DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi 0
Para 4.7 Decision
MEETING NUMBER : 5/82ALC4/2013 MEETING DATE : 30.05.2013 The Meeting No. 5/82 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 held on 30.05.2013, 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, Consultant 3. Shri Manoj Kumar, Deputy Director, DC(MSME) 4. Shri Nitin K Jain Scientist –D, D/o Biotechnology
Case No. B43
M/s. Cipla Limited Norms Committee Meeting No.5/AM14 F.No. 01/82/50/01514/AM 08/DES III Meeting Date:30.05.2013 RLA F.No. 03/94/040/00814/AM08 Advance Licence No.0310449495 dated 06.11.2007 Decision: It was decided to amend the description of import item at Sr. No. 2 from “2,5 Difluoromethoxy2Mercapto1 H Benzimidazole” to “5Difluoromethoxy2Mercapto Benzimidazole (PZL THIOL)”. Rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee. Case.No. – B 44 M/s. DSM AntiInfectives India Ltd. Sl.No. F.No. RLA F.No. Adv. Lic. Nos. 1 F.No.01/83/50/1029/AM08 22/24/40/38/AM08 2210007006 dt. 28.08.07 2 F.No.01/82/50/1292/AM06 22/24/40/79/AM06 2210005206 dt. 31.01.06 3 F.No.01/82/50/0247/AM07 22/24/40/41/AM07 2210005553 dt. 19.05.06 M.No. – 5/AM 14 30.05.2013 4 F.No.01/82/50/0301/AM07 22/24/40/55/AM07 2210005581 dt. 30.0506 5 F.No.01/82/50/0306/AM07 22/24/40/63/AM07 2210005588 dt. 31.05.06 6 F.No.01/82/50/0460/AM07 22/24/40/92/AM07 2210005698 dt. 28.06.06
7 F.No.01/82/50/0513/AM08 22/24/40/38/AM07 2210005724 dt. 04.07.06 8 F.No.01/82/50/0512/AM07 22/24/40/111/AM07 2210005723 dt. 04.07.06 9 F.No.01/82/50/0528/AM07 22/24/40/123/AM07 2210005750 dt. 10.07.06 10 F.No.01/82/50/0539/AM07 22/24/40/118/AM07 2210005758 dt. 12.07.06 11 F.No.01/82/50/0645/AM07 22/24/40/152/AM07 2210005831 dt. 31.07.06 12 F.No.01/82/50/0684/AM07 22/24/40/159/AM07 2210005855 dt. 07.08.06 13 F.No.01/82/50/0683/AM07 22/24/40/161/AM07 2210005854 dt. 07.08.06 14 F.No.01/82/50/1066/AM07 22/24/40/258/AM07 2210006081 dt. 28.09.06 15 F.No.01/82/50/1065/AM07 22/24/40/259/AM07 2210006080 dt. 28.09.06 16 F.No.01/82/50/1473/AM07 22/24/40/280/AM07 2210006310 dt. 19.12.06 17 F.No.01/82/50/1540/AM07 22/24/40/287/AM07 2210006358 dt. 10.01.07 18 F.No.01/82/50/0057/AM08 22/24/40/292/AM07 2210006468 dt. 02.02.07 19 F.No.01/82/50/0063/AM08 22/24/40/296/AM07 2210006483 dt. 13.02.07 20 F.No.01/82/50/0021/AM08 22/24/40/001/AM08 2210006652 dt. 10.04.07 21 F.No.01/82/50/0096/AM08 22/24/40/002/AM08 2210006653 dt. 10.04.07 22 F.No.01/82/50/0410/AM08 22/24/40/010/AM08 2210006746 dt. 28.05.07 23 F.No.01/82/50/0514/AM08 22/24/40/012/AM08 2210006786 dt. 12.06.07 24 F.No.01/82/50/0515/AM08 22/24/40/014/AM08 2210006787 dt. 12.06.07 25 F.No.01/82/50/0541/AM08 22/24/40/015/AM08 2210006806 dt. 18.06.07 26 F.No.01/82/50/0542/AM08 22/24/40/016/AM08 2210006807 dt. 18.06.07 27 F.No.01/82/50/0869/AM08 22/24/40/020/AM08 2210006928 dt. 31.07.07 28 F.No.01/82/50/0914/AM08 22/24/40/028/AM08 2210006954 dt. 07.08.07
29 F.No.01/82/50/1115/AM08 22/24/40/036/AM08 2210007033 dt. 06.09.07 30 F.No.01/82/50/1114/AM08 22/24/40/037/AM08 2210007032 dt. 06.09.07 Decision: The matter was thoroughly examined by Department of Pharmaceuticals and they have furnished their comments vide their OM No. 35011/193/2013PI (Norms) dated 09.5.2013, which interalia are: 1. Norms for drugs are recommended by comparison of efficiency of firm in terms of conversion yields and recovery of solvents. 2. There is a separate provision for Noninfringing process in the policy. 3. There is no provision available in the Trade Policy for considering Green chemistry or Environmental Friendly process to decide the norms on higher side than given in conventional process. 4. As far as the quality of drug is concerned, these are specified under various Pharmacopoea such as IP/BP/EP/USP etc. 5. The drop in consumption norms from 1.88 BOU to 1.66 BOU during 2 years period i.e. May 2006 to Feb. 2008 is appreciated. However, sudden change needs to be explained. Probable gradual reduction in consumption norms for PenG may be called for to arrive at the admissible reduction level to be considered in the case. 6. It is also felt that in view of substantial improvement in yields achieved by the firm to match the SION, there is a possibility of further improvement in consumption of PenG in the subsequent years, which may also be called for by the Norms Committee to make further improvement in the norms. It was decided to seek clarification from the firm on the above points, alongwith Central Excise Certified consumption data. The case may examined further on receipt of information.
Case No. B45
M/s. PI Industries Limited, Udaipur Meeting no. 5/AM 13 Dated 30.05.2013 01/82/050/00703/AM 13/DES III RLA File No. 13/24/040/00028/AM 13 Advance Authorisation No. 1310041094 dated 20.9.2012 Decision: It was decided to defer the case for 27.6.2013 comments of Department of Chemicals and Petrochemicals.
Case No. B46
M/s. Panacea Biotec Limited, New Delhi Meeting no. 5/AM 14 Dated 30.05.2013 01/82/050/00427/AM 10/DES III 01/82/050/00927/AM 11/DES III
01/82/050/00927/AM 11/DES III 01/82/050/00327/AM 12/DES III RLA File No. 05/24/040/00156/AM 11 05/24/040/00235/AM 11 05/24/040/00070/AM 12 Adv. Lic. No. 0510269042 dated 26.07.2010 Adv. Lic. No. 0510274701 dated 11.10.2010 Adv. Lic. No. 0510292280 dated 31.05.2011 Decision: In the light of written comments received from Department of Biotechnology vide their OM No. BT/IL/05/316/2010PID dated 07.5.2013, it was decided to seek comments from DCGI on issue mentioned in the application. The case was deferred for 27.6.2013.
Case No. B47
M/s. Metropolitan Exim Chem Limited Meeting no. 5/AM 14 Dated 30.05.2013 01/82/050/00532/AM 13/DES III RLA File No. 05/24/040/00156/AM 11 Adv. Lic. No. 0310702889 dated 24.07.2012 Decision: It was decided to reject the request of the firm. The Committee observed that the same norms are given to other companies also and there is no need for enhancement.
Case No. B48
M/s. Medchl Chem. & Pharma Limited Meeting no. 5/AM 14 Dated 30.05.2013 File No. 01/82/50/01760/AM 11 File No. 01/82/50/00911/AM 11 File No. 01/82/50/01258/AM 11 RLA File No. 09/24/40/00539/AM 11 RLA File No. 09/24/40/00231/AM 12 RLA File No. 09/24/40/00324/AM 11 Adv. Lic. No. 0910045802 dated 4.3.2011 Adv. Lic. No. 0910048496 dated 29.8.2011 Adv. Lic. No. 0910044428 dated 24.11.2010 Decision: In the light of earlier decision taken in meeƟng no. 4/82 dated 16.5.2013, 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 Export Qty. Sl.No. Import items Qty. allowed kg/kg D2 Aminobutanol 1 kg 1 2 DL2 Aminobutanol Monosodium Glutamate 2.2642 kg 1 00 kg
2 3 Monosodium Glutamate Toluene 1.00 kg 0.709 kg RA concerned may take further necessary action as per above decision of NC.
