IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2013-12-02

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 16/82ALC4/2013 MEETING DATE : 21.11.2013 Actually held on 02.12.2013 The Meeting No. 16/82 of 201314 to consider the cases/issues under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling under Chapter 29 and 30 was held on 02.12.2013 under the Chairmanship of, Shri Jaikant Singh, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi. Following members were present: 1. Shri D.N. Mathur. Consultantr, Department of Pharmaceutical 2. Shri Jasbir Singh, Consultantr, Department of C&PC 3. Shri R.C. Meena, Deputy Director General of Foreign Trade 1. Since no communication /comments were received from any of the Administrative Departments. The minutes of the meeting held on 02.12.2013 was treated as approved. 2. The following cases/issues were discussed and the committee took the decision as mentioned against the case:

Case No. A‐22

M/s Divis Laboratories Ltd., Hyderabad Mee浸ng No. 16/AM14 dated – 21.11.2013 F.No. 01/82/162/00621/AM13/DES‐III Decision: It was decided to defer the case for 02.01.2014 for comments of Department of Pharmaceuticals.

Case No. A‐23

M/s Wockhardt Ltd. (100% EOU) F.No. 01/82/162/009/AM14/DES‐III Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/507/2013PI(Norms) dated 21.11.2013, it was decided to call from the firm a copy of MasterBatch formula for each export product duly authenticated by Quality – Control Incharge. The case was deferred for 02.01.2014. .

Case No. A‐24

M/s Sandoz Pvt Ltd. F.No. 01/82/162/00087/AM14/DES‐III To F.No. 01/82/162/00099/AM14/DES‐III Decision: In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/519/2013PI(Norms) dated 21.11.2013, it was decided to call from the firm a copy of MasterBatch formula for each export product duly authenticated by Quality – Control Incharge of export product Mirtazapine 15 mg Orodispersible Tabs (13 Export Items). The case was deferred for 02.01.2014.

Case No. B‐194

M/s Srini Pharmaceu浸cals Ltd. F.No. 01/82/50/00848/AM13/DES‐III F.No. 01/82/50/01337/AM13/DES‐III RA F.No. 09/24/040/00251/AM13 RA F.No. 09/24/040/00406/AM13 Adv. Lic. No. 0910053668 dated 05.09.2012 Adv. Lic. No. 0910054373 dated 23.11.2012 Committee considered case as per agenda and in consultation with technical authority present in the meeting and decided to maintain Status quo. RA concerned may take further necessary action as per above decision of NC.

Case No. B‐195

M/s Yasho Industries Pvt Ltd F.No. 01/82/50/00318/AM13/DES‐III RA F.No. 03/95/040/152/AM13 Adv. Lic. No. 0310696440 dated 28.05.2012 Decision: In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011‐Ch II dated 02.04.2013, 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

METHYL EUGENOL ( 99% MIN) 1 kg 1. CLOVE LEAF OIL (EUGENOL CONTENT 78%) 1.40 kg RA may take appropriate ac浸on as per the decision of Norms Commi浸ee.

Case No. B‐196

M/s Gitanjali Chemicals Pvt Ltd. F.No. 01/82/162/190/AM14/DES‐III RA F.No. 03/94/040/00422/AM13 Adv. Lic. No. 0310708275 dated 10.09.2012 Decision: In the light of earlier decision taken in mee浸ng no. 4/82 dated 26.04.2011, it was decided to ra浸fy 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 item Qty. allowed Anisole Pure (Min.99%) 1 Kg. 1. Anisole Crude (Max. 96%) 1.207 kg 2. Caustic Soda Flakes 0.120 kg RA concerned may take further necessary action as per above decision of NC.

Case No. B‐197

M/s Glenmark Generics Ltd. F.No. 01/82/050/430/AM14/DES‐III Decision: The case was earlier approved in Norms Committee meeting no. 12/82 dated 19.09.2012. The firm has requested for amendment in the description of import items. The Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of import items as applied by the firm without any other changes. The rest of the minutes would remain same. Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg

Cilostazol 1 kg 1. 5(4Chlorobutyl)1Cyclohexyl1H Tetrazole] 0.88 2. 6Hydroxy3, 4Dihydro 1H Quinolinone 2One 0.59 RA may take appropriate action as per the decision of Norms Committee.

Case No. B‐198

M/s Gopinath Chem‐Tech Ltd. F.No. 01/82/050/1424/AM13/DES‐III Decision: It was decided to defer the case for 02.01.2014 for comments of Department of Pharmaceuticals.

Case No. B‐199

M/s Indo Amines Ltd., Thane F.No. 01/82/050/00306/AM12/DES‐III RA F.No. 03/95/040/00990/AM11 Adv. Lic.No. 0310625341 dated 06.04.2011 Decision: The Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of export product as “INDOEMUL TO 1515” instead of “2INDO EMUL TO 15 Tallow Ammine Ethoxylate (15 Moles)” as applied by the firm without any other changes. The rest of the minutes would remain same.

Case No. B‐200

M/s Indo Amines Ltd., Thane F.No. 01/82/050/00344/AM12/DES‐III Adv. Lic.No. 0310625340 dated 06.04.2011 RA F.No. 03/94/040/00991/AM11 Decision: The Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of export product as “INDOEMUL TO 1515” instead of “2INDO EMUL TO 1515 (77% of Tallow Ammine Ethoxylate 15 Moles Ethoxylate & OF PEG 200)” as applied by the firm without any other changes. The rest of the minutes would remain same.

Case No. B‐201

M/s Kusuma Pharma, Mumbai. F.No. 01/82/050/00104/AM12/DES‐III Adv. Lic.No. 0310669397 dated 08.12.2011 RA F.No. 03/94/040/00787/AM12 Decision: In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/32/2013‐Ch II dated 30.08.2013, 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 Sodium Saccharin ( Pure Dental Grade) 1 kg 1. Sodium Saccharin (BP) 99% purity 1.02 kg

Case No. B‐202

M/s Haldia Petrochemicals Ltd. F.No. 01/82/050/01534/AM09/DES‐III Adv. Lic.No. 0210122139 dated 13.01.2009 RA F.No. 02/24/040/00248/AM09 Decision: It was decided to defer the case for 02.01.2014 for comments of Petrochemical division of Department of C&PC.

Case No. B‐203

M/s ADI Finechem (Formerly known as H.K. FinechemLtd.). F.No. 01/82/050/00146/AM09/DES‐III Adv. Lic.No. 0810067303 dated 21.09.2007 RA F.No. 08/24/040/149/AM08 Decision: The commi浸ee considered the case of the firm and It was noted that the ITC HS code of export product men浸oned in chapter 38. It was decided to transfer the case to Norms commi浸ee IV.

Case No. B‐204

M/s AMI Life Sciences Pvt Ltd., Baroda F.No. 01/82/050/545/AM13/DES‐III Adv. Lic.No. 3410034467 dated 22.06.2012 RA F.No. 34/24/040/00072/AM13

Decision: It was decided to defer the case for 02.01.2014 for comments of Department of Pharmaceuticals.

Case No. B‐205

M/s Fine Organics Industries Pvt Ltd F.No. 01/82/050/868/AM10/DES‐III Adv. Lic. No.0310553708 dated 05.01.2010 Decision: The Committee considered case as per agenda and in consultation with technical authority present in meeting, decided to amend the description of export product from “Behenamide” to “FinavaxX (Microbeads Behenamide” as applied by the firm without any other changes. The rest of the minutes would remain same. 1

Case No.:11/20/82ALC4/2009

Party Name:NEULAND LABORATORIES LTD Meet No/Date:16/82ALC4/2013 21.11.2013 Status:Case Deferred HQ File :01/82/050/00422/AM10/ RLA File :09/24/040/00144/AM10/ Lic.No/Date:0910038818 06.08.2009 Defer Date:19.12.2013 Decision :Copy of application along with a report received from RA Hyderabad has been already sent to Department of Pharmaceuticals on 18.11.2013. The case was deferred for 19.12.2013. 2

Case No.:6/18/82ALC4/2011

Party Name:VIVIMED LABS LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/00510/AM12/ RLA File :09/24/040/00094/AM12/ Lic.No/Date:0910047017 06.06.2011 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011‐Ch II dated 02.07.2013, it was decided to ra浸fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed REVERSACOL RUSH YELLOW 1 kg 1. BENZO PHENONE 1.120 kg 2. TETRO HYDRO FURAN (THF) 1.809 kg 3. TRIMETHYL SILYL ACETYLENE (TMSA) 0.862 kg 4. HEYL LITHIUM 3.440 kg 5. METHANOL 7.800 kg 6. TOLUENE 3.250 kg

