IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2010-03-23

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 52/82‐ALC4/2009 MEETING DATE : 23.03.2010 The Meeting No.52/82 in the year 2009‐10 to consider the cases under Duty Exemption Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to products falling in Chapter 29 and 30 was held on 23.03.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Shaish Kumar, IA, DIPP 2. Shri D.N. Mathur, Dy. IA, Department of Pharmaceuticals 3. Shri M. Mitra, Dy. Drugs Controller (I), DCGI 4. Shri Shyam Lal, FTDO At the outset, minutes of Norms Committee Meeting No. 49/82 dated 02.03.2010 and 50/82 meeting dated 09.03.2010 were ratified by the Committee.

Case No.B‐512

M/S Yasho Industries Pvt. Ltd. Norms Committee Meeting No.52/82 F.No.01/83/050/00646/AM08 F.No.01/83/050/01077/AM07 Meeting Date:23.03.2010 RA F.No.03/95/040/00281/AM08 RA F.No.03/95/040/01183/AM07 Adv.Lic.No.0310433842 dated 25.06.2007 Adv.Lic.No.0310413968 dated 29.12.2006 Committee decided to defer case for 20.04.2010 for comments of Department of C&PC.

Case No.B‐513

M/S J.S. Chemicals Norms Committee Meeting No.52/82 F.No.01/82/050/01179/AM09 Meeting Date:23.03.2010 RA F.No.52/24/040/00019/AM09 Adv.Lic.No.5210024577 dated 21.10.2008 Committee decided to defer case for 20.04.2010 for comments of Department of C&PC.

Case No.B‐514

M/S Wockhardt Ltd Norms Committee Meeting No.52/10 F.No. 01/83/050/01037/AM03 F.No.01/83/050/01396/AM03 F.No.01/83/050/01441/AM03 F.No.01/82/162/00043/AM10 Meeting Date:23.03.2010 RA F.No.03/24/040/01637/AM03

RA F.No.03/24/040/01942/AM03 RA F.No.03/24/040/01916/AM03 RA F.No.03/24/040/00076/AM04 Adv.Lic.No.0310175096 dated 30.12.2002 Adv.Lic.No.0310184492 dated 18.02.2003 Adv.Lic.No.0310185265 dated 25.02.2003 Adv.Lic.No.0310199778 dated 05.05.2003 Committee considered case as per agenda. Committee was informed that Dep. Of Bio‐tech had recommended the proposal of the firm in principal subject to the condition that the enzymes to be imported are free of any Genetically modified organism/nucle acid etc. to be certified by the suppliers from the country of origin interalia indicating that the input materials namely Denimax/indiage are genetically engineered enzymes and as such their import provisions pertaining to Bio safety and under the rules the import of such engineered enzymes as permitted only a䬀er the approval of Genetic Engineering approval Committee (GEAC) under the Ministry of Environment and Forest and accordingly firm may be asked to take the necessary clearance from the GEAC for importing the Engineered Enzymes into the country. Committee while considering the cases in its meeting held on 19.02.2004 decided that the firm may be advised to obtain NOC/clearnnce from Ministry of Environment and Forests. The firm has not been able to send the above referred clearance/NOC from Ministry of E&F 奱�ll date. The above referred licences date back to 2002 and 2003 and are not valid at present for import/export. The firm has stated that the company is status holder Trading House and submitted copy of Trading House Certificate. They have stated to have fulfilled the export obligation in 2003 and redemption of these licences is pending in the office of Zonal Jt. DGFT, Mumbai because of non fixation of norms. The informed that they visited Ministry of Environment and Forests various 奱�mes, but they have not received the co‐operation of said Ministry. They have further informed that their annual export turn over is Rs.500 Crores. Committee a䬀er detailed deliberations and taking submission of the firm to the effect that export and import have been completed long back, Committee felt that at this stage, NOC from Ministry of Environment and Forests need not be insisted. It was, therefore, decided to clear these cases on the line of M/S Biostadt India Ltd as per details below or as applied by the firm which is lower. Export product Export Qty. Sl.No. Import items Qty. allowed Environ AC 1 kg. 1. Biofixation NIP GG Powder 0.177 kg. 2. Lithothmme Granular Mixture 0.973 kg. RA concerned may take further necessary action as per above decision of NC.

Case No.B‐514A

M/S Halcyon Labs Pvt. Ltd. Norms Committee Meeting No.52/10 F.No.01/82/162/00702/AM10 Meeting Date: 23.03.2010 RA F.No.03/85/039/00001/AM07 RA F.No.03/85/039/00002/AM07

RA F.No.03/85/039/00002/AM08 RA F.No.03/84/039/00001/AM02 Adv.Lic. No.0310377498 dated 25.04.2006 Adv.Lic. No.0310381457 dated 23.05.2006 Adv.Lic. No.0310448539 dated 31.10.2007 Adv.Lic. No.0310097156 dated 10.08.2001 Committee considered case as per agenda and observed that PRC in its 07/10 meeting held on 06.01.2010 has condone the lapse of the firm by making exports against Annual Advance Licences on the basis of adhoc norms fixed by ALC against advance licence issued under para 4.7 of HBP. Committee a䬀er detailed deliberations, Committee in light of decision taken in 5/82 meeting held on 29.04.2008 and 14/08 meeting held on 07.08.2007 and in consultation with technical authority present in meeting, decided to fixe the norms as per details below: Adv.Lic. No.0310377498 dated 25.04.2006 Adv.Lic. No.0310381457 dated 23.05.2006 Adv.Lic. No.0310097156 dated 10.08.2001 Export product Export Qty. Sl.No. Import items Qty. allowed Clobetasol Propionate BP 1 kg. 1. Betamethasone Base BP 1.19 kg Adv.Lic. No.0310448539 dated 31.10.2007 Export product Export Qty. Sl.No. Import items Qty. allowed Clobetasol Propionate BP 1 kg. 1. Betamethasone Base BP 1.19 kg Dexamethasone Sodium Phosphate 1 kg. 1. Dexamethasone 0.80 kg

Case No.A‐227

M/S Gitanjali Chemicals Pvt. Ltd. Norms Committee Meeting No.52/82 F.No.01/82/162/01033/AM10 Meeting Date:23.03.2010 RA F.No.03/94/040/01276/AM09 Adv.Lic.No.0310465769 dated 19.03.2008 Committee decided to defer case for 20.04.2010 for comments of Department of C&PC. 1

Case No.:567/24/83‐ALC1/2007

Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:52/82‐ALC4/2009 23.03.2010 Status:Case Deferred Lic.No/Date:3410018711

HQ File :01/83/050/00243/AM08/ RLA File :34/24/040/00166/AM07/ 03.05.2007 Defer Date:18.05.2010 Decision :Committee decided to defer case for 18.05.2010 for comments of Department of Pharmaceuticals. 2

Case No.:811/24/83‐ALC1/2007

Party Name:SUPREET CHEMICALS PVT.LTD. 23.03.2010 Status:Case Approved HQ File :01/83/050/00790/AM08/ RLA File :03/95/040/00272/AM08/ Lic.No/Date:0310435349 09.07.2007 Decision : Committee considered case as per agenda and in light of earlier decision taken in 26/83 meeting held on 04.10.2006 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‐Diamino Benzoic Acid 1 Kg. 1. Benzoic Acid 2.000 kg 2. Caustic Soda Flakes 0.790 kg 3

Case No.:17/46/82‐ALC4/2007

Party Name:ARCH PHARMALABS LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/00571/AM08/ RLA File :03/94/040/01117/AM08/ Lic.No/Date:0310461019 14.02.2008 Defer Date:18.05.2010 Decision : Committee decided to defer case for 18.05.2010 for comments of Department of Pharmaceuticals. 4

Case No.:62/9/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 23.03.2010 Status:Case Deferred HQ File :01/83/050/00234/AM09/ RLA File :03/94/040/01245/AM08/ Lic.No/Date:0310466401 27.03.2008 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for comments of Department of Pharmaceuticals. 5

Case No.:39/9/82‐ALC4/2008

Party Name:CIPLA LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/00272/AM09/ RLA File :03/94/040/01345/AM08/ Lic.No/Date:0310466954 01.04.2008 Decision : Committee considered case as per agenda and observed that Ministry of Environment and Forests (Ozone Cell) have given their No Objection Certificate for import of Zephex 134a (1,1,1,2 Tetrafluoroethane) (HFA 134A Propolen) vide their O.M. No.11/10/2008‐OC dated 04.03.2010. It was, therefore, in light of written comments forwarded by DOP vide their U.O. No.35011/101/2008‐PI‐III dated 03.12.2008 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 Aerobud 100mcg Inhaler (200MD) with 50mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 50mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. 0.5 mm OD Acuators with dust covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. Zephex 134 A (1,1,1,2 Tetrafluoro ethane)(HFA 134 A Propellant) 14.4 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 100mcg Inhaler (200MD) with 58mcl Aerosol Valve (Budenoside inhaler 100mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. Aerosol Valves 58mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler 1 No. 1. Budenoside 0.04 gm.