Case No. B49
M/s. Crown Chemicals Pvt. Limited Meeting no. 2/AM 13 Dated 18.4.2013 01/82/162/00622/AM 13/DES III RLA File No. 03/94/40/00309/AM 13 Adv. Lic. No. 0310703754 dated 1.8.2012 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/175/2011Ch. II dated 20.05.2013, 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 Piperonal Min. Purity 98% 1 kg 1. Catechol (Min. Purity 99%) 1.355 kg 2. Dichloromethane (Min. Purity 99%) 1.375 kg 3. Dimethyl Sulfoxide (Min. Purity 99%) 0.875 kg 4. Hexamine ( Purity 96%) 1.000 kg 5. Toluene ( Purity 97%) 0.232 kg 6. Isopropyl Alcohol ( Purity 99%) 0.250 kg RA may take appropriate action as per the decision of Norms Committee.
Case No. B 50
M/s. Medreich Limited Meeting no. 33/AM 13 dated 21.3.2013 01/82/050/00764/AM 09/DES III 01/82/050/778/AM 09 DES III 01/82/050/779/AM 09 DES III 01/82/050/1334/AM 09 DES III Advance Authorisation No. 0710058625 dated 18.7.2008 0710058622 dated 22.7.2008 0710058663 dated 22.7.2008
0710061410 dated 28.11.2008 RLA’s File No Decision: Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/310/2012PI (Norms) dated.09.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: [A] Export Product Quantity Sl.No. Import items Quantity allowed for 1 number tablet. Paracetamol 100mg, Aspirin 400mg, Caffeine 30mg Tablets 1 no, of tablet 1. Paracetamol [Paracetamol Powder] BP/USP/EP 102.0 mg 2. Aspirin BP/USP/EP [Rhodine 3126/Aspirin (22/44) USP [Acetyl Salicylic Acid] 408.0 mg 3. Hydrogenated Cottonseed Oil [Rylo TG 11 Pharma Kosher] 5.0 mg [B] Export Product Quantity Sl.No. Import items Quantity allowed for 1 number tablet. Paracetamol 450mg + Caffeine Anhydrous 45 mg or 50mg or 30 mg + Doxylamine Succinate 5mg+Codeine Phosphate 10mg Tablets 1 no. of tablet 1. Paracetamol [Paracetamol Powder] BP/USP/EP 459 mg 2. Doxylamine Succinate BP/USP/EP 5.10 mg 3. 14037 Yellow [Colour yellow Anstead 18900] 1.848 mg 4. Hydrogenated Coퟀ�onseed Oil [Rylo TG 11 Pharma Kosher] 16.8 mg RA concerned may take further necessary action as per above decision of NC.
Case No. C6
M/s. Encee Aromatics Pvt. Limited Meeting no. 2/AM 13 Dated 18.4.2013 01/82/162/00745/AM 12/DES III
Decision: It was decided to request the Chemexcil and the firm to furnish All Industry data of other manufacturers exporting this product. Accordingly, the case was deferred for 27.06.2013. 1
Case No.:26/2/82ALC4/2013
Party Name:LUPIN LIMITED Meet No/Date:5/82ALC4/2013 30.05.2013 Status:Case Approved HQ File :01/82/050/00026/AM14/ RLA File :03/95/040/00564/AM10/ Lic.No/Date:0310549173 04.12.2009 Defer Date: Decision : In the light of earlier decision taken in meeting no. 5/82 dated 03.05.2011, 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 Quantity Sl.No. Import items Quantity allowed Rifampicin BP/USP 1 kg 1. Sodium RifaS 0.98 kga 2. Chloroform 0.661 kg 3. Acetic Acid 0.16 kg 4. Piperzine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg 6. Isopropyl Alcohol 0.51 kg 7. Dimethyl Formamide 0.75 kg 8. Tertiary Butyl Amine 0.19 kg 9. Acetone 0.832 kg 10. 1Amino4Methyl Piperazine 0.16 kg RA concerned may take further necessary action as per above decision of NC. 2
Case No.:71/15/82ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 30.05.2013 Status:Case Approved HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/310/2012PI (Norms) dated.09.2012 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Quantity Sl.No. Import items Quantity allowed kg/kg 4‐Methoxybenzyl‐3‐ chloromethyl‐7‐(2‐ phenylacetamido)‐3‐ cephem‐4‐ carboxylate (GCLE) 1 kg 1. Penicillin G Potassium First Crystals 4.503 BOU/kg 2. Methylene Chloride 1.36 3. Tetra butyl ammonium bromide 0.107 4. pMethoxy bezyl alcohol (PMBA) 1.248 5. Sodium Carbonate 2.28 6 M h l 1 11
Methanol 1.11 7. Sodium thiosulfate Not shown in process 8. Acetic Acid 2.83 9. Hydrogen peroxide 48% 1.987 10. Acetone 1.30 11 Mercaptobenzothiazole (MBT) 0.511 12 1,4Dioxane 2.00 13 HCL (30%) Not an importable item 14 Sodium benzene sulfinic acid 1.98 15 Isopropyl alcohol (IPA) 0.72 16 Oxalic acid 0.015 17 Chlorine Not an importable item 18 N,NDimethyl formamide 1.46 19 Ammonia Gas Not a importable item RA concerned may take further necessary action as per above decision of NC. 3
Case No.:43/48/82ALC4/2010
30.05.2013 Status:Case Approved HQ File :01/82/050/01686/AM11/ RLA File :22/24/040/00078/AM11/ Lic.No/Date:2210010769 22.12.2010 Defer Date: Decision : In the light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/51/2011PI (Norms) dated 07.12.2011 and in consultation with technical authority present in meeting, it was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Quantity Sl.No. Import items Quantity allowed kg/kg Meropenem for InjecƟon 1 kg 1. Meropenem Trihydrate (Nonsterile) 1.032 2. Sodium Carbonate (Nonsterile) 0.16 3. Acetone 1.85 4. Methanol 2.01 5. Activated Carbon 0.065 RA concerned may take further necessary action as per above decision of NC. 4
Case No.:4/1/82ALC4/2013
Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/01362/AM13/ RLA File :04/21/040/00680/AM11/ Lic.No/Date:0410121541 10 02 2011 Defer Date:27 06 2013
10.02.2011 Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Pharmaceuticals. 5
Case No.:53/47/82ALC4/2010
Party Name:NEULAND LABORATORIES LTD 30.05.2013 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:27.06.2013 6
Case No.:5/4/82ALC4/2011
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 30.05.2013 Status:Case Deferred HQ File :01/82/050/00056/AM12/ RLA File :03/95/040/00949/AM11/ Lic.No/Date:0310620143 08.03.2011 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Biotechnology. 7
Case No.:56/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01414/AM13/ RLA File :08/24/040/00394/AM11/ Lic.No/Date:0810098384 20.04.2011 Defer Date:27.06.2013 Decision :It was decided to defer the case for27.06.2013 for comments of Department of Pharmaceuticals. 8
Case No.:19/10/82ALC4/2011
Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/00278/AM12/ RLA File :61/24/040/00097/AM11/ Lic.No/Date:6110000608 03.05.2011 Defer Date:27.06.2013 Decision :It was decided to give a final reminder to the firm to furnish the following information within 15 days failing which their case would be closed: Complete set of application form indicating export item and required detailed import and indigenous inputs. Technical literature and detailed manufacturing process indicating the quantity required in kg. of imported and indigenous inputs per kg of export product. Consumption data of imported and indigenous inputs used for the manufacture of export product quantitywise duly certified by excise department for the last three years. Detailed justification of wastage claimed, if any of each stage. Copy of the formulation of export product duly approved by concerned authority under drug and cosmetic act. The case was deferred for 27.06.2013.
