IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2013-04-04

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision

MEETING NUMBER : 1/82ALC4/2013 MEETING DATE : 04.04.2013 The Meeting No. 1/82 in the year 201314 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was scheduled to be held on 4.4.2013 but was actually held on 8.4.2013 under the Chairmanship of, Shri Mukesh Bhatnagar, Addl DGFT in Room No.11, Udyog Bhawan, New Delhi.. Following members were present: 1. Shri D.N. Mathur. Advisor, Department of Pharmaceutical 2. Shri Jasbir Singh, Advisor, Department of Chemicals and Petrochemicals 3. Shri R.C. Meena, Deputy Director General of Foreign Trade

Case No. A 1

M/s. Richter Themis Medicare (I) Pvt. Ltd. Meeting no. 1/AM 13 01/82/162/00434/AM 13/DES III Dated 4.4.2013 Decision: It was decided to defer the case for 2.5.2013 for comments of Department of Pharmaceuticals.

Case No. B 1

M/s. Sandoz Pvt. Ltd. Meeting no. 1/AM 13 Dated 4.4.2013 S. No F. No Name of the export product 1. 01/82/162/00309/AM 13/DES III Tacrolimus 5 MG HGC 2. 01/82/162/00310/AM 13/DES III Tacrolimus 1 MG HGC 3. 01/82/162/00311/AM 13/DES III Tapiramate 50 MG Film coated tablets

01/82/162/00312/AM 13/DES III Tapiramate 100 MG Film coated tablets 5. 01/82/162/00313/AM 13/DES III Tapiramate 25 MG Film coated tablets. Decision: It was decided to call from the firm a copy of Master Batch Formula. The case was deferred for 2.5.2013.

Case No. B 2

M/s. Sandoz Pvt. Ltd. Meeting no. 1/AM 13 Dated 4.4.2013 S. No F. No Name of the export product 1. 01/82/162/00285/AM 13/DES III Tacrolimus 0.5 MG HGC 2. 01/82/162/00292/AM 13/DES III Sibutramine Hydrochloride 3. 01/82/162/00303/AM 13/DES III Ropinirole 4 MG Tablets FCT 4. 01/82/162/00290/AM 13/DES III Sildenafil Citrate 25 MG Tablets 5. 01/82/162/00293/AM 13/DES III Ripinirole 5 MG Prolonged Release Tablets. Decision: It was decided to call from the firm a copy of Master Batch Formula. The case was deferred for 2.5.2013.

Case No. B 3

M/s. Sandoz Pvt. Ltd. Meeting no. 1/AM 13 Dated 4.4.2013 S. No F. No Name of the export product 1. 01/82/162/00300/AM 13/DES III Risperidone 0.5 MG Tablets (ODT) / / / / / i id bl ( )

01/82/162/00301/AM 13/DES III Risperidone 2 MG Tablets (ODT) 3. 01/82/162/00302/AM 13/DES III Riluzole 50 MG Tablets FCT 4. 01/82/162/00289/AM 13/DES III Repaglinide 1 MG Tablets 5. 01/82/162/00288/AM 13/DES III Repaglinide 0.5 MG Tablets Decision: It was decided to call from the firm a copy of Master Batch Formula. The case was deferred for 2.5.2013.

Case No. B 4

M/s. Sandoz Pvt. Ltd. Meeting no. 1/AM 13 Dated 4.4.2013 S. No F. No Name of the export product 1. 01/82/162/00291/AM 13/DES III Sildenafil Citrate 50 MG Tablets 2. 01/82/162/00298/AM 13/DES III Risperidone 2 MG Tablets (ODT) 3. 01/82/162/00297/AM 13/DES III Risperidone 3 MG Tablets (ODT) 4. 01/82/162/00299/AM 13/DES III Risperidone 2 MG Tablets (ODT) 5. 01/82/162/00295/AM 13/DES III Ropinirole 3 MG Prolonged Release Tablets 6. 01/82/162/00305/AM 13/DES III Ropinirole 1 MG Tablets FCT Decision: It was decided to call from the firm a copy of Master Batch Formula. The case was deferred for 2.5.2013.

Case No. B 5

M/s. Sandoz Pvt. Ltd. Meeting no. 1/AM 13 Dated 4.4.2013 S. No F. No Name of the export product

01/82/162/00294/AM 13/DES III Sibutramine Dydrochloride Monohyderate 10 MG HGC 2. 01/82/162/00307/AM 13/DES III Ropinirole 0.25 MG Tablets FCT 3. 01/82/162/00306/AM 13/DES III Ropinirole 0.5 Tablets FCT 4. 01/82/162/00304/AM 13/DES III Ropinirole 2 MG Tablets FCT 5. 01/82/162/00308/AM 13/DES III Topiramate 15 MG capsules. Decision: It was decided to call from the firm a copy of Master Batch Formula. The case was deferred for 2.5.2013.

Case No. B 6

M/s. Sandoz Pvt. Ltd. Meeting no. 1/AM 13 Dated 4.4.2013 S. No F. No Name of the export product 1. 01/82/162/00283/AM 13/DES III Topiramate 200 MG Film coated tablets 2. 01/82/162/00287/AM 13/DES III Ranitidine 300 mg FCT 3. 01/82/162/00284/AM 13/DES III Sildenafil Citrate 100 MG Tablets 4. 01/82/162/00286/AM 13/DES III Ranitidine 150 mg FCT 5. 01/82/162/00296/AM 13/DES III Risperidone 4 MG Tablets USP Decision: It was decided to call from the firm a copy of Master Batch Formula. The case was deferred for 2.5.2013.

Case No. B 7

M/s. PCL Oil & Solvents Limited, New Delhi Meeting no. 1/AM 13 01/82/162/917/AM 13/DES III

Meeting no. 1/AM 13 01/82/162/917/AM 13/DES III Dated 4.4.2013 RLA’s File No 05/27/040/00083/AM 13 05/27/040/00454/AM 13 05/27/040/00455/AM 13 Decision: The Committee clarified that as per SION A 1303, PVC Plasticizer and DOP are one and same chemicals. It was decided to send a clarification in this regard to CLA, New Delhi.

Case No. B 8

M/s. Divis Laboratories Limited Meeting no. 1/AM 13 01/82/50/00038/AM 12/DES III Dated 4.4.2013 R.A No. 09/24/040/00497/AM 11 Adv. Lic. No. & Date 0910045589 dated 18.2.2011 Decision: It was decided to remind the firm to furnish a copy of production and consumption data duly certified by Central Excise Authority. The case was deferred for 2.5.2013.

Case No. B 9

M/s. Arch Pharmalabs Limited, Mumbai Meeting no. 1/AM 13 01/82/50/00870/AM 09/DES III (Pt.) Dated 4.4.2013 Advance License No. 0310481979 dated 8.8.2008 RLA File No. 03/94/040/00393/AM 09 Decision: It was decided to defer the case for 2.5.2013 for comments of Department of Pharmaceuticals. Case.No. – B 10 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

3 F.No.01/82/50/0247/AM07 22/24/40/41/AM07 2210005553 dt. 19.05.06 M.No. – 1/AM 14 4.4.2013 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

30 F.No.01/82/50/1114/AM08 22/24/40/037/AM08 2210007032 dt. 06.09.07 Decision: It was decided to defer the case for 2.5.2013 for comments of Department of Pharmaceuticals.

Case No. B 11

M/s. Torrent Pharmaceuticals Limited Meeting no. 1/AM 13 01/82/50/000507/AM 13/DES III Dated 4.4.2013 Advance License No. 0810113626 dated 23.7.2012 Advance License No. 0810113680 dated 25.07.2012 Advance License No. 0810114131 dated 9.8.2012 Advance License No. 0810114353 dated 17.8.2012 Advance License No. 0810114951 dated 10.9.2012 Decision: It was clarified that no higher inputs are allowed under Deemed Export Scheme. However, the firm can import unregistered pharma in excess of the wastage allowed by NC on payment of duty, subject to No Objection Certificate from Drug Controller General of India. 1

Case No.:71/15/82ALC4/2010

Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:1/82ALC4/2013 04.04.2013 Status:Case Deferred HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Pharmaceuticals. 2

Case No.:4/1/82ALC4/2013

Party Name:ACTAVIS PHARMA MANUFACTURING PVT.LTD 04.04.2013 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:02.05.2013

Case No.:53/47/82ALC4/2010

Party Name:NEULAND LABORATORIES LTD 04.04.2013 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:02.05.2013 Decision :It was decided to call a copy of application from the Regional Authority and forward it to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 4

Case No.:5/4/82ALC4/2011

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Biotechnology. 5

Case No.:32/8/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00232/AM12/ RLA File :03/94/040/01167/AM11/ Lic.No/Date:0310625603 07.04.2011 Defer Date: 2.5.2013 Decision : It was decided to defer the case for 2.5.2013 for comments of Department of Pharmaceuticals. 6

Case No.:56/1/82ALC4/2013

Party Name:CADILA HEALTHCARE LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/01414/AM13/ RLA File :08/24/040/00394/AM11/ Lic.No/Date:0810098384 20.04.2011 Defer Date: 7

Case No.:19/10/82ALC4/2011

Party Name:PLANET HERBS LIFE SCIENCES PVT.LTD. 04.04.2013 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:02.05.2013 Decision :DC(MSME) vide thier letter No. 23(3)/2013Chem dated 7.3.2012 has requested the firm to furnish the following information: 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. earlier authorisation of the above product, if any. It was decided to give a reminder to the firm to furnish the information immediately. The case was deferred for 2.5.2013. 8

Case No.:2/15/82ALC4/2011

Party Name:ACHARYA CHEMICALS 04.04.2013 Status:Case Deferred HQ File :01/82/050/00442/AM12/ RLA File :03/94/040/00130/AM12/ Lic.No/Date:0310633824 31.05.2011 Defer Date: Decision :The reply received from the firm was sent to Department of Pharmaceuticals on 28.8.2012. The case was deferred for 2.5.2013. 9

Case No.:18/11/82ALC4/2011

Party Name:VIVIMED LABS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00332/AM12/ RLA File :09/24/040/00080/AM12/ Lic.No/Date:0910046973 02.06.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/102/2012Ch. II dated 8.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Jarocol Yellow 2 or HC Yellow 2 1 kg 1. Ortho Nitro Fluoro Benzene or 2Fluoro Nitro Benzene 1.000 kg 2. Mono Ethanol Amine 1.304 kg RA may take appropriate action as per the decision of Norms Committee. 10

Case No.:55/1/82ALC4/2013

04.04.2013 Status:Case Approved HQ File :01/82/050/01413/AM13/ RLA File :08/24/040/00028/AM12/ Lic.No/Date:0810100266 08.06.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 20.9.2012, 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: Item of Export Quantity S,No Item of Import Quantity allowed Sumamed 500 MG Inj. 1 vial 1. Azithromycin dihydrate 0.5765 gm/vial 2. Sodium Hydroxide 1.5926 gm/vial 3. Packing Materials (as per general norms for packing Relevant, as per packing policy

general norms for packing material) a. 20 ML 20 MM Clr Type II LYO Inj. packing policy 4. 3 b. RS CB LTO RTU (At V9172 FM 140/6) Relevant, as per packing policy 5. 3. c 20 MM TEAR OFF SEAL AL SEAL ATB Relevant, as per packing policy 11

Case No.:4/16/82ALC4/2011

Party Name:BOSTIK INDIA PRIVATE LIMITED 04.04.2013 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:02.05.2013 Decision : It was decided to defer the case for 2.5.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. The case was deferred for 2.5.2013. 12

Case No.:35/19/82ALC4/2011

04.04.2013 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:02.05.2013 13

Case No.:97/22/82ALC4/2012

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:1/82ALC4/2013 04.04.2013 Status:Case Approved HQ File :01/82/050/00800/AM13/ RLA File :34/24/040/00058/AM12/ Lic.No/Date:3410030822 05.07.2011 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/633/2012PI(Norms) dated 12.3.2013, 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: Item of Export Quantity S,No Item of Import Quantity allowed Fenofibrate 1 kg 1. 4 Chloron 4 Hydroxybenophenone 1.270 kg 2. Acetone 2.79 kg 3. Ethyl Acetate 0.576 kg 4. Isopropyl Alcohol 4.147 kg 5. Methylene Chloride 3.031 kg 6. Activated Charcoal 0.059 kg 14

Case No.:39/31/82ALC4/2011

Party Name:SAURAV CHEMICALS LTD, 04.04.2013 Status:Case Rejected HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date: D i i It d id d t l th th fi h t f i h d i f ti d it t d i d

Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 15

Case No.:84/1/82ALC4/2013

Party Name:ANUS LABORATORIES LTD., 04.04.2013 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:02.05.2013 16

Case No.:96/1/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 04.04.2013 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:02.05.2013 17

Case No.:16/35/82ALC4/2011

Party Name:HIRAN ORGOCHEM LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00943/AM12/ RLA File :03/94/040/00474/AM12/ Lic.No/Date:0310657248 30.09.2011 Defer Date:02.05.2013 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: Stepwise complete and balanced chemical reaction showing Mol. Wt. of each input and output item. % yield on molar basis for each step. Requirement and recovery at each step. 18

Case No.:86/1/82ALC4/2013

Party Name:SVR LABORATORIES PRIVATE LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01444/AM13/ RLA File :09/24/040/00271/AM12/ Lic.No/Date:0910049193 30.09.2011 Defer Date: Decision : In the light of earlier decision taken in meeting no. 47/82 dated 21.2.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Exp. Qty. S.No Import Item Qty. allowed kg/kg {3aS[3s*(R*)]3a alpha,8a alpha]} (3,3a,8,8a)tetrahydro 2 2 di h l 3 (2 1 kg 1 2 Indene A i il 1.932 2 90

2,2dimethyl3(2 oxyranylmethyl)1 oxo3phenyl propyl)2Hindino (1,2d)oxazole 2 3 4 5 Acetonitrile L(+) Tartaric Acid 2Methoxy Propene Tetrahydrofuran 2.90 1.781 0.947 14.95 19

Case No.:93/1/82ALC4/2013

Party Name:MATRIX LABORATORIES LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01451/AM13/ RLA File :09/24/040/00315/AM12/ Lic.No/Date:0910049346 14.10.2011 Defer Date:02.05.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 20

Case No.:113/42/82ALC4/2011

Party Name:NEULAND LABORATORIES LTD 04.04.2013 Status:Deffered HQ File :01/82/050/01148/AM12/ RLA File :09/24/040/00310/AM12/ Lic.No/Date:0910049392 19.10.2011 Defer Date:02.05.2013 Decision : It was decided to give a final reminder to the firm to furnish the requisite technical details within 15 days failing which their case would be closed. The case was deferred for 2.5.2013. 21

Case No.:3/45/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01180/AM12/ RLA File :03/94/040/00691/AM12/ Lic.No/Date:0310664617 14.11.2011 Defer Date:02.05.2013 Decision :The firm was requested for furnish Master Batch Formula. However, the firm has submitted a copy of Certificate of Pharmaceutical product. A copy of COP was sent to Department of Pharmaceuticals for examination. The case was deferred for 2.5.2013 for comments of Department of Pharmaceuticals. 22

Case No.:22/45/82ALC4/2011

Party Name:AUCTUS PHARMA LIMITED 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Biotechnology.

