DGFT Minutes
In force — no superseding record on file.
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 14/82ALC4/2013 MEETING DATE : 24.10.2013 The Meeting No. 14/82 in the year 201314 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was scheduled to be held on 24.10..2013 but was actually held on 29.10.2013 under the Chairmanship of, Shri Jaikant Singh, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present: 1. Shri D.N. Mathur. Consultantr, Department of Pharmaceutical 2. Shri Jasbir Singh, Consultantr, Department of C&PC 3. Shri R.C. Meena, Deputy Director General of Foreign Trade 1. The minutes of the earlier meeting dated scheduled to be held on 03.10..2013 but was actually held on 12.10.2013 s approved. 2. The following points are discussed and took the decision as mentioned against the case:
Case No. A16
M/s Sandoz Pvt Ltd Meeting No. 14/AM14 dated – 24.10.2013 F.No. 01/82/162/00087/AM14/DESIII To F.No. 01/82/162/00099/AM14/DESIII Sl. No. Product File No. 1 Mirtazapine 15 MG Orodispersible Tablets F.No.01/82/162/00087/AM14/DES‐III Mirtazapine 30 MG Orodispersible Tablets Mirtazapine 45 MG Orodispersible Tablets 2 Escitalopram 5 MG Film coated Tablets F.No.01/82/162/00088/AM14/DES‐III
Escitalopram 15 MG Film coated Tablets Escitalopram 20 MG Film coated Tablets 3 Donepezil 5 MG Film coated Tablets F.No.01/82/162/00089/AM14/DES‐III Donepezil 10 MG Film coated Tablets 4 Cetrizine Hydrochloride Chewable Tablets 5 MG F.No.01/82/162/00090/AM14/DES‐III Cetrizine Hydrochloride Chewable Tablets 10 MG 5 Mycophenolate Mofetil 250 MG Capsules F.No.01/82/162/00091/AM14/DES‐III Mycophenolate Mofetil 500 MG Capsules 6 Lamotrigine 25 MG Capsules F.No.01/82/162/00092/AM14/DES‐III Lamotrigine 25 MG Capsules 7 Fluvastatin 20 MG Capsules F.No.01/82/162/00093/AM14/DES‐III Fluvastatin 40 MG Capsules 8 Donepezil 5 MG ODT F.No.01/82/162/00094/AM14/DES‐III Donepezil 10 MG ODT 19 Ondansetron 4 MG ODT USP F.No.01/82/162/00095/AM14/DES‐III Ondansetron 8 MG ODT USP 10 Valciclovie 250 MG Film coated Tablets F.No.01/82/162/00096/AM14/DES‐III 11 Naratriptan 2.5 MG FCT F.No.01/82/162/00097/AM14/DES‐III 12 Acenocoumarol 1 MG Tablets F.No.01/82/162/00098/AM14/DES‐III 13 Clopidogrel Bisulfate 75 MG FCT F.No.01/82/162/00099/AM14/DES‐III
‐III 11 Naratriptan 2.5 MG FCT F.No.01/82/162/00097/AM14/DES‐III 12 Acenocoumarol 1 MG Tablets F.No.01/82/162/00098/AM14/DES‐III 13 Clopidogrel Bisulfate 75 MG FCT F.No.01/82/162/00099/AM14/DES‐III Decision: It was decided to call from the firm a copy of Master Batch Formula and Batch Log Sheet duly certified by Central Excise Authority. The case was deferred for 05.12.2013.
Case No. A17
M/s Divis Laboratories Ltd., Hyderabad F.No. 01/82/162/00621/AM13/DESIII
Decision: It was decided to defer the case for 05.12.2013 for comments of Department of Pharmaceuticals.
Case No. A18
M/s Wockhardt Ltd., (100% EOU) F.No. 01/82/162/009/AM14/DESIII SEEPZSEZ/EOU/20/200304/Vol.X Decision: It was decided to advise the firm to furnish separate application for each export item along with all technical details as per Appendix33. The case was deferred for 05.12.2013.
Case No. B159
M/s Chiral Bioscience Ltd (Formerly Allied Fabrichem Pvt Ltd.) Mee󠅃ng No. 14/AM14 dated – 24.10.2013 F.No. 01/82/162/00163/AM13/DESIII RLA F. No. 09/24/040/00102/AM10 Adv. Lic. No. 0910038495 dated 08.07.2009 Decision: It was decided to defer the case for 05.12.2013 for comments of Department of Pharmaceuticals.
Case No. B160
M/s Chirag Enterprise, Jamnagar, Gujarat F.No. 01/82/050/00256/AM11/DESIII F.No. 01/82/050/01090/AM11/DESIII RLA F. No. 24/24/040/00009/AM11 RLA F. No. 24/24/040/00014/AM11 Adv. Lic. No.2410029974 dated 27.10.2010 Adv. Lic. No.2410030871 dated 27.10.2010 Decision: It was decided to defer the case for 05.12.2013 for comments of Department of Petrochemicals of C&PC.
Case No. B161
M/s Glenmark Generic Ltd., Mumbai F.No. 01/82/050/295/AM14/DESIII RLA F. No. 03/94/40/904/AM13/DESIII Adv. Lic. No.0310728269 dated 15.03.2013 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to amend the description of Import item Sr. No. 1, 2 and Sr. No. 5 in the minutes of the NC meeting no. 10/82 dated 22.08.2013 as details given below. The rest of the minutes would remain same. Export product Exp. Qty. Sl.No. Import items Qty. allowed Perindopril Erbumine 1 Kg. 1. 2‐(S)‐Indoline‐2‐carboxylic acid 1.00 kg 2. L‐norvaline 1.60 kg
Methanol 1.43 kg 4. Toluene 3.22 kg 5. Methylene Chloride/Methylene Dichloride/MDC 15.19 kg 6. Acetonitrile 3.57 kg 7. Sodium Pyruvate 1.50 kg RA may take appropriate action as per the decision of Norms Committee.
Case No. B162
M/s Haldia Petrochemicals Ltd. F.No. 01/82/050/01534/AM09/DESIII RLA F. No. 02/24/40/00248/AM09 Adv. Lic. No.0210122139 dated 13.01.2009 It was decided to defer the case for 05.12.2013 for comments of Department of C&PC (Petrochemical Division).
Case No. B163
M/s ADI Finechem Ltd., F.No. 01/82/050/00146/AM09/DESIII RLA F. No. 08/24/040/149/AM08 Adv. Lic. No.0810067303 dated 21.09.2007 Decision: The committee considered the case of the firm and It was noted that the ITC HS code of export product mentioned in chapter 38. It was decided to transfer the case to Norms committee IV.
Case No. B164
M/s Alkaloids Corporation. F.No. 01/82/050/1417/AM13/DESIII F.No. 01/82/050/1407/AM13/DESIII F.No. 01/82/050/1408/AM13/DESIII RLA F. No. 02/24/040/00002/AM13 RLA F. No. 02/24/040/00054/AM13 RLA F. No. 02/24/040/00074/AM13 Adv. Lic. No.0210177059 dated 30.04.2012 Adv. Lic. No.0210178880 dated 25.06.2012 Adv. Lic. No.0210180511 dated 02.08.2012 Decision: Committee considered the case and in the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/340/2013PI(Norms) dated 26.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less:
Item of Export Qty Item of Import Qty N‐Butyl Lithium (15% w/w in n‐ Hexane as 100% Ac󠅃ve ingredient) 1 kg. Lithium Metal n‐Butyl Chloride 0.284 kg. 1.88 kg. Export product Export Quantity Sl.No. Import items Qty. allowed kg/kg Noscapine BP/Noscapine Hcl BP 1 kg 1 Noscapine 95% 1.158
Case No. B165
M/s AMI Life Sciences Pvt. Ltd.,.Baroda Meeting No. 14/AM14 dated –24.10.2013 F.No. 01/82/050/545/AM13/DESIII RLA F. No. 34/24/040/00072/AM13 Adv. Lic. No.3410034467 dated 22.06.2012 Decision: It was decided to defer the case for 05.12.2013 for comments of Department of Pharmaceuticals
Case No. B166
M/s FMC Agricultural Products, Bangalore F.No. 01/82/050/00612/AM08/DESIII F.No. 01/82/050/01173/AM08/DESIII F.No. 01/82/050/01575/AM08/DESIII F.No. 01/82/050/00212/AM08/DESIII Adv. Lic. No.0710053369 dated 14.09.2007 Adv. Lic. No.0710054550 dated 16.11.2007 Adv. Lic. No.0710056002 dated 22.02.2008 Adv. Lic. No.0710056292 dated 07.03.2008 Decision: Commi洄�ee considered the case and in the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2011‐Ch II dated 05.09.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
n‐Hexane ‐‐‐‐‐‐‐‐
Case No. B167
M/s Panacea Biotec Ltd., New Delhi F.No. 01/82/050/00427/AM10/DESIII F.No. 01/82/050/00927/AM11/DESIII F.No. 01/82/050/00327/AM12DESIII RLA F. No. 02/24/040/00156/AM11 RLA F. No. 02/24/040/00235/AM11 RLA F. No. 02/24/040/00007/AM12 Adv. Lic. No.0510269042 dated 26.07.2010 Adv. Lic. No.0510274701 dated 11.10.2010 Adv. Lic. No.0510292280 dated 31.05.2012 Decision: Committee considered the case and in the light of written comments received from Drug Controller General of India vide their F. No. 12/83/PANACEA/PACDTPHep/2011Ch II dated 04.09.2013, has clarified that the formulation I DTwPBFHep BPEBL – HibNV) and formulation II (DTwPBFHep BPEBL – HibPEBL) manufactured by M/s Panacea Biotec Ltd., New Delhi are approved by DCGI. However, they have clarified that they have approve license for manufacture for sale of Drugs in proper/generic name only as per direction issued by the Ministry of Health and Family welfare vide their letter of file No. X.11011/1/2011 DFQC dated 1.10.2012 and 09.11.2012.