(200MD) with 63mcl Aerosol Valve (Budenoside inhaler 200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 2. Aerosol Valves 63 mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 15.5 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler (300MD) with 40mcl Aerosol Valve (Budenoside inhaler 100mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.03 gm. 2. Aerosol Valves 40mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.0 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.06 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.0 gm. Salbutamol 100mcg Inhaler Valve (Asthavent 100 mcg inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. 1 No. 1. Salbutamol 0.02 gm. 2. As per packing

inhaler (200MD)) with 58 mcl Aerosol Valve) policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler inhaler (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.03 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.00 gm. Beclate 50mcg Inhaler Valve (Beclomethasone Dipropionate‐50 mcg inhaler (200MD)) with 63 mcl Aerosol Valve) 1 No. 1. Beclomethasone Dipropionate 0.01 gm. 2. Aerosol Valves 63mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler Valve (Beclomethasone Dipropionate‐100 mcg inhaler Valve) 1 No. 1. 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler 1 No. 1. 0.04 gm. 2. As per packing

Valve (Beclomethasone Dipropionate‐200 mcg inhaler Valve) policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler Valve (Beclomethasone Dipropionate‐250 mcg inhaler Valve) 1 No. 1. 0.05 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The above norms have been ratified by NC subject to the following conditions:‐ 1. The quantity of HFA 134‐A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. 2. The firm will maintain a separate record for the actual consumption of HFA 134‐A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. 6

Case No.:79/9/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 23.03.2010 Status:Case Deferred HQ File :01/83/050/00251/AM09/ RLA File :03/94/040/01323/AM08/ Lic.No/Date:0310466988 01.04.2008 Defer Date:20.04.2010 7

Case No.:43/14/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 23.03.2010 Status:Case Deferred HQ File :01/83/050/00413/AM09/ RLA File :03/94/040/00065/AM09/ Lic.No/Date:0310471590 19.05.2008 Defer Date:20.04.2010

Case No.:47/14/83‐ALC1/2008

Party Name:EXON LABORATORIES PVT LTD 23.03.2010 Status:Case Deferred HQ File :01/83/050/00417/AM09/ RLA File :03/94/040/00064/AM09/ Lic.No/Date:0310471586 19.05.2008 Defer Date:20.04.2010 9

Case No.:12/17/82‐ALC4/2008

Party Name:ANUS LABORATORIES LTD., 23.03.2010 Status:Case Approved HQ File :01/82/050/00736/AM09/ RLA File :09/24/040/00552/AM08/ Lic.No/Date:0910034576 11.07.2008 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in 13/08 meeting held on 31.07.2007 and in consultation with technical authority present in meeting, decided to ratify the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Quantity allowed Acrylate (Methyl‐3‐Cyclopropyl Amino 2‐(2,4‐Dichloro‐5‐fluro benzyl acrylate) 1 kg 1. 2,4 Dichloro‐5‐fluoro acetophenone 0.765 kg 2. Di‐methyl carbonate 0.726 kg 3. Sodium hydride 0.258 kg 4. Toluene 1.10 kg 5. Dimethyl formamide 0.396 kg 6. Acetic Acid 0.264 kg 7. Cyclopropylamine 0.180 kg RLA concerned may take further necessary action as per above decision of NC. 10

Case No.:60/29/82‐ALC4/2008

23.03.2010 Status:Case Approved HQ File :01/82/050/01142/AM09/ RLA File :03/94/040/00672/AM09/ Lic.No/Date:0310489879 10.10.2008 Decision : Committee considered case as per agenda and observed that Ministry of Environment and Forests (Ozone Cell) have given their No Objection Certificate for import of Zephex 134a (1,1,1,2 Tetrafluoroethane) (HFA 134A Propolen) vide their O.M. No.11/10/2008‐OC dated 04.03.2010. It was, therefore, in light of written comments forwarded by DOP vide their U.O. No.35011/101/2008‐PI‐III dated 03.12.2008 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 Aerobud 100mcg Inhaler 1 No. 1. Budenoside 0.02 gm.

Valve (Budenoside inhaler 100mcg (200MD)) with 50 mcl Aerosol Valve) 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 100mcg Inhaler Valve (Budenoside inhaler 100mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 63 mcl As per packing policy

200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 15.5 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler Valve (Budenoside inhaler 100mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.03 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.0 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.06 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.0 gm. inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. 1 No. 1. Salbutamol 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing

inhaler (200MD)) with 58 mcl Aerosol Valve) policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler inhaler (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.03 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.00 gm. Beclate 50mcg Inhaler Valve (Beclomethasone Dipropionate‐50 mcg inhaler Valve) 1 No. 1. 0.01 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler Valve (Beclomethasone Dipropionate‐100 mcg inhaler Valve) 1 No. 1. 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler Valve (Beclomethasone Dipropionate‐200 mcg inhaler 1 No. 1. 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing

Valve) policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler Valve (Beclomethasone Dipropionate‐250 mcg inhaler Valve) 1 No. 1. 0.05 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The above norms have been ratified by NC subject to the following conditions:‐ 3. The quantity of HFA 134‐A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. 4. The firm will maintain a separate record for the actual consumption of HFA 134‐A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. 11

Case No.:12/37/82‐ALC4/2008

Party Name:MEGHMANI ORGANICS LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01331/AM09/ RLA File :08/24/040/00172/AM09/ Lic.No/Date:0810076282 27.11.2008 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for comments of Department of C&PC. 12

Case No.:14/37/82‐ALC4/2008

Party Name:MEDREICH LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01333/AM09/ RLA File :07/24/040/00470/AM09/ Lic.No/Date:0710061378 27.11.2008 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/94/2009‐PI‐III 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 Clindamycin Capsules 300 mg 1 No. 1. Clindamycin Hcl BP 347.06 mg 13

Case No.:12/49/82‐ALC4/2008

Party Name:SHREE GANESH REMEDIES PVT.LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01654/AM09/ RLA File :34/24/040/00207/AM09/ Lic.No/Date:3410023501 13.02.2009 Decision : Committee considered case as per agenda and observed that Export Cell vide their U.O. 01/91/110/40/AM10/Export Cell dated 03.07.2009 has confirmed that the export product “Di Methyl Amino Propyl Chloride Hydrochloride” does not fall under the Scomet list. They had also furnished the copy of letter dated 23.06.2009 received from Cabinet Secretariate wherein it has been mentioned that the above said export product does not fall under the Scomet. In view of above and and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/135/2009‐PI‐III dated 21.10.2009 and in consultation with technical authority present in meeting, it was 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. 1‐Bromo‐3‐Chloro Propane 0.684 kg 14

Case No.:1/14/82‐ALC4/2009

Party Name:MAKSON INDUSTRIES PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00171/AM10/ RLA File :03/95/040/01025/AM09/ Lic.No/Date:0310515322 13.04.2009 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for comments of DC(MSME). 15

Case No.:34/14/82‐ALC4/2009

Party Name:R L FINE CHEM 23.03.2010 Status:Case Deferred HQ File :01/82/050/00204/AM10/ RLA File :07/24/040/00007/AM10/ Lic.No/Date:0710064267 20.04.2009 Defer Date:18.05.2010 Decision : Committee decided to defer case for 18.05.2010 for comments of Department of Pharmaceuticals. 16

Case No.:9/14/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD Status:Case

23.03.2010 Deferred HQ File :01/82/050/00179/AM10/ RLA File :09/24/040/00466/AM09/ Lic.No/Date:0910037701 20.04.2009 Defer Date:20.04.2010 Decision :Committee decided to defer case for 20.04.2010 for comments of Department of Pharmaceuticals. 17

Case No.:29/13/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/00169/AM10/ RLA File :03/94/040/00207/AM10/ Lic.No/Date:0310523667 11.06.2009 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for comments of Ministry of FPI. 18

Case No.:7/28/82‐ALC4/2009

Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00567/AM10/ RLA File :03/94/040/01121/AM09/ Lic.No/Date:0310524602 17.06.2009 Defer Date:18.05.2010 Decision :Committee decided to call for Production and Consumption data certified by Central Excise Authority from firm. Accordingly, case was deferred for 18.05.2010. 19

Case No.:3/17/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/00266/AM10/ RLA File :03/94/040/00279/AM10/ Lic.No/Date:0310527467 06.07.2009 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for comments of Ministry of FPI. 20

Case No.:20/21/83‐ALC1/2009

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 23.03.2010 Status:Case Deferred HQ File :01/83/050/00391/AM10/ RLA File :03/95/040/00126/AM10/ Lic.No/Date:0310528685 13.07.2009 Defer Date:20.04.2010 Decision :Committee decided to defer case for 20.04.2010 for comments of Department of Bio‐technology. 21

Case No.:34/17/83‐ALC1/2009

Party Name:AJANTA PHARMA LTD., 23.03.2010 Status:Case Deferred HQ File :01/83/050/00316/AM10/ RLA File :03/94/040/00220/AM10/ Lic.No/Date:0310529278 16.07.2009 Defer Date:04.05.2010 Decision :Committee considered case as per agenda and observed that the import and export items are same and there is no manufacturing activity involved in manufacturing the export product. It was, therefore, decided to call for the following information/documents from firm‐

1. Copy of Formulation issued under Cosmatics Act. 2. Correct ITC(HS) Code of the export product. Accordingly, case was deferred for 04.05.2010. 22

Case No.:54/48/82‐ALC4/2009

Party Name:STERLING AUXILIARIES PVT LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01117/AM10/ RLA File :03/95/040/00254/AM10/ Lic.No/Date:0310530172 22.07.2009 Defer Date:20.04.2010 Decision :Committee decided to defer case for 20.04.2010 for comments of Department of C&PC. 23

