DGFT Minutes
In force — no superseding record on file.
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 7/82ALC4/2013 MEETING DATE : 27.06.2013 The Meeting No. 7/82 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 27.6.2013 but was actually held on 1.7.2013 under the Chairmanship of, Shri Mukesh Bhatnagar, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi.. Following members were present: 1. Shri D.N. Mathur. Advisor, Department of Pharmaceutical 2. Shri Jasbir Singh, Advisor, Department of Chemicals and Petrochemicals. 3. Shri R.C. Meena, Deputy Director General of Foreign Trade
Case No. B72
M/s Lepro Herbals Pvt. Ltd. Meeting no. 7/AM 14 Dated 1.7.2013 01/82/050/01652/AM 07/DES III RLA File No. 05/24/40/00927/AM 07 Advance Authorisation No. 0510199597 dated 15.2.2007 Decision: The Committee recommended to condone the delay in the filing the representation. It was decided to forward the request of the firm for condonation to PRC for the approval of DGFT. With regard to enhancing the quantity of import item “Glycyrrhic Acid” for the export of Enoxolone EP/BP, the Committee decided to revise the quantity to 12.65 kg/kg for regularization purpose. Repeat licenses are not to be issued based on this decision. It was also decided to advice the firm to give specification of their import items along with Certificate of Analysis from foreign supplier in future otherwise the case would be decided on merits.
Case No. B73
M/s. Divis Laboratories Limited
01/82/50/00038/AM 12/DES III RLA File No. 09/24/040/00497/AM 11 0910045589 dated 18.2.2011 Decision: The Committee recommended to condone the delay in the filing the representation. It was decided to forward the request of the firm for condonation to PRC for the approval of DGFT. The case was discussed in the meeting and comments were given by the member from Department of Pharmaceuticals followed by written comments. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/645/2012PI(Norms) dated 3.7.2013, it was decided to revise the 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 Nateglinide 1 kg 1 DPhenylanine 1.04 kg 2. Trans4Isopropyl Cyclohexane Carboxylic Acid 1.09 kg 3. NHeptane 4.185 kg Development Commissioner may take appropriate action as per the decision of Norms Committee.
Case No. B74
M/s. Dorf Ketal Chemicals (I) pvt. Limited 01/82/50/1099/AM 12/DES III RLA File No. 03/94/040/000586/AM 16 0310658202 dated 5.10.2011 Decision: The case was discussed in the meeting and it was noticed that inadvertently incomplete name of the export product had been communicated to the firm. It was decided to amend the description of export product as “Chemical Äntifloulant, Trade Name DA2339/DA2313/DA2316/DA2339M/DA2394/DA2304C/DA2309/DA 2331/DA 7315. It was also decided to amend the description of import item as Dinpropylamine/DNPA. Rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee.
Case No. B75
M/s. Blue Circle Organics Pvt. Limited, Mumbai 01/82/50/01491/AM 12/DES III RLA File No. 03/94/040/00757/AM 12 0310682083 dated 15.2.2012 Decision: The Committee decided to reject the case as there was no justification for enhancement.
Case No. B76
M/s. Torrent Pharamaceutical Limited, Ahmedabad 01/82/50/00966/AM 10/DES III RLA File No. 08/24/040/001777/AM 10 0810082718 dated 27.10.2009 Decision: The norms were ratified as per SION A 412, at 2% wastage against the applied wastage of 5.57%. The firm has requested either to allow higher wastage as applied by them or to allow them to pay customs duty on the difference between applied quantity and the quantity ratified by NC, on the API imported from the Unregistered sources. Keeping in view the provisions contained in Policy Circular NO. 18 dated 30.10.2007, the committee decided to consider the request of the firm subject to the following conditions: The firm shall produce Production, Actual consumption of Acemetacin relevant against the present Advance Authorization duly certified by Central Excise Authorities. The firm shall pay customs Duty+ Interest etc. as per policy on the import from Un registered sources in excess of the wastage allowed by NC. The firm shall produce No Objection Certificate from DCGI/Jurisdictional Drug Controlling Authority.
RA may take appropriate action as per the decision of Norms Committee.
Case No. B77
M/s. Torrent Pharamaceutical Limited, Ahmedabad 01/82/50/00826/AM 13/DES III 01/82/050/00907/AM 13/DES III 01/82/050/00719/AM 13/DES III 01/82/050/00962/AM 13/DES III 01/82/050/01291/AM 13/DES III 01/82/050/00370/AM 13/DES III 0810115144 dated 14.9.2012 0810116239 dated 9.11.2012 0810116742 dated 7.12.2012 0810116756 dated 10.12.2012 0810117848 dated 28.1.2013 0810118081 dated 21.3.2013 Decision: The norms were ratified as per SION A 412, at 2% wastage against the applied wastage of 5.57%. The firm has requested either to allow higher wastage as applied by them or to allow them to pay customs duty on the difference between applied quantity and the quantity ratified by NC, on the API imported from the Unregistered sources. Keeping in view the provisions contained in Policy Circular NO. 18 dated 30.10.2007, the committee decided to consider the request of the firm subject to the following conditions: The firm shall produce Production, Actual consumption of API relevant against the present Advance Authorization duly certified by Central Excise Authorities. The firm shall pay customs Duty+ Interest etc. as per policy on the import from Un registered sources in excess of the wastage allowed by NC. The firm shall produce No Objection Certificate from DCGI/Jurisdictional Drug Controlling Authority.
Case No. B78
M/s. Torrent Pharamaceutical Limited, Ahmedabad 01/82/50/171/00073/AM 13/DES III RLA File No. 08/93/040/00197/AM 11 08/93/040/00094/Am 11 0810092846 dated 6.10.2010 and 0810089877 dated 22.6.2010 Decision: The norms were ratified as per SION A 412, at 2% wastage. The firm has requested either to allow higher wastage as applied by them or to allow them to pay customs duty on the difference between applied quantity and the quantity ratified by NC, on the API imported from the Unregistered sources. Keeping in view the provisions contained in Policy Circular NO. 18 dated 30.10.2007, the committee decided to consider the request of the firm subject to the following conditions: The firm shall produce Production, Actual consumption of Loratadine relevant against the present Advance Authorization duly certified by Central Excise Authorities. The firm shall pay customs Duty+ Interest etc. as per policy on the import from Un registered sources in excess of the wastage allowed by NC. The firm shall produce No Objection Certificate from DCGI/Jurisdictional Drug Controlling Authority.
Case No. B79
M/s. Torrent Pharamaceutical Limited, Ahmedabad 01/82/50/01274/AM 10/DES III RLA File No 08/24/040/001777/AM 10 Advance Authorisation No
RLA File No. 08/24/040/001777/AM 10 0810085981 dated 25.01.2010 Decision: The norms were ratified as per SION A 412, at 2% wastage against the applied wastage of 5.57%. The firm has requested either to allow higher wastage as applied by them or to allow them to pay customs duty on the difference between applied quantity and the quantity ratified by NC, on the API imported from the Unregistered sources. Keeping in view the provisions contained in Policy Circular NO. 18 dated 30.10.2007, the committee decided to consider the request of the firm subject to the following conditions: The firm shall produce Production, Actual consumption data of relevant API, duly certified by Central Excise Authorities. The firm shall pay customs Duty+ Interest etc. as per policy on the import from Un registered sources in excess of the wastage allowed by NC. The firm shall produce No Objection Certificate from DCGI/Jurisdictional Drug Controlling Authority.
Case No. B80
M/s. Torrent Pharamaceutical Limited, Ahmedabad 01/82/50/00831/AM 13/DES III 01/82/50/00825/AM 13/DES III 01/82/50/001415/AM 13/DES III 01/82/50/01419/AM 13/DES III RLA File No. 08/24/040/00241/AM 13 08/24/040/00343/AM 13 08/24/040/00196/AM 13 08/24/040/00394/AM 13 0810115743 dated 12.10.2012 0810114835 dated 7.9.2012 0810117768 dated 23 1 2013
08/24/040/00394/AM 13 0810117768 dated 23.1.2013 0810119018 dated 5.3.2013 Decision: The norms were ratified as per SION A 412, at 2% wastage against the applied wastage of 5.57%. The firm has requested either to allow higher wastage as applied by them or to allow them to pay customs duty on the difference between applied quantity and the quantity ratified by NC, on the API imported from the Unregistered sources. Keeping in view the provisions contained in Policy Circular NO. 18 dated 30.10.2007, the committee decided to consider the request of the firm subject to the following conditions: The firm shall produce Production, Actual consumption data of relevant API duly certified by Central Excise Authorities. The firm shall pay customs Duty+ Interest etc. as per policy on the import from Un registered sources in excess of the wastage allowed by NC. The firm shall produce No Objection Certificate from DCGI/Jurisdictional Drug Controlling Authority.