Case No. B168
M/s Mylan Laboratories Ltd., Hyderabad F.No. 01/82/050/00212/AM12/DESIII RLA F. No. 09/24/040/00485/AM11 Adv. Lic. No.0910045600 dated 18.02.2011 It was decided to send a copy of application to Department of Pharmaceuticals for their comments. The case was deferred for 05.12.2013.
Case No. B169
M/s Arch Pharma Labs Ltd. F.No. 01/82/050/00870/AM09/DESIII(pt.) RLA F. No. 09/24/040/00485/AM11 Adv. Lic. No.0310481979 dated 08.08.2008
Decision:It was decided to reject the case as the firm has not furnished information despite repeated reminders.
Case No. B170
M/s Pregna International Ltd., Mumbai F.No. 01/82/050/00941/AM13/DESIII RLA F. No. 03/95/040/00635/AM12 Adv. Lic. No.0310665072 dated 15.11.2011 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo.
Case No. B171
M/s Medreich Ltd., Bangalore F.No. 01/82/171/00061/AM14/DESIII RLA F. No. 07/24/040/00796/AM08 Adv. Lic. No.0710056381 dated 13.03.2008 Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 2/AM13 dated 18.04.2013 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Export Qty. Import items Qty allowed per unit of export product Paracetamol 450mg + Caffiene Anhydrous 45mg or 50 mg or 30 mg + Doxylamine Succinate 5mg + Codeine Phosphate 10mg tablets (ITC(HS)No.30049039) 1 tablet 1.Paracetamol 459mg/tab. 2.Doxylamine Succinate 5.1mg/tab. 3.Spectracolquinoline yellow 800744 B‐20 2.43 mg/tab. 4.Spectracolquinoline Yellow LK 805002 4.56 mg/tablet
Case No. B172
M/s Astrix Labs Pvt Ltd
F.No. 01/82/50/00165/AM13/DESIII RLA F. No. 09/24/040/538/AM12 Adv. Lic. No.0910051472 dated 27.02.2012 Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 38/82 dated 20.12.2011 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. S.No Import Item Qty. allowed kg/kg NEVIRAPINE (CARBOXAMIDE ROUTE) 1000 kg 1. 2ChloroN(2chloro4 methyl3pyridinyl)3 pyridineCarboxamide (Carboxamide) 1.428 2. Cyclopropylamine 0.57 3. Methanol 1.082 4. N,NDimethyl Formamide 0.292 RA concerned may take further necessary action as per above decision of NC.
Case No. B173
M/s IPCA Labs Ltd., F.No. 01/82/162/104/AM14/DESIII RLA F. No. 03/94/040/183/AM12 Adv. Lic. No.0310644410 dated 26.07.2011 Decision: It was decided send a copy of application to Department of Pharmaceuticals and defer the case for 05.12.2013.
Case No. B174
M/s Lupin Ltd., F.No. 01/82/50/647/AM13/DESIII RLA F. No. 03/94/040/304/AM13 Adv. Lic. No.0310704078 dated 03.08.2012 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo.
Case No. B175
M/s Gaurav Pharma Ltd., New Delhi F.No. 01/82/171/00018/AM13/DESIII Decision: It was decided to defer the case for 05.12.2013 for comments of Department of C&PC.
Case No. B176
M/s Vijaysri Organics Ltd., F.No. 01/82/50/00030/AM13/DESIII RLA F. No. 03/95/040/933/AM11 Adv. Lic. No.0310617980 dated 25.02.2011 Decision: It was decided to ask the firm to furnish Central Excise data for last three years. The case was deferred for 05.12.2013
Case No. B177
M/s Shilpa Medicare Ltd. F.No. 01/82/50/800/AM04/DESIII RLA F. No. 07/24/040/231/AM04 Adv. Lic. No.0710023074 dated 05.08.2003 Decision: Commi洄�ee considered case as per agenda and in consultation with technical authority present in the meeting and in the light of earlier decision taken by NC in its meeting no. 4/AM11 dated 27.04.2010 decided to delete the pre‐import condi󠅃on from Advance Authorisa󠅃on No. 0710023074 dated 05.08.2003 (The Drug Control Department Government of Karnataka vide their le洄�er No. MCD/CR‐Misc‐53/MFG/09‐10 has informed that the Import item Cholic Acid is not Drug).
Case No. B178
M/s Glenmark Generic Ltd., Mumbai F.No. 01/82/50/065/AM14/DESIII RLA F. No. 03/94/40/892/AM13/DESIII Adv. Lic. No.0310725673 dated 26.02.2013 Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to amend the description of Import item Sr. No. 1 and 2 in the minutes of the NC meeting no. 4/82 dated 16.05.2013.2013 as details given below. The rest of the minutes would remain same. S.No. From To 1. [5(4Chlorobutyl)1Cyclohexyl1H 5(4Chlorobutyl1Cyclohexyl1HTetrazole.
Tetrazole] {CBT Cilostazol} 2. 6Hydroxy3,4Dihydroquinolinone [HCS Cilostazol] 6Hydroxy3,4Dihydro1HQuinolin2One. RA concerned may take further necessary action as per above decision of NC.
Case No. B ‐ 179
M/s RA Chem Pharma Ltd. Mee󠅃ng No. 14/AM14 dated – 24.10.2013 F.No.01/82/50/00985/AM12/DES‐III F.No.01/82/50/00884/AM10/DES‐III F.No.01/82/50/01012/AM11/DES‐III F.No.01/82/50/00856/AM12/DES‐III RA.No. 09/24/040/00410/AM09 RA.No. 09/24/040/00411/AM10 RA.No. 09/24/040/00328/AM11 RA.No. 09/24/040/00199/AM12 adv. lic. 0910038108 dated 03.06.2010 adv. lic. 0910040593 dated 12.01.2010 adv. lic. 0910044225 dated 10.11.2010 adv. lic. 0910048014 dated 01.08.2011 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to amend the description of Import item Sr. No. 1 in respect of above mentioned advance authorizations as details given below. The rest of the minutes would remain same. S.No. From To 1. Methyl2Chloromethyl Propionate Methyl2Chloro Propionate RA concerned may take further necessary action as per above decision of NC.