Case No.:4/24/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/00501/AM10/ RLA File :03/94/040/00454/AM10/ Lic.No/Date:0310535251 26.08.2009 Defer Date:20.04.2010 24

Case No.:6/24/82‐ALC4/2009

Party Name:KLJ PLASTICIZERS LTD, 23.03.2010 Status:Case Deferred HQ File :01/82/050/00503/AM10/ RLA File :05/24/040/00242/AM10/ Lic.No/Date:0510248395 26.08.2009 Defer Date:20.04.2010 25

Case No.:9/24/82‐ALC4/2009

Party Name:LIFE LINE INDUSTRIES LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00506/AM10/ RLA File :03/95/040/00328/AM10/ Lic.No/Date:0310535518 27.08.2009 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for reply from firm. 26

Case No.:14/24/82‐ALC4/2009

Party Name:ASTRIX LABORATORIES LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/00511/AM10/ RLA File :09/24/040/00168/AM10/ Lic.No/Date:0910039133 28.08.2009 Defer Date:20.04.2010

Case No.:33/46/82‐ALC4/2009

Party Name:KORES (INDIA) LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00949/AM10/ RLA File :03/94/040/00418/AM10/ Lic.No/Date:0310537562 14.09.2009 Defer Date:04.05.2010 Decision :Committee decided to defer case for 04.05.2010 for reply from firm. 28

Case No.:1/27/83‐ALC1/2009

Party Name:VIVIMED LABS LIMITED 23.03.2010 Status:Transferred to Different Section HQ File :01/83/050/00493/AM10/ RLA File :09/24/040/00217/AM10/ Lic.No/Date:0910039305 16.09.2009 Decision :Committee decided to transfer the case to NC‐IV as the export product falls under Chapter 28 of ITC(HS) Code. 29

Case No.:69/48/82‐ALC4/2009

Party Name:CHEMIESYNTH (VAPI)LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01132/AM10/ RLA File :03/94/040/00450/AM10/ Lic.No/Date:0310539253 24.09.2009 Defer Date:20.04.2010 30

Case No.:51/48/82‐ALC4/2009

Party Name:RATNAGIRI CHEMICALS PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01114/AM10/ RLA File :03/95/040/00416/AM10/ Lic.No/Date:0310539888 30.09.2009 Defer Date:20.04.2010 31

Case No.:25/29/82‐ALC4/2009

Party Name:KAMUD DRUGS PVT.LIMITED., 23.03.2010 Status:Case Approved HQ File :01/82/050/00595/AM10/ RLA File :31/21/040/00198/AM10/ Lic.No/Date:3110040141 05.10.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/4/2009‐ PI‐III dated 01.06.2009 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 Exp. Qty. Sl.No. Import items Qty. allowed Zopiclone 1 Kg. 1. 2,3 Pyrazine Dicarboxycil Acid 1.73 kg 2. Acetic Anhydride 7.10 kg 3. 1‐Chloro Carbonyl‐4‐Methyl Piperazine Hcl 1.33 kg 4. 2‐Amino 5 Chloro Pyridine 1.33 kg

Case No.:3/29/87‐ALC1/2009

Party Name:PARABOLIC DRUGS LTD., 23.03.2010 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:20.04.2010 33

Case No.:8/30/82‐ALC4/2009

23.03.2010 Status:Case Approved HQ File :01/82/050/00609/AM10/ RLA File :03/94/040/00577/AM10/ Lic.No/Date:0310541231 09.10.2009 Decision : Committee considered case as per agenda and observed that Ministry of Environment and Forests (Ozone Cell) have given their No Objection Certificate for import of Zephex 134a (1,1,1,2 Tetrafluoroethane) (HFA 134A Propolen) vide their O.M. No.11/10/2008‐OC dated 04.03.2010. It was, therefore, in light of written comments forwarded by DOP vide their U.O. No.35011/101/2008‐PI‐III dated 03.12.2008 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 Aerobud 100mcg Inhaler Valve (Budenoside inhaler 100mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 100mcg Inhaler 1 No. 1. Budenoside 0.02 gm.

Valve (Budenoside inhaler 100mcg (200MD)) with 58 mcl Aerosol Valve) 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 63 mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 15.5 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler Valve (Budenoside inhaler 100mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.03 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.0 gm. Aerobud 200mcg Inhaler 1 No. 1. Budenoside 0.06 gm. 2. As per packing

Valve (Budenoside inhaler 200mcg (300MD)) with 40 mcl Aerosol Valve) policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.0 gm. inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. inhaler (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler inhaler (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.03 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.00 gm. Beclate 50mcg Inhaler Valve (Beclomethasone Dipropionate‐50 mcg inhaler 1 No. 1. 0.01 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing

Valve) policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler Valve (Beclomethasone Dipropionate‐100 mcg inhaler Valve) 1 No. 1. 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler Valve (Beclomethasone Dipropionate‐200 mcg inhaler Valve) 1 No. 1. 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler Valve (Beclomethasone Dipropionate‐250 mcg inhaler Valve) 1 No. 1. 0.05 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The above norms have been ratified by NC subject to the following conditions:‐

5. The quantity of HFA 134‐A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. 6. The firm will maintain a separate record for the actual consumption of HFA 134‐A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. 34

Case No.:47/39/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 23.03.2010 Status:Case Deferred HQ File :01/83/050/00754/AM10/ RLA File :52/24/040/00016/AM10/ Lic.No/Date:5210028576 13.10.2009 Defer Date:04.05.2010 Decision : Committee decided to defer case for 04.05.2010 for comments of Department of Bio‐technology. 35

Case No.:49/34/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 23.03.2010 Status:Case Deferred HQ File :01/83/050/00634/AM10/ RLA File :52/24/040/00014/AM10/ Lic.No/Date:5210028574 13.10.2009 Defer Date:04.05.2010 Decision : Committee decided to defer case for 04.05.2010 for comments of Department of Bio‐technology. 36

Case No.:50/34/83‐ALC1/2009

Party Name:SPAN DIAGNOSTICS LTD 23.03.2010 Status:Case Deferred HQ File :01/83/050/00635/AM10/ RLA File :52/24/040/00015/AM10/ Lic.No/Date:5210028575 13.10.2009 Defer Date:04.05.2010 Decision : Committee decided to defer case for 04.05.2010 for comments of Department of Bio‐technology. 37

Case No.:52/48/82‐ALC4/2009

Party Name:DORF‐KETAL CHEMICALS INDIA PVT.LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01115/AM10/ RLA File :03/94/040/00538/AM10/ Lic.No/Date:0310541878 23.10.2009 Defer Date:20.04.2010 38

Case No.:9/32/82‐ALC4/2009

23.03.2010 Status:Case Approved HQ File :01/82/050/00623/AM10/ RLA File :03/94/040/00580/AM10/ Lic.No/Date:0310541570 23.10.2009

Decision : Committee considered case as per agenda and observed that Ministry of Environment and Forests (Ozone Cell) have given their No Objection Certificate for import of Zephex 134a (1,1,1,2 Tetrafluoroethane) (HFA 134A Propolen) vide their O.M. No.11/10/2008‐OC dated 04.03.2010. It was, therefore, in light of written comments forwarded by DOP vide their U.O. No.35011/101/2008‐PI‐III dated 03.12.2008 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 Aerobud 100mcg Inhaler Valve (Budenoside inhaler 100mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 14.4 gm. Aerobud 100mcg Inhaler Valve (Budenoside inhaler 100mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Budenoside 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. As per packing

covers/caps fi܂ng to 19ml Aluminium Can policy 5. 18.2 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (200MD)) with 63 mcl Aerosol Valve (Contains Zephex 134 A & Ethanol) 1 No. 1. Budenoside 0.04 gm. 2. Aerosol Valves 63 mcl As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 15.5 gm. 6. Ethanol 2.73 gm. Aerobud 100mcg Inhaler Valve (Budenoside inhaler 100mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.03 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.0 gm. Aerobud 200mcg Inhaler Valve (Budenoside inhaler 200mcg (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Budenoside 0.06 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.0 gm. inhaler (200MD)) with 50 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml As per packing policy

Aluminium Can 5. 14.4 gm. inhaler (200MD)) with 58 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 18.2 gm. Salbutamol 300mcg Inhaler inhaler (300MD)) with 40 mcl Aerosol Valve) 1 No. 1. Salbutamol 0.03 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.00 gm. Beclate 50mcg Inhaler Valve (Beclomethasone Dipropionate‐50 mcg inhaler Valve) 1 No. 1. 0.01 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 17.74 gm. 6. Ethanol 0.455 gm. Beclate 100mcg Inhaler Valve (Beclomethasone Dipropionate‐100 mcg inhaler Valve) 1 No. 1. 0.02 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy

