DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision
MEETING NUMBER : 24/82‐ALC4/2008 MEETING DATE : 09.09.2008 The Meeting No.24/09 in the year 2008‐09 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 09.09.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. Following members were present:‐ 1. Shri Jasbir Singh, IA, Chemical Division, C & PC 2. Shri D.N. Mathur, Dy. IA, PI Division, C & PC. 3. Shri Rajinder Pal Singh, Dy. DGFT 4. Shri Shyam Lal, FTDO At the outset minutes of Norms Committee Meeting No.21/09 dated 19.08.2008 and No.22/09 dated 26.08.2008 were ratified by the Committee.
Case No.B‐181
M/S Yasho Industries Pvt. Ltd Norms Committee Meeting No.24/09 F.No.01/82/050/585/AM08 Meeting Date: 09.09.2008 RA F.No.03/95/040/01141/AM08 Adv.Lic.No.0310462797 dated 26.02.2008 Committee considered case as per agenda for ratification of norms and in consultation with technical authority present in meeting and taking a cue from SION at S.No.967, 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 Yantq 2020 (20% Solution of Tertiary Butyl Hydroquinone) 1 Kg. 1. Hydroquinone 0.282 kg 2. Tertiary Butanol 0.208 Kg. 3. Propylene Glycol Not allowed as technical literature for use of this item in Export Product not given. RA concerned may take further necessary action as per above decision of NC.
Case No.B‐182
M/S Vivimed Labs Ltd F.No.01/83/050/01552/AM08 RA F.No.09/24/040/00311/AM08 Adv.Lic.No.0910032056 dated 12.11.2007 Committee decided to defer case for 07.10.2008 for comments of PI Division.
Case No.B‐183
M/S Vivimed Labs Ltd F.No.01/82/050/479/AM09 RA F.No.09/24/040/00421/AM08 Adv.Lic.No.0910032245 dated 28.11.2007 Committee considered case as per agenda and in light of its earlier decision taken in its 21/09 meeting held on 19.08.2008 and in consultation with technical authority present in meeting decided to enhance the quantity of Methanol to read as 2.056 kg. in the minutes of NC 12/82 dt. 17.6.2008.
Case No.B‐184
M/S Redox Pharmachem Pvt. Ltd F.No.01/82/050/440/AM08 RA F.No.05/24/040/00500/AM08 Adv.Lic.No.0510210770 dated 18.10.2007 Committee decided to defer case for 07.10.2008 for comments of Chemical Division.
Case No.B‐185
M/S Medreich Ltd F.No.01/83/050/313/AM08 RA F.No.07/24/40/651/AM08 Adv.Lic.No.0710055104 dated 26.12.2007 Committee considered the case as per agenda for enhancement in the quantity of inputs and in consultation with technical authority present in meeting decided to maintain status quo as there is no justification for enhancement in the quantity of inputs.
Case No.B‐186
M/S Salicylates and Chemicals Pvt. Ltd. F.No.01/83/050/527/AM08 RA F.No.09/24/040/00075/AM08
Adv.Lic.No.0910030571 dated 15.06.2007 Committee decided to defer case for 07.10.2008 for comments of Chemical Division.
Case No.B‐187
M/S Medreich Ltd F.No.01/83/050/1790/AM07 RA F.No.07/24/40/718/AM07 Adv.Lic.No.0710049763 dated 24.01.2007 Committee decided to defer case for 07.10.2008 for comments of PI Division.
Case No.B‐188
M/S Shilpa Medicare Ltd. F.No.01/83/050/01418/AM08 RA F.No.07/24/040/00420/AM08 Adv.Lic.No.0710054000 dated 24.10.2007 Committee considered the case as per agenda for enhancement in the quantity of inputs and in consultation with technical authority present in meeting decided to maintain status quo as there is no justification for enhancement in the quantity of inputs. Firm may be advised to apply for revision of SION, if they so desire, as per procedure.
Case No.B‐189
M/S Medreich Ltd. F.No.01/83/050/48/AM08 RA F.No.07/24/40/810/AM08 Adv.Lic.No.0710050467 dated 06.03.2007 Committee decided to defer case for 07.10.2008 for comments of PI Division.
Case No.B‐190
M/S Srini Pharmaceuticals Ltd. F.No.01/83/050/1613/AM08 RA F.No.09/24/040/00385/AM08 Adv.Lic.No.0910032245 dated 28.11.2007 Committee considered the case as per agenda for enhancement in the quantity of inputs and in consultation with technical authority present in meeting decided to maintain status quo as there is no justification for enhancement in the quantity of inputs.
Case No.B‐191
M/S Redox Pharmachem Pvt. Ltd. F.No.01/82/050/600/AM09 RA F.No.05/24/040/00190/AM09 Adv.Lic.No.051022426 dated 19.06.2008 Committee decided to defer case for 07.10.2008 for comments of Chemical Division.
Case No.B‐192
M/S Innovative Healthcare India Pvt. Ltd F.No.01/85/050/227/AM06 RA F.No.04/24/40/372/AM06 Adv.Lic.No.0410078032 dated 18.01.2006 Committee decided to defer case for 07.10.2008 for comments of Department of MSME.
Case No.B‐193
M/S Medreich Ltd F.No.01/82/050/421/AM08 RA F.No.07/24/40/375/AM08 Adv.Lic.No.0710053068 dated 27.08.2007 Committee considered case as per agenda and observed that the Advance Licence was issued on 27.08.2007 and inputs have been allowed as per DML issued to the firm in 2006. Committee also observed that the firm has got the DML amended in 2008 and have requested to allow inputs against Advance Licence issued during 2007 based on DML amended in 2008. It was, therefore, decided to maintain status quo.
Case No.B‐194
M/S Lepro Herbals Pvt. Ltd. F.No.01/83/050/1355/AM08 RA F.No.05/24/40/546/AM08 Adv.Lic.No.0510210501 dated 15.10.2007 Committee considered the case as per agenda for enhancement in the quantity of inputs and in consultation with technical authority present in meeting decided to maintain status quo as there is no justification for enhancement in the quantity of inputs.
Case No.B‐195
M/S Scitech Specialities Pvt. Ltd F.No.01/82/050/580/AM08 RA F.No.03/95/040/01130/AM08 Adv.Lic.No.0310461460 dated 18.02.2008
Committee decided to defer case for 07.10.2008 for comments of Chemical Division.
Case No.B‐196
M/S Sterling Auxiliaries Pvt. Ltd. F.No.01/82/050/449/AM08 RA F.No.03/95/040/00634/AM08 Adv.Lic.No.0310450751 dated 20.11.2007 Committee decided to defer case for 07.10.2008 for comments of Chemical Division.
Case No.B‐197
M/S Shilpa Medicare Ltd F.No.01/82/050/379/AM09 RA F.No.07/24/040/00873/AM08 Adv.Lic.No.0710056742 dated 02.04.2008 Committee considered the case as per agenda for enhancement in the quantity of inputs and in consultation with technical authority present in meeting decided to maintain status quo as there is no justification for enhancement in the quantity of inputs.Firm may be advised to apply for revision of SION, if they so desire, as per procedure.
Case No.B‐198
M/S Lepro Herbals Pvt. Ltd. F.No.01/83/050/517/AM07 RA F.No.05/24/40/546/AM08 Adv.Lic.No.0510210501 dated 15.10.2007 Committee considered the case as per agenda for enhancement in the quantity of inputs and in consultation with technical authority present in meeting decided to maintain status quo as there is no justification for enhancement in the quantity of inputs.
