IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2013-05-16

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 4/82ALC4/2013 MEETING DATE : 16.05.2013 The Meeting No. 4/82 in the year 201314 to consider the cases under Duty Exemption Scheme (Chapter4) of Foreign Trade Policy, 200914 pertaining to products falling in Chapter 29 and 30 was held on 16.5.2013 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. B 35

M/s. FMC Agricultural Products, Bangalore Meeting no. 4/AM 13 dated 16.5.2013. 01/82/50/00612/AM 08/DES III 01/82/50/01173/AM 08/DES III 01/82/50/01575/AM 08/DES III 01/82/50/00212/AM 08/DES III Advance Authorisation NO. 0710053369 dated 14.9.2007 0710054550 dated 16.11.2007 0710056002 dated 22.2.2008 0710056292 dated 07.03.2008 Decision: It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals.

Case No. B 36

M/s. Aarti Industries Limited 01/82/50/427/AM 13/DES III R.A File No. 03/94/040/187/AM 13. Advance Licence No. 0310698861 dated 15.6.2012 Decision: It was decided to amend the description of import item “Crude Theophylline 7080% WET w/w (LOD NMT)” t “C d Th h lli ” f thi li l f l i ti Th t f th i t

(LOD NMT)” to “Crude Theophylline” for this license only for regularisation purpose. The rest of the minutes would remain same. RA may take appropriate action as per the decision of Norms Committee.

Case No. B 37

M/s RA Chem Pharma Limited, Hyderabad 01/82/50/1426/AM 12/DES III 01/82/50/668/AM 13/DES III 01/82/50/16/AM 13/DES III 01/82/50/00019/AM 13/DES III RLA File No. 09/24/040/00412/AM 12 09/24/040/00213/AM 12 09/24/040/00450/AM 12 09/24/040/00516/AM 12 Advance Authorisation NO 0910050064 dated 7.12.2011 0910051056 dated 1.2.2012 0910050474 dated 29.12.2011 0910053324 dated 23.7.2012 Decision: It was decided to make following amendments in the description of import items: In respect of Advance License no. 910050064, 910051056, 910053324 and 91005150562 Import item at S. No 2 would be read as 2Bromo4Hydroxyacetophenone The firm has also requested to fix norms for the 3rd import item 4Hydroxyacetophenone. Committee turned down the request of the firm as this item was not required in the process.

Case No. B 38

M/s. Vivimed Labs Limited Meeting no. 4/AM 130 dated 16.5.2013. F. No. 01/82/50/00284/AM 13/DES III R.A File No. 09/24/40/646/AM 12 Advance Licence No. 0910051917 dated 28.3.2012 Decision: In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch. II dated 27.11.2012, 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 Piroctone Olamine or Vipirox 1 kg 1 3,3Di Methyl Acrylic Acid 1.125 kg 2. Isononanoyl Chloride or 3, 5,5Trimethyl Haxanyl Chl id 1.544 kg

Chloride 3. Hydroxylamine Hydro Chloride 1.224 kg 4. Methanol 2.155 kg 5. Di Chloro Methane (MDC) 0.700 kg 6. Ethylene Di Chloride (EDC) 1.750 kg 7. Toluene 0.350 kg 8. Hydro Quinone 0.112 kg RA may take appropriate action as per the decision of Norms Committee.

Case No. B 39

M/s. Jubilant Life Sciences Limited 01/82/50/00718/AM 13/DES III R.A File No. 05/23/040/000208/AM 13 Advance Licence No. 0510334566 dated 13.9.2012 Decision: . The Committee noted that the norms were fixed as per SION A 1945 (Granules) with 1% wastage and conversion factor was also taken into account while fixing the norms. It was therefore, decided to reject the request of the firm.

Case No. B 40

M/s. Zandu Chemicals Limited 01/82/50/741/AM 05/DES III R.A File No. 03/94/040/2135/AM 05 Advance Licence No. 0310314526 dated 1.2.2005 Decision: The Committee recommended to condone the delay for filing the case after such a long period. It was decided to refer the case to PRC for approval of DGFT for condoning the delay. However, the case was deferred for 13.6.2013 for comments of Department of Pharmaceuticals.