17.30 gm. 6. Ethanol 0.91 gm. Beclate 200mcg Inhaler Valve (Beclomethasone Dipropionate‐200 mcg inhaler Valve) 1 No. 1. 0.04 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 16.4 gm. 6. Ethanol 1.82 gm. Beclate 250mcg Inhaler Valve (Beclomethasone Dipropionate‐250 mcg inhaler Valve) 1 No. 1. 0.05 gm. 2. As per packing policy 3. 19ml Aluminium Cans As per packing policy 4. covers/caps fi܂ng to 19ml Aluminium Can As per packing policy 5. 15.9 gm. 6. Ethanol 2.27 gm. The above norms have been ratified by NC subject to the following conditions:‐ 7. The quantity of HFA 134‐A Propellant Gas in the above norms is inclusive of 20% overages to compensate leakage, priming and non retrieval dose remaining inside the Can and and allowance for shot weight variation. However no wastage is claimed for APIs by the firm. 8. The firm will maintain a separate record for the actual consumption of HFA 134‐A Propellant Gas and will pay duty on the surplus quantity of gas remained unutilized, if any. 39

Case No.:35/48/82‐ALC4/2009

Party Name:GALAXY SURFACTANTS LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01098/AM10/ RLA File :03/94/040/00129/AM10/ Lic.No/Date:0310543281 29.10.2009 Defer Date:20.04.2010

Case No.:44/48/82‐ALC4/2009

Party Name:AVA CHEMICALS PVT.LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01107/AM10/ RLA File :03/94/040/00475/AM10/ Lic.No/Date:0310543630 03.11.2009 Defer Date:20.04.2010 41

Case No.:27/34/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Defer Date:20.04.2010 42

Case No.:31/34/82‐ALC4/2009

Party Name:NAPROD LIFE SCIENCES PVT. LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/00676/AM10/ RLA File :03/95/040/00096/AM10/ Lic.No/Date:0310544100 05.11.2009 Decision : Committee considered case as per agenda and in consultation with technical authorities 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 Exp. Qty. Sl.No. Import items Qty. allowed Imatinib Granules 52.64% 1 00 kg 1. Imatinib Bas 44.49 kg 43

Case No.:32/34/82‐ALC4/2009

Party Name:PREGNA INTERNATIONAL LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/00677/AM10/ RLA File :03/95/040/00286/AM10/ Lic.No/Date:0310544168 05.11.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by P.C. Division of Department of C&PC vide their O.M. No.46011/22/2008‐PC.II dated 15.03.2010, 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 Intrauterine Contraceptive Device CU 375 1 No. 1. Copper Wire 0.350 gm 2. Compound of LDPE Resin & Barium Sulphate Granule 0.595 kg 3. HDPE Granule 1.15 gm

Relevant Pouches Net + 10% 5. PVC Granule 0.125 gm 6. HDPE Granule 0.02 gm 44

Case No.:33/34/82‐ALC4/2009

Party Name:PREGNA INTERNATIONAL LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/00678/AM10/ RLA File :03/95/040/00285/AM10/ Lic.No/Date:0310544171 05.11.2009 Decision : Committee considered case as per agenda and in light of written comments forwarded by P.C. Division of Department of C&PC vide their O.M. No.46011/22/2008‐PC.II dated 15.03.2010, 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 Intrauterine Contraceptive Device Copper T 380 A with Safe Load 1 No. 1. Copper Wire 0.200 gm 2. Relevant Insert Tube Net + 15% 3. Relevant Pouches Net + 10% 4. Relevant Copper Sleeves Net + 15% 5. Polypropylene Granule 1.65 gm 6. Compound of LDPE Resin & Barium Sulphate 0.49 gm 7. PVC Granule 1.25 gm 8. HDPE Granule 0.02 gm 9. Polypropylene Granules (Gama Radiation Stabilized) 2.5 gm 45

Case No.:34/34/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/00679/AM10/ RLA File :05/24/040/00291/AM10/ Lic.No/Date:0510252005 06.11.2009 Defer Date:20.04.2010 46

Case No.:35/34/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/00680/AM10/ RLA File :05/24/040/00337/AM10/ Lic.No/Date:0510252006 06.11.2009 Defer Date:20.04.2010

Case No.:44/34/82‐ALC4/2009

Party Name:DELTA FINOCHEM PVT.LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00689/AM10/ RLA File :03/94/040/00556/AM10/ Lic.No/Date:0310544608 09.11.2009 Defer Date:20.04.2010 48

Case No.:45/34/82‐ALC4/2009

Party Name:OMKAR SPECIALITY CHEMICALS PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00690/AM10/ RLA File :03/95/040/00486/AM10/ Lic.No/Date:0310544624 09.11.2009 Defer Date:20.04.2010 49

Case No.:70/48/82‐ALC4/2009

Party Name:CHEMPRO EXPORTS (INDIA) 23.03.2010 Status:Case Deferred HQ File :01/82/050/01133/AM10/ RLA File :03/94/040/00613/AM10/ Lic.No/Date:0310544665 09.11.2009 Defer Date:20.04.2010 50

Case No.:39/48/82‐ALC4/2009

Party Name:RELIANCE LIFE SCIENCES PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01102/AM10/ RLA File :03/95/040/00475/AM10/ Lic.No/Date:0310544816 10.11.2009 Defer Date:20.04.2010 51

Case No.:101/46/82‐ALC4/2009

Party Name:ANUS LABORATORIES LTD., 23.03.2010 Status:Case Approved HQ File :01/82/050/01017/AM10/ RLA File :09/24/040/00232/AM10/ Lic.No/Date:0910039924 13.11.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 13/08 meeting held on 31.07.2007 and in consultation with technical authority present in meeting, decided to ratify the norms on repeat basis under para 4.7 of HBP as per details below or as applied by the firm whichever is lower. Export Product Export Qty. Sl.No. import items Quantity allowed Acrylate (Methyl‐3‐Cyclopropyl 1 kg 1. 2,4 Dichloro‐5‐fluoro acetophenone 0.765 kg

Amino 2‐(2,4‐Dichloro‐5‐fluro benzyl acrylate) 2. Di‐methyl carbonate 0.726 kg 3. Sodium hydride 0.258 kg 4. Toluene 1.10 kg 5. Dimethyl formamide 0.396 kg 6. Acetic Acid 0.264 kg 7. Cyclopropylamine 0.180 kg RLA concerned may take further necessary action as per above decision of NC. 52

Case No.:6/36/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.03.2010 Status:Case Approved HQ File :01/82/050/00731/AM10/ RLA File :05/24/040/00363/AM10/ Lic.No/Date:0510252688 16.11.2009 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/150/2009‐PI (Norms) dated 01.02.2010 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 Export Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate 500 mg & Clavulanate Potassium + Microcrystalline Cellulose (1:1) (250 + 125 mg Tablet 1No.. 1. Amoxycillin Trihydrate (OR) 255 mg/tablet Its raw materials as per revised SION A‐57 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet Amoxycillin Trihydrate 500 mg + Potassium Calavulanate 125 mg + Microcrystalline Cellulose (1:1) Tablet 1 No. 1. Amoxycillin Trihydrate (OR) 510 mg/tablet Its raw materials as per revised SION A‐57 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet Amoxycillin Trihydrate 750 mg + Potassium Calavulanate 125 mg + Microcrystalline Cellulose (1:1) Tablet 1 No. 1. Amoxycillin Trihydrate (OR) 765 mg/tablet Its raw materials as per revised SION A‐57 2. Potassium Lavulanate + Microcrystalline Cellulose (1:1) 303.45 mg/tablet 53

Case No.:14/36/82‐ALC4/2009

Party Name:KAJAY REMEDIES PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00739/AM10/ RLA File :03/94/040/00571/AM10/ Lic.No/Date:0310545944 Defer

17.11.2009 Date:20.04.2010 54

Case No.:15/36/82‐ALC4/2009

Party Name:K.PATEL CHEMO PHARMA PVT LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/00740/AM10/ RLA File :03/94/040/00620/AM10/ Lic.No/Date:0310545949 17.11.2009 Defer Date:20.04.2010 55

Case No.:17/36/82‐ALC4/2009

Party Name:METROPOLITAN EXIMCHEM LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00742/AM10/ RLA File :03/95/040/00512/AM10/ Lic.No/Date:0310546022 17.11.2009 Defer Date:20.04.2010 56

Case No.:18/36/82‐ALC4/2009

Party Name:SHALINA LABORATORIES PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00743/AM10/ RLA File :03/95/040/00441/AM10/ Lic.No/Date:0310546039 17.11.2009 Defer Date:20.04.2010 57

Case No.:61/48/82‐ALC4/2009

23.03.2010 Status:Case Approved HQ File :01/82/050/01124/AM10/ RLA File :03/94/040/00605/AM10/ Lic.No/Date:0310546153 17.11.2009 Decision : Committee considered case as per agenda and in light of earlier decision taken in 15/82 meeting held on 14.08.2007 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 Tylocip Powder 50%/Tylosin Soluble Powder 50% w/w (100 gm Pack) 1 Kg. 1. Tylosin Tartarate BP (Vet.) 0.505 kg 58

Case No.:62/48/82‐ALC4/2009

23.03.2010 Status:Case

Deferred HQ File :01/82/050/01125/AM10/ RLA File :03/94/040/00698/AM10/ Lic.No/Date:0310546317 18.11.2009 Defer Date:20.04.2010 59

Case No.:47/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01110/AM10/ RLA File :03/94/040/00599/AM10/ Lic.No/Date:0310547381 25.11.2009 Defer Date:20.04.2010 60

Case No.:45/48/82‐ALC4/2009

Party Name:GALAXY SURFACTANTS LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01108/AM10/ RLA File :03/94/040/00637/AM10/ Lic.No/Date:0310547805 26.11.2009 Defer Date:20.04.2010 61

Case No.:5/38/82‐ALC4/2009

Party Name:LIFE LINE INDUSTRIES LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00778/AM10/ RLA File :03/95/040/00553/AM10/ Lic.No/Date:0310548279 30.11.2009 Defer Date:18.05.2010 Decision : Committee decided to defer case for 18.05.2010 for reply from firm. 62

Case No.:6/38/82‐ALC4/2009

Party Name:LIFE LINE INDUSTRIES LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00779/AM10/ RLA File :03/95/040/00541/AM10/ Lic.No/Date:0310548289 30.11.2009 Defer Date:18.05.2010 Decision : Committee decided to defer case for 18.05.2010 for reply from firm. 63

Case No.:69/46/82‐ALC4/2009

Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00985/AM10/ RLA File :03/94/040/00681/AM10/ Lic.No/Date:0310548622 01.12.2009 Defer Date:18.05.2010 Decision :Committee decided to call for Production and Consumption data certified by Central Excise Authority from firm. Accordingly, case was deferred for 18.05.2010.