Case No.B‐199
M/S Srini Pharma Ltd F.No.01/83/050/678/AM04 RA F.No.09/24/040/00142/AM04 Adv.Lic.No.0910015414 dated 14.08.2003 Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their U.O. No.35011/112/2007‐PI‐III dated 09.09.2008 and in consultation with technical authority present in meeting decided to amend the description and quantity of import item i.e. “3‐Amino‐1‐ Phenylbutane” to read as “3‐Amino‐1‐Phenyl Butane/1‐Methyl‐3‐Phenyl propylamine‐ 2.70 Kgs.” without any
change in other inputs. The earlier decision of ALC taken in respect of same Advance Licence stands amended to above extent.
Case No.B‐200
M/S Monomer Chemical Industries Ltd. F.No.01/82/050/392/AM07 RA F.No.03/95/040/00249/AM07 Adv.Lic.No.0310384771 dated 13.06.2006 Committee in consultation with technical authority present in meeting decided to transfer the case to NC4.
Case No.B‐201
M/S Rallis India Ltd. F.No.01/83/050/90/AM07 RA F.No.03/95/040/01556/AM06 Adv.Lic.No.0310377448 dated 22.04.2006 Committee decided to defer case for 07.10.2008 for comments of PC Division.
Case No.A‐80
M/S Dabur Pharma Ltd F.No.01/82/162/346/AM09 RA F.No.05/24/40/254/AM09 Application under para 4.4.2 of HBP Committee decided to defer case for 07.10.2008 for comments of PI Division. 1
Case No.:71/42/82‐ALC4/2007
Party Name:RALLIS INDIA LIMITED Meet No/Date:24/82‐ALC4/2008 09.09.2008 Status:Case Deferred HQ File :01/82/050/00407/AM08/ RLA File :03/95/040/00251/AM08/ Lic.No/Date:0310433412 21.06.2007 Defer Date:07.10.2008 Decision :Committee decided to defer case for 07.10.2008 for comments of PC Division. 2
Case No.:728/24/83‐ALC1/2007
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.09.2008 Status:Case Rejected
HQ File :01/83/050/00615/AM08/ RLA File :04/24/040/00111/AM08/ Lic.No/Date:0410090132 28.06.2007 Decision :Committee considered the case as per agenda for ratification of norms and observed that the firm was requested to furnish technical information vide letter dated 01.08.2008, but no reply has been received and norms can not be fixed in absence of required information. It was, therefore, decided to close the case. 3
Case No.:730/24/83‐ALC1/2007
Party Name:SUVEN LIFE SCIENCES LIMITED 09.09.2008 Status:Case Rejected HQ File :01/83/050/00623/AM08/ RLA File :09/24/040/00120/AM08/ Lic.No/Date:0910030686 29.06.2007 Decision : Committee considered the case as per agenda for ratification of norms and observed that the firm was requested to furnish technical information vide letter dated 01.08.2008, but no reply has been received and norms can not be fixed in absence of required information. It was, therefore, decided to close the case. 4
Case No.:54/9/82‐ALC4/2008
Party Name:CIPLA LIMITED 09.09.2008 Status:Case Approved HQ File :01/82/050/00287/AM09/ RLA File :03/94/040/00437/AM08/ Lic.No/Date:0310437618 27.07.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No. 35011/83/2008‐PI‐III dated 27.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import items Qty. allowed per kg of Lamivudine Triomune 30 and Triomune 40 tablets (Lamivudine 153 mg/tablet of Triomune 30 and 1 Kg. 1. (1’R, 2’S, 5’R)‐Methyl‐5S‐ (Cytosine‐1”‐YL)‐1,3‐ Oxathiolane‐2R‐ Carboxylate/Cme Compoune 2.19 kg 2. Sodium Borohybride 0.48 kg. 3. Dipotassium Hydrogen Phosphate Not allowed as neither shown in process nor in reaction.
Lamividine 153mg/tablet of Triomune 40) 5
Case No.:21/27/83‐ALC1/2007
Party Name:UMA ORGANICS PVT. LTD. 09.09.2008 Status:Case Approved HQ File :01/83/050/01095/AM08/ RLA File :09/24/040/00207/AM08/ Lic.No/Date:0910031380 03.09.2007 Decision :Case has already been approved by NC in its 23/82 meeting held on 02.09.2008. 6
Case No.:191/27/83‐ALC1/2007
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.09.2008 Status:Case Deferred HQ File :01/83/050/01265/AM08/ RLA File :04/24/040/00235/AM08/ Lic.No/Date:0410091280 01.10.2007 Defer Date:07.10.2008 Decision :Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 07.10.2008. 7
Case No.:95/42/82‐ALC4/2007
09.09.2008 Status:Case Approved HQ File :01/82/050/00431/AM08/ RLA File :03/94/040/00674/AM08/ Lic.No/Date:0310445040 03.10.2007 Decision :Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/83/2008‐ PI‐III dated 27.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Telmisartan and Amlodipine Tablet 40/10 mg (Each uncoated tablet contains Telmisartan Granules 67.36 mg equivalent to Telmisartan 40mg Amlodipine USP 10 mg 1 No. 1. Telmisartan Granules 68.707 mg/tablet Telmisartan and Amlodipine Tablet 80/10 mg 1 No. 1. Telmisartan Granules 137.414 mg/tablet
(Each uncoated tablet contains Telmisartan Granules 134.72 mg equivalent to Telmisartan 80mg Amlodipine USP 10 mg Telmisartan and Amlodipine Tablet 40/5 mg (Each uncoated tablet contains Telmisartan Granules 67.36 mg equivalent to Telmisartan 40mg Amlodipine USP 5 mg 1 No. 1. Telmisartan Granules 68.707 mg/tablet Telmisartan and Amlodipine Tablet 80/5 mg (Each uncoated tablet contains Telmisartan Granules 134.72 mg equivalent to Telmisartan 80mg Amlodipine USP 5 mg 1 No. 1. Telmisartan Granules 137.414 mg/tablet RA Concerned may take further necessary action as per above decision of NC. 8
Case No.:6/9/82‐ALC4/2008
Party Name:MATRIX LABORATORIES LTD 09.09.2008 Status:Case Deferred HQ File :01/82/050/00239/AM09/ RLA File :09/24/040/00243/AM08/ Lic.No/Date:0910031765 12.10.2007 Defer Date:07.10.2008 Decision :Committee decided to defer case for 07.10.2008 for comments of PI Division. 9
Case No.:15/20/82‐ALC4/2008
Party Name:EMAMI LIMITED, 09.09.2008 Status:Case Deferred HQ File :01/82/050/00808/AM09/ RLA File :02/24/040/00183/AM08/ Lic.No/Date:0210106154 19.11.2007 Defer Date:07.10.2008 Decision :Committee decided to defer case for 07.10.2008 for comments of Department of MSME. 10