Case No :5/45/83 ALC1/2011

Party Name:SPAN DIAGNOSTICS LTD Meet No/Date:1/82 ALC4/2013 Status:Case

Case No.:5/45/83ALC1/2011

Party Name:SPAN DIAGNOSTICS LTD 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Biotechnology. 24

Case No.:7/27/85ALC3/2011

Party Name:BELOOR BAYIR BIOTECH LTD, 04.04.2013 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:02.05.2013 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. The case was deferred for 2.5.2013. 25

Case No.:11/1/82ALC4/2013

Party Name:BIOCON LIMITED, 04.04.2013 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:02.05.2013 26

Case No.:23/45/82ALC4/2011

Party Name:SUTURES INDIA PRIVATE LIMITED, 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Industrial Policy and Promotion. 27

Case No.:24/46/82ALC4/2011

Party Name:ASHISH LIFE SCIENCE PVT.LTD. 04.04.2013 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 Date:02.05.2013 Decision : It was decided to give a final reminder to the firm to furnish the requisite information immediately. The case was deferred for 2.5.2013. 28

Case No.:59/46/82ALC4/2011

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 04.04.2013 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:02.05.2013 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 which their case would be closed. The case was deferred for 2.5.2013.

Case No :11/3/82ALC4/2012

Party Name:VIVIMED LABS LIMITED Meet No/Date:1/82ALC4/2013 Status:Case

Case No.:11/3/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00015/AM13/ RLA File :09/24/040/00460/AM12/ Lic.No/Date:0910050479 29.12.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch. II dated 7.3.2013, 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: Item of Export Quantity S,No Item of Import Quantity allowed Reversacol Berry Red 1 kg 1 Acetophenone 4.158 kg 2. Dimethyl Succinate 8.261 kg 3. 4,4Dimethoxy Benxophenone 1.428 kg 4. Methanol 23.228 kg 5. THF (Tetra Hydro Furan) 11.375 kg 6. Toluene 7.075 kg 7. Hexane 3.000 kg 8. TMSA (Tri Methyl Silyl Acetylene) 1.000 kg 9. Siralox 0.833 kg 30

Case No.:18/1/82ALC4/2013

Party Name:TRANSPEK INDUSTRY LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01376/AM13/ RLA File :34/24/040/00217/AM12/ Lic.No/Date:3410032918 11.01.2012 Defer Date:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Chemicals and Petrochemicals. 31

Case No.:18/1/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01460/AM12/ RLA File :09/24/040/00493/AM12/ Lic.No/Date:0910050772 13.01.2012 Defer Date:02.05.2013 Decision :It was decided to give final reminder to the firm to furnish the following information without any further, else their case would be closed: The chemistry of Step III and IV do not match with the material balance. Yields of Step III and IV are not given. 32

Case No.:67/1/82ALC4/2012

Party Name:CHEMSPEC CHEMICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01509/AM12/ RLA File :03/94/040/01007/AM12/ Lic.No/Date:0310682171 15.02.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to both the Departments i.e. Department of Pharmaceuticals and Department of Chemicals and

Petrochemicals. However, no comments have been received from any of the Department. It was decided to defer the case for 2.5.2013 for their comments. 33

Case No.:51/1/82ALC4/2012

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01493/AM12/ RLA File :09/24/040/00579/AM12/ Lic.No/Date:0910051360 21.02.2012 Defer Date:02.05.2013 Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 34

Case No.:26/4/82ALC4/2012

Party Name:ARCH PHARMALABS LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00106/AM13/ RLA File :03/94/040/01048/AM12/ Lic.No/Date:0310683210 23.02.2012 Defer Date:18.04.2013 Decision :It was decided to call the firm for Personal Hearing on 26.4.2013 with all the technical details sought earlier. The case was deferred for 26.4.2013 35

Case No.:60/49/82ALC4/2011

04.04.2013 Status:Case Deferred HQ File :01/82/050/01369/AM12/ RLA File :03/94/040/00125/AM12/ Lic.No/Date:0310683824 29.02.2012 Defer Date:18.04.2013 Decision :It was decided to call the firm for personal hearing on 26.4.2013 along with all the technical details sought earlier. The case was deferred for 26.4.2013. 36

Case No.:19/3/82ALC4/2012

04.04.2013 Status:Case Rejected HQ File :01/82/050/00023/AM13/ RLA File :03/94/040/01095/AM12/ Lic.No/Date:0310684494 02.03.2012 Defer Date: Decision :It was noticed that the case has already been closed in meeting no. 33 dated 21.3.2013. 37

Case No.:30/4/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00110/AM13/ RLA File :03/94/040/01096/AM12/ Lic.No/Date:0310684923 05.03.2012 Defer Date:02.05.2013 38

Case No.:33/4/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00113/AM13/ RLA File :03/94/040/01099/AM12/ Lic.No/Date:0310684919 05.03.2012 Defer Date:18.04.2013

Decision :It was decided to call the firm for Personal Hearing on 26.4.2013 along with the technical details sought earlier. The case was deferred for 26.4.2013. 39

Case No.:34/4/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00114/AM13/ RLA File :03/94/040/01077/AM12/ Lic.No/Date:0310684930 05.03.2012 Defer Date:18.04.2013 Decision :It was decided to call the firm for Personal Hearing on 26.4.2013 along with the technical details sought earlier. The case was deferred for 26.4.2013. 40

Case No.:1/4/82ALC4/2012

Party Name:BELCO PHARMA 04.04.2013 Status:Case Approved HQ File :01/82/050/00081/AM13/ RLA File :05/23/040/00485/AM12/ Lic.No/Date:0510319713 06.03.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 9/82 dated 31.5.2011, 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 Exp. Qty. Sl.No. Import items Qty. allowed Hydrocortisone Cream/Ointment 5 gm Tube 1 No. 1. Hydrocortisone Base 0.0510 gm/5 gm Tube Hydrocortisone Cream/Ointment 15 gm Tube 1 No. 1. Hydrocortisone Base 0.153 gm/15 gm Tube 41

Case No.:28/4/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00108/AM13/ RLA File :03/94/040/01102/AM12/ Lic.No/Date:0310684966 06.03.2012 Defer Date:18.04.2013 Decision :It was decided to call the firm for Personal Hearing on 26.4.2013 along with the technical details sought earlier. The case was deferred for 26.4.2013. 42

Case No.:29/4/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00109/AM13/ RLA File :03/94/040/01104/AM12/ Lic.No/Date:0310684961 06.03.2012 Defer Date:18.04.2013 Decision :It was decided to call the firm for Personal Hearing on 26.4.2013 along with the technical details sought earlier. The case was deferred for 26.4.2013.

Case No.:31/4/82ALC4/2012

04.04.2013 Status:Case Deferred

43 HQ File :01/82/050/00111/AM13/ RLA File :03/94/040/01101/AM12/ Lic.No/Date:0310684973 06.03.2012 Defer Date:18.04.2013 Decision :It was decided to call the firm for Personal Hearing on 26.4.2013 along with the technical details sought earlier. The case was deferred for 26.4.2013. 44

Case No.:41/4/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00121/AM13/ RLA File :03/94/040/01105/AM12/ Lic.No/Date:0310684976 06.03.2012 Defer Date:18.04.2013 Decision :It was decided to call the firm for Personal Hearing on 26.4.2013 along with the technical details sougth earlier. The case was deferred for 26.4.2013. 45

Case No.:61/4/82ALC4/2012

Party Name:ANUGRAHA CHEMICALS 04.04.2013 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:02.05.2013 46

Case No.:47/3/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00051/AM13/ RLA File :08/24/040/00285/AM12/ Lic.No/Date:0810109597 13.03.2012 Defer Date:02.05.2013 Decision :It was decided to remind the firm to furnish the following information: Import details for each export item. Master Batch Formula for each export product duly certified by Quality Control Incharge. 47

Case No.:71/3/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 04.04.2013 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:02.05.2013 Decision : Earlier the case was referred to Department of Industrial Policy and Promotion for their comments. However, it is decided in the meeting to send a copy of application to Petrochemicals Division of Department of Chemicals and Petrochemicals as the case pertains to them.

Case No.:39/11/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 04.04.2013 Status:Case Deferred

48 HQ File :01/82/050/00306/AM13/ RLA File :09/24/040/00600/AM12/ Lic.No/Date:0910051800 16.03.2012 Defer Date:02.05.2013 Decision :It was decided to remind the firm to furnish the following information: Complete technical details as per Appendix 33 Past production visavis actual consumption of raw materials duly certified by Central Excise Authorities. 49

Case No.:40/8/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 04.04.2013 Status:Case Approved HQ File :01/82/050/00232/AM13/ RLA File :07/24/040/00520/AM12/ Lic.No/Date:0710087119 20.03.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/549/2012PI(Norms) dated 14.1.2013, 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 Brexecam Tablets – No. of Tablets 615312 (Each tablet contains Beta Cyclodextrin 191.20 mg equivalent to 20 mg of Piroxicam) 1000 tablets 1. Piroxicam Betacyclodextrine BP/USP/EP (PiroxicamBetadex 20 gm 50

Case No.:76/4/82ALC4/2012

04.04.2013 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:02.05.2013 51

Case No.:9/11/82ALC4/2012

Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 04.04.2013 Status:Deffered HQ File :01/82/050/00276/AM13/ RLA File :34/24/040/00298/AM12/ Lic.No/Date:3410033741 29.03.2012 Defer Date:02.05.2013 Decision : It was decided to defer the case for 2.5.2013 for comments of Department of Pharmaceuticals. 52

Case No.:2/2/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 04.04.2013 Status:Case Deferred HQ File :01/82/050/00002/AM13/ RLA File :03/95/040/01032/AM12/ Lic.No/Date:0310688856 30.03.2012 Defer Date:02.05.2013 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 2.5.2013.

Case No.:3/2/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 04.04.2013 Status:Deffered HQ File :01/82/050/00003/AM13/ RLA File :03/95/040/01037/AM12/ Lic.No/Date:0310688874 30.03.2012 Defer Date:02.05.2013 Decision : It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 2.5.2013. 54

Case No.:4/7/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 04.04.2013 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:02.05.2013 55

Case No.:38/16/82ALC4/2012

Party Name:BRILLIANT BIO PHARMA LIMITED 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Biotechnology. 56

Case No.:3/11/82ALC4/2012

Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 04.04.2013 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:02.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide thier OM No. 35011/598/2012PI(Norms) dated 7.2.2013, it was decided to call from the firm the complete technical details as per Appendix 33. The case was deferred for 2.5.2013. 57

Case No.:50/3/83ALC1/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Biotechnology.

Case No.:10/11/82ALC4/2012

Party Name:AMI LIFESCIENCES P LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/00277/AM13/ RLA File :34/24/040/00012/AM13/ Lic.No/Date:3410033877 16.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/618/2012PI(Norms) dated

58 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/618/2012 PI(Norms) dated 12.3.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Doxofylline Description: White Crystalline Powder loss on Drying : NMT 1.0% W/W Assay by HPLC between 98% to 101% W/W (on dry basis) 1 kg 1. Theophylline Anhydrous Description: White Crystalline Powder Loss on drying: NMT0.5% W/W Assay: between 98.0% to 101.0% 0.80 kg 59

Case No.:18/11/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00285/AM13/ RLA File :22/24/040/00001/AM13/ Lic.No/Date:2210012759 24.04.2012 Defer Date:02.05.2013 Decision : A copy of application was sent to Department of Pharmaceuticals vide this office U.O dated 23.7.2012. However, as requested by Department of Pharmaceuticals, it was decided to send a copy of application again to Department of Pharmaceuticals for their comments. 60

Case No.:59/1/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 04.04.2013 Status:Case Approved HQ File :01/82/050/01417/AM13/ RLA File :02/24/040/00002/AM13/ Lic.No/Date:0210177059 30.04.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 25011/340/2012PI(Norms) dated 13.9.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed Noscapine BP/Noscapine Hcl BP 1 kg 1. Noscapine crude 95% 1.085 kg 61

Case No.:13/1/82ALC4/2013

Party Name:DSM ANTIINFECTIVES INDIA LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/01371/AM13/ RLA File :22/21/040/00024/AM13/ Lic.No/Date:2210012792 02.05.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/06/2013PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through enzymatic route Tech. Spec: ASSY not less than 84% as such or 96% on dr basis 1 kg 1. 6Amino Pencillanic Acide (6APA) 0.568 kg 2. Formidase (Enzyme) 0.005 kg 3. Methanol Not required in the process given by the fi

dry basis firm 4. D()PHydroxy Phenyl Glycine Methylester 0.608 kg 62

Case No.:51/1/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 04.04.2013 Status:Case Deferred HQ File :01/82/050/01409/AM13/ RLA File :02/24/040/00023/AM13/ Lic.No/Date:0210177494 11.05.2012 Defer Date:02.05.2013 63

Case No.:52/1/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 04.04.2013 Status:Case Deferred HQ File :01/82/050/01410/AM13/ RLA File :02/24/040/00024/AM13/ Lic.No/Date:0210177499 11.05.2012 Defer Date:02.05.2013 64

Case No.:21/14/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 04.04.2013 Status:Case Deferred HQ File :01/82/050/00398/AM13/ RLA File :05/23/040/00037/AM13/ Lic.No/Date:0510324671 14.05.2012 Defer Date:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Industrial Policy and Promotion. 65

Case No.:6/16/82ALC4/2012

Party Name:STELLENCE PHARMSCIENCE PVT LTD 04.04.2013 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:02.05.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33. The case was deferred for 2.5.2013. 66

Case No.:4/13/82ALC4/2012

Party Name:ATUL LIMITED, 04.04.2013 Status:Case Deferred HQ File :01/82/050/00339/AM13/ RLA File :08/24/040/00048/AM13/ Lic.No/Date:0810111728 17.05.2012 Defer Date:02.05.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 67

Case No.:29/14/82ALC4/2012

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 04.04.2013 Status:Case Deferred HQ File :01/82/050/00406/AM13/ RLA File :03/94/040/00705/AM12/ Lic.No/Date:0310695318 Defer

67 18.05.2012 Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for the comments of Department of Pharmaceuticals. 68

Case No.:29/16/82ALC4/2012

04.04.2013 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:02.05.2013 Decision :It was decided to remind the firm to furnish the requisite information/details within 15 days else their case would be closed. The case was deferred for 2.5.2013. 69

Case No.:30/14/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00407/AM13/ RLA File :03/94/040/00706/AM12/ Lic.No/Date:0310695305 18.05.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for 70

Case No.:31/14/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00408/AM13/ RLA File :03/94/040/00807/AM12/ Lic.No/Date:0310695310 18.05.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for 71

Case No.:32/14/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00409/AM13/ RLA File :03/94/040/00802/AM12/ Lic.No/Date:0310695307 18.05.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for 72

Case No.:33/14/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00410/AM13/ RLA File :03/94/040/00815/AM12/ Lic.No/Date:0310695316 18.05.2012 Defer Date:02.05.2013 Decision : The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for

Case No.:5/9/83ALC1/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 04.04.2013 Status:Case Deferred HQ File :01/83/050/00179/AM13/ RLA File :03/95/040/00088/AM13/ Lic.No/Date:0310695328 18.05.2012 Defer Date:02.05.2013 Decision :Department of Pharmaceuticals vide their OM No. 35011/646/2012PI(Norms) dated 12.3.2013 has advised to refer the case to Department of Biotechnology, who have earlier also owned this item. It was decided to send a copy of application to Department of Biotechnology for their Comments. The case was deferred for 2.5.2013. 74

Case No.:16/13/82ALC4/2012

Party Name:NIFTY LABS PVT LTD., 04.04.2013 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:02.05.2013 Decision :Department of Pharmaceuticals vide their OM No. 35011/580/2012PI(Norms) dated 6.2.2013 has informed that the export product does not match with the process/chemistry given by the firm. It was decided to convey the observations of Department of Pharmaceuticals to the firm with the request to give clarification at the earliest. The case was deferred for 2.5.2013. 75

Case No.:27/14/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00404/AM13/ RLA File :03/94/040/00804/AM12/ Lic.No/Date:0310695480 21.05.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for 76

Case No.:28/14/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00405/AM13/ RLA File :03/94/040/00805/AM12/ Lic.No/Date:0310695474 21.05.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for 77

Case No.:3/16/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 04.04.2013 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:02.05.2013 Decision :It was decided to give a final reminder to the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge along with composition of Paracetamol DC applied for import. The case was deferred for 2.5.2013.