Case No. B 41

M/s. Organica Aromatics Pvt. Limited 01/82/50/1034/AM 09/DES III 01/82/50/1612/AM 09/DES III R.A File No. 07/24/40/280/AM 09 RA File NO 07/24/40/564/AM 09 Advance Licence No. 0710059944 dated 19 9 2008

RA File NO. 07/24/40/564/AM 09 0710059944 dated 19.9.2008 0710062745 dated 4.2.2009 Decision: The case was discussed and technical members present in the meeting were of the view that there is not justification for enhancement in this case. The Committee, therefore, decided to reject the request of the firm.

Case No. B 42

M/s. Ajanta Pharma Limited 01/82/162/00011/AM 14/DES III R.A File No. 03/94/040/1131/AM 04 Advance Licence No. 0310256392 dated 5.3.2004 Decision: It was decided to reject the request of the firm as the case was delayed for a too long period.

Case No. C 3

M/s. Bliss GVS Pharma Limited 01/82/162/1192/AM 10/DES III Decision: Department of Pharmaceuticals vide their OM No. 35011/703/2012PI(Norms) dated 1.4.2013 has informed that they are not in favour of amending SION A 412 because of the following reasons: 1. The process of manufacture of Suppositories/Passaries is different than Tablets/Capsules. 2. Excipients used in the manufacture are different. 3. Mode of delivery is entirely different. 4. Tests for Bioavailability is different Keeping in view the above reasons, the Committee decided to close the case and advised the firm to apply for fresh SION in accordance with Policy and Procedures.

Case No. C 4

M/s. Encee Aromatics Pvt. Limited Meeting no 4/AM 13 dated 16 5 2013 01/82/162/00008/AM 13/DES III

01/82/162/00008/AM 13/DES III Decision: It was decided to write to Chemexcil to furnish All Industry data of other exporters, if any, manufacturing this product. The case was deferred for 13.6.2013.

Case No. C 5

M/s. Encee Aromatics Pvt. Limited 01/82/162/00020/Am 10 DES III Decision: It was decided to remind the Chemcexil to furnish All Industry Data for fixation of norms. The case was deferred for 13.6.2013 1

Case No.:2/36/82ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., Meet No/Date:4/82ALC4/2013 16.05.2013 Status:Case Deferred HQ File :01/82/050/00727/AM10/ RLA File :03/95/040/00485/AM10/ Lic.No/Date:0310545426 13.11.2009 Defer Date:13.06.2013 Decision :It was decided to call a copy of application from RA/firm and forward it to Department of Chemicals and Petrochemicals for their comments. The case was deferred for 13.6.2013. 2

Case No.:15/50/82ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01169/AM10/ RLA File :03/95/040/00779/AM10/ Lic.No/Date:0310561977 25.02.2010 Defer Date:13.06.2013 Decision :It was decided to call a copy of application from RA/firm and forward it to Department of Chemicals and Petrochemicals for their comments. The case was deferred for 13.6.2013.

Case No.:7/14/82ALC4/2010

Party Name:ARCH PHARMALABS LTD Status:Case

3 16.05.2013 Deferred HQ File :01/82/050/00369/AM11/ RLA File :03/94/040/01082/AM10/ Lic.No/Date:0310571324 26.04.2010 Defer Date:13.06.2013 Decision :It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 4

Case No.:22/6/82ALC4/2010

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 16.05.2013 Status:Case Deferred HQ File :01/82/050/00169/AM11/ RLA File :03/95/040/00396/AM10/ Lic.No/Date:0310571937 29.04.2010 Defer Date:13.06.2013 5

Case No.:7/24/82ALC4/2010

Party Name:YASHO INDUSTRIES PVT.LTD. 16.05.2013 Status:Case Approved HQ File :01/82/050/00807/AM11/ RLA File :03/95/040/00419/AM11/ Lic.No/Date:0310591096 06.09.2010 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 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 Dipentamethylene Thiuram Tetra Sulfide (Qureacc DPTT) 1 kg 1. Piperidine 0.466 kg 6

Case No.:25/2/82ALC4/2013

Party Name:LUPIN LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00025/AM14/ RLA File :03/95/040/00418/AM11/ Lic.No/Date:0310595268 05.10.2010 Defer Date:13.06.2013 7