Case No.:68/39/83‐ALC1/2007
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.09.2008 Status:Case Deferred HQ File :01/83/050/01647/AM08/ RLA File :04/24/040/00289/AM08/ Lic.No/Date:0410092451 30.11.2007 Defer Date:07.10.2008 Decision :Committee considered case as per agenda and observed that the firm has been requested to furnish technical information vide letter dated 14.08.2008. but no reply has been received. It was, therefore, decided to await reply of firm and defer the case for 07.10.2008. 11
Case No.:136/39/83‐ALC1/2007
Party Name:KDAC CHEM PVT LTD 09.09.2008 Status:Case Rejected HQ File :01/83/050/01715/AM08/ RLA File :34/24/040/00182/AM08/ Lic.No/Date:3410020288
10.12.2007 Decision :Committee perused the reply of the firm and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/97/2007‐Ch.II dated 21.07.2007 observed that the firm has not furnished authentic technical literature in support of requirement of Styrene for the manufacture of Phenyl Ethyl alcohol and also the details of manufacturing process given is very sketchy (even the formula of Phenyl Ethyl Alcohol given by the firm is wrong). It was, therefore decided to close the case. 12
Case No.:57/20/82‐ALC4/2008
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00850/AM09/ RLA File :03/95/040/00961/AM08/ Lic.No/Date:0310456184 02.01.2008 Defer Date:07.10.2008 Decision :Committee considered the case as per agenda and observed that the firm was requested to furnish Production and Consumption data certified by Central Excise Authority and Pharmexcil was requested to furnish All Industry data for revision of SION. It was also decided in NC meeting held on 15.7.2008, that if the firm fails to submit data for revision of SIONs of Amodiaquine Base/Amodiaquine Hydrochloride, ad‐hoc norms for these products will not be ratified. However, data has neither been received from firm nor from PHARMEXCIL. It was, therefore, decided to remind the firm and Pharmexcil to furnish the required data and defer the case for 07.10.2008. 13
Case No.:12/42/83‐ALC1/2007
Party Name:PARABOLIC DRUGS LTD., 09.09.2008 Status:Case Deferred HQ File :01/83/050/01788/AM08/ RLA File :22/24/040/00053/AM08/ Lic.No/Date:2210007356 04.01.2008 Defer Date:21.10.2008 Decision :Committee considered case as per agenda and decided to call for technical details as per Appendix 33 from firm. Accordingly, case was deferred for 21.10.2008. 14
Case No.:20/45/82‐ALC4/2007
Party Name:ALKALOIDS CORPORATION 09.09.2008 Status:Case Deferred HQ File :01/82/050/00483/AM08/ RLA File :02/24/040/00272/AM08/ Lic.No/Date:0210107833 04.01.2008 Defer Date:07.10.2008 Decision :Committee decided to defer case for 07.10.2008 for comments of PI Division. 15
Case No.:56/20/82‐ALC4/2008
Party Name:INDO AMINES LIMITED 09.09.2008 Status:Case Deferred
HQ File :01/82/050/00849/AM09/ RLA File :03/94/040/01274/AM07/ Lic.No/Date:0310457744 16.01.2008 Defer Date:07.10.2008 Decision : Committee decided to defer case for 07.10.2008 for comments of Chemical Division. 16
Case No.:54/6/82‐ALC4/2008
Party Name:AUROBINDO PHARMA LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00137/AM09/ RLA File :09/24/040/00526/AM08/ Lic.No/Date:0910033127 28.02.2008 Defer Date:21.10.2008 Decision: Committee decided to call for the copy of Drug Manufacturing licence from firm. Accordingly, case was deferred for 21.10.2008. 17
Case No.:19/12/82‐ALC4/2008
Party Name:SILVASSA PLAST 09.09.2008 Status:Case Approved HQ File :01/82/050/00487/AM09/ RLA File :05/24/040/00917/AM08/ Lic.No/Date:0510217767 12.03.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/30/2008/Ch.III dated 30.06.2008 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 Di‐Propyl Heptyl Phthalate 1 Kg. 1. Propyl Heptanol 0.747 kg. 2. Phthalic Anhydride 0.350 kg 3. HM‐HDPE Granules As per packing policy RA Concerned may take further necessary action as per above decision of NC. 18
Case No.:118/6/82‐ALC4/2008
Party Name:CADILA HEALTHCARE LTD., 09.09.2008 Status:Case Deferred HQ File :01/82/050/00201/AM09/ RLA File :08/24/040/00275/AM08/ Lic.No/Date:0810070672 13.03.2008 Defer Date:21.10.2008
Decision :Committee decided to call for a copy of Drug Manufacturing Licence from firm. Accordingly, case was deferred for 21.10.2008. 19
Case No.:53/6/82‐ALC4/2008
Party Name:KAMUD DRUGS PVT.LIMITED., 09.09.2008 Status:Case Deferred HQ File :01/82/050/00136/AM09/ RLA File :31/24/040/00394/AM08/ Lic.No/Date:3110033090 14.03.2008 Defer Date:07.10.2008 Decision :Committee decided to defer case for 07.10.2008 for comments of PI Division. 20
Case No.:3/24/82‐ALC4/2008
09.09.2008 Status:Case Deferred HQ File :01/82/050/00936/AM09/ RLA File :03/94/040/00073/AM09/ Lic.No/Date:0310468658 16.04.2008 Defer Date:07.10.2008 Decision : Committee decided to defer case for 07.10.2008 for comments of PI Division. 21
Case No.:88/11/82‐ALC4/2008
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 09.09.2008 Status:Case Rejected HQ File :01/82/050/00408/AM09/ RLA File :03/95/040/00039/AM09/ Lic.No/Date:0310469298 23.04.2008 Decision :Committee considered case as per agenda and observed that the firm was request to furnish technical information vide C&PC letter No.14010/96/2005‐Ch.II dated 09.07.2008, but no reply has been received and norms can not be fixed in absence of required information. It was, therefore, decided to close the case. 22
Case No.:5/12/82‐ALC4/2008
09.09.2008 Status:Case Approved HQ File :01/82/050/00473/AM09/ RLA File :03/94/040/00113/AM09/ Lic.No/Date:0310469862 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No. 35011/83/2008‐PI‐III dated 27.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import items Qty. allowed per kg of Budinoside Budecort 200 Inhaler (200MD) 1 No. 1. 16alpha‐Hydroxy Prednisolone 1.093 kg.