NAPATHOL 1.033 kg 3

Case No.:100/14/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/00685/AM14/ RLA File :09/24/040/00018/AM13/ Lic.No/Date:0910052271 23.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/88/2010PI(Norms) dated 05.10.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg NEVIRAPINE HEMIHYDRATE 1 kg 1. 2 Chloro Nicotinic Acid 0.902 2. Acetone 1.513 3. Carbon Enoanticromos ( Activated Carbon) 0.100 4. Cyclohexane 1.109 5. Cyclopropylamine 0.57 6. Diethylene Glycol Dimethyl Ether ( Diglyme ) 2.16 7. Malano Nitrile 0.84 8. Methanol 8.43 9. Methylene Chloride 1.30 10. Pyridine 0.47 11. Thionyl Chloride 1.947 4

Case No.:101/14/82ALC4/2013

Party Name:MSN PHARMACHEM PRIVATE LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00686/AM14/ RLA File :09/24/040/00064/AM13/ Lic.No/Date:0910052663 17.05.2012 Defer Date:19.12.2013 Decision : It was decided to defer the case for 19.12.2013 for comments of Department of Pharmaceuticals. 5

Case No.:16/24/82ALC4/2012

Party Name:OGENE SYSTEMS INDIA PVT. LTD. 21.11.2013 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:19.12.2013 Decision :It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 6

Case No.:148/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/01295/AM13/ RLA File :09/24/040/00359/AM13/ Lic.No/Date:0910054335 15.11.2012 Defer Date:19.12.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/306/2013PI(Norms) dated 10.06.2013, it was decided to call from the firm a copy of complete set of application alongwith details on Appendix 33. The case was deferred for 19.12.2013. 7

Case No.:13/12/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, 21.11.2013 Status:Deffered and Reindexed HQ File :01/82/050/00437/AM14/ RLA File :09/24/040/00495/AM13/ Lic.No/Date:0910054735 09.01.2013 Defer Date:19.12.2013 Decision : It was decided to defer the case for 19.12.2013 for comments of Department of Pharmaceuticals. 8

Case No.:11/31/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/01051/AM13/ RLA File :04/24/040/00217/AM13/ Lic.No/Date:0410142687 18.01.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/321/2013PI(Norms) dated 11.09.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg [Alpha(Alpha,Beta)]Beta MethylAlphaPhenyl1 Pyrrolidineethanol base 1 kg 1. dlPhenyl Propanolamine Hcl 4.21 2. Iso Propyl Alcohol 3.26 3. Methanol 2.10 4. Methyl Isobutyl Ketone 0.84 5. Toluene 2.70 6. Acetone 0.63 7. Causticsoda Flakes 1.27 8. 1,4Dibromo butane 1.94

Case No.:14/12/82ALC4/2013

Party Name:IPCA LABORATORIES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00438/AM14/ RLA File :03/94/040/00903/AM13/ Lic.No/Date:0310722358 30.01.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case for 19.12.2013 for comments of Department of Pharmaceuticals. 10

Case No.:28/4/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 21.11.2013 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:02.01.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/490/2013PI(Norms) dated 21.11.2013, it was decided to call from the firm the following technical details: (a) Complete technical details as per Appendix 33. (b) Past production visavis Actual consumption of all inputs yearwise for last 3 years, duly certified by Central Excise Aiuthority. The case was deferred for 02.01.2014. 11

Case No.:1/36/85ALC3/2012

Party Name:SRIAM LABS PRIVATE LIMITED 21.11.2013 Status:Case Deferred HQ File :01/85/050/00169/AM13/ RLA File :09/24/040/00502/AM13/ Lic.No/Date:0910054980 08.02.2013 Defer Date:02.01.2014 Decision :In 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. of Pharma 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 02.01.2014. 12

Case No.:111/1/82ALC4/2013

Party Name:VINDHYA PHARMA (INDIA)PVT LTD. Meet No/Date:16/82ALC4/2013 21.11.2013 Status:Case Approved HQ File :01/82/050/01469/AM13/ RLA File :09/24/040/00479/AM13/ Lic.No/Date:0910055022 12.02.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/410/2013PI(Norms) dated 21.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg DIBENZOYLLACTOL 1 kg 1. Ethyl2, 2difluoro3 hydroxy3 (2,2dimethyl 1, 3 dioxolan 4yl) propionate (DBL3) 1.047 13

Case No.:58/4/82ALC4/2013

Party Name:NECTAR LIFESCIENCES LIMITED, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00099/AM14/ RLA File :22/24/040/00077/AM13/ Lic.No/Date:2210013693 06.03.2013 Defer Date:19.12.2013 Decision :It was decided to remind the firm to furnish technical details as per Appendix 33 along with % composition of the export product should be reached before 18.12.2013 otherwise the case will be rejected. The case was deferred for 19.12.2013. 14

Case No.:55/4/82ALC4/2013

Party Name:SHREE GANESH REMEDIES PVT.LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00096/AM14/ RLA File :34/24/040/00287/AM13/ Lic.No/Date:3410036329 06.03.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 15

Case No.:18/8/82ALC4/2013

Party Name:VIVIMED LABS LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/00149/AM14/ RLA File :09/24/040/00572/AM13/ Lic.No/Date:0910055306 07.03.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/558/2013PI(Norms) dated 21.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg PENTOL7 OR 2 (CHLOROMETHYL)3,4 DIMETHOXYPYRIDINE HYDROCHLORIDE 1 kg 1. MALTOL 0.91 2. POTASSIUM CARBONATE 1.03 3. PHOSPHOROUS OXYCHLORIDE 1.64 4. THIONYL CHLORIDE 0.82 TOLUENE

0.26 6. ACETONE 1.20 7. METHANOL 0.50 8. CHLOROFORM 2.38 9. DICHLORO METHANE 0.50 16

Case No.:27/10/82ALC4/2013

Party Name:VIVIMED LABS LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00210/AM14/ RLA File :09/24/040/00589/AM13/ Lic.No/Date:0910055307 07.03.2013 Defer Date:19.12.2013 17

Case No.:114/10/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00297/AM14/ RLA File :03/94/040/00991/AM13/ Lic.No/Date:0310727451 08.03.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 18

Case No.:30/10/82ALC4/2013

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00213/AM14/ RLA File :09/24/040/00548/AM13/ Lic.No/Date:0910055356 11.03.2013 Defer Date:19.12.2013 19

Case No.:214/10/82ALC4/2013

Party Name:SHREE GANESH REMEDIES PVT.LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00397/AM14/ RLA File :34/24/040/00299/AM13/ Lic.No/Date:3410036377 12.03.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 20

Case No.:31/10/82ALC4/2013

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00214/AM14/ RLA File :09/24/040/00593/AM13/ Lic.No/Date:0910055380 13.03.2013 Defer Date:19.12.2013

Case No.:141/10/82ALC4/2013

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00324/AM14/ RLA File :03/94/040/00982/AM13/ Lic.No/Date:0310728214 14.03.2013 Defer Date:19.12.2013 22

Case No.:59/10/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00242/AM14/ RLA File :09/24/040/00585/AM13/ Lic.No/Date:0910055390 14.03.2013 Defer Date:19.12.2013 23

Case No.:25/8/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 21.11.2013 Status:Case Approved HQ File :01/82/050/00156/AM14/ RLA File :05/24/040/00469/AM13/ Lic.No/Date:0510349278 15.03.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Pharmaceu浸cals vide their OM No. 35011/555/2013‐PI(Norms) dated 11.09.2013, it was decided to ra浸fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product IRBESARTAN (7 Export Item) [A] For Export of 5000 Kg of IRBESARTAN Norms recommended for IRBESARTAN S.No. Import Item Norms recommended for 1 kg 1 2 Cyano 4 Bromomethyl Biphenyl 1.04 kg 2 Acetone 0.303 3 Diazaspiro Hydrochloride (2Butyl1,3 diazaspiro(4.4)non1en4 one hydrochloride) 0.88 4 Ethyl Acetate 2.275 5 Methylene Chloride 1.376 6 Methanol 1.057 7 METHYLTBUTYLETHER 0.74 8 Toluene 2.789 9 Trinbutyltin chloride 0.691