Case No.:36/14/82ALC4/2012

04.04.2013 Status:Case Deferred

78 HQ File :01/82/050/00413/AM13/ RLA File :03/94/040/00811/AM12/ Lic.No/Date:0310695482 21.05.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for 79

Case No.:87/1/82ALC4/2013

04.04.2013 Status:Case Deferred HQ File :01/82/050/01445/AM13/ RLA File :03/94/040/00816/AM12/ Lic.No/Date:0310695487 21.05.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013 for 80

Case No.:11/13/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 04.04.2013 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:02.05.2013 81

Case No.:6/13/82ALC4/2012

Party Name:BHARAT PARENTERALS LTD, 04.04.2013 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:02.05.2013 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 2.5.2013. 82

Case No.:4/16/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 04.04.2013 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:02.05.2013 Decision :It was decided to give a final reminder to the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge along with composition of Paracetamol DC applied for import. The case was deferred for 2.5.2013. 83

Case No.:7/13/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00342/AM13/ RLA File :08/24/040/00062/AM13/ Lic.No/Date:0810111893 24.05.2012 Defer Date:02.05.2013

Case No.:12/13/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD Status:Case

84 04.04.2013 Deferred HQ File :01/82/050/00347/AM13/ RLA File :05/24/040/00061/AM13/ Lic.No/Date:0510325945 25.05.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 85

Case No.:46/16/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 04.04.2013 Status:Case Deferred HQ File :01/82/050/00482/AM13/ RLA File :07/21/040/00128/AM13/ Lic.No/Date:0710088534 30.05.2012 Defer Date:02.05.2013 Decision : It was decided to defer the case for 2.5.2013 for comments of Department of Pharmaceuticals. 86

Case No.:45/14/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 04.04.2013 Status:Case Rejected HQ File :01/82/050/00422/AM13/ RLA File :03/95/040/00081/AM13/ Lic.No/Date:0310699034 18.06.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished the information despite repeated reminders. 87

Case No.:68/1/82ALC4/2013

Party Name:PARAMOUNT PHARMA 04.04.2013 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:02.05.2013 88

Case No.:49/1/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 04.04.2013 Status:Case Approved HQ File :01/82/050/01407/AM13/ RLA File :02/24/040/00054/AM13/ Lic.No/Date:0210178880 25.06.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 25011/340/2012PI(Norms) dated 13.9.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed Noscapine BP/Noscapine Hcl BP 1 kg 1. Noscapine crude 95% 1.085 kg 89

Case No.:31/13/82ALC4/2012

Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/00366/AM13/ RLA File :03/95/040/00055/AM13/ Lic No/Date:0310699970 Defer

89 HQ File :01/82/050/00366/AM13/ RLA File :03/95/040/00055/AM13/ Lic.No/Date:0310699970 27.06.2012 Defer Date:02.05.2013 90

Case No.:58/1/82ALC4/2013

Party Name:ROHAN DYES AND INTERMEDIATES LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01416/AM13/ RLA File :08/24/040/00225/AM11/ Lic.No/Date:0810113534 19.07.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 23.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import items Qty. allowed 4,4 Diamino Sulphanilide 1 kg. 1. Aniline Oil 0.458 kg 2. Acetic Acid 0.317 kg 3. Para Nitro Aniline 0.728 kg 4. Caustic Soda Flakes 0.545 kg 5. Soda Ash 0.350 kg 91

Case No.:20/24/82ALC4/2012

Party Name:DECCAN NUTRACEUTICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00824/AM13/ RLA File :31/83/040/00058/AM13/ Lic.No/Date:3110055158 27.07.2012 Defer Date:02.05.2013 Decision :It was decided to remind the firm to furnish the full description of the export product along with copy of relevant pharmacopiea within 15 days else their case would be closed. The case was deferred for 2.5.2013. 92

Case No.:15/20/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 04.04.2013 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:02.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/632/2012PI(Norms) dated 12.3.2013, it was decided call the technical details from the firm as per Appendix 33 mainly Mol. wt. of imported inputs and % yield on molar basis along with copy of relevant technical literature. The case was deferred for 2.5.2013. 93

Case No.:16/20/82ALC4/2012

04.04.2013 Status:Case Approved HQ File :01/82/050/00627/AM13/ RLA File :05/24/040/00150/AM13/ Lic.No/Date:0510331127 01.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/626/2012PI(Norms) dated 12.3.2013, 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 Candesartan Cilexetil 1 kg 1. 1chloroethyl chloroformate 0.45 kg 2 4 (Bromomethyl) 2 1 66 kg

4(Bromomethyl)2 cyanobiphenyl 1.66 kg 3. Acetone 3.45 kg 4. Acetonitrile 2.50 kg 5. Activated Carbon 0.100 kg 6. Cyclohexane 5.88 kg 7. Dimethyl formamide 1.52 kg 8. Ethyl acetate 10.00 9. Formic Acid 1.30 kg 10. Iso Propyl Alcohol 0.50 kg 11. Methanol 10.00 kg 12. Methylene Chloride 5.00 kg 13. Tertiary butanol 2.00 kg 14. Tetra ethyl ortho carbonate 1.19 kg 15 Tetra butyl ammonium bromide (TBAB) 0.18 kg 16. Toluene 5.00 kg 17 Triethylamine 0.31 kg 94

Case No.:18/20/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/00629/AM13/ RLA File :09/24/040/00223/AM13/ Lic.No/Date:0910053402 01.08.2012 Defer Date:02.05.2013 95

Case No.:50/1/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 04.04.2013 Status:Case Approved HQ File :01/82/050/01408/AM13/ RLA File :02/24/040/00074/AM13/ Lic.No/Date:0210180511 02.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 25011/340/2012PI(Norms) dated 13.9.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed Noscapine BP/Noscapine Hcl BP 1 kg 1. Noscapine crude 95% 1.085 kg 96

Case No.:47/16/82ALC4/2012

Party Name:PARAMOUNT PHARMA 04.04.2013 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:02.05.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments The case was deferred for

Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 97

Case No.:48/16/82ALC4/2012

Party Name:PARAMOUNT PHARMA 04.04.2013 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:02.05.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 98

Case No.:26/22/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00729/AM13/ RLA File :09/24/040/00243/AM13/ Lic.No/Date:0910053480 10.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/102/2012Ch. II dated 8.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed 5Nitro Benzimidazole Base or Jarocol 5NBI 1 kg 1. 4NitroOPhenylene Diamine (4 NOPD) 1.250 kg 2. Sodium Hypo Chlorite (NaOCI) 0.625 kg 99

Case No.:68/22/82ALC4/2012

Party Name:GITANJALI CHEMICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00771/AM13/ RLA File :03/94/040/00209/AM13/ Lic.No/Date:0310705334 16.08.2012 Defer Date:02.05.2013 100

Case No.:32/22/82ALC4/2012

Party Name:SYMBIOTEC PHARMALAB LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/00735/AM13/ RLA File :56/24/040/00017/AM13/ Lic.No/Date:5610000974 24.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/666/2012PI(Norms) dated 12.3.2013, 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 Methylpredisolone Sodium Succinate for injection USP for manufacturers use (Methylprednisolone Sodium Succinate Buffered 3% Sterile) 1 kg 1 Methylprednisolone Hemisuccinate USP Organic Chemicals 0.966 kg

101

Case No.:32/24/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00836/AM13/ RLA File :09/24/040/00248/AM13/ Lic.No/Date:0910053559 24.08.2012 Defer Date:02.05.2013 102

Case No.:33/24/82ALC4/2012

04.04.2013 Status:Case Approved HQ File :01/82/050/00837/AM13/ RLA File :09/24/040/00247/AM13/ Lic.No/Date:0910053560 24.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/65/2013PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Pregabalin 1 kg 1. (+/)3(Carbamoyl)5 Methylhexanoic acid ((+/) CMH Acid) 2.94 kg 2. ®(+)aPhenyl ethyl amine 0.114 kg 3. Isopropyl alcohol 0.96 lit/kg 103

Case No.:37/22/82ALC4/2012

Party Name:FDC LTD 04.04.2013 Status:Deffered HQ File :01/82/050/00740/AM13/ RLA File :03/94/040/00374/AM13/ Lic.No/Date:0310706515 27.08.2012 Defer Date:02.05.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/07/2013PI(Norms) dated 1.4.2013, it was decided to call from the firm a copy of Drug Manufacturing License along with list of approved items showing composition of Oral Rehydrat Salt. The case was deferred for 2.5.2013. 104

Case No.:41/24/82ALC4/2012

Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00845/AM13/ RLA File :09/24/040/00256/AM13/ Lic.No/Date:0910053578 27.08.2012 Defer Date:02.05.2013 105

Case No.:30/24/82ALC4/2012

Party Name:MSN LABORATORIES LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00834/AM13/ RLA File :09/24/040/00271/AM13/ Lic.No/Date:0910053602 28.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/73/2013PI(Norms) dated

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/73/2013 PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Rosuvastatin Calcium 1 kg 1. (4RCis)6 [(acetyloxy)methyl]2,2 dimethyl1,3dioxane4acetic acid, 1,1dimethyl ethyl ester 1.871 kg 2. Diisobutylaluminum Hydride 25% in Toluene (Dibah 25% in Toluene) 2.79 kg 106

Case No.:12/24/82ALC4/2012

Party Name:HETERO LABS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00816/AM13/ RLA File :09/24/040/00275/AM13/ Lic.No/Date:0910053624 29.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/70/2013PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Emtricitabine 1 kg 1. Glyoxylic acid (50%) 2.234 kg 2. 2,5dihydroxy1,4dithiane 0.90 kg 3. 5Fluoro cytosine 1.348 kg 4. Hexamethyl disilazane 1.86 kg 5. Dimethyl formamide 1.00 kg 107

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

04.04.2013 Status:Case Approved HQ File :01/82/050/00828/AM13/ RLA File :09/24/040/00220/AM13/ Lic.No/Date:0910053621 29.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/65/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Quinapril Hydrochloride 1 kg 1. N(1(S)Ethoxy Carbonyl3 Phentyl)LAlanine 0.88 kg 2. TIQBenzyl Ester PTSA Salt (Benzyl(S) 1,2,3,4Tetrahydro 3Isoquinoline 1.263 kg 3. Methylene Dichloride 10.21 kg 4. 1,3Dicyclohexyl Carbomide 0.59 kg 5. HOBT (1, Hydroxy Benzotriazole) 0.39 kg 6. Triethylamine 0.144 kg 7. Tetrahydrofuran 5.91 kg 8. Iso Propyl Ether 0.171 kg 9 Acetonitrile 0 114 kg

Acetonitrile 0.114 kg 108

Case No.:26/24/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00830/AM13/ RLA File :09/24/040/00246/AM13/ Lic.No/Date:0910053623 29.08.2012 Defer Date:02.05.2013 109

Case No.:28/24/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00832/AM13/ RLA File :09/24/040/00274/AM13/ Lic.No/Date:0910053628 29.08.2012 Defer Date:02.05.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/40/2013PI(Norms) dated 1.4.2013, it was decided to call from the firm the following technical details/clarifications:  Both import and export products have same API.  The firm has shown export product as Crystalline whereas as per COA furnished by the firm, export product is Fine White Powder.  There is no justification given in the details furnished by the firm, for 40% wastage on API and 27.65 kg of Acetone requirement against 1 kg export. 110

Case No.:30/22/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00733/AM13/ RLA File :07/24/040/00237/AM13/ Lic.No/Date:0710090496 30.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/36/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Bromazepam 1 kg 1. 2Amino Benzonitrile 0.99 kg 111

Case No.:4/20/82ALC4/2012

04.04.2013 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:02.05.2013

Case No.:29/28/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED Status:Case

112 04.04.2013 Deferred HQ File :01/82/050/00996/AM13/ RLA File :09/70/040/00061/AM13/ Lic.No/Date:0910053637 31.08.2012 Defer Date:02.05.2013 113

Case No.:28/28/82ALC4/2012

04.04.2013 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:02.05.2013 114

Case No.:42/22/82ALC4/2012

04.04.2013 Status:Case Approved HQ File :01/82/050/00745/AM13/ RLA File :03/94/040/00116/AM13/ Lic.No/Date:0310707575 04.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/686/2012PI(Norms) dated 12.3.2013, 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 Silyl Ester (2,4OBis (trimethylsilyl) erythromycinA9[O(1 methoxy1methyl ethyl) oxime 1 kg 1. Erythromycin Thiocyanate (on 100% Activity Basis) 0.86 kg 2. Hydroxylamine Hydrochloride 0.377 kg 3. 2Methoxy Propene 0.233 kg 115

Case No.:43/22/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00746/AM13/ RLA File :03/94/040/00101/AM13/ Lic.No/Date:0310707592 04.09.2012 Defer Date:02.05.2013 Decision :It was decided to remind the firm to furnish the technical details as per Appendix 33. The case was deferred for 2.5.2013. 116

Case No.:10/22/82ALC4/2012

Party Name:DIVIS LABORATORIES LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/00713/AM13/ RLA File :09/24/040/00281/AM13/ Lic.No/Date:0910053672 05.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/50/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed 3OAcetyl1,6Anhydro2 1 kg 1. Acetonitrile 4.37 kg

y y Azido2Deoxy4O(Methyl 2,3DiOBenzylBetaD glucopyranosyluronate) BetaDGlucopyranose g g 2. bDGlucopyranose, 1,6 Anhydro2Azido4O[2,3BIS OPhenylmethyl4,6O PhenylmethylenebD glucopyranosyl]2Deoxy 3OAC. 2.47 kg 3. 2,2,6,6Tetramethylpiperidine 1Oxyl (Tempo) 0.019 kg 117

Case No.:40/26/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00948/AM13/ RLA File :09/24/040/00254/AM13/ Lic.No/Date:0910053671 05.09.2012 Defer Date:02.05.2013 118

Case No.:44/24/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 04.04.2013 Status:Approved HQ File :01/82/050/00848/AM13/ RLA File :09/24/040/00251/AM13/ Lic.No/Date:0910053668 05.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/84/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Pregabalin 1 kg 1. R()3(Carbamoyl Methyl5 Methylhexanoic acid 1.47 kg 119

Case No.:25/26/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00933/AM13/ RLA File :09/24/040/00283/AM13/ Lic.No/Date:0910053686 06.09.2012 Defer Date:02.05.2013 120

