DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 21/82ALC4/2013 MEETING DATE : 06.02.2014 The Meeting No. 21/82 of 201314 to consider the cases/issues under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products and falling under Chapter 29 and 30 was to be held on 06.02.2014 but actually held on 13.02.2014 under the Chairmanship of, Shri Jaikant Singh, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present: 1. Shri D.N. Mathur. Consultantr, Department of Pharmaceutical 2. Shri Jasbir Singh, Consultantr, Department of C&PC 3. Shri R.C. Meena, Deputy Director General of Foreign Trade 4. Dr. Nitin Jain D/o Biotechnology 1. Since no communication /comments were received from any of the Administrative Departments. The minutes of the meeting held on 31.01.2014 was treated as approved. 2. The following cases/issues were discussed and the committee took the decision as mentioned against the case: 1
Case No.:1/21/82ALC4/2010
Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:21/82ALC4/2013 06.02.2014 Status:Case Deferred HQ File :01/82/050/00639/AM11/ RLA File :09/24/040/00182/AM11/ Lic.No/Date:0910043061 12.08.2010 Defer Date:06.03.2014 Decision :: It was decided to remind the firm to furnish the following inofrmation: • Details of manufaturing process of 3,4 Ethylene DioxyThiophene (EDOT) with chemcialequatinos, molecular formula, molecular wights has been furnished. Kindly furnish yield obtained in each step supported with Authentic technical literature. • Material balance • CA certificate certifying the production of export item acheived by you for the past three years and correspondening consumption of each input • Detailed calculation, arriving at the norms applied. The case was deferred for 06.03.2014
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Case No.:5/45/83ALC1/2011
Party Name:SPAN DIAGNOSTICS LTD 06.02.2014 Status:Case Approved HQ File :01/83/050/00780/AM12/ RLA File :52/24/040/00033/AM12/ Lic.No/Date:5210037002 15.11.2011 Defer Date: Decision : In the light of wriƩen comments received from Department of Biotechnology vide their OM No. BT/IL/05/367/2012‐PID dated 02.01.2014, it was decided to raƟfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export QuanƟty S,No Item of Import QuanƟty allowed kg/kg HBV (ELISA)TEST KIT MICROSCREEN (96 TESTS) HBsAg TEST KIT. 1 kg 1. TRIS 6.933 kg 2. TWEEN 20 2.86 Litre 3. SERAMUM BLAU SLOW [ELISA], TMB/SUBSTRATE SOLUTION, READY TO USE 125 Litre 4. BOVINE SERUM ALBUMIN PROTEASE FREE POWDER. 7.365 kg 5. FETAL BOVINE SERUM. 18.5 Litre 6. MAB antiHBs (INVIVO). 0.23 lItre 7. HBsAg ELISA ENZYME HORSE RADDISH PEROXIDASE (HRP). 0.204 gm 8. CORNING COSTAR STRIPWELL TM PLATES 1 X 8. 10417 Nos RA may take appropriate acƟon as per the decision of Norms CommiƩee’s. 3
Case No.:6/21/82ALC4/2013
Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/01036/AM14/ RLA File :05/24/040/00363/AM12/ Lic.No/Date:0510316016 01.02.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/370/2012PI(Norms) dated Sept. 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 kg/kg 7Phenylacetamideo 3 Kg 1. Penicillin G Potassium 1st Crystals 2.85
Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) White/LightYellow Powder White/LightYellow Powder 2. Methanol Liquid 2.00 3. Dimethyl Formamide Colourless Liquide 3.86 4. Methylene Chloride Colourless Liquide 2.09 5. 2Mercaptobenzothiazole Ceramish Powder 0.511 6. Isopropyl Alcohol Liquid 1.25 A may take appropriate acƟon as per the decision of Norms CommiƩee. 4
Case No.:9/31/82ALC4/2012
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/01049/AM13/ RLA File :04/24/040/00182/AM13/ Lic.No/Date:0410141372 29.11.2012 Defer Date:06.03.2014 Decision :It was decided to defer the case for 06.03.2014 for comments of Department of Pharmaceuticals 5
Case No.:188/33/82ALC4/2012
Party Name:JUBILANT LIFE SCIENCES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/01335/AM13/ RLA File :05/23/040/00345/AM13/ Lic.No/Date:0510340432 07.12.2012 Defer Date:06.03.2014 Decision :It was decided to defer the case for 06.03.2014 for comments of Department of Pharmaceuticals. 6
Case No.:2/30/82ALC4/2012
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 06.02.2014 Status:Case Deferred HQ File :01/82/050/01038/AM13/ RLA File :05/24/040/00389/AM13/ Lic.No/Date:0510343975 23.01.2013 Defer Date:06.03.2014 7
Case No.:28/4/82ALC4/2013
Party Name:MYLAN LABORATORIES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00069/AM14/ RLA File :09/24/040/00520/AM13/ Lic.No/Date:0910054940 05.02.2013 Defer Date:06.03.2014 Decision :It was decided to remind the firm to furnish the following technical details:
(a) Complete technical details as per Appendix 33. (b) Past production visavis Actual consumption of all inputs year wise for last 3 years, duly certified by Central Excise Authority. The case was deferred for 06.03.2014. 8
Case No.:1/36/85ALC3/2012
Party Name:SRIAM LABS PRIVATE LIMITED 06.02.2014 Status:Case Rejected HQ File :01/85/050/00169/AM13/ RLA File :09/24/040/00502/AM13/ Lic.No/Date:0910054980 08.02.2013 Defer Date: Decision: It was decided to reject the case as the firm has not furnished information despite repeated reminders. 9
Case No.:33/2/82ALC4/2013
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 06.02.2014 Status:Case Deferred HQ File :01/82/050/01480/AM13/ RLA File :05/24/040/00481/AM13/ Lic.No/Date:0510350279 26.03.2013 Defer Date:06.03.2014 Decision :it was decided to remind the firm to furnish the following technical details: (a) Yield on molar basis for each step along with copy of technical literature in support of the yield envisaged. (b) BatchLog sheet for the last 3 batches. 10
Case No.:42/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00225/AM14/ RLA File :09/24/040/00635/AM13/ Lic.No/Date:0910055653 02.04.2013 Defer Date:06.03.2014 Decision :As per the TA D/o of Biotechnology stated that the information given by the firm is incomplete. Remind the firm to furnish the complete information as called by DBT: Drug Manufacturing Licensing of the export product (DML enclosed with the application does not mention the export product. To submit QA approved Batch Manufacturing Record (norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type B (HIB) Combined vaccine with vaccine vial monitor (VVM) (5000000.00) against the import inputs mentioned in the application) The case was deferred for 06.03.2014. Defer Date :06.03.2014 11
Case No.:85/10/82ALC4/2013
Party Name:BIOLOGICAL E LTD Status:Case
06.02.2014 Deferred HQ File :01/82/050/00268/AM14/ RLA File :09/24/040/00636/AM13/ Lic.No/Date:0910055652 02.04.2013 Defer Date:06.03.2014 Decision :As per the TA D/o of Biotechnology stated that the information given by the firm is incomplete. Remind the firm to furnish the complete information as called by DBT: Drug Manufacturing Licensing of the export product (DML enclosed with the application does not mention the export product. To submit QA approved Batch Manufacturing Record (norms for the export item called DTPHEPB (Pentavalent Vaccine) fully liquid combination vaccine single does vial, Pediatric does Diphtheria, Tetanus, Pertussis, Hepatitis B Recombinant and Heamophilus Type B (HIB) Combined vaccine with vaccine vial monitar (VVM) (5000000.00) against the import inputs mentioned in the application) The case was deferred for 06.03.2014. Defer Date :06.03.2014 12
Case No.:142/10/82ALC4/2013
Party Name:WOCKHARDT LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00325/AM14/ RLA File :03/95/040/00101/AM14/ Lic.No/Date:0310734494 15.05.2013 Defer Date:06.03.2014 Decision : The firm was requested to furnish the production and consumption data for the last three years certified by Central Excise Authority , reminder letter has been also sent on 09.01.2014. Copy of application has been already sent to DCGI for their comments. 13
Case No.:41/15/82ALC4/2013
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00803/AM14/ RLA File :03/94/040/00541/AM13/ Lic.No/Date:0310734622 16.05.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/668/2012PI(Norms) dated 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Losartan Potassium Kg 1. Losartan Base 0.936 14
Case No.:36/13/82ALC4/2013
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00512/AM14/ RLA File :03/94/040/00542/AM13/ Lic.No/Date:0310734791 17.05.2013 Defer Date:
Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/668/2012PI(Norms) dated 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Losartan Potassium Kg 1. Losartan Base 0.936 15
Case No.:10/21/82ALC4/2013
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/01040/AM14/ RLA File :03/94/040/00494/AM13/ Lic.No/Date:0310734784 17.05.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/172/2013PI(Norms) dated 09.05.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg VALGANCICLOVIR HYDROCHLORIDE Kg 1. GANCICLOVIR 2.00 2. CBZLVALINE 2.465 16
Case No.:42/20/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/01028/AM14/ RLA File :09/24/040/00058/AM14/ Lic.No/Date:0910056110 23.05.2013 Defer Date:06.03.2014 Decision :It was decided to request the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 06.03.2014. 17
Case No.:41/19/82ALC4/2013
Party Name:CIPLA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00986/AM14/ RLA File :03/94/040/01130/AM13/ Lic.No/Date:0310736948 06.06.2013 Defer Date:06.03.2014
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Case No.:156/14/82ALC4/2013
Party Name:EYTAN LABS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00741/AM14/ RLA File :09/24/040/00087/AM14/ Lic.No/Date:0910056288 07.06.2013 Defer Date:06.03.2014 19
Case No.:77/14/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00662/AM14/ RLA File :09/24/040/00106/AM14/ Lic.No/Date:0910056304 10.06.2013 Defer Date:06.03.2014 Decision :It was decided to request the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 06.03.2014. 20
Case No.:88/10/82ALC4/2013
Party Name:MAHESHRAJ CHEMICALS PVT.LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00271/AM14/ RLA File :08/24/040/00099/AM14/ Lic.No/Date:0810121913 13.06.2013 Defer Date:06.03.2014 Decision :It has been decided to remind the firm to furnish the following technical details: Details of Manufacturing process of cooper Formazone indicating use of Ortho Amine Phenol and SulphoAnthrantilic Acid with Chemical equations, molecular formula, molecular weights. Yield obtained in each step. Authentic technical literature in support of yield obtained. Material balance. CA certificate certifying the production of export item achieved by you for the past three years and corresponding consumption of each input Detailed calculations, arriving at the norms applied for. The case was deferred for 06.03.2014 for comments of D/o C&PC. 21
Case No.:49/12/82ALC4/2013
Party Name:INDOCO REMEDIES LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00473/AM14/ RLA File :03/94/040/00155/AM14/ Lic.No/Date:0310737785 14.06.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/657/2013PI(Norms) dated 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less:
Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg AZELASTINE HYDROCHLORIDE. OPHTHALMIC SOLUTION , 0.05%0.5mg / ml6 ml Bottle. Kg 1. AZELASTINE HCL 3.06 mg/6 ml BoƩle 22
Case No.:51/12/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00475/AM14/ RLA File :03/94/040/00240/AM14/ Lic.No/Date:0310737875 17.06.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/659/2013PI(Norms) dated 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed kg/kg RECTICIN100 SUPPOSITORY NET CONTENT OF IMPORT ITEM USEDINDOMETHACIN BP98.035 KGS Kg 1. INDOMETHACIN BP 102 mg/ 100 mg Suppository 23
Case No.:199/10/82ALC4/2013
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00382/AM14/ RLA File :04/24/040/00048/AM14/ Lic.No/Date:0410147196 17.06.2013 Defer Date:06.03.2014 Decision :it was decided to call from the firm the following technical details: • The firm has applied the norms from Guannosine. However, the chemistry is given from 2Amino Adenosine Stage. • Copy of technical literature in support of yields envisaged may be furnished. • Past production visavis Actual consumption of all the imported inputs duly certified by Central Excise Authority for past 3 years may be furnished The case was deferred for 06.03..2014. 24
Case No.:40/12/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED Status:Case
06.02.2014 Deferred HQ File :01/82/050/00464/AM14/ RLA File :09/24/040/00113/AM14/ Lic.No/Date:0910056355 17.06.2013 Defer Date:06.03.2014 25
Case No.:88/14/82ALC4/2013
Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 06.02.2014 Status:Case Approved HQ File :01/82/050/00673/AM14/ RLA File :09/24/040/00102/AM14/ Lic.No/Date:0910056373 18.06.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/292/2012PI(Norms) dated 03.07 2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg (1S, 4R)4[(2AMINO6 CHLORO5FORMAMIDO 4PYRIMIDINYL)AMINO] 2CYCLO PENTENE1 METHANOL Kg 1. N(2AMINO4,6DICHLORO5 PYRIMIDINYL) FORMAMIDE 0.764 2. (+)2AZABICYCLO[2.2.1]HEPT5 EN3ONE (VINCELACTAM) 1.832 3. D()TARTARIC ACID 1.06 4. SODIUM BOROHYDRIDE 0.226 5. PYRIDINE 1.00 6. ISOPROPYL ALCOHOL 4.70 7. METHANOL 4.23 8. DICHLORO METHANE 2.47 26
Case No.:28/12/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00452/AM14/ RLA File :03/94/040/00245/AM14/ Lic.No/Date:0310738193 19.06.2013 Defer Date:06.03.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/660/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm the following technical details: 1. COA for foreign supplier indicating Potency of Nystatin imported under present A.A 2. Detailed calculation of arriving at the quantity of API applied. The case was deferred for 06.03..2014.