Case No.:2/15/82ALC4/2011
Party Name:ACHARYA CHEMICALS 30.05.2013 Status:Case Deferred
9 HQ File :01/82/050/00442/AM12/ RLA File :03/94/040/00130/AM12/ Lic.No/Date:0310633824 31.05.2011 Defer Date:27.06.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals on 28.8.2012. The case was deferred for 27.06.2013 for comments of Department of Pharmaceuticals. 10
Case No.:4/16/82ALC4/2011
Party Name:BOSTIK INDIA PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00462/AM12/ RLA File :07/24/040/00073/AM12/ Lic.No/Date:0710079777 13.06.2011 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 11
Case No.:35/19/82ALC4/2011
30.05.2013 Status:Case Deferred HQ File :01/82/050/00549/AM12/ RLA File :22/24/040/00022/AM12/ Lic.No/Date:2210011532 28.06.2011 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Pharmaceuticals 12
Case No.:84/1/82ALC4/2013
Party Name:ANUS LABORATORIES LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01442/AM13/ RLA File :09/24/040/00205/AM11/ Lic.No/Date:0910049025 23.09.2011 Defer Date:27.06.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM .No. 35011/141/2012PI(Norms) dated 04.07.2012, it was decided to call from the firm the following technical details: Complete Technical details as per Appendix33 of the proforma. Past production visavis actual consumption of all inputs duly certified by Central Excise Authority. The case was deferred for 27.06.2013. 13
Case No.:96/1/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01454/AM13/ RLA File :09/24/040/00308/AM12/ Lic.No/Date:0910049099 28.09.2011 Defer Date:27.06.2013 14
Case No.:22/45/82ALC4/2011
Party Name:AUCTUS PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01199/AM12/ RLA File :09/24/040/00341/AM12/ Lic.No/Date:0910049706 15.11.2011 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27 06 2013 for comments of Department of Biotechnology
Decision :It was decided to defer the case for 27.06. 2013 for comments of Department of Biotechnology. 15
Case No.:5/45/83ALC1/2011
Party Name:SPAN DIAGNOSTICS LTD 30.05.2013 Status:Case Deferred HQ File :01/83/050/00780/AM12/ RLA File :52/24/040/00033/AM12/ Lic.No/Date:5210037002 15.11.2011 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Biotechnology. 16
Case No.:7/27/85ALC3/2011
Party Name:BELOOR BAYIR BIOTECH LTD, 30.05.2013 Status:Case Deferred HQ File :01/85/050/00151/AM12/ RLA File :07/24/040/00317/AM12/ Lic.No/Date:0710084045 18.11.2011 Defer Date:27.06.2013 Decision :It was decided to give a final reminder to the firm to clarify whether the items are drug items. If yes, furnish a copy of Drug Manufacturing License. If not a drug item, elaborate under which ITC(HS) code the firm is claiming the norms within 15 days failing which their case would be closed. The case was deferred for 27.06.2013. 17
Case No.:11/1/82ALC4/2013
Party Name:BIOCON LIMITED, 30.05.2013 Status:Case Deferred HQ File :01/82/050/01369/AM13/ RLA File :07/24/040/00329/AM12/ Lic.No/Date:0710084173 23.11.2011 Defer Date:27.06.2013 18
Case No.:23/45/82ALC4/2011
Party Name:SUTURES INDIA PRIVATE LIMITED, 30.05.2013 Status:Case Deferred HQ File :01/82/050/01200/AM12/ RLA File :07/24/040/00341/AM12/ Lic.No/Date:0710084630 13.12.2011 Defer Date:27.06.2013 Decision : It was decided to remind the firm to furnish the following information immediately: 1. A chartered Accountant Certificate indicating the content (quantity / number) of each box containing `Skin Barrier Micro Porous Surgical Tape including the Width of the tape 2. GSM of the import & Export product. 3. Consumption of all the raw material (both indigenous & imported) with corresponding production of the export item, duly certified by the concerned Central Excise Authority / Chartered Accountant for the last 3 years. 4. Complete manufacturing process indicating stage wise wastage. The case is deferred for 27.06.2013
Case No.:24/46/82ALC4/2011
Party Name:ASHISH LIFE SCIENCE PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01240/AM12/ RLA File :03/94/040/00737/AM12/ Lic.No/Date:0310670672 14 12 2011 Defer 2 06 2013
19 14.12.2011 Date:27.06.2013 Decision :It was decided to remind the firm to furnish the following information immediately Quantity of different formulations to be exported. • Composition of each type of formulation (strength wise) • Copy of DML allowing manufacturing of Praziquantel bases Syringes with approved composition. • The unit of measurement of each export product. 20
Case No.:59/46/82ALC4/2011
Party Name:INCHEM LABORATORIES PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01275/AM12/ RLA File :09/24/040/00413/AM12/ Lic.No/Date:0910050238 15.12.2011 Defer Date:27.06.2013 Decision :It was decided to give a final reminder to the firm to furnish the technical details as per Appendix 33, within 15 days failing otherwise their case would be closed. The case was deferred for 27.06.2013. 21
Case No.:61/4/82ALC4/2012
Party Name:ANUGRAHA CHEMICALS 30.05.2013 Status:Case Deferred HQ File :01/82/050/00141/AM13/ RLA File :07/24/040/00489/AM12/ Lic.No/Date:0710086840 07.03.2012 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish the following information: • Complete technical details as per Appendix 33; and • Past production visàvis actual consumption of raw materials duly certified by Central Excise Authority. 22
Case No.:71/3/82ALC4/2012
Party Name:FORACE POLYMERS (P) LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/00075/AM13/ RLA File :05/23/040/00502/AM12/ Lic.No/Date:0510320188 15.03.2012 Defer Date:27.06.2013 Decision :In the light of written comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their OM No. 46011/18/2011PCII dated 21.5.2013, it was decided to call from the firm the following technical details: 1. Technical specification % composition (by weight) along with specific end use/application and the copy of export order for the export product i.e. Hardener Fortech 1000 may be furnished. 2. Technical specifications and foreign supplier catalogue for the raw material to be imported may also be furnished 3. Details and quantity of other indigenous input to be used in the manufacture of the export product may be indicated 4. Detailed manufacturing process along with balanced chemical reaction indicating % yield/wastage along with balanced chemical reaction indicating % yield/wastage along with technical justification for wastage along with technical justification for wastage at each stage and also on each of the raw material may be furnished. 5 Complete material balance indicating input and output material at each stage of manufacturing process
5. Complete material balance indicating input and output material at each stage of manufacturing process. 6. Standard/authentic technical literature in support of the raw material requirement /formulation for the manufacture of export product. 7. Details of production of export product under reference and corresponding consumption of raw material in the year 201112 and 201213 duly certified by CA may be furnished. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA. 8. Any other relevant information,. The case was deferred for 27.06.2013 23
Case No.:39/11/82ALC4/2012
Party Name:MYLAN LABORATORIES LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00306/AM13/ RLA File :09/24/040/00600/AM12/ Lic.No/Date:0910051800 16.03.2012 Defer Date:27.06.2013 Decision :It was decided to give final reminder to the firm to furnish the following information within 15 days otherwise their case would be closed: Complete technical details as per Appendix 33 . Past production visavis actual consumption of raw materials duly certified by Central Excise Authorities. 24
Case No.:76/4/82ALC4/2012
Party Name:CADILA HEALTHCARE LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/00156/AM13/ RLA File :08/24/040/00301/AM12/ Lic.No/Date:0810110001 22.03.2012 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula. The case was deferred for 27.06.2013 25
Case No.:9/11/82ALC4/2012
Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/00276/AM13/ RLA File :34/24/040/00298/AM12/ Lic.No/Date:3410033741 29.03.2012 Defer Date:27.06.2013 26
Case No.:2/2/82ALC4/2012
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 30.05.2013 Status:Case Rejected HQ File :01/82/050/00002/AM13/ RLA File :03/95/040/01032/AM12/ Lic.No/Date:0310688856 30.03.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished the information despite repeated reminders.