Case No.:81/22/82ALC4/2012

Party Name:BHARAT CHEMICALS 04.04.2013 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:02.05.2013 121

Case No.:21/24/82ALC4/2012

Party Name:TORRENT PHARMACEUTICALS Meet No/Date:1/82ALC4/2013 Status:Case

121

Case No.:21/24/82 ALC4/2012

Party Name:TORRENT PHARMACEUTICALS LTD. Meet No/Date:1/82 ALC4/2013 04.04.2013 Status:Case Approved HQ File :01/82/050/00825/AM13/ RLA File :08/24/040/00196/AM13/ Lic.No/Date:0810114835 07.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/69/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Valsartan Tablets USP 40 mg (Pack Size 90 tablets) Each film coated tablet contains Valsartan UPS 40 mg, 1 no. of Tablet 1. Valsartan 40.8 mg Valsartan Tablets USP 80 contains: Valsartan USP 80 mg 1 no. of Tablet 1. Valsartan 81.60 mg Valsartan Tablets USP 160 contains: Valsartan USP 160 mg 1 no. of Tablet 1. Valsartan 163.20 mg Valsartan Tablets USP 320 contains: Valsartan USP 320 mg 1 no. of Tablet 1. Valsartan 326.4 mg Amlodipine and Valsartan Tablets 5/160 mg (Pack size 30 Tablets) Amlodipine Besylate USP eq. to Amlodipine 5 mg Valsartan USP 160 mg 1 no. of Tablet 1. Valsartan 163.20 mg Amlodipine and Valsartan Tablets 5/320 mg (Pack size 30 tablets) Each film coated tablet contains Amlodipine Besylate USP eq. to Amlodipine 5 mg Valsartan USP 320 mg. 1 no. of Tablet 1. Valsartan 326.4 mg Amlodipine and Valsartan Tablets 10/160 mg (Pack size 30 tablets) Each film coated tablet contains eq. to Amlodipine 10 mg Valsartan USP 160 mg. 1 no. of Tablet 1. Valsartan 163.20 mg Amlodipine and Valsartan Tablets 10/320 mg (Pack size 30 tablets) Each film coated tablet contains 1 no. of Tablet 1. Valsartan 326.4 mg

coated tablet contains Valsartan USP 320 mg. Amlodipine, valsartan and Hydrochlorothiazide Tablets 5/160/12.5 mg (Pack size 30 tablets) each film coated tablet contains: eq. to Amlodipine 5 mg Valsartan USP 160 mg, Hydrochlorothiazide USP 12.5 mg 1 no. of Tablet 1. Valsartan 163.2 mg Hydrochlorothiazide Tablets 5/160/25 mg (Pack size 30 tablets) each film coated tablet contains: eq. to Amlodipine 5 mg Hydrochlorothiazide USP 25 mg 1 no. of Tablet 1. Valsartan 163.2 mg Hydrochlorothiazide Tablets 10/160/12.5 mg Hydrochlorothiazide USP 12.5 mg 1 no. of Tablet 1. Valsartan 163.2 mg Hydrochlorothiazide Tablets 10/160/25 mg Hydrochlorothiazide USP 25 mg 1 no. of Tablet 1. Valsartan 163.2 mg Hydrochlorothiazide Tablets 10/320/25 mg eq to Amlodipine 10 mg 1 no. of Tablet 1. Valsartan 326.4 mg

Valsartan USP 320 mg, Hydrochlorothiazide USP 25 mg 122

Case No.:35/26/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, 04.04.2013 Status:Case Deferred HQ File :01/82/050/00943/AM13/ RLA File :09/24/040/00297/AM13/ Lic.No/Date:0910053714 07.09.2012 Defer Date:02.05.2013 123

Case No.:46/22/82ALC4/2012

Party Name:LUPIN LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00749/AM13/ RLA File :03/95/040/00306/AM13/ Lic.No/Date:0310708068 07.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/10/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Lamivudine 150 MG+Zidovudine 300 MG Tabs (Net Weight 4500 kgs, weight of drug 4590 kgs] 1 tablet 1. Zidovudine 306.0 mg 2. Lactose Monohydrate (DMV INT DCL 11) 118.50 mg 3. DCP (Dihydrate/Ditab/Rhodia) 29.625 mg 4. Sodium Starch Glycolate (Primogel Type A) 131.0 mg 5. Povidine (K30 BASF) 15.0 mg 6. Magnesium Stearate Veg. Grade 5.625 mg 7. 33 MM CR closure with HS 12335 PRT KERR Relevant, as per packing policy 124

Case No.:77/22/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00780/AM13/ RLA File :03/94/040/00436/AM13/ Lic.No/Date:0310708090 07.09.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for thier comments. The case was deferred for 2.5.2013 for comments of Department of Pharmaceuticals. 125

Case No.:17/22/82ALC4/2012

04.04.2013 Status:Case Approved HQ File :01/82/050/00720/AM13/ RLA File :08/24/040/00199/AM13/ Lic.No/Date:0810114964 10.09.2012 Defer Date:

Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/54/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Azithromycin Zydus (Zythrocin) 250 mg tablets 1 tablet of 250 mg 1. Azithromycin Dihydrate 259.50 mg Azithromycin Zydus 250 mg tablets (Cristers) (Active Ingredient: Azithromycin Dihydrate: 265.50 kgs) 1 tablet of 250 mg 1. Azithromycin Dihydrate 259.50 mg 126

Case No.:11/22/82ALC4/2012

Party Name:HONEST BIOVET PVT. LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/00714/AM13/ RLA File :08/24/040/00208/AM13/ Lic.No/Date:0810115029 12.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/672/2012PI(Norms) dated 12.3.2013, 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 Menadione Sodium Bisulphite Complex (Feed Supplement) (MSB 65%) 1 kg 1. Beta Methyl Naphthalene 0.88 kg 2. Sodium Dichromate 1.62 kg 3. NButanol 0.28 kg 127

Case No.:12/22/82ALC4/2012

Party Name:HONEST BIOVET PVT. LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/00715/AM13/ RLA File :08/24/040/00206/AM13/ Lic.No/Date:0810115027 12.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/672/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Menadione Nicotinamide Bisulphite (Feed Supplement) 1 kg 1. Beta Methyl Naphthalene 1.24 kg 2. NButanol 0.40 kg 3 Sodium Dichromate 2.29 kg 4. Niacinamide 0.40 kg 128

Case No.:13/22/82ALC4/2012

Party Name:HONEST BIOVET PVT. LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/00716/AM13/ RLA File :08/24/040/00207/AM13/ Lic.No/Date:0810115028 12.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/707/2012PI(Norms) dated

g p ( ) 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Medione Dimethyl Pyrimidinol Bisulphite (Feed Supplement) 1 kg 1. Beta Methyl Naphthalene 1.24 kg 2. NButanol 0.4 kg 3. Sodium Dichromate 2.29 kg 4. Acetyl Acetone 0.4 kg 129

Case No.:21/1/82ALC4/2013

Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 04.04.2013 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:02.05.2013 130

Case No.:50/22/82ALC4/2012

Party Name:SARNA CHEMICALS PVT.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/00753/AM13/ RLA File :52/24/040/00014/AM13/ Lic.No/Date:5210038997 12.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/48/2008Ch. II dated 3.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed 4(2Chloro Ethylsulfonyl Butyril chloride)/Schwander Acid Chloride 1 kg 1. YButyrolactone (Gamma Butyrolactone) 0.658 kg 2. Isopropyl Alcohol 0.687 kg 3. Caustic Soda Flakes 1.058 kg 4. 2 Mercapto Ethanol 0.683 kg 5. Thionyl Chloride 1.770 kg 131

Case No.:96/22/82ALC4/2012

Party Name:ACTGEN PHARMA PVT. LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/00799/AM13/ RLA File :03/94/040/00476/AM13/ Lic.No/Date:0310708985 13.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/02/2013PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Levofloxacin Hemihydrate 1 kg 1. Levofloxacin Q Acid 0.8571 kg 2. Dimethyl Suphoxide 0.2193 kg 3. Dimethyl Formamide Not required in the process 4. N Methyl Piperazine 0.432 kg

132

Case No.:14/24/82ALC4/2012

Party Name:HETERO LABS LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00818/AM13/ RLA File :09/24/040/00306/AM13/ Lic.No/Date:0910053810 14.09.2012 Defer Date:02.05.2013 133

Case No.:24/26/82ALC4/2012

Party Name:ECOLOGIC CHEMICALS LIMITED 04.04.2013 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:02.05.2013 134

Case No.:31/26/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 04.04.2013 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:02.05.2013 135

Case No.:32/28/82ALC4/2012

Party Name:STERICON PHARMA PVT.LTD., 04.04.2013 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:02.05.2013 Decision :Department of Pharmaceuticals vide their OM No. 35011/655/2012PI(Norms) dated 12.3.2013 has informed that 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. The case was deferred for 2.5.2013. 136

Case No.:89/22/82ALC4/2012

04.04.2013 Status:Case Approved HQ File :01/82/050/00792/AM13/ RLA File :22/24/040/00035/AM13/ Lic.No/Date:2210013297 19.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/597/2012PI(Norms) dated 6.2.2013, 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 Cefepime for Injection (Cefepime HCL+LArginine in 68:32 ratio) “The export product shall 1 kg 1. Cefepime HCL Non Sterile 0.655 kg 2. LArginine 0.37 kg 3. Acetone (89.6% Rec.) 1.816 kg 4 Methanol 0 742 kg

The export product shall account for 287 Nos. Aluminium Bottole Anodized with Tear of alu & Chlorobutyl Plug 4. Methanol 0.742 kg 5. Eno Carbon 0.034 kg 6. Aluminium Bottle Anodized with Tear off alu cap & chlorobuty plug Relevant, as per packing policy RA may take appropriate action as per the packing policy. 137

Case No.:90/22/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 04.04.2013 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:02.05.2013 138

Case No.:10/24/82ALC4/2012

Party Name:VASISTA LIFE SCIENCES PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00814/AM13/ RLA File :09/24/040/00308/AM13/ Lic.No/Date:0910053881 21.09.2012 Defer Date: 16.05.2013 Decision :It was decided to defer the case for 16.5.2013 for comments of Department of Pharmaceuticals due to difference in description of export product. 139

Case No.:26/26/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 04.04.2013 Status:Case Approved HQ File :01/82/050/00934/AM13/ RLA File :07/24/040/00144/AM13/ Lic.No/Date:0710090859 21.09.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 39/82 dated 28.12.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Qty. Sl.No. Import items Qty. allowed Magnesium LAspartate 1 Kg. 1. LAspartic Acid 1.02 kg Calcium LAspartate 1 Kg. 1. LAspartic Acid 0.932 kg Zinc LAspartate 1 Kg. 1. LAspartic Acid 0.896 kg 140

Case No.:38/26/82ALC4/2012

Party Name:VASISTA LIFE SCIENCES PVT LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/00946/AM13/ RLA File :09/24/040/00309/AM13/ Lic.No/Date:0910053880 21.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/98/2012Ch.II dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Methyl Magnesium Chloride 3 M in THF 1 kg 1. Tetrahydrofuran 0.780 kg 2 Magnesium Metal 0 072 kg

Chloride 3 M in THF 2. Magnesium Metal 0.072 kg 141

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

Party Name:OGENE SYSTEMS INDIA PVT. LTD. 04.04.2013 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:02.05.2013 142

Case No.:28/26/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 04.04.2013 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:02.05.2013 143

Case No.:37/26/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00945/AM13/ RLA File :09/24/040/00319/AM13/ Lic.No/Date:0910053895 25.09.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/102/2012Ch.II dated 7.3.2013, 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 Jarocol TDS 1 kg 1. Di Aminotoluene Sulfate 1.102 kg 2. NaOH (Caustic Soda) 0.441 kg 3. Carbon 0.036 kg 4. H2SO4(Sulfuric Acid) 0.496 kg 144

Case No.:43/24/82ALC4/2012

04.04.2013 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:02.05.2013 Decision :In the light of written comments received from Department of Pharamceuticals vide thier OM No. 35011/76/2013PI(Norms) dated 1.4.2013, it was decided to call from the firm the 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.

145

Case No.:15/1/82ALC4/2013

Party Name:BAL PHARMA LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/01373/AM13/ RLA File :07/24/040/00267/AM13/ Lic.No/Date:0710091002 27.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/680/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Amiloride HCL 1 kg 1. Methyl 3,5Diamino6Chloro Pyrazine2Carboxylate 0.836 kg 2. Guanidine HCL 0.40 kg 146

Case No.:36/26/82ALC4/2012

Party Name:AKTINOS PHARMA PVT LTD, 04.04.2013 Status:Case Deferred HQ File :01/82/050/00944/AM13/ RLA File :09/24/040/00321/AM13/ Lic.No/Date:0910053915 27.09.2012 Defer Date:02.05.2013 147

Case No.:37/24/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00841/AM13/ RLA File :09/24/040/00289/AM13/ Lic.No/Date:0910053917 27.09.2012 Defer Date:02.05.2013 148

Case No.:1/23/82ALC4/2012

04.04.2013 Status:Case Approved HQ File :01/82/050/00801/AM13/ RLA File :05/24/040/00235/AM13/ Lic.No/Date:0510336113 28.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/62/2013PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Orlistat 1 kg 1. (S)()2,2Bis (diphenylphosphino)1,1 binaphthyl 0.003 kg 2. 2 methoxy propene 3.246 kg 3. Acetone 3.82 kg 4. Activated Carbon 0.100 kg 5 Dicyclohexyl carbodiimide 1 003 kg

Dicyclohexyl carbodiimide 1.003 kg 6. Diisobutyl Aluminium Hydride 6.606 kg 7. Dimethyl Formamide 0.057 kg 8. Formic Acid 0.52 kg 9. LLeucine 0.46 kg 10. Lithium Hexamethyldisilazide in THF (Undistilled) 1.971 kg 11. Methylene Chloride 12.23 kg 12. Meldrum Acid 2.095 kg 13. Methanol 19.45 kg 14. NHexane 4.15 kg 15. NOctanoyl Benzotriazole 2.809 kg 16. Palladium sponge 0.0004 kg 17. Pivaloyl Chloride 0.841 kg 18. Pyridine 0.58 kg 19. Dichloro(pcymene)ruthenium (II)dimer 0.001 kg 20. Tetrahydrofuran 4.53 kg 21. Toluene 12.78 kg 22. Triethylamine 0.774 kg 149

Case No.:36/24/82ALC4/2012

Party Name:MSN PHARMACHEM PRIVATE LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00840/AM13/ RLA File :09/24/040/00324/AM13/ Lic.No/Date:0910053933 28.09.2012 Defer Date:02.05.2013 150

Case No.:23/28/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00990/AM13/ RLA File :09/24/040/00318/AM13/ Lic.No/Date:0910053939 01.10.2012 Defer Date:02.05.2013 151

Case No.:16/26/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00924/AM13/ RLA File :03/94/040/00467/AM13/ Lic.No/Date:0310711374 03.10.2012 Defer Date:02.05.2013 152

Case No.:21/26/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00929/AM13/ RLA File :03/94/040/00077/AM13/ Lic.No/Date:0310711357 03 10 2012 Defer 02 0 2013

03.10.2012 Date:02.05.2013 153

Case No.:5/26/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00913/AM13/ RLA File :03/94/040/00014/AM13/ Lic.No/Date:0310711407 03.10.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 154