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Case No.:23/12/82ALC4/2013
Party Name:CIRON DRUGS & PHARMACEUTICALS P. LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00447/AM14/ RLA File :03/94/040/00094/AM14/ Lic.No/Date:0310738255 19.06.2013 Defer Date:06.02.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/648/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm the following technical details: 1. Copy of DML for the export product. 2. Detailed working for arriving the import quantity applied by the firm. The case was deferred for 06.03..2014. 28
Case No.:145/14/82ALC4/2013
Party Name:METROCHEM API PVT. LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00730/AM14/ RLA File :09/24/040/00107/AM14/ Lic.No/Date:0910056390 19.06.2013 Defer Date: Decision : In the light of earlier decision taken in its meeting No. 3/82 meeting dated 02.05.2013, 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 Kg 1. 2(2(3(S)(3(2(7chloro2 quinolinyl)ethenyl)phenyl)3 hydroxypropyl)phenyl)2propanol 1.24 kg 2. 1methyl mercapto cyclo propane acetic acid 0.40 kg 29
Case No.:183/10/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00366/AM14/ RLA File :13/24/040/00032/AM12/ Lic.No/Date:1310043416 19.06.2013 Defer Date:06.03.2014 30
Case No.:22/12/82ALC4/2013
Party Name:INDOFIL INDUSTRIES LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00446/AM14/ RLA File :03/94/040/00197/AM14/ Lic.No/Date:0310738404 Defer
20.06.2013 Date:06.03.2014 Decision :It was decided to defer the case for 06.03.2014 for comments of Department of C&PC.. 31
Case No.:126/14/82ALC4/2013
Party Name:ZIM LABORATORIES LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00711/AM14/ RLA File :03/95/040/00225/AM14/ Lic.No/Date:0310738604 21.06.2013 Defer Date:06.03.2014 32
Case No.:111/10/82ALC4/2013
Party Name:STERICAT GUTSTRINGS PVT. LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00294/AM14/ RLA File :05/24/040/00091/AM14/ Lic.No/Date:0510358000 25.06.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case for 06.03.2014 for comments of Department of IPP. 33
Case No.:90/14/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00675/AM14/ RLA File :09/24/040/00128/AM14/ Lic.No/Date:0910056460 26.06.2013 Defer Date:06.03.2014 34
Case No.:39/12/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00463/AM14/ RLA File :09/24/040/00138/AM14/ Lic.No/Date:0910056466 26.06.2013 Defer Date:06.03.2014 35
Case No.:172/14/82ALC4/2013
Party Name:RECKON DIAGNOSTICS PVT. LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00757/AM14/ RLA File :34/24/040/00044/AM14/ Lic.No/Date:3410037268 27.06.2013 Defer Date:06.03.2014 Decision :Department of Biotechnology vide their letter NO. BT/IL/05/398/2013PID dated 26.12.2013 has requested the firm to furnish the copy of Manufacturing process flow chart, copy DML (Drug Manufacturing Licence),Batch Manufacturing Record and clarification on the quantities of import inputs (whether it is in Grams or in Milligrams) mentioned in the application.
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Case No.:201/10/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00384/AM14/ RLA File :04/24/040/00063/AM14/ Lic.No/Date:0410147551 27.06.2013 Defer Date:06.03.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/648/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. 37
Case No.:204/10/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00387/AM14/ RLA File :04/24/040/00065/AM14/ Lic.No/Date:0410147559 27.06.2013 Defer Date:06.03.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/648/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. 38
Case No.:222/10/82ALC4/2013
Party Name:ANUPAM RASAYAN (INDIA) LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00405/AM14/ RLA File :52/24/040/00009/AM14/ Lic.No/Date:5210039910 28.06.2013 Defer Date:06.03.2014 Decision :It was decided to send a last reminder to the firm to furnish the following information: • Details of manufacturing process of 2Amino 4Trifluoro Methyl 4 ChloroDiphenyl Ether with chemicalequations, molecular formula, molecular weights. • Yield obtained in each step • Authentic technicalliterature in support of yield obtained • Material balance • CA certificate the production of export item achieved by you for the past three years and corresponding consumption of each input • Role of copper Sulphate in the process, supported with authentic technical literature. • Detailed calculation, arriving at the norms applied. The case was deferred for 06.03.2014 39
Case No.:223/10/82ALC4/2013
Party Name:ANUPAM RASAYAN (INDIA) LTD Status:Case
06.02.2014 Deferred HQ File :01/82/050/00406/AM14/ RLA File :52/24/040/00011/AM14/ Lic.No/Date:5210039911 28.06.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case 06.03.2014 for comments of Department of Chemicals and Petrochemicals. 40
Case No.:224/10/82ALC4/2013
Party Name:ANUPAM RASAYAN (INDIA) LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00407/AM14/ RLA File :52/24/040/00008/AM14/ Lic.No/Date:5210039909 28.06.2013 Defer Date:06.03.2014 Decision :It was decided to remind the firm to furnish the following information: • Details of manufacturing process of 2Amino 4Trifluoro Methyl 4 ChloroDiphenyl Ether with chemicalequations, molecular formula, molecular wights. • Yield obtained in each step • Authentic technicalliterature in support of yield obtained • Material balance • CA certificate the production of export item achieved by you for the past three years and corresponding consumption of each input • Role of copper Sulphate in the process, supported with authentic technical literature. • Detailed calculation, arriving at the norms applied. The case was deferred for 06.03.2014 41
Case No.:41/8/82ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00172/AM14/ RLA File :03/95/040/01020/AM13/ Lic.No/Date:0310739495 28.06.2013 Defer Date:06.02.2014 Decision :It was decided to defer the case for 06.02.2014 for comments of Department of C&PC. 42
Case No.:173/14/82ALC4/2013
Party Name:ALEMBIC PHARMACEUTICALS LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00758/AM14/ RLA File :34/24/040/00065/AM14/ Lic.No/Date:3410037281 01.07.2013 Defer Date:06.03.2014 43
Case No.:1/8/85ALC3/2013
Party Name:SRIAM LABS PRIVATE LIMITED 06.02.2014 Status:Case Deferred
HQ File :01/85/050/00054/AM14/ RLA File :09/24/040/00115/AM14/ Lic.No/Date:0910056522 01.07.2013 Defer Date:06.03.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their letter No. Q 35021/10/2013PI(Norms) dated 06.09.2013 and 26.06.2013 has stated that the firm has mentioned Chapter 30 wrongly and it should be covered under chapter 29 of ITC(HS). Deptt. ofPharma has requested to advise the firm to suitably revised their application using proper HS code before the matter is processed further. The case is Deferred for 06.03.2014. 44
Case No.:24/12/82ALC4/2013
Party Name:WOCKHARDT LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00448/AM14/ RLA File :03/95/040/00256/AM14/ Lic.No/Date:0310739850 02.07.2013 Defer Date:06.03.2014 Decision :The firm was requested to furnish the production and consumption data for the last three years certified by Central Excise Authority reminder letter has been also snet on 09.01.2014. Copy of application has been already sent to DCGI for their comments. The case was deferred for 06.03.2014. 45
Case No.:159/14/82ALC4/2013
Party Name:RUCHI INFRASTRUCTURE LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00744/AM14/ RLA File :56/24/040/00010/AM14/ Lic.No/Date:5610002426 04.07.2013 Defer Date:06.03.2014 Decision : It was decided to send last reminder to the firm to furnish the following technical details: 1. Details of manufacturing process with chemical equations, molecular formula and molecular weight. 2. Yield obtained in each manufacturing step. 3. Production and consumption data duly certified by CA. 4. Material balance. 5. Detailed calculations, arriving at the norms applied for. 46
Case No.:27/14/82ALC4/2013
Party Name:OGENE SYSTEMS INDIA PVT. LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00612/AM14/ RLA File :09/24/040/00132/AM14/ Lic.No/Date:0910056690 05.07.2013 Defer Date: Decision : In the light of wriƩen comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/97/2011‐Ch II dated 23.01.2014, it was decided to raƟfy 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 3,4ETHYLENE DIOXY 1 kg 1. Diethyl thioglycolate 4.33 kg
THIOPHENE [EDOT] 2. Methanol 2.49 kg 3. Tetra butyl Ammonium bromide 0.354 kg 47
Case No.:33/12/82ALC4/2013
Party Name:THINQ PHARMACRO LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00457/AM14/ RLA File :03/95/040/00207/AM14/ Lic.No/Date:0310740446 05.07.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/679/2013PI(Norms) dated 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed Kg/kg RACTOPAMINE HYDROCHLORIDE Kg 1. (4HYDROXYPHENYL) ETHANOLAMINE HYDROCHLORIDE 0.77 48
Case No.:102/10/82ALC4/2013