Case No. C18
M/s Encee Aromatics Pvt Ltd F.No. 01/82/162/00745/AM12/DESIII Chemexcil has forwarded the request of the firm for modification of SION for the export product Secondary Butyl Quinoline. In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/53/2012Ch. II dated 05.082013, it was decided to modification of SION A3147, under Para 4.8(a) of HBP v 1 as per details given below: Export Product Export S.No Import Item Qty. allowed
Qty. kg/kg Secondary Butyl Quinoline 1 kg 1. Secondary Butyl Benzene OR 1.890 kg 2. Secondary Butyl Aniline 1.412 kg 3. Glycerine 2.748 kg Decision: The above modification of SION would be notified through Public Notice
Case No. C19
M/s Encee Aromatics Pvt Ltd F.No. 01/82/162/00008/AM13/DESIII Chemexcil has forwarded the request of the firm for modification of SION for the export product Secondary Butyl Quinoline. In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/53/2012Ch. II dated 05.082013, it was decided to modification of SION A1730, under Para 4.8(a) of HBP v 1 as per details given below: Export Product Export Qty. S.No Import Item Qty. allowed kg/kg Ambrettolide 1 kg 1. Trimethyl Orthoformate 1.724 kg 2. Britol (Paraffinic Mineral Oil) 1.020 kg 3. Glycerine 3.053 kg 4. Seedlac 12.757 kg Decision: The above modification of SION would be notified through Public Notice
Case No. C20
M/s Encee Aromatics Pvt Ltd F.No. 01/82/162/00020/AM10/DESIII Decision: Committee considered the case as per agenda and in the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/53/2012Ch. II dated 05.082013, it was decided to ratify the norms, under Para 4.2.2 of HBP v 1 as per details given below:
Export Product Export Qty. S.No Import Item Qty. allowed kg/kg Enamber/Kephalis/Tetrambrone 1 kg 1. Triethyl Orthoformate 2.400 kg 3. Di Acetone Alcohol 5.720 kg RA concerned may take further necessary action as per above decision of NC.
Case No. C21
M/s RA Chem Pharma Ltd F.No. 01/82/50/86/AM14/DESIII Committee considered the case as per agenda and in consultation with technical members present in the meeting and it was decided to modification of SION A2611, under Para 4.8(a) of HBP v 1 as per details given below: Export product Export Qty. Sl.No. Import items Qty. allowed 2Aminomethyl7Chloro2,3 Dihydro5(2 Fluorophenyl)1H1,4 Benzodiazepine Dimaleate 1 Kg. 1. 2Amino5Chloro2Fluoro Benzophenone 0.932 kg 2. Chloro acetaldehyde Dimethyl acetal 0.696 kg 3. Manganese Dioxide 0.852 kg 4. Raney Nickle 0.163 kg 5. Dimethyl Sulfoxide 0.405 kg 6. Acetone 0.405 kg Decision: The above modification of SION would be notified through Public Notice. 1
Case No.:27/19/82ALC4/2011
Party Name:VIVIMED LABS LIMITED Meet No/Date:14/82ALC4/2013 24.10.2013 Status: Approved HQ File :01/82/050/00541/AM12/ RLA File :09/24/040/00086/AM12/ Lic.No/Date:0910046997 06.06.2011 Defer Date:
Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011‐Ch II dated 19.08.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed REVERSACOL OCEAN BLUE 1 kg 1. 4,4 DIMETHYL BENZOPHENONE 1.400 kg 2. DIMETHYL SUCCINATE 4.000 kg 3. SODIUM ACETATE 0.600 kg 4. ETHANOL 6.00 kg 5. TRIMETHYL SILYL ACETYLENE (TMSA) 0.800 kg 6. SIRALOX 1.200 kg 7. TOLUENE 18.000 kg 8. TETRA HYDRO FURAN (THF) 9.000 kg 9. METHANOL 15.000 kg 10. HEXANE 3.000 kg RA may take appropriate ac󠅃on as per the decision of Norms Commi洄�ee. 2
Case No.:100/14/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 24.10.2013 Status:Case Deferred HQ File :01/82/050/00685/AM14/ RLA File :09/24/040/00018/AM13/ Lic.No/Date:0910052271 23.04.2012 Defer Date:21.11.2013 Decision : It was decided to defer the case for 21.11.2013 for comments of Department of Pharmaceuticals. 3
Case No.:101/14/82ALC4/2013
Party Name:MSN PHARMACHEM PRIVATE LIMITED 24.10.2013 Status:Case Deferred HQ File :01/82/050/00686/AM14/ RLA File :09/24/040/00064/AM13/ Lic.No/Date:0910052663 17.05.2012 Defer Date:21.11.2013 4
Case No.:6/22/82ALC4/2012
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 24.10.2013 Status:Deffered and Reindexed
HQ File :01/82/050/00709/AM13/ RLA File :03/95/040/00262/AM13/ Lic.No/Date:0310705888 22.08.2012 Defer Date: 21.11.2013 5
Case No.:77/24/82ALC4/2012
Party Name:ASHISH LIFE SCIENCE PVT.LTD. 24.10.2013 Status:Case Rejected HQ File :01/82/050/00881/AM13/ RLA File :03/94/040/00378/AM13/ Lic.No/Date:0310709108 14.09.2012 Defer Date: Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders. 6
Case No.:16/24/82ALC4/2012
Party Name:OGENE SYSTEMS INDIA PVT. LTD. 24.10.2013 Status:Deffered and Re indexed HQ File :01/82/050/00820/AM13/ RLA File :09/24/040/00312/AM13/ Lic.No/Date:0910053896 25.09.2012 Defer Date: 21.11.2013 7
Case No.:148/33/82ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 24.10.2013 indexed HQ File :01/82/050/01295/AM13/ RLA File :09/24/040/00359/AM13/ Lic.No/Date:0910054335 15.11.2012 Defer Date: 21.11.2013 8
Case No.:179/33/82ALC4/2012
Party Name:SRINI PHARMACEUTICALS LTD., 24.10.2013 Status:Case Approved HQ File :01/82/050/01326/AM13/ RLA File :09/24/040/00393/AM13/ Lic.No/Date:0910054348 20.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/366/2013PI(Norms) dated 26.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Bicalutamide Kg 1. N‐(4‐Cyano‐3‐ (Trifluoromethyl)phenyl‐2‐ methyloxirance carboxamide 0.90 2. 4‐Fluorobenzenethiol 0.50
A may take appropriate ac󠅃on as per the decision of Norms Commi洄�ee. 9
Case No.:9/31/82ALC4/2012
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 24.10.2013 Status:Case Rejected HQ File :01/82/050/01049/AM13/ RLA File :04/24/040/00182/AM13/ Lic.No/Date:0410141372 29.11.2012 Defer Date: Decision : It was decided to reject the case as the firm has not furnished information despite repeated reminders. 10
Case No.:168/33/82ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 24.10.2013 HQ File :01/82/050/01315/AM13/ RLA File :08/24/040/00253/AM13/ Lic.No/Date:0810116731 07.12.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/340/2013PI(Norms) dated 26.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed MESALAMINE DELAYED RELEASE TABLETS 1.2 GRAMS Kg 1. MESALAMINE USP 1.224 gm/tablets 2. 225 CC WHT CRC BOTTLE Relevant, as per packing policy 3. CRC WH CAP 45MM 11
Case No.:85/31/82ALC4/2012
Party Name:SANOFI INDIA LIMITED 24.10.2013 indexed HQ File :01/82/050/01125/AM13/ RLA File :03/95/040/00465/AM13/ Lic.No/Date:0310717240 14.12.2012 Defer Date: 05.12.2013 Decision : It was decided to put up the case on file . The case was deferred for 05.12.2013
12
Case No.:13/12/82ALC4/2013
Party Name:HETERO DRUGS LIMITED, 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00437/AM14/ RLA File :09/24/040/00495/AM13/ Lic.No/Date:0910054735 09.01.2013 Defer Date: 21.11.2013 Decision : Copy of application has been already sent to D/o Pharmaceuticals. It was decided to defer the case for 21.11.2013 for comments of Department of Pharmaceuticals. 13
Case No.:42/12/82ALC4/2013
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 24.10.2013 HQ File :01/82/050/00466/AM14/ RLA File :09/24/040/00454/AM13/ Lic.No/Date:0910054767 11.01.2013 Defer Date: Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/34/2011‐Ch II dated 10.12.2012, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed ALLANTOIN 10. GLYOXYLIC ACID 50% 1.248 kg 14
Case No.:48/4/82ALC4/2013