Case No :3/2/82 ALC4/2012
Part Name:PIRAMAL HEALTHCARE LTD Meet No/Date:5/82 ALC4/2013 Status:Case
27
Case No.:3/2/82ALC4/2012
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 30.05.2013 Status:Case Rejected HQ File :01/82/050/00003/AM13/ RLA File :03/95/040/01037/AM12/ Lic.No/Date:0310688874 30.03.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished the information despite repeated reminders. 28
Case No.:4/7/82ALC4/2012
Party Name:PROMED EXPORTS PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/00188/AM13/ RLA File :05/24/040/00471/AM12/ Lic.No/Date:0510321506 30.03.2012 Defer Date:27.06.2013 29
Case No.:38/16/82ALC4/2012
Party Name:BRILLIANT BIO PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00474/AM13/ RLA File :09/24/040/00664/AM12/ Lic.No/Date:0910052111 11.04.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Biotechnology 30
Case No.:3/11/82ALC4/2012
Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 30.05.2013 Status:Case Deferred HQ File :01/82/050/00270/AM13/ RLA File :03/94/040/00007/AM13/ Lic.No/Date:0310690582 12.04.2012 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33. The case was deferred for 27.06.2013. 31
Case No.:50/3/83ALC1/2012
Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 30.05.2013 Status:Case Deferred HQ File :01/83/050/00053/AM13/ RLA File :03/95/040/01118/AM12/ Lic.No/Date:0310690527 12.04.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Biotechnology 32
Case No.:14/14/82ALC4/2012
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00391/AM13/ RLA File :03/94/040/00070/AM13/ Lic.No/Date:0310693809 08.05.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for27.06.2013 for comments of Department of Pharmaceuticals. 33
Case No.:51/1/82ALC4/2013
Party Name:ALKALOIDS CORPORATION 30.05.2013 Status:Case Deferred HQ File :01/82/050/01409/AM13/ RLA File :02/24/040/00023/AM13/ Lic No/Date:0210177494 Defer
33 HQ File :01/82/050/01409/AM13/ RLA File :02/24/040/00023/AM13/ Lic.No/Date:0210177494 11.05.2012 Defer Date:27.06.2013 34
Case No.:6/16/82ALC4/2012
Party Name:STELLENCE PHARMSCIENCE PVT LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/00442/AM13/ RLA File :07/24/040/00062/AM13/ Lic.No/Date:0710088213 16.05.2012 Defer Date:27.06.2013 Decision :It was decided to remind 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 27.06.2013. 35
Case No.:29/16/82ALC4/2012
30.05.2013 Status:Case Deferred HQ File :01/82/050/00465/AM13/ RLA File :09/24/040/00067/AM13/ Lic.No/Date:0910052682 18.05.2012 Defer Date:27.06.2013 Decision :It was decided to give a final reminder to the firm to furnish the requisite information immediately failing which their case would be closed. The case was deferred for 27.06.2013. 36
Case No.:16/13/82ALC4/2012
Party Name:NIFTY LABS PVT LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/00351/AM13/ RLA File :09/24/040/00076/AM13/ Lic.No/Date:0910052711 21.05.2012 Defer Date:27.06.2013 Decision :The committee has observed that the Party`s reply is not relevant to the export product mentioned in the licence. It was decided to seek a clarification in this regard from the firm. 37
Case No.:3/16/82ALC4/2012
Party Name:ADCOCK INGRAM LTD, 30.05.2013 Status:Case Deferred HQ File :01/82/050/00439/AM13/ RLA File :07/24/040/00075/AM13/ Lic.No/Date:0710088327 21.05.2012 Defer Date:27.06.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 27.06.2013 for comments of Department of Pharmaceuticals. 38
Case No.:11/13/82ALC4/2012
Party Name:PROMED EXPORTS PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/00346/AM13/ RLA File :05/24/040/00048/AM13/ Lic.No/Date:0510325611 23.05.2012 Defer Date:27.06.2013 C N 6/13/82 ALC4/2012 P t N BHARAT PARENTERALS LTD M t N /D t 5/82 ALC4/2013 St t C
39
Case No.:6/13/82ALC4/2012
Party Name:BHARAT PARENTERALS LTD, 30.05.2013 Status:Case Deferred HQ File :01/82/050/00341/AM13/ RLA File :34/24/040/00045/AM13/ Lic.No/Date:3410034190 23.05.2012 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately for further processing of the case. The case was deferred for 27.06.2013 40
Case No.:4/16/82ALC4/2012
Party Name:ADCOCK INGRAM LTD, 30.05.2013 Status:Case Deferred HQ File :01/82/050/00440/AM13/ RLA File :07/24/040/00078/AM13/ Lic.No/Date:0710088441 24.05.2012 Defer Date:27.06.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 27.06.2013 for comments of Department of Pharmaceuticals. 41
Case No.:12/13/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/00347/AM13/ RLA File :05/24/040/00061/AM13/ Lic.No/Date:0510325945 25.05.2012 Defer Date:27.06.2013 42
Case No.:68/1/82ALC4/2013
Party Name:PARAMOUNT PHARMA 30.05.2013 Status:Case Deferred HQ File :01/82/050/01426/AM13/ RLA File :05/24/040/00082/AM13/ Lic.No/Date:0510327775 19.06.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.069.2013 for comments of Department of Pharmaceuticals. 43
Case No.:31/13/82ALC4/2012
Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/00366/AM13/ RLA File :03/95/040/00055/AM13/ Lic.No/Date:0310699970 27.06.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Chemicals and Petrochemicals. 44
Case No.:15/20/82ALC4/2012
Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00626/AM13/ RLA File :03/94/040/00336/AM13/ Lic.No/Date:0310703768 01.08.2012 Defer Date:27.06.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 27.06.2013 for comments of Department of Pharmaceuticals.
45
Case No.:47/16/82ALC4/2012
Party Name:PARAMOUNT PHARMA 30.05.2013 Status:Case Deferred HQ File :01/82/050/00483/AM13/ RLA File :05/24/040/00178/AM13/ Lic.No/Date:0510331427 07.08.2012 Defer Date:27.06.2013 46
Case No.:48/16/82ALC4/2012
Party Name:PARAMOUNT PHARMA 30.05.2013 Status:Case Deferred HQ File :01/82/050/00484/AM13/ RLA File :05/24/040/00179/AM13/ Lic.No/Date:0510331428 07.08.2012 Defer Date:27.06.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals. Accordingly, the case was deferred for 27.06.2013 for comments of Department of Pharmaceuticals. 47
Case No.:6/22/82ALC4/2012
Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00709/AM13/ RLA File :03/95/040/00262/AM13/ Lic.No/Date:0310705888 22.08.2012 Defer Date:30.05.2013 Decision :It was decided to remind the firm to furnish following technical details: Complete technical details as per Appendix 33. End use of the export product. In case of drug intermediate, name of bulk drug produced from it may be given. 48
Case No.:37/22/82ALC4/2012
Party Name:FDC LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/00740/AM13/ RLA File :03/94/040/00374/AM13/ Lic.No/Date:0310706515 27.08.2012 Defer Date:27.06.2013 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. The case was deferred for 27.06.2013. 49
Case No.:41/24/82ALC4/2012
Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED 30.05.2013 Status:Deffered and Reindexed HQ File :01/82/050/00845/AM13/ RLA File :09/24/040/00256/AM13/ Lic.No/Date:0910053578 27.08.2012 Defer Date:30.05.2013 Decision : Department of Pharmaceuticals vide their letter No. 35011/92/2013PI (Norms) dated 01.05.2013 has stated that export product is not found in the list of Approved items in Drug Manufacturing Licence. It was decided to seek clarification from the firm in this regard. The case was deferred for 27.06.2013
50
Case No.:4/20/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/00615/AM13/ RLA File :05/24/040/00323/AM12/ Lic.No/Date:0510333154 30.08.2012 Defer Date:27.06.2013 51
Case No.:29/28/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00996/AM13/ RLA File :09/70/040/00061/AM13/ Lic.No/Date:0910053637 31.08.2012 Defer Date:27.06.2013 52
Case No.:28/28/82ALC4/2012
30.05.2013 Status:Case Deferred HQ File :01/82/050/00995/AM13/ RLA File :09/24/040/00270/AM13/ Lic.No/Date:0910053660 04.09.2012 Defer Date:27.06.2013 53
Case No.:81/22/82ALC4/2012
Party Name:BHARAT CHEMICALS 30.05.2013 Status:Case Deferred HQ File :01/82/050/00784/AM13/ RLA File :03/94/040/00433/AM13/ Lic.No/Date:0310707963 06.09.2012 Defer Date:30.05.2013 54
Case No.:21/1/82ALC4/2013
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01379/AM13/ RLA File :07/24/040/00252/AM13/ Lic.No/Date:0710090700 12.09.2012 Defer Date:27.06.2013 55
Case No.:24/26/82ALC4/2012
Party Name:ECOLOGIC CHEMICALS LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00932/AM13/ RLA File :09/24/040/00296/AM13/ Lic.No/Date:0910053811 14.09.2012 Defer Date:27.06.2013 Decision : It was decided to remind the firm to furnish following technical details from the firm: Complete technical details as per Appendix 33 mainly stepwise % yield on molar basis, molar requirement of reactants and Recovery of Solvent in the entire process.