Party Name:YELURI FORMULATIONS PRIVATE LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00285/AM14/ RLA File :09/24/040/00149/AM14/ Lic.No/Date:0910056680 05.07.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/634/2013PI(Norms) dated 22.01.2014, 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 Amoxicillin & Clavulanate Potassium for Oral Suspension USP 312.50 mg suspension Pack size:100 ml, Kg 1. Amoxicillin Trihydrate USP 6.0257 gm/BoƩle 2. Potassium Clavulanate Diluted USP (Potassium Clavulanate with Silicon Dioxide (1:1) 3.124 gm/ BoƩle
49
Case No.:44/12/82ALC4/2013
Party Name:ENCUBE ETHICALS PVT LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00468/AM14/ RLA File :03/94/040/00306/AM14/ Lic.No/Date:0310740922 10.07.2013 Defer Date:06.03.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/647/2013PI(Norms) dated 22.01.2014, it was decided to call from the firm copy of Master Batch Formula duly certified by Quality control Incharge. The case was deferred for 06.03.2014 50
Case No.:175/14/82ALC4/2013
Party Name:ONEIRO CHEMICALS LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00760/AM14/ RLA File :34/24/040/00071/AM14/ Lic.No/Date:3410037375 10.07.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case 06.03.2014 for comments of Department of Chemicals and Petrochemicals. 51
Case No.:160/14/82ALC4/2013
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00745/AM14/ RLA File :04/24/040/00050/AM14/ Lic.No/Date:0410147942 11.07.2013 Defer Date:06.03.2014 52
Case No.:26/12/82ALC4/2013
Party Name:SANOFI INDIA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00450/AM14/ RLA File :03/95/040/00227/AM14/ Lic.No/Date:0310741158 11.07.2013 Defer Date:06.03.2014 Decision : It was decided to defer the case for 06.03.2014 for comments of Department of Pharmaceuticals. 53
Case No.:5/21/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/01035/AM14/ RLA File :08/24/040/00157/AM14/ Lic.No/Date:0810122789 15.07.2013 Defer Date:06.03.2014 54
Case No.:60/14/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 06.02.2014 Status:Case Deferred
HQ File :01/82/050/00645/AM14/ RLA File :09/24/040/00085/AM14/ Lic.No/Date:0910056772 16.07.2013 Defer Date:06.03.2014 Decision :It was decided to request the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 06.03.2014. 55
Case No.:21/12/82ALC4/2013
Party Name:WOCKHARDT LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00445/AM14/ RLA File :03/95/040/00306/AM14/ Lic.No/Date:0310741992 18.07.2013 Defer Date:06.03.2014 Decision :The firm was requested to furnish the production and consumption data for the last three years certified by Central Excise Authroity reminder letter has been also snet on 09.01.2014. Copy of application has been already sent to DCGI for their comments. The case was deferred for 06.03.2014. 56
Case No.:68/17/82ALC4/2013
Party Name:BHARAT PARENTERALS LTD, 06.02.2014 Status:Case Deferred HQ File :01/82/050/00930/AM14/ RLA File :34/21/040/00163/AM14/ Lic.No/Date:3410037475 23.07.2013 Defer Date:06.03.2014 57
Case No.:52/12/82ALC4/2013
Party Name:UNIJULES LIFE SCIENCES LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00476/AM14/ RLA File :03/95/040/00305/AM14/ Lic.No/Date:0310742481 23.07.2013 Defer Date:06.03.2014 58
Case No.:1/19/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00946/AM14/ RLA File :09/24/040/00176/AM14/ Lic.No/Date:0910056894 24.07.2013 Defer Date:06.03.2014 59
Case No.:46/14/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00631/AM14/ RLA File :09/24/040/00185/AM14/ Lic.No/Date:0910056909 25.07.2013 Defer Date:06.03.2014
60
Case No.:24/17/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00886/AM14/ RLA File :09/24/040/00180/AM14/ Lic.No/Date:0910056902 25.07.2013 Defer Date:06.03.2014 61
Case No.:43/12/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00467/AM14/ RLA File :52/24/040/00015/AM14/ Lic.No/Date:5210040038 30.07.2013 Defer Date:06.03.2014 Decision :It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 06.03.2014 for comments of 62
Case No.:1/10/82ALC4/2013
Party Name:MICRO LABS LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00184/AM14/ RLA File :07/24/040/00111/AM14/ Lic.No/Date:0710097180 30.07.2013 Defer Date:06.03.2014 63
Case No.:22/14/82ALC4/2013
Party Name:MSN LABORATORIES PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00607/AM14/ RLA File :09/24/040/00192/AM14/ Lic.No/Date:0910056971 31.07.2013 Defer Date:06.03.2014 64
Case No.:21/14/82ALC4/2013
Party Name:MSN PHARMACHEM PRIVATE LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00606/AM14/ RLA File :09/24/040/00193/AM14/ Lic.No/Date:0910056972 31.07.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/519/2013PI(Norms) dated 12.11.2012, 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 Kg/kg PREGABALIN Kg 1. (+/) 3 (CarbamoylMethyl)5 Methyl Hexanoic acid 2.94
65
Case No.:48/14/82ALC4/2013
Party Name:LOUIS PHARMACEUTICALS PVT LTD Meet No/Date:21/82ALC4/2013 06.02.2014 Status:Case Deferred HQ File :01/82/050/00633/AM14/ RLA File :09/24/040/00200/AM14/ Lic.No/Date:0910057008 02.08.2013 Defer Date:06.03.2014 66
Case No.:148/14/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00733/AM14/ RLA File :09/24/040/00189/AM14/ Lic.No/Date:0910057006 02.08.2013 Defer Date:06.03.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 06.03.2014 67
Case No.:42/14/82ALC4/2013
Party Name:AVA CHEMICALS PVT.LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00627/AM14/ RLA File :03/94/040/00220/AM14/ Lic.No/Date:0310744155 05.08.2013 Defer Date:06.03.2014 Decision :It was decided to call for a copy of application from the firm and sent to Department of C&PC for their comments. The case was deferred for 06.03.2014 68
Case No.:18/14/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.02.2014 Status:Deffered and Reindexed HQ File :01/82/050/00603/AM14/ RLA File :09/24/040/00207/AM14/ Lic.No/Date:0910057031 05.08.2013 Defer Date:06.02.2014 69
Case No.:45/14/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 06.02.2014 Status:Case Deferred HQ File :01/82/050/00630/AM14/ RLA File :07/24/040/00137/AM14/ Lic.No/Date:0710097392 06.08.2013 Defer Date:06.03.2014 Decision :It was decided to call from the firm a coppoy of complete technical detals as per Appendix 33. The case was deferred for 06.03.2014
70
Case No.:40/14/82ALC4/2013
Party Name:CTX LIFESCIENCES PVT LTD, 06.02.2014 Status:Case Deferred HQ File :01/82/050/00625/AM14/ RLA File :03/94/040/00307/AM14/ Lic.No/Date:0310744552 07.08.2013 Defer Date:06.03.2014 Decision :It was decided to call from the firm a coppoy of complete technical detals as per Appendix 33. The case was deferred for 06.03.2014 71
Case No.:165/14/82ALC4/2013
Party Name:MEDREICH LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00750/AM14/ RLA File :07/24/040/00135/AM14/ Lic.No/Date:0710097410 07.08.2013 Defer Date:06.03.2014 72
Case No.:24/14/82ALC4/2013
Party Name:VASUDHA PHARMA CHEM LTD 06.02.2014 Status:Case Approved HQ File :01/82/050/00609/AM14/ RLA File :09/24/040/00089/AM14/ Lic.No/Date:0910057115 08.08.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/210/2012PI(Norms) dated July, .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 Kg/kg 2Butyl1HImidazole4 Carboxaldehyde (or) 2Butyl1H Imidazole5Carbaldehyde (or) 2 Butyl4Formyl Imidazole Description : White to Slightly yellowish crystalline powder Assay : NLT 98.5% Kg 1. 2(nButyl)4Chloro5Formyl Imidazole 1.45 Methanol 3.18 Chloroform 0.635 Activated Carbon 0.100 73
Case No.:33/19/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00978/AM14/ RLA File :09/24/040/00220/AM14/ Lic.No/Date:0910057149 12.08.2013 Defer Date: Decision : In the light of earlier decision taken in meeƟng No. 13/82 dated 03.10.2013. it was decided to raƟfy 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 kg/kg METHYL (E)‐2‐(2‐ CHLOROMETHYLPHENYL)‐3‐ METHOXYACRYLATE 1 kg 1. 3‐ISOCHROMANONE 0.957 2. O‐XYLENE 1.04 3. SODIUM METHOXIDE POWDER 0.416 4. METHANOL 2.31 RA may take appropriate acƟon as per the decision of Norms CommiƩee. 74
Case No.:34/13/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 06.02.2014 Status:Case Deferred HQ File :01/82/050/00510/AM14/ RLA File :03/95/040/00132/AM14/ Lic.No/Date:0310744838 12.08.2013 Defer Date:06.03.2014 75
Case No.:36/14/82ALC4/2013
Party Name:GLOBE TROTTERS PVT LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00621/AM14/ RLA File :03/94/040/00359/AM14/ Lic.No/Date:0310745177 13.08.2013 Defer Date:06.03.2014 76
Case No.:147/14/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00732/AM14/ RLA File :09/24/040/00201/AM14/ Lic.No/Date:0910057191 14.08.2013 Defer Date:06.03.2014 77
Case No.:122/14/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 06.02.2014 Status:Case Deferred HQ File :01/82/050/00707/AM14/ RLA File :03/95/040/00203/AM14/ Lic.No/Date:0310745264 14.08.2013 Defer Date:06.03.2014
78
Case No.:17/14/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 06.02.2014 Status:Deffered and Reindexed HQ File :01/82/050/00602/AM14/ RLA File :03/94/040/00978/AM13/ Lic.No/Date:0310745508 16.08.2013 Defer Date:06.02.2014 Decision : 79
Case No.:66/14/82ALC4/2013