[B] For Export of Tablets and Capsules (Export item No. 2 to 7) S.NO. Bulk Drug / Import Item For export of 1 Million Tablets / Capsule (Quan浸ty in kgs) 75 mg 150 mg 300 mg 150/12.5 300/12.05 300/25 1 IRBESARTAN 76.5 kg 153.0 kg 306.0 kg 153.0 kg 306.0 kg 306.0 kg 2 Hydrochlorothiazide NIL NIL NIL 12.75 12.75 25.50 24

Case No.:32/8/82ALC4/2013

Party Name:BIOLOGICAL E LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00163/AM14/ RLA File :09/24/040/00607/AM13/ Lic.No/Date:0910055421 19.03.2013 Defer Date:19.12.2013 Decision :It was decided to send a copy of application again to Department of Biotechnology for their comments. The case was deferred for 19.12.2013 25

Case No.:57/10/82ALC4/2013

Party Name:BIOLOGICAL E LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00240/AM14/ RLA File :09/24/040/00606/AM13/ Lic.No/Date:0910055420 19.03.2013 Defer Date:19.12.2013 Decision :It was decided to send a copy of application again to Department of Biotechnology for their comments. The case was deferred for 19.12.2013 26

Case No.:140/10/82ALC4/2013

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00323/AM14/ RLA File :03/94/040/00981/AM13/ Lic.No/Date:0310728713 19.03.2013 Defer Date:19.12.2013 27

Case No.:24/10/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00207/AM14/ RLA File :22/24/040/00083/AM13/ Lic.No/Date:2210013724 20.03.2013 Defer Date:19.12.2013 28

Case No.:125/10/82ALC4/2013

Party Name:LAXMI ORGANIC INDUSTRIES LTD., Status:Case

21.11.2013 Deferred HQ File :01/82/050/00308/AM14/ RLA File :03/95/040/00911/AM13/ Lic.No/Date:0310728818 20.03.2013 Defer Date:19.12.2013 Decision :It was decided to remind the firm to furnish the following information sought by Department of Chemicals and Petrochemicals vide their letter dated 1.3.2013: Details of manufacturing process with chemical equations, molecular formula, molecular weight. Yield obtained in each step. Authentic technical literature in support of yield obtained. CA certificate certifying the production of export item achieved by the firm for the last three years and corresponding consumption of each input. Detailed calculations, arriving at the norms applied for. This information should be reached by 18.12.2013 otherwise case will be closed. The case was deferred for 19.12.2013. 29

Case No.:29/8/82ALC4/2013

Party Name:CADILA HEALTHCARE LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00160/AM14/ RLA File :08/24/040/00454/AM13/ Lic.No/Date:0810119673 21.03.2013 Defer Date:19.12.2013 30

Case No.:58/10/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00241/AM14/ RLA File :09/24/040/00583/AM13/ Lic.No/Date:0910055475 21.03.2013 Defer Date:19.12.2013 31

Case No.:60/10/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00243/AM14/ RLA File :09/24/040/00586/AM13/ Lic.No/Date:0910055474 21.03.2013 Defer Date:19.12.2013 32

Case No.:27/8/82ALC4/2013

Party Name:STERILE INDIA PRIVATE LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/00158/AM14/ RLA File :05/24/040/00477/AM13/ Lic.No/Date:0510349855 21.03.2013 Defer Date: Decision : : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/548/2013PI(Norms) dated 21.11.2013, 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

MEROPENEM FOR INJECTION USP (Containing MEROPENEM NLT 84%) 1 kg 1. MEROPENEM TRIHYDRATE NON STERILE 1.032 kg 33

Case No.:25/10/82ALC4/2013

Party Name:ANUS LABORATORIES LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00208/AM14/ RLA File :09/24/040/00186/AM12/ Lic.No/Date:0910055523 22.03.2013 Defer Date:19.12.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33 . This information should be reached by 18.12.2013 otherwise case will be closed. The case was deferred for 19.12.2013 34

Case No.:61/10/82ALC4/2013

Party Name:GRANULES INDIA LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00244/AM14/ RLA File :09/24/040/00610/AM13/ Lic.No/Date:0910055505 22.03.2013 Defer Date:19.12.2013 35

Case No.:6/10/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00189/AM14/ RLA File :05/24/040/00480/AM13/ Lic.No/Date:0510350030 22.03.2013 Defer Date:19.12.2013 36

Case No.:19/10/82ALC4/2013

Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00202/AM14/ RLA File :09/24/040/00601/AM13/ Lic.No/Date:0910055530 25.03.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case for 19.12.2013 for comments of Department of Biotechnology. 37

Case No.:20/10/82ALC4/2013

Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00203/AM14/ RLA File :09/24/040/00605/AM13/ Lic.No/Date:0910055537 25.03.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case for 19.12.2013 for comments of Department of Biotechnology.

Case No.:55/10/82ALC4/2013

Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00238/AM14/ RLA File :09/24/040/00602/AM13/ Lic.No/Date:0910055529 25.03.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case for 19.12.2013 for comments of Department of Biotechnology. 39

Case No.:119/10/82ALC4/2013

Party Name:MICRO ORGOCHEM 21.11.2013 Status:Case Deferred HQ File :01/82/050/00302/AM14/ RLA File :03/95/040/00672/AM13/ Lic.No/Date:0310729719 26.03.2013 Defer Date:19.12.2013 40

Case No.:33/2/82ALC4/2013

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 21.11.2013 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:02.01.2014 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/489/2013PI(Norms) dated 21.10.2013, it was decided to call from the firm the following technical details: (a) Yield on molar basis for each step alongwith copy of technical literature in support of the yield envisaged. (b) BatchLogsheet for the last 3 batches. The case was deferred for 02.01.2014. 41

Case No.:113/14/82ALC4/2013

Party Name:PARAMOUNT AROMACHEM PVT.LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00698/AM14/ RLA File :05/24/040/00488/AM13/ Lic.No/Date:0510350269 26.03.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 42

Case No.:13/8/82ALC4/2013

Party Name:SARACA LABORATORIES LTD 21.11.2013 Status:Case Approved HQ File :01/82/050/00144/AM14/ RLA File :09/24/040/00598/AM13/ Lic.No/Date:0910055571 27.03.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/556/2013PI(Norms) dated

21.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg GABAPENTIN HCL POWDER 1 kg 1. 1,1 CYCLOHEXANE Dl ACETIC ACID MONO AMIDE (CAM) POWDER 0.988 2. BROMINE LIQUID 0.923 43

Case No.:117/10/82ALC4/2013

Party Name:PRASOL CHEMICALS LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00300/AM14/ RLA File :03/95/040/00881/AM13/ Lic.No/Date:0310729886 28.03.2013 Defer Date:21.11.2013 Decision : Copy of application has been already sent to D/o C&PC on 12.09.2013. It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 44

Case No.:216/10/82ALC4/2013

Party Name:GULBRANDSEN CHEMICALS PVT LTD 21.11.2013 Status:Case Approved HQ File :01/82/050/00399/AM14/ RLA File :34/24/040/00319/AM13/ Lic.No/Date:3410036563 01.04.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/49/2011‐Ch II dated 28.11.2013, it was decided to ra浸fy 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 60/40 Mixed Butyl Tin Chloride (60/40 MBTC) 1 kg 1. Tin Ingots 0.447 kg 2. Aluminium Grit/Granules 0.048 kg 3. Butene1 0.368 kg 45

Case No.:4/8/82ALC4/2013

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00135/AM14/ RLA File :03/95/040/00899/AM13/ Lic.No/Date:0310729960 01.04.2013 Defer Date:19.12.2013 Decision :It was decided to remind the firm Purity of Import itesm. Purity of export item. The case was deferred for 19.12.2013.s

Case No.:42/10/82ALC4/2013

Party Name:BIOLOGICAL E LTD 21.11.2013 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:02.01.2014 Decision :Remind the firm to furnish the following information as called by DBT: Drug Manufaturing Licensing of the export product (DML encloased with the application does not mention the export product. To submit QA approved Batch Manufacturing Record (norms for the export item called DTP HEPB (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 02.01.2014. 47

Case No.:85/10/82ALC4/2013

Party Name:BIOLOGICAL E LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00268/AM14/ RLA File :09/24/040/00636/AM13/ Lic.No/Date:0910055652 02.04.2013 Defer Date:02.01.2014 Decision :Remind the firm to furnish the following information as called by DBT: Drug Manufaturing Licensing of the export product (DML encloased with the application does not mention the export product. To submit QA approved Batch Manufacturing Record (norms for the export item called DTP HEPB (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 02.01.2014. 48