Case No. B81
M/s Alembic Limited 01/82/50/00095/AM 10/DES III 01/82/050/00323/AM 10/DES III RLA File No. 34/24/040/00018/AM 10 34/24/040/00041/AM 10 3410024139 dated 8.5.2009 3410024500 dated 19.6.2009 Decision: The Committee decided to advice RA to calculate the norms for Azithromycin tablets on the basis of Norms earlier given by the Committee in their meeting no. 17/82 dated 21.7.2009 for the export product Azithromycin Step IV and norms ratified by the NC in their meeting no. 22/82 dated 30 8 2011 for export of Azithromycin Tablet 250 mg Azithromycin Tablet 500 mg
22/82 dated 30.8.2011 for export of Azithromycin Tablet 250 mg, Azithromycin Tablet 500 mg and Azithromycin Tablet 600 mg. It was also decided to forward a copy of the minutes of both the above said export products to RA for calculation.
Case No. B82
M/s. ADI Fine chem Limited (Formerly known as H.K. Finechem Limited) 01/82/50/00146/AM 09/DES III RLA File No. 08/24/040/149/AM 08 0810067303 dated 21.9.2007 Decision: It was decided to send a copy of application along with the details to the Department of Chemicals and Petrochemicals. The case was deferred for 25.7.2013.
Case No. B83
M/s Lepro Herbals Pvt. Ltd. 01/82/050/00517/AM 07 01/82/50/00468/AM 08 01/82/50/00484/AM09 RLA File No05/24/40/00277/AM 07 05/24/40/00131/AM 08 05/24/40/00064/AM 09 0510185826 dated 5.7.2006 0510204503 dated 5.6.2007 0510220854 dated 22.5.2008 Decision: The Committee recommended to condone the delay in the filing the representation. It was decided to forward the request of the firm for condonation to PRC for the approval of DGFT. With regard to enhancing the quantity of import item “Glycyrrhic Acid” for the export Glycyrrehetinic Acid, the Committee decided to revise the quantity to 11.50 kg/kg for
Glycyrrehetinic Acid, the Committee decided to revise the quantity to 11.50 kg/kg for regularization purpose. Repeat licenses are not to be issued based on this decision. It was also decided to advice the firm to give specification of their import items along with Certificate of Analaysis from the foreign Supplier in future otherwise the case would be decided on merits.
Case No. B84
M/s. Survival Technology Pvt. Limited 01/82/50/01110/AM 11/DES III F. No 01/82/50/00225/AM 11/DES III RLA File No. 03/94/040/207/AM 11 03/94/040/822/AM 10 0310580570 dated 24.6.2010 0310566726 dated 26.3.2010 Decision: It was decided to defer the case for 25.7.2013 for comments of Department of Chemicals and Petrochemicals and recommended to PRC for condonation of delay.
Case No. C7
M/s. Godrej Industries Limited, Mumbai 01/82/50/00519/AM 13/DES III Decision: Chemexcil has forwarded the request of the firm for fixation of SION for the export product Sodium Lauryl Ether Sulphate (Active Matter 69%). In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/155/2011 Ch. II dated 3.5.2013, it was decided to fix SION under Para 4.8(a) of HBP v 1 as per details given below: Export product Exp. Qty. Sl.No. Import items Qty. allowed Sodium Lauryl 1 kg 1 Palm Kernel Fatty Acid 0 49 kg
Sodium Lauryl Ether Sulphate (Active Matter 69% min.) 1 kg 1 Palm Kernel Fatty Acid Distillate 0.49 kg 2. Copper Chromite Catalyst 0.004 kg 3. Ethylene Oxide 0.170 kg 4. Caustic Soda Flakes 0.06 kg 5. Sulphur 0.06 kg Decision: The above fixation of norms would be notified through Public Notice 1
Case No.:4/1/82ALC4/2013
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD Meet No/Date:7/82ALC4/2013 27.06.2013 Status:Case Approved HQ File :01/82/050/01362/AM13/ RLA File :04/21/040/00680/AM11/ Lic.No/Date:0410121541 10.02.2011 Defer Date: Decision : It was noticed that the export product is Valacyclovir Tablets and the import product is valacyclovir. The Committee decided to advice RA to finalise the case as per SION i.e. 2% wastage. 2
Case No.:53/47/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 27.06.2013 Status:Case Deferred HQ File :01/82/050/01643/AM11/ RLA File :09/24/040/00519/AM11/ Lic.No/Date:0910045550 14.02.2011 Defer Date:25.07.2013 Decision :It was decided to defer the case for 25.07.2013 for comments of Department of Pharmaceuticals. 3
Case No.:5/4/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 27.06.2013 HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Defer Date:25.07.2013 Decision :Department of Biotechnology vide their letter NO. BT/IL/05/319/2010PID dated 5.6.2013 has requested the firm to furnish the following information: Copy of drug manufacturing license. copy of Batch Manufacturing record duly approved by QA. Manufacturing process flow diagram of export product showing the wastage involved.
It was decided to remind the firm to furnish the information. The case was deferred for 25.07.2013 4
Case No.:56/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 27.06.2013 HQ File :01/82/050/01414/AM13/ RLA File :08/24/040/00394/AM11/ Lic.No/Date:0810098384 20.04.2011 Defer Date:25.07.2013 Decision :It was decided to defer the case for 11.07.2013 for comments of Department of Pharmaceuticals. 5
Case No.:19/10/82ALC4/2011
Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 27.06.2013 HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the requisite information within next 10 days failing which the case would be closed. The case was deferred for 25.07.2013 6
Case No.:2/15/82ALC4/2011
Party Name:ACHARYA CHEMICALS 27.06.2013 HQ File :01/82/050/00442/AM12/ RLA File :03/94/040/00130/AM12/ Lic.No/Date:0310633824 31.05.2011 Defer Date:25.07.2013 Decision :The representative from the Department of Pharmaceuticals has stated that the firm has not forwarded the information as sought by them. It was, therefore, decided to request the firm to furnish the following information immediately: Complete technical details as per Appendix 33 of the Policy End use of the export product. Past production visavis actual consumption of inputs duly certified by Central Excise Authorites. The case was deferred for25.07.2013 7
Case No.:4/16/82ALC4/2011
Party Name:BOSTIK INDIA PRIVATE LIMITED 27.06.2013 HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:25.07.2013 Decision :It was decided to defer the case for 25.07.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 8
Case No.:35/19/82ALC4/2011
Party Name:NECTAR LIFESCIENCES LIMITED, 27.06.2013 HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer Date:25.07.2013 Decision :It was decided to defer the case for 25 07 2013 for comments of Department of Pharmaceuticals
9
Case No.:84/1/82ALC4/2013
Party Name:ANUS LABORATORIES LTD., 27.06.2013 HQ File :01/82/050/01442/AM13/ RLA File :09/24/040/00205/AM11/ Lic.No/Date:0910049025 23.09.2011 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 30.5.2013 immediately. The case was deferred for 25.07.2013 10
Case No.:96/1/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/01454/AM13/ RLA File :09/24/040/00308/AM12/ Lic.No/Date:0910049099 28.09.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/328/2013PI(Norms) dated 24.6.2013, 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 Levofloxacin 1 kg 1. Levofloxacin Carboxylic Acid 0.8571 kg 2. Dimethyl Sulfoxide 0.2193 kg 3. NMethyl Piperazine 0.432 kg 4. Carbon Enonticromos (Activated Carbon) 0.010 kg 5. Steam/Thermal Coal As per fuel policy 11
Case No.:113/42/82ALC4/2011
Party Name:NEULAND LABORATORIES LTD 27.06.2013 Status:Case Approved HQ File :01/82/050/01148/AM12/ RLA File :09/24/040/00310/AM12/ Lic.No/Date:0910049392 19.10.2011 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/272/2013PI(Norms) dated 24.6.2013, 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 Besifloxacin Hydrochloride 1 kg 1 DLysine Hydrochloride 6.10 kg 2. 2Chloro4,5Difluorobenzoic Acid 9.18 kg 3. Lithium Aluminium Hydride 3.78 kg
12
Case No.:22/45/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/01199/AM12/ RLA File :09/24/040/00341/AM12/ Lic.No/Date:0910049706 15.11.2011 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/292/2012PI(Norms) dated September, 2012, 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 (+) MethylAlpha(2 Thienylethamino)(2 Chloro Phenyl) Acetate Hydrochloride 1 kg 1 DL2Chlorophenyl Glycine 1.00 kg 2. Thiophene2Ethanol 0.60 kg 3. Toluene 0.60 kg 4. Methylene Chloride 1.81 kg 5. Acetone 1.96 kg 6. Methanol 2.56 kg 7. Ethyl Acetate 1.81 kg 8. Isopropyl Acetate 0.60 kg 13