Party Name:SRINI PHARMACEUTICALS LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00651/AM14/ RLA File :09/24/040/00216/AM14/ Lic.No/Date:0910057203 16.08.2013 Defer Date:06.03.2014 80
Case No.:121/14/82ALC4/2013
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 06.02.2014 Status:Case Deferred HQ File :01/82/050/00706/AM14/ RLA File :03/95/040/00505/AM13/ Lic.No/Date:0310745576 16.08.2013 Defer Date:06.03.2014 81
Case No.:62/14/82ALC4/2013
Party Name:DR REDDYS LABORATORIES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00647/AM14/ RLA File :09/24/040/00223/AM14/ Lic.No/Date:0910057232 19.08.2013 Defer Date:06.03.2014 82
Case No.:34/14/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00619/AM14/ RLA File :09/24/040/00231/AM14/ Lic.No/Date:0910057244 19.08.2013 Defer Date:06.03.2014 83
Case No.:117/14/82ALC4/2013
Party Name:MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00702/AM14/ RLA File :03/95/040/00407/AM14/ Lic.No/Date:0310745962 20.08.2013 Defer Date:06.03.2014
84
Case No.:26/14/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00611/AM14/ RLA File :09/24/040/00190/AM14/ Lic.No/Date:0910057247 20.08.2013 Defer Date:06.03.2014 85
Case No.:57/14/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00642/AM14/ RLA File :09/24/040/00229/AM14/ Lic.No/Date:0910057251 20.08.2013 Defer Date:06.03.2014 86
Case No.:65/14/82ALC4/2013
Party Name:SRIAM LABS PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00650/AM14/ RLA File :09/24/040/00178/AM14/ Lic.No/Date:0910057260 21.08.2013 Defer Date:06.03.2014 Decision :IIn the light of written comments received from Department of Pharmaceuticals vide thier letter No. Q 35021/10/2013PI(Norms) dated 06.09.2013 and 26.06.2013 has stated that the firm has mentioned Chapter 21 wrongly and it should be covered under chapter 29 of ITC(HS). Deptt. ofPharma has requested to advise the firm to suitably revised their application using proper HS code before the matter is processed further. The case is Deferred for 06.03.2014. 87
Case No.:3/12/82ALC4/2013
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00427/AM14/ RLA File :04/24/040/00095/AM14/ Lic.No/Date:0410148864 22.08.2013 Defer Date:06.03.2014 Decision :It was decided to send a copy of application again to DCGI for their comments (solution of import items contains 8% water). The case was deferred for 06.03.2014. 88
Case No.:32/14/82ALC4/2013
Party Name:ALEMBIC PHARMACEUTICALS LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00617/AM14/ RLA File :34/24/040/00110/AM14/ Lic.No/Date:3410037709 22.08.2013 Defer Date:06.03.2014
89
Case No.:33/14/82ALC4/2013
Party Name:INCHEMLABORATORIES PRIVATE LIMITED 06.02.2014 Status: CaseApproved HQ File :01/82/050/00618/AM14/ RLA File :09/24/040/00224/AM14/ Lic.No/Date:0910057266 22.08.2013 Defer Date: Decision : In the light of earlier decision taken in its meeting No. 3/82 meeting dated 02.05.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed MONTELUKAST SODIUM Kg 1. 2(2(3(S)(3(2(7chloro2 quinolinyl)ethenyl)phenyl)3 hydroxypropyl)phenyl)2propanol 1.24 kg 2. 1methyl mercapto cyclo propane acetic acid 0.40 kg 90
Case No.:47/14/82ALC4/2013
Party Name:VIVIMED LABS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00632/AM14/ RLA File :09/24/040/00251/AM14/ Lic.No/Date:0910057280 22.08.2013 Defer Date:06.03.2014 91
Case No.:152/14/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00737/AM14/ RLA File :09/24/040/00211/AM14/ Lic.No/Date:0910057368 27.08.2013 Defer Date:06.03.2014 92
Case No.:116/14/82ALC4/2013
Party Name:UNIJULES LIFE SCIENCES LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00701/AM14/ RLA File :03/95/040/00215/AM14/ Lic.No/Date:0310747079 27.08.2013 Defer Date:06.03.2014 93
Case No.:146/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00731/AM14/ RLA File :03/95/040/00429/AM14/ Lic.No/Date:0310747495 Defer
29.08.2013 Date:06.03.2014 94
Case No.:51/14/82ALC4/2013
Party Name:RATNAMANI BIO CHEMICALS & PHARMACEUTICALS PVT. LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00636/AM14/ RLA File :34/24/040/00125/AM14/ Lic.No/Date:3410037783 02.09.2013 Defer Date:06.03.2014 Decision :It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 06.03.2014 95
Case No.:54/14/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 06.02.2014 Status:CaseDeferred HQ File :01/82/050/00639/AM14/ RLA File :05/23/040/00233/AM14/ Lic.No/Date:0510364656 05.09.2013 Defer Date:06.03.2014 96
Case No.:29/14/82ALC4/2013
Party Name:MAITHRI LABORATORIES (P) LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00614/AM14/ RLA File :09/24/040/00242/AM14/ Lic.No/Date:0910057495 05.09.2013 Defer Date:06.03.2014 97
Case No.:53/14/82ALC4/2013
Party Name:STERILE INDIA PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00638/AM14/ RLA File :05/24/040/00203/AM14/ Lic.No/Date:0510364653 05.09.2013 Defer Date:06.03.2014 98
Case No.:176/14/82ALC4/2013
Party Name:AMI LIFESCIENCES P LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00761/AM14/ RLA File :34/24/040/00132/AM14/ Lic.No/Date:3410037845 06.09.2013 Defer Date:06.03.2014 99
Case No.:30/14/82ALC4/2013
Party Name:HONEST BIOVET PVT. LTD 06.02.2014 Status:Case Deferred
HQ File :01/82/050/00615/AM14/ RLA File :08/24/040/00250/AM14/ Lic.No/Date:0810124568 06.09.2013 Defer Date:06.03.2014 100
Case No.:103/14/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00688/AM14/ RLA File :08/24/040/00242/AM14/ Lic.No/Date:0810124544 06.09.2013 Defer Date:06.03.2014 101
Case No.:56/14/82ALC4/2013
Party Name:VIVEK PHARMACHEM (INDIA) LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00641/AM14/ RLA File :13/24/040/00021/AM14/ Lic.No/Date:1310044273 09.09.2013 Defer Date:06.03.2014 102
Case No.:54/17/82ALC4/2013
Party Name:CIREX PHARMACEUTICALS LIMITED Meet No/Date:21/82ALC4/2013 06.02.2014 Status:Case Deferred HQ File :01/82/050/00916/AM14/ RLA File :09/24/040/00258/AM14/ Lic.No/Date:0910057517 10.09.2013 Defer Date:06.03.2014 103
Case No.:149/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00734/AM14/ RLA File :03/95/040/00465/AM14/ Lic.No/Date:0310748925 10.09.2013 Defer Date:06.03.2014 104
Case No.:150/14/82ALC4/2013
Party Name:MACLEODS PHARMACEUTICALS LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00735/AM14/ RLA File :03/95/040/00459/AM14/ Lic.No/Date:0310748979 10.09.2013 Defer Date:06.03.2014 105
Case No.:69/14/82ALC4/2013
Party Name:ONEIRO CHEMICALS LTD Status:Case
06.02.2014 Deferred HQ File :01/82/050/00654/AM14/ RLA File :34/24/040/00138/AM14/ Lic.No/Date:3410037862 11.09.2013 Defer Date:06.03.2014 106
Case No.:63/17/82ALC4/2013
Party Name:DR REDDYS LABORATORIES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00925/AM14/ RLA File :09/24/040/00261/AM14/ Lic.No/Date:0910057546 13.09.2013 Defer Date:06.03.2014 107
Case No.:10/16/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00823/AM14/ RLA File :07/24/040/00201/AM14/ Lic.No/Date:0710098284 16.09.2013 Defer Date:06.03.2014 108
Case No.:151/14/82ALC4/2013
Party Name:THINQ PHARMACRO LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00736/AM14/ RLA File :03/95/040/00432/AM14/ Lic.No/Date:0310749651 16.09.2013 Defer Date:06.03.2014 109
Case No.:51/17/82ALC4/2013
06.02.2014 Status:Case Approved HQ File :01/82/050/00913/AM14/ RLA File :09/24/040/00260/AM14/ Lic.No/Date:0910057595 17.09.2013 Defer Date: Decision : In the light of earlier decision taken in its meeting No. 12/82 meeting dated 22.06.2010, it was decided to ratify norms under para 4.7 of HBP v 1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Dihydroartemisinin 1 Kg. 1. Artemisinin 1.12 kg 2. Sodium Boro Hydride 0.14 kg 3. Methanol 0.675 kg RA concerned may take further necessary acƟon as per above decision of NC.
110
Case No.:35/17/82ALC4/2013
Party Name:S M S PHARMACEUTICALS LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00897/AM14/ RLA File :09/24/040/00083/AM14/ Lic.No/Date:0910057602 18.09.2013 Defer Date:06.03.2014 111
Case No.:46/16/82ALC4/2013
Party Name:SHASUN PHARMACEUTICALS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00859/AM14/ RLA File :04/24/040/00127/AM14/ Lic.No/Date:0410149960 18.09.2013 Defer Date:06.03.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/648/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm a copy of Master Batch Formula duly certified by Quality Control Incharge. 112
Case No.:49/16/82ALC4/2013
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00862/AM14/ RLA File :04/24/040/00100/AM14/ Lic.No/Date:0410149961 18.09.2013 Defer Date:06.03.2014 113
Case No.:28/17/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.02.2014 Status:CaseDeferred HQ File :01/82/050/00890/AM14/ RLA File :09/24/040/00267/AM14/ Lic.No/Date:0910057604 18.09.2013 Defer Date:06.03.2014 114
Case No.:50/17/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00912/AM14/ RLA File :09/24/040/00294/AM14/ Lic.No/Date:0910057628 19.09.2013 Defer Date:06.03.2014 Decision : It was decided to request the firm to furnish Central Excise Data and also Batch Log Sheet for last 5 batches . The case was deferred for 06.03.2014.