Case No.:38/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01101/AM10/ RLA File :03/94/040/00598/AM10/ Lic.No/Date:0310549279 04.12.2009 Defer Date:20.04.2010 65

Case No.:42/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01105/AM10/ RLA File :03/94/040/00597/AM10/ Lic.No/Date:0310549287 04.12.2009 Defer Date:20.04.2010 66

Case No.:43/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01106/AM10/ RLA File :03/94/040/00596/AM10/ Lic.No/Date:0310549266 04.12.2009 Defer Date:20.04.2010 67

Case No.:48/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01111/AM10/ RLA File :03/94/040/00476/AM10/ Lic.No/Date:0310549284 04.12.2009 Defer Date:20.04.2010 68

Case No.:41/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01104/AM10/ RLA File :03/94/040/00531/AM10/ Lic.No/Date:0310549545 07.12.2009 Defer Date:20.04.2010 69

Case No.:49/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01112/AM10/ RLA File :03/94/040/00501/AM10/ Lic.No/Date:0310549541 07.12.2009 Defer Date:20.04.2010

Case No.:46/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01109/AM10/ RLA File :03/94/040/00685/AM10/ Lic.No/Date:0310550099 09.12.2009 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for comments of Ministry of E&F. 71

Case No.:1/40/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/00816/AM10/ RLA File :52/24/040/00023/AM10/ Lic.No/Date:5210029109 15.12.2009 Defer Date:20.04.2010 72

Case No.:3/40/82‐ALC4/2009

Party Name:BALAJI AMINES LIMITED 23.03.2010 HQ File :01/82/050/00818/AM10/ RLA File :31/24/040/00180/AM10/ Lic.No/Date:3110041089 15.12.2009 Defer Date:20.04.2010 73

Case No.:14/40/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/00829/AM10/ RLA File :03/94/040/00513/AM10/ Lic.No/Date:0310551191 16.12.2009 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for comments of DC(MSME). 74

Case No.:4/40/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD 23.03.2010 HQ File :01/82/050/00819/AM10/ RLA File :09/24/040/00257/AM10/ Lic.No/Date:0910040253 16.12.2009 Defer Date:20.04.2010 75

Case No.:58/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01121/AM10/ RLA File :03/94/040/00782/AM10/ Lic.No/Date:0310551036 16.12.2009 Defer Date:20.04.2010

Case No.:9/40/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/00824/AM10/ RLA File :05/24/040/00404/AM10/ Lic.No/Date:0510254651 16.12.2009 Defer Date:20.04.2010 77

Case No.:16/40/82‐ALC4/2009

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00831/AM10/ RLA File :09/24/040/00384/AM10/ Lic.No/Date:0910040330 17.12.2009 Defer Date:20.04.2010 78

Case No.:17/40/82‐ALC4/2009

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00832/AM10/ RLA File :09/24/040/00382/AM10/ Lic.No/Date:0910040331 17.12.2009 Defer Date:20.04.2010 79

Case No.:34/48/82‐ALC4/2009

Party Name:TITAN LABORATORIES PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01097/AM10/ RLA File :03/95/040/00617/AM10/ Lic.No/Date:0310551871 21.12.2009 Defer Date:04.05.2010 Decision :Committee decided to call for a copy of valid relevant Drug Manufacturing Licence from firm. Accordingly, case was deferred for 04.05.2010. 80

Case No.:83/46/82‐ALC4/2009

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00999/AM10/ RLA File :03/94/040/00805/AM10/ Lic.No/Date:0310552288 23.12.2009 Defer Date:04.05.2010 Decision :Committee decided to defer case for 04.05.2010 for reply from firm. 81

Case No.:87/46/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01003/AM10/ RLA File :03/94/040/00820/AM10/ Lic.No/Date:0310552364 23.12.2009 Defer Date:20.04.2010

Decision : Committee decided to defer case for 20.04.2010 for comments of Ministry of E&F. 82

Case No.:21/46/82‐ALC4/2009

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 23.03.2010 Status:Case Rejected HQ File :01/82/050/00937/AM10/ RLA File :04/24/040/00227/AM10/ Lic.No/Date:0410110415 29.12.2009 Decision :Committee considered case as per agenda and observed that the description of export product does not tally with the description of export product given in the Drug Manufacturing Licence furnished by the firm. Accordingly, case was rejected. 83

Case No.:59/48/82‐ALC4/2009

23.03.2010 Status:Case Deferred HQ File :01/82/050/01122/AM10/ RLA File :03/94/040/00837/AM10/ Lic.No/Date:0310553012 30.12.2009 Defer Date:20.04.2010 84

Case No.:53/48/82‐ALC4/2009

Party Name:SUNSHIELD CHEMICALS LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01116/AM10/ RLA File :03/95/040/00592/AM10/ Lic.No/Date:0310554251 07.01.2010 Defer Date:20.04.2010 85

Case No.:4/44/82‐ALC4/2009

Party Name:SARNA CHEMICALS PVT.LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00889/AM10/ RLA File :03/95/040/00601/AM10/ Lic.No/Date:0310555001 13.01.2010 Defer Date:20.04.2010 86

Case No.:6/44/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/00891/AM10/ RLA File :03/95/040/00683/AM10/ Lic.No/Date:0310555180 13.01.2010 Defer Date:20.04.2010 87

Case No.:7/44/82‐ALC4/2009

Party Name:ANUPAM RASAYAN (INDIA) LTD Status:Case

23.03.2010 Deferred HQ File :01/82/050/00892/AM10/ RLA File :52/24/040/00027/AM10/ Lic.No/Date:5210029364 13.01.2010 Defer Date:20.04.2010 88

Case No.:9/44/82‐ALC4/2009

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 23.03.2010 HQ File :01/82/050/00894/AM10/ RLA File :31/24/040/00130/AM10/ Lic.No/Date:3110041489 13.01.2010 Defer Date:20.04.2010 89

Case No.:10/44/82‐ALC4/2009

Party Name:SANDOZ PRIVATE LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/00895/AM10/ RLA File :03/95/040/00667/AM10/ Lic.No/Date:0310555381 14.01.2010 Defer Date:20.04.2010 90

Case No.:8/44/82‐ALC4/2009

Party Name:EMAMI LIMITED, 23.03.2010 HQ File :01/82/050/00893/AM10/ RLA File :02/24/040/00173/AM10/ Lic.No/Date:0210136503 14.01.2010 Defer Date:20.04.2010 Decision : Committee decided to defer case for 20.04.2010 for comments of DC(MSME). 91

Case No.:13/45/82‐ALC4/2009

Party Name:LAFFANS PETROCHEMICALS LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/00908/AM10/ RLA File :03/95/040/00674/AM10/ Lic.No/Date:0310555745 18.01.2010 Defer Date:20.04.2010 92

Case No.:3/45/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 23.03.2010 Status:Case Deferred HQ File :01/82/050/00898/AM10/ RLA File :05/24/040/00410/AM10/ Lic.No/Date:0510256550 18.01.2010 Defer Date:20.04.2010

Case No.:6/45/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 23.03.2010 Status:Case Deferred HQ File :01/82/050/00901/AM10/ RLA File :05/24/040/00444/AM10/ Lic.No/Date:0510256554 18.01.2010 Defer Date:20.04.2010 94

Case No.:16/48/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01079/AM10/ RLA File :03/94/040/00926/AM10/ Lic.No/Date:0310556732 22.01.2010 Defer Date:20.04.2010 95

Case No.:13/46/82‐ALC4/2009

Party Name:GEMINI EXPORTS., 23.03.2010 Status:Case Deferred HQ File :01/82/050/00929/AM10/ RLA File :03/94/040/00948/AM10/ Lic.No/Date:0310557481 28.01.2010 Defer Date:20.04.2010 96

Case No.:1/48/82‐ALC4/2009

Party Name:YASHO INDUSTRIES PVT.LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01064/AM10/ RLA File :03/95/040/00722/AM10/ Lic.No/Date:0310558310 03.02.2010 Defer Date:20.04.2010 97

Case No.:2/48/82‐ALC4/2009

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01065/AM10/ RLA File :31/24/040/00408/AM08/ Lic.No/Date:3110041801 03.02.2010 Defer Date:20.04.2010 98

Case No.:6/48/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01069/AM10/ RLA File :05/24/040/00445/AM10/ Lic.No/Date:0510257659 03.02.2010 Defer Date:20.04.2010