Case No.:6/26/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00914/AM13/ RLA File :03/94/040/00015/AM13/ Lic.No/Date:0310711401 03.10.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 155

Case No.:7/26/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00915/AM13/ RLA File :03/94/040/00794/AM12/ Lic.No/Date:0310711411 03.10.2012 Defer Date:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for their comments. The case was deferred for 2.5.2013. 156

Case No.:10/1/82ALC4/2013

Party Name:STERICON PHARMA PVT.LTD., 04.04.2013 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:02.05.2013 Decision :Department of Pharmaceuticals vide their OM No. 35011/655/2012PI(Norms) dated 12.3.2013 has pointed out that 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. The case was deferred for 2.5.2013. 157

Case No.:15/26/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00923/AM13/ RLA File :03/94/040/00493/AM13/ Lic.No/Date:0310711651 04.10.2012 Defer Date:02.05.2013 158

Case No.:17/26/82ALC4/2012

04.04.2013 Status:Case Deferred HQ File :01/82/050/00925/AM13/ RLA File :03/94/040/00468/AM13/ Lic.No/Date:0310711631 Defer

04.10.2012 Date:02.05.2013 159

Case No.:21/28/82ALC4/2012

Party Name:HETERO LABS LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00988/AM13/ RLA File :09/24/040/00331/AM13/ Lic.No/Date:0910053955 04.10.2012 Defer Date:02.05.2013 160

Case No.:45/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00849/AM13/ RLA File :05/23/040/00260/AM13/ Lic.No/Date:0510336434 04.10.2012 Defer Date:02.05.2013 161

Case No.:46/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00850/AM13/ RLA File :05/23/040/00256/AM13/ Lic.No/Date:0510336433 04.10.2012 Defer Date:02.05.2013 162

Case No.:50/24/82ALC4/2012

Party Name:INDO PHYTO CHEMICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00854/AM13/ RLA File :05/23/040/00255/AM13/ Lic.No/Date:0510336432 04.10.2012 Defer Date:02.05.2013 163

Case No.:33/22/82ALC4/2012

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 04.04.2013 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:02.05.2013 164

Case No.:17/28/82ALC4/2012

Party Name:DECCAN NUTRACEUTICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/00984/AM13/ RLA File :31/83/040/00117/AM13/ Lic.No/Date:3110056020 09.10.2012 Defer Date:02.05.2013

165

Case No.:56/24/82ALC4/2012

Party Name:AMI ORGANICS PVT LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/00860/AM13/ RLA File :52/24/040/00029/AM13/ Lic.No/Date:5210039086 09.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2012Ch. II dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed 4Hydroxy Coumarin 99% min. 1 kg 1. Ortho Hydroxy Hydroxyacetophenone98% Min. 0.950 kg 2. Dimethyl Carbonate98% Min. 1.654 kg 166

Case No.:57/24/82ALC4/2012

Party Name:AMI ORGANICS PVT LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/00861/AM13/ RLA File :52/24/040/00028/AM13/ Lic.No/Date:5210039089 09.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2012Ch. II dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed 1(2[2Hydroxy Ethoxy]Ethyl) Piperazine 99% Min. 1 kg 1. 2(2Chloro Ethoxy) Ethanol 98% Min. 1.100 kg 2. Piperazine Anhydrous 98% Min. 1.626 kg 167

Case No.:88/1/82ALC4/2013

04.04.2013 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:02.05.2013 168

Case No.:20/28/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/00987/AM13/ RLA File :09/24/040/00333/AM13/ Lic.No/Date:0910054047 12.10.2012 Defer Date:02.05.2013

Case No.:22/28/82ALC4/2012

Party Name:ASTRIX LABORATORIES LTD., 04.04.2013 Status:Case Deferred

169 HQ File :01/82/050/00989/AM13/ RLA File :09/24/040/00284/AM13/ Lic.No/Date:0910054046 12.10.2012 Defer Date:02.05.2013 170

Case No.:25/28/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/00992/AM13/ RLA File :09/24/040/00356/AM13/ Lic.No/Date:0910054051 12.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/102/2012Ch. II dated 7.3.2013, 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 Sodium Ascorbyl Phosphate or CVite 1 kg 1. (2R)2[(1S)1,2 Dimethoxyethyl]4,5 Dihydroxyfuran3One 1.110 kg 2. Methanol 2.664 kg 3. Potassium Carbonate 4.610 kg 171

Case No.:27/24/82ALC4/2012

Party Name:TORRENT PHARMACEUTICALS LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/00831/AM13/ RLA File :08/24/040/00241/AM13/ Lic.No/Date:0810115743 12.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/69/2012PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Valsartan Tablets USP 40 contains Valsartan UPS 40 mg, 1 no. of Tablet 1. Valsartan 40.8 mg Valsartan Tablets USP 80 contains: Valsartan USP 80 mg 1 no. of Tablet 1. Valsartan 81.60 mg Valsartan Tablets USP 160 contains: Valsartan USP 160 mg 1 no. of Tablet 1. Valsartan 163.20 mg Valsartan Tablets USP 320 contains: Valsartan USP 320 mg 1 no. of Tablet 1. Valsartan 326.4 mg

g Amlodipine and Valsartan Tablets 5/160 mg (Pack size 30 Tablets) Amlodipine Besylate USP eq. to Amlodipine 5 mg Valsartan USP 160 mg 1 no. of Tablet 1. Valsartan 163.20 mg Amlodipine and Valsartan Tablets 5/320 mg (Pack size 30 tablets) Each film coated tablet contains eq. to Amlodipine 5 mg Valsartan USP 320 mg. 1 no. of Tablet 1. Valsartan 326.4 mg Amlodipine and Valsartan Tablets 10/160 mg (Pack size 30 tablets) Each film coated tablet contains Valsartan USP 160 mg. 1 no. of Tablet 1. Valsartan 163.20 mg Amlodipine and Valsartan Tablets 10/320 mg (Pack size 30 tablets) Each film coated tablet contains Valsartan USP 320 mg. 1 no. of Tablet 1. Valsartan 326.4 mg Hydrochlorothiazide Tablets 5/160/12.5 mg eq. to Amlodipine 5 mg Hydrochlorothiazide USP 12.5 mg 1 no. of Tablet 1. Valsartan 163.2 mg Hydrochlorothiazide Tablets 5/160/25 mg (Pack size 30 tablets) each film coated tablet contains: eq. to Amlodipine 5 mg Hydrochlorothiazide USP 25 mg 1 no. of Tablet 1. Valsartan 163.2 mg Hydrochlorothiazide Tablets 10/160/12.5 mg fil t d t bl t t i 1 no. of Tablet 1. Valsartan 163.2 mg

Hydrochlorothiazide USP 12.5 mg Hydrochlorothiazide Tablets 10/160/25 mg Hydrochlorothiazide USP 25 mg 1 no. of Tablet 1. Valsartan 163.2 mg Hydrochlorothiazide Tablets 10/320/25 mg Valsartan USP 320 mg, Hydrochlorothiazide USP 25 mg 1 no. of Tablet 1. Valsartan 326.4 mg 172

Case No.:19/28/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/00986/AM13/ RLA File :09/24/040/00344/AM13/ Lic.No/Date:0910054092 15.10.2012 Defer Date:02.05.2013 173

Case No.:22/1/82ALC4/2013

Party Name:SHILPA MEDICARE LTD., 04.04.2013 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:02.05.2013 174

Case No.:30/28/82ALC4/2012

04.04.2013 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:02.05.2013

175

Case No.:54/24/82ALC4/2012

04.04.2013 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:02.05.2013 Decision :The reply received from the firm was sent to Department of Pharmaceuticals for thier comments. The case was deferred for 2.5.2013 176

Case No.:97/1/82ALC4/2013

Party Name:VIVIMED LABS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01455/AM13/ RLA File :09/24/040/00358/AM13/ Lic.No/Date:0910054125 17.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 29/AM 13 dated 24.1.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Octyl Dimethyl Para Amino Benzoic Acid 1 kg 1. Para Nitro Benzoic Acid (PNBA) 0.742 kg 2. 2Ethyl Hexanol 0.620 kg 3. Perchloro Ethylene (PCE) 0.555 kg 4. Methanol 0.727 kg 5. Hexane 0.577 kg 177

Case No.:24/28/82ALC4/2012

Party Name:KREATIVE ORGANICS (P) LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/00991/AM13/ RLA File :09/24/040/00348/AM13/ Lic.No/Date:0910054145 18.10.2012 Defer Date:02.05.2013 178

Case No.:41/26/82ALC4/2012

Party Name:AMI ORGANICS PVT LTD. 04.04.2013 Status:Case Deferred HQ File :01/82/050/00949/AM13/ RLA File :52/24/040/00030/AM13/ Lic.No/Date:5210039119 19.10.2012 Defer Date:02.05.2013 179

Case No.:50/28/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01017/AM13/ RLA File :03/95/040/00523/AM13/ Lic.No/Date:0310713233 19.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2012Ch. II d d 21 3 2013 i d id d if d P 4 7 f HBP 1 d il i b l li d b h fi hi h i l

179 dated 21.3.2013, 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 DADAS (4,4Diamino Diphenylamine Sulfate) 1 kg 1. 4,4Diamino Diphenylamine 2 Sulfonic Acid 1.260 kg 2. Activated Carbon 0.150 kg 180

Case No.:42/28/82ALC4/2012

Party Name:ZIM LABORATORIES LTD. 04.04.2013 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:02.05.2013 181

Case No.:89/1/82ALC4/2013

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 04.04.2013 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:02.05.2013 182

Case No.:12/28/82ALC4/2012

04.04.2013 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:02.05.2013 183

Case No.:14/1/82ALC4/2013

Party Name:R L FINE CHEM 04.04.2013 Status:Case Approved HQ File :01/82/050/01372/AM13/ RLA File :07/24/040/00286/AM13/ Lic.No/Date:0710091556 25.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 13.9.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Doxilamine Succinate BP/USP 1 Kg. 1. 2 Acetyl Pyridine 0.58 kg 2. Tetrahydrofuran 1.03 kg

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

Party Name:R L FINE CHEM 04.04.2013 Status:Case Approved HQ File :01/82/050/01374/AM13/ RLA File :07/24/040/00291/AM13/ Lic.No/Date:0710091552 25.10.2012 Defer Date: D i i I th li ht f li d i i t k i ti 16/82 d t d 16 8 2012 it d id d t tif d P 4 7 f HBP 1

184 Decision : In the light of earlier decision taken in meeting no. 16/82 dated 16.8.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Cyclobenzaprine Hcl 1 kg 1. 1 Bromo 3 Chloro Propane 0.95 kg 2. Tetra Hydro Furan 1.00 kg 3. Acetone Not allowed as not shown in process 185

Case No.:16/28/82ALC4/2012

Party Name:CADILA PHARMACEUTICALS LTD. 04.04.2013 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:02.05.2013 186

Case No.:17/1/82ALC4/2013

Party Name:R L FINE CHEM 04.04.2013 Status:Case Approved HQ File :01/82/050/01375/AM13/ RLA File :07/24/040/00288/AM13/ Lic.No/Date:0710091559 25.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 33/82 dated 21.3.2013, it was decided to ratify norms under Para 4.7 of HBP 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) Nortriptyline HCL BP/USP 1 kg 1 1,Bromo 3 Chloro Propane 0.96 2 Tetra Hydro Furan 0.71 3 Ethyl Chloro Formate 0.46 187

Case No.:49/28/82ALC4/2012

Party Name:S M B CORPORATION OF INDIA 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals.

Case No.:6/28/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:1/82ALC4/2013 Status:Case

188

Case No.:6/28/82 ALC4/2012

Meet No/Date:1/82 ALC4/2013 04.04.2013 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:02.05.2013 189

Case No.:1/24/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 04.04.2013 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:02.05.2013 190

Case No.:10/28/82ALC4/2012

04.04.2013 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:02.05.2013 191

Case No.:102/1/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 04.04.2013 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:02.05.2013 192

Case No.:45/26/82ALC4/2012

Party Name:PAYAL POLYPLAST PVT.LTD., 04.04.2013 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:02.05.2013 193

Case No.:8/28/82ALC4/2012

Party Name:MSN LABORATORIES LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00975/AM13/ RLA File :09/24/040/00379/AM13/ Lic.No/Date:0910054186 29.10.2012 Defer Date:02.05.2013 194

Case No.:3/24/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00807/AM13/ RLA File :09/24/040/00332/AM13/ Lic.No/Date:0910054196 30 10 2012 Defer Date:02 05 2013

30.10.2012 Date:02.05.2013 195

Case No.:36/28/82ALC4/2012

Party Name:PI INDUSTRIES LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/01003/AM13/ RLA File :13/24/040/00035/AM13/ Lic.No/Date:1310041436 30.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/6/2010Ch. II dated 15.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ethyl 4Chloro2 Fluoro5[({isopropryl (methyl)amino]sulfonyl}amino) carbonyl]phenylcarbamate (PCM) 1 kg 1. 2Chloro4Fluoro Toluene 0.615 kg 2. Methyl Iso Propyl Amine 0.346 kg 3, CF 1082 BV/W 1% PT+2%V (Pt/C Catalyst(+1%PT+2%V/C, 64% H2O)) 0.008 kg 4. Methanol 0.743 kg 5. Toluene 0.743 kg 6. Ethyl Chloroformate 0.370 kg 7. Sulfuryl Chloride 0.715 kg 196

Case No.:43/28/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 04.04.2013 Status:Case Deferred HQ File :01/82/050/01010/AM13/ RLA File :03/95/040/00561/AM13/ Lic.No/Date:0310713820 30.10.2012 Defer Date:02.05.2013 197

Case No.:47/28/82ALC4/2012

Party Name:YASHO INDUSTRIES PVT.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01014/AM13/ RLA File :03/95/040/00580/AM13/ Lic.No/Date:0310713891 30.10.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Yantq 3030B (30% solution of tertiary Butyl Hydroquinone) 1 kg 1. Hydroquinone 0.423 kg 2. Tertiary Butanol 0.312 kg 3. Propylene Glycol 0.700 kg

Case No.:37/28/82ALC4/2012

Party Name:DEEPAK NITRITE LIMITED 04.04.2013 Status:Case Deferred HQ Fil 01/82/050/01004/AM13/ RLA Fil 34/24/040/00015/AM13/ Li N /D t 3410035376 D f

198 HQ File :01/82/050/01004/AM13/ RLA File :34/24/040/00015/AM13/ Lic.No/Date:3410035376 31.10.2012 Defer Date:02.05.2013 Decision :It was decided to call from the firm the following technical details: Manufacturing process in brief. Balanced chemical reaction showing all the reactants, product and by product with thier molecular formula and molecular weight Stagewise % yield on molecular weight basis along with justification supported with authentic/printed technical literature. Complete material balance Photocopy of the earlier norms fixed by ALC for same export item in the recent past. Production of export item in the past 3 years and corresponding consumption of each input duly certified by Chartered Accountant The case was deferred for 2.5.2013.. 199

Case No.:4/24/82ALC4/2012

Party Name:VIVIN LABORATORIES PRIVATE LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00808/AM13/ RLA File :09/24/040/00362/AM13/ Lic.No/Date:0910054208 31.10.2012 Defer Date:02.05.2013 200