[Budinoside = 0.04 gms/pack of Budecort 200 Inhaler) Budecort 100 Inhaler (200MD) [Budinoside = 0.02 gms/pack of Budecort‐100 Inhaler] 1 No. 1. 16alpha‐Hydroxy Prednisolone 1.093 kg. 23
Case No.:23/20/82‐ALC4/2008
09.09.2008 Status:Case Deferred HQ File :01/82/050/00816/AM09/ RLA File :09/21/040/00559/AM07/ Lic.No/Date:0910034001 19.05.2008 Defer Date:07.10.2008 Decision :Committee decided to defer case for 07.10.2008 for comments of PI Division. 24
Case No.:147/11/82‐ALC4/2008
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00467/AM09/ RLA File :04/24/040/00022/AM09/ Lic.No/Date:0410095980 22.05.2008 Defer Date:07.10.2008 25
Case No.:26/10/82‐ALC4/2008
Party Name:GOPINATH CHEM‐TECH LTD., 09.09.2008 Status:Case Deferred HQ File :01/82/050/00318/AM09/ RLA File :08/24/040/00029/AM09/ Lic.No/Date:0810072024 22.05.2008 Defer Date:07.10.2008 Decision : Committee decided to call for copy of application, DML, if applicable, and technical details as per Appendix 33 from RA / firm. Accordingly, the case was deferred for 7.10.2008. 26
Case No.:148/11/82‐ALC4/2008
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 09.09.2008 Status:Case Approved HQ File :01/82/050/00468/AM09/ RLA File :04/24/040/00035/AM09/ Lic.No/Date:0410096011 23.05.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No. 35011/122/2007‐PI‐III dated 17.07.2008 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 Levetiracetam 1 Kg. 1. (‐)‐2(S)‐(2‐oxo‐pyrrolidin‐1‐YL)‐butyric 1.75 kg
acid (S‐PIA) 2. Methanol 3.50 kg 3. Acetone 4.12 kg 27
Case No.:61/14/82‐ALC4/2008
Party Name:PHAARMASIA LTD., 09.09.2008 Status:Case Deferred HQ File :01/82/050/00613/AM09/ RLA File :09/24/040/00041/AM09/ Lic.No/Date:0910034054 23.05.2008 Defer Date:07.10.2008 Decision :Committee decided to defer case for 07.10.2008 for comments of PI Division. 28
Case No.:63/14/82‐ALC4/2008
Party Name:VIVIMED LABS LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00615/AM09/ RLA File :09/24/040/00053/AM09/ Lic.No/Date:0910034055 23.05.2008 Defer Date:07.10.2008 Decision : Committee decided to defer case for 07.10.2008 for comments of Chemical Division. 29
Case No.:21/14/82‐ALC4/2008
Party Name:NIKITA CHEMICAL INDUSTRIES 09.09.2008 Status:Case Deferred HQ File :01/82/050/00573/AM09/ RLA File :03/95/040/00163/AM09/ Lic.No/Date:0310472488 29.05.2008 Defer Date:07.10.2008 30
Case No.:24/14/82‐ALC4/2008
09.09.2008 Status:Case Deferred HQ File :01/82/050/00576/AM09/ RLA File :03/94/040/00148/AM09/ Lic.No/Date:0310473302 05.06.2008 Defer Date:07.10.2008 31
Case No.:1/12/82‐ALC4/2008
Party Name: SILVASSA PLAST 09.09.2008 Status:Case Deferred HQ File :01/82/050/00469/AM09/ RLA File :05/24/040/00146/AM09/ Lic.No/Date:0510221655 Defer
05.06.2008 Date:07.10.2008 32
Case No.:23/14/82‐ALC4/2008
09.09.2008 Status:Case Approved HQ File :01/82/050/00575/AM09/ RLA File :03/94/040/00266/AM09/ Lic.No/Date:0310473365 05.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No. 35011/83/2008‐PI‐III dated 27.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl. No. Import items Qty. allowed per kg of Budinoside Budecort 200 Inhaler (200MD) [Budinoside = 0.04 gms/pack of Budecort 200 Inhaler) 1 No. 1. 16alpha‐Hydroxy Prednisolone 1.093 kg. Budecort 100 Inhaler (200MD) [Budinoside = 0.02 gms/pack of Budecort‐100 Inhaler] 1 No. 1. 16alpha‐Hydroxy Prednisolone 1.093 kg. 33
Case No.:87/14/82‐ALC4/2008
Party Name:MEDREICH LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00639/AM09/ RLA File :07/24/040/00107/AM09/ Lic.No/Date:0710057749 06.06.2008 Defer Date:07.10.2008 Decision :Committee decided to defer the case for 07.10.2008 for comments of PI Division. 34
Case No.:7/16/82‐ALC4/2008
Party Name:LAFFANS PETROCHEMICALS LTD., Status:Case
09.09.2008 Deferred HQ File :01/82/050/00700/AM09/ RLA File :03/95/040/00209/AM09/ Lic.No/Date:0310473617 09.06.2008 Defer Date:07.10.2008 Decision : Committee decided to defer the case for 07.10.2008 for comments of PC Division. 35
Case No.:20/12/82‐ALC4/2008
Party Name:ATUL LIMITED, 09.09.2008 Status:Case Deferred HQ File :01/82/050/00488/AM09/ RLA File :08/24/040/00039/AM09/ Lic.No/Date:0810072444 09.06.2008 Defer Date:07.10.2008 Decision : Committee decided to defer the case for 07.10.2008 for comments of PC Division. 36
Case No.:28/14/82‐ALC4/2008
Party Name:AMBUJA INTERMEDIATES PVT. LTD. 09.09.2008 Status:Case Deferred HQ File :01/82/050/00580/AM09/ RLA File :03/94/040/00191/AM09/ Lic.No/Date:0310474041 10.06.2008 Defer Date:07.10.2008 Decision : Committee decided to defer the case for 07.10.2008 for comments of Chemical Division. 37
Case No.:77/14/82‐ALC4/2008
Party Name:KDAC CHEM PVT LTD 09.09.2008 Status:Case Rejected HQ File :01/82/050/00629/AM09/ RLA File :34/24/040/00040/AM09/ Lic.No/Date:3410021586 11.06.2008 Decision : Committee perused the reply of the firm and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/97/2007‐Ch.II dated 21.07.2007 observed that the firm has not furnished authentic technical literature in support of requirement of Styrene for the manufacture of Phenyl Ethyl alcohol and also the details of manufacturing process given is very sketchy (even the formula of Phenyl Ethyl Alcohol given by the firm is wrong). It was, therefore decided to close the case. 38
Case No.:79/14/82‐ALC4/2008
09.09.2008 Status:Case Deferred HQ File :01/82/050/00631/AM09/ RLA File :03/94/040/00295/AM09/ Lic.No/Date:0310475486 19.06.2008 Defer Date:07.10.2008 Decision: Committee decided to defer case for 07.10.2008 for comments of PI Division.
39
Case No.:1/16/82‐ALC4/2008
Party Name:MEDREICH LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00694/AM09/ RLA File :07/24/040/00143/AM09/ Lic.No/Date:0710058296 03.07.2008 Defer Date:07.10.2008 40
Case No.:22/16/82‐ALC4/2008
Party Name:SONIC BIOCHEM EXTRACTIONS LTD., 09.09.2008 Status:Transferred to Different Section HQ File :01/82/050/00715/AM09/ RLA File :11/24/040/00010/AM09/ Lic.No/Date:1110017655 07.07.2008 Defer Date:09.09.2008 Decision :Committee observed that the another case of the firm for same export product was approved by NC‐6. It was, therefore, decided to transfer this case to NC‐6. 41
Case No.:24/16/82‐ALC4/2008
Party Name:ALEMBIC LIMITED 09.09.2008 Status:Case Approved HQ File :01/82/050/00717/AM09/ RLA File :34/24/040/00038/AM09/ Lic.No/Date:3410021757 08.07.2008 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 42
Case No.:25/16/82‐ALC4/2008