Case No.:5/45/83ALC1/2011
Party Name:SPAN DIAGNOSTICS LTD 27.06.2013 HQ File :01/83/050/00780/AM12/ RLA File :52/24/040/00033/AM12/ Lic.No/Date:5210037002 15.11.2011 Defer Date:25.07.2013 Decision : Department of Biotechnology vide their letter no. BT/IL/05/367/2012PID dated 5.6.2013 has requested the firm to furnish the following information: Whether the quantity of export product mentioned in the condition sheet is in terms of No. of tests or No. of Kits. Please provide production and consumption data duly certified by the Chartered Accountant/Cost and Work Accountant/Jurisdictional Central Excise Authority for the last three years. In import items one of the inputs i.e. Bovine serum albumin is mentioned at Sr. No. 5 & 6. Please provide a copy of Drug Manufacturing License and QA approved Master Batch Formula/Batch Manufacturing record. It was decided to remind the firm to furnish the above information immediately. The case was deferred for 25.07.2013 14
Case No.:7/27/85ALC3/2011
Party Name:BELOOR BAYIR BIOTECH LTD, 27.06.2013 HQ File :01/85/050/00151/AM12/ RLA File :07/24/040/00317/AM12/ Lic.No/Date:0710084045 18.11.2011 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the requisite information without any further delay else their case would be closed. The case was
q y y deferred for 25.07.2013 15
Case No.:11/1/82ALC4/2013
Party Name:BIOCON LIMITED, 27.06.2013 HQ File :01/82/050/01369/AM13/ RLA File :07/24/040/00329/AM12/ Lic.No/Date:0710084173 23.11.2011 Defer Date:25.07.2013 16
Case No.:23/45/82ALC4/2011
Party Name:SUTURES INDIA PRIVATE LIMITED, 27.06.2013 HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 25.07.2013 17
Case No.:24/46/82ALC4/2011
Party Name:ASHISH LIFE SCIENCE PVT.LTD. 27.06.2013 HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14.12.2011 Defer Date:25.07.2013 Decision :It was decided to give a final reminder to the firm to furnish the requisite information without any further delay, else their case would be closed. The case was deferred for 25.07.2013 18
Case No.:59/46/82ALC4/2011
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 27.06.2013 Status:Case Rejected HQ File :01/82/050/01275/AM12/ RLA File :09/24/040/00413/AM12/ Lic.No/Date:0910050238 15.12.2011 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 19
Case No.:61/4/82ALC4/2012
Party Name:ANUGRAHA CHEMICALS 27.06.2013 Status:Case Approved HQ File :01/82/050/00141/AM13/ RLA File :07/24/040/00489/AM12/ Lic.No/Date:0710086840 07.03.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/299/2013PI(Norms) dated 24.6.2013, 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 MDI 101 (All Trans Retionoic Acid, 1 Hydroxy3 3 1 kg 1 All Trans Retionic Acid 1.05 kg 2. 1Chloropinacolone 0.469 kg
Hydroxy3,3 Dimethyl 12 Butanone Ester p g 3. Cesium Carbonate 1.135 kg 20
Case No.:71/3/82ALC4/2012
Party Name:FORACE POLYMERS (P) LTD. 27.06.2013 Status:Case Rejected HQ File :01/82/050/00075/AM13/ RLA File :05/23/040/00502/AM12/ Lic.No/Date:0510320188 15.03.2012 Defer Date:11.07.2013 Decision :It was noticed that the case was approved in meeting no. 3 dated 17.4.2012. It was, therefore, decided to withdraw the case. 21
Case No.:39/11/82ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 27.06.2013 Status:Case Rejected HQ File :01/82/050/00306/AM13/ RLA File :09/24/040/00600/AM12/ Lic.No/Date:0910051800 16.03.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished the information despite repeated reminders. 22
Case No.:76/4/82ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 27.06.2013 HQ File :01/82/050/00156/AM13/ RLA File :08/24/040/00301/AM12/ Lic.No/Date:0810110001 22.03.2012 Defer Date:11.07.2013 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula immediately. The case was deferred for 11.7.2013. 23
Case No.:9/11/82ALC4/2012
Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 27.06.2013 HQ File :01/82/050/00276/AM13/ RLA File :34/24/040/00298/AM12/ Lic.No/Date:3410033741 29.03.2012 Defer Date:11.07.2013 Decision :It was decided to defer the case for 11.7.2013 for comments of Department of Pharmaceuticals. 24
Case No.:4/7/82ALC4/2012
Party Name:PROMED EXPORTS PVT.LTD. 27.06.2013 HQ File :01/82/050/00188/AM13/ RLA File :05/24/040/00471/AM12/ Lic.No/Date:0510321506 30.03.2012 Defer Date:11.07.2013
Case No.:38/16/82ALC4/2012
Party Name:BRILLIANT BIO PHARMA LIMITED 27.06.2013
25 HQ File :01/82/050/00474/AM13/ RLA File :09/24/040/00664/AM12/ Lic.No/Date:0910052111 11.04.2012 Defer Date:11.07.2013 Decision :Department of Biotechnology vide their letter No. BT/IL/05/386/2013PID dated 5.6.2013 has requested the firm to furnish the following information: Unit of measurement for the export product has been mentioned in MT, while in manufacturing process flow chart the final product is 100 ml vial. Justification for 10% wastage. To provide a copy of Drug manufacturing License and QA approved Batch Manufacturing Record. It was decided to remind the firm to furnish the above information immediately. The case was deferred for 11.7.2013. 26
Case No.:3/11/82ALC4/2012
Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 27.06.2013 HQ File :01/82/050/00270/AM13/ RLA File :03/94/040/00007/AM13/ Lic.No/Date:0310690582 12.04.2012 Defer Date:11.07.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals. The case was deferred for 11.7.2013 for comments of Department of Pharmaceuticals. 27
Case No.:50/3/83ALC1/2012
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 27.06.2013 HQ File :01/83/050/00053/AM13/ RLA File :03/95/040/01118/AM12/ Lic.No/Date:0310690527 12.04.2012 Defer Date:11.07.2013 Decision :It was decided to defer the case for 11.7.2013 for comments of Department of Biotechnology. 28
Case No.:14/14/82ALC4/2012
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/00391/AM13/ RLA File :03/94/040/00070/AM13/ Lic.No/Date:0310693809 08.05.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/234/2013PI(Norms) dated 24.6.2013, 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 Phenytoin Sodium/Base 1 kg 1 Benzil 99.5^% 0.95 kg 29
Case No.:51/1/82ALC4/2013
Party Name:ALKALOIDS CORPORATION 27.06.2013 HQ File :01/82/050/01409/AM13/ RLA File :02/24/040/00023/AM13/ Lic No/Date:0210177494 Defer
29 HQ File :01/82/050/01409/AM13/ RLA File :02/24/040/00023/AM13/ Lic.No/Date:0210177494 11.05.2012 Defer Date:25.07.2013 Decision :It was decided to defer the case for 25.07.2013 for the comments of Department of Pharmaceuticals. 30
Case No.:6/16/82ALC4/2012
Party Name:STELLENCE PHARMSCIENCE PVT LTD 27.06.2013 HQ File :01/82/050/00442/AM13/ RLA File :07/24/040/00062/AM13/ Lic.No/Date:0710088213 16.05.2012 Defer Date:11.07.2013 Decision :It was decided to give final reminder to the firm to furnish the technical details as per Appendix 33 within 15 days failing which their case would be closed. The case was deferred for 11.7.2013. 31
Case No.:29/16/82ALC4/2012
27.06.2013 Status:Case Rejected HQ File :01/82/050/00465/AM13/ RLA File :09/24/040/00067/AM13/ Lic.No/Date:0910052682 18.05.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 32
Case No.:16/13/82ALC4/2012
Party Name:NIFTY LABS PVT LTD., 27.06.2013 HQ File :01/82/050/00351/AM13/ RLA File :09/24/040/00076/AM13/ Lic.No/Date:0910052711 21.05.2012 Defer Date:11.07.2013 Decision :It was decided to remind the firm to furnish clarification sought vide minutes dated 30.5.2013. The case was deferred for 11.7.2013. 33
Case No.:3/16/82ALC4/2012
Party Name:ADCOCK INGRAM LTD, 27.06.2013 HQ File :01/82/050/00439/AM13/ RLA File :07/24/040/00075/AM13/ Lic.No/Date:0710088327 21.05.2012 Defer Date:11.07.2013 34
Case No.:6/13/82ALC4/2012
Party Name:BHARAT PARENTERALS LTD, 27.06.2013 HQ File :01/82/050/00341/AM13/ RLA File :34/24/040/00045/AM13/ Lic.No/Date:3410034190 23.05.2012 Defer Date:11.07.2013 Decision :It was decided to give final reminder to the firm to furnish the requisite information within 15 days failing which their case would be closed. The case was deferred for 11.7.2013.