Case No.:14/2/82ALC4/2013

Party Name:LUPIN LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00014/AM14/ RLA File :03/95/040/00580/AM11/ Lic.No/Date:0310598211 21.10.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 9/82 dated 1.6.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export quantity S.No. Import item Quantity allowed (Kgs.) Cefixime 1 Kg 1 7Phenylacelamido3 chloromethyl 1.555

chloromethyl Cephalosporanic Acid P Methoxybenzyl Ester (GCLE). 2. Ammonia 0.395 3. Dimethyl Aniline 0.62 4. Formaldehyde 1.7419 5. Phosphorus Pentachloride 0.88 6. Soda Ash/Sodium Cabonate 0.2686 7. Triphenyl Phosphine EDTA Disodium 1.22 8. Etylenediamine Tetra Acetic Acid Disodium Salt (E.D.T.A Disodium) 0.020 9. Diethylthiophosphoryl(Z)2 (2aminothiazol4Y1)2 (Terbutoxycarbonyl) Methoxyiminoacetate (DATMA) 0.923 10. Activated Carbon 0.100 11. NMethyl Morpholine 0.120 12. Sodium Bicarbonate 0.6471 13. Sodium Hydrosulphate 0.001 14. Dimethyl Formamide 0.49 15. Ethyl Acetate 5.98 16. Methanol 3.69 17. Methylene Chloride 16.57 18. Methyl Isobutyl Ketone 0.42 8

Case No.:8/32/82ALC4/2010

Party Name:SAURAV CHEMICALS LTD, 16.05.2013 Status:Case Deferred HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:13.06.2013 Decision :It was decided to send a copy of application to Department of Pharmaceuticals for thier comments. The case was deferred for 13.6.2013. 9

Case No.:8/2/82ALC4/2013

Party Name:SUPREET CHEMICALS PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00008/AM14/ RLA File :03/95/040/01043/AM11/ Lic.No/Date:0310623747 28.03.2011 Defer Date:13.06.2013 Decision :It was decided to send a copy of application again to Department of Chemicals and Petrochemicals for their comments. The case was d f d f 13 6 2013

deferred for 13.6.2013. 10

Case No.:4/2/82ALC4/2013

Party Name:METROPOLITAN EXIMCHEM LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00004/AM14/ RLA File :03/95/040/00983/AM11/ Lic.No/Date:0310626783 15.04.2011 Defer Date:13.06.2013 Decision :It was decided to defer the case for 13.6.2013 for comments of Department of Chemicals and Petrochemicals. 11

Case No.:47/14/82ALC4/2011

Party Name:FDC LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00438/AM12/ RLA File :03/94/040/00152/AM12/ Lic.No/Date:0310637790 22.06.2011 Defer Date:13.06.2013 12

Case No.:25/26/82ALC4/2011

Party Name:ENCUBE ETHICALS PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00708/AM12/ RLA File :03/94/040/00385/AM12/ Lic.No/Date:0310646711 05.08.2011 Defer Date: 13.6.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 13

Case No.:38/32/82ALC4/2011

Party Name:GRANULES INDIA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/AM12/ Lic.No/Date:0910048379 25.08.2011 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License along with list of approved items with their composition immediately. The case was deferred for 13.6.2013. 14

Case No.:7/45/82ALC4/2011

Party Name:SANO MEDICAL KITS PVT. LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/AM12/ Lic.No/Date:0410131205 01.12.2011 Defer Date:13.06.2013 Decision :Department of Industrial Policy and Promotion was requested to furnish wastage in each import item separately. The comments from DIPP in this regard have not been received so far. The case was deferred for 13.6.2013 for comments of Department of Industrial Policy and Promotion.

Case No.:38/3/82ALC4/2012

Party Name:BROOKS LABORATORIES LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00042/AM13/ RLA File :22/24/040/00068/AM12/ Lic.No/Date:2210012375 29 12 2011 Defer Date:13 06 2013

15 29.12.2011 Date:13.06.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/181/2013PI(Norms) dated 9.5.2013, it was decided to call from the firm the following technical details:  Export product is Amoxycillin & Potassium for Oral Suspension, 70 ml Bottle. Under ANF 4A, the export product is shown as Amoxycillin & Clavulanate Pot. Tablets 375 mg. Kindly clarify.  In the reply received from the firm vide their letter dated 7.12.2012, there is not DML for Tablets and the Master Batch formula is given for 3.3 gm/30 ml suspension which is not matching with export product. The case was deferred for 13.6.2013. 16