Party Name:SINGH PLASTICISERS & RESINS (I) PVT.LTD. 09.09.2008 Status:Case Deferred HQ File :01/82/050/00718/AM09/ RLA File :05/24/040/00242/AM09/ Lic.No/Date:0510223574 09.07.2008 Defer Date:07.10.2008 Decision :Committee observed that TA/firm were requested to furnish copy of application, DML, if applicable and technical details as per Appendix 33 vide letter dated 14.08.2008, but no reply has been received. It was, therefore, decided to await reply from RA/firm and defer case for 07.10.2008. 43
Case No.:30/16/82‐ALC4/2008
Party Name:ARCH PHARMALABS LTD 09.09.2008 Status:Case Deferred HQ File :01/82/050/00723/AM09/ RLA File :05/24/040/00136/AM09/ Lic.No/Date:0510223638 09.07.2008 Defer Date:07.10.2008 Decision :Committee decided to forward a copy of reply of the firm dated 22.08.2008 to PI Division for their comments. Accordingly, case was deferred for 07.10.2008. 44
Case No.:31/16/82‐ALC4/2008
Party Name:MAYUKA LABS PRIVATE LIMITED 09.09.2008 Status:Case Deferred
HQ File :01/82/050/00724/AM09/ RLA File :05/24/040/00156/AM09/ Lic.No/Date:0510223639 10.07.2008 Defer Date:07.10.2008 45
Case No.:17/18/82‐ALC4/2008
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00770/AM09/ RLA File :04/24/040/00091/AM09/ Lic.No/Date:0410097322 21.07.2008 Defer Date:07.10.2008 46
Case No.:19/18/82‐ALC4/2008
Party Name:YAG MAG LABS PVT.LTD., 09.09.2008 Status:Case Approved HQ File :01/82/050/00772/AM09/ RLA File :09/24/040/00159/AM09/ Lic.No/Date:0910034724 22.07.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 8/83 meeting held on 24.05.2006 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 Export Qty. Sl. No. Import items Qty. allowed 4‐Methyl Thio Semi Carbazide 1Kg. 1. Hydrazine hydrate 0.35 kg 2. Methylene dichloride 0.44 kg 47
Case No.:20/18/82‐ALC4/2008
Party Name:NEULAND LABORATORIES LTD 09.09.2008 Status:Case Deferred HQ File :01/82/050/00773/AM09/ RLA File :09/24/040/00130/AM09/ Lic.No/Date:0910034725 22.07.2008 Defer Date:07.10.2008 48
Case No.:21/18/82‐ALC4/2008
Party Name:AICO LABORATORIES INDIA LTD. 09.09.2008 Status:Case Deferred
HQ File :01/82/050/00774/AM09/ RLA File :08/24/040/00066/AM09/ Lic.No/Date:0810073464 22.07.2008 Defer Date:07.10.2008 Decision :Committee decided to call for Production and Consumption data certified by Central excise Authority from firm. Accordingly, case was deferred for 07.10.2008. 49
Case No.:1/20/82‐ALC4/2008
Party Name:PAUSHAK LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00793/AM09/ RLA File :34/24/040/00049/AM09/ Lic.No/Date:3410021924 25.07.2008 Defer Date:07.10.2008 Decision :Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 07.10.2008. 50
Case No.:10/20/82‐ALC4/2008
Party Name:MAHARASHTRA ORGANO METALLIC CATALYSTS PVT.LTD. 09.09.2008 Status:Case Deferred HQ File :01/82/050/00802/AM09/ RLA File :03/95/040/00358/AM09/ Lic.No/Date:0310480301 25.07.2008 Defer Date:07.10.2008 Decision : Committee observed that Department of C&PC vide their letter No.14010/53/2008‐Ch.II dated 05.09.2008 has called for technical information from firm. It was, therefore, decided to await reply of form and defer the case for 07.10.2008. 51
Case No.:2/20/82‐ALC4/2008
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 09.09.2008 Status:Case Deferred HQ File :01/82/050/00794/AM09/ RLA File :05/24/040/00232/AM09/ Lic.No/Date:0510224474 28.07.2008 Defer Date:07.10.2008 Decision : Committee decided to defer case for 07.10.2008 for comments of Chemical Division. 52
Case No.:5/20/82‐ALC4/2008
Party Name:MOREPEN LABORATORIES LTD., 09.09.2008 Status:Case Deferred HQ File :01/82/050/00797/AM09/ RLA File :05/24/040/00269/AM09/ Lic.No/Date:0510224493 28.07.2008 Defer Date:07.10.2008 53
Case No.:6/20/82‐ALC4/2008
Party Name:MOREPEN LABORATORIES LTD., 09.09.2008 Status:Case Deferred
HQ File :01/82/050/00798/AM09/ RLA File :05/24/040/00270/AM09/ Lic.No/Date:0510224498 28.07.2008 Defer Date:07.10.2008 54
Case No.:7/20/82‐ALC4/2008
Party Name:MOREPEN LABORATORIES LTD., 09.09.2008 Status:Case Deferred HQ File :01/82/050/00799/AM09/ RLA File :05/24/040/00271/AM09/ Lic.No/Date:0510224505 28.07.2008 Defer Date:07.10.2008 55
Case No.:59/20/82‐ALC4/2008
Party Name:HETERO DRUGS LIMITED, 09.09.2008 Status:Case Deferred HQ File :01/82/050/00852/AM09/ RLA File :09/24/040/00160/AM09/ Lic.No/Date:0910034948 06.08.2008 Defer Date:07.10.2008 56
Case No.:1/24/82‐ALC4/2008
Party Name:TECKBOND LABORATORIES PVT. LTD. 09.09.2008 Status:Case Deferred HQ File :01/82/050/00934/AM09/ RLA File :09/24/040/00226/AM09/ Lic.No/Date:0910035159 28.08.2008 Defer Date:21.10.2008 Decision :Committee decided to call for a copy of application, end use of export product and technical details as per Appendix 33 from RA/firm. Accordingly, case was deferred for 21.10.2008. 57
Case No.:2/24/82‐ALC4/2008
Party Name:TECKBOND LABORATORIES PVT. LTD. 09.09.2008 Status:Case Deferred HQ File :01/82/050/00935/AM09/ RLA File :09/24/040/00227/AM09/ Lic.No/Date:0910035160 28.08.2008 Defer Date:21.10.2008 Decision : Committee decided to call for a copy of application, end use of export product and technical details as per Appendix 33 from RA/firm. Accordingly, case was 58
Case No.:4/24/82‐ALC4/2008
Party Name:VIVIMED LABS LIMITED 09.09.2008 Status:Case Deferred
HQ File :01/82/050/00937/AM09/ RLA File :09/24/040/00224/AM09/ Lic.No/Date:0910035166 28.08.2008 Defer Date:07.10.2008 Decision : Committee decided to defer case for 07.10.2008 for comments of Chemical Division. 59
Case No.:5/24/82‐ALC4/2008
Party Name:ARCH PHARMALABS LTD 09.09.2008 Status:Case Deferred HQ File :01/82/050/00938/AM09/ RLA File :05/24/040/00342/AM09/ Lic.No/Date:0510226449 28.08.2008 Defer Date:07.10.2008 60
Case No.:6/24/82‐ALC4/2008
Party Name:HALDIA PETROCHEMICALS LTD. 09.09.2008 Status:Case Deferred HQ File :01/82/050/00939/AM09/ RLA File :02/24/040/00145/AM09/ Lic.No/Date:0210116684 29.08.2008 Defer Date:07.10.2008 Decision : Committee decided to call for a copy of application, end use of export product and technical details as per Appendix 33 from RA/firm. Accordingly, case was 61
Case No.:7/24/82‐ALC4/2008
Party Name:VITAL HEALTHCARE PVT.LTD. 09.09.2008 Status:Case Approved HQ File :01/82/050/00940/AM09/ RLA File :03/95/040/00391/AM09/ Lic.No/Date:0310484419 29.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 9/08 meeting held on 03.07.2007 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 Export Qty. Sl. No. Import items Qty. allowed Artemether 1Kg. 1. Artemisinin 1.50 kg 62
Case No.:8/24/82‐ALC4/2008
Party Name:J.B. CHEMICALS & PHARMACEUTICALS Status:Case