Case No.:11/13/82ALC4/2012
Party Name:PROMED EXPORTS PVT.LTD. 27.06.2013
35 HQ File :01/82/050/00346/AM13/ RLA File :05/24/040/00048/AM13/ Lic.No/Date:0510325611 23.05.2012 Defer Date:11.07.2013 36
Case No.:4/16/82ALC4/2012
Party Name:ADCOCK INGRAM LTD, 27.06.2013 HQ File :01/82/050/00440/AM13/ RLA File :07/24/040/00078/AM13/ Lic.No/Date:0710088441 24.05.2012 Defer Date:11.07.2013 37
Case No.:12/13/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 27.06.2013 HQ File :01/82/050/00347/AM13/ RLA File :05/24/040/00061/AM13/ Lic.No/Date:0510325945 25.05.2012 Defer Date:11.07.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/592/2012PI(Norms) dated 6.2.2013, it was decided to call from the firm complete technical details mainly Mol. Wt. of all input/output product, % yield on molar basis and solvent details as per Appendix 33. The case was deferred for 11.7.2013. 38
Case No.:45/14/82ALC4/2012
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/00422/AM13/ RLA File :03/95/040/00081/AM13/ Lic.No/Date:0310699034 18.06.2012 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/204/2013PI(Norms) dated 24.6.2013, 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 Lumefantrine 1kg 1 2,7DichloroA(Dibutylamino) Methyl9HFluorene4Methanol (DBA) 0.974 kg 2. 4Chlrorobenzadehyde 0.3478 kg 3. Methanol 0.695 kg 4. Caustic Flakes (NaOH) 0.13 kg 5. Ethyl Acetate 0.420 kg 6. Activated carbon 0.011 kg 7. Hexanes 0.084 kg
Case No.:68/1/82ALC4/2013
Party Name:PARAMOUNT PHARMA Status:Case
39 y 27.06.2013 Approved HQ File :01/82/050/01426/AM13/ RLA File :05/24/040/00082/AM13/ Lic.No/Date:0510327775 19.06.2012 Defer Date: Decision : The case was discussed in the meeting and the representative from Department of Pharmaceuticals has given comments in the meeting followed by the written comments. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/330/2013PI(Norms) dated 3.7.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Paracetamol IP/BP 1 kg 1 Acetic Acid 1.071 kg 2. Para Amino Phenol 0.91 kg 40
Case No.:31/13/82ALC4/2012
Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., 27.06.2013 HQ File :01/82/050/00366/AM13/ RLA File :03/95/040/00055/AM13/ Lic.No/Date:0310699970 27.06.2012 Defer Date:11.07.2013 Decision :It was decided in the meeting that the case pertains to Petrochemicals Division. Therefore, it was decided to send a copy of application to Petrochemicals Division of Department of Chemicals and Petrochemicals. 41
Case No.:15/20/82ALC4/2012
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/00626/AM13/ RLA File :03/94/040/00336/AM13/ Lic.No/Date:0310703768 01.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/234/2013PI(Norms) dated 24.6.2013, 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 Phenytoin Sodium/Base 1 kg 1 Benzil 99.5^% 0.95 kg 42
Case No.:47/16/82ALC4/2012
Party Name:PARAMOUNT PHARMA 27.06.2013 Status:Case Approved HQ File :01/82/050/00483/AM13/ RLA File :05/24/040/00178/AM13/ Lic.No/Date:0510331427 07.08.2012 Defer Date: Decision : The case was discussed in the meeting and the representative from Department of Pharmaceuticals has given comments in the meeting followed by the written comments. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/330/2013PI(Norms) dated 3.7.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Paracetamol IP/BP 1 kg 1 Acetic Acid 1.071 kg 2. Para Amino Phenol 0.91 kg 43
Case No.:48/16/82ALC4/2012
Party Name:PARAMOUNT PHARMA 27.06.2013 Status:Case Approved HQ File :01/82/050/00484/AM13/ RLA File :05/24/040/00179/AM13/ Lic.No/Date:0510331428 07.08.2012 Defer Date: Decision : The case was discussed in the meeting and the representative from Department of Pharmaceuticals has given comments in the meeting followed by the written comments. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/330/2013PI(Norms) dated 3.7.2013, 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 Exp. Qty. Sl.No. Import items Qty. allowed Paracetamol IP/BP 1 kg 1 Acetic Acid 1.071 kg 2. Para Amino Phenol 0.91 kg 44
Case No.:37/22/82ALC4/2012
Party Name:FDC LTD 27.06.2013 HQ File :01/82/050/00740/AM13/ RLA File :03/94/040/00374/AM13/ Lic.No/Date:0310706515 27.08.2012 Defer Date:11.07.2013 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License along with list of approved items showing composition of Oral Rehydrat Salt within 15 days failing which their case would be closed. The case was deferred for 11.7.2013. 45
Case No.:41/24/82ALC4/2012
Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED 27.06.2013 HQ File :01/82/050/00845/AM13/ RLA File :09/24/040/00256/AM13/ Lic.No/Date:0910053578 27.08.2012 Defer Date:11.07.2013 Decision :It was decided to remind the firm to furnish clarification sought vide minutes dated 30.5.2013. The case was deferred for 11.7.2013. 46
Case No.:4/20/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 27.06.2013 HQ File :01/82/050/00615/AM13/ RLA File :05/24/040/00323/AM12/ Lic.No/Date:0510333154 30.08.2012 Defer Date:11.07.2013
47
Case No.:29/28/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 27.06.2013 HQ File :01/82/050/00996/AM13/ RLA File :09/70/040/00061/AM13/ Lic.No/Date:0910053637 31.08.2012 Defer Date:25.07.2013 Decision :It was decided to defer the case for 25.7.2013 for comments of Department of Pharmaceuticals. 48
Case No.:28/28/82ALC4/2012
27.06.2013 HQ File :01/82/050/00995/AM13/ RLA File :09/24/040/00270/AM13/ Lic.No/Date:0910053660 04.09.2012 Defer Date:25.07.2013 Decision : The case was discussed in the meeting and representative from Department of Pharmaceuticals has given his comments followed by written comments. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/205/2013PI(Norms) dated 3.7.2013, it was decided to call from the firm the following technical details: Stepwise complete chemistry, mol. Wt of each input/output items and there Molar requirement alongwith technical justification. % yield on molar basis for each step. Quantity and Recovery of Solvents at each stage. Past Production visàvis Actual consumption of all the inputs duly certified by Central Excise Authorities. The case was deferred for 25.7.2013. 49
Case No.:21/1/82ALC4/2013
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 27.06.2013 Status:Case Approved HQ File :01/82/050/01379/AM13/ RLA File :07/24/040/00252/AM13/ Lic.No/Date:0710090700 12.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 33/82 dated 21.3.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 on prorata basis, as per details given below or as applied by the them, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amikacin 2 ML (100 MG) BP Vial Size: 3 ML (57,742 KGB) Each vial contains Amikacin (Base) 100 MG/2 ML 1000 No. 1. Amikacin Sulphate Sterile BP/USP (57.742 KGBASE BP/USP) 146.792 gm
Case No.:24/26/82ALC4/2012
Party Name:ECOLOGIC CHEMICALS LIMITED 27.06.2013
50 7.06. 0 3 HQ File :01/82/050/00932/AM13/ RLA File :09/24/040/00296/AM13/ Lic.No/Date:0910053811 14.09.2012 Defer Date:11.07.2013 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 30.5.2013 immediately. The case was deferred for 11.7.2013. 51
Case No.:31/26/82ALC4/2012