Case No.:7/48/82‐ALC4/2009

Party Name:PARABOLIC DRUGS LTD., 23.03.2010 HQ File :01/82/050/01070/AM10/ RLA File :05/24/040/00407/AM10/ Lic.No/Date:0510257661 03.02.2010 Defer Date:20.04.2010 100

Case No.:13/48/82‐ALC4/2009

Party Name:KDAC CHEM PVT LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01076/AM10/ RLA File :34/24/040/00195/AM10/ Lic.No/Date:3410026274 04.02.2010 Defer Date:20.04.2010 101

Case No.:4/48/82‐ALC4/2009

Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01067/AM10/ RLA File :31/24/040/00218/AM10/ Lic.No/Date:3110041820 04.02.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/6/2009‐Ch.II dated 02.03.2010 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 Monomethyl Ether of Hydroquinone 1 Kg. 1. Phenol 1.20 kg 2. Dimethyl Sulphate 0.650 kg 3. Caustic Soda Flakes 0.415 kg 4. Hydrogen Peroxide (50%) 0.610 kg 5. Acetone 0.300 kg 102

Case No.:5/48/82‐ALC4/2009

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 23.03.2010 Status:Case Deferred HQ File :01/82/050/01068/AM10/ RLA File :03/94/040/00927/AM10/ Lic.No/Date:0310558485 04.02.2010 Defer Date:20.04.2010

103

Case No.:8/48/82‐ALC4/2009

Party Name:GUJARAT ORGANICS LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01071/AM10/ RLA File :03/94/040/00963/AM10/ Lic.No/Date:0310558552 04.02.2010 Defer Date:20.04.2010 104

Case No.:11/48/82‐ALC4/2009

Party Name:IPCA LABORATORIES LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01074/AM10/ RLA File :03/94/040/00889/AM10/ Lic.No/Date:0310558811 05.02.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 24/08 meeting held on 20.09.2006 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 Morantel Citrate 1 Kg. 1. 3‐Methyl Thiophene 0.330 kg 2. Acetonitrile 0.180 kg 3. Dimethyl Formamide 0.270 kg 4. Citric Acid 6.40 kg 5. Ethylene Dichloride 0.165 kg 6. Isopropyl Alcohol 0.225 kg 105

Case No.:14/48/82‐ALC4/2009

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 23.03.2010 Status:Case Deferred HQ File :01/82/050/01077/AM10/ RLA File :05/23/040/00153/AM10/ Lic.No/Date:0510257903 05.02.2010 Defer Date:20.04.2010 106

Case No.:15/48/82‐ALC4/2009

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 23.03.2010 Status:Case Deferred HQ File :01/82/050/01078/AM10/ RLA File :05/23/040/00165/AM10/ Lic.No/Date:0510257905 05.02.2010 Defer Date:20.04.2010 107

Case No.:17/48/82‐ALC4/2009

Party Name:AMOLI ORGANICS PVT. LTD., 23.03.2010 Status:Case Deferred

HQ File :01/82/050/01080/AM10/ RLA File :03/94/040/00025/AM10/ Lic.No/Date:0310558999 08.02.2010 Defer Date:20.04.2010 108

Case No.:18/48/82‐ALC4/2009

Party Name:VASUDHA PHARMA CHEM LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01081/AM10/ RLA File :09/24/040/00435/AM10/ Lic.No/Date:0910040860 08.02.2010 Defer Date:20.04.2010 109

Case No.:19/48/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01082/AM10/ RLA File :09/24/040/00454/AM10/ Lic.No/Date:0910040861 08.02.2010 Defer Date:20.04.2010 110

Case No.:20/48/82‐ALC4/2009

Party Name:VIJAYASRI ORGANICS LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01083/AM10/ RLA File :09/24/040/00455/AM10/ Lic.No/Date:0910040862 08.02.2010 Defer Date:20.04.2010 111

Case No.:22/48/82‐ALC4/2009

Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01085/AM10/ RLA File :03/95/040/00724/AM10/ Lic.No/Date:0310559152 09.02.2010 Defer Date:20.04.2010 112

Case No.:23/48/82‐ALC4/2009

Party Name:LAKE CHEMICALS PRIVATE LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01086/AM10/ RLA File :07/24/040/00418/AM10/ Lic.No/Date:0710069899 09.02.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 43/82 meeting held on 26.02.2008 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 Quantity Sl.No. Import items Qty. allowed

Dorzolamide 1kg. 1. Methyl‐R‐hydroxy Butyrate 4.78 kg 2. Thiophene 2.70 kg 3. Boron trifluoride Etherate 2.78 kg 113

Case No.:24/48/82‐ALC4/2009

Party Name:TECKBOND LABORATORIES PRIVATE LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/01087/AM10/ RLA File :09/24/040/00450/AM10/ Lic.No/Date:0910040868 09.02.2010 Defer Date:20.04.2010 114

Case No.:25/48/82‐ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01088/AM10/ RLA File :03/95/040/00733/AM10/ Lic.No/Date:0310559189 09.02.2010 Defer Date:20.04.2010 115

Case No.:28/48/82‐ALC4/2009

Party Name:SARNA CHEMICALS PVT.LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01091/AM10/ RLA File :03/95/040/00739/AM10/ Lic.No/Date:0310559500 10.02.2010 Defer Date:20.04.2010 116

Case No.:30/48/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01093/AM10/ RLA File :05/24/040/00476/AM10/ Lic.No/Date:0510258284 11.02.2010 Defer Date:20.04.2010 117

Case No.:31/48/82‐ALC4/2009

Party Name:SARAF CHEMICALS LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01094/AM10/ RLA File :03/95/040/00747/AM10/ Lic.No/Date:0310559872 11.02.2010 Defer Date:20.04.2010

118

Case No.:19/50/82‐ALC4/2009

Party Name:SHIVA PHARMACHEM PVT. LTD, 23.03.2010 Status:Case Deferred HQ File :01/82/050/01173/AM10/ RLA File :34/24/040/00203/AM10/ Lic.No/Date:3410026496 26.02.2010 Defer Date:20.04.2010 119

Case No.:21/50/82‐ALC4/2009

Party Name:SHIVA PHARMACHEM PVT. LTD, 23.03.2010 Status:Case Deferred HQ File :01/82/050/01175/AM10/ RLA File :34/24/040/00205/AM10/ Lic.No/Date:3410026498 26.02.2010 Defer Date:20.04.2010 120

Case No.:22/50/82‐ALC4/2009

Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01176/AM10/ RLA File :31/24/040/00231/AM10/ Lic.No/Date:3110042170 26.02.2010 Defer Date:20.04.2010 121

Case No.:23/50/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01177/AM10/ RLA File :09/24/040/00466/AM10/ Lic.No/Date:0910041107 02.03.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/225/2009‐PI‐(Norms) dated 20.01.2010 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 the firm whichever is lower:‐ Export product Export Qty. Sl. No. Import items Qty. allowed Doxofylline 1kg. 1. Theophylline 1.17kg 2. Chloro acetaldehyde dimethyl acetal 0.81kg 3. Potassium carbonate 0.89kg 4. Methanol 0.63kg 5. Dimethyl formamide 0.56kg RA concerned may take further necessary action as per above decision of Norms Committee. 122

Case No.:24/50/82‐ALC4/2009

Party Name:VINEET LABORATORIES PRIVATE Status:Case

LIMITED 23.03.2010 Deferred HQ File :01/82/050/01178/AM10/ RLA File :09/24/040/00439/AM10/ Lic.No/Date:0910041108 02.03.2010 Defer Date:20.04.2010 123

Case No.:25/50/82‐ALC4/2009

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 23.03.2010 Status:Case Approved HQ File :01/82/050/01179/AM10/ RLA File :09/24/040/00489/AM10/ Lic.No/Date:0910041112 02.03.2010 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 Exp. Qty. Sl.No. Import items Qty. allowed 1,1‐Cyclohexane Diacetic Anhydride 1 Kg. 1. 1,1 Cyclohexane Diacetic Acid 1.20 kg 124

Case No.:26/50/82‐ALC4/2009

Party Name:CENTURY PHARMACEUTICALS LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01180/AM10/ RLA File :34/24/040/00208/AM10/ Lic.No/Date:3410026508 02.03.2010 Defer Date:20.04.2010 125

Case No.:27/50/82‐ALC4/2009

Party Name:TECKBOND LABORATORIES PRIVATE LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01181/AM10/ RLA File :09/24/040/00498/AM10/ Lic.No/Date:0910041130 02.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/105/2009‐PI‐III dated 01.06.2009 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 Qty. Sl.No. Import items Qty. allowed Mitrazapine Acid/1‐3(3‐ Carboxy Pyridyl‐2)‐4‐ Methyl‐2‐ Phenylpiperazine 1 Kg. 1. N‐Methyl 1 3‐Phenyl Piperazine 1.10 kg 2. Potassium Fluoride 0.365 kg 3. 2‐Chloro nicotino nitrile 0.80 kg 4. Dimethyl Formamide 3.45 kg 5. Toluene 2.42 kg

Chloroform 3.45 kg 7. Methanol 2.42 kg 126

Case No.:28/50/82‐ALC4/2009

Party Name:SMILAX LABORATORIES LIMITED 23.03.2010 HQ File :01/82/050/01182/AM10/ RLA File :09/24/040/00446/AM10/ Lic.No/Date:0910041147 03.03.2010 Defer Date:20.04.2010 127

