2011
Party Name:PANACEA BIOTEC LTD., 09.08.2011 Status:Case Approved HQ File :01/82/050/00557/AM12/ RLA File :05/24/040/00148/AM12/ Lic.No/Date:0510297755 27.07.2011 Decision : Committee considered case as per agenda and in light of earlier decision taken in 17/12 meeting held on 26.07.2011 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 DTwPHepBHib Pentavalent Vaccine (Easyfive) 1 Unit (One unit dose Vial) 1. Diphtheria Bulk 29 Lf (includes label claim, overfill & overages 2. Tetanus Bulk 11 Lf (includes label claim, overfill & overages 3. Pertussis Bulk 17.5 OU (includes label claim, overfill & overages 135
Case No.:44/19/82ALC4/2011
Party Name:RANBAXY LABORATORIES LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/00558/AM12/ RLA File :05/24/040/00145/AM12/ Lic.No/Date:0510297774 27.07.2011 Defer Date:13.09.2011 Decision :Committee decided to defer case for 13.09.2011 for comments of Department of Pharmaceuticals. 136
Case No.:45/19/82ALC4/2011
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 09.08.2011 Status:Case Deferred HQ File :01/82/050/00559/AM12/ RLA File :31/83/040/00081/AM12/ Lic.No/Date:3110049481 27.07.2011 Defer Date:06.09.2011 Decision :Committee decided to defer case for 06.09.2011 for comments of Department of C&PC. 137 Case No.:46/19/82ALC4/2011 Party Name:BALAJI AMINES LIMITED 09.08.2011 Status:Case Deferred
HQ File :01/82/050/00560/AM12/ RLA File :31/83/040/00085/AM12/ Lic.No/Date:3110049482 27.07.2011 Defer Date:06.09.2011 Decision : Committee decided to defer case for 06.09.2011 for comments of Department of C&PC. 138
Case No.:47/19/82ALC4/2011
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 09.08.2011 Status:Case Deferred HQ File :01/82/050/00561/AM12/ RLA File :04/24/040/00104/AM12/ Lic.No/Date:0410126561 28.07.2011 Defer Date:13.09.2011
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