Party Name:SRINI PHARMACEUTICALS LTD., 27.06.2013 Status:Case Approved HQ File :01/82/050/00939/AM13/ RLA File :09/24/040/00304/AM13/ Lic.No/Date:0910053812 14.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 48/82 dated 23.2.2010, 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 Export Qty. Sl.No. Import items Qty. allowed Labetalol Hydro Chloride 1kg. 1. 3Amino1Phenyl Butane/1 Methyl3Phenyl Propylamine 2.70 kg 2. 5(bromocetyl) salicylamide 2.48 kg 3. Sodium borohydride 0.20 kg 52
Case No.:32/28/82ALC4/2012
Party Name:STERICON PHARMA PVT.LTD., 27.06.2013 Status:Case Approved HQ File :01/82/050/00999/AM13/ RLA File :07/24/040/00272/AM13/ Lic.No/Date:0710090783 17.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/254/2013PI(Norms) dated 24.6.2013, 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 Vizulise Moisturizing & comfort Eye drops – 0.1% 10 ml (0.01 Gm required per bottle for 225000 bottle) 1 no. of 10 ml bottle 1. Sodium Hyaluronate BP 0.01 gm/10 ml Bottle Vizulise Intensive Moisturing and comfort Eye drops – 0.3%, 10 ml (0.03 gm 1 no. of 10 ml bottle 1 Sodium Hyaluronate BP 0.03 gm/10 ml Bottle
required per bottle for 25000 bottle) 53
Case No.:90/22/82ALC4/2012
Party Name:INDSWIFT LABORATORIES LTD., 27.06.2013 Status:Case deferred HQ File :01/82/050/00793/AM13/ RLA File :22/24/040/00033/AM13/ Lic.No/Date:2210013300 19.09.2012 Defer Date: 25.07.2013 Decision : It was decided to defer the case for 25.7.2013 for comments of Department of Pharmaceuticals. 54
Case No.:88/24/82ALC4/2012
Party Name:CHEMSPEC CHEMICALS PVT LTD 27.06.2013 Status:Case Approved HQ File :01/82/050/00892/AM13/ RLA File :03/94/040/00230/AM13/ Lic.No/Date:0310709870 21.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/214/2013PI(Norms) dated 24.6.2013 , 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 Spiro HCL (Diazaspiro) 1 kg 1 Cyclopentanone 0.667 kg 2. Sodium Cyanide 0.467 kg 3. MDC (Methylene Chloride) 0.637 kg 4. Methanol 0.813 kg 5. Triethylamine 0.287 kg 6. Valeryl Chloride 1.089 kg 7. Acetone 0.280 kg 8. Propanol HCL 0.932 kg 55
Case No.:16/24/82ALC4/2012
Party Name:OGENE SYSTEMS INDIA PVT. LTD. 27.06.2013 HQ File :01/82/050/00820/AM13/ RLA File :09/24/040/00312/AM13/ Lic.No/Date:0910053896 25.09.2012 Defer Date:11.07.2013 56
Case No.:28/26/82ALC4/2012
Party Name:LAKE CHEMICALS PRIVATE LIMITED 27.06.2013 HQ File :01/82/050/00936/AM13/ RLA File :07/24/040/00268/AM13/ Lic.No/Date:0710090949 25.09.2012 Defer Date:25.07.2013
Decision :It was decided to remind the firm to furnish a copy of complete set of technical details as per Appendix 33. The case was deferred for 25.7.2013. 57
Case No.:43/24/82ALC4/2012
27.06.2013 HQ File :01/82/050/00847/AM13/ RLA File :09/24/040/00288/AM13/ Lic.No/Date:0910053905 26.09.2012 Defer Date:11.07.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 11.7.2013. 58
Case No.:12/26/82ALC4/2012
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 27.06.2013 HQ File :01/82/050/00920/AM13/ RLA File :03/94/040/00522/AM13/ Lic.No/Date:0310711393 03.10.2012 Defer Date:11.07.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 11.7.2013. 59
Case No.:10/1/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 27.06.2013 Status:Case Approved HQ File :01/82/050/01368/AM13/ RLA File :07/24/040/00282/AM13/ Lic.No/Date:0710091171 04.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/254/2013PI(Norms) dated 24.6.2013, 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 Vizulise Moisturizing & comfort Eye drops – 0.1% 10 ml (0.01 Gm required per bottle for 225000 bottle) 1 no. of 10 ml bottle 1. Sodium Hyaluronate BP 0.01 gm/10 ml Bottle Vizulise Intensive Moisturing and comfort Eye drops – 0.3% 10 ml (0.03 gm required per bottle for 25000 bottle) 1 no. of 10 ml bottle 1 Sodium Hyaluronate BP 0.03 gm/10 ml Bottle
60
Case No.:33/22/82ALC4/2012
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 27.06.2013 HQ File :01/82/050/00736/AM13/ RLA File :09/24/040/00295/AM13/ Lic.No/Date:0910053985 08.10.2012 Defer Date:11.07.2013 61
Case No.:88/1/82ALC4/2013
27.06.2013 HQ File :01/82/050/01446/AM13/ RLA File :09/24/040/00287/AM13/ Lic.No/Date:0910054034 11.10.2012 Defer Date:25.07.2013 62
Case No.:22/1/82ALC4/2013
Party Name:SHILPA MEDICARE LTD., 27.06.2013 HQ File :01/82/050/01380/AM13/ RLA File :07/24/040/00290/AM13/ Lic.No/Date:0710091373 15.10.2012 Defer Date:25.07.2013 63
Case No.:30/28/82ALC4/2012
27.06.2013 HQ File :01/82/050/00997/AM13/ RLA File :09/24/040/00354/AM13/ Lic.No/Date:0910054116 16.10.2012 Defer Date:25.07.2013 Decision : The case was discussed in the meeting and Shri Mathur from Department of Pharmaceuticals has assured that the written comments will be sent shortly. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/260/213PI(Norms) dated 3.7.2013, it was decided to call from the firm the following technical details: Stepwise % yield on molar basis. Requirement and Recovery of Solvents. Past production visàvis Actual consumption of all the inputs duly certified by the Central Excise Authorities. The case was deferred for 25.7.2013. 64
Case No.:54/24/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 27.06.2013 HQ File :01/82/050/00858/AM13/ RLA File :05/24/040/00252/AM13/ Lic.No/Date:0510337284 16.10.2012 Defer Date:11.07.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/592/2012PI(Norms) dated 6.2.2013, it
was decided to call from the firm complete technical details mainly Mol. Wt. of all input/output product, % yield on molar basis and solvent details as per Appendix 33. The case was deferred for 11.7.2013. 65
Case No.:42/28/82ALC4/2012
Party Name:ZIM LABORATORIES LTD. 27.06.2013 HQ File :01/82/050/01009/AM13/ RLA File :03/95/040/00542/AM13/ Lic.No/Date:0310713482 23.10.2012 Defer Date:25.07.2013 Decision : The case was discussed in the meeting. The representative from Department of Pharmaceuticals has given his comments in the meeting followed by written comments. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/266/2013PI(Norms) dated 3.7.2013, it was decided to call from the firm the following technical details: From the DML furnished by the firm, the export item appears to be formulation product and the export obligation should be in Nos. of packs and not in KGs. The firm has shown NIL wastage in the application. Detailed working on import requirement may be furnished. It was decided to defer the case for 25.7.2013 66
Case No.:89/1/82ALC4/2013
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 27.06.2013 HQ File :01/82/050/01447/AM13/ RLA File :09/24/040/00355/AM13/ Lic.No/Date:0910054151 23.10.2012 Defer Date:25.07.2013 67
Case No.:12/28/82ALC4/2012
27.06.2013 HQ File :01/82/050/00979/AM13/ RLA File :09/24/040/00335/AM13/ Lic.No/Date:0910054160 25.10.2012 Defer Date:25.07.2013 Decision : It was decided to defer the case for 25.7.2013 for comments of Department of Pharmaceuticals. 68
Case No.:16/28/82ALC4/2012
Party Name:CADILA PHARMACEUTICALS LTD. 27.06.2013 HQ File :01/82/050/00983/AM13/ RLA File :08/24/040/00259/AM13/ Lic.No/Date:0810115897 25.10.2012 Defer Date:25.07.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/203/2013PI(Norms) dated 24.6.2013, it was decided to call from the firm fresh production consumption data duly certified by Central Excise Authorities. The case was deferred for 25.7.2013.