115
Case No.:68/14/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00653/AM14/ RLA File :09/24/040/00283/AM14/ Lic.No/Date:0910057606 19.09.2013 Defer Date:06.03.2014 116
Case No.:64/17/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00926/AM14/ RLA File :09/24/040/00120/AM14/ Lic.No/Date:0910057630 19.09.2013 Defer Date:06.03.2014 117
Case No.:55/14/82ALC4/2013
Party Name:SAIBABA SURFACTANTS (P) LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00640/AM14/ RLA File :08/24/040/00268/AM14/ Lic.No/Date:0810124942 19.09.2013 Defer Date:06.03.2014 Decision : Department of Chemicals and Petrochemicals vide their letter No. 14010/56/2013Ch. II dated 19.12.2013 requested the firm to furnish the following information: • Details of manufacturing process of poly Ethylene glycol 400 with chemical equations, molecular formula, molecular weights. • Yield obtained in each step • Authentic technical literature in support of yield obtained The case was deferred for 06.03.2014 118
Case No.:53/17/82ALC4/2013
Party Name:HETERO DRUGS LIMITED, 06.02.2014 Status:Case Deferred HQ File :01/82/050/00915/AM14/ RLA File :09/24/040/00293/AM14/ Lic.No/Date:0910057642 20.09.2013 Defer Date:06.03.2014 119
Case No.:48/16/82ALC4/2013
Party Name:SOFTGEL HEALTH CARE PVT. LTD., 06.02.2014 Status:Deffered and Reindexed HQ File :01/82/050/00861/AM14/ RLA File :04/24/040/00099/AM14/ Lic.No/Date:0410150142 20.09.2013 Defer Date:06.02.2014
120
Case No.:29/17/82ALC4/2013
06.02.2014 Status:Case Approved HQ File :01/82/050/00891/AM14/ RLA File :09/24/040/00289/AM14/ Lic.No/Date:0910057663 24.09.2013 Defer Date: Decision : In the light of earlier decision taken in its 15/82 meeƟng dated 31.10.2013 , it was decided to raƟfy 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 Artemether 1 Kg. 1. Artemisinin 1.235 kg 2. Sodium Borohydride 0.188 kg 3. Trimethyl Ortho Acetate Not shown in the process 121
Case No.:62/17/82ALC4/2013
Party Name:SMILAX LABORATORIES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00924/AM14/ RLA File :09/24/040/00292/AM14/ Lic.No/Date:0910057671 24.09.2013 Defer Date:06.03.2014 122
Case No.:20/16/82ALC4/2013
Party Name:STERICAT GUTSTRINGS PVT. LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00833/AM14/ RLA File :05/24/040/00214/AM14/ Lic.No/Date:0510366620 24.09.2013 Defer Date: Decision : In the light of wriƩen comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/103/2011‐PC‐ II dated 28.01.2014, it was decided to raƟfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item to be Exported QuanƟty Monofilament Polypropylene Mesh in Various size 1 Sq. Meter Raw‐material recommended for import QuanƟty / kg Non Sterile Monofilament Polypropylene Mesh in Various size 1.02 Sq. Meter 123
Case No.:30/17/82ALC4/2013
Party Name:BRUNDAVAN LABORATORIES Status:Case
PRIVATE LTD., 06.02.2014 Deferred HQ File :01/82/050/00892/AM14/ RLA File :09/24/040/00296/AM14/ Lic.No/Date:0910057708 25.09.2013 Defer Date:06.03.2014 124
Case No.:21/19/82ALC4/2013
Party Name:GOPALDAS VISRAM & CO.LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00966/AM14/ RLA File :03/94/040/00502/AM14/ Lic.No/Date:0310751325 26.09.2013 Defer Date:06.03.2014 125
Case No.:20/19/82ALC4/2013
Party Name:CAMPHOR& ALLIED PRODUCTS LIMITED, 06.02.2014 Status:Case Approved HQ File :01/82/050/00965/AM14/ RLA File :03/94/040/00560/AM14/ Lic.No/Date:0310751566 27.09.2013 Defer Date: Decision : In the light of wriƩen comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2011‐Ch II dated 14.01.2014, it was decided to raƟfy 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 ASTROMUSK (S) (Astromusk content : 100%) 1 kg 1. ISOAMYLENE 0.580 kg 2. PROPYLENE OXIDE 0.380 kg 3. ALPHA METHYL STYRENE 0.769 kg 4. PARAFORMALDEHYDE 0.117 kg 126
Case No.:43/17/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00905/AM14/ RLA File :09/24/040/00307/AM14/ Lic.No/Date:0910057723 27.09.2013 Defer Date:06.03.2014 127
Case No.:32/19/82ALC4/2013
Party Name:ELDER PHARMACEUTICALS LTD., 06.02.2014 Status:Case Approved HQ File :01/82/050/00977/AM14/ RLA File :03/94/040/00559/AM14/ Lic.No/Date:0310751610 30.09.2013 Defer Date:
Decision : In the light of earlier decision taken by NC in its 10/82 meeting dated 05.06.2012, it was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export product Exp. Qty. Sl.No. Import items Qty. allowed DIACEREIN 1 kg 1. ALOE EMODIN 95% 1.053 kg/kg RA concerned may take further necessary action as per above decision of NC 128
Case No.:14/16/82ALC4/2013
Party Name:SHAMSHREE LIFESCIENCES LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00827/AM14/ RLA File :22/24/040/00046/AM14/ Lic.No/Date:2210014253 30.09.2013 Defer Date:06.03.2014 129
Case No.:41/17/82ALC4/2013
Party Name:HETERO LABS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00903/AM14/ RLA File :09/24/040/00317/AM14/ Lic.No/Date:0910057783 01.10.2013 Defer Date:06.03.2014 130
Case No.:46/17/82ALC4/2013
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00908/AM14/ RLA File :09/24/040/00288/AM14/ Lic.No/Date:0910057784 01.10.2013 Defer Date:06.03.2014 131
Case No.:48/17/82ALC4/2013
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00910/AM14/ RLA File :09/24/040/00287/AM14/ Lic.No/Date:0910057785 01.10.2013 Defer Date:06.03.2014 132
Case No.:32/16/82ALC4/2013
Party Name:FINE CURE PHARMACEUTICALS LTD. Meet No/Date:21/82ALC4/2013 06.02.2014 Status:Case Deferred HQ File :01/82/050/00845/AM14/ RLA File :08/24/040/00292/AM14/ Lic.No/Date:0810125295 03.10.2013 Defer Date:06.03.2014
133
Case No.:42/16/82ALC4/2013
Party Name:INDIA GLYCOLS LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00855/AM14/ RLA File :05/23/040/00269/AM14/ Lic.No/Date:0510367396 03.10.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case for 06.03.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 134
Case No.:39/16/82ALC4/2013
Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 06.02.2014 Status:Case Deferred HQ File :01/82/050/00852/AM14/ RLA File :04/24/040/00146/AM14/ Lic.No/Date:0410150519 03.10.2013 Defer Date:06.03.2014 Decision :It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 06.03.2014 135
Case No.:7/17/82ALC4/2013
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00869/AM14/ RLA File :34/24/040/00159/AM14/ Lic.No/Date:3410038104 03.10.2013 Defer Date:06.03.2014 Decision :It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 06.03.2014 136
Case No.:15/17/82ALC4/2013
Party Name:AGIO PHARMACEUTICALS LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00877/AM14/ RLA File :03/94/040/00542/AM14/ Lic.No/Date:0310752494 07.10.2013 Defer Date:06.03.2014 137
Case No.:25/16/82ALC4/2013
Party Name:ATUL LIMITED, 06.02.2014 Status:Case Deferred HQ File :01/82/050/00838/AM14/ RLA File :08/24/040/00244/AM14/ Lic.No/Date:0810125378 07.10.2013 Defer Date:06.03.2014 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 06.03.2014 138
Case No.:9/14/82ALC4/2013
Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00594/AM14/ RLA File :03/94/040/00515/AM14/ Lic.No/Date:0310752496 07.10.2013 Defer Date:
Decision : In the light of earlier decision taken in its 30/82 meeting dated 07.02.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Imipenem & Cilastatin for injection USP 500 mg 1 vial 1 Imipenem & Cilastatin USP (with Buffered Sodium Bicarbonate) 1114.187 mg/vial RA may take appropriate action as per the decision of Norms Committee. 139
Case No.:34/19/82ALC4/2013
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:21/82ALC4/2013 06.02.2014 Status:Case Deferred HQ File :01/82/050/00979/AM14/ RLA File :03/94/040/00552/AM14/ Lic.No/Date:0310752484 07.10.2013 Defer Date:06.03.2014 140
Case No.:52/17/82ALC4/2013
Party Name:MSN PHARMACHEM PRIVATE LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00914/AM14/ RLA File :09/24/040/00299/AM14/ Lic.No/Date:0910057839 07.10.2013 Defer Date: Decision : : In the light of earlier decision taken in its meeting No. 18/82 meeting dated 02.08.2011, it was decided to ratify norms under para 4.7 of HBP v 1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed MONTELUKAST SODIUM Kg 1. a[3[2(7Chloro2 QuinolinylEthenyl]Phenyl]2(1 Hydroxy1Methylethyl),[S(E)] Benzenepropanol 1.24 kg 2. 1Mercaptomethyl Cyclopropane acetic acid 0.40 kg 141
Case No.:11/16/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 06.02.2014 Status:Case Approved HQ File :01/82/050/00824/AM14/ RLA File :05/23/040/00281/AM14/ Lic.No/Date:0510367867 08.10.2013 Defer Date:
Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/467/2012PI(Norms) dated 21.11 2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Nandrolone Decanoate Bulk Drug Kg 1. Sitolactone Intermediate 1.237 2. 5Chloro2Pentanone Reagent 1.149 3. Tetrahydrofuran Solvent 3.09 4. Pyridine Reagent 0.55 5. Decanoyl Chloride Reagent 0.45 142
Case No.:12/16/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00825/AM14/ RLA File :08/24/040/00303/AM14/ Lic.No/Date:0810125470 08.10.2013 Defer Date:06.03.2014 143
Case No.:26/16/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00839/AM14/ RLA File :08/24/040/00302/AM14/ Lic.No/Date:0810125462 08.10.2013 Defer Date:06.03.2014 144
Case No.:24/16/82ALC4/2013
Party Name:S.M. HERBALS PVT.LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00837/AM14/ RLA File :05/24/040/00232/AM14/ Lic.No/Date:0510367885 08.10.2013 Defer Date:06.03.2014 Decision :It was decided to call from the firm the following technical details: • COA from foreign supplier for relevant import consignment for the imported input. • COA from Independent and approved Testing Laboratory for export product.