LIMITED 09.09.2008 Approved HQ File :01/82/050/00941/AM09/ RLA File :03/94/040/00483/AM09/ Lic.No/Date:0310484421 29.08.2008 Decision Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/162/2006‐PI‐III dated 09.09.2008 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 Kanamycin Acid Sulphate Injection 1gm Vial 1 Vial 1. Kanamycin Acid Sulphate 1.39 gm/vial RA concerned may take further necessary action as per above decision of NC. : 63
Case No.:9/24/82‐ALC4/2008
Party Name:UNICHEM LABORATORIES LIMITED 09.09.2008 Status:Case Approved HQ File :01/82/050/00942/AM09/ RLA File :03/95/040/00364/AM09/ Lic.No/Date:0310484426 29.08.2008 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 40/82 meeting held on 05.02.2008 vide Case No.14/37/83 and in consultation with representative of PI Division 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. Description of import item Qty. allowed Amlodipine Maleate 1kg. 1. Phthaloyl Amlodipine 1.08kg 2. Methylene chloride 4.50kg 3. Isopropyl alcohol 2.40kg 64
Case No.:10/24/82‐ALC4/2008
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 09.09.2008 Status:Case Approved HQ File :01/82/050/00943/AM09/ RLA File :03/94/040/00528/AM09/ Lic.No/Date:0310484508 29.08.2008
Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/9/2005/Ch.II dated 03.10.2005 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. Description of import item Qty. allowed Camphor USP 1kg. 1. Acetic Acid 0.387 kg 2. Alpha Pinene 1.20 kg 65
Case No.:11/24/82‐ALC4/2008
Party Name:ASTRIX LABORATORIES LTD., 09.09.2008 Status:Case Deferred HQ File :01/82/050/00944/AM09/ RLA File :09/24/040/00088/AM09/ Lic.No/Date:0910035174 29.08.2008 Defer Date:07.10.2008 66
Case No.:12/24/82‐ALC4/2008
Party Name:ASTRIX LABORATORIES LTD., 09.09.2008 Status:Case Approved HQ File :01/82/050/00945/AM09/ RLA File :09/24/040/00124/AM09/ Lic.No/Date:0910035175 29.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/68/2008‐PI‐III dated 17.07.2008 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. Description of import item Qty. allowed 5‐O‐Trityl Thymidine 1kg. 1. Beta Thymidine 0.507 kg 2. Trityl Chloride 0.583 kg 3. Triethylamine 0.757 kg 4. 1,4‐Dioxane 1.94 kg 5. Toluene 2.32 kg
67
Case No.:13/24/82‐ALC4/2008
Party Name:MATRIX LABORATORIES LTD 09.09.2008 Status:Case Deferred HQ File :01/82/050/00946/AM09/ RLA File :09/24/040/00205/AM09/ Lic.No/Date:0910035176 29.08.2008 Defer Date:21.10.2008 Decision :Committee decided to call for a copy of application, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 68
Case No.:14/24/82‐ALC4/2008
Party Name:VIVIN LABORATORIES PRIVATE LIMITED Meet No/Date:24/82‐ALC4/2008 09.09.2008 Status:Case Deferred HQ File :01/82/050/00947/AM09/ RLA File :09/24/040/00183/AM09/ Lic.No/Date:0910035179 29.08.2008 Defer Date:21.10.2008 Decision : Committee decided to call for a copy of application, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 69
Case No.:15/24/82‐ALC4/2008
Party Name:VIVIMED LABS LIMITED 09.09.2008 Status:Case Deferred HQ File :01/82/050/00948/AM09/ RLA File :09/24/040/00228/AM09/ Lic.No/Date:0910035181 29.08.2008 Defer Date:21.10.2008 Decision : Committee decided to call for a copy of application, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 70
Case No.:16/24/82‐ALC4/2008
09.09.2008 Status:Case Approved HQ File :01/82/050/00949/AM09/ RLA File :09/24/040/00194/AM09/ Lic.No/Date:0910035182 29.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No. 35011/81/2007‐PI‐III dated 09.09.2008 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 Nevirapine 1 Kg. 1. 2‐chloro Nicotinic Acid 1.13 kg 2. Cyclo Propylamine 1.20 kg 3. Malono Nitrile 1.088 kg 4. Acetone 2.31 kg 5. Pyridine 0.566 kg 6. Diglyme 2.16 kg 7. Methylene chloride 1.30 kg 8. Methanol 8.43 kg 9. Activated Carbon 0.100 kg 71
Case No.:17/24/82‐ALC4/2008
09.09.2008 Status:Case Approved HQ File :01/82/050/00950/AM09/ RLA File :09/24/040/00193/AM09/ Lic.No/Date:0910035183 29.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No. 35011/81/2007‐PI‐III dated 09.09.2008 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 Paroxetin Hcl Hemihydrate 1 Kg. 1. Paroxetine Carbinol ((‐)Carboninol) 1.33 kg 2. 4‐Dimethyl Amino Pyridine 0.02 kg 3. Acetone 0.398 kg 4. Anhydrous Potassium Carbonate 1.91 kg 5. Carbon Enoanticromos (Activated carbon) 0.100 kg 6. Methane sulphonyl chloride 0.754 kg 7. Methanol 0.0475 kg 8. Methyl Isobutyl Ketone 1.06 kg 9. Methylene Chloride 3.28 kg 10. N,N‐Di Isopropylethylamine 0.0907 kg 11. Sesamol (3,4‐Methylenedioxyphenol) 0.55 kg 12. Toluene 7.84 kg 13. Triethylamine 0.786 kg
72
Case No.:18/24/82‐ALC4/2008
09.09.2008 Status:Case Approved HQ File :01/82/050/00951/AM09/ RLA File :09/24/040/00190/AM09/ Lic.No/Date:0910035184 29.08.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No. 35011/81/2007‐PI‐III dated 09.09.2008 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 1 Kg. 1. Adenine 1.28 kg 2. Diethyl‐p‐tolunesulfonylmethyl Phosphonate 3.52 kg 3. Dimethyl formamide 6.66 kg 4. (R)‐(+)‐Propylene carbonate 1.19 kg 5. Methylene dichloride 19.18 kg 6. Acetonitrile 3.20 kg 7. Acetone 0.93 kg 8. N‐methyl‐2‐pyrrolidone 3.92 kg 9. Triethylamine 1.080 kg 10. Chloromethyl isopropyl carbonate 2.708 kg 11. Isopropyl alcohol 6.18 kg 73
Case No.:19/24/82‐ALC4/2008
09.09.2008 Status:Case Deferred HQ File :01/82/050/00952/AM09/ RLA File :09/24/040/00191/AM09/ Lic.No/Date:0910035185 29.08.2008 Defer Date:07.10.2008 74
Case No.:20/24/82‐ALC4/2008
Party Name:CADILA HEALTHCARE LTD., Status:Case
09.09.2008 Approved HQ File :01/82/050/00953/AM09/ RLA File :08/24/040/00121/AM09/ Lic.No/Date:0810074382 01.09.2008 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 75
Case No.:21/24/82‐ALC4/2008
Party Name:BASE METAL CHLORINATIONS (P) LTD 09.09.2008 Status:Case Approved HQ File :01/82/050/00954/AM09/ RLA File :34/24/040/00102/AM09/ Lic.No/Date:3410022213 01.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No. 14010/147/2004/Ch.II dated 28.10.2004 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 Calcium Butyrate 1 Kg. 1. Butyric Acid 0.788 kg 76
Case No.:22/24/82‐ALC4/2008
Party Name:SHALINA LABORATORIES PVT. LTD. 09.09.2008 Status:Case Deferred HQ File :01/82/050/00955/AM09/ RLA File :03/95/040/00435/AM09/ Lic.No/Date:0310484735 01.09.2008 Defer Date:21.10.2008 Decision : Committee decided to call for a copy of application, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 77
Case No.:23/24/82‐ALC4/2008
Party Name:SCITECH SPECIALITIES PVT. LTD. 09.09.2008 Status:Case Deferred HQ File :01/82/050/00956/AM09/ RLA File :03/95/040/00324/AM09/ Lic.No/Date:0310484762 01.09.2008 Defer Date:21.10.2008 Decision : Committee decided to call for a copy of application, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 78