Case No.:49/28/82ALC4/2012
Party Name:S M B CORPORATION OF INDIA 27 06 2013
69 27.06.2013 HQ File :01/82/050/01016/AM13/ RLA File :03/95/040/00568/AM13/ Lic.No/Date:0310713614 25.10.2012 Defer Date:25.07.2013 Decision : The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 25.07.2013 70
Case No.:6/28/82ALC4/2012
27.06.2013 Status:Case Approved HQ File :01/82/050/00973/AM13/ RLA File :09/24/040/00352/AM13/ Lic.No/Date:0910054161 25.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/198/2013PI(Norms) dated 24.6.2013, 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 4Amino5 fluoro1(2R hydroxy methyl [1,3]oxothiolane 5Syl)1H pyrimidin2one (EMTII) 1 kg 1. (2R, 5S)5(4Amino5fluoro2 oxo2Hpyrimidin1yl) [1,3]oxathiolane2 carboxylicacid2SIsopropyl5R Methyl1Rcyclohexyl ester (FCE) 2.075 kg 2. Sodium Borohydride 0.423 kg 3. Isopropyl Alcohol 1.75 kg 4. Toluene 0.135 kg 5. Methanol 0.271 kg 6. Triethylamine 0.913 kg 7. Methylene Dichloride 1.421 kg 71
Case No.:1/24/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 27.06.2013 HQ File :01/82/050/00805/AM13/ RLA File :09/24/040/00371/AM13/ Lic.No/Date:0910054177 29.10.2012 Defer Date:11.07.2013 72
Case No.:10/28/82ALC4/2012
27.06.2013 Status:Case Approved HQ File :01/82/050/00977/AM13/ RLA File :09/24/040/00339/AM13/ Lic.No/Date:0910054180 29.10.2012 Defer Date: Decision : The case was discussed in the meeting. Shri Mathur, Consultant, from Department of Pharmaceuticals has assured that the written comments will be sent sooon. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/200/2013PI(Norms) dated 3.7.2013. 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:
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 Lopinavir (CDI Route) 1 kg 1. (5S)2Amino5(N,N dibenzylamino)4oxo1,6 diphenylhex2ene (DAH2) 1.897 kg 2. (2S)(1tetrahydropyrimid2 only)3methylbutanoic acid (TPA) 1.161 kg 3. N,NCarbonyl diimidazole (CDI) 0.647 kg 4. 2,6Dimethyl Phenol 0.618 kg 5. Toluene 2.65 kg 6. Dimethyl Formamide 1.96 kg 7. Methylene Dichloride 1.57 kg 8. Sodium Borohydride 0.819kg 9. Methane Sulfonic Acid 1.867 kg 10. Triethanolamine 2.02 kg 11. Dimethyl Acetamide 1.20 kg 12. Isopropyl Alcohol 0.84 kg 13. 1,2Dimethoxyethane 10.16 kg 14. Methyl Tert Butyl Ether 2.25 kg 15. Methanol 6.02 kg 16. (L)Pyroglutamic Acid 0.316 kg 73
Case No.:102/1/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/01460/AM13/ RLA File :09/24/040/00360/AM13/ Lic.No/Date:0910054178 29.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/329/2013PI(Norms) dated 24.6.2013, 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 Meropenem for injection 1 kg 1 1BetaMethyl Vinyl Phosphate (MAP) 1.808 kg 2. Acetone 11.00 kg 3. Activated Carbon (Carbon Enoanticromos) 0.114 kg 4. Dimethyl Formamide (DMF) 5.15 kg 5. Mercaptan Intermediate for Project Meropenem 1.133 kg 6. Tetra Hydrofuran (THF) 5.229 kg
Tetra Hydrofuran (THF) 5.229 kg 7. 10% Palladium on Charcoal 0.093 kg 74
Case No.:45/26/82ALC4/2012
Party Name:PAYAL POLYPLAST PVT.LTD., 27.06.2013 Status:Case Rejected HQ File :01/82/050/00953/AM13/ RLA File :05/24/040/00255/AM13/ Lic.No/Date:0510337699 29.10.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 75
Case No.:3/24/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 27.06.2013 HQ File :01/82/050/00807/AM13/ RLA File :09/24/040/00332/AM13/ Lic.No/Date:0910054196 30.10.2012 Defer Date:11.07.2013 76
Case No.:20/1/82ALC4/2013
Party Name:SHILPA MEDICARE LTD., 27.06.2013 HQ File :01/82/050/01378/AM13/ RLA File :07/24/040/00312/AM13/ Lic.No/Date:0710091677 01.11.2012 Defer Date:11.07.2013 77
Case No.:7/28/82ALC4/2012
Party Name:MELZER CHEMICALS PVT. LTD 27.06.2013 HQ File :01/82/050/00974/AM13/ RLA File :31/83/040/00134/AM13/ Lic.No/Date:3110056196 05.11.2012 Defer Date:27.06.2013 Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 78
Case No.:19/1/82ALC4/2013
Party Name:CDYMAX (INDIA) PHARMA PVT. LTD. 27.06.2013 HQ File :01/82/050/01377/AM13/ RLA File :07/24/040/00317/AM13/ Lic.No/Date:0710091789 06.11.2012 Defer Date:25.07.2013 79
Case No.:35/28/82ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 27.06.2013 Status:Case Approved HQ File :01/82/050/01002/AM13/ RLA File :05/24/040/00280/AM13/ Lic.No/Date:0510338316 06 11 2012 Defer Date:
06.11.2012 Decision : The case was discussed in the meeting. The representative from Department of Pharmaceuticals has given his comments followed by written comments. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/255/2013PI(Norms) dated 3.7.2013, 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 Export Qty. Sl.No. Import items Qty. allowed Noradrenaline Acid Tartarate Injection BP 4 mg (Noralin) (Ampoules) 1 no. 1. Noradrenaline BiTartrate Raw Pharmaceutical Ingredient (Ampoules) Not allowed as no DML is found for this export product. Cisplatin Injection 50 mg/50 ml (Uniplatin 50) 1 no. 1. Cisplatin 52.5 mg/vial 80
Case No.:99/1/82ALC4/2013
Party Name:S.KANT HEALTHCARE LTD. 27.06.2013 Status:Case Approved HQ File :01/82/050/01457/AM13/ RLA File :03/95/040/00565/AM13/ Lic.No/Date:0310714576 07.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/252/2013PI(Norms) dated 24.6.2013, 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 Di Hydro Artemisinin 1 kg 1. Artemisinin 1.11 kg/kg Artesunate 1 kg 1 Artemisinin 0.889 kg/kg Artemether 1 kg 1 Artemisinin 1.235 kg/kg 81
Case No.:27/28/82ALC4/2012
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 27.06.2013 HQ File :01/82/050/00994/AM13/ RLA File :04/24/040/00160/AM13/ Lic.No/Date:0410141072 16.11.2012 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the information sought vide minutes dated 30.5.2013 immediately. The case was deferred for 25.07.2013 82
Case No.:69/1/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 27.06.2013 HQ File :01/82/050/01427/AM13/ RLA File :05/24/040/00302/AM13/ Lic.No/Date:0510339191 Defer
20.11.2012 Date:25.07.2013 83
Case No.:53/1/82ALC4/2013
Party Name:MAHESHRAJ CHEMICALS PVT.LTD 27.06.2013 HQ File :01/82/050/01411/AM13/ RLA File :08/24/040/00282/AM13/ Lic.No/Date:0810116435 23.11.2012 Defer Date:25.07.2013 Decision :It was decided to send a copy of application to Department of Chemicals and Petrochemicals as the matter pertains to them. the case was deferred for 25.07.2013 84
Case No.:191/33/82ALC4/2012
Party Name:VANI PHARMA LABS LTD. 27.06.2013 HQ File :01/82/050/01338/AM13/ RLA File :09/24/040/00357/AM13/ Lic.No/Date:0910054379 26.11.2012 Defer Date:25.07.2013 85
Case No.:40/28/82ALC4/2012
Party Name:HETERO LABS LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/01007/AM13/ RLA File :09/24/040/00447/AM13/ Lic.No/Date:0910054591 20.12.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/309/2013PI(Norms) dated 24.6.2013, 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 Imatinib Mesylate (Alpha/Beta/Amorphous) 1 kg 1 3Acetyl Pyridine 0.857 kg 2. Dimethyl Formamide Dimethyl Acetal 0.857 kg 3. 2Methyl5Nitroaniline 1.50 kg 4. Cyanamide 1.357 kg 5. Methanol 6.29 kg 6. 4Cyano Benzyl Bromide 1.571 kg 7. Pyridine 1.40 kg 8. Isopropanol 3.58 kg 9. Acetone 2.95 kg 93
Case No.:54/28/82ALC4/2012
Party Name:NECTAR LIFESCIENCES LIMITED, 27.06.2013 HQ File :01/82/050/01021/AM13/ RLA File :22/24/040/00053/AM13/ Lic.No/Date:2210013461 20.12.2012 Defer Date:25.07.2013
Case No.:9/1/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 27 06 2013
94 27.06.2013 HQ File :01/82/050/01367/AM13/ RLA File :22/24/040/00052/AM13/ Lic.No/Date:2210013462 20.12.2012 Defer Date:25.07.2013 95
Case No.:62/28/82ALC4/2012