Case No.:29/50/82‐ALC4/2009

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/01183/AM10/ RLA File :09/24/040/00497/AM10/ Lic.No/Date:0910041148 03.03.2010 Defer Date:20.04.2010 128

Case No.:30/50/82‐ALC4/2009

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.03.2010 Status:Case Approved HQ File :01/82/050/01184/AM10/ RLA File :03/94/040/01030/AM10/ Lic.No/Date:0310562796 03.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/9/2005‐Ch.II dated 22.05.2005 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 Astrolide in Diethyl Phthalate/Isopropyl Myristate/Benzyl Benzoate Main Total Astrokide content: 62.5% minimum 1 Kg. 1. Alpha Methyl Styrene 0.500 kg 2. Isoamylene 0.380 kg 3. Propylene Oxide 0.280 kg 4. Para Formaldehyde 0.088 kg 129

Case No.:31/50/82‐ALC4/2009

23.03.2010 Status:Case Approved HQ File :01/82/050/01185/AM10/ RLA File :03/94/040/01036/AM10/ Lic.No/Date:0310562806 03.03.2010

Decision : Committee considered case as per agenda and in light of earlier decision taken in 9/82 meeting held on 27.05.2008 and in consultation with representative of Department of Pharmaceuticals 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 Sulfamethazine & Trimethoprim Oral Powder/Cobalt Powder 1 pack of 100 gm 1. Sulfamethazine USP 20.20 gm/pack 2. Trimethoprim USP 4.04 gm/pack 130

Case No.:32/50/82‐ALC4/2009

23.03.2010 Status:Case Approved HQ File :01/82/050/01186/AM10/ RLA File :03/94/040/01039/AM10/ Lic.No/Date:0310562816 03.03.2010 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 26/82 meeting held on 23.09.2008 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 Tenofovir Disoproxil Fumerate Tablets 300mg/Tenvir Tablets Total weight of Tenofovir Disoproxil Fumerate— 1246.105 kg. 4072240 Nos. 1. 9‐[2‐(Phosphonyl Methoxy)Propyl] Adenine 0.8026kg/kg of Tenofovir Disoproxil Fumerate 2. Chloromethyl Isopropyl carbonate 2.08670kg/kg of Tenofovir Disoproxil Fumerate RA concerned may take further necessary action as per above decision of NC. 131

Case No.:33/50/82‐ALC4/2009

Party Name:VDH INTERNATIONAL 23.03.2010 Status:Case Deferred HQ File :01/82/050/01187/AM10/ RLA File :05/24/040/00456/AM10/ Lic.No/Date:0510259764 03.03.2010 Defer Date:20.04.2010 132

Case No.:34/50/82‐ALC4/2009

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01188/AM10/ RLA File :31/24/040/00235/AM10/ Lic.No/Date:3110042200 03.03.2010 Defer Date:20.04.2010

133

Case No.:35/50/82‐ALC4/2009

Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01189/AM10/ RLA File :31/24/040/00233/AM10/ Lic.No/Date:3110042201 03.03.2010 Defer Date:20.04.2010 134

Case No.:36/50/82‐ALC4/2009

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 23.03.2010 Status:Case Approved HQ File :01/82/050/01190/AM10/ RLA File :03/94/040/01040/AM10/ Lic.No/Date:0310562949 04.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.14010/9/2005‐Ch.II dated 22.05.2005 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 Astrolide in Diethyl Phthalate/Isopropyl Myristate/Benzyl Benzoate Main Total Astrokide content: 62.5% minimum 1 Kg. 1. Alpha Methyl Styrene 0.500 kg 2. Isoamylene 0.380 kg 3. Propylene Oxide 0.280 kg 4. Para Formaldehyde 0.088 kg 135

Case No.:38/50/82‐ALC4/2009

Party Name:HALDIA PETROCHEMICALS LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01192/AM10/ RLA File :02/24/040/00238/AM10/ Lic.No/Date:0210138852 04.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of C&PC vide their U.O. No.46011/159/2004‐PC.II dated 24.09.2009 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 Cyclopentane 1 MT. 1. Naphtha 1.158 MT 136

Case No.:39/50/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD Status:Case

23.03.2010 Deferred HQ File :01/82/050/01193/AM10/ RLA File :05/24/040/00496/AM10/ Lic.No/Date:0510259862 04.03.2010 Defer Date:20.04.2010 137

Case No.:7/52/82‐ALC4/2009

Party Name:ARCH PHARMALABS LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01200/AM10/ RLA File :03/94/040/01033/AM10/ Lic.No/Date:0310563317 08.03.2010 Defer Date:20.04.2010 138

Case No.:8/52/82‐ALC4/2009

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 23.03.2010 Status:Case Deferred HQ File :01/82/050/01201/AM10/ RLA File :03/94/040/01018/AM10/ Lic.No/Date:0310563354 08.03.2010 Defer Date:20.04.2010 139

Case No.:1/52/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 23.03.2010 HQ File :01/82/050/01194/AM10/ RLA File :09/24/040/00488/AM10/ Lic.No/Date:0910041233 09.03.2010 Defer Date:04.05.2010 Decision :Committee considered case as per agenda and decided to call for complete description of export product alongwith a copy of valid relevant Drug manufacturing Licence from firm. Accordingly, case was deferred for 04.05.2010. 140

Case No.:10/52/82‐ALC4/2009

Party Name:KOPRAN LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01203/AM10/ RLA File :03/94/040/01038/AM10/ Lic.No/Date:0310563658 09.03.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/10 meeting held on 16.02.2010 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 Ce䬀riaxone Sodium Sterile 1 Kg. 1. Ce䬀riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg

141

Case No.:11/52/82‐ALC4/2009

Party Name:KOPRAN LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01204/AM10/ RLA File :03/94/040/01035/AM10/ Lic.No/Date:0310563667 09.03.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/10 meeting held on 16.02.2010 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 Ce䬀riaxone Sodium Sterile 1 Kg. 1. Ce䬀riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 142

Case No.:12/52/82‐ALC4/2009

Party Name:ARIHANTANAM ORGANICS 23.03.2010 Status:Case Approved HQ File :01/82/050/01205/AM10/ RLA File :03/94/040/01024/AM10/ Lic.No/Date:0310563692 09.03.2010 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 Artemether 1 Kg. 1. Artemisinin 1.50 kg 143

Case No.:13/52/82‐ALC4/2009

Party Name:SHALINA LABORATORIES PVT. LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01206/AM10/ RLA File :03/95/040/00734/AM10/ Lic.No/Date:0310563700 09.03.2010 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 29/82 meeting held on 14.10.2008 and in consultation with technical authority present in meeting decided to ratify norms on repeat basis as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Epiderm Lotion 30 ml 1 No. 30 ml bottle 1. Betamethasone Base BP 17.24 mg/30 ml bottle

144

Case No.:2/52/82‐ALC4/2009

Party Name:RA CHEM PHARMA LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01195/AM10/ RLA File :09/24/040/00487/AM10/ Lic.No/Date:0910041234 09.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/243/2008‐PI‐III dated 24.03.2009 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 2‐(2,3‐Dichlorophenyl) Methylene Hydazine Carboximidamidine 1 Kg. 1. 2,3‐Dichloro Benzoyl Chloride 2.045 kg 2. Amino Guanidine Bicarbonate 1.06 kg 3. Cuprous Cyanide 1.09 kg 4. Hexane 2.03 kg 5. Ortho Dichloro Benzene Not a raw material. Hence not allowed 145

Case No.:3/52/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01196/AM10/ RLA File :09/24/040/00500/AM10/ Lic.No/Date:0910041235 09.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/332/2009‐PI‐(Norms) dated 09.01.2010 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 Methyl 2‐2‐ Chloromethylphenyl‐3‐ Methoxy‐2‐Acrylate 1 Kg. 1. 3‐Isochromanone 0.957 kg 2. O‐Xylene 1.04 kg 3. Sodium Methoxide Powder 0.416 kg 4. N‐Methylformaniolde 0.083 kg 5. Methanol 2.31 kg 146

Case No.:4/52/82‐ALC4/2009

Party Name:SUVEN LIFE SCIENCES LIMITED 23.03.2010 Status:Case Deferred

HQ File :01/82/050/01197/AM10/ RLA File :09/24/040/00499/AM10/ Lic.No/Date:0910041236 09.03.2010 Defer Date:20.04.2010 147

Case No.:5/52/82‐ALC4/2009

Party Name:VIVIMED LABS LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/01198/AM10/ RLA File :09/24/040/00496/AM10/ Lic.No/Date:0910041237 09.03.2010 Defer Date:20.04.2010 148

Case No.:6/52/82‐ALC4/2009

Party Name:NEULAND LABORATORIES LTD 23.03.2010 Status:Case Approved HQ File :01/82/050/01199/AM10/ RLA File :09/24/040/00472/AM10/ Lic.No/Date:0910041238 09.03.2010 Decision :Committee decided to defer case fore 20.04.2010 for comments of Department of Pharmaceuticals. 149

Case No.:9/52/82‐ALC4/2009

Party Name:KOPRAN LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01202/AM10/ RLA File :03/94/040/01037/AM10/ Lic.No/Date:0310563642 09.03.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 47/10 meeting held on 16.02.2010 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 Ce䬀riaxone Sodium Sterile 1 Kg. 1. Ce䬀riaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 150