Party Name:SRINI PHARMACEUTICALS LTD., 24.10.2013 HQ File :01/82/050/00089/AM14/ RLA File :09/24/040/00463/AM13/ Lic.No/Date:0910054762 11.01.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/508/2013PI(Norms) dated 21.10.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg METHYL ALPHA‐(4,5,6,7‐ TETRAHYDRA‐5‐THIENO (3,2‐C) PYRIDYL)(2‐ CHLOROPHENYL)ACETATE HYDROCHLORIDE (CPG 20) Kg 1. 4,5,6,7‐TETRAHYDROTHIENO [3,2 ‐ C] PYRIDINE HYDROCHLORIDE (CPG 10) 0.74 2. N‐BROMO SUCCINAMIDE 0.81 3. ETHYLENE DI CHLORIDE / DI CHLORO ETHANE 3.60
15
Case No.:14/12/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00438/AM14/ RLA File :03/94/040/00903/AM13/ Lic.No/Date:0310722358 30.01.2013 Defer Date:21.11.2013 16
Case No.:113/1/82ALC4/2013
Party Name:PERKIN LABORATORIES 24.10.2013 HQ File :01/82/050/01471/AM13/ RLA File :09/24/040/00523/AM13/ Lic.No/Date:0910054915 04.02.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/396/2013PI(Norms) dated 26.09.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Diethyl Cyclopropane 1,1‐ dicarboxylate Kg 1. Diethyl Malonate 1.50 2. Dimethyl Formamide 1.00 3. Potassium Carbonate 1.30 4. Ethylene Dichloride 2.00 17
Case No.:28/4/82ALC4/2013
24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00069/AM14/ RLA File :09/24/040/00520/AM13/ Lic.No/Date:0910054940 05.02.2013 Defer Date:21.11.2013
18
Case No.:111/1/82ALC4/2013
Party Name:VINDHYA PHARMA (INDIA)PVT LTD. Meet No/Date:14/82ALC4/2013 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/01469/AM13/ RLA File :09/24/040/00479/AM13/ Lic.No/Date:0910055022 12.02.2013 Defer Date:21.11.2013 19
Case No.:55/4/82ALC4/2013
Party Name:SHREE GANESH REMEDIES PVT.LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00096/AM14/ RLA File :34/24/040/00287/AM13/ Lic.No/Date:3410036329 06.03.2013 Defer Date:21.11.2013 Decision : It was decided to defer the case 21.11.2013 for comments of Department of Chemicals and Petrochemicals. 20
Case No.:58/4/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00099/AM14/ RLA File :22/24/040/00077/AM13/ Lic.No/Date:2210013693 06.03.2013 Defer Date:21.11.2013 Decision : , it was decided to remind the firm to furnish technical details as per Appendix 33 along with % composition of the export product 21
Case No.:18/8/82ALC4/2013
Party Name:VIVIMED LABS LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00149/AM14/ RLA File :09/24/040/00572/AM13/ Lic.No/Date:0910055306 07.03.2013 Defer Date:21.11.2013 22
Case No.:27/10/82ALC4/2013
Party Name:VIVIMED LABS LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00210/AM14/ RLA File :09/24/040/00589/AM13/ Lic.No/Date:0910055307 07.03.2013 Defer Date:21.11.2013 23
Case No.:114/10/82ALC4/2013
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00297/AM14/ RLA File :03/94/040/00991/AM13/ Lic.No/Date:0310727451 08.03.2013 Defer Date:21.11.2013 Decision : It was decided to defer the case for 21.11.2013 for comments of Department of C&PC.
24
Case No.:30/10/82ALC4/2013
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00213/AM14/ RLA File :09/24/040/00548/AM13/ Lic.No/Date:0910055356 11.03.2013 Defer Date:21.11.2013 25
Case No.:214/10/82ALC4/2013
Party Name:SHREE GANESH REMEDIES PVT.LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00397/AM14/ RLA File :34/24/040/00299/AM13/ Lic.No/Date:3410036377 12.03.2013 Defer Date:21.11.2013 26
Case No.:31/10/82ALC4/2013
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00214/AM14/ RLA File :09/24/040/00593/AM13/ Lic.No/Date:0910055380 13.03.2013 Defer Date:21.11.2013 27
Case No.:141/10/82ALC4/2013
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00324/AM14/ RLA File :03/94/040/00982/AM13/ Lic.No/Date:0310728214 14.03.2013 Defer Date:21.11.2013 28
Case No.:59/10/82ALC4/2013
24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00242/AM14/ RLA File :09/24/040/00585/AM13/ Lic.No/Date:0910055390 14.03.2013 Defer Date:21.11.2013 29
Case No.:13/10/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 24.10.2013 HQ File :01/82/050/00196/AM14/ RLA File :22/24/040/00075/AM13/ Lic.No/Date:2210013720 15.03.2013 Defer Date:
Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/526/2013PI(Norms) dated 11.09.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg Cefpodoxime Proxe󠅃l 1 kg 1. 7‐ACA 0.956 2. Sulfolane 1.18 3. Methanol 0.74 4. Methylene Chloride 3.66 5. Triethylamine 0.562 6. Tetrahydrofuran 0.58 7. MAEM 0.956 8. Chloroethyl Isopropyl Carbonate 0.550 9. Sodium Iodide 0.39 10. 18‐Crown‐6‐Ether 0.022 11. Cyclohexane 1.75 12. Acetone 0.33 13. 1,8‐Diazabicyclo (DBU) 0.341 14. Dimethyl Acetamide 0.49 15. Eno Carbon 0.100 16. Toluene 0.25 30
Case No.:25/8/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00156/AM14/ RLA File :05/24/040/00469/AM13/ Lic.No/Date:0510349278 15.03.2013 Defer Date:21.11.2013
31
Case No.:140/10/82ALC4/2013
Party Name:EUROLIFE HEALTHCARE PVT. LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00323/AM14/ RLA File :03/94/040/00981/AM13/ Lic.No/Date:0310728713 19.03.2013 Defer Date:21.11.2013 32
Case No.:32/8/82ALC4/2013
Party Name:BIOLOGICAL E LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00163/AM14/ RLA File :09/24/040/00607/AM13/ Lic.No/Date:0910055421 19.03.2013 Defer Date:21.11.2013 Decision : It was decided to remind the firm to furnish the following information: Drug Manufacturing Licensing of the export product (DML enclosed with the application does not mention the export product. To submit QA approved Batch Manufacturing Record. The case was deferred for 21.11.2013 33
Case No.:57/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00240/AM14/ RLA File :09/24/040/00606/AM13/ Lic.No/Date:0910055420 19.03.2013 Defer Date:21.11.2013 Decision : It was decided to remind the firm to furnish the following information: Drug Manufacturing Licensing of the export product (DML enclosed with the application does not mention the export product. To submit QA approved Batch Manufacturing Record. 34
Case No.:125/10/82ALC4/2013
Party Name:LAXMI ORGANIC INDUSTRIES LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00308/AM14/ RLA File :03/95/040/00911/AM13/ Lic.No/Date:0310728818 20.03.2013 Defer Date:21.11.2013 Decision : It was decided to remind the firm to furnish the following information sought by Department of Chemicals and Petrochemicals vide their letter dated 1.3.2013:
Details of manufacturing process with chemical equations, molecular formula, molecular weight. Yield obtained in each step. Authentic technical literature in support of yield obtained. CA certificate certifying the production of export item achieved by the firm for the last three years and corresponding consumption of each input. Detailed calulations, arriving at the norms applied for. The case was deferred for 21.11.2013. 35
Case No.:24/10/82ALC4/2013
Party Name:KUDOS CHEMIE LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00207/AM14/ RLA File :22/24/040/00083/AM13/ Lic.No/Date:2210013724 20.03.2013 Defer Date:21.11.2013 36
Case No.:52/4/82ALC4/2013
Party Name:CHIRAG ENTERPRISE 24.10.2013 HQ File :01/82/050/00093/AM14/ RLA File :24/24/040/00017/AM13/ Lic.No/Date:2410038507 20.03.2013 Defer Date: Decision : In the light of wri洄�en comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/1/2007‐PC‐ II dated 28.10.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed REGENERATED METHYL METHACRYLATE MONOMER [PURITY GREATER THAN OR EQULA TO 99%] 1 kg 1. ACRYLIC PLASTIC STRIPS/OFFCUT/MIX LOT OF A P SHEETS & CUT THEREOF OR ACRYLIC PLASTIC LUMPS [HS CODE 39069090] 1.63 kg 37