• Stepwise process with wastage envisaged in the process. 145
Case No.:13/16/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00826/AM14/ RLA File :08/24/040/00296/AM14/ Lic.No/Date:0810125464 08.10.2013 Defer Date:06.03.2014 146
Case No.:18/17/82ALC4/2013
Party Name:CIPLA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00880/AM14/ RLA File :03/94/040/00591/AM14/ Lic.No/Date:0310753016 09.10.2013 Defer Date:06.03.2014 147
Case No.:20/17/82ALC4/2013
Party Name:CIPLA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00882/AM14/ RLA File :03/94/040/00588/AM14/ Lic.No/Date:0310753013 09.10.2013 Defer Date:06.03.2014 148
Case No.:21/17/82ALC4/2013
Party Name:CIPLA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00883/AM14/ RLA File :03/94/040/00601/AM14/ Lic.No/Date:0310753018 09.10.2013 Defer Date:06.03.2014 149
Case No.:27/17/82ALC4/2013
Party Name:EYTAN LABS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00889/AM14/ RLA File :09/24/040/00340/AM14/ Lic.No/Date:0910057882 09.10.2013 Defer Date:06.03.2014 150
Case No.:73/14/82ALC4/2013
Party Name:MSN LABORATORIES PRIVATE LIMITED 06.02.2014 Status:Case Deferred
HQ File :01/82/050/00658/AM14/ RLA File :09/24/040/00325/AM14/ Lic.No/Date:0910057878 09.10.2013 Defer Date:06.03.2014 151
Case No.:36/17/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00898/AM14/ RLA File :09/24/040/00300/AM14/ Lic.No/Date:0910057877 09.10.2013 Defer Date:06.03.2014 152
Case No.:28/16/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 06.02.2014 Status:Case Deferred HQ File :01/82/050/00841/AM14/ RLA File :22/24/040/00048/AM14/ Lic.No/Date:2210014277 09.10.2013 Defer Date:06.03.2014 153
Case No.:6/17/82ALC4/2013
Party Name:AMI ORGANICS PVT LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00868/AM14/ RLA File :52/24/040/00024/AM14/ Lic.No/Date:5210040263 10.10.2013 Defer Date:06.03.2014 154
Case No.:55/17/82ALC4/2013
Party Name:SHODHANA LABORATORIES LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00917/AM14/ RLA File :09/24/040/00315/AM14/ Lic.No/Date:0910057889 10.10.2013 Defer Date:06.03.2014 155
Case No.:37/17/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00899/AM14/ RLA File :09/24/040/00316/AM14/ Lic.No/Date:0910057908 11.10.2013 Defer Date:06.03.2014 156
Case No.:38/16/82ALC4/2013
Party Name:INTAS PHARMACEUTICALS LTD., Status:Case
06.02.2014 Deferred HQ File :01/82/050/00851/AM14/ RLA File :08/24/040/00321/AM14/ Lic.No/Date:0810125616 14.10.2013 Defer Date:06.03.2014 157
Case No.:38/17/82ALC4/2013
06.02.2014 Status:Case Deferred HQ File :01/82/050/00900/AM14/ RLA File :09/24/040/00322/AM14/ Lic.No/Date:0910057914 14.10.2013 Defer Date:06.03.2014 158
Case No.:18/16/82ALC4/2013
Party Name:NEULAND LABORATORIES LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00831/AM14/ RLA File :09/24/040/00323/AM14/ Lic.No/Date:0910057916 14.10.2013 Defer Date:06.03.2014 159
Case No.:4/17/82ALC4/2013
Party Name:ALEMBIC PHARMACEUTICALS LTD 06.02.2014 Status:Case Approved HQ File :01/82/050/00866/AM14/ RLA File :34/24/040/00173/AM14/ Lic.No/Date:3410038222 17.10.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/604/2012PI(Norms) dated 06.02 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: AZITHROMYCIN TABLET 600 MG 250 MG and 500 MG (a) AZITHROMYCIN TABLET 600 MG S. No. Import Items Qty. recommended 1. Azithromycin Dihydrate or Its raw material as per SION A‐2440 on pro‐rata basis 622.82 mg 2. PREGELATINIZED STARCH ( STARCH 1500) 62.91 mg 3. ANHYDROUS DIBASIC CALCIUM PHOSPHATE 323.50 mg 4. CROSCARMELLOSE SODIUM (Ac Di Sol) 20.97 mg 5. MAGNESIUM STEARATE 8.89 mg 6. SODIUM LAURYL SULPHATE 2.16 mg 7. HDPE BOTTLE Relevant as per packing policy 8. CLOSURE OR CAPS
ALUMINIUM FOIL 10. PVC FOIL 11. PEELABLE PAPER / ALUMINIUM FOIL (b) AZITHROMYCIN TABLET 250 MG S. No. Import Items Qty. recommended 1. Azithromycin Dihydrate or Its raw material as per SION A‐2440 on pro‐rata basis 259.50 mg 2. PREGELATINIZED STARCH ( STARCH 1500) 26.21 mg 3. ANHYDROUS DIBASIC CALCIUM PHOSPHATE 138.80 mg 4. CROSCARMELLOSE SODIUM (Ac Di Sol) 8.74 mg 5. MAGNESIUM STEARATE 3.628 mg 6. SODIUM LAURYL SULPHATE 0.900 mg 7. HDPE BOTTLE Relevant as per packing policy 8. CLOSURE OR CAPS 9. ALUMINIUM FOIL 10. PVC FOIL 11. PEELABLE PAPER / ALUMINIUM FOIL ( C) AZITHROMYCIN TABLET 500 MG S. No. Import Items Qty. recommended 1. Azithromycin Dihydrate or Its raw material as per SION A‐2440 on pro‐rata basis 519.02 mg 2. PREGELATINIZED STARCH ( STARCH 1500) 52.42 mg 3. ANHYDROUS DIBASIC CALCIUM PHOSPHATE 269.58 mg 4. CROSCARMELLOSE SODIUM (Ac Di Sol) 17.48 mg 5. MAGNESIUM STEARATE 7.348 mg 6. SODIUM LAURYL SULPHATE 1.80 mg 7. HDPE BOTTLE Relevant as per packing policy 8. CLOSURE OR CAPS 9. ALUMINIUM FOIL 10. PVC FOIL 11. PEELABLE PAPER / ALUMINIUM FOIL 160
Case No.:39/17/82ALC4/2013
Party Name:ASTRIX LABORATORIES LTD., 06.02.2014 Status:Case Deferred
HQ File :01/82/050/00901/AM14/ RLA File :09/24/040/00312/AM14/ Lic.No/Date:0910057944 17.10.2013 Defer Date:06.03.2014 161
Case No.:22/17/82ALC4/2013
Party Name:ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00884/AM14/ RLA File :03/94/040/00458/AM14/ Lic.No/Date:0310753955 17.10.2013 Defer Date:06.03.2014 162
Case No.:67/17/82ALC4/2013
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00929/AM14/ RLA File :09/24/040/00286/AM14/ Lic.No/Date:0910057945 17.10.2013 Defer Date:06.03.2014 163
Case No.:2/17/82ALC4/2013
Party Name:AMI LIFESCIENCES P LTD 06.02.2014 Status:Case Approved HQ File :01/82/050/00864/AM14/ RLA File :34/24/040/00180/AM14/ Lic.No/Date:3410038227 18.10.2013 Defer Date: Decision : In the light of wriƩen comments received from Department of PharmaceuƟcals vide their OM No. 35011/666/2013‐PI(Norms) dated 22.01.2014, it was decided to raƟfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product 1. RUTOSIDE TRIHYDRATE EP EP ………………….1 kg 2. QUERCETIN DIHYDRATE …………………0.445 kg Sl.No Import Item QuanƟty allowed kg/kg 1. FAVA POWDER (RUTIN‐30%) 5.27 kg 2. CRUDE RUTIN (UNCARIA) ASSAY BY HPLC : Between 85 % to 92 % ON ANHYDROUS BASIS 0.42 kg 164
Case No.:23/17/82ALC4/2013
Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:21/82ALC4/2013 Status:Case
06.02.2014 Deferred HQ File :01/82/050/00885/AM14/ RLA File :03/94/040/00586/AM14/ Lic.No/Date:0310754273 18.10.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case for 06.03.2014 for comments of Department of C&PC. 165
Case No.:5/17/82ALC4/2013
Party Name:TIDE INDUSTRIES 06.02.2014 Status:Case Deferred HQ File :01/82/050/00867/AM14/ RLA File :34/24/040/00177/AM14/ Lic.No/Date:3410038223 18.10.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case for 06.03.2014 for comments of Department of C&PC. 166
Case No.:58/17/82ALC4/2013
Party Name:INDSWIFT LABORATORIES LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00920/AM14/ RLA File :22/24/040/00052/AM14/ Lic.No/Date:2210014299 21.10.2013 Defer Date:06.03.2014 167
Case No.:59/17/82ALC4/2013
Party Name:INDSWIFT LABORATORIES LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00921/AM14/ RLA File :22/24/040/00050/AM14/ Lic.No/Date:2210014300 21.10.2013 Defer Date:06.03.2014 168
Case No.:73/17/82ALC4/2013
Party Name:RELIANCE INDUSTRIES LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00935/AM14/ RLA File :03/95/040/00515/AM14/ Lic.No/Date:0310754530 21.10.2013 Defer Date:06.03.2014 Decision :It was decided to defer the case for 06.03.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 169
Case No.:29/19/82ALC4/2013
Party Name:BALAJI AMINES LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00974/AM14/ RLA File :31/83/040/00095/AM14/ Lic.No/Date:3110060791 22.10.2013 Defer Date: Decision : In the light of wriƩen comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011‐Ch II dated 13.02.2014, it was decided to raƟfy 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 GAMMA BUTYROLACTONE 1 kg 1. 1,4 BUTANEDIOL 1.16 kg 2. GBL CATALYST 0.001 kg 170
Case No.:11/21/82ALC4/2013
Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/01041/AM14/ RLA File :22/21/040/00055/AM14/ Lic.No/Date:2210014316 23.10.2013 Defer Date: Decision : In the light of earlier decision taken in meeting No. 1/82 dated 04.04.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through enzymatic route Tech. Spec: ASSY not less than 84% as such or 96% on dry basis 1 kg 1. 6Amino Pencillanic Acide (6APA) 0.568 kg 2. Formidase (Enzyme) 0.005 kg 3. D()PHydroxy Phenyl Glycine Methylester 0.608 kg 171
Case No.:60/17/82ALC4/2013
Party Name:SHAMSHREE LIFESCIENCES LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/00922/AM14/ RLA File :22/24/040/00051/AM14/ Lic.No/Date:2210014319 24.10.2013 Defer Date:06.03.2014 172
Case No.:35/19/82ALC4/2013
Party Name:BALAJI AMINES LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00980/AM14/ RLA File :31/83/040/00111/AM14/ Lic.No/Date:3110060889 25.10.2013 Defer Date: Decision : In the light of wriƩen comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011‐Ch II dated 13.02.2014, it was decided to raƟfy 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 GAMMA BUTYROLACTONE 1 kg 1. 1,4 BUTANEDIOL 1.16 kg 2. GBL CATALYST 0.001 kg 173
Case No.:37/19/82ALC4/2013
Party Name:BALAJI AMINES LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00982/AM14/ RLA File :31/83/040/00097/AM14/ Lic.No/Date:3110060890 25.10.2013 Defer Date: Decision : In the light of wriƩen comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011‐Ch II dated 13.02.2014, it was decided to raƟfy 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 NETHYL2PYRROLIODNE 1 kg 1. 1,4 BUTANEDIOL 0.882 kg 2. AMMONIA ANHYDROUS 0.167 kg 3. ALCOHOL (95% MINIMUM) 0.504 kg 4. ETHYLAMINE CATALYST 0.001 kg 174
Case No.:10/19/82ALC4/2013
Party Name:BELCHEM INDS. INDIA PVT. LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00955/AM14/ RLA File :03/94/040/00633/AM14/ Lic.No/Date:0310755691 28.10.2013 Defer Date: Decision : In the light of wriƩen comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/45/2012‐Ch II dated 20.01.2014, it was decided to raƟfy 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 13,DIMETHYLOL5,5DIMETHYL HYDANTOIN (DMDM Hydantoin 52%55%) Assay 55% Max. (BELGUARD DMDMH) 1 kg 1. 5,5 Dimethyl Hydantoin Assay min.99%ColourPure White 0.382 kg
175
Case No.:8/21/82ALC4/2013
Party Name:MICRO INKS LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/01038/AM14/ RLA File :03/95/040/00561/AM14/ Lic.No/Date:0310755754 28.10.2013 Defer Date: Decision : In the light of earlier decision taken in meeting No. 9/82 dated 21.05.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Polyester Acrylate (Di Trimethylol Propane Based) 1 kg 1. Acrylic Acid 0.475 kg 2. Dimer Acid 0.085 kg 3. Phthalic Anhydride 0.077 kg 4. Di Trimethylol Propane 0.490 kg 176
Case No.:36/19/82ALC4/2013
Party Name:SOHAM ORGANICS PVT LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00981/AM14/ RLA File :31/83/040/00124/AM14/ Lic.No/Date:3110060943 29.10.2013 Defer Date:06.03.2014 177
Case No.:6/19/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00951/AM14/ RLA File :03/94/040/00632/AM14/ Lic.No/Date:0310756255 30.10.2013 Defer Date:06.03.2014 178
Case No.:24/19/82ALC4/2013
Party Name:IPCA LABORATORIES LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/00969/AM14/ RLA File :03/94/040/00656/AM14/ Lic.No/Date:0310756260 30.10.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per
Export product Exp. Qty. Sl.No. Import items Qty. allowed PREDNISOLONE ACETATE 1 Kg. 1. Prednisolone (Prednisolone Base) 0.90 kg 179
Case No.:13/19/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 06.02.2014 Status:Case Approved HQ File :01/82/050/00958/AM14/ RLA File :03/94/040/00686/AM14/ Lic.No/Date:0310756544 01.11.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/659/2013PI(Norms) dated 22.01.2014, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl. No. Import items Qty. allowed kg/kg RECTICIN100 SUPPOSITORY NET CONTENT OF IMPORT ITEM USEDINDOMETHACIN BP98.035 KGS Kg 1. INDOMETHACIN BP 102 mg/ 100 mg Suppository 180
Case No.:14/19/82ALC4/2013
Party Name:BLISS GVS PHARMA LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00959/AM14/ RLA File :03/94/040/00687/AM14/ Lic.No/Date:0310756546 01.11.2013 Defer Date:06.03.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/660/2013PI(Norms) dated 22..01.2014, it was decided to call from the firm the following technical details: 1. COA for foreign supplier indicating Potency of Nystatin imported under present A.A 2. Detailed calculation of arriving at the quantity of API applied. The case was deferred for 06.03..2014. 181
Case No.:9/21/82ALC4/2013
Party Name:YASHO INDUSTRIES PVT.LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/01039/AM14/ RLA File :03/95/040/00617/AM14/ Lic.No/Date:0310756660 01.11.2013 Defer Date:06.03.2014 Decision :It was decided to send a copy of application to Department of C&PC and defer the case for 06.03.2014 .