Case No.:13/3/82ALC4/2012

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00017/AM13/ RLA File :09/24/040/00467/AM12/ Lic.No/Date:0910050600 03.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/179/2013Pi(Norms) dated 9.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ractopamine HCL for veterinary usage 1 kg 1 (RS) 4(2 Amino1Hydroxy Ethyl) Phenol HCL 1.063 kg 2. 4(4Hydroxy Phenyl)2 Butanone 0.978 kg 3. Nitro Methane or Hydroxyl Amino Sulphate Not shown in reaction. 17

Case No.:16/29/85ALC3/2011

Party Name:S.R.S.PHARMACEUTICALS PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/85/050/00173/AM12/ RLA File :03/95/040/00831/AM12/ Lic.No/Date:0310674968 05.01.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish a copy of Drug Manufacturing License along with list of approved items, showing composition of export products immediately. The case was deferred for 13.6.2013. 18

Case No.:56/3/82ALC4/2012

Party Name:VINDHYA PHARMA (INDIA)PVT LTD. 16.05.2013 Status:Case Approved HQ File :01/82/050/00060/AM13/ RLA File :09/24/040/00494/AM12/ Lic.No/Date:0910051044 31.01.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/189/2013Pi(Norms) dated 9.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed (S S S) 2 1 kg 1 Recemiac 2 Azabycyclo 2 127 kg

(S,S,S)2 Azabicyclo(3,3,0) Octane3Carboxylic Acid Benzyl Ester HCL 1 kg 1 Recemiac2Azabycyclo (3,3,0)octane3Carboxylic Acid Benzyle Ester HCL 2.127 kg 19

Case No.:55/4/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00135/AM13/ RLA File :03/95/040/00886/AM12/ Lic.No/Date:0310681867 14.02.2012 Defer Date:13.06.2013 Decision :It was decided to send a copy of reply received from the firm to Department of Pharmaceuticals for their comments. The case was deferred for 13.6.2013. 20

Case No.:22/4/82ALC4/2012

Party Name:ARCH PHARMALABS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00102/AM13/ RLA File :03/94/040/01067/AM12/ Lic.No/Date:0310684092 29.02.2012 Defer Date:13.06.2013 21

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

Party Name:ARCH PHARMALABS LTD 16.05.2013 Status:Deferred HQ File :01/82/050/00114/AM13/ RLA File :03/94/040/01077/AM12/ Lic.No/Date:0310684930 05.03.2012 Defer Date:13.06.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 22

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

Party Name:ARCH PHARMALABS LTD 16.05.2013 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:13.06.2013 23

Case No.:1/2/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 16.05.2013 Status:Case Deferred HQ File :01/82/050/00001/AM13/ RLA File :03/95/040/00970/AM12/ Lic.No/Date:0310688849 30.03.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge immediately. The case was deferred for 13.6.2013.

Case No.:36/11/82ALC4/2012

Party Name:LAKE CHEMICALS PRIVATE LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00303/AM13/ RLA File :07/24/040/00004/AM13/ Lic.No/Date:0710087698 16.04.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish a copy of complete set of technical details as per Appendix 33 immediately. The case was deferred for 13.6.2013. 25

Case No.:77/4/82ALC4/2013

Party Name:IOL CHEMICALS AND PHARMACEUTICALS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00118/AM14/ RLA File :30/21/040/00003/AM13/ Lic.No/Date:3010085321 20.04.2012 Defer Date:13.06.2013 Decision :It was decided to send a copy of application to Department of Chemicals and Petrochemicals for their comments. The case was deferred for 13.6.2013. 26

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

Party Name:ADCOCK INGRAM LTD, 16.05.2013 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:13.06.2013 Decision : It was decided to request the firm to furnish a copy of Master Batch Formula duly certified by Quality Control Incharge along with composition of Paracetomol DC applied for import. The case was deferred for 13.6.2013. 27

Case No.:46/14/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00423/AM13/ RLA File :03/94/040/00188/AM13/ Lic.No/Date:0310697620 06.06.2012 Defer Date:13.06.2013 28

Case No.:53/14/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00430/AM13/ RLA File :03/94/040/00888/AM12/ Lic.No/Date:0310697981 08.06.2012 Defer Date:13.06.2013 29