Case No.:53/4/82ALC4/2013
Party Name:CHIRAG ENTERPRISE 24.10.2013 HQ File :01/82/050/00094/AM14/ RLA File :24/24/040/00014/AM13/ Lic.No/Date:2410038508 20.03.2013 Defer Date: Decision : In the light of wri洄�en comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/1/2007‐PC‐ II dated 28.10.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed REGENERATED METHYL METHACRYLATE MONOMER (PURITY
99%) 1 kg
MIX LOT OF ACRYLIC PLASTIC SHEETS & CUT THEREOF / ACRYLIC PLASTIC OFFCUTS / ACRYLIC PLASTIC STRIPS 1.63 kg 38
Case No.:27/8/82ALC4/2013
Party Name:STERILE INDIA PRIVATE LIMITED 24.10.2013 indexed HQ File :01/82/050/00158/AM14/ RLA File :05/24/040/00477/AM13/ Lic.No/Date:0510349855 21.03.2013 Defer Date:21.11.2013 39
Case No.:29/8/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00160/AM14/ RLA File :08/24/040/00454/AM13/ Lic.No/Date:0810119673 21.03.2013 Defer Date:21.11.2013 40
Case No.:58/10/82ALC4/2013
24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00241/AM14/ RLA File :09/24/040/00583/AM13/ Lic.No/Date:0910055475 21.03.2013 Defer Date:21.11.2013 41
Case No.:60/10/82ALC4/2013
24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00243/AM14/ RLA File :09/24/040/00586/AM13/ Lic.No/Date:0910055474 21.03.2013 Defer Date:21.11.2013 42
Case No.:25/10/82ALC4/2013
Party Name:ANUS LABORATORIES LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00208/AM14/ RLA File :09/24/040/00186/AM12/ Lic.No/Date:0910055523 Defer
22.03.2013 Date:21.11.2013 Decision : It was decided to remind the firm to furnish the technical details as per Appendix 33 . The case was deferred for 21.11.2013 43
Case No.:6/10/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00189/AM14/ RLA File :05/24/040/00480/AM13/ Lic.No/Date:0510350030 22.03.2013 Defer Date:21.11.2013 44
Case No.:61/10/82ALC4/2013
Party Name:GRANULES INDIA LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00244/AM14/ RLA File :09/24/040/00610/AM13/ Lic.No/Date:0910055505 22.03.2013 Defer Date:21.11.2013 45
Case No.:19/10/82ALC4/2013
Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00202/AM14/ RLA File :09/24/040/00601/AM13/ Lic.No/Date:0910055530 25.03.2013 Defer Date:24.10.2013 Decision : It was decided to remind the firm to furnish the following information: 1. Justification for 10% wastage for rubber stoppers and flip of seas. 2. Use/applicaiton of import inputs Nos. 4 to 12 in manufaturing of Revac B (1). 3. In DML aluminium hydroxyl Gel is mentioned as 0.5 mg as Al+++ whereas its impoet quantity is is liters. Please provide information on mgs of Al+++ present in l ml of aluminium hydroxyl Gel. 46
Case No.:20/10/82ALC4/2013
Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00203/AM14/ RLA File :09/24/040/00605/AM13/ Lic.No/Date:0910055537 25.03.2013 Defer Date:21.11.2013 Decision : It was decided to remind the firm to furnish the following information: 1. Justification for 10% wastage for rubber stoppers and flip of seas. 2. Use/applicaiton of import inputs Nos. 4 to 12 in manufaturing of Revac B (1).
3. In DML aluminium hydroxyl Gel is mentioned as 0.5 mg as Al+++ whereas its impoet quantity is is liters. Please provide information on mgs of Al+++ present in l ml of aluminium hydroxyl Gel. 47
Case No.:55/10/82ALC4/2013
Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00238/AM14/ RLA File :09/24/040/00602/AM13/ Lic.No/Date:0910055529 25.03.2013 Defer Date:21.11.2013 Decision : It was decided to remind the firm to furnish the following information: 1. Justification for 10% wastage for rubber stoppers and flip of seas. 2. Use/applicaiton of import inputs Nos. 4 to 12 in manufaturing of Revac B (1). 3. In DML aluminium hydroxyl Gel is mentioned as 0.5 mg as Al+++ whereas its impoet quantity is is liters. Please provide information on mgs of Al+++ present in l ml of aluminium hydroxyl Gel. 48
Case No.:9/8/82ALC4/2013
Party Name:GULBRANDSEN CHEMICALS PVT LTD 24.10.2013 HQ File :01/82/050/00140/AM14/ RLA File :34/24/040/00311/AM13/ Lic.No/Date:3410036520 25.03.2013 Defer Date: Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/49/2011‐Ch II dated 19.08.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Monobutyl Tin Trichloride (MBTC) 1 kg OR 1 kg 1. Tin Ingots 530.500 kg 2. Aluminium Granules/Grit 79.000kg Dibutyl Tin Oxide (DBTO) 3. Butene‐1 591.00 kg
49
Case No.:113/14/82ALC4/2013
Party Name:PARAMOUNT AROMACHEM PVT.LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00698/AM14/ RLA File :05/24/040/00488/AM13/ Lic.No/Date:0510350269 26.03.2013 Defer Date:21.11.2013 Decision : It was decided to defer the case 21.11.2013 for comments of Department of Chemicals and Petrochemicals. 50
Case No.:119/10/82ALC4/2013
Party Name:MICRO ORGOCHEM 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00302/AM14/ RLA File :03/95/040/00672/AM13/ Lic.No/Date:0310729719 26.03.2013 Defer Date:21.11.2013 51
Case No.:14/8/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 24.10.2013 HQ File :01/82/050/00145/AM14/ RLA File :09/24/040/00615/AM13/ Lic.No/Date:0910055544 26.03.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/483/2013PI(Norms) dated 21.10.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Kg/kg CYANO ACETIC ACID 98% 1 kg 1. CYANO ACETIC ACID 70% SOLUTION 1.587 2. METHYL ISO BUTYL KETONE (MIBK) 1.25 52
Case No.:33/2/82ALC4/2013
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/01480/AM13/ RLA File :05/24/040/00481/AM13/ Lic.No/Date:0510350279 26.03.2013 Defer Date:21.11.2013 53
Case No.:13/8/82ALC4/2013
Party Name:SARACA LABORATORIES LTD 24.10.2013 Status:Deffered and Reindexed
HQ File :01/82/050/00144/AM14/ RLA File :09/24/040/00598/AM13/ Lic.No/Date:0910055571 27.03.2013 Defer Date:21.11.2013 54
Case No.:117/10/82ALC4/2013
Party Name:PRASOL CHEMICALS LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00300/AM14/ RLA File :03/95/040/00881/AM13/ Lic.No/Date:0310729886 28.03.2013 Defer Date:21.11.2013 55
Case No.:146/10/82ALC4/2013
Party Name:GALAXY SURFACTANTS LTD., 24.10.2013 Status: Approved HQ File :01/82/050/00329/AM14/ RLA File :03/94/040/01113/AM13/ Lic.No/Date:0310729942 01.04.2013 Defer Date: Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/148/2011‐Ch II dated 03.09.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Cocomonoetbanlamide 1 kg 1. Coconut fa洄�y Acid 0.830 kg 2. Mono Ethanolamine 0.243 kg 56
Case No.:216/10/82ALC4/2013
Party Name:GULBRANDSEN CHEMICALS PVT LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00399/AM14/ RLA File :34/24/040/00319/AM13/ Lic.No/Date:3410036563 01.04.2013 Defer Date:21.11.2013 Decision : It was decided to defer the case 21.11.2013 for comments of Department of Chemicals and Petrochemicals. 57
Case No.:4/8/82ALC4/2013
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00135/AM14/ RLA File :03/95/040/00899/AM13/ Lic.No/Date:0310729960 01.04.2013 Defer Date:21.11.2013
Decision : It was decided to remind the firm to furnish the following information sought by Department of Chemicals and Petrochemicals vide their letter dated 1.3.2013: Purity of Import item. Purity of export item. The case was deferred for 21.11.2013. 58