182
Case No.:3/16/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00816/AM14/ RLA File :09/24/040/00366/AM14/ Lic.No/Date:0910058142 05.11.2013 Defer Date:06.03.2014 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/324/2012PI(Norms) dated 24.06.2013, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg CEFIXIME (CEFIXIME TRIHYDRATE) 1. Acetone 1.355 2. Activated Carbon [ Carbon Enoanticromos ] 0.100 3. Dimethyl Formamide (DMF) 1.584 4. G.C.L.E 1.50 5. Methylene Chloride 4.153 6. Methanol 7.913 7. 2Mercaptobenzothiazoyl (Z)2(2 Aminothiazoyl4yl)2 ( MICA Ester ) 0.820 8. Triphenyl Phosphine 0.820 183
Case No.:2/19/82ALC4/2013
Party Name:GLENMARK GENERICS LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00947/AM14/ RLA File :03/94/040/00668/AM14/ Lic.No/Date:0310756884 06.11.2013 Defer Date:06.03.2014 184
Case No.:18/19/82ALC4/2013
Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 06.02.2014 Status:Case Approved HQ File :01/82/050/00963/AM14/ RLA File :34/24/040/00196/AM14/ Lic.No/Date:3410038397 07.11.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/24/2012PI(Norms) dated 28.11.2011, 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. Sl.No. Import items Qty. allowed
Qty. kg/kg CHLOROMEHTYL ISOPROPYL CARBONATE 1. METHYL CHLOROFORMATE 0.943 185
Case No.:19/19/82ALC4/2013
Party Name:NECTAR LIFESCIENCES LIMITED, 06.02.2014 Status:Case Deferred HQ File :01/82/050/00964/AM14/ RLA File :22/24/040/00056/AM14/ Lic.No/Date:2210014366 08.11.2013 Defer Date:06.03.2014 186
Case No.:33/17/82ALC4/2013
Party Name:EMCURE PHARMACEUTICALS LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00895/AM14/ RLA File :31/83/040/00149/AM14/ Lic.No/Date:3110061033 11.11.2013 Defer Date:06.03.2014 187
Case No.:3/19/82ALC4/2013
Party Name:SIRMAXO CHEMICALS PVT LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00948/AM14/ RLA File :03/95/040/00625/AM14/ Lic.No/Date:0310757730 13.11.2013 Defer Date:06.03.2014 188
Case No.:45/17/82ALC4/2013
Party Name:TORRENT PHARMACEUTICALS LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00907/AM14/ RLA File :08/24/040/00352/AM14/ Lic.No/Date:0810126495 18.11.2013 Defer Date:06.03.2014 189
Case No.:40/19/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/00985/AM14/ RLA File :05/23/040/00334/AM14/ Lic.No/Date:0510371304 Defer
20.11.2013 Date:06.03.2014 190
Case No.:10/17/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00872/AM14/ RLA File :09/24/040/00407/AM14/ Lic.No/Date:0910058254 20.11.2013 Defer Date:06.03.2014 191
Case No.:11/17/82ALC4/2013
Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. 06.02.2014 Status:Case Deferred HQ File :01/82/050/00873/AM14/ RLA File :03/95/040/00573/AM14/ Lic.No/Date:0310758641 21.11.2013 Defer Date:06.03.2014 Decision : It was decided to send a copy of application to Department of C&PC and defer the case for 06.03.2014 . 192
Case No.:4/21/82ALC4/2013
Party Name:DIVIS LABORATORIES LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/01034/AM14/ RLA File :09/24/040/00411/AM14/ Lic.No/Date:0910058365 27.11.2013 Defer Date:06.03.2014 Decision : It was decided to send a copy of application to Department of Pharmaceuticals and defer the case for 06.03.2014 . 193
Case No.:72/17/82ALC4/2013
Party Name:RA CHEM PHARMA LIMITED 06.02.2014 Status:Case Deferred HQ File :01/82/050/00934/AM14/ RLA File :09/24/040/00413/AM14/ Lic.No/Date:0910058435 03.12.2013 Defer Date:06.03.2014 194
Case No.:3/21/82ALC4/2013
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/01033/AM14/ RLA File :52/24/040/00036/AM14/ Lic.No/Date:5210040460 05.12.2013 Defer Date: Decision : In the light of wriƩen comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/45/2010‐Ch II dated 10.04.2012, it was decided to raƟfy 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
2 CARBETHOXY AMINO 5 NAPHTHOL 7 SULFONIC ACID 1 kg 1. J ACID 0.904 kg 2. ETHYL CHLORO FORMATE 0.530 kg 195
Case No.:1/21/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 06.02.2014 Status:Case Approved HQ File :01/82/050/01031/AM14/ RLA File :09/24/040/00521/AM14/ Lic.No/Date:0910058957 17.01.2014 Defer Date: Decision : In the light of earlier decision taken by NC in its 17/82 meeting dated 05.12.2013, it was decided to raƟfy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg CEPHALOTHIN SODIUM STERILE USP/BP Condition: The firm shall have to account for 3,000 Nos of Sl.No.9 of Import item List which should be reflected in SBs. 1 kg 1. 7ACA 0.80 2. 2Ethylhexanoic Acid 0.52 3. Triethylamine 0.36 4. 2Thiophene Acetyl chloride [ Thiophene 2Acetyl Chloride ] 0.528 5. Carbon Enoanticromos [ Activated Carbon ] 0.100 6. Acetone 0.67 7. Methylene Chloride 5.05 8. Methyl Isobutyl Ketone [ MIBK ] 0.119 9. Aluminium Canisters with inner & Outer Lids (with eaquel Plugs/Caps) [20 Ltrs.(10Kg Capacity) /14 Ltrs (5kg Capacity) / 12.5 Ltrs (5kg Capacity)] As per packing policy 196
Case No.:2/21/82ALC4/2013
Party Name:HONEST BIOVET PVT. LTD 06.02.2014 Status:Case Deferred HQ File :01/82/050/01032/AM14/ RLA File :08/24/040/00456/AM14/ Lic.No/Date:0810128144 20.01.2014 Defer Date:06.03.2014 197
Case No.:7/21/82ALC4/2013
Party Name:SHILPA MEDICARE LTD., Status:Case
06.02.2014 Approved HQ File :01/82/050/01037/AM14/ RLA File :07/24/040/00369/AM14/ Lic.No/Date:0710101503 22.01.2014 Defer Date: Decision : In line with the earlier decision taken in meeting no. 9/82 dated 25.7.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed Gemcitabine HCL 1 Kg. 1. 4Amino1(3,3difluoro4hydroxy 5(Hydroxymethyl) Tetrahydrofuran 2yl)1HPyrimidine2one (Technical Grade) 0.97 kg RA may take appropriate action as per the decision of Norms Committee. 198
Case No.:12/21/82ALC4/2013
Party Name:KUDOS CHEMIE LTD., 06.02.2014 Status:Case Deferred HQ File :01/82/050/01042/AM14/ RLA File :22/21/040/00096/AM14/ Lic.No/Date:2210014544 23.01.2014 Defer Date:06.03.2014 199
Case No.:13/21/82ALC4/2013
Party Name:BAL PHARMA LTD 06.02.2014 Status:Case Approved HQ File :01/82/050/01043/AM14/ RLA File :07/24/040/00371/AM14/ Lic.No/Date:0710101770 30.01.2014 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/61/2011PI(Norms) dated 08.12.2011, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Amiloride HCL (Bulk Drug) 1. METHYL 3,5DIAMINO6 CHLOROPYRAZINE 2 Carboxylate 0.836
Case No. B‐1 (Part‐II)
M/s Metropolitan Eximchem Limited MeeƟng No. 18/AM14 dated – 19.12.2013 F.No.01/82/50/793/AM11/DES‐III RA No. 03/95/040/00405/AM11 Licence No. 0310589693 dated 14.02.2012 Decision: In the light of wriƩen comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/75/2008‐Ch II dated 09.05.2013, it was decided to revise the norms already fixed in meeting no. 23/82 dated 07.09.2010, 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 NEthyl Carbozole 1 kg 1. Carbozole 1.13 kg kg
Case No. B‐2 (Part‐II)
M/s Drof Ketal Chemicals I Pvt. Ltd. MeeƟng No. 21/AM14 dated – 13.02.2014 01/82/050/00369/AM10/DESIII 01/82/050/01512/AM10/DESIII RA No. 03/94/040/00280/AM10 RA No. 03/94/040/00838/AM09 Ad. Licence No. 0310529903 dated 21.07.2009 Ad. Licence No. 0310501369 dated 06.01.2009 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo.