Case No.:7/24/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 04.04.2013 Status:Case Deferred HQ File :01/82/050/00811/AM13/ RLA File :34/24/040/00168/AM13/ Lic.No/Date:3410035379 31.10.2012 Defer Date:02.05.2013 201

Case No.:20/1/82ALC4/2013

Party Name:SHILPA MEDICARE LTD., 04.04.2013 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:02.05.2013 202

Case No.:39/28/82ALC4/2012

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01006/AM13/ RLA File :34/24/040/00184/AM13/ Lic.No/Date:3410035411 01.11.2012 Defer Date:02.05.2013 Decision :It was decided to call from the firm the following technical details: 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. 203

Case No.:46/28/82ALC4/2012

Party Name:ZENITH DYEINTERMEDIATES LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01013/AM13/ RLA File :03/95/040/00571/AM13/ Lic.No/Date:0310714165 02.11.2012 Defer Date:02.05.2013 Decision :Department of Chemicals and Petrochemicals vide tier letter dated 26.3.2013 has requested the firm to furnish the following information: Balanced chemical reaction showing all the reactants, products and by products with thier Mol. Formula & Mol. Wt. Stagewise % yield on Mol. Wt. basis along with justification supported with authentic/printed technical literature. Complete material balance. Composition of export item giving % of each constituent and % pigment content. Production of export item for the past two years up to March, 2013 and corresponding consumption of each input duly certified by CA. It was decided to remind the firm to furnish the above information. The case was deferred for 2.5.2013 204

Case No.:48/28/82ALC4/2012

Party Name:YASHO INDUSTRIES PVT.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01015/AM13/ RLA File :03/95/040/00594/AM13/ Lic.No/Date:0310714182 02.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Zinc Piperidine Dithiocarbamate (ZPD) 1 kg 1. Piperidine 0.542 kg 205

Case No.:22/26/82ALC4/2012

Party Name:RELIANCE INDUSTRIES LTD. 04.04.2013 Status:Case Deferred HQ File :01/82/050/00930/AM13/ RLA File :03/95/040/00370/AM13/ Lic.No/Date:0310714238 05.11.2012 Defer Date:04.04.2013 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their OM No. 46011/06/2013PC II dated 8.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Benzene 1 MT 1 Reformate 0.866 MT

Case No.:33/28/82ALC4/2012

Party Name:DHARUHERA PHARMACEUTICALS PVT LTD 04.04.2013 Status:Case Deferred

206 HQ File :01/82/050/01000/AM13/ RLA File :05/23/040/00264/AM13/ Lic.No/Date:0510338287 05.11.2012 Defer Date:02.05.2013 207

Case No.:41/28/82ALC4/2012

Party Name:PREGNA INTERNATIONAL LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01008/AM13/ RLA File :03/95/040/00444/AM13/ Lic.No/Date:0310714240 05.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their OM No. 46011/22/2008PC II dated 8.2.2013, 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 Intra Uterine Contraceptive Device CU 380 AG 1 No. 1. Copper Wire with Silver core 0.000455 kg 2. HDPE Granules 0.000130 kg 3. Pouches (Plastic) Net +10% 4. Compound of LDPE Resin and Barium Sulphate 0.000560 kg `5. PVC Granules 0.000736 kg 6. HDPE Granules (or Nylon Resin) Medical Grade 0.000059 kg 7. Polypropylene Granules 0.002092 kg Intra Uterine Contraceptive Device – Copper T 380 A 1 No. 1 Copper Wire of high conductivity 99.99% Pure Copper 0.000204 kg 2. HDPE Granules 0.001202 kg 3. Pouches (Plastic) Net+10% 4. Copper Tube or high conductivity 99.99% pure copper 0.000169 kg 5. Polypropylene Granules 0.0015543 kg 6 Compound of LDPE Resin & Barium Sulphate 0.000415 kg 7. PVC Granules 0.000658 kg 8. HDPE Granules (or Nylon Resin) Medical Grade 0.000177 kg 208

Case No.:7/28/82ALC4/2012

Party Name:MELZER CHEMICALS PVT. LTD 04.04.2013 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:02.05.2013 Decision :Department of Chemicals and Petrochemicals vide their letter No. 14010/72/2012/Ch. II dated 12.3.2013 has requested the firm to furnish the following information:

208 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. 209

Case No.:19/1/82ALC4/2013

Party Name:CDYMAX (INDIA) PHARMA PVT. LTD. 04.04.2013 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:02.05.2013 210

Case No.:35/28/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 04.04.2013 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:02.05.2013 211

Case No.:30/1/82ALC4/2013

04.04.2013 Status:Case Approved HQ File :01/82/050/01388/AM13/ RLA File :22/24/040/00042/AM13/ Lic.No/Date:2210013384 07.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/597/2012PI(Norms) dated 6.2.2013, 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 Ceftazidime for Injection “The export product shall be account for 54 nos. Aluminium Bottle Anodized with Tear of Alu & Chlorobutyl plug 1 kg 1. Ceftazidime Pentahydrate Sterile (UnBuffered) 0.928 kg 2. Sodium Carbonate 0.082 kg 3. Aluminium Bottle Relevant, as per packing policy 212

Case No.:90/1/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 04.04.2013 Status:Case Approved HQ File :01/82/050/01448/AM13/ RLA File :03/94/040/00604/AM13/ Lic.No/Date:0310714528 07.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/29/2011Ch. II dated 25 5 2012 it was decided to ratify norms under para 4 7 of HBP v 1 as per details given below or as applied by the firm whichever is less:

212 dated 25.5.2012, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Para Chloro Phenyl Acetic Acid 1 kg 1 Para Chloro Benzyl Cyanide 1.021 kg 2. Toluene 0.230 kg 3. Caustic Soda Flakes 0.360 kg 213

Case No.:99/1/82ALC4/2013

Party Name:S.KANT HEALTHCARE LTD. 04.04.2013 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:02.05.2013 214

Case No.:34/28/82ALC4/2012

04.04.2013 Status:Case Approved HQ File :01/82/050/01001/AM13/ RLA File :05/24/040/00283/AM13/ Lic.No/Date:0510338695 08.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/62/2013PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Orlistat 1 kg 1. (S)()2,2Bis (diphenylphosphino)1,1 binaphthyl 0.003 kg 2. 2 methoxy propene 3.246 kg 3. Acetone 3.82 kg 4. Activated Carbon 0.100 kg 5. Dicyclohexyl carbodiimide 1.003 kg 6. Diisobutyl Aluminium Hydride 6.606 kg 7. Dimethyl Formamide 0.057 kg 8. Formic Acid 0.52 kg 9. LLeucine 0.46 kg 10. Lithium Hexamethyldisilazide in THF (Undistilled) 1.971 kg 11. Methylene Chloride 12.23 kg 12. Meldrum Acid 2.095 kg 13. Methanol 19.45 kg 14. NHexane 4.15 kg 15. NOctanoyl Benzotriazole 2.809 kg 16. Palladium sponge 0.0004 kg 17. Pivaloyl Chloride 0.841 kg 18. Pyridine 0.58 kg 19. Dichloro(pcymene)ruthenium (II)dimer 0.001 kg 20 T t h d f 4 53 k

Tetrahydrofuran 4.53 kg 21. Toluene 12.78 kg 22. Triethylamine 0.774 kg 215

Case No.:75/31/82ALC4/2012

Party Name:SUNSHIELD CHEMICALS LTD. 04.04.2013 Status:Case Rejected HQ File :01/82/050/01115/AM13/ RLA File :03/95/040/00584/AM13/ Lic.No/Date:0310714772 09.11.2012 Defer Date: Decision :The case was withdrawn in meeting no. 31/82 dated 21.2.2013. 216

Case No.:4/28/82ALC4/2012

Party Name:POSY PHARMACHEM PVT. LTD. 04.04.2013 Status:Case Deferred HQ File :01/82/050/00971/AM13/ RLA File :08/24/040/00242/AM13/ Lic.No/Date:0810116296 12.11.2012 Defer Date:02.05.2013 Decision :Department of Chemicals and Petrochemicals vide their letter No. 14010/106/2012Chem dated 11.3.2013 has requested the firm to furnish the following technical details: Details of manufacturing process with chemical equations, molecular formula, molecular weight. There are three types of Citrates, Mono Sodium Citrate, Di Sodium Citrate and Tri Sodium Citrate. What is the exact export product? The manufacturing process of the same may please be furnished. Yield obtained in each step. Authentic technical literature in support of yield obtained. CA certificate certifying the production of export item achieved by them for the past three years and corresponding consumption of each input. It was decided to remind the firm to furnish the above information. The case was deferred for 2.5.2013. 217

Case No.:12/1/82ALC4/2013

Party Name:R L FINE CHEM 04.04.2013 Status:Case Approved HQ File :01/82/050/01370/AM13/ RLA File :07/24/040/00315/AM13/ Lic.No/Date:0710091953 14.11.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 23/82 dated 1.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as 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

Case No.:26/28/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 04.04.2013 Status:Case Deferred

218 HQ File :01/82/050/00993/AM13/ RLA File :04/24/040/00126/AM13/ Lic.No/Date:0410141071 16.11.2012 Defer Date:02.05.2013 219

Case No.:27/28/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 04.04.2013 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:02.05.2013 220

Case No.:27/1/82ALC4/2013

04.04.2013 Status:Case Approved HQ File :01/82/050/01385/AM13/ RLA File :22/24/040/00044/AM13/ Lic.No/Date:2210013395 19.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/673/2013PI(Norms) dated 12.3.2013, 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 Ceftriaxone Sodium Sterile 1 kg 1. Ceftriaxone Sodium (Non Sterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylenediamine Tetra Acetic Acid Disodium Salt Dihydrate (EDTA) 0.010 kg 4. Eno Carbon 51.66 gm/kg 5. Aluminium Bottle Relevant, as per packing policy 221

Case No.:28/1/82ALC4/2013

04.04.2013 Status:Case Approved HQ File :01/82/050/01386/AM13/ RLA File :22/24/040/00045/AM13/ Lic.No/Date:2210013396 19.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/597/2012PI(Norms) dated 6.2.2013, 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 Ceftazidime for Injection “The export product shall be account for 109 nos. Aluminium Bottle Anodized with Tear of Alu & Chlorobutyl plug 1 kg 1. Ceftazidime Pentahydrate Sterile (UnBuffered) 0.928 kg 2. Sodium Carbonate 0.082 kg 3. Aluminium Bottle Anodized with Tear of alu cap & chlorobutyl plug Relevant, as per packing policy

222

Case No.:69/1/82ALC4/2013

04.04.2013 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:02.05.2013 223

Case No.:71/1/82ALC4/2013

Party Name:UNITED BIOTECH PVT.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01429/AM13/ RLA File :05/24/040/00296/AM13/ Lic.No/Date:0510339190 20.11.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/29/2013PI(Norms) dated 1.4..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 Oxaliplatin Injection 100mg/50 ml (Oplatin 100) 1 vial 1. Oxaliplatin Raw Pharmaceutical Ingredient 0.105 gm 224

Case No.:53/1/82ALC4/2013

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 04.04.2013 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:02.05.2013 225

Case No.:70/1/82ALC4/2013

04.04.2013 Status:Case Approved HQ File :01/82/050/01428/AM13/ RLA File :05/24/040/00292/AM13/ Lic.No/Date:0510339396 23.11.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 28/82 dated 10.1.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as S. No Export Item Norms allowed for tablets Atorvastatin Calcium 1. Atorvastatin Calcium Tablets 10 mg 10.2 mg/tablets 2. Atorvastatin Calcium Tablets 20 mg 20.4 mg/tablets 3. Atorvastatin Calcium Tablets 40 mg 40.8 mg/tablets 4. Atorvastatin Calcium Tablets 80 mg 81.6 mg/tablets Export Item: Atorvastatin Calcium Trihydrate – 1 kg S No Import Item Quantity Allowed kg/kg

S. No Import Item Quantity Allowed kg/kg 1. ASC 3 (4RCIS)1,1DIMETHYL ETHYL6CYANO METHYL 2,2DIMETHYL1,3DIOXANE4ACETATE 0.733 2. ACTIVATED CARBON 0.047 3. CYCLOHEXANE 0.235 4. DKT 34FLUOROALPHA (2METHYL1OXOPROPYL)) GAMAOXONBETADIPHENYL BENZENE BUTANAMIDE} 1.15 5. ISOPROPYL ALCOHOL 0.58 6 METHANOL 2.82 7 METHYLTBUTYLETHER 1.36 8 NHEPTANE 0.83 9 TETRAHYDROFURAN 1.10 10 TOLUENE 1.46 RA may take appropriate action as per the decision of Norms Committee 226

Case No.:3/26/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 04.04.2013 Status:Case Approved HQ File :01/82/050/00911/AM13/ RLA File :34/24/040/00205/AM13/ Lic.No/Date:3410035547 26.11.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/65/2007Ch. II dated 12.10.2011, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed 2Methoxy Ethyl Chloride 1 kg 1 2Methoxy Ethanol Appearance: Clear colourless liquid Assay: Min. 99% 0.890 kg 227

Case No.:72/1/82ALC4/2013

04.04.2013 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:02.05.2013 228

Case No.:26/1/82ALC4/2013

Party Name:INDSWIFT LABORATORIES LTD., 04.04.2013 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:02.05.2013

229

Case No.:29/1/82ALC4/2013

Party Name:INDSWIFT LABORATORIES LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/01387/AM13/ RLA File :22/24/040/00047/AM13/ Lic.No/Date:2210013408 27.11.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 47/82 dated 21.2.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import items Qty. allowed Clopidogrel Hydrogen Sulphate) 1 Kg. 1. DL2Chlorophenyl Glycine 1.00 kg 2. L(+) Tartaric Acid 0.667 kg 3. Thiphene2Ethonal 0.60 kg 4. PToluene Sulphonyl Chloride 1.029 kg 5. Methanol 4.87 kg 6. Methylene Chloride 2.03 kg 7. Acetone 0.34 kg 8. Toluene 1.11 kg 9. Isopropyl Alcohol 0.99 kg 230

Case No.:98/1/82ALC4/2013

Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 04.04.2013 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:02.05.2013 231

Case No.:47/26/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/00955/AM13/ RLA File :09/24/040/00375/AM13/ Lic.No/Date:0910054404 29.11.2012 Defer Date:02.05.2013 232

Case No.:54/1/82ALC4/2013

04.04.2013 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:02.05.2013

233

Case No.:61/28/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01028/AM13/ RLA File :09/24/040/00436/AM13/ Lic.No/Date:0910054444 05.12.2012 Defer Date:02.05.2013 234

Case No.:2/32/82ALC4/2012

Party Name:CHAMPION DAIICHI TECHNOLIGIES INDIA LTD. 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals. 235

Case No.:67/1/82ALC4/2013

Party Name:PARABOLIC DRUGS LTD., 04.04.2013 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:02.05.2013 236

Case No.:40/28/82ALC4/2012

Party Name:HETERO LABS LIMITED 04.04.2013 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:02.05.2013 237

Case No.:54/28/82ALC4/2012

04.04.2013 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:02.05.2013 238

Case No.:9/1/82ALC4/2013

04.04.2013 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:02.05.2013 239

Case No.:55/28/82ALC4/2012

Party Name:ADVANCE PETROCHEMICALS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01022/AM13/ RLA File :08/24/040/00337/AM13/ Lic No/Date:0810117116 Defer Date:

HQ File :01/82/050/01022/AM13/ RLA File :08/24/040/00337/AM13/ Lic.No/Date:0810117116 26.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2012Ch. II dated 26.3.2013, 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 2Methoxy Ethanol 1 kg 1. Methanol 0.589 kg 2. Ethylene Oxide 0.443 kg 240

Case No.:8/1/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/01366/AM13/ RLA File :22/24/040/00057/AM13/ Lic.No/Date:2210013472 26.12.2012 Defer Date:02.05.2013 241

Case No.:62/28/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 04.04.2013 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:02.05.2013 242

Case No.:63/28/82ALC4/2012

Party Name:UNIMARK REMEDIES LIMITED., 04.04.2013 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:02.05.2013 243

Case No.:65/28/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 04.04.2013 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:02.05.2013 244

Case No.:33/1/82ALC4/2013

Party Name:INDSWIFT LABORATORIES LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/01391/AM13/ RLA File :22/24/040/00059/AM13/ Lic.No/Date:2210013506 07.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 16/82 dated 16.8.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as

Decision : In the light of earlier decision taken in meeting no. 16/82 dated 16.8.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export product Export Qty. Sl.No. Import items Qty. allowed Clarithromycin Granules 27.5% (Suspension Grade) 1kg. 1. Clarithromycin (OR) 0.2777 kg Its raw material as per SION A 2263 on prorata basis 2. Carbopol 0.20 kg 3. HPMC Phthalate 0.54 kg 245

Case No.:36/1/82ALC4/2013

04.04.2013 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:02.05.2013 246

Case No.:5/32/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01146/AM13/ RLA File :05/23/040/00416/AM13/ Lic.No/Date:0510342949 10.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Cefditoren Pivoxil 1 kg 1 7Phenylacetamideo 3Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 3.12 2 TRIPHENYL PHOSPHINE 1.626 3 SODIUM IODIDE 1.612 4 MTHA (4Methyl,5Formyl thiazol) or (4 methyl thiazole 5aldehyde) 1.722 5 PROPAN1ol ( nPropanol) 1.44 6 CHLOROFORM 9.51 7 METHANOL 8.35 8 POTASSIUM METABISULPHITE 5.27 9 PHENOL 1.984 10 TRIFLUORO ACETIC ACID (TFA) 0.75 11 ACETONE 22.50

12 MAEM (2Mercaptobenzothiazolyl (Z)2(2Aminothaizole 4YL)2 Methoxyimino Acetate 1.166 13 TRIETHYLAMINE (TEA) 0.30 14 SODIUM2ETHYL HEXANOATE 2.40 15 NNDIMETHYL FORMAMIDE (DMF) 1.53 16 TETRABUTYL AMMONIUM BROMIDE 0.064 17 Dichloro Methane (Methylene Chloride) 2.53 18 CHLOROMETHYL PIVALATE 0.548 19 ACTIVATED CARBON 0.200 247

Case No.:1/30/82ALC4/2012

Party Name:ADVANCE PETROCHEMICALS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01037/AM13/ RLA File :08/24/040/00356/AM13/ Lic.No/Date:0810117592 16.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2012Ch. II dated 26.3.2013, 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 2Methoxy Ethanol 1 kg 1. Methanol 0.589 kg 2. Ethylene Oxide 0.443 kg 248

Case No.:46/1/82ALC4/2013

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01404/AM13/ RLA File :22/24/040/00064/AM13/ Lic.No/Date:2210013561 18.01.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/06/2013PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through enzymatic route Tech. Spec: ASSY not less than 84% as such or 96% on dry basis 1 kg 1. 6Amino Pencillanic Acide (6APA) 0.568 kg 2. Formidase (Enzyme) 0.005 kg 3. Methanol Not required in the process given by the firm 4. D()PHydroxy Phenyl Glycine Methylester 0.608 kg RA may take appropriate action as per the decision of Norms Committee

249

Case No.:120/1/82ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., 04.04.2013 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:02.05.2013 250

Case No.:107/1/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 04.04.2013 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:02.05.2013 251

Case No.:2/30/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 04.04.2013 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:02.05.2013 252

Case No.:3/30/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 04.04.2013 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:02.05.2013 253

Case No.:4/30/82ALC4/2012

Party Name:MEDREICH LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01040/AM13/ RLA File :07/24/040/00448/AM13/ Lic.No/Date:0710093283 23.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 21/82 dated 4.10.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Clindamycin Capsules 150 mg 1 No. 1. Clindamycin Hcl BP 173.53 mg Clindamycin Capsules 300 mg 1 No. 1. Clindamycin Hcl BP 347.06 mg 254

Case No.:57/1/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 04.04.2013 Status:Case Approved

HQ File :01/82/050/01415/AM13/ RLA File :08/24/040/00343/AM13/ Lic.No/Date:0810117768 23.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Moxonidine Tablets Moxonidine Heumann 0.2 mg Filmtabletten (Pack Size 30, 50 & 100 Tablets) Each film coated tablet contains: Moxonidine Ph. Eur. 0.2mg Colours: Titanium Dioxide and Red Oxide of Iron, Excipient q.s. Net content of active ingredient Moxonidine should not be less than 2.5 kgs in export product 1tablet Moxonidine 0.204 mg Moxonidine Tablets Moxonidine Heumann 0.3 mg Filmtabletten (Pack Size 30, 50 & 100 Tablets) Each film coated tablet contains: Moxonidine Ph. Eur. 0.3mg Colours: Titanium Dioxide and Red Oxide of Iron, Excipient q.s. Net content of active ingredient Moxonidine should not be less than 2.5 kgs in export product 1 tablet Moxonidine 0.306 mg Moxonidine Tablets Moxonidine Heumann 0.4 mg Filmtabletten (Pack Size 30, 50 & 100 Tablets) Each film coated tablet contains: Moxonidine Ph. E 0 4 C l 1 tablet Moxonidine 0.408 mg

Eur. 0.4mg Colours: Titanium Dioxide and Red Oxide of Iron, Excipient q.s. Net content of active ingredient Moxonidine should not be less than 2.0 kgs in export product 255

Case No.:34/1/82ALC4/2013

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 04.04.2013 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:02.05.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/18/2011PI(Norms) dated 28.11.2013, it was decided to call from the firm the following technical details:  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. 256

Case No.:32/1/82ALC4/2013

04.04.2013 Status:Case Deferred HQ File :01/82/050/01390/AM13/ RLA File :22/24/040/00068/AM13/ Lic.No/Date:2210013593 30.01.2013 Defer Date:02.05.2013 257

Case No.:42/1/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/01400/AM13/ RLA File :22/24/040/00066/AM13/ Lic.No/Date:2210013592 30.01.2013 Defer Date:02.05.2013 258

Case No.:31/1/82ALC4/2013

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01389/AM13/ RLA File :22/24/040/00071/AM13/ Lic.No/Date:2210013598 Defer Date:

31.01.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/06/2013PI(Norms) dated 1.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through enzymatic route Tech. Spec: ASSY not less than 84% as such or 96% on dry basis 1 kg 1. 6Amino Pencillanic Acide (6APA) 0.568 kg 2. Formidase (Enzyme) 0.005 kg 3. D()PHydroxy Phenyl Glycine Methylester 0.608 kg 259

Case No.:106/1/82ALC4/2013

Party Name:GOPALDAS VISRAM & CO.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01464/AM13/ RLA File :03/94/040/00915/AM13/ Lic.No/Date:0310722696 01.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import items Qty. allowed FunbactA Cream 30 gms/FunbactA Lotion 30 gms 30 gm Tube 1. Clotrimazole USP 0.306 gm/30 gm Tube 2. Neomycin Sulphate USP 0.153 gm/30 gm Tube 260

Case No.:116/1/82ALC4/2013

Party Name:GRANULES INDIA LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01474/AM13/ RLA File :09/24/040/00508/AM13/ Lic.No/Date:0910054897 01.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 11/82 dated 19.6.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Compresso PAP 90CPC (Paracetamol Granules DC Grade 90%) 1No. 1. Acetaminophen/Paracetamol 0.90 kg/kg 2. Povidone (K‐30) 0.006 kg/kg 3. PregelaƟnised Starch 0.084 kg/kg 4. Stearic Acid 0.01 kg/kg 261

Case No.:119/1/82ALC4/2013

Party Name:GLAND PHARMA LIMITED 04.04.2013 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:02.05.2013 262

Case No.:113/1/82ALC4/2013

Party Name:PERKIN LABORATORIES 04.04.2013 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:02.05.2013 263

Case No.:2/1/82ALC4/2013

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01360/AM13/ RLA File :04/24/040/00244/AM13/ Lic.No/Date:0410143070 04.02.2013 Defer Date:02.05.2013 264

Case No.:101/1/82ALC4/2013

Party Name:INDO AMINES LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01459/AM13/ RLA File :03/94/040/00905/AM13/ Lic.No/Date:0310723011 05.02.2013 Defer Date:02.05.2013 265

Case No.:103/1/82ALC4/2013

Party Name:INDO AMINES LIMITED 04.04.2013 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:02.05.2013 266

Case No.:118/1/82ALC4/2013

Party Name:EYTAN LABS LIMITED 04.04.2013 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:02.05.2013 267

Case No.:85/1/82ALC4/2013

Party Name:DELTA FINOCHEM PVT.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01443/AM13/ RLA File :03/94/040/00938/AM13/ Lic.No/Date:0310723006 05.02.2013 Defer Date:

05.02.2013 Decision : In the light of earlier decision taken in meeting no. 24/82 dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Ethyl Triphenyl Phosphonium Bromide 1 kg 1. Triphenyl Phosphine 0.785 2. Ethyl Bromide 0.230 268

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

Party Name:ARJUN CHEMICALS PVT. LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/01359/AM13/ RLA File :04/24/040/00245/AM13/ Lic.No/Date:0410143108 06.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/150/2011/Ch. II dated 18.4.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed KeydimeAKD (Alkyl Ketene Dimer Emulsion) 1 kg 1. Alkyl Ketene Dimer AKD Wax 0.100 kg 2. Solbond C40S (Emcal E6LZS) Cationic Potato Starch 0.070 kg 269

Case No.:83/1/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 04.04.2013 Status:Case Approved HQ File :01/82/050/01441/AM13/ RLA File :03/94/040/00811/AM13/ Lic.No/Date:0310723118 06.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/29/2011Ch. II dated 25.5.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed 4Chloro Benzyl Cyanide 75% in NButyl Acetate or Para Chloro Benzyl Cyanide 75% in NButyl Acetate 1 kg 1 Para Chloro Benzyl Cyanide 0.787 kg 2. NButyl Acetate 0.262 kg 270

Case No.:100/1/82ALC4/2013

Party Name:GLENMARK GENERICS LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01458/AM13/ RLA File :03/94/040/00894/AM13/ Lic.No/Date:0310723234 07.02.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/659/2012PI(Norms) dated 12.3.2013, 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:

12.3.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Olmesartan Medoxomill 1 kg 1 4(1Hydroxy1MethylEthyl)2 Propyl1HImidazole 5 Carboxylic Acid Ethyl Ester 0.78 kg 2. 5(4Bromomethyl) (1,1 Biphenyl)2YL Triphenyl1H Tetrazole 95% 1.786 kg 3. 4Chloromethyl5Methyl1,3 Dioxolen 2 One 0.48 kg 4. Dimethyl Formamide 6.72 kg 5. Tetrahydrofuran 3.43 kg 6. Potassium Carbonate 0.57 kg 7. Toluene 2.41 kg 271

Case No.:110/1/82ALC4/2013

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 04.04.2013 Status:Case Deferred HQ File :01/82/050/01468/AM13/ RLA File :09/24/040/00525/AM13/ Lic.No/Date:0910054981 08.02.2013 Defer Date:02.05.2013 272

Case No.:48/1/82ALC4/2013

Party Name:SOMU ORGANO CHEM PVT.LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/01406/AM13/ RLA File :07/24/040/00471/AM13/ Lic.No/Date:0710093635 08.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/151/2011Ch. II dated 21.3.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed 1,3Cyclohexanedione (Cyclohexane1,3 Dione) Dihydroxy Resorcinol 1 kg 1. Resorcinol 1.24 kg 273

Case No.:104/1/82ALC4/2013

Party Name:ALKYL AMINES CHEMICALS LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/01462/AM13/ RLA File :03/94/040/00914/AM13/ Lic.No/Date:0310723557 11.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/85/2012Ch. II dated 25.5.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Acetonitrile 1 kg 1. Acetic Acid 1.460 kg

274

Case No.:112/1/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01470/AM13/ RLA File :09/24/040/00526/AM13/ Lic.No/Date:0910054987 11.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 17/82 dated 26.7.2011, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export product Export Qty. Sl.No. Import items Qty. allowed 2Aminomethyl7Chloro2,3 Dihydro5(2Fluorophenyl)1H 1,4Benzodiazepine Dimaleate 1 Kg. 1. 2Amino5Chloro2Fluoro Benzophenone 0.932 kg 2. Chloro acetaldehyde Dimethyl acetal 0.696 kg 3. Manganese Dioxide 0.852 kg 4. Dimethyl Sulfoxide 0.405 kg 5. Acetone 0.405 kg 275

Case No.:115/1/82ALC4/2013

Party Name:BIOLOGICAL E LTD 04.04.2013 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:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Biotechnology 276

Case No.:117/1/82ALC4/2013

Party Name:BIOLOGICAL E LTD 04.04.2013 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:02.05.2013 277

Case No.:1/32/82ALC4/2012

Party Name:S M S PHARMACEUTICALS LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01142/AM13/ RLA File :09/24/040/00503/AM13/ Lic.No/Date:0910055024 12.02.2013 Defer Date:02.05.2013 278

Case No.:105/1/82ALC4/2013

Party Name:GOPALDAS VISRAM & CO.LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01463/AM13/ RLA File :03/94/040/00976/AM13/ Lic.No/Date:0310723706 12.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as

Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Export Qty. Sl.No. Import items Qty. allowed FunbactA Cream 30 gms/FunbactA Lotion 30 gms 30 gm Tube 1. Clotrimazole USP 0.306 gm/30 gm Tube 2. Neomycin Sulphate USP 0.153 gm/30 gm Tube 279

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

Party Name:VINDHYA PHARMA (INDIA)PVT LTD. 04.04.2013 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: 280

Case No.:44/1/82ALC4/2013

Party Name:ADCOCK INGRAM LTD, 04.04.2013 Status:Case Approved HQ File :01/82/050/01402/AM13/ RLA File :07/24/040/00480/AM13/ Lic.No/Date:0710093697 13.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Acurate Tabs Paracetamol 450 mg+Doxylamine Succinate 5 mg+Caffeine 30 mg+Codeine Phosphate 10 mg+Colour quinolone Yellow 2 mg Tablets 1 no. of tablet 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 mg 2. CaffeineAnhydrous BP 2010/USP/EP/PH. EUR/BP 30.6 mg 3. Codiene Phsophate BP/USP/EP/PH. EUR 10.2 mg 4. Color Quinoline Yellow CI 47005 2.0 mg 281

Case No.:3/32/82ALC4/2012

Party Name:R.K.INDUSTRIES, 04.04.2013 Status:Case Approved HQ File :01/82/050/01144/AM13/ RLA File :08/24/040/00398/AM13/ Lic.No/Date:0810118377 14.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/11/2012Ch. II dated 30.11.2011, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed O th T l idi 5 1 k 1 O th T l idi 0 642 k