Party Name:UNIMARK REMEDIES LIMITED., 27.06.2013 HQ File :01/82/050/01029/AM13/ RLA File :03/95/040/00718/AM13/ Lic.No/Date:0310718680 31.12.2012 Defer Date:25.07.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 35011/216/2013PI(Norms) dated 24.6.2013, it was decided to call from the firm the following technical details: While applying the norms, the firm has shown many options to choose the inputs. The firm should be advised to give final list of imported inputs to be actually used in the process of manufacture, and Past production visavis Actual consumption of all the relevant imported inputs for last 3 years duly certified by Central Excise Authorities. The case was deferred for 25.07.2013 96
Case No.:63/28/82ALC4/2012
Party Name:UNIMARK REMEDIES LIMITED., 27.06.2013 Status:Case Approved HQ File :01/82/050/01030/AM13/ RLA File :03/95/040/00719/AM13/ Lic.No/Date:0310718683 31.12.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/229/2013PI(Norms) dated 24.6.2013, 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 Montelukast Sodium 1 kg 1. MNTVI(2(2(3(S)3(2(7 Chloro2Quinnolinyl Ethenyl)3Hydroxypropyl Phenyl)2Propanol 1.438 kg 2. Diisopropylethylamine 0.557 kg 3. Methane Sulfonyl Chloride 0.474 kg 4. Toluene 4.466 kg 5. Acetonitrile 1.545 kg 6. MCAVI(side chain) 1 (Mercaptomethyl)Cyclopropane Acetic Acid 0.600 kg 7. Sodium Methoxide 0.670 kg 8. Activated Carbon 0.100 kg 9 E h l A 10 811 k
Ethyl Acetate 10.811 kg 10. Hexane 7.145 kg 11. Methanol 2.528 kg 12. Di Methyl Formamide 0.891 kg 13. NHeptane 1.262 kg 97
Case No.:65/28/82ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 27.06.2013 Status:Case Approved HQ File :01/82/050/01032/AM13/ RLA File :05/24/040/00375/AM13/ Lic.No/Date:0510342192 01.01.2013 Defer Date: Decision : The case was discussed in the meeting. The representative from Department of Pharmaceuticals has given his comments followed by written comments. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/255/2013PI(Norms) dated 3.7.2013, 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 Export Qty. Sl.No. Import items Qty. allowed Cisplatin Injection 50 mg/50 ml (Uniplatin 50) 1 no. 1. Cisplatin 52.5 mg/vial RA may take appropriate action as per the decision of Norms Committee. 98
Case No.:36/1/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 27.06.2013 HQ File :01/82/050/01394/AM13/ RLA File :22/24/040/00056/AM13/ Lic.No/Date:2210013510 07.01.2013 Defer Date:25.07.2013 99
Case No.:120/1/82ALC4/2013
Party Name:SRINI PHARMACEUTICALS LTD., 27.06.2013 HQ File :01/82/050/01478/AM13/ RLA File :09/24/040/00498/AM13/ Lic.No/Date:0910054820 21.01.2013 Defer Date:25.07.2013 100
Case No.:4/3/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 27.06.2013 HQ File :01/82/050/00037/AM14/ RLA File :22/24/040/00065/AM13/ Lic.No/Date:2210013567 22.01.2013 Defer Date:25.07.2013
101
Case No.:2/30/82ALC4/2012
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 27.06.2013 HQ File :01/82/050/01038/AM13/ RLA File :05/24/040/00389/AM13/ Lic.No/Date:0510343975 23.01.2013 Defer Date: 25.07.2013 Decision : It was decided to defer the case for 25.7.2013 for comments of Department of Pharmaceuticals. 102
Case No.:34/1/82ALC4/2013
Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 27.06.2013 HQ File :01/82/050/01392/AM13/ RLA File :22/24/040/00067/AM13/ Lic.No/Date:2210013583 24.01.2013 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 25.07.2013. 103
Case No.:119/1/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 27.06.2013 HQ File :01/82/050/01477/AM13/ RLA File :09/24/040/00518/AM13/ Lic.No/Date:0910054887 01.02.2013 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish production and consumption data for the year 201213 and also Batch Log Sheet immediately. The case was deferred for 25.07.2013. 104
Case No.:113/1/82ALC4/2013
Party Name:PERKIN LABORATORIES 27.06.2013 HQ File :01/82/050/01471/AM13/ RLA File :09/24/040/00523/AM13/ Lic.No/Date:0910054915 04.02.2013 Defer Date:25.07.2013 105
Case No.:103/1/82ALC4/2013
Party Name:INDO AMINES LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/01461/AM13/ RLA File :03/94/040/00906/AM13/ Lic.No/Date:0310723012 05.02.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their U.O No. 14010/36/2005/Ch. II dated 27.10.2005, 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 Oleyl Diamine 1 kg 1 Oleic Acid 0.941 kg 106
Case No.:118/1/82ALC4/2013
Party Name:EYTAN LABS LIMITED 27.06.2013
HQ File :01/82/050/01476/AM13/ RLA File :09/24/040/00504/AM13/ Lic.No/Date:0910054950 05.02.2013 Defer Date:25.07.2013 107
Case No.:115/1/82ALC4/2013
Party Name:BIOLOGICAL E LTD 27.06.2013 HQ File :01/82/050/01473/AM13/ RLA File :09/24/040/00535/AM13/ Lic.No/Date:0910055011 11.02.2013 Defer Date:25.07.2013 Decision :Department of Biotechnology vide their letter No. BT/IL/05/382/2013PID dated 11.6.2013 has requested the firm to furnish the following information: Wastage has been claimed at 10% level for all the inputs except for glass vials and labels. where 15% wastage is claimed. Please justify the wastage claimed. To submit QA approved Batch Manufacturing Record. It was decided to remind the firm to furnish the above information immediately. The case was deferred for 25.07.2013 108
Case No.:117/1/82ALC4/2013
Party Name:BIOLOGICAL E LTD 27.06.2013 HQ File :01/82/050/01475/AM13/ RLA File :09/24/040/00534/AM13/ Lic.No/Date:0910055012 11.02.2013 Defer Date:25.07.2013 Decision :It was decided to defer the case for 25.07.2013 for comments of Department of Biotechnology. 109
Case No.:7/3/82ALC4/2013
Party Name:WOCKHARDT LIMITED 27.06.2013 HQ File :01/82/050/00040/AM14/ RLA File :03/95/040/00886/AM13/ Lic.No/Date:0310723636 11.02.2013 Defer Date:25.07.2013 Decision : The reply received from the firm vide their letter dated 24.6.2013 is not as per the information sought from the firm. It was decided to remind the firm to furnish the following information immediately: Production and consumption data for the last three years, from the basic stage and from the stage mentioned in the application separately visàvis details regarding exports done. The case was deferred for 25.7.2013. 110
Case No.:111/1/82ALC4/2013
Party Name:VINDHYA PHARMA (INDIA)PVT LTD. 27.06.2013 HQ File :01/82/050/01469/AM13/ RLA File :09/24/040/00479/AM13/ Lic.No/Date:0910055022 12.02.2013 Defer Date:25.07.2013
111
Case No.:47/1/82ALC4/2013
Party Name:SHIVA PHARMACHEM LTD, 27.06.2013 Status:Case Approved HQ File :01/82/050/01405/AM13/ RLA File :34/24/040/00247/AM13/ Lic.No/Date:3410036116 14.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/164/2011Ch. II dated 15.5.2013, 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 Cyclopropane Carbonyl Chloride 1 kg 1 Gamma Butyrolactone 1.47 kg 2. Sodium Methoxide 0.922 kg 112
Case No.:37/1/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 27.06.2013 HQ File :01/82/050/01395/AM13/ RLA File :07/24/040/00487/AM13/ Lic.No/Date:0710093719 15.02.2013 Defer Date:25.07.2013 Decision : The case was discussed in the meeting and Shri Mathur, Consultant from Department of Pharmaceuticals has assured the Committee that the written comments will be sent shortly. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/294/2012 PI(Norms) dated 3.7.2013, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 25.7.2013. 113
Case No.:39/1/82ALC4/2013
Party Name:CENTURY PHARMACEUTICALS LTD. 27.06.2013 HQ File :01/82/050/01397/AM13/ RLA File :34/24/040/00267/AM13/ Lic.No/Date:3410036143 15.02.2013 Defer Date:25.07.2013 114
Case No.:65/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 27.06.2013 HQ File :01/82/050/01423/AM13/ RLA File :08/24/040/00401/AM13/ Lic.No/Date:0810118474 18.02.2013 Defer Date:25.07.2013 115
Case No.:60/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 27.06.2013 HQ File :01/82/050/01418/AM13/ RLA File :08/24/040/00405/AM13/ Lic.No/Date:0810118586 20.02.2013 Defer Date:25.07.2013 Decision :It was decided to defer the case for 11.7.2013 for comments of Department of Pharmaceuticals.