Case No.:42/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00225/AM14/ RLA File :09/24/040/00635/AM13/ Lic.No/Date:0910055653 02.04.2013 Defer Date:21.11.2013 Decision : Department of Biotechnology vide their letter No. BT/IL/05/382/2013PID dated 29.08.2013 has mentioned that the norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type B (HIB) Combined vaccine with vaccine vial monitar (VVM) (5000000.00) against the import inputs mentioned in the application. You are requested to furnish the following information: Drug Manufaturing Licensing of the export product (DML encloased with the application does not mention the export product. To submit QA approved Batch Manufacturing Record. 59
Case No.:85/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00268/AM14/ RLA File :09/24/040/00636/AM13/ Lic.No/Date:0910055652 02.04.2013 Defer Date:21.11.2013 Decision : Department of Biotechnology vide their letter No. BT/IL/05/382/2013PID dated 29.08.2013 has mentioned that the norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type B (HIB) Combined vaccine with vaccine vial monitar (VVM) (5000000.00) against the import inputs mentioned in the application. You are requested to furnish the following information: Drug Manufaturing Licensing of the export product (DML encloased with the application does not mention the export product. To submit QA approved Batch Manufacturing Record. 60
Case No.:11/8/82ALC4/2013
Party Name:PREMIER INDUSTRIES Status:Deffered and
24.10.2013 Reindexed HQ File :01/82/050/00142/AM14/ RLA File :50/24/040/00020/AM13/ Lic.No/Date:5010001635 03.04.2013 Defer Date:21.11.2013 Decision : It was decided to defer the case 21.11.2013 for comments of Department of Chemicals and Petrochemicals. 61
Case No.:148/10/82ALC4/2013
Party Name:ANTHEA AROMATICS PVT.LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00331/AM14/ RLA File :03/94/040/00996/AM13/ Lic.No/Date:0310730232 03.04.2013 Defer Date:21.11.2013 Decision : It was decided to defer the case 21.11.2013 for comments of Department of Chemicals and Petrochemicals. 62
Case No.:37/10/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00220/AM14/ RLA File :09/24/040/00004/AM14/ Lic.No/Date:0910055673 03.04.2013 Defer Date:21.11.2013 63
Case No.:82/10/82ALC4/2013
Party Name:VEGESNA LABORATORIES PRIVATE LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00265/AM14/ RLA File :09/24/040/00637/AM13/ Lic.No/Date:0910055659 03.04.2013 Defer Date:21.11.2013 64
Case No.:20/8/82ALC4/2013
Party Name:RAY CHEMICALS PRIVATE LIMITED, 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00151/AM14/ RLA File :07/24/040/00518/AM13/ Lic.No/Date:0710094644 04.04.2013 Defer Date:21.11.2013 65
Case No.:147/10/82ALC4/2013
Party Name:CONCEPT PHARMACEUTICALS LTD., Meet No/Date:14/82ALC4/2013 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00330/AM14/ RLA File :03/94/040/00004/AM14/ Lic.No/Date:0310730523 05.04.2013 Defer Date:21.11.2013 Decision : It was decided to defer the case 21.11.20s13 for comments of Department of Chemicals and Petrochemicals.
66
Case No.:17/10/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00200/AM14/ RLA File :05/24/040/00478/AM13/ Lic.No/Date:0510350968 08.04.2013 Defer Date:21.11.2013 67
Case No.:4/10/82ALC4/2013
Party Name:ESTEEM INDUSTRIES PVT. LTD, 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00187/AM14/ RLA File :17/24/040/00001/AM14/ Lic.No/Date:1710005280 08.04.2013 Defer Date:21.11.2013 68
Case No.:120/10/82ALC4/2013
Party Name:MEHTA API PVT LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00303/AM14/ RLA File :03/95/040/00020/AM14/ Lic.No/Date:0310730905 09.04.2013 Defer Date:21.11.2013 69
Case No.:38/10/82ALC4/2013
Party Name:ARENE LIFE SCIENCES LIMITED. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00221/AM14/ RLA File :09/24/040/00613/AM13/ Lic.No/Date:0910055691 09.04.2013 Defer Date:21.11.2013 70
Case No.:166/14/82ALC4/2013
Party Name:R L FINE CHEM 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00751/AM14/ RLA File :07/24/040/00153/AM14/ Lic.No/Date:0710097749 23.08.2013 Defer Date:05.12.2013 302
Case No.:71/14/82ALC4/2013
Party Name:SAURAV CHEMICALS LTD, 24.10.2013 Status: Approved HQ File :01/82/050/00656/AM14/ RLA File :22/24/040/00037/AM14/ Lic.No/Date:2210014159 26.08.2013 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 15/82 dated 09.08.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg L‐PROLINE BENZYL ESTER HYDROCHLORIDE Kg 1. L‐PROLINE 0.60
BENZYL ALCOHOL 0.676 303
Case No.:116/14/82ALC4/2013
Party Name:UNIJULES LIFE SCIENCES LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00701/AM14/ RLA File :03/95/040/00215/AM14/ Lic.No/Date:0310747079 27.08.2013 Defer Date:05.12.2013 304
Case No.:152/14/82ALC4/2013
24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00737/AM14/ RLA File :09/24/040/00211/AM14/ Lic.No/Date:0910057368 27.08.2013 Defer Date:05.12.2013 305
Case No.:31/14/82ALC4/2013
Party Name:GULBRANDSEN CHEMICALS PVT LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00616/AM14/ RLA File :34/24/040/00117/AM14/ Lic.No/Date:3410037748 27.08.2013 Defer Date:05.12.2013 306
Case No.:64/14/82ALC4/2013
24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00649/AM14/ RLA File :09/24/040/00215/AM14/ Lic.No/Date:0910057367 27.08.2013 Defer Date:05.12.2013 307
Case No.:111/14/82ALC4/2013
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:14/82ALC4/2013 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00696/AM14/ RLA File :03/95/040/00435/AM14/ Lic.No/Date:0310747304 28.08.2013 Defer Date:05.12.2013 308
Case No.:63/14/82ALC4/2013
Party Name:ASTRIX LABORATORIES LTD., Status:Deffered and
24.10.2013 Reindexed HQ File :01/82/050/00648/AM14/ RLA File :09/24/040/00213/AM14/ Lic.No/Date:0910057393 28.08.2013 Defer Date:05.12.2013 309
Case No.:146/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00731/AM14/ RLA File :03/95/040/00429/AM14/ Lic.No/Date:0310747495 29.08.2013 Defer Date:05.12.2013 310
Case No.:97/14/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00682/AM14/ RLA File :04/24/040/00122/AM14/ Lic.No/Date:0410149281 29.08.2013 Defer Date:05.12.2013 311
Case No.:35/14/82ALC4/2013
Party Name:VIRCHOW PETROCHEMICAL PVT LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00620/AM14/ RLA File :09/24/040/00232/AM14/ Lic.No/Date:0910057435 30.08.2013 Defer Date:05.12.2013 312
Case No.:51/14/82ALC4/2013
Party Name:RATNAMANI BIO CHEMICALS & PHARMACEUTICALS PVT. LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00636/AM14/ RLA File :34/24/040/00125/AM14/ Lic.No/Date:3410037783 02.09.2013 Defer Date:05.12.2013 313
Case No.:163/14/82ALC4/2013
Party Name:ADCOCK INGRAM LTD, 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00748/AM14/ RLA File :07/24/040/00179/AM14/ Lic.No/Date:0710097974 03.09.2013 Defer Date:05.12.2013 Decision : In the light of earlier decision taken in mee󠅃ng no. 4/82 dated 16.05.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as
Export product Exp. Qty. Sl.No. Import items Qty. allowed Syndol Tabs – Paracetamol 450 mg + Caffeine 30 mg + Doxylamine Succinate 5 mg +Codeine Phosphate 10 mg Tablets 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phsophate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 1.632 kg Adco Dol Tab – Paracetamol 450 mg+ Codeine Phosphate 10 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 2.43 kg 4. Colour Quinoline Yellow WS (spectracol) 4.56 kg Betapyn Tabs – Tablets containing Paracetamol 450 mg +Caffeine 50 mg +Doxylamine Succinate 5 mg+ Codeine Phsophate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 IH Do not match with MBF Pynstop Tabs – tablets containing Paracetamol 450 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg+Codeine Phosphate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 314