Ortho Toluidine 5 Sulfonic Acid 1 kg 1 Ortho Toluidine 0.642 kg 2. Caustic Soda 0.282 kg 282

Case No.:47/1/82ALC4/2013

Party Name:SHIVA PHARMACHEM LTD, 04.04.2013 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:02.05.2013 283

Case No.:37/1/82ALC4/2013

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 04.04.2013 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:02.05.2013 284

Case No.:39/1/82ALC4/2013

Party Name:CENTURY PHARMACEUTICALS LTD. 04.04.2013 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:02.05.2013 285

Case No.:40/1/82ALC4/2013

Party Name:DSM ANTIINFECTIVES INDIA LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01398/AM13/ RLA File :22/24/040/00010/AM13/ Lic.No/Date:2210013646 18.02.2013 Defer Date: 30.5.2013 Decision : It was decided to defer the case for 30.5.2013 for comments of Department of Pharmaceuticals. 286

Case No.:65/1/82ALC4/2013

04.04.2013 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:02.05.2013

Case No.:79/1/82ALC4/2013

Party Name:STERICAT GUTSTRINGS PVT. LTD. 04.04.2013 Status:Case Deferred HQ File :01/82/050/01437/AM13/ RLA File :05/24/040/00420/AM13/ Lic.No/Date:0510346353 18.02.2013 Defer Date:02.05.2013

287 Decision :In the light of written comments received from Department of Industrial Policy and Promotion vide their note No. 7/106/2012TSW dated 3.4.2013, it was decided to call from the firm the following information: Documents pertaining to their application duly certified by a Chartered Accountant for further examination An undertaking, clearly indicating the import content of each input in the export product along with its specification like weight, width, thickness of import item No. 1,7,13,19, 24. A detailed calculation sheet to be furnished accounting for the total individual item of proposed import as also to the net content of individual item in the 5 individual consignment of the proposed item of export in 540, 28735, 25, 1260 and 1440 boxes respectively. 288

Case No.:91/1/82ALC4/2013

Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/01449/AM13/ RLA File :03/94/040/00899/AM13/ Lic.No/Date:0310724423 18.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/10/2009Ch. II dated 16.4.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Kubochem401 (Diethyl ketone or 3Pentanone) 1 kg 1 Propionic Acid Purity 99.0% Min. 1.92 kg 289

Case No.:92/1/82ALC4/2013

Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/01450/AM13/ RLA File :03/94/040/00927/AM13/ Lic.No/Date:0310724426 18.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/10/2009Ch. II dated 16.4.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Kubochem401 (Diethyl ketone or 3Pentanone) 1 kg 1 Propionic Acid Purity 99.0% Min. 1.92 kg 290

Case No.:109/1/82ALC4/2013

Party Name:SAINOR LABORATORIES PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01467/AM13/ RLA File :09/24/040/00506/AM13/ Lic.No/Date:0910055104 19.02.2013 Defer Date:02.05.2013

291

Case No.:3/1/82ALC4/2013

Party Name:EXUBER CHEMICALS P LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/01361/AM13/ RLA File :04/24/040/00230/AM13/ Lic.No/Date:0410143457 19.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 44/82 dated 31.1.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg D2 Aminobutanol 1 kg 1 2 3 DL2 Aminobutanol Monosodium Glutamate Toluene 2.2642 0.647 0.60 292

Case No.:38/1/82ALC4/2013

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 04.04.2013 Status:Case Approved HQ File :01/82/050/01396/AM13/ RLA File :07/24/040/00468/AM13/ Lic.No/Date:0710093776 19.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 23/82 dated 1.11.2012, it was decided to ratify norms under para 4.7 of HBP v1 as Export product Export Quantity S.No Import items Quantity Allowed kg/kg Magnesium Lacatate Gluconate 1 kg 1. Glucono Delta Lactone 0.755 kg Cobalt Gluconate 1 kg 1. 1.036 kg Zinc Gluconate 1 kg 1. 0.945 kg Magnesium Gluconate 1 kg 1. 0.945 kg Potassium Gluconate 1 kg 1. 0.930 kg Ferrous Gluconate 1 kg 1. 0.887 kg Manganese Gluconate 1 kg 1 0.945 kg Calcium Magnesium Lactate Gluconate 1 kg 1 0.831 kg

293

Case No.:45/1/82ALC4/2013

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 04.04.2013 Status:Case Deferred HQ File :01/82/050/01403/AM13/ RLA File :07/24/040/00466/AM13/ Lic.No/Date:0710093775 19.02.2013 Defer Date:02.05.2013 294

Case No.:60/1/82ALC4/2013

04.04.2013 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:02.05.2013 295

Case No.:63/1/82ALC4/2013

04.04.2013 Status:Case Approved HQ File :01/82/050/01421/AM13/ RLA File :08/24/040/00408/AM13/ Lic.No/Date:0810118587 20.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: S. No Import Item For export of 1 million tablets (Qty in Kg) Losartan Potassium 25 mg Losartan Potassium 50 mg Losartan Potassium 100 mg Losartan Potassium Hydrochlorothiazide 50/12.5 mg tab Losartan Potassium Hydrochlorothiazide 100/25 mg tab 1. Toulene 36.72 73.44 146.88 73.44 146.88 2. 1Triethyl5[4’ (Bromomethyl) {1,1’ Biphenyl}4yl] 1 H Tetrazole 37.23 74.46 148.92 74.46 148.92 3. 2Butyl4Chloro5 Formyl Imidazole (BFCI) 12.75 25.50 51.0 25.50 51.0 4. Aceto Nitrile 81.60 163.20 326.40 163.20 326.40 5. Methylene Chloride (MDC) 43.605 87.21 174.42 87.21 174.42 6. NHeptane 31.62 63.24 126.48 63.24 126.48 7. Lactose Monohydrate NF 43.00 86.00 172.00 86.00 172.00 8. Microcrystalline Cellulose NF (Avicel PH 102) 5.0 10.0 20.0 10.0 20.0 9. Low substituted hyroxypropyl Cellulose 2.50 5.0 10.0 5.0 10.0 10 Magnesium Stearate NF 1.00 2.00 4.00 2.00 4.00

NF 11 Bottles & Caps (packing materials in finished form) 1. 60 CC while HDPE bottle Relevant, as per packing policy. 12 11 b. CRC white cap 33 mm pulp liner 13 11 c. 150 cc white HDPE bottle 14 11 d. white continuous (Thread 38 MM cap) 15 11 e 400 CC White HDPE bottle 16 11 f. NCRC white cap 53 MM pulp liner 17 11 g 750 CC white HDPE bottle 18 11 h. 300 CC WH HDPE Bottle 19 11 i. NCRC WH Cap 45 MM 296

Case No.:64/1/82ALC4/2013

04.04.2013 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:02.05.2013 297

Case No.:78/1/82ALC4/2013

Party Name:S.M. HERBALS PVT.LTD. 04.04.2013 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:02.05.2013 298

Case No.:41/1/82ALC4/2013

Party Name:ENVEE DRUGS PVT LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/01399/AM13/ RLA File :34/24/040/00275/AM13/ Lic.No/Date:3410036215 21.02.2013 Defer Date: Decision : The Committee decided to ratify norms under Para 4.7 of HBP v 1 as applied by the firm, as per details given below: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Clobetasole Propionate BP/USP 1 kg 1 Betamethasone BP/USP/IP 1.04

BP/USP It was also decided to call All Industry data from Pharmexil for revision of SION A 84, A 2476, A 2288, A 2287. 299

Case No.:81/1/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 04.04.2013 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:02.05.2013 300

Case No.:108/1/82ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/01466/AM13/ RLA File :09/24/040/00541/AM13/ Lic.No/Date:0910055166 22.02.2013 Defer Date:02.05.2013 301

Case No.:114/1/82ALC4/2013

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 04.04.2013 Status:Case Approved HQ File :01/82/050/01472/AM13/ RLA File :09/24/040/00553/AM13/ Lic.No/Date:0910055165 22.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2008/Ch. II dated 21.9.2010, it was decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Export Quantity S.No Import items Quantity Allowed kg/kg Benzophenone3 (Faint Yellow Crystalline Powder purity more than 99%) 1 kg 1 Benzophenone3 Crude (Purity 9597%) (Yellow Crystalline powder) 1.04 kg 2. Methanol (Liquid) 0.400 kg 302

Case No.:35/1/82ALC4/2013

Party Name:VENUS REMEDIES LTD., 04.04.2013 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:02.05.2013

Case No.:6/32/82ALC4/2012

Party Name:VARUN MEDIMPEX INC. 04.04.2013 Status:Case Deferred HQ File :01/82/050/01147/AM13/ RLA File :05/24/040/00405/AM13/ Lic.No/Date:0510347194 Defer

303 22.02.2013 Date:02.05.2013 Decision : It was decided to call the specific comments from the technical authority that 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? The case was deferred for 2.5.2013. 304

Case No.:80/1/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01438/AM13/ RLA File :05/23/040/00467/AM13/ Lic.No/Date:0510347163 22.02.2013 Defer Date:02.05.2013 305

Case No.:95/1/82ALC4/2013

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 04.04.2013 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:02.05.2013 306

Case No.:23/1/82ALC4/2013

Party Name:STERICON PHARMA PVT.LTD., 04.04.2013 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:02.05.2013 Decision : Department of Pharmaceuticals vide their OM No. 35011/655/2012PI(Norms) dated 12.3.2013 has pointed out that 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. The case was deferred for 2.5.2013. 307

Case No.:66/1/82ALC4/2013

Party Name:GOPINATH CHEMTECH LTD., 04.04.2013 Status:Case Approved HQ File :01/82/050/01424/AM13/ RLA File :08/24/040/00416/AM13/ Lic.No/Date:0810118864 26.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2012Ch. II dated 6.8.2012, 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 items Quantity Allowed kg/kg 4,4 Diamino Sulfananilide (DASA) 1 kg 1 Para Nitro Aniline 0.728 kg 2. Aniline Oil 0.468 kg 3. Acetic Acid 0.317 kg 4. Caustic Soda Flakes or Caustic Soda Lye (on 100% Real Basis) 0.587 kg

308

Case No.:73/1/82ALC4/2013

Party Name:JUBILANT LIFE SCIENCES LIMITED 04.04.2013 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:02.05.2013 309

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

Party Name:PROMED EXPORTS PVT.LTD. 04.04.2013 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:02.05.2013 310

Case No.:94/1/82ALC4/2013

Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 04.04.2013 Status:Case Deferred HQ File :01/82/050/01452/AM13/ RLA File :03/95/040/00953/AM13/ Lic.No/Date:0310725764 26.02.2013 Defer Date:02.05.2013 311

Case No.:25/1/82ALC4/2013

Party Name:R L FINE CHEM 04.04.2013 Status:Case Approved HQ File :01/82/050/01383/AM13/ RLA File :07/24/040/00495/AM13/ Lic.No/Date:0710093955 27.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 13.9.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Doxilamine Succinate BP/USP 1 Kg. 1. 2 Acetyl Pyridine 0.58 kg 2. Tetrahydrofuran 1.03 kg 312

Case No.:77/1/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01435/AM13/ RLA File :05/23/040/00500/AM13/ Lic.No/Date:0510347743 28.02.2013 Defer Date:02.05.2013 313

Case No.:76/1/82ALC4/2013

Party Name:FORACE POLYMERS (P) LTD. 04.04.2013 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:02 05 2013

01.03.2013 Date:02.05.2013 Decision :It was decided to defer the case for 2.5.2013 for comments of Department of Industrial Policy and Promotion and Petrochemicals Division of Department of Chemicals and Petrochemicals. 314

Case No.:24/1/82ALC4/2013

Party Name:SAURAV CHEMICALS LTD, 04.04.2013 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:02.05.2013 315

Case No.:61/1/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 04.04.2013 Status:Case Approved HQ File :01/82/050/01419/AM13/ RLA File :08/24/040/00394/AM13/ Lic.No/Date:0810119018 05.03.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 25/82 dated 29.11.2012, it was decided to ratify norms under Para 4.7 of HBP v 1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed Propafenone Tablet 150 mg Propafenone 150 Heumann 1 No. 1. Propafenone Hcl 153 mg Propafenone Tablet 300 mg Propafenone 300 Heumann 1 No. 1. Propafenone Hcl 306 mg 316

Case No.:75/1/82ALC4/2013

Party Name:V.D.H. ORGANICS PVT. LTD 04.04.2013 Status:Case Approved HQ File :01/82/050/01433/AM13/ RLA File :05/24/040/00450/AM13/ Lic.No/Date:0510348250 05.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/58/2010Ch. II dated 19.11.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed Thymol Crystals (2 isopropyl 5methylphenol) Purity 99% and above. 1 kg 1 Meta Cresol (MCresol) 0.785 kg 317

Case No.:121/1/82ALC4/2013

Party Name:PIONEER LABORATORIES INDIA PVT. LTD., 04.04.2013 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:02.05.2013

318

Case No.:43/1/82ALC4/2013

Party Name:RIDDHI PHARMA 04.04.2013 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:02.05.2013 319

Case No.:62/1/82ALC4/2013

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 04.04.2013 Status:Case Deferred HQ File :01/82/050/01420/AM13/ RLA File :08/24/040/00424/AM13/ Lic.No/Date:0810119074 06.03.2013 Defer Date:02.05.2013 320

Case No.:5/1/82ALC4/2013

Party Name:PI INDUSTRIES LTD., 04.04.2013 Status:Case Deferred HQ File :01/82/050/01363/AM13/ RLA File :13/24/040/00053/AM13/ Lic.No/Date:1310042456 13.03.2013 Defer Date:02.05.2013 321

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

Party Name:SHIVA PHARMACHEM LTD, 04.04.2013 Status:Case Approved HQ File :01/82/050/01364/AM13/ RLA File :34/24/040/00304/AM13/ Lic.No/Date:3410036436 18.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/164/2011Ch. II dated 12.6.2012, 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 Exp. Qty. Sl.No. Import items Qty. allowed Propoxy Ethyl Chloride Clear colourless liquid Assay Min. 99% 1 Kg. 1. 2Propoxy Ethanol Clear colourless liquid Assay: Min. 99% 0.941 kg 322

Case No.:7/1/82ALC4/2013

Party Name:DL INTRACHEM 04.04.2013 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:02.05.2013 323

Case No.:74/1/82ALC4/2013

Party Name:ATUL INTERMEDIATES 04.04.2013 Status:Case Deferred HQ File :01/82/050/01432/AM13/ RLA File :08/24/040/00423/AM13/ Lic.No/Date:0810119733 Defer

25.03.2013 Date:02.05.2013

Case No. Outside Agenda No. 1

M/s. Ciron Drugs Pharmaceuticals Limited Meeting no. 1/AM 13 01/82/50/637/AM 13 DES III Dated 4.4.2013 Advance License No. 0310703455 dated 27.7.2012 RLA File No. 03/94/040/00326/AM 13 Decision: It was noticed that the export quantity was inadvertently written as 1 kg instead of 188680 in the minutes ratified by NC in its meeting no. 21/AM 13 dated 4.10.2012. The committee decided to correct the export quantity as 188680 numbers. Rest of the minutes would remain. Date:15.04.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer

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Para 4.7 Decision

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Case No.:71/15/82­ALC4/2010

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