Case No.:148/10/82ALC4/2013

Party Name:ANTHEA AROMATICS PVT.LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00331/AM14/ RLA File :03/94/040/00996/AM13/ Lic.No/Date:0310730232 03.04.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 49

Case No.:37/10/82ALC4/2013

Party Name:NIFTY LABS PVT LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00220/AM14/ RLA File :09/24/040/00004/AM14/ Lic.No/Date:0910055673 03.04.2013 Defer Date:19.12.2013 50

Case No.:11/8/82ALC4/2013

Party Name:PREMIER INDUSTRIES 21.11.2013 Status:Case Deferred HQ File :01/82/050/00142/AM14/ RLA File :50/24/040/00020/AM13/ Lic.No/Date:5010001635 Defer

03.04.2013 Date:19.12.2013 Decision : Copy of application has been already sent to D/o C&PC on 26.07.2013. It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 51

Case No.:82/10/82ALC4/2013

Party Name:VEGESNA LABORATORIES PRIVATE LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00265/AM14/ RLA File :09/24/040/00637/AM13/ Lic.No/Date:0910055659 03.04.2013 Defer Date:19.12.2013 52

Case No.:20/8/82ALC4/2013

Party Name:RAY CHEMICALS PRIVATE LIMITED, 21.11.2013 Status:Case Approved HQ File :01/82/050/00151/AM14/ RLA File :07/24/040/00518/AM13/ Lic.No/Date:0710094644 04.04.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/551/2013PI(Norms) dated 21.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg DOXEPIN HCL 1 kg 1. 1 BROMO 3 CHLORO PROPANE 1.12 2. TETRA HYDRO FURAN 0.68 3. MAGNESIUM INGOT 0.19 53

Case No.:147/10/82ALC4/2013

Party Name:CONCEPT PHARMACEUTICALS LTD., Meet No/Date:16/82ALC4/2013 21.11.2013 Status:Case Deferred HQ File :01/82/050/00330/AM14/ RLA File :03/94/040/00004/AM14/ Lic.No/Date:0310730523 05.04.2013 Defer Date:19.12.2013 54

Case No.:4/10/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 21.11.2013 Status:Case Approved HQ File :01/82/050/00187/AM14/ RLA File :17/24/040/00001/AM14/ Lic.No/Date:1710005280 08.04.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/69/2011‐Ch II dated 28.10.2013, it

was decided to ra浸fy 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 PEGDST60 (POLYETHYLENE GLYCOL DISTERATE) (Appearance: White to creamish Flakes / Solid) 1 kg 1. DIETHYLENE GLYCOL (Colourless liquid) 0.0146 kg 2. ETHYLENE OXIDE (Colourless clear liquid) 0.912 kg 3. STEARIC ACID (Pale Yellow / White insoluble flakes) 0.0785 kg 55

Case No.:17/10/82ALC4/2013

Party Name:RANBAXY LABORATORIES LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00200/AM14/ RLA File :05/24/040/00478/AM13/ Lic.No/Date:0510350968 08.04.2013 Defer Date:19.12.2013 56

Case No.:38/10/82ALC4/2013

Party Name:ARENE LIFE SCIENCES LIMITED. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00221/AM14/ RLA File :09/24/040/00613/AM13/ Lic.No/Date:0910055691 09.04.2013 Defer Date:19.12.2013 57

Case No.:120/10/82ALC4/2013

Party Name:MEHTA API PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00303/AM14/ RLA File :03/95/040/00020/AM14/ Lic.No/Date:0310730905 09.04.2013 Defer Date:19.12.2013 58

Case No.:129/10/82ALC4/2013

Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 21.11.2013 Status:Case Rejected HQ File :01/82/050/00312/AM14/ RLA File :03/94/040/01061/AM13/ Lic.No/Date:0310730972 10.04.2013 Defer Date: Decision :It was decided to reject the case the firm has not furnished information despite repeated reminders.

Case No.:5/10/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 21.11.2013 Status:Case Approved HQ File :01/82/050/00188/AM14/ RLA File :17/24/040/00004/AM14/ Lic.No/Date:1710005285 10.04.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/69/2011‐Ch II dated 28.10.2013, it was decided to ra浸fy 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 PRODUCTABT (ALKYL BENZOATE) (Appearance: Light Yellow Colourless Clear Liquid) 1 kg 1. LAURYL ALCOHOL (C12C14 ALCOHOL / LAURYL MYRISTYL ALCOHOL) (Colourless clear insoluble liquid) 0.648 kg 2. BENZOIC ACID (Crystalline Solid) 0.412 kg 60

Case No.:36/10/82ALC4/2013

Party Name:EYTAN LABS LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/00219/AM14/ RLA File :09/24/040/00006/AM14/ Lic.No/Date:0910055745 15.04.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/465/2010PI(Norms) dated 21.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg (2R,CIS)5FLUORO(4 AMINO1, 2DIHYDRO2 OXO1PYRIMIDINYL1, 3 0XATHIOLANE2 CARBOXYLIC ACID (2R,5R) MENTHYLESTER(FCE) 1 kg 1. GLYOXYLIC ACID 50% 0.68 2. 2,5 DI HYDROXY 1, 4 DITHIANE 0.28 3. 5FLUORO CYTOSINE 0.531 4. HEXAMETHYL DISILAZANE (HMDS) 0.70 5. DIMETHYL FORMAMIDE 0.3333 6. CYCLOHEXANE Not shown in CA Certificate 7. TRIETHYL AMINE 8. NHEXANE

TOLUENE 10. METHYLENE CHLORIDE 61

Case No.:150/10/82ALC4/2013

Party Name:KOPRAN LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00333/AM14/ RLA File :03/94/040/00021/AM14/ Lic.No/Date:0310731505 16.04.2013 Defer Date:19.12.2013 62

Case No.:92/10/82ALC4/2013

Party Name:CATAPHARMA CHEMICALS PVT. LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00275/AM14/ RLA File :31/83/040/00214/AM13/ Lic.No/Date:3110057970 17.04.2013 Defer Date:19.12.2013 63

Case No.:68/4/82ALC4/2013

Party Name:HALDIA PETROCHEMICALS LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00109/AM14/ RLA File :02/24/040/00002/AM14/ Lic.No/Date:0210188734 17.04.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case 19.12.2013 for comments of Petrocemical Division of Department of Chemicals and Petrochemicals. 64

Case No.:80/10/82ALC4/2013

Party Name:PORUS LABORATORIES PVT LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00263/AM14/ RLA File :09/24/040/00010/AM14/ Lic.No/Date:0910055794 17.04.2013 Defer Date:19.12.2013 65

Case No.:160/10/82ALC4/2013

Party Name:RIOCARE INDIA PRIVATE LIMITED. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00343/AM14/ RLA File :03/95/040/00024/AM14/ Lic.No/Date:0310731584 17.04.2013 Defer Date:19.12.2013

p 66

Case No.:195/10/82ALC4/2013

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00378/AM14/ RLA File :04/24/040/00292/AM13/ Lic.No/Date:0410145340 18.04.2013 Defer Date:19.12.2013 67

Case No.:51/10/82ALC4/2013

Party Name:PARABOLIC DRUGS LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00234/AM14/ RLA File :05/24/040/00015/AM14/ Lic.No/Date:0510351967 18.04.2013 Defer Date:19.12.2013 68

Case No.:43/10/82ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00226/AM14/ RLA File :09/24/040/00017/AM14/ Lic.No/Date:0910055800 19.04.2013 Defer Date:19.12.2013 69

Case No.:35/10/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00218/AM14/ RLA File :09/24/040/00008/AM14/ Lic.No/Date:0910055819 22.04.2013 Defer Date:19.12.2013 70

Case No.:76/14/82ALC4/2013

Party Name:ASTRIX LABORATORIES LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00661/AM14/ RLA File :09/24/040/00611/AM13/ Lic.No/Date:0910055845 23.04.2013 Defer Date:19.12.2013 71

Case No.:87/14/82ALC4/2013

Party Name:ASTRIX LABORATORIES LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00672/AM14/ RLA File :09/24/040/00009/AM14/ Lic.No/Date:0910055844 23.04.2013 Defer Date:19.12.2013

Case No.:11/12/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00435/AM14/ RLA File :17/24/040/00009/AM14/ Lic.No/Date:1710005298 26.04.2013 Defer Date:19.12.2013 Decision : Copy of application has been already sent on 30.09.2013. It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 19.12.2013 73