Case No. B‐3 (Part‐II)
M/s Bharat Parentrals Ltd. 01/82/050/00341/am13/DESIII 3410034190 Dt.23.05.2012 01/82/050/01512/AM10/DESIII RA No. 03/94/040/00280/AM10 RA No. 03/94/040/00838/AM09 Ad. Licence No. 3410034190 Dt.23.05.2012 Ad. Licence No. 0310501369 dated 06.01.2009 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/594/2012PI(Norms) dated 11.09.2013, it was decided to revised the norms for the export of Procain penicillin for Oral Suspension, Amoxycillin for Oral Suspension and Erythromycin Stearate Tablets under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Item No. 12
12 There is typographical error in the minutes. The export item recommended as Injection whereas the due to mistyped as suspension. Hence , the export item may be corrected to read as : Procain penicillin for Injection BP, 3 gm Import item and quantity will remain unchanged Export Item No. 13 13 As per SION A207, 5% wastage on API is allowed for export of Syrups and hence the norms may be recommended as under: The export item may be corrected to read as Amoxycillin for Oral Suspension BP 250 mg/5ml 100 ml plastic bottle 1 No. Import Recommednded Amoxycillin Trihydrate BP5250 mg per 100 ml bottle Export Item No. 14 (SION A222) 14 Erythromycin Stearate Tablets BP 500mg Import Recommended Erythromycin Stearate BP 790 mg per 500 mg tablets
Case No. B‐4 (Part‐II)
M/s. Srini PharmaceuƟcals Ltd. F.No.01/82/50/01466/AM13/DESIII Adv.Lic.No. 0910055166 dated 22.02.2013 RAF.No.09/24/040/00541/AM13 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/594/2012PI(Norms) dated 11.09.2013, it was decided to amend the description of import items 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 Kg/kg METHYL ALPHA‐(4,5,6,7‐ TETRAHYDRA‐5‐ THIENO(3,2‐C)PYRIDYL) (2‐ CHLOROPHENYL)ACETATE HYDROCHLORIDE (CPG‐ 20) 1 kg 1. 4,5,6,7‐ TETRAHYDROTHIENO (3,2 ‐C)PYRIDINE HYDROCHLORIDE(CPG‐ 10) 0.74 2. METHYL ISO BUTYL KETONE (MIBK) 0.81 3. ETHYLENE DI CHLORIDE / DI CHLORO ETHANE 0.77
Case No. B‐5 (Part‐II)
M/s Ranboxy Labs. Ltd. 01/82/050/00239/AM13/DES‐III RA No. 05/24/040/00011/AM10 Ad. Licence No. 0510322536 dated 19.04.2012 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to it was decided to amendment in the description of export product as Imipenem Technical Crude instead of Imipenem / Imipenem Crude and amendment in the UOM of import item sl. No. 16 (Tetrahydrofuran) as kg instead of GMS the norms already fixed in meeting no. 28/82 dated 10.01.2013,
Case No. B‐6 (Part‐II)
M/s Malladi Drugs and Pharmaceuticals Limited 01/82/050/00853/AM10/DESIII RA No. 04/24/040/00152/AM14 Ad. Licence No. 0410151307 dated 28.10.2013 Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/590/2013PI(Norms) dated 24.12.2013, it was decided to revised the norms already fixed in meeting no. 8/82 dated 19.12.2013 norms under Para 4.7 of HBP v1 as per
Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg Alpha‐(Alpha,Beta)‐Beta‐ Methyl‐Alpha‐Phenyl‐1‐ pyrrolidineethanol (or) (1R,2S)‐ Pyrrolidinylnorephedrine 1 kg 1. Propiophenone 3.21 2. Bromine 4.31 3. Toluene 2.50 4. Pyrrolidine 1.90 5. Causticsoda flakes 5.98 6. LGlutamic acid 0.89 7. Acetone 2.67
Case No. B‐7 (Part‐II)
M/s RA Chem Pharma Ltd. F. No. 01/82/50/00016/AM13/DES‐III F. No. 01/82/50/00019/AM13/DES‐III F. No. 01/82/50/00668/AM13/DES‐III F. No. 01/82/50/01426/AM12/DES‐III F. No. 01/82/50/01500/AM12/DES‐III RA.No. 09/24/040/00450/AM12 RA.No. 09/24/040/00516/AM12 RA.No. 09/24/040/00213/AM13 RA.No. 09/24/040/00412/AM12 RA.No. 09/24/040/00564/AM12 Adv. Lic. No. 0910050474 dated 09.12.2011 Adv. Lic. No. 0910051056 dated 01.02.2012 Adv. Lic. No. 0910053324 dated 23.07.2012 Adv. Lic. No. 0910050064 dated 07.12.2011 Adv. Lic. No. 0910051391 dated 22.02.2012 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and the following decision has been taken in respect of above advance authorizations as per details given below: (a) In respect of Adv. Lic. No. 0910050474 dated 09.12.2011 and Adv. Lic. No. 0910051056 dated 01.02.2012 amendment in the descripƟon of import item From To 4‐Hydroxy‐Alpha Bromo Acetophenone 2‐Bromo‐4‐Hydroxyacetophenone / 4‐Hydroxy‐Alpha Bromo Acetophenone (b) Decision: In respect of Adv. Lic. No. 0910053324 dated 23.07.2012 Adv. Lic. No. 0910050064 dated 07.12.2011 Adv. Lic. No. 0910051391 dated 22.02.2012 as per written comments received from Department of
Pharmaceuticals vide their OM No. 35011/401/2012PI(Norms) dated September 2012, and it was decided to amend the descripƟon of import item sl. No. 2 and 3 as per details given below: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg Ractopamine HCL 1 kg 1. 4‐(4‐Hydroxy Phenyl)‐2‐ Butanone 1.063 2. 2‐Bromo‐4‐ Hydroxyacetophenone 1.063 3. 4‐Hydroxyacetophenone Not required in the process 4. Methanol 3.91 5. Ethyl Acetate 4.11 6. Toluene 1.28 7. Acetone 0.33
Case No. B‐8 (Part‐II)
M/s Sentiss Pharma Pvt. Ltd. (Formerly known as Promed Export Pvt. Ltd. 01/82/050/00230/AM14/DESIII 01/82/050/00235/AM14/DESIII RA No. 03/94/040/00028/AM14 RA No. 03/94/040/00014/AM14 Ad. Licence No. 0510354173 dated 14.05.2013 Ad. Licence No. 0510352314 dated 25.04.2013 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo.
Case No. B‐9 (Part‐II)
M/s Dalas Biotech Ltd. 01/82/050/01175/AM12/DESIII 01/82/050/00902/AM12/DESIII 01/82/050/00901/AM12/DESIII RA No. 05/23/040/00344/AM12 RA No. 05/23/040/00250/AM12 RA No. 05/23/040/00249/AM12 Ad. Licence No. 0510311321 dated 15.12.2011 Ad. Licence No. 0510305027 dated 12.10.2011 Ad. Licence No. 0510305026 dated 12.10.2011
Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and it was decided amend the export product and allow import items as per SION A2462 details as under : Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg Cefixime USP 1 kg 1. GCLE 1.555 kg 2. 4‐Chloro‐2(Z) Methyxy Carboxyl Nethoxy Amino‐3‐Oxobutyric Acid Or Alpha‐2‐Amino‐Thiozol‐4YL‐ Alpha‐Tert. Butoxy Carbonyl 0.82 kg 1.29 kg
Case No. B‐10 (Part‐II)
M/s J.B. Chemicals & Petrochemicals Ltd., Mumbai F.No. 01/82/050/00179/AM13/DES‐III F.No. 01/82/050/00737/AM13/DES‐III F.No. 01/82/050/00390/AM13/DES‐III F.No. 01/82/050/01103/AM13/DES‐III RLA F. No. 03/94/040/00055/AM13 RLA F. No. 03/94/040/00328/AM13 RLA F. No. 03/94/040/00068/AM13 RLA F. No. 03/94/040/00619/AM13 Adv. Lic. No.0310692273 dated 28.04.2012 Adv. Lic. No.0310706512 dated 27.03.2012 Adv. Lic. No.0310693154 dated 02.05.2012 Adv. Lic. No.0310714039 dated 01.11.2012 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to amend the description of export Import items as details given below: Export Product Export Qty S.No Import Item Qty. allowed Kanamycin Acid Sulphate Injection 1 gm/ 3ml Vial/ Ampoules pack of 10x3 ml 1 Ampoule 1. Kanamycin Acid Sulphate BP 2010 1.39 gm RA concerned may take further necessary action as per above decision of NC.
Case No. B‐11 (Part‐II)
M/s. Wanbury LTD. (Formerly Known as Doctors Organic Chemicals Ltd.) F.No. 01/82/50/00599/AM06/DESIII F.No. 01/82/50/00069/AM06/DESIII Adv.Lic.No. 2610004911 dated 02.09.2005 Adv.Lic.No. 2610004676 dated 27.04.2005 RAF.No.26/80/040/00020/AM06 RAF.No.26/80/040/00003/AM06 In respect of Adv.Lic.No. 2610004676 dated 27.04.2005 Decision :The CommiƩee considered this case for fixaƟon of I/O norms for the export product Mefenamic Acid under para 4.7 of HBP as per agenda. The CommiƩee in light of the oral comments of the representaƟve of D/o PharmaceuƟcals in the meeƟng decided to fix I/O Norms for the export product as per SION at Sr. No. A286 for the purpose of para 4.7 of HBP only. RLA concerned may please take further necessary acƟon as per Policy and Procedure in light of the above decision of the CommiƩee. And In respect of Adv.Lic.No. 2610004676 dated 27.04.2005 Adv.Lic.No. 2610004911 dated 02.09.2005 The commiƩee considered this case for inclusion for “Iso Propyl alcohol” as solvent as an addiƟonal item under para 4.7 of HBP on repeat basis as per earlier decision taken in its meeƟng No. 37/05 dated 12.01.2005 against adv. Lic. No. 2610001850 dated 11.03.2002. It was decided to revise the quanƟty of IPA ( Iso Propyl alcohol) to 3.27 kg/kg in respect of Adv.Lic.No. 2610004676 dated 27.04.2005 and Adv.Lic.No. 2610004911 dated 02.09.2005 without any other changes for regularizaƟon purpose only. RA concerned may take further necessary action as per above decision of NC.
Case No. B‐12 (Part‐II)
M/s RA Chem Pharma Ltd. F. No. 01/82/50/00219/AM12/DES‐III RA.No. 09/24/040/00071/AM12 Adv. Lic. No. 0910046667 dated 06.05.2011 Decision: It was decided to reject the case as the firm has not furnished Central Excise Data despite repeated reminders.
Case No. B‐13 (Part‐II)
M/s Drof Ketal Chemicals I Pvt. Ltd. 01/82/171/280/AM14/DESIII Ad. Licence No. 03104180237 Dt. 0.12..2006 Ad. Licence No. 0310478565 Dt. 14.07.2008 Ad. Licence No. 0310491961 Dt. 24.10.2008 Ad. Licence No. 0310526499 Dt. 30.06.2009 (Reject) Ad. Licence No. 0310541892 Dt. 23.10..2009 Ad. Licence No. 0310548591 Dt. 01.12.2009 Ad. Licence No. 0310548598 Dt. 01.12..2009 Ad. Licence No. 0310560279 Dt. 15.02.2010 Ad. Licence No. 0310560279 Dt. 15.02.2010 Ad. Licence No. 0310582532 Dt. 26.07.2010 Ad. Licence No. 0310594926 Dt. 04.10..2009 Decision: Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo. Date:14.02.2014 Place:New Delhi R.C.Meena Dy. Director General of Foreign Trade
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