56
Case No.:31/26/82ALC4/2012
Party Name:SRINI PHARMACEUTICALS LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/00939/AM13/ RLA File :09/24/040/00304/AM13/ Lic.No/Date:0910053812 14.09.2012 Defer Date:27.06.2013 57
Case No.:32/28/82ALC4/2012
Party Name:STERICON PHARMA PVT.LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/00999/AM13/ RLA File :07/24/040/00272/AM13/ Lic.No/Date:0710090783 17.09.2012 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish the following details immediately or their case would be decided on merits: DML for the Export Item No. 2 and 3 are not found in the approved list of DML furnished by the firm. The applicant may be advised to furnish the clarification for the same immediately 58
Case No.:90/22/82ALC4/2012
Party Name:INDSWIFT LABORATORIES LTD., 30.05.2013 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:27.06.2013 59
Case No.:88/24/82ALC4/2012
Party Name:CHEMSPEC CHEMICALS PVT LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/00892/AM13/ RLA File :03/94/040/00230/AM13/ Lic.No/Date:0310709870 21.09.2012 Defer Date:27.06.2013 Decision :it was decided to remind the firm to furnish following technical details: • Complete description of export product. • Complete technical details from the applicant firm as per Appendix 33 of the application proforma. 60
Case No.:16/24/82ALC4/2012
Party Name:OGENE SYSTEMS INDIA PVT. LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/00820/AM13/ RLA File :09/24/040/00312/AM13/ Lic.No/Date:0910053896 25.09.2012 Defer Date:27.06.2013
61
Case No.:28/26/82ALC4/2012
Party Name:LAKE CHEMICALS PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00936/AM13/ RLA File :07/24/040/00268/AM13/ Lic.No/Date:0710090949 25.09.2012 Defer Date:27.06.2013 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 27.06.2013 62
Case No.:43/24/82ALC4/2012
30.05.2013 Status:Case Deferred HQ File :01/82/050/00847/AM13/ RLA File :09/24/040/00288/AM13/ Lic.No/Date:0910053905 26.09.2012 Defer Date:27.06.2013 Decision : It was decided to remind the firm to furnish following technical details: Stepwise complete and balanced chemical reaction showing % yield on molar basis. Material Balance for the entire process. Requirement and Recovery of solvent of each step. Copy of technical literature in support of yield envisaged. past production visavis Actual consumption of inputs duly certified by Central Excise Authorities. 63
Case No.:12/26/82ALC4/2012
Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/00920/AM13/ RLA File :03/94/040/00522/AM13/ Lic.No/Date:0310711393 03.10.2012 Defer Date:27.06.2013 Decision : It was decided to remind the firm to furnish following technical details: 1. While the firm has applied OTNB@0.81 kg/kg the chemistry, process and c.c. given by the firm are from BrOTBN @ 0.81 kg/kg. Technical justification along with amended chemistry may be furnished. 2. Complete technical details as per Appendix 33. 64
Case No.:10/1/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01368/AM13/ RLA File :07/24/040/00282/AM13/ Lic.No/Date:0710091171 04.10.2012 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish the following information immediately : DML for the Export Item No 2 and 3 are not found in the approved list of DML furnished by the firm It was decided to request the firm to furnish
DML for the Export Item No. 2 and 3 are not found in the approved list of DML furnished by the firm. It was decided to request the firm to furnish the same immediately for further consideration of the case. 65
Case No.:33/22/82ALC4/2012
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00736/AM13/ RLA File :09/24/040/00295/AM13/ Lic.No/Date:0910053985 08.10.2012 Defer Date:27.06.2013 66
Case No.:88/1/82ALC4/2013
30.05.2013 Status:Case Deferred HQ File :01/82/050/01446/AM13/ RLA File :09/24/040/00287/AM13/ Lic.No/Date:0910054034 11.10.2012 Defer Date:27.06.2013 67
Case No.:22/1/82ALC4/2013
Party Name:SHILPA MEDICARE LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01380/AM13/ RLA File :07/24/040/00290/AM13/ Lic.No/Date:0710091373 15.10.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Pharmaceuticals.. 68
Case No.:30/28/82ALC4/2012
30.05.2013 Status:Case Deferred HQ File :01/82/050/00997/AM13/ RLA File :09/24/040/00354/AM13/ Lic.No/Date:0910054116 16.10.2012 Defer Date:27.06.2013 69
Case No.:54/24/82ALC4/2012
Party Name:RANBAXY LABORATORIES LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/00858/AM13/ RLA File :05/24/040/00252/AM13/ Lic.No/Date:0510337284 16.10.2012 Defer Date:27.06.2013 70
Case No.:42/28/82ALC4/2012
Party Name:ZIM LABORATORIES LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01009/AM13/ RLA File :03/95/040/00542/AM13/ Lic.No/Date:0310713482 23.10.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Pharmaceuticals.
71
Case No.:89/1/82ALC4/2013
Party Name:VIVIN LABORATORIES PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01447/AM13/ RLA File :09/24/040/00355/AM13/ Lic.No/Date:0910054151 23.10.2012 Defer Date:27.06.2013 72
Case No.:12/28/82ALC4/2012
30.05.2013 Status:Case Deferred HQ File :01/82/050/00979/AM13/ RLA File :09/24/040/00335/AM13/ Lic.No/Date:0910054160 25.10.2012 Defer Date:27.06.2013 73
Case No.:16/28/82ALC4/2012
Party Name:CADILA PHARMACEUTICALS LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/00983/AM13/ RLA File :08/24/040/00259/AM13/ Lic.No/Date:0810115897 25.10.2012 Defer Date:27.06.2013 74
Case No.:49/28/82ALC4/2012
Party Name:S M B CORPORATION OF INDIA 30.05.2013 Status:Case Deferred HQ File :01/82/050/01016/AM13/ RLA File :03/95/040/00568/AM13/ Lic.No/Date:0310713614 25.10.2012 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish following information: Technical specifications, % composition 9by weight), weight per piece and the copy of export order for the export product i.e. Intrauterine Contraceptive Device Copper T 380 Ag may be furnished. Details and quantity of other indigenous inputs to be used in the manufacture of the export product may be indicated. Detailed manufacturing process along with justification for wastages at each stage and also on each of the raw material may be furnished. The net weight of item of import i.e. Copper Silver 10 Alloy Silver Content 10% Nominal) in one piece of export product and quantity applied (net content+wastages, if any) may be furnished with technical justification. Complete material balance indicating input and output material at each stage of manufacturing process. Details of production of export product under reference and corresponding consumption of raw material in the year 201112 and 201213 (April to December) duly certified by CA may be furnished. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA. Any other relevant information. The case was deferred for 27.06.2013
75
Case No.:6/28/82ALC4/2012
30.05.2013 Status:Case Deferred HQ File :01/82/050/00973/AM13/ RLA File :09/24/040/00352/AM13/ Lic.No/Date:0910054161 25.10.2012 Defer Date:27.06.2013 76
Case No.:1/24/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00805/AM13/ RLA File :09/24/040/00371/AM13/ Lic.No/Date:0910054177 29.10.2012 Defer Date:27.06.2013 77
Case No.:10/28/82ALC4/2012
30.05.2013 Status:Case Deferred HQ File :01/82/050/00977/AM13/ RLA File :09/24/040/00339/AM13/ Lic.No/Date:0910054180 29.10.2012 Defer Date:27.06.2013 78
Case No.:102/1/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01460/AM13/ RLA File :09/24/040/00360/AM13/ Lic.No/Date:0910054178 29.10.2012 Defer Date:27.06.2013 79
Case No.:45/26/82ALC4/2012
Party Name:PAYAL POLYPLAST PVT.LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/00953/AM13/ RLA File :05/24/040/00255/AM13/ Lic.No/Date:0510337699 29.10.2012 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish the following information: Details of manufacturing process with chemical equations, molecular formula, molecular weight. Yield obtained in each step. Authentic technical literature in support of yield obtained. CA certificate certifying the production of export item achieved by firm for the past three years and corresponding consumption of each input. 80
Case No.:3/24/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ Fil 01/82/050/00807/AM13/ RLA Fil 09/24/040/00332/AM13/ Li N /D t 0910054196 D f
80 HQ File :01/82/050/00807/AM13/ RLA File :09/24/040/00332/AM13/ Lic.No/Date:0910054196 30.10.2012 Defer Date:27.06.2013 81