Case No.:158/10/82ALC4/2013

Party Name:MEHTA API PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00341/AM14/ RLA File :03/95/040/00035/AM14/ Lic.No/Date:0310732641 26.04.2013 Defer Date:19.12.2013 74

Case No.:219/10/82ALC4/2013

Party Name:RENOWN PHARMACEUTICALS PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00402/AM14/ RLA File :34/24/040/00005/AM14/ Lic.No/Date:3410036732 29.04.2013 Defer Date:19.12.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 19.12.2013 75

Case No.:177/10/82ALC4/2013

Party Name:ATLAS FINE CHEMICALS PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00360/AM14/ RLA File :03/94/040/00845/AM13/ Lic.No/Date:0310732910 30.04.2013 Defer Date:19.12.2013 Decision : Copy of application has been already sent on 11.12.2013. It was decided to send a copy of application again to Department of C&PC for their comments. The case was deferred for 19.12.2013 76

Case No.:93/14/82ALC4/2013

Party Name:VIVIMED LABS LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00678/AM14/ RLA File :09/24/040/00627/AM13/ Lic.No/Date:0910055879 30.04.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 77

Case No.:34/10/82ALC4/2013

Party Name:MAHESHRAJ CHEMICALS PVT.LTD Status:Case

21.11.2013 Deferred HQ File :01/82/050/00217/AM14/ RLA File :08/24/040/00024/AM14/ Lic.No/Date:0810120820 07.05.2013 Defer Date:19.12.2013 Decision :Department of Chemicals and Petrochemicals vide their OM No. 14010/9/2013ChIII dated 30.08.2013 has requested the firm to furnish the following technical details: Details of Manufacturing process of cooper Formazone indicating use of Ortho Amine Phenol and Sulpho Anthrantilic 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. It was decided to remind the firm to furnish the same immediately. The case was deferred for 19.12.2013. 78

Case No.:170/10/82ALC4/2013

Party Name:AGOG PHARMA LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00353/AM14/ RLA File :03/94/040/00075/AM14/ Lic.No/Date:0310733767 09.05.2013 Defer Date:19.12.2013 79

Case No.:186/10/82ALC4/2013

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00369/AM14/ RLA File :03/94/040/00023/AM13/ Lic.No/Date:0310734610 16.05.2013 Defer Date:19.12.2013 80

Case No.:143/10/82ALC4/2013

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/00326/AM14/ RLA File :03/95/040/00009/AM14/ Lic.No/Date:0310734807 17.05.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/143/2011‐Ch II dated 29.10.2013, it was decided to ra浸fy 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 ETHYLENE DIAMINE DIHYDRO IODIDE 1 kg 1. IODINE 0.946 kg 2. HYDRAZINE HYDRATE 0.186 kg

g 81

Case No.:39/10/82ALC4/2013

Party Name:SCOTTEDIL PHARMACIA LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00222/AM14/ RLA File :22/24/040/00015/AM14/ Lic.No/Date:2210013866 17.05.2013 Defer Date:19.12.2013 82

Case No.:172/10/82ALC4/2013

Party Name:IPCA LABORATORIES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00355/AM14/ RLA File :03/94/040/00055/AM14/ Lic.No/Date:0310734945 20.05.2013 Defer Date:19.12.2013 83

Case No.:91/14/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 21.11.2013 Status:Case Deferred HQ File :01/82/050/00676/AM14/ RLA File :02/21/040/00025/AM14/ Lic.No/Date:0210189840 21.05.2013 Defer Date:19.12.2013 84

Case No.:136/14/82ALC4/2013

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00721/AM14/ RLA File :03/94/040/00507/AM13/ Lic.No/Date:0310735110 21.05.2013 Defer Date:19.12.2013 85

Case No.:211/10/82ALC4/2013

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00394/AM14/ RLA File :07/24/040/00037/AM14/ Lic.No/Date:0710095520 22.05.2013 Defer Date:19.12.2013 Decision :it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 19.12.2013. 86

Case No.:210/10/82ALC4/2013

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 21.11.2013 Status:Case Deferred

HQ File :01/82/050/00393/AM14/ RLA File :07/24/040/00034/AM14/ Lic.No/Date:0710095553 23.05.2013 Defer Date:19.12.2013 Decision :it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 19.12.2013. 87

Case No.:132/14/82ALC4/2013

Party Name:BLUE DIP ORGANIC INDUSTRIES, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00717/AM14/ RLA File :03/94/040/00067/AM14/ Lic.No/Date:0310735418 23.05.2013 Defer Date:19.12.2013 Decision : Copy of application has been already sent on 28.10.2013. It was decided to defer the case for 19.12.2013 for comments of Department of Pharmaceuticals. 88

Case No.:1/6/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00124/AM14/ RLA File :09/24/040/00077/AM14/ Lic.No/Date:0910056114 23.05.2013 Defer Date:19.12.2013 Decision :It was decided to send a copy of application to Department of Pharmaceuticals for their comments. The case was deferred for 19.12.2013 89

Case No.:79/14/82ALC4/2013

Party Name:AGOG PHARMA LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00664/AM14/ RLA File :03/94/040/00093/AM14/ Lic.No/Date:0310735570 24.05.2013 Defer Date:19.12.2013 90

Case No.:92/14/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00677/AM14/ RLA File :05/23/040/00043/AM14/ Lic.No/Date:0510355138 24.05.2013 Defer Date:19.12.2013 91

Case No.:12/19/87ALC1/2013

Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 21.11.2013 Status:Case Approved HQ File :01/87/050/00152/AM14/ RLA File :03/95/040/00146/AM14/ Lic.No/Date:0310735559 24.05.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/22/2011‐Ch II dated 11.11.2013, it was decided to ra浸fy 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 NUA (4PIPERIDINOL, 2,2,6,6TETRAMETHYL1 (UNDEXYLOXY) 1 kg 1. LA7RD(1PIPERIDINYLEXY 4 HYDROXY 2,2,6,6 TETRA METHYL 0.700 kg 2. LAUROX (LAUROYL PEROXIDE) 1.589 kg 3. D40 (SOLVENT) 1.459 kg 4. METHANOL 0.213 kg 92

Case No.:33/10/82ALC4/2013

Party Name:HESTER BIOSCIENCES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00216/AM14/ RLA File :08/24/040/00081/AM14/ Lic.No/Date:0810121432 27.05.2013 Defer Date:19.12.2013 Decision :Remind the firm to furnish the following information: 1. Drug Manufaturing Licensing of the export product 2. QA approved Batch Manufacturing Record The case was deferred for 19.12.2013 93

Case No.:71/10/82ALC4/2013

Party Name:SCOTTEDIL PHARMACIA LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00254/AM14/ RLA File :22/24/040/00016/AM14/ Lic.No/Date:2210013890 28.05.2013 Defer Date:19.12.2013 94

Case No.:78/14/82ALC4/2013

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 21.11.2013 Status:Case Approved HQ File :01/82/050/00663/AM14/ RLA File :03/94/040/00120/AM14/ Lic.No/Date:0310735992 29.05.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2011‐Ch II dated 22.11.2013, it was decided to ra浸fy 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 CONCENTRATE 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

Case No.:130/14/82ALC4/2013

Party Name:ENCUBE ETHICALS PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00715/AM14/ RLA File :03/94/040/00141/AM14/ Lic.No/Date:0310735929 29.05.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case for 19.12.2013 for comments of Department of MSME 96

Case No.:79/10/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00262/AM14/ RLA File :05/23/040/00058/AM14/ Lic.No/Date:0510355497 29.05.2013 Defer Date:19.12.2013 97

Case No.:108/14/82ALC4/2013

Party Name:MERIDIAN ENTERPRISES PVT. LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00693/AM14/ RLA File :03/95/040/00174/AM14/ Lic.No/Date:0310735976 29.05.2013 Defer Date:19.12.2013 98

Case No.:143/14/82ALC4/2013

Party Name:CHORUS LABS LIMITED, 21.11.2013 Status:Case Approved HQ File :01/82/050/00728/AM14/ RLA File :09/24/040/00088/AM14/ Lic.No/Date:0910056180 30.05.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/482/2013PI(Norms) dated 21.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg ETODOLAC :USP/Ph.Eur 1 kg 1. 7 ETHYLTRYPTOPHOL :98 PCT.MIN 0.72 2. METHYL 3 OXO PENTANOATE :99 PCT.MIN 0.54