Case No.:14/52/82‐ALC4/2009

Party Name:RANBAXY LABORATORIES LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01207/AM10/ RLA File :05/24/040/00507/AM10/ Lic.No/Date:0510260189 10.03.2010 Defer Date:20.04.2010 151

Case No.:16/52/82‐ALC4/2009

Party Name:SHALINA LABORATORIES PVT. LTD. 23.03.2010 Status:Case Approved

HQ File :01/82/050/01209/AM10/ RLA File :03/95/040/00762/AM10/ Lic.No/Date:0310563852 10.03.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 4/10 meeting held on 28.04.2009 and in consultation with technical authority present in meeting decided to ratify norms as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import item Qty. allowed Betasol Cream 15 gm tube 1 No. 1. Betamethasone Base BP 8.408 mg Betasol Cream 30 gm tube 1 No. 1. Betamethasone Base BP 16.816 mg 152

Case No.:17/52/82‐ALC4/2009

Party Name:TITAN LABORATORIES PVT. LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01210/AM10/ RLA File :03/95/040/00812/AM10/ Lic.No/Date:0310563872 10.03.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 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 Export Qty. Sl.No. Import items Qty. allowed Orlistat Pellets 50% 1 Kg. 1. Orlistat 0.505 kg 153

Case No.:18/52/82‐ALC4/2009

Party Name:TITAN LABORATORIES PVT. LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01211/AM10/ RLA File :03/95/040/00816/AM10/ Lic.No/Date:0310563875 10.03.2010 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 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 Export Qty. Sl.No. Import items Qty. allowed Orlistat Pellets 50% 1 Kg. 1. Orlistat 0.505 kg

154

Case No.:15/52/82‐ALC4/2009

Party Name:SRINI PHARMACEUTICALS LTD., 23.03.2010 Status:Case Approved HQ File :01/82/050/01208/AM10/ RLA File :09/24/040/00511/AM10/ Lic.No/Date:0910041263 11.03.2010 Decision : Committee considered case as per agenda and in light of earlier decision taken in 26/82 meeting held on 23.09.2008 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 RAM‐88 [(2S,3aS,6aS)‐1‐[(S)‐1‐ (Ethoxy Carbonyl)‐3‐phenyl propyl] amino] Praponoyl] Octahydro Cyclopenta [b] pyrrole‐2‐carboxylic Acid Benzyl Ester maleic acid Salt 1 Kg 1. (+/‐)Cis‐Endo‐2‐Aza Bicyclo(3,3.0)Octoane‐3‐Carboxylic Acid Benzyl Ester Hydrochloride 1.356 kg 2. 1,1‐Carbonyldiimdozol/N, N‐ Carbonyldiimdozol 0.50 kg 3. N‐(1S) Ethoxy Carbonyl‐3‐Phenyl Propyl‐L‐Alanine 0.62 kg 155

Case No.:19/52/82‐ALC4/2009

Party Name:ATUL LIMITED, 23.03.2010 Status:Case Deferred HQ File :01/82/050/01212/AM10/ RLA File :08/24/040/00288/AM10/ Lic.No/Date:0810087221 11.03.2010 Defer Date:20.04.2010 156

Case No.:20/52/82‐ALC4/2009

Party Name:TORRENT PHARMACEUTICALS LTD. 23.03.2010 Status:Case Deferred HQ File :01/82/050/01213/AM10/ RLA File :08/24/040/00340/AM10/ Lic.No/Date:0810087222 11.03.2010 Defer Date:20.04.2010 Decision :Committee decided to defer case for 20.04.2010 for comments of Department of Pharmaceuticals. 157

Case No.:21/52/82‐ALC4/2009

Party Name:TORRENT PHARMACEUTICALS LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01214/AM10/ RLA File :08/24/040/00341/AM10/ Lic.No/Date:0810087223 11.03.2010 Decision : Committee considered case as per agenda and taking cue from SION A‐412 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 Export Qty. Sl.No. Import items Qty. allowed Metoprolol Tartrate Tablets 50 mg Metoprolol 50 Heumann 1 No. 1. Metoprolol Tartrate EP 51 mg/tablet Metoprolol Tartrate Tablets 100 mg Metoprolol 100 Heumann 1 No. 1. Metoprolol Tartrate EP 102 mg/tablet 158

Case No.:22/52/82‐ALC4/2009

Party Name:GOPINATH CHEM‐TECH LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01215/AM10/ RLA File :08/24/040/00313/AM10/ Lic.No/Date:0810087248 11.03.2010 Defer Date:22.04.2010 159

Case No.:23/52/82‐ALC4/2009

Party Name:PROMED EXPORTS PVT.LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01216/AM10/ RLA File :05/24/040/00508/AM10/ Lic.No/Date:0510260293 11.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/30/2009‐PI‐III 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 Inokain Eye Drops 0.4% Solution, 5 ml Vial 1 No. 1. Benoxinate Hcl 0.021 gm/Vial of 5 ml 160

Case No.:24/52/82‐ALC4/2009

Party Name:TORRENT PHARMACEUTICALS LTD. 23.03.2010 Status:Case Approved HQ File :01/82/050/01217/AM10/ RLA File :08/24/040/00342/AM10/ Lic.No/Date:0810087253 11.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/178/2009‐PI‐III dated 12.11.2009 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 Export Qty. Sl.No. Import items Qty. allowed Propafenone tablets 150 mg 1 No. 1. Propafenone Hcl 153 mg 161

Case No.:25/52/82‐ALC4/2009

Party Name:YASHASHVI RASAYAN PVT.LTD 23.03.2010 Status:Case Deferred HQ File :01/82/050/01218/AM10/ RLA File :52/24/040/00040/AM10/ Lic.No/Date:5210029979 12.03.2010 Defer Date:20.04.2010 162

Case No.:26/52/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 23.03.2010 Status:Case Approved HQ File :01/82/050/01219/AM10/ RLA File :05/24/040/00519/AM10/ Lic.No/Date:0510260378 12.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their U.O. No.35011/156/2008‐PI‐III dated 14.11.2008 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 Atorvastatin Calcium 1 Kg. 1. (4RCis)1,1,dimethylethyl6(2[2(4 fluorophenyl)5(1, methylethyl)3phenyl 4[{(phenylamino)carbonyl]1Hpyrrol1 yl)ethyl)2,2dimethyl1,3dioxane4acetate 1.26 kg 2. Methylene Chloride 3.15 kg 3. Diisopropyl ether 1.43 kg RA concerned may take further necessary action as per above decision of NC. 163

Case No.:27/52/82‐ALC4/2009

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 23.03.2010 Status:Case Approved HQ File :01/82/050/01220/AM10/ RLA File :05/24/040/00511/AM10/ Lic.No/Date:0510260379 12.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/216/2009/‐PI‐(Norms) dated 25.02.2010 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

4‐OxiranylMethoxy‐9(H) Cabazole (CD3) Min. Assay 99% 1 Kg. 1. 4‐Hydroxy Carbazole (CD2) 1.13 kg 2. Epichlorohydrin Min. Assay 98% 0.90 kg 3. Isopropanol Min, Assay 99% 0.95 kg 164

Case No.:28/52/82‐ALC4/2009

Party Name:MSN LABORATORIES LIMITED 23.03.2010 Status:Case Approved HQ File :01/82/050/01221/AM10/ RLA File :09/24/040/00519/AM10/ Lic.No/Date:0910041306 12.03.2010 Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/159/2009‐PI‐(Norms) dated 18.01.2010 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 Rosuvastatin Calcium 1 Kg. 1. S‐4‐Chloro‐3‐Hydroxybutanenitrile 2.47 kg 2. Sodium Borohydride 1.11 kg 3. Diethylmethoxy Borane 1.922 kg 4. Methyl Isobutyl Acetate 2.11 kg 5. Diisobutyl Aluminium Hydride 2.79 kg 6. 2,2‐Dimethoxy Propane 4.141 kg 7. Tert. Butyl Bromoacetate 11.20 kg 8. Para Toluene Sulfonyl Chloride 2.77 kg 9. Para Fluoro Benzaldehide 1.95 kg 165

Case No.:29/52/82‐ALC4/2009

Party Name:AARTI INDUSTRIES LIMITED 23.03.2010 Status:Case Deferred HQ File :01/82/050/01222/AM10/ RLA File :03/94/040/01071/AM10/ Lic.No/Date:0310564649 12.03.2010 Defer Date:20.04.2010 166

Case No.:30/52/82‐ALC4/2009

Party Name:PI INDUSTRIES LTD., 23.03.2010 Status:Case Deferred HQ File :01/82/050/01223/AM10/ RLA File :13/24/040/00032/AM10/ Lic.No/Date:1310031602 12.03.2010 Defer Date:20.04.2010

Outside Agenda M/S Esskay Pharmaceuticals Ltd. Norms Committee Meeting No.52/10 Adv.Lic.No.P/K/1525932 dated 08.03.1994 Meeting Date: 23.02.2010 Committee considered Case as per agenda and could not find any source from which the details of import and export item applied by form and documentary evidence as to what item had been imported by the firm. It was, therefore, decided to call for a report alongwith photo copy of concerned file from RA. Accordingly, case was deferred for 20.04.2010.

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