Case No.:24/24/82‐ALC4/2008
Party Name:SARNA CHEMICALS PVT.LTD. 09.09.2008 Status:Case Approved HQ File :01/82/050/00957/AM09/ RLA File :03/95/040/00352/AM09/ Lic.No/Date:0310484770
01.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No. 14010/77/2006/Ch.II dated 22.01.2007 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 Export Qty. Sl. No. Import items Qty. allowed 2‐Amino dimethyl Terphthalate 1 Kg. 1. Dimethyl Terphthalate 1.260 kg 2. Ortho Dichloro Benzene 0.980 kg 3. Formic Acid 0.020 kg 79
Case No.:25/24/82‐ALC4/2008
Party Name:ALKALOIDS CORPORATION 09.09.2008 Status:Case Deferred HQ File :01/82/050/00958/AM09/ RLA File :02/24/040/00133/AM09/ Lic.No/Date:0210116782 02.09.2008 Defer Date:21.10.2008 Decision : Committee decided to call for a copy of application, copy of DML, if applicable and technical details as per Appendix 33 from RA/firm. Accordingly, case was 80
Case No.:26/24/82‐ALC4/2008
Party Name:SKM PHARMA(P)LTD., 09.09.2008 Status:Case Deferred HQ File :01/82/050/00959/AM09/ RLA File :07/24/040/00284/AM09/ Lic.No/Date:0710059513 02.09.2008 Defer Date: 21.10.2008 Decision :Committee considered case as per agenda and in light of written comments forwarded by PI Division vide their U.O. No.35011/9/2007‐PI‐III dated 09.09.2008 decided to call for a detailed working in line with the Drug Manufacturing Licence from firm. Accordingly, the case was deferred for 21.10.2008. 81
Case No.:27/24/82‐ALC4/2008
Party Name:HALDIA PETROCHEMICALS LTD. 09.09.2008 Status:Case Approved HQ File :01/82/050/00960/AM09/ RLA File :02/24/040/00154/AM09/ Lic.No/Date:0210116835 02.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 13/82 meeting held on 24.06.2008 vide case No.40/45/82 decided to ratify norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐
Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Benzene (from Olefin Complex) 1 MT 1. Naphtha 1.194 MT. 82
Case No.:28/24/82‐ALC4/2008
09.09.2008 Status:Case Deferred HQ File :01/82/050/00961/AM09/ RLA File :03/94/040/00555/AM09/ Lic.No/Date:0310484907 02.09.2008 Defer Date:07.10.2008 83
Case No.:29/24/82‐ALC4/2008
09.09.2008 Status:Case Deferred HQ File :01/82/050/00962/AM09/ RLA File :03/94/040/00550/AM09/ Lic.No/Date:0310484927 02.09.2008 Defer Date: 7.10.2008 84
Case No.:30/24/82‐ALC4/2008
Party Name:LUPIN LIMITED 09.09.2008 Status:Case Approved HQ File :01/82/050/00963/AM09/ RLA File :03/95/040/00212/AM09/ Lic.No/Date:0310484949 02.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 21/82 meeting held on 19.08.2008 vide case No.533/21/82 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 Rifampicin BP/USP 1 Kg. 1. Sodium Rifa‐S 1.02 KGA 2. Chloroform 0.661 kg 3. Acetic Acid 0.16 kg 4. Piperazine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg. 6. Isopropyl alcohol 0.615 kg 7. Dimethyl formamide 0.80 kg 8. Tertiary Butyl Amine 0.314 kg 9. Acetone 0.832 kg
g 10. 1‐Amino‐4‐methyl piperazine 0.16 kg 85
Case No.:31/24/82‐ALC4/2008
Party Name:LUPIN LIMITED 09.09.2008 Status:Case Approved HQ File :01/82/050/00964/AM09/ RLA File :03/95/040/00300/AM09/ Lic.No/Date:0310484974 02.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 21/82 meeting held on 19.08.2008 vide case No.533/21/82 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 Rifampicin BP/USP 1 Kg. 1. Sodium Rifa‐S 1.02 KGA 2. Chloroform 0.661 kg 3. Acetic Acid 0.16 kg 4. Piperazine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg. 6. Isopropyl alcohol 0.615 kg 7. Dimethyl formamide 0.80 kg 8. Tertiary Butyl Amine 0.314 kg 9. Acetone 0.832 kg 10. 1‐Amino‐4‐methyl piperazine 0.16 kg 86
Case No.:32/24/82‐ALC4/2008
Party Name:LUPIN LIMITED 09.09.2008 Status:Case Approved HQ File :01/82/050/00965/AM09/ RLA File :03/95/040/00389/AM09/ Lic.No/Date:0310484982 02.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 21/82 meeting held on 19.08.2008 vide case No.533/21/82 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 Rifampicin BP/USP 1 Kg. 1. Sodium Rifa‐S 1.02 KGA 2. Chloroform 0.661 kg 3. Acetic Acid 0.16 kg 4. Piperazine Anhydrous 0.12 kg
Methylene Chloride 0.933 kg. 6. Isopropyl alcohol 0.615 kg 7. Dimethyl formamide 0.80 kg 8. Tertiary Butyl Amine 0.314 kg 9. Acetone 0.832 kg 10. 1‐Amino‐4‐methyl piperazine 0.16 kg 87
Case No.:33/24/82‐ALC4/2008
Party Name:LUPIN LIMITED 09.09.2008 Status:Case Approved HQ File :01/82/050/00966/AM09/ RLA File :03/95/040/00190/AM09/ Lic.No/Date:0310484993 02.09.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/98/2008‐PI‐III dated 30.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Rifampicin 75 mg. Capsules Not allowed as DML has not been submitted Rifampicin 150 mg Capsules Not allowed as DML has not been submitted Isoniazid 75 mg Tablets 1 No. 1. Isoniazid 76.5 mg Isoniazid 150 mg Tablets 1 No. 1. Isoniazid 153 mg Ethambutol 200 mg Tabs. [Ethambutol =204 mg/Tablet] 1 No. 1. DL‐2 Aminobutanol 1.6014 kg/kg of Ethambutol 2. Tartaric Acid 0.1977 kg/kg of Ethambutol 3. Methanol 0.5620 kg/kg of Ethambutol 4. Isopropyl Alcohol 0.3436 kg/kg of Ethambutol 5. Ethylene Dichloride 0.490 kg/kg of Ethambutol 6. Caustic Soda Flakes 0.4264 kg/kg of Ethambutol 7. Cyclohexane 0.0056 kg/kg of Ethambutol 8. Calcium Hydroxide 2.4525 kg/kg of Ethambutol
Ethambutol 400 mg Tablets [Ethambutol = 408 mg/tablet] 1 No. 1. DL‐2 Aminobutanol 1.6014 kg/kg of Ethambutol 2. Tartaric Acid 0.1977 kg/kg of Ethambutol 3. Methanol 0.5620 kg/kg of Ethambutol 4. Isopropyl Alcohol 0.3436 kg/kg of Ethambutol 5. Ethylene Dichloride 0.490 kg/kg of Ethambutol 6. Caustic Soda Flakes 0.4264 kg/kg of Ethambutol 7. Cyclohexane 0.0056 kg/kg of Ethambutol 8. Calcium Hydroxide 2.4525 kg/kg of Ethambutol Pyrazinamide 250 mg Tablets [Pyrazinamide=255 mg/tablet] 1 No. 1. 2‐Cyano Pyrazine 0.952 kg/kg of Pyrazinamide Pyrazinamide 500 mg Tablets [Pyrazinamide=510 mg/tablet] 1 No. 1. 2‐Cyano Pyrazine 0.952 kg/kg of Pyrazinamide 88
Case No.:34/24/82‐ALC4/2008
09.09.2008 Status:Case Approved HQ File :01/82/050/00967/AM09/ RLA File :03/94/040/00501/AM09/ Lic.No/Date:0310485070 02.09.2008 Decision : Committee considered case as per agenda and in light of its earlier decision taken in its 19/82 meeting held on 05.08.2008 vide Case No.34/24/82 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 item Qty. allowed per unit of export product Stavudine Capsules 15 mg [Stavudine = 15.0 mg] 1 Kg. 1. 2’,3’‐dihydro,5’‐O‐ Benzoyl,5‐Methyl Uridine 2.00 kg/kg of Stavudine Stavudine Capsules 20mg 1 Kg.