Case No.:43/28/82ALC4/2012
Party Name:METROPOLITAN EXIMCHEM LTD. 30.05.2013 Status:Case Approved HQ File :01/82/050/01010/AM13/ RLA File :03/95/040/00561/AM13/ Lic.No/Date:0310713820 30.10.2012 Defer Date: Decision : : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2010Ch. II dated 26.08.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity allowed MR‐3 (2,4,6‐TRI [(2,4‐ DIHYDROXY 3‐METHYL) PHENYL] 1,3,5 ‐ TRIAZINE 1 kg 1 2 Methyl Resorcinol 1.140 kg 2. Cyanuric Chloride 0.479 kg 3. Sulfolane 1.800 kg RA may take appropriate action as per the decision of Norms Committee. 82
Case No.:37/28/82ALC4/2012
Party Name:DEEPAK NITRITE LIMITED 30.05.2013 Status:Case Approved HQ File :01/82/050/01004/AM13/ RLA File :34/24/040/00015/AM13/ Lic.No/Date:3410035376 31.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2012Ch. II dated 18.05.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity allowed Ortho Toluidine 1 kg 1 Toluene 1.040 kg RA may take appropriate action as per the decision of Norms Committee. It was also decided to request Chemexcil to provide All Industry Data for fixation of SION for Ortho Toluidine. 83
Case No.:20/1/82ALC4/2013
Party Name:SHILPA MEDICARE LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01378/AM13/ RLA File :07/24/040/00312/AM13/ Lic.No/Date:0710091677 01.11.2012 Defer Date:27.06.2013
84
Case No.:7/28/82ALC4/2012
Party Name:MELZER CHEMICALS PVT. LTD 30.05.2013 Status:Case Deferred 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 remind the firm to furnish the following information: Details of manufacturing process with chemical equations, molecular formula, molecular weights. Yield obtained in each step. Authentic technical literature in support of yield obtained. CA certificate certifying the production of export item achieved by the firm for the past three years and corresponding consumption of each input. 85
Case No.:19/1/82ALC4/2013
Party Name:CDYMAX (INDIA) PHARMA PVT. LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01377/AM13/ RLA File :07/24/040/00317/AM13/ Lic.No/Date:0710091789 06.11.2012 Defer Date:27.06.2013 86
Case No.:35/28/82ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01002/AM13/ RLA File :05/24/040/00280/AM13/ Lic.No/Date:0510338316 06.11.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.6.2013 for comments of Department of Pharmaceuticals. 87
Case No.:99/1/82ALC4/2013
Party Name:S.KANT HEALTHCARE LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01457/AM13/ RLA File :03/95/040/00565/AM13/ Lic.No/Date:0310714576 07.11.2012 Defer Date:27.06.2013 88
Case No.:27/28/82ALC4/2012
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00994/AM13/ RLA File :04/24/040/00160/AM13/ Lic.No/Date:0410141072 16.11.2012 Defer Date:27.06.2013 Decision :it was decided to remind the firm to furnish following technical details: • The firm has applied the norms from Guanosine. However, the chemistry is given from 2Amino Adenosine Stage. C f t h i l lit t i t f i ld i d t b f i h d
• Copy of technical literature in support of yields envisaged to be furnished • Past production visàvis actual consumption of all the imported inputs duly certified by Central Excise Authorities for the past three years to be furnished. 89
Case No.:69/1/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/01427/AM13/ RLA File :05/24/040/00302/AM13/ Lic.No/Date:0510339191 20.11.2012 Defer Date:27.06.2013 90
Case No.:53/1/82ALC4/2013
Party Name:MAHESHRAJ CHEMICALS PVT.LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/01411/AM13/ RLA File :08/24/040/00282/AM13/ Lic.No/Date:0810116435 23.11.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of C&PC 91
Case No.:72/1/82ALC4/2013
Party Name:RANBAXY LABORATORIES LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/01430/AM13/ RLA File :05/24/040/00291/AM13/ Lic.No/Date:0510339518 26.11.2012 Defer Date:27.06.2013 92
Case No.:26/1/82ALC4/2013
Party Name:INDSWIFT LABORATORIES LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01384/AM13/ RLA File :22/24/040/00048/AM13/ Lic.No/Date:2210013411 27.11.2012 Defer Date:27.06.2013 93
Case No.:98/1/82ALC4/2013
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01456/AM13/ RLA File :52/24/040/00033/AM13/ Lic.No/Date:5210039209 27.11.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of C&PC. 94
Case No.:47/26/82ALC4/2012
Party Name:AUROBINDO PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00955/AM13/ RLA File :09/24/040/00375/AM13/ Lic.No/Date:0910054404 Defer
29.11.2012 Date:27.06.2013 95
Case No.:54/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01412/AM13/ RLA File :08/24/040/00275/AM13/ Lic.No/Date:0810116505 29.11.2012 Defer Date:27.06.2013 96
Case No.:2/32/82ALC4/2012
Party Name:CHAMPION DAIICHI TECHNOLIGIES INDIA LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01143/AM13/ RLA File :03/94/040/00792/AM13/ Lic.No/Date:0310717692 19.12.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Petrochemical Division of Chemicals and Petrochemicals.. 97
Case No.:67/1/82ALC4/2013
Party Name:PARABOLIC DRUGS LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01425/AM13/ RLA File :05/24/040/00181/AM12/ Lic.No/Date:0510341238 19.12.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Chemicals and Petrochemicals. 98
Case No.:40/28/82ALC4/2012
Party Name:HETERO LABS LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01007/AM13/ RLA File :09/24/040/00447/AM13/ Lic.No/Date:0910054591 20.12.2012 Defer Date:27.06.2013 99
Case No.:54/28/82ALC4/2012
30.05.2013 Status:Case Deferred HQ File :01/82/050/01021/AM13/ RLA File :22/24/040/00053/AM13/ Lic.No/Date:2210013461 20.12.2012 Defer Date:27.06.2013 100
Case No.:9/1/82ALC4/2013
30.05.2013 Status:Case Deferred HQ File :01/82/050/01367/AM13/ RLA File :22/24/040/00052/AM13/ Lic.No/Date:2210013462 20.12.2012 Defer Date:27.06.2013
101
Case No.:62/28/82ALC4/2012
Party Name:UNIMARK REMEDIES LIMITED., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01029/AM13/ RLA File :03/95/040/00718/AM13/ Lic.No/Date:0310718680 31.12.2012 Defer Date:27.06.2013 Decision :It was decided to defer the case for27.06.2013 for comments of Department of Pharmaceuticals. 102
Case No.:63/28/82ALC4/2012
Party Name:UNIMARK REMEDIES LIMITED., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01030/AM13/ RLA File :03/95/040/00719/AM13/ Lic.No/Date:0310718683 31.12.2012 Defer Date:27.06.2013 103
Case No.:65/28/82ALC4/2012
Party Name:UNITED BIOTECH PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01032/AM13/ RLA File :05/24/040/00375/AM13/ Lic.No/Date:0510342192 01.01.2013 Defer Date:27.06.2013 104
Case No.:36/1/82ALC4/2013
30.05.2013 Status:Case Deferred HQ File :01/82/050/01394/AM13/ RLA File :22/24/040/00056/AM13/ Lic.No/Date:2210013510 07.01.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for27.06.2013 for comments of Department of Pharmaceuticals. 105
Case No.:120/1/82ALC4/2013
Party Name:SRINI PHARMACEUTICALS LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01478/AM13/ RLA File :09/24/040/00498/AM13/ Lic.No/Date:0910054820 21.01.2013 Defer Date:27.06.2013 106
Case No.:4/3/82ALC4/2013
30.05.2013 Status:Case Deferred HQ File :01/82/050/00037/AM14/ RLA File :22/24/040/00065/AM13/ Lic.No/Date:2210013567 22.01.2013 Defer Date:27.06.2013
107
Case No.:107/1/82ALC4/2013
Party Name:SUVEN LIFE SCIENCES LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01465/AM13/ RLA File :09/24/040/00471/AM13/ Lic.No/Date:0910054824 23.01.2013 Defer Date:30.05.2013 108
Case No.:2/30/82ALC4/2012
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 30.05.2013 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:27.06.2013 109
Case No.:3/30/82ALC4/2012
Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 30.05.2013 Status:Case Deferred HQ File :01/82/050/01039/AM13/ RLA File :05/24/040/00393/AM13/ Lic.No/Date:0510343986 23.01.2013 Defer Date:30.05.2013 110
Case No.:34/1/82ALC4/2013
Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01392/AM13/ RLA File :22/24/040/00067/AM13/ Lic.No/Date:2210013583 24.01.2013 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish the following information immediately: • Complete chemical reactions for each step showing Mol. Wt. and molar requirement of each reactant and output product. • % yield on Molar Basis for each step of manufacturing process. • Material Balance for entire process showing justification for requirement of enzymes used in the process. • Requirement and Recovery of solvents of each step of manufacturing process. 111