Case No.:84/18/82ALC4/2012

Party Name:STERICON PHARMA PVT.LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00579/AM13/ RLA File :07/24/040/00108/AM13/ Lic.No/Date:0710088798 13.06.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the following technical details immediately:

DML for the export item no. 2 & 3 as the same is not found in the approved list of DML furnished by them. The case was deferred for 13.6.2013. 30

Case No.:2/23/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00802/AM13/ RLA File :22/24/040/00012/AM13/ Lic.No/Date:2210013015 14.06.2012 Defer Date:13.06.2013 31

Case No.:109/18/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00604/AM13/ RLA File :05/23/040/00491/AM12/ Lic.No/Date:0510328334 27.06.2012 Defer Date: 13.6.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 32

Case No.:35/18/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00530/AM13/ RLA File :08/24/040/00128/AM13/ Lic.No/Date:0810113566 20.07.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33 immediately. The case was deferred for 13.6.2013. 33

Case No.:61/21/82ALC4/2012

Party Name:SATYADEVA PHARMACEUTICALS /P/ LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00691/AM13/ RLA File :09/24/040/00184/AM13/ Lic.No/Date:0910053311 20.07.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the complete technical details as per Appendix 33 immediately. The case was deferred for 13.06.2013. 34

Case No.:27/21/82ALC4/2012

Party Name:STELLENCE PHARMSCIENCE PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00657/AM13/ RLA File :07/24/040/00183/AM13/ Lic.No/Date:0710089972 31.07.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33 and End use of the export product. The case was deferred for 13.6.2013.

Case No.:35/21/82ALC4/2012

Party Name:PADMINI AROMATICS PVT. LTD 16 05 2013 Status:Case Deferred

35 16.05.2013 Deferred HQ File :01/82/050/00665/AM13/ RLA File :07/24/040/00177/AM13/ Lic.No/Date:0710090045 03.08.2012 Defer Date:13.06.2013 Decision :The Committee noted that the export products are perfumery compounds and in terms of Para 4.7 (b) of HBP v 1, RA is advised not to issue license for perfume or perfumery compounds. The firm was also advised to apply under Para 4.4.2 of HBP v1. It was also decided to remind the firm to furnish a copy of production consumption data duly certified by Central Excise Authority. The case was deferred for 13.6.2013. 36

Case No.:29/4/82ALC4/2013

Party Name:KLJ PLASTICIZERS LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/00070/AM14/ RLA File :05/23/040/00156/AM13/ Lic.No/Date:0510331554 08.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2011Ch. II dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanatol7720 (Packed in 851 Nos. of HMHDPE Drums made of HM HDPE Blowing Grade) 1 kg 1 Phthalic Anhydride 0.380 kg 2. 2Ethyl Hexanol 0.545 kg 3. 2Propyl Heptanol 0.174 kg 4. HMHDPE Drums made of HMHDPE Blowing Grade Relevant, as per packing policy 37

Case No.:65/21/82ALC4/2012

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00695/AM13/ RLA File :09/24/040/00239/AM13/ Lic.No/Date:0910053490 14.08.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/179/2013Pi(Norms) dated 9.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ractopamine HCL for veterinary usage 1 kg 1 (RS) 4(2 Amino1Hydroxy Ethyl) Phenol HCL 1.063 kg 2. 4(4Hydroxy Phenyl)2 Butanone 0.978 kg RA may take appropriate action as per the decision of Norms Committee

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

Party Name:GITANJALI CHEMICALS PVT LTD 16.05.2013 Status:Case Approved HQ File :01/82/050/00771/AM13/ RLA File :03/94/040/00209/AM13/ Lic.No/Date:0310705334 16.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/41/2011Ch. II

38 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/41/2011 Ch. II dated 16.4.2013, 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 4Chloro4Hydroxy Benzophenone 1 kg 1 Anisole Crude 0.788 kg 2. 4Chloro Benzoyl Chloride (para Chloro Benzoyl Chloride) 1.045 kg 3. Mono Chloro Benzene 1.125 KG 4. Iso Propyl Alcohol 0.850 kg 5. Aluminium Chloride 2.250 kg 39

Case No.:25/22/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00728/AM13/ RLA File :09/24/040/00250/AM13/ Lic.No/Date:0910053546 17.08.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33 immediately. The case was deferred for 13.6.2013. 40