Case No.:225/10/82ALC4/2013

Party Name:APEX HEALTHCARE LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00408/AM14/ RLA File :34/24/040/00035/AM14/ Lic.No/Date:3410037038 31.05.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case for 19.12.2013 for comments of Department of Pharmaceuticals 100

Case No.:209/10/82ALC4/2013

Party Name:R L FINE CHEM 21.11.2013 Status:Case Approved HQ File :01/82/050/00392/AM14/ RLA File :07/24/040/00033/AM14/ Lic.No/Date:0710095687 31.05.2013 Defer Date: Decision In the light of earlier decision taken in mee浸ng no. 12/82 dated 19.09.2012, it was decided to ra浸fy 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 CHLORPROMAZINE HCL 1 1 BROMO 3 CHLORO PROPANE 0.95 2 2 CHLORO PHENOTHIAZINE 0.90 3 ACETONE 3.33 101

Case No.:96/10/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00279/AM14/ RLA File :08/24/040/00085/AM14/ Lic.No/Date:0810121573 31.05.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case for 19.12.2013 for comments of Department of Pharmaceuticals 102

Case No.:46/12/82ALC4/2013

Party Name:TRIGON CHEMICALS PVT. LTD. 21.11.2013 Status:Case Approved HQ File :01/82/050/00470/AM14/ RLA File :31/83/040/00019/AM14/ Lic.No/Date:3110058563 31.05.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/52/2011‐Ch II dated 29.10.2013, it was decided to ra浸fy 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

Sodium Benzoate Micronised 1kg 1 Sodium Benzoate 1.01 kg 103

Case No.:140/14/82ALC4/2013

Party Name:AMBUJA INTERMEDIATES LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/00725/AM14/ RLA File :03/94/040/01120/AM13/ Lic.No/Date:0310736597 04.06.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/103/2012‐Ch II dated 08.11.2013, it was decided to ra浸fy 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 4,4Diamino Benz Sulfanilide (DASA) Raw Material 1kg 1. Para Nitro Aniline (Raw Material) 0.658 kg 2. Acetanilide (Raw Material) 0.801 kg 104

Case No.:108/10/82ALC4/2013

Party Name:CADILA HEALTHCARE LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00291/AM14/ RLA File :08/24/040/00091/AM14/ Lic.No/Date:0810121695 04.06.2013 Defer Date:19.12.2013 105

Case No.:98/10/82ALC4/2013

Party Name:CADILA HEALTHCARE LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00281/AM14/ RLA File :08/24/040/00089/AM14/ Lic.No/Date:0810121696 04.06.2013 Defer Date:19.12.2013 106

Case No.:106/14/82ALC4/2013

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 21.11.2013 Status:Case Approved HQ File :01/82/050/00691/AM14/ RLA File :03/94/040/00185/AM14/ Lic.No/Date:0310736606 04.06.2013 Defer Date: Decision : In the light of earlier decision taken in mee浸ng no. 2/82 dated 18.04.2013, it was decided to ra浸fy 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 Quan浸ty S.No Import Product Quan浸ty Allowed 4‐chloro‐2,6‐Di (Pyrrolidin‐1‐yl)Pyrimidine 1 kg 1. 2,4,6‐Trichloro Pyrimidine 0.773 kg 107

Case No.:139/14/82ALC4/2013

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00724/AM14/ RLA File :03/94/040/00160/AM14/ Lic.No/Date:0310736610 04.06.2013 Defer Date:19.12.2013 108

Case No.:125/14/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00710/AM14/ RLA File :03/94/040/00179/AM14/ Lic.No/Date:0310736687 05.06.2013 Defer Date:19.12.2013 Decision : Copy of application has been already sent on 11.12.2013. It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 109

Case No.:227/10/82ALC4/2013

Party Name:SPAN DIAGNOSTICS LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00410/AM14/ RLA File :52/24/040/00002/AM14/ Lic.No/Date:5210039825 05.06.2013 Defer Date:19.12.2013 Decision :It was decided to defer the case for 19.12.2013 for comments of Department of Biotechnology. 110

Case No.:86/14/82ALC4/2013

Party Name:EYTAN LABS LIMITED 21.11.2013 Status:Deffered and Reindexed HQ File :01/82/050/00671/AM14/ RLA File :09/24/040/00082/AM14/ Lic.No/Date:0910056266 06.06.2013 Defer Date:21.11.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/465/2010PI(Norms) dated 21.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed kg/kg (2R,CIS)5FLUORO(4 1 kg 1. GLYOXYLIC ACID 0.68

AMINO1, 2DIHYDRO2 OXO1PYRIMIDINYL1, 3 0XATHIOLANE2 CARBOXYLIC ACID (2R,5R) MENTHYLESTER(FCE) 50% 2. 2,5 DI HYDROXY 1, 4 DITHIANE 0.28 3. 5FLUORO CYTOSINE 0.531 4. HEXAMETHYL DISILAZANE (HMDS) 0.70 5. DIMETHYL FORMAMIDE 0.3333 6. CYCLOHEXANE Not shown in CA certificate 7. TRIETHYL AMINE 8. NHEXANE 9. TOLUENE 10. METHYLENE CHLORIDE 111

Case No.:138/14/82ALC4/2013

Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 21.11.2013 Status:Case Approved HQ File :01/82/050/00723/AM14/ RLA File :03/94/040/00178/AM14/ Lic.No/Date:0310736969 06.06.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/100/2012‐Ch II dated 12.11.2013, it was decided to ra浸fy 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 Quan浸ty S.No Import Product Quan浸ty Allowed DIPHENYL ISODECYL PHOSPHITE 1 kg 1. PHENOL 0.558 kg 2. ISODECYL ALCOHOL 0.419 kg 3. YELLOW PHOSPHORUS 0.09 kg 112

Case No.:68/10/82ALC4/2013

Party Name:ZEE LABORATORIES 21.11.2013 Status:Case Deferred HQ File :01/82/050/00251/AM14/ RLA File :05/24/040/00047/AM14/ Lic.No/Date:0510356364 06.06.2013 Defer Date:19.12.2013

113

Case No.:19/12/82ALC4/2013

Party Name:IPCA LABORATORIES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00443/AM14/ RLA File :03/94/040/01070/AM13/ Lic.No/Date:0310737096 07.06.2013 Defer Date:19.12.2013 114

Case No.:1/8/85ALC3/2013

Party Name:SRIAM LABS PRIVATE LIMITED 21.11.2013 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:02.01.2014 Decision :In 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 30 wrongly and it should be covered under chapter 29 of ITC(HS). Deptt. of Pharma 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 02.01.2014. 115

Case No.:31/16/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 21.11.2013 Status:Case Approved HQ File :01/82/050/00844/AM14/ RLA File :17/24/040/00049/AM14/ Lic.No/Date:1710005431 05.07.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/69/2011‐Ch II dated 29.10.2013, it was decided to ra浸fy 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 Quan浸ty S.No Import Product Quan浸ty Allowed PRODUCTR1680 (70% ACTIVE FORMULATED PRODUCT) (Appearance: Brown coloured viscous liquid) 1 kg 1. QUINOLINE (Appearance: Liquid) 0.189 kg 2. TALLOW DIAMINE (Appearance: Liquid) 0.0762 kg 3. ETHYLENE OXIDE (Colourless clear liquid) 0.123 kg 116

Case No.:30/16/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00843/AM14/ RLA File :17/24/040/00054/AM14/ Lic.No/Date:1710005445 11.07.2013 Defer Date:19.12.2013

Decision :It was decided to send a copy of application to Department of C&PC for their comments. The case was deferred for 19.12.2013 117

Case No.:157/14/82ALC4/2013

Party Name:HETERO LABS LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00742/AM14/ RLA File :09/24/040/00170/AM14/ Lic.No/Date:0910056762 15.07.2013 Defer Date:19.12.2013 118

Case No.:46/13/82ALC4/2013

Party Name:JUBILANT LIFE SCIENCES LIMITED 21.11.2013 Status:Case Approved HQ File :01/82/050/00522/AM14/ RLA File :05/23/040/00164/AM14/ Lic.No/Date:0510360738 24.07.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Pharmaceu浸cals vide their OM No. 35011/547/2013‐PI(Norms) dated 21.11.2013, it was decided to ra浸fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product : Enrofloxacin Flavored Tablets 22.7 mg , 68 mg s and 136 mg tabs S.NO. Import Item Quan浸ty recommended 22.7 mg tabs 68 mg tabs 136 mg tabs 1 Enrofloxacin 23.154 mg 69.36 mg 138.72 mg 119