Case No.:32/1/82ALC4/2013
30.05.2013 Status:Case Approved HQ File :01/82/050/01390/AM13/ RLA File :22/24/040/00068/AM13/ Lic.No/Date:2210013593 30.01.2013 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/51/2011PI (Norms) dated 07.12.2011 and in consultation with technical authority present in meeting, decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: Export Product Quantity Sl.No. Import items Quantity allowed k /k
kg/kg Meropenem for Injection 1 kg 1. Meropenem Trihydrate (Nonsterile) 1.032 2. Sodium Carbonate (Nonsterile) 0.16 3. Acetone 1.85 4. Methanol 2.01 5. Activated Carbon 0.065 RA concerned may take further necessary action as per above decision of NC. 112
Case No.:119/1/82ALC4/2013
Party Name:GLAND PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01477/AM13/ RLA File :09/24/040/00518/AM13/ Lic.No/Date:0910054887 01.02.2013 Defer Date:27.06.2013 Decision :It was decided to request the firm to furnish production and consumption data for the year 201213 and also Batch Log Sheet . 113
Case No.:113/1/82ALC4/2013
Party Name:PERKIN LABORATORIES 30.05.2013 Status:Case Deferred HQ File :01/82/050/01471/AM13/ RLA File :09/24/040/00523/AM13/ Lic.No/Date:0910054915 04.02.2013 Defer Date:27.06.2013 114
Case No.:101/1/82ALC4/2013
Party Name:INDO AMINES LIMITED 30.05.2013 Status:Case Approved HQ File :01/82/050/01459/AM13/ RLA File :03/94/040/00905/AM13/ Lic.No/Date:0310723011 05.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/81/2010Ch. II dated 29.06.2011, 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 Quantity S.No Import Product Quantity allowed INDOEMUL TO 1515 1 kg 1. TALLOW AMINE 0.218 kg 2. ETHYLENE OXIDE 0.731 kg RA may take appropriate action as per the decision of Norms Committee. 115
Case No.:103/1/82ALC4/2013
Party Name:INDO AMINES LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01461/AM13/ RLA File :03/94/040/00906/AM13/ Lic.No/Date:0310723012 05.02.2013 Defer Date:27.06.2013
116
Case No.:118/1/82ALC4/2013
Party Name:EYTAN LABS LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01476/AM13/ RLA File :09/24/040/00504/AM13/ Lic.No/Date:0910054950 05.02.2013 Defer Date:27.06.2013 117
Case No.:115/1/82ALC4/2013
Party Name:BIOLOGICAL E LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/01473/AM13/ RLA File :09/24/040/00535/AM13/ Lic.No/Date:0910055011 11.02.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Biotechnology 118
Case No.:117/1/82ALC4/2013
Party Name:BIOLOGICAL E LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/01475/AM13/ RLA File :09/24/040/00534/AM13/ Lic.No/Date:0910055012 11.02.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Biotechnology 119
Case No.:7/3/82ALC4/2013
Party Name:WOCKHARDT LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00040/AM14/ RLA File :03/95/040/00886/AM13/ Lic.No/Date:0310723636 11.02.2013 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish production and consumption data for the last three years, from the basic stage and from the stage mentioned in the application separately vis a vis details regarding exports done. 120
Case No.:111/1/82ALC4/2013
Party Name:VINDHYA PHARMA (INDIA)PVT LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01469/AM13/ RLA File :09/24/040/00479/AM13/ Lic.No/Date:0910055022 12.02.2013 Defer Date:27.06.2013 121
Case No.:47/1/82ALC4/2013
Party Name:SHIVA PHARMACHEM LTD, 30.05.2013 Status:Case Deferred HQ File :01/82/050/01405/AM13/ RLA File :34/24/040/00247/AM13/ Lic.No/Date:3410036116 14.02.2013 Defer Date:27.06.2013 d id d d f h f f f f h i l d h i l
Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Chemicals and Petrochemicals. 122
Case No.:37/1/82ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 30.05.2013 Status:Case Deferred HQ File :01/82/050/01395/AM13/ RLA File :07/24/040/00487/AM13/ Lic.No/Date:0710093719 15.02.2013 Defer Date:27.06.2013 123
Case No.:39/1/82ALC4/2013
Party Name:CENTURY PHARMACEUTICALS LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01397/AM13/ RLA File :34/24/040/00267/AM13/ Lic.No/Date:3410036143 15.02.2013 Defer Date:27.06.2013 124
Case No.:40/1/82ALC4/2013
Party Name:DSM ANTIINFECTIVES INDIA LTD 30.05.2013 Status:Case Approved HQ File :01/82/050/01398/AM13/ RLA File :22/24/040/00010/AM13/ Lic.No/Date:2210013646 18.02.2013 Defer Date: Decision : Committee considered case as per agenda and in light of written comments forwarded by Department of Pharmaceuticals vide their O.M. No.35011/185/2013PI (Norms) dated 09.05.2013 and in consultation with technical authority present in meeting, decided to ratify norms under
para 4.7 of HBP as per details below or as applied by firm whichever is lower:
Export Product Quantity Sl.No. Import items Quantity allowed kg/kg AMPICILLIN TRIHYDRATE THROUGH 6‐APA ROUTE THROUGH ENZYMATIC ROUTE 1 kg 1. 6‐AMINO PENICILLANIC ACIDE(6‐APA) TECH.SPEC.:‐ white to off‐ white powder assy not less than 96% 0.596 2. FORMIDASE (ENZYME) TECH.SPEC :‐ SPHERICAL BALLS IN SUSPENSION OF BROWN COLOUR 5.00 gm/kg 3. D(‐)Alpha Phenyl Glycine Base TECH.SPEC.:‐ white to almost white crystalline powder min. assay not less than 99% 0.417 4. METHANOL TECH.SPEC :‐ TRANSPARENT AND COLORLESS LIQUID ASSY NOT LESS THAN 98% 0.400
RA concerned may take further necessary action as per above decision of NC. 125
Case No.:65/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01423/AM13/ RLA File :08/24/040/00401/AM13/ Lic.No/Date:0810118474 18.02.2013 Defer Date:27.06.2013 126
Case No.:60/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01418/AM13/ RLA File :08/24/040/00405/AM13/ Lic.No/Date:0810118586 20.02.2013 Defer Date:27.06.2013 127
Case No.:64/1/82ALC4/2013
Party Name:CADILA HEALTHCARE LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01422/AM13/ RLA File :08/24/040/00409/AM13/ Lic.No/Date:0810118585 20.02.2013 Defer Date:27.06.2013 128
Case No.:78/1/82ALC4/2013
Party Name:S.M. HERBALS PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01436/AM13/ RLA File :05/24/040/00423/AM13/ Lic.No/Date:0510346839 20.02.2013 Defer Date:27.06.2013 129
Case No.:81/1/82ALC4/2013
Party Name:INDO PHYTO CHEMICALS PVT LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/01439/AM13/ RLA File :05/23/040/00478/AM13/ Lic.No/Date:0510346879 21.02.2013 Defer Date:27.06.2013 130
Case No.:35/1/82ALC4/2013
Party Name:VENUS REMEDIES LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01393/AM13/ RLA File :22/24/040/00076/AM13/ Lic.No/Date:2210013655 22.02.2013 Defer Date:27.06.2013
131
Case No.:6/32/82ALC4/2012
Party Name:VARUN MEDIMPEX INC. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01147/AM13/ RLA File :05/24/040/00405/AM13/ Lic.No/Date:0510347194 22.02.2013 Defer Date:27.06.2013 Decision :It was decided to remind the firm to clarify whether the imported fabric is accounted for in the export product by matching the GSM. It was also decided to call clarification from the firm how they are using the name of Dettol? 132
Case No.:95/1/82ALC4/2013
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01453/AM13/ RLA File :03/95/040/00884/AM13/ Lic.No/Date:0310725621 25.02.2013 Defer Date:27.06.2013 133
Case No.:23/1/82ALC4/2013
Party Name:STERICON PHARMA PVT.LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01381/AM13/ RLA File :07/24/040/00496/AM13/ Lic.No/Date:0710093938 26.02.2013 Defer Date:27.06.2013 Decision :It was decided to remind the firm to furnish following details immediately: DML for the Export Item No. 2 and 3 are not found in the approved list of DML furnished by the firm. 134
Case No.:82/1/82ALC4/2013
Party Name:PROMED EXPORTS PVT.LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01440/AM13/ RLA File :05/24/040/00385/AM13/ Lic.No/Date:0510347521 26.02.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Pharmaceuticals 135
Case No.:6/3/82ALC4/2013
Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 30.05.2013 Status:Case Approved HQ File :01/82/050/00039/AM14/ RLA File :03/95/040/00961/AM13/ Lic.No/Date:0310725755 26.02.2013 Defer Date: Decision : : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/83/2010Ch. II dated 26.12.2011, 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 Quantity S.No Import Product Quantity allowed DISODIUM EDTA 1 k 1 EDTA ACID 0 810 k