[Stavudine = 20.0 mg Stavudine Capsules 30 mg [Stavudine = 30.0 mg] 1 Kg. Stavudine Capsules 40 mg [Stavudine = 40.0 mg] 1 kg. 31 Outside Agenda‐1 09.09.2008 Status:Case Approved HQ File :01/82/050/00518/AM09/ RLA File :09/24/040/00592/AM08/ Lic.No/Date:0910033594 09.04.2008 This case was earlier considered by Committee in its 21/82 meeting held on 19.08.2008 and following decision was taken: “Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/22/2007‐PI‐ III dated 21.08.2008 and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Lamivudine 1 Kg. 1. 2‐5‐Dihydroxy‐1,4 Dithiane 0.739 kg 2. Cystosine 0.955 kg 3. Sodium borohydride 0.480 kg 4. Glyoxalic acid 50% 1.80 kg 5. Acetic Acid 0.213 kg 6. Triethylamine 2.00 kg 7. Toluene 4.08 kg 8. Dimethyl Formamide 0.68 kg 9. Trimethyl Chlorosilane 2.74 kg 10. Methylene Chloride 7.13 kg 11. Methanol 1.035 kg 12. Carbon Eoanticromos (Activated Carbon) 0.100 kg 13. Acetone 0.510 kg 14. Ethyl Acetate 4.98 kg
The representative of PI Division informed the Committee that the firm has applied for import of 16 inputs and PI Division have furnished revised comments vide their O.M. No.35011/89/2008‐PI‐III dated 30.08.2008 recommending import of 16 items. Committee, therefore, in light of above written comments and in consultation with technical authority present in meeting decided to revise the above norms as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Lamivudine 1 Kg. 1. n‐Hexamae 3.55 kg 2. 2‐5‐Dihydroxy‐1,4 Dithiance 0.739 kg 3. Acetone 0.510 kg 4. Carbon Eoanticromos (Activated Carbon) 0.100 kg 5. Cyclohexane 2.486 kg 6. Acetic Acid 0.213 kg 7. Dimethyl Formamide 0.680 kg 8 Cystosine 0.955 kg 9. Ethyl Acetate 4.980 kg 10. Glyoxalic acid 50% 1.80 kg 11. Trimethyl Chlorosilane (TMCS) 2.74 kg 12. Methylene Chloride 7.13 kg 13. Methanol (Methyl alcohol 1.035 kg 14.. Sodium borohydride 0.480 kg 15. Triethylamine (TEA) 2.00 kg 16. Toluene 4.08 kg The earlier decision of NC held on 19.8.2008 may be treated as withdrawn. 33 Outside Agenda‐2 09.09.2008 Status:Case Approved HQ File :01/82/050/00515/AM09/ RLA File :09/24/040/00585/AM08/ Lic.No/Date:0910033736 24.04.2008 This case was considered by NC in its 21/82 meeting held on 19.08.2008 and following decision was taken: “Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/81/2007‐PI‐ III dated 19.09.2007 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 Export Qty. Sl.No. Import items Qty. allowed Nelfinavir Mesylate 1 Kg. 1. Cis‐2‐Butane‐1,4‐Diol 1.061 kg
y g g 2. 2,2 Dimethoxy Propane 2.507 kg 3. 3‐Acetoxy‐2‐Methylbenzoic Acid 0.448 kg 4. Acetone 3.14 kg 5. Acetonitrile 0.43 kg 6. Carbon Enoanticromos (Activated Carbon) 0.090 kg 7. Isopropyl alcohol 3.74 kg 8. Methane Sulfonyl chloride 0.649 kg 9. Methanol 4.26 kg 10. Methylene Chloride 7.93 kg 11. Methyl Isobutyl Ketone 4.58 kg 12. (S)‐N‐T‐Butyl decahydro Iso Quinoline Carboxamide (PHIQ) 0.801 kg 13. Thiophenol (Benzene Thiol) 0.479 kg 14. Toluene 7.57 kg The representative of PI Division informed the Committee that the firm has applied for import of 17 inputs and PI Division have furnished revised comments vide their O.M. No.35011/89/2008‐PI‐III dated 30.08.2008 recommending import of 17 items. Committee, therefore, in light of above written comments and in consultation with technical authority present in meeting decided to revise the above norms as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Nelfinavir Mesylate 1 Kg. 1. (R,S)‐1‐Phenylethylamine()DL Alpha Phenyl Ethylamine 0.910 kg 2. (S)‐1,1,1‐Bi‐2‐Naphthol 0.010 kg 3. 2,2‐Dimethoxypropane 2.507 kg 4. 3‐Acetoxy‐2‐Methylbenzoic Acid 0.448 kg 5. Acetone 3.14 kg 6. Activated Carbon (Carbon Enoanticromos) 0.090 kg 7. Cis‐2‐Butene‐1,4‐Diol 1.061 kg 8. Isopropyl alcohol 3.74 kg 9. Methanol 4.26 kg 10. Methylene Chloride 7.93 kg 11. (S)‐N‐T‐Butyl decahydro Iso Quinoline (Carboxamide‐PHIQ) 0.801 kg 12. Acetonitrile 0.43 kg 13. Chloroform 1.07 kg 14. Cyclohexane 1.71 kg 15. Methane Sulfonyl Chloride 0.649 kg 16. MIBK (Methyl Isobutyl Ketone) 4.58 kg 17. Potassium Carbonate 1.725 kg
The earlier decision taken in NC meeting held on 19.8.2008 may be treated as withdrawn. Outside Agenda‐3 M/S Vivimed Labs. F.No.01/83/050/00387/AM08 RA F.No.09/24/040/00060/AM08 Adv.Lic.No.0910030333 dated 24.05.2007 This case was considered by NC in its 21/09 meeting held on 19.08.2008 and following decision was taken; “Committee considered the case as per agenda and observed that NC in its 1/83 meeting held on 02.04.2008 had allowed the quantity of Para Tertiary Butyl as 1.387 kg, while the firm has applied the quantity of said product as 1.148 kg. Committee, therefore, decided to reduce the quantity of Para Tertiary Butyl to read as 1.148 kg. and to enhance the quantity of Methanol to read as 2.056 kg.” During communicating the decision of NC to RA/firm, it was observed that Advance licence No. and date has been recorded as “0910030685 dated 29.06.2007” in place of correct Advance Licence No.0910030333 dated 24.05.2007. Committee, therefore, decided to correct Advance licence No. and date to read as 0910030333 dated 24.05.2007.
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