Case No.:164/14/82ALC4/2013
Party Name:ADCOCK INGRAM LTD, 24.10.2013 Status: Approved HQ File :01/82/050/00749/AM14/ RLA File :07/24/040/00178/AM14/ Lic.No/Date:0710097975 03.09.2013 Defer Date: Decision : In the light of earlier decision taken in mee󠅃ng no. 4/82 dated 16.05.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Acurate Tabs Paracetamol 450 mg+Doxylamine Succinate 5 1 no. of tablet 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 mg 2. CaffeineAnhydrous BP 30.6 mg
mg+Caffeine 30 mg+Codeine Phosphate 10 mg+Colour quinolone Yellow 2 mg Tablets 2010/USP/EP/PH. EUR/BP 3. Codiene Phsophate BP/USP/EP/PH. EUR 10.2 mg 4. Color Quinoline Yellow CI 47005 2.0 mg 315
Case No.:50/14/82ALC4/2013
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 24.10.2013 Status: Apporved HQ File :01/82/050/00635/AM14/ RLA File :05/24/040/00195/AM14/ Lic.No/Date:0510364317 03.09.2013 Defer Date: Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/28/2012‐Ch II dated 28.10.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed MENTHOL 1 kg 1. META ‐ CRESOL ABOVE 98.5% PURE 1.50 kg 2. ISO PROPYL ALCOHOL 1.80 kg 316
Case No.:114/14/82ALC4/2013
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00699/AM14/ RLA File :03/95/040/00444/AM14/ Lic.No/Date:0310748199 04.09.2013 Defer Date:05.12.2013 317
Case No.:70/14/82ALC4/2013
Party Name:INDSWIFT LABORATORIES LTD., 24.10.2013 Status: Approved HQ File :01/82/050/00655/AM14/ RLA File :22/24/040/00039/AM14/ Lic.No/Date:2210014184 04.09.2013 Defer Date: Decision : In the light of earlier decision taken in mee󠅃ng no. 10/82 dated 22.08.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:
Export product Export Qty. Sl.No. Import items Qty. allowed Clarithromycin Granules 27.5% (Suspension Grade) 1kg. 1. Clarithromycin (OR) 0.2777 kg Its raw material as per SION A‐ 2263 on pro‐rata basis 2. Carbopol 0.20 kg 3. HPMC Phthalate 0.54 kg 318
Case No.:29/14/82ALC4/2013
Party Name:MAITHRI LABORATORIES (P) LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00614/AM14/ RLA File :09/24/040/00242/AM14/ Lic.No/Date:0910057495 05.09.2013 Defer Date:05.12.2013 319
Case No.:53/14/82ALC4/2013
Party Name:STERILE INDIA PRIVATE LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00638/AM14/ RLA File :05/24/040/00203/AM14/ Lic.No/Date:0510364653 05.09.2013 Defer Date:05.12.2013 320
Case No.:54/14/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00639/AM14/ RLA File :05/23/040/00233/AM14/ Lic.No/Date:0510364656 05.09.2013 Defer Date:05.12.2013 321
Case No.:103/14/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00688/AM14/ RLA File :08/24/040/00242/AM14/ Lic.No/Date:0810124544 06.09.2013 Defer Date:05.12.2013 322
Case No.:176/14/82ALC4/2013
Party Name:AMI LIFESCIENCES P LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00761/AM14/ RLA File :34/24/040/00132/AM14/ Lic.No/Date:3410037845 Defer
06.09.2013 Date:05.12.2013 323
Case No.:30/14/82ALC4/2013
Party Name:HONEST BIOVET PVT. LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00615/AM14/ RLA File :08/24/040/00250/AM14/ Lic.No/Date:0810124568 06.09.2013 Defer Date:05.12.2013 324
Case No.:56/14/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00641/AM14/ RLA File :13/24/040/00021/AM14/ Lic.No/Date:1310044273 09.09.2013 Defer Date:05.12.2013 325
Case No.:149/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00734/AM14/ RLA File :03/95/040/00465/AM14/ Lic.No/Date:0310748925 10.09.2013 Defer Date:05.12.2013 326
Case No.:150/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00735/AM14/ RLA File :03/95/040/00459/AM14/ Lic.No/Date:0310748979 10.09.2013 Defer Date:05.12.2013 327
Case No.:161/14/82ALC4/2013
Party Name:ADCOCK INGRAM LTD, 24.10.2013 Status: Approved HQ File :01/82/050/00746/AM14/ RLA File :07/24/040/00172/AM14/ Lic.No/Date:0710098184 10.09.2013 Defer Date: Decision : In the light of earlier decision taken in mee󠅃ng no. 4/82 dated 16.05.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Syndol Tabs – Paracetamol 1 million 1. Doxylamine Succinate USP/Ph. EUr 5.10 kg
y 450 mg + Caffeine 30 mg + Doxylamine Succinate 5 mg +Codeine Phosphate 10 mg Tablets tablets y Grade g 2. Codiene Phsophate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 1.632 kg Adco Dol Tab – Paracetamol 450 mg+ Codeine Phosphate 10 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 2.43 kg 4. Colour Quinoline Yellow WS (spectracol) 4.56 kg Betapyn Tabs – Tablets containing Paracetamol 450 mg +Caffeine 50 mg +Doxylamine Succinate 5 mg+ Codeine Phsophate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 IH Do not match with MBF Pynstop Tabs – tablets containing Paracetamol 450 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg+Codeine Phosphate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 328
Case No.:154/14/82ALC4/2013
Party Name:CADILA PHARMACEUTICALS LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00739/AM14/ RLA File :08/24/040/00264/AM14/ Lic.No/Date:0810124684 11.09.2013 Defer Date:05.12.2013 329
Case No.:155/14/82ALC4/2013
Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. 24.10.2013 Status: Approved HQ File :01/82/050/00740/AM14/ RLA File :03/94/040/00494/AM14/ Lic.No/Date:0310749114 11.09.2013 Defer Date: Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/129/2011‐Ch II dated 04.06.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed
STEARYL ERUCAMIDE 1. ERUCIC ACID 0.592 kg 2. STEARYL AMINE 0.471 kg 330
Case No.:69/14/82ALC4/2013
Party Name:ONEIRO CHEMICALS LTD 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00654/AM14/ RLA File :34/24/040/00138/AM14/ Lic.No/Date:3410037862 11.09.2013 Defer Date:05.12.2013 331
Case No.:72/14/82ALC4/2013
Party Name:SAURAV CHEMICALS LTD, 24.10.2013 Status: Approved HQ File :01/82/050/00657/AM14/ RLA File :22/24/040/00042/AM14/ Lic.No/Date:2210014205 11.09.2013 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 1/82 dated 04.04.2013 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg LEVOFLOXACIN HEMIHYDRATE Kg 1. LEVOFLOXACIN Q ACID 0.8571 kg 332
Case No.:5/12/82ALC4/2013
Party Name:AUCTUS PHARMA LIMITED 24.10.2013 indexed HQ File :01/82/050/00429/AM14/ RLA File :09/24/040/00277/AM14/ Lic.No/Date:0910057572 13.09.2013 333
Case No.:52/14/82ALC4/2013
Party Name:JUBILANT LIFE SCIENCES LIMITED 24.10.2013 Status: Approved HQ File :01/82/050/00637/AM14/ RLA File :05/23/040/00242/AM14/ Lic.No/Date:0510365511 Defer Date:
Q 13.09.2013 Decision : Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to ratify norms under Para 4.7 of HBP v1 as per SION A412 with 2 % wastage. RA concerned may take further necessary action as per above decision of NC. 334
Case No.:151/14/82ALC4/2013
Party Name:THINQ PHARMACRO LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00736/AM14/ RLA File :03/95/040/00432/AM14/ Lic.No/Date:0310749651 16.09.2013 Defer Date:05.12.2013 335
Case No.:112/14/82ALC4/2013