DISODIUM EDTA. WHITE POWDER 1 kg 1 EDTA ACID WHITE POWDER 0.810 kg RA may take appropriate action as per the decision of Norms Committee. 136
Case No.:73/1/82ALC4/2013
Party Name:JUBILANT LIFE SCIENCES LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/01431/AM13/ RLA File :05/23/040/00468/AM13/ Lic.No/Date:0510347436 26.02.2013 Defer Date:27.06.2013 Decision : Department of Chemicals and Petrochemicals vide their OM No. 14010/62/2004/Ch. II dated 29.1.2008 has recommended the norms for the export product 4(Dimethyl amino)Pyridine. The Committee decided to request Department of Chemicals and Petrochemicals to furnish fresh comments after examination of data received from the firm. The case was deferred for 27.6.2013. 137
Case No.:94/1/82ALC4/2013
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 30.05.2013 Status:Case Approved HQ File :01/82/050/01452/AM13/ RLA File :03/95/040/00953/AM13/ Lic.No/Date:0310725764 26.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/62/2010Ch. II dated 20.05.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity allowed 5BROMO2,4 DICHLOROPYRIMIDINE 1 kg 1 URACIL 2.342 kg 2. METHYLENE CHLORIDE (MDC) 3.750 kg 3. TRIETHYL AMINE 3.200 kg 4. METHYL TERT BUTYL ETHER (MTBE) 3.360 kg RA may take appropriate action as per the decision of Norms Committee. 138
Case No.:76/1/82ALC4/2013
Party Name:FORACE POLYMERS (P) LTD. 30.05.2013 Status:Case Deferred HQ File :01/82/050/01434/AM13/ RLA File :05/23/040/00493/AM13/ Lic.No/Date:0510347987 01.03.2013 Defer Date:27.06.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 46011/18/2011PCII dated 21.5.2013, it was decided to call from the firm the following technical details: 1. Technical specification % composition (by weight) along with specific end use/application and the copy of export order for the export product i.e. Hardener Fortech 1000 may be furnished. 2. Technical specification and foreign supplied catalogue for the raw material to be imported may also be furnished 3. Details and quantity of other indigenous input to be used in the manufacture of the export product may be indicated 4 Detailed manufacturing process along with balanced chemical reaction indicating % yield/wastage along with balanced chemical reaction
4. Detailed manufacturing process along with balanced chemical reaction indicating % yield/wastage along with balanced chemical reaction indicating % yield/wastage along with technical justification for wastage along with technical justification for wastage at each stage and also on each of the raw material may be furnished. 5. Complete material balance indicating input and output material at each stage of manufacturing process. 6. Standard/authentic technical literature in support of the raw material requirement /formulation for the manufacture of export product. 7. Details of production of export product under reference and corresponding consumption of raw material in the year 201112 and 201213 duly certified by CA may be furnished. If the production has not commenced in the past, the details from commencement of production may be furnished duly certified by CA. 8. Any other relevant information,. The case was deferred for 27.06.2013 139
Case No.:24/1/82ALC4/2013
Party Name:SAURAV CHEMICALS LTD, 30.05.2013 Status:Case Deferred HQ File :01/82/050/01382/AM13/ RLA File :22/24/040/00074/AM13/ Lic.No/Date:2210013689 05.03.2013 Defer Date:27.06.2013 140
Case No.:121/1/82ALC4/2013
Party Name:PIONEER LABORATORIES INDIA PVT. LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/01479/AM13/ RLA File :56/24/040/00040/AM13/ Lic.No/Date:5610001786 06.03.2013 Defer Date:27.06.2013 141
Case No.:43/1/82ALC4/2013
Party Name:RIDDHI PHARMA 30.05.2013 Status:Case Deferred HQ File :01/82/050/01401/AM13/ RLA File :34/24/040/00266/AM13/ Lic.No/Date:3410036326 06.03.2013 Defer Date:27.06.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 14011/76/2010PCII dated 21.5.2013, it was decided to call from the firm the following technical details: 1. Deatils of manufacturing process with chemical equations, molecular formula, molecular weights. 2. Yield obtained in each step. 3. Authentic technical literature in support of yield obtained 4. Material balance. 5. CA certificate certifying the production of export item achieved by you for the post three years and corresponding consumption of each input. 6. Detailed calculations, arriving at the norms applied for The case was deferred for 27.06.2013 142
Case No.:62/1/82ALC4/2013
Party Name:MAHESHRAJ CHEMICALS PVT.LTD 30.05.2013 Status:Deffered
HQ File :01/82/050/01420/AM13/ RLA File :08/24/040/00424/AM13/ Lic.No/Date:0810119074 06.03.2013 Defer Date:27.6.2013 Decision : Department of Chemicals and Petrochemicals vide their OM No. 14010/9/2013ChIII dated 09.5.2013 has requested the firm to furnish the following technical details: 1. Details of Manufacturing process of cooper Formazone indicating use of Ortho Amine Phenol and Sulpho Anthrantilic Acid with Chemical equations, molecular formula, molecular weights. 2. Yield obtained in each step. 3. Authentic technical literature in support of yield obtained. 4. Material balance. 5. CA certificate certifying the production of export item achieved by you for the past three years and corresponding consumption of each input 6. Detailed calculations, arriving at the norms applied for. It was decided to remind the firm to furnish the same immediately. The case was deferred for 27.6.2013. 143
Case No.:5/1/82ALC4/2013
Party Name:PI INDUSTRIES LTD., 30.05.2013 Status:Case Rejected HQ File :01/82/050/01363/AM13/ RLA File :13/24/040/00053/AM13/ Lic.No/Date:1310042456 13.03.2013 Defer Date: Decision :It was decided to withdraw the case . The firm through their email dated 29.05.2013 informed that they have taken advance authorization on repeat basis under para 4.7.1 HBP v1. 144
Case No.:7/1/82ALC4/2013
Party Name:DL INTRACHEM 30.05.2013 Status:Case Deferred HQ File :01/82/050/01365/AM13/ RLA File :08/24/040/00462/AM13/ Lic.No/Date:0810119608 20.03.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Chemicals and Petrochemicals. 145
Case No.:74/1/82ALC4/2013
Party Name:ATUL INTERMEDIATES 30.05.2013 Status:Case Deferred HQ File :01/82/050/01432/AM13/ RLA File :08/24/040/00423/AM13/ Lic.No/Date:0810119733 25.03.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Chemicals and Petrochemicals 146
Case No.:1/3/82ALC4/2013
Party Name:NIFTY LABS PVT LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/00034/AM14/ RLA File :09/24/040/00013/AM14/ Lic.No/Date:0910055748 15.04.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Pharmaceuticals
147
Case No.:3/3/82ALC4/2013
Party Name:LAKE CHEMICALS PRIVATE LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00036/AM14/ RLA File :07/24/040/00003/AM14/ Lic.No/Date:0710094921 18.04.2013 Defer Date:27.06.2013 148
Case No.:1/5/82ALC4/2013
30.05.2013 Status:Case Deferred HQ File :01/82/050/00119/AM14/ RLA File :09/24/040/00020/AM14/ Lic.No/Date:0910055978 10.05.2013 Defer Date:27.06.2013 149
Case No.:2/5/82ALC4/2013
30.05.2013 Status:Case Deferred HQ File :01/82/050/00120/AM14/ RLA File :09/24/040/00023/AM14/ Lic.No/Date:0910055979 10.05.2013 Defer Date:27.06.2013 150
Case No.:3/5/82ALC4/2013
Party Name:PI INDUSTRIES LTD., 30.05.2013 Status:Case Deferred HQ File :01/82/050/00121/AM14/ RLA File :13/24/040/00006/AM14/ Lic.No/Date:1310042992 14.05.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for 27.06.2013 for comments of Department of Chemicals Na Petrochemicals. 151
Case No.:4/5/82ALC4/2013
Party Name:BIOLOGICAL E LTD 30.05.2013 Status:Case Deferred HQ File :01/82/050/00122/AM14/ RLA File :09/24/040/00466/AM12/ Lic.No/Date:0910056004 16.05.2013 Defer Date:27.06.2013 152
Case No.:5/5/82ALC4/2013
Party Name:AUROBINDO PHARMA LIMITED 30.05.2013 Status:Case Deferred HQ File :01/82/050/00123/AM14/ RLA File :09/24/040/00042/AM14/ Lic.No/Date:0910056036 17.05.2013 Defer Date:27.06.2013 Decision :It was decided to defer the case for27.06.2013 for comments of Department of Pharmaceuticals. Date:31.05.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer
Place:New Delhi Foreign Trade Development Officer
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