Case No.:23/14/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00608/AM14/ RLA File :09/24/040/00191/AM14/ Lic.No/Date:0910056934 29.07.2013 Defer Date:19.12.2013 120

Case No.:61/14/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00646/AM14/ RLA File :09/24/040/00206/AM14/ Lic.No/Date:0910057007 02.08.2013 Defer Date:19.12.2013

121

Case No.:90/13/82ALC4/2013

Party Name:CATAPHARMA CHEMICALS PVT. LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00566/AM14/ RLA File :31/83/040/00054/AM14/ Lic.No/Date:3110060069 23.08.2013 Defer Date:19.12.2013 122

Case No.:15/16/82ALC4/2013

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00828/AM14/ RLA File :07/24/040/00177/AM14/ Lic.No/Date:0710097973 03.09.2013 Defer Date:19.12.2013 Decision :it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 19.12.2013. 123

Case No.:43/16/82ALC4/2013

Party Name:SYMBIOTEC PHARMALAB LTD., 21.11.2013 Status:Case Approved HQ File :01/82/050/00856/AM14/ RLA File :56/24/040/00017/AM14/ Lic.No/Date:5610002765 03.09.2013 Defer Date: Decision : In the light of earlier decision taken in mee浸ng no. 46/82 dated 14.02.2012, it was decided to ra浸fy 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. S.No Import Product Qty. Allowed Hydrocortisone Sodium Succinate Buffered 5% Sterile (Hydrocortisone Sodium Succinate for Injection USP for manufacturers use) 1 kg 1. Hydrocortisone Hemisuccinate IP/BP Organic Chemicals 1.00 kg 124

Case No.:16/16/82ALC4/2013

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00829/AM14/ RLA File :07/24/040/00189/AM14/ Lic.No/Date:0710098183 10.09.2013 Defer Date:19.12.2013 125

Case No.:35/16/82ALC4/2013

Party Name:CHIRAG ENTERPRISE Status:Case

21.11.2013 Approved HQ File :01/82/050/00848/AM14/ RLA File :24/24/040/00012/AM14/ Lic.No/Date:2410039888 11.09.2013 Defer Date: Decision : In the light of wri浸en comments received from Petrochemical Division of Department of Chemicals and Petrochemicals vide their U.O No. 46011/1/2007‐PC‐ II dated 28.10.2013, it was decided to ra浸fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed REGENERATED METHYL METHACRYLATE MONOMER (PURITY 99%) 1 kg 1. ACRYLIC PLASTIC STRIP / OFFCUTS / MIX LOT OF ACRYLIC SHEETS & CUT THEREOFF AND ACRLIC PLASTIC SCRAP [HS CODE 39159030] 1.63 kg 126

Case No.:47/16/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00860/AM14/ RLA File :04/24/040/00130/AM14/ Lic.No/Date:0410149741 11.09.2013 Defer Date:19.12.2013 127

Case No.:33/16/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, 21.11.2013 Status:Case Deferred HQ File :01/82/050/00846/AM14/ RLA File :09/24/040/00278/AM14/ Lic.No/Date:0910057537 12.09.2013 Defer Date:19.12.2013 128

Case No.:9/16/82ALC4/2013

Party Name:RASULA PHARMACEUTICALS & FINE CHEMICALS 21.11.2013 Status:Case Deferred HQ File :01/82/050/00822/AM14/ RLA File :09/24/040/00262/AM14/ Lic.No/Date:0910057540 12.09.2013 Defer Date:19.12.2013 Decision : Copy of application has been already sent on 06.12.2013 to Department of C&PC. It was decided to defer the case for 19.12.2013 for comments of Department of C&PC 129

Case No.:5/12/82ALC4/2013

Party Name:AUCTUS PHARMA LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00429/AM14/ RLA File :09/24/040/00277/AM14/ Lic.No/Date:0910057572 Defer

13.09.2013 Date:19.12.2013 130

Case No.:21/16/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00834/AM14/ RLA File :09/24/040/00247/AM14/ Lic.No/Date:0910057543 13.09.2013 Defer Date:19.12.2013 131

Case No.:44/16/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00857/AM14/ RLA File :09/24/040/00269/AM14/ Lic.No/Date:0910057544 13.09.2013 Defer Date:19.12.2013 132

Case No.:41/16/82ALC4/2013

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00854/AM14/ RLA File :07/24/040/00188/AM14/ Lic.No/Date:0710098283 16.09.2013 Defer Date:19.12.2013 133

Case No.:10/16/82ALC4/2013

Party Name:STERICON PHARMA PVT.LTD., 21.11.2013 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:19.12.2013 Decision : It was decided to defer the case for 19.12.2013 for comments of Department of Pharmaceuticals. 134

Case No.:46/16/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 21.11.2013 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:02.01.2014 Decision :It was decided to defer the case for 02.01.2014 for comments of Department of Pharmaceuticals. 135

Case No.:49/16/82ALC4/2013

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 21.11.2013 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:02.01.2014 136

Case No.:6/16/82ALC4/2013

Party Name:STERLING AUXILIARIES PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00819/AM14/ RLA File :03/95/040/00037/AM14/ Lic.No/Date:0310750179 18.09.2013 Defer Date:19.12.2013 Decision : Copy of application has been already sent on 05.12.2013. It was decided to defer the case 19.12.2013 for comments of Department of Chemicals and Petrochemicals. 137

Case No.:17/16/82ALC4/2013

Party Name:TADIMETY AROMATICS PVT. LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00830/AM14/ RLA File :07/24/040/00195/AM14/ Lic.No/Date:0710098354 18.09.2013 Defer Date:02.01.2041 Decision : Copy of application has been already sent on 11.12.2013. It was decided to defer the case 02.01.2014 for comments of Department of Chemicals and Petrochemicals. 138

Case No.:45/16/82ALC4/2013

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 21.11.2013 Status:Case Deferred HQ File :01/82/050/00858/AM14/ RLA File :05/24/040/00219/AM14/ Lic.No/Date:0510366235 19.09.2013 Defer Date:02.01.2014 139

Case No.:48/16/82ALC4/2013

Party Name:SOFTGEL HEALTH CARE PVT. LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00861/AM14/ RLA File :04/24/040/00099/AM14/ Lic.No/Date:0410150142 20.09.2013 Defer Date:02.01.2014 140

Case No.:20/16/82ALC4/2013

Party Name:STERICAT GUTSTRINGS PVT. LTD. 21.11.2013 Status:Case Deferred HQ File :01/82/050/00833/AM14/ RLA File :05/24/040/00214/AM14/ Lic.No/Date:0510366620 24.09.2013 Defer Date:02.01.2014 Decision : Copy of application has been already sent on 09.12.2013. It was decided to defer the case for 02.01.2014 for comments of Department of

Pharmaceuticals. 141

Case No.:36/16/82ALC4/2013

Party Name:CADILA HEALTHCARE LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00849/AM14/ RLA File :08/24/040/00259/AM14/ Lic.No/Date:0810125075 25.09.2013 Defer Date:19.12.2013 142

Case No.:19/16/82ALC4/2013

Party Name:SIDDHI VINAYAKA SPECHEM PVT.LTD., 21.11.2013 Status:Case Approved HQ File :01/82/050/00832/AM14/ RLA File :07/24/040/00221/AM14/ Lic.No/Date:0710098567 25.09.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/154/2011‐Ch II dated 27.02.2012, it was decided to ra浸fy 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 Dithiothreitol / DTT 1 kg 1. Thioacetic acid 2.581 kg 3. Cis2Butene 1 4 diol 3.038 kg 143

Case No.:7/16/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00820/AM14/ RLA File :04/24/040/00142/AM14/ Lic.No/Date:0410150374 26.09.2013 Defer Date:02.01.2014 144

Case No.:23/16/82ALC4/2013

Party Name:R L FINE CHEM 21.11.2013 Status:Case Approved HQ File :01/82/050/00836/AM14/ RLA File :07/24/040/00151/AM14/ Lic.No/Date:0710098623 27.09.2013 Defer Date: Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/498/2010PI(Norms) dated 21.11.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed

Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg 145

Case No.:27/16/82ALC4/2013

Party Name:NECTAR LIFESCIENCES LIMITED, 21.11.2013 Status:Case Approved HQ File :01/82/050/00840/AM14/ RLA File :22/24/040/00047/AM14/ Lic.No/Date:2210014252 30.09.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 12/82 dated 19.09.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Tazobactam Sodium+Piperacillin Sodium Sterile (1:8) 1 Kg. 1. Piperacillin Acid 0.9153 kg 2. Tazobactam Acid 0.1130 kg 3. Sodium Bicarbonate 0.174 kg 4. Aluminium Bottle Anodized with Tear off alu cap & chlorobutyl plug Relevant, as per packing policy A may take appropriate ac浸on as per the decision of Norms Commi浸ee. 146

Case No.:14/16/82ALC4/2013

Party Name:SHAMSHREE LIFESCIENCES LTD., 21.11.2013 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:02.01.2014 147

Case No.:32/16/82ALC4/2013

Party Name:FINE CURE PHARMACEUTICALS LTD. Meet No/Date:16/82ALC4/2013 21.11.2013 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:02.01.2014 Decision :It was decided to defer the case 02.01.2014 for comments of Department of Chemicals and Petrochemicals. 148

Case No.:42/16/82ALC4/2013

Party Name:INDIA GLYCOLS LTD., 21.11.2013 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:02.01.2014

Decision: Copy of application has been already sent on 02.12.2013. It was decided to defer the case for 02.01.2014 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 149

Case No.:39/16/82ALC4/2013

Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, 21.11.2013 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:02.01.2014 Decision : Copy of application has been already sent on 06.12.2013. It was decided to defer the case 02.01.2014 for comments of Department of Chemicals and Petrochemicals. 150

Case No.:8/16/82ALC4/2013

Party Name:H.J.AROCHEM PVT. LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00821/AM14/ RLA File :08/24/040/00286/AM14/ Lic.No/Date:0810125341 04.10.2013 Defer Date:02.01.2014 Decision :It was decided to defer the case 02.01.2014 for comments of Department of Chemicals and Petrochemicals. 151

Case No.:25/16/82ALC4/2013

Party Name:ATUL LIMITED, 21.11.2013 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:02.01.2014 Decision :It was decided to defer the case 02.01.2014 for comments of Department of Chemicals and Petrochemicals. 152

Case No.:34/16/82ALC4/2013

Party Name:GOPINATH CHEMTECH LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00847/AM14/ RLA File :08/24/040/00304/AM14/ Lic.No/Date:0810125463 08.10.2013 Defer Date:02.01.2014 Decision :It was decided to defer the case 02.01.2014 for comments of Department of Chemicals and Petrochemicals. 153

Case No.:11/16/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 21.11.2013 Status:Case Deferred HQ File :01/82/050/00824/AM14/ RLA File :05/23/040/00281/AM14/ Lic.No/Date:0510367867 08.10.2013 Defer Date:02.01.2014 154

Case No.:12/16/82ALC4/2013

Party Name:INTAS PHARMACEUTICALS LTD., Status:Case

21.11.2013 Deferred HQ File :01/82/050/00825/AM14/ RLA File :08/24/040/00303/AM14/ Lic.No/Date:0810125470 08.10.2013 Defer Date:02.01.2014 155

Case No.:26/16/82ALC4/2013

Party Name:INTAS PHARMACEUTICALS LTD., 21.11.2013 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:02.01.2014 156

Case No.:24/16/82ALC4/2013

Party Name:S.M. HERBALS PVT.LTD. 21.11.2013 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:02.01.2014 Decision :It was decided to call from the firm the following technical details: • COA from foreign supplier for relevant import consignement for the imported input. • COA from Independent and approved Testing Laboratary for export product. • Stepwise process with wastage envisaged in the process. The case was deferred for 02.01.2014. 157

Case No.:29/16/82ALC4/2013

Party Name:S.M. HERBALS PVT.LTD. 21.11.2013 Status:Case Approved HQ File :01/82/050/00842/AM14/ RLA File :05/24/040/00239/AM14/ Lic.No/Date:0510367886 08.10.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 11/82 dated 05.09.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Quinoline Based Alkaloid Camptothecin ( Chemical ) HPLC Purity Not Less Than 98.5% 1kg 1. Quinoline Based Alkaloid Camptothecin ( Chemical ) (HPLC Purity Not less Than 99% and NMT 968%) 1.0346 kg

158

Case No.:13/16/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 21.11.2013 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:02.01.2014 159

Case No.:28/16/82ALC4/2013

Party Name:NECTAR LIFESCIENCES LIMITED, 21.11.2013 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:02.01.2014 160

Case No.:37/16/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 21.11.2013 Status:Case Approved HQ File :01/82/050/00850/AM14/ RLA File :05/23/040/00287/AM14/ Lic.No/Date:0510368379 14.10.2013 Defer Date: Decision : In the light of earlier decision taken in mee浸ng no. 13/82 dated 03.10.2013, it was decided to ra浸fy 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 Quan浸ty S.No Import Product Quan浸ty Allowed Allylestrenol Bulk Drug 1 kg 1. Sitolactone Intermediate 1.95 kg 2. 5‐Chloro‐2‐pentanone Reagent 1.81 kg 3. Tetrahydrofuran Solvent 5.80 kg 4. Pyridine Reagent 0.87 kg 161

Case No.:38/16/82ALC4/2013

Party Name:INTAS PHARMACEUTICALS LTD., 21.11.2013 Status:Case Deferred HQ File :01/82/050/00851/AM14/ RLA File :08/24/040/00321/AM14/ Lic.No/Date:0810125616 14.10.2013 Defer Date:02.01.2014

162

Case No.:18/16/82ALC4/2013

Party Name:NEULAND LABORATORIES LTD 21.11.2013 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:02.01.2014 163

Case No.:22/16/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 21.11.2013 Status:Case Approved HQ File :01/82/050/00835/AM14/ RLA File :05/23/040/00295/AM14/ Lic.No/Date:0510368767 18.10.2013 Defer Date: Decision : : In the light of wri浸en comments received from Department of Pharmaceu浸cals vide their OM No. 35011/401/2013‐PI(Norms) dated 21.11.2013, it was decided to ra浸fy 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 Quan浸ty S.No Import Product Qty. Allowed kg/kg Nandrolone Phenylpropionate Bulk Drug 1 kg 1. Sitolactone Intermediate 1.27 2. 5Chloro2Pentanone Reagent 1.18 3. Tetrahydrofuran Solvent 3.175 4. Pyridine Reagent 0.565 164

Case No.:40/16/82ALC4/2013

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00853/AM14/ RLA File :04/24/040/00152/AM14/ Lic.No/Date:0410151307 28.10.2013 Defer Date:19.12.2013 165

Case No.:1/16/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 21.11.2013 Status:Case Approved HQ File :01/82/050/00814/AM14/ RLA File :08/24/040/00332/AM14/ Lic.No/Date:0810126139 30.10.2013 Defer Date: Decision : In the light of earlier decision taken in mee浸ng no. 10/82 dated 22.08.2013, it was decided to ra浸fy 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

Bisoprolol Fumerate 5mg Tablets (Pack Size 30 Tab) 1 No. 1. Bisoprolol Fumarate 5.1 mg Bisoprolol Fumerate 10mg Tablets (Pack Size 30 Tab) 1 No. 1. Bisoprolol Fumarate 10.2 mg 166

Case No.:2/16/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00815/AM14/ RLA File :09/24/040/00367/AM14/ Lic.No/Date:0910058141 05.11.2013 Defer Date:02.01.2014 167

Case No.:3/16/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 21.11.2013 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:02.01.2014 168

Case No.:4/16/82ALC4/2013

Party Name:JUBILANT LIFE SCIENCES LIMITED 21.11.2013 Status:Case Deferred HQ File :01/82/050/00817/AM14/ RLA File :05/23/040/00312/AM14/ Lic.No/Date:0510370486 07.11.2013 Defer Date:02.01.2014 169

Case No.:5/16/82ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. 21.11.2013 Status:Case Approved HQ File :01/82/050/00818/AM14/ RLA File :03/95/040/00623/AM14/ Lic.No/Date:0310757173 07.11.2013 Defer Date: Decision : In the light of wri浸en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011‐Ch II dated 02.04.2013, it was decided to ra浸fy 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 METHYL EUGENOL ( 99% MIN) 1 kg 1. CLOVE LEAF OIL (EUGENOL CONTENT 78%) 1.40 kg

Date:03.12.2013 Place:New Delhi R.C.Meena Dy. Director General of Foreign Trade

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Para 4.7 Decision(DRAFT)

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