ec s o : t was dec ded to de e t e case o .7. 0 3 o co e ts o epa t e t o a aceut ca s. 116
Case No.:64/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 27.06.2013 HQ File :01/82/050/01422/AM13/ RLA File :08/24/040/00409/AM13/ Lic.No/Date:0810118585 20.02.2013 Defer Date:25.07.2013 117
Case No.:78/1/82ALC4/2013
Party Name:S.M. HERBALS PVT.LTD. 27.06.2013 HQ File :01/82/050/01436/AM13/ RLA File :05/24/040/00423/AM13/ Lic.No/Date:0510346839 20.02.2013 Defer Date:25.07.2013 118
Case No.:81/1/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 27.06.2013 HQ File :01/82/050/01439/AM13/ RLA File :05/23/040/00478/AM13/ Lic.No/Date:0510346879 21.02.2013 Defer Date:25.07.2013 119
Case No.:35/1/82ALC4/2013
Party Name:VENUS REMEDIES LTD., 27.06.2013 HQ File :01/82/050/01393/AM13/ RLA File :22/24/040/00076/AM13/ Lic.No/Date:2210013655 22.02.2013 Defer Date:25.07.2013 120
Case No.:6/32/82ALC4/2012
Party Name:VARUN MEDIMPEX INC. 27.06.2013 HQ File :01/82/050/01147/AM13/ RLA File :05/24/040/00405/AM13/ Lic.No/Date:0510347194 22.02.2013 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 25.7.2013. 121
Case No.:95/1/82ALC4/2013
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 27.06.2013 HQ File :01/82/050/01453/AM13/ RLA File :03/95/040/00884/AM13/ Lic.No/Date:0310725621 25.02.2013 Defer Date:25.07.2013
122
Case No.:23/1/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 27.06.2013 Status:Case Approved HQ File :01/82/050/01381/AM13/ RLA File :07/24/040/00496/AM13/ Lic.No/Date:0710093938 26.02.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/254/2013PI(Norms) dated 24.6.2013, 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 Vizulise Moisturizing & comfort Eye drops – 0.1%, 10 ml (0.01 Gm required per bottle for 225000 bottle) 1 no. of 10 ml bottle 1. Sodium Hyaluronate BP 0.01 gm/10 ml Bottle Vizulise Intensive Moisturing and comfort Eye drops – 0.3%, 10 ml (0.03 gm required per bottle for 25000 bottle) 1 no. of 10 ml bottle 1 Sodium Hyaluronate BP 0.03 gm/10 ml Bottle 123
Case No.:73/1/82ALC4/2013
Party Name:JUBILANT LIFE SCIENCES LIMITED 27.06.2013 Status:Case Approved HQ File :01/82/050/01431/AM13/ RLA File :05/23/040/00468/AM13/ Lic.No/Date:0510347436 26.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/38/2011Ch II dated 15.4.2013, 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 4(Dimethyl Amino)Pyridine 1 kg 1. Alumino Silicate Catalyst 0.0436 kg 2. Denatured Ethyl Alcohol 5.34 kg 3. Methanol 3.22 kg 4. Thionyl Chloride 4.14 kg 5. Dimethyl Formamide 1.00 kg 6. Toluene 2.00 kg
124
Case No.:82/1/82ALC4/2013
Party Name:PROMED EXPORTS PVT.LTD. 27.06.2013 Status:Case Approved HQ File :01/82/050/01440/AM13/ RLA File :05/24/040/00385/AM13/ Lic.No/Date:0510347521 26.02.2013 Defer Date: Decision : The case was discussed in the meeting. Shri D.N. Mathur, Consultant from Department of Pharmaceuticals has assured in the meeting that written comments will be sent shortly. In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/316/2013 PI(Norms) dated 3.7.2013, 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 Irifin Eye Drops 2.5% 5 ml (net content of bulk drug = 90.58 Kgs) 5 ml pack 1. Phenylephrine Hydrochloride 127.50 mg/5 ml pack 125
Case No.:76/1/82ALC4/2013
Party Name:FORACE POLYMERS (P) LTD. 27.06.2013 HQ File :01/82/050/01434/AM13/ RLA File :05/23/040/00493/AM13/ Lic.No/Date:0510347987 01.03.2013 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 11.7.2013. 126
Case No.:24/1/82ALC4/2013
Party Name:SAURAV CHEMICALS LTD, 27.06.2013 HQ File :01/82/050/01382/AM13/ RLA File :22/24/040/00074/AM13/ Lic.No/Date:2210013689 05.03.2013 Defer Date:25.07.2013 Decision :It was decided to defer the case for25.07.2013 for comments of Department of Pharmaceuticals. 127
Case No.:121/1/82ALC4/2013
Party Name:PIONEER LABORATORIES INDIA PVT. LTD., 27.06.2013 HQ File :01/82/050/01479/AM13/ RLA File :56/24/040/00040/AM13/ Lic.No/Date:5610001786 06.03.2013 Defer Date:25.07.2013 128
Case No.:43/1/82ALC4/2013
Party Name:RIDDHI PHARMA 27.06.2013 Status:Case Approved HQ File :01/82/050/01401/AM13/ RLA File :34/24/040/00266/AM13/ Lic.No/Date:3410036326 06.03.2013 Defer Date:
Decision : : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/76/2010/Ch. II dated 12.6.2013, 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 4Amino 1,2,4 Triazole 1 kg 1 Hydrazine Hydrate 1,252 kg 2. Formic Acid Purity 85% 1.350 kg 129
Case No.:62/1/82ALC4/2013
Party Name:MAHESHRAJ CHEMICALS PVT.LTD 27.06.2013 HQ File :01/82/050/01420/AM13/ RLA File :08/24/040/00424/AM13/ Lic.No/Date:0810119074 06.03.2013 Defer Date:25.07.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 11.7.2013. 130
Case No.:7/1/82ALC4/2013
Party Name:DL INTRACHEM 27.06.2013 Status:Case Approved HQ File :01/82/050/01365/AM13/ RLA File :08/24/040/00462/AM13/ Lic.No/Date:0810119608 20.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/14/2010/Ch. II dated 13.6.2013, 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 2,3 Dichloro 1,4 Naphthaquinone 1 kg 1. Sodium Naphthionate Powder 1.495 kg 131
Case No.:74/1/82ALC4/2013
Party Name:ATUL INTERMEDIATES 27.06.2013 HQ File :01/82/050/01432/AM13/ RLA File :08/24/040/00423/AM13/ Lic.No/Date:0810119733 25.03.2013 Defer Date: 25.7.2013 Decision :It was decided to defer the case for 25.07.2013 for comments of Department of Chemicals and Petrochemicals. 132
Case No.:2/7/82ALC4/2013
Party Name:YASHO INDUSTRIES PVT.LTD. 27.06.2013 Status:Case Approved HQ File :01/82/050/00131/AM14/ RLA File :03/95/040/00003/AM14/ Lic.No/Date:0310730391 04.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011/Ch. II dated 12.6.2013, 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 Butylated H d A i l 1 kg 1 Hydroquinone 1.247 kg i l k
Hydroxy Anisole (BHA) 2. Tertiary Butanol 0.839 kg 3. Phosphonic Acid 1.00 kg 4. Hexane 1.00 kg 133
Case No.:1/3/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 27.06.2013 HQ File :01/82/050/00034/AM14/ RLA File :09/24/040/00013/AM14/ Lic.No/Date:0910055748 15.04.2013 Defer Date:25.07.2013 134
Case No.:3/3/82ALC4/2013
Party Name:LAKE CHEMICALS PRIVATE LIMITED 27.06.2013 HQ File :01/82/050/00036/AM14/ RLA File :07/24/040/00003/AM14/ Lic.No/Date:0710094921 18.04.2013 Defer Date:25.07.2013 135
Case No.:1/5/82ALC4/2013
27.06.2013 HQ File :01/82/050/00119/AM14/ RLA File :09/24/040/00020/AM14/ Lic.No/Date:0910055978 10.05.2013 Defer Date: 22.08.2013 Decision : It was decided to defer the case for 22.8.2013 for comments of Department of Pharmaceuticals. 136
Case No.:2/5/82ALC4/2013
27.06.2013 HQ File :01/82/050/00120/AM14/ RLA File :09/24/040/00023/AM14/ Lic.No/Date:0910055979 10.05.2013 Defer Date:25.07.2013 137
Case No.:3/5/82ALC4/2013
Party Name:PI INDUSTRIES LTD., 27.06.2013 Status:Case Approved HQ File :01/82/050/00121/AM14/ RLA File :13/24/040/00006/AM14/ Lic.No/Date:1310042992 14.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/6/2010Ch. II dated 1.7.2013, 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 2Chloro6 Thi th l 1 kg 1. 3Chloro2Methyl Aniline (CMA) 1.116 kg
Thiomethyl Toluene (2C6SMT) (CMA) 2. Sodium Methyl Mercaptide (21%) 2.845 kg 3. Sodium Nitrite 0.660 kg 138
Case No.:4/5/82ALC4/2013
Party Name:BIOLOGICAL E LTD 27.06.2013 HQ File :01/82/050/00122/AM14/ RLA File :09/24/040/00466/AM12/ Lic.No/Date:0910056004 16.05.2013 Defer Date:25.07.2013 139
Case No.:5/5/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 27.06.2013 HQ File :01/82/050/00123/AM14/ RLA File :09/24/040/00042/AM14/ Lic.No/Date:0910056036 17.05.2013 Defer Date:25.07.2013 140
Case No.:1/7/82ALC4/2013
Party Name:SHIVA PHARMACHEM LTD, 27.06.2013 Status:Case Approved HQ File :01/82/050/00130/AM14/ RLA File :34/24/040/00048/AM14/ Lic.No/Date:3410037111 13.06.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/89/2010/Ch. II dated 24.6.2011, 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 Isooctyl Chloride 1 kg 1. 2Ethylhexanol/Isooctyl Alcohol 0.972 kg Outside Agenda No. 1 M/s. Camphor and Allied Products Limited 01/82/050/01578/AM 11/DES III RLA File No. 03/94/040/00624/AM 11 0310597668 dated 19.10.2010
Decision: It was decided to amend the description of the export product as Astrolide (DPG) (Astrolide in Dipropylene Glycol, Main Astrolide content: 62.5% min). Rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee. Outside Agenda No. 2 M/s. Mohini Organics Private Limited 01/82/050/00479/AM 11/DES III RLA File No. 03/95/040/00029/AM 11 0310571002 dated 23.4.2010 Decision: This was noticed that the description of export product given in the Advance License as Pentaerythritol Tetra Stearate. Description of export product given by the NC as Fatty Acid Ester (Pentaerythritol Tetra Stearate. Description of the export product given in the Shipping Bill as Fatty Acid Ester.
l Tetra Stearate. Description of export product given by the NC as Fatty Acid Ester (Pentaerythritol Tetra Stearate. Description of the export product given in the Shipping Bill as Fatty Acid Ester. It was clarified that technically, description of export product given in Advance Authorization, NC approval letter and in the Shipping Bill are the same. Date:03.07.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer
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