Party Name:V.D.H. ORGANICS PVT. LTD 24.10.2013 Status: Approved HQ File :01/82/050/00697/AM14/ RLA File :05/24/040/00218/AM14/ Lic.No/Date:0510365901 17.09.2013 Defer Date:05.12.2013 Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/129/2011‐Ch II dated 04.06.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed THYMOL CRYSTAL (2‐isopropyl‐ 5‐methylphenol) Purity 99% and above 1 kg 1. META CRESOLS (M‐CRESOL) 0.0785 kg 336
Case No.:98/14/82ALC4/2013
Party Name:V.D.H. ORGANICS PVT. LTD 24.10.2013 Status: Approved HQ File :01/82/050/00683/AM14/ RLA File :05/24/040/00217/AM14/ Lic.No/Date:0510365900 17.09.2013 Defer Date:05.12.2013 Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/129/2011‐Ch II dated 04.06.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed THYMOL CRYSTAL (2‐isopropyl‐ 5‐methylphenol) Purity 99% and above 1 kg 1. META CRESOLS (M‐CRESOL) 0.0785 kg
337
Case No.:55/14/82ALC4/2013
Party Name:SAIBABA SURFACTANTS (P) LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00640/AM14/ RLA File :08/24/040/00268/AM14/ Lic.No/Date:0810124942 19.09.2013 Defer Date:05.12.2013 Decision : It was decided to defer the case for 05.12.2013 for comments of Department of C&PC.. 338
Case No.:68/14/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00653/AM14/ RLA File :09/24/040/00283/AM14/ Lic.No/Date:0910057606 19.09.2013 Defer Date:05.12.2013 339
Case No.:3/13/82ALC4/2013
Party Name:PI INDUSTRIES LTD., 24.10.2013 Status: Approved HQ File :01/82/050/00479/AM14/ RLA File :13/24/040/00025/AM14/ Lic.No/Date:1310044453 24.09.2013 Defer Date: Decision : Committee considered case as per agenda and in light of earlier decision taken in meeting no. 24/82 dated 15.11.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg MIPD KETAL (1E)‐1‐(2,5,5‐ Trimethyl‐1,3‐Dioxane‐2‐yl)‐ Propane‐1,2‐Dione‐1‐(O‐ methyl oxime) 1 kg 1 Acetyl Acetone 0.578 2. Methyl Ter󠅃ary Butyl Ether (MTBE HP 99.9 PCT) 0.583 3. Di Methyl Formamide 0.300 4. Neo Pentyl Glycol (NPG) 0.503 5. Potassium Carbonate Granule 0.950 6. Sodium Nitrite 0.412 7. Toluene 0.273 8. Methanol 0.258
340
Case No.:3/14/82ALC4/2013
Party Name:BAL PHARMA LTD 24.10.2013 Status: Apporved HQ File :01/82/050/00588/AM14/ RLA File :07/24/040/00213/AM14/ Lic.No/Date:0710098759 03.10.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 04.04.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amiloride HCL 1 kg 1. Methyl 3,5Diamino6Chloro Pyrazine2 Carboxylate 0.836 kg 341
Case No.:4/14/82ALC4/2013
Party Name:SHILPA MEDICARE LTD., 24.10.2013 Status: Approved HQ File :01/82/050/00589/AM14/ RLA File :07/24/040/00230/AM14/ Lic.No/Date:0710098799 04.10.2013 Defer Date: Decision : : In line with the earlier decision taken in meeting no. 9/82 dated 25.7.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Gemcitabine 1 Kg. 1. 4Amino1(3,3difluoro4hydroxy 5(Hydroxymethyl) Tetrahydrofuran 2yl)1HPyrimidine2one (Technical Grade) 0.923 kg RA may take appropriate action as per the decision of Norms Committee. 342
Case No.:5/14/82ALC4/2013
Party Name:SHILPA MEDICARE LTD., 24.10.2013 Status: Approved HQ File :01/82/050/00590/AM14/ RLA File :07/24/040/00229/AM14/ Lic.No/Date:0710098798 04.10.2013 Defer Date: Decision : In line with the earlier decision taken in meeting no. 9/82 dated 25.7.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Gemcitabine 1 Kg. 1. 4Amino1(3,3difluoro4hydroxy 5(Hydroxymethyl) Tetrahydrofuran 0.923 kg
2yl)1HPyrimidine2one (Technical Grade) RA may take appropriate action as per the decision of Norms Committee. 343
Case No.:6/14/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00591/AM14/ RLA File :09/24/040/00319/AM14/ Lic.No/Date:0910057838 07.10.2013 Defer Date:05.12.2013 344
Case No.:7/14/82ALC4/2013
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00592/AM14/ RLA File :03/94/040/00478/AM14/ Lic.No/Date:0310752448 07.10.2013 Defer Date:05.12.2013 345
Case No.:8/14/82ALC4/2013
Party Name:AARTI DRUGS LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00593/AM14/ RLA File :03/94/040/00549/AM14/ Lic.No/Date:0310752488 07.10.2013 Defer Date:05.12.2013 346
Case No.:9/14/82ALC4/2013
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00594/AM14/ RLA File :03/94/040/00515/AM14/ Lic.No/Date:0310752496 07.10.2013 Defer Date:05.12.2013 347
Case No.:25/14/82ALC4/2013
Party Name:VIVIMED LABS LIMITED 24.10.2013 Status: Approved HQ File :01/82/050/00610/AM14/ RLA File :09/24/040/00341/AM14/ Lic.No/Date:0910057883 09.10.2013 Defer Date: Decision : In the light of wri洄�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/102/2011‐Ch II dated 20.05.2013, it was decided to ra󠅃fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed
p p p Q y p Q y REVERSACOL OLIVINE 1 kg 1. 3,4‐dimethoxy Benzophenone 3.00 kg 2. Dimethyl Succinate(DMS) 7.77 kg 3. 4,4 Dimethoxy Benzophenone 1.77 kg 4. Trimethyl Silyl Acetate (TMSA) 0.91 kg 5. Siralox 2.88 kg 6. Toluene 24.44 kg 7. Tetra Hydro Furan(THF) 9.695 kg 8. Methanol 33.325 kg 9. Hexane 4.00 kg 10. Xylene 8.332 kg 348
Case No.:73/14/82ALC4/2013
Party Name:MSN LABORATORIES PRIVATE LIMITED 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00658/AM14/ RLA File :09/24/040/00325/AM14/ Lic.No/Date:0910057878 09.10.2013 Defer Date:05.12.2013 349
Case No.:174/14/82ALC4/2013
Party Name:JAINEX SPECIALITY CHEMICAL 24.10.2013 Status:Deffered and Reindexed HQ File :01/82/050/00759/AM14/ RLA File :34/24/040/00170/AM14/ Lic.No/Date:3410038226 18.10.2013 Defer Date:05.12.2013 Outside Agenda No. 1 M/s. ENALTEC LABS PVT.LTD., Mee󠅃ng No. 14/AM 14 Dated 24.10.2013. F.No. 01/82/50/00147/AM14/DES III RLA F. No. 03/94/040/01040/AM13 Adv. Lic. No. 0310728023 dated 13.03.2013 Decision: It was decided to amend the description of import items without any other changes as details given
below: Export product Exp. Qty. Sl.No. Import items Qty. allowed Montelukast Sodium 1 kg 1. 2[3(S)[3[2(7 CHLOROQUINOLINE2 YL) ETHENYL]PHENYL]3 HYDROXYPROPYL ] BENZENE2PROPANOL 1.424 kg 2 2(1MERCAPTOMETHYL) CYCLOPROPYL) ACETIC ACID 0.52 kg Outside Agenda No. 2 M/s. Indian Immunologicals Limited Mee󠅃ng No. 14/AM 14 Dated 24.10.2013. 01/82/050/01379/AM 11/DES‐III 01/82/050/01259/AM 11/DES III Advance License No. 0910042621 dated 06.07.2010 0910043933 dated 15.10.2010 RLA F.No. 09/24/040/00004/AM11 RLA F.No. 09/24/040/00301/AM11 Decision: The norms for the above mentioned advance licenses were ratified by NC in its meeting no. 2/AM13 dated 18.04.2013. It was decided to amend the description of advance authorization as 0910043933 dated 15.10.2010 instead of adv. Lic. No.0910042621 dated 6.7.2010 (which was earlier men󠅃oned as same advance authoriza󠅃on twice instead of two different adv. Lic. NOs.) (amend the export quantity from “1 Unit (1000
adv. Lic. No.0910042621 dated 6.7.2010 (which was earlier men󠅃oned as same advance authoriza󠅃on twice instead of two different adv. Lic. NOs.) (amend the export quantity from “1 Unit (1000 vials) to 1 unit (1000 doses)..Rest of the minutes would remain same. Outside Agenda No.3 M/s Relaince Life Sciences Pvt. Ltd. Ltd Meeting No. 14/AM 14 Dated 24.10.2013 F.No. 01/82/50/985/AM12/DESIII RLA F. No. 03/95/040/538/AM12 Adv. Lic. No.0310668193 dated 30.11.2011 Decision : Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo. RA concerned may take further necessary action as per above decision of NC.
Date:22.10.2013 Place:New Delhi R.C.Meena Dy. Director General of Foreign Trade
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