Case No.:27/22/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00730/AM13/ RLA File :09/24/040/00249/AM13/ Lic.No/Date:0910053547 17.08.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33 immediately. The case was deferred for 13.6.2013. 41

Case No.:40/21/82ALC4/2012

Party Name:VITAL LABORATORIES PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00670/AM13/ RLA File :03/95/040/00254/AM13/ Lic.No/Date:0310705409 17.08.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish complete technical details as per Appendix 33. The case was deferred for 13.6.2013. 42

Case No.:41/21/82ALC4/2012

Party Name:MEDLEY PHARMACEUTICALS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00671/AM13/ RLA File :03/95/040/00273/AM13/ Lic.No/Date:0310705411 17.08.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish a copy of DML for the export product immediately. The case was deferred for 13.6.2013.

Case No.:64/21/82ALC4/2012

Party Name:ECOLOGIC CHEMICALS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00694/AM13/ RLA File :09/24/040/00199/AM13/ Lic No/Date:0910053533 Defer

43 HQ File :01/82/050/00694/AM13/ RLA File :09/24/040/00199/AM13/ Lic.No/Date:0910053533 17.08.2012 Defer Date:13.06.2013 Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/141/2013PI(Norms), it was decided to call from the firm the following technical details: Complete technical details as per Appendix 33 mainly stepwise % yield on molar basis, molar requirement of reactants and Recovery of Solvent in the entire process. The case was deferred for 13.6.2013. 44

Case No.:36/21/82ALC4/2012

Party Name:CADILA HEALTHCARE LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00666/AM13/ RLA File :08/24/040/00147/AM13/ Lic.No/Date:0810114381 21.08.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details sought vide minutes dated 18.4.2013 immediately. The case was deferred for 13.6.2013. 45

Case No.:40/4/82ALC4/2013

Party Name:KLJ PLASTICIZERS LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/00081/AM14/ RLA File :05/23/040/00171/AM13/ Lic.No/Date:0510332241 22.08.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O no. 14010/36/2011Ch. II dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanatol1056 (packed in 1277 Nos. of HMHDPE Drums made of HM HDPE Blowing Grade 1 kg 1 Phthalic Anhydride 0.425 kg 2. Sabutol 0.227 kg 3. 2Propyl Heptanol 0.460 kg 4. HMHDPE Drums made of HMHDPE blowing grade Relevant, as per packing policy 46

Case No.:5/22/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00708/AM13/ RLA File :03/95/040/00318/AM13/ Lic.No/Date:0310706473 27.08.2012 Defer Date:13.06.2013

Case No.:40/22/82ALC4/2012

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 16.05.2013 Status:Case Deferred

47 HQ File :01/82/050/00743/AM13/ RLA File :03/94/040/00109/AM13/ Lic.No/Date:0310707803 05.09.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details sought vide minutes dated 18.4.2013 immediately. The case was deferred for 13.6.2013. 48

Case No.:39/26/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00947/AM13/ RLA File :09/24/040/00276/AM13/ Lic.No/Date:0910053682 06.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/142/2013Pi(Norms) dated 9.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Telmisartan 1 kg 1 2Cyano4Methyle Biphenyl (OTBN) 0.576 kg 2. 2NPropyl4Methyl6(1 Methyl Benzimidazole2 yl)1HBenzimidazole 0.82 kg 3. Methylene Dichloride (MDC) 0.733 kg 4. Methyl Iso Butyl Ketone (MIBK) 1.813 kg 5. Methanol 3.70 kg 49

Case No.:58/22/82ALC4/2012

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00761/AM13/ RLA File :03/94/040/00113/AM13/ Lic.No/Date:0310707983 06.09.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details sought vide minutes dated 18.4.2013 immediately. The case was deferred for 13.6.2013. 50

Case No.:2/21/82ALC4/2012

Party Name:ZEE LABORATORIES 16.05.2013 Status:Case Deferred HQ File :01/82/050/00632/AM13/ RLA File :05/24/040/00220/AM13/ Lic.No/Date:0510334505 12.09.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details sought vide minutes dated 18.4.2013. The case was deferred for 13.6.2013. 51

Case No.:3/21/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/00633/AM13/ RLA File :08/24/040/00144/AM13/ Lic.No/Date:0810115056 12.09.2012 Defer Date:13.06.2013

Case No.:77/24/82ALC4/2012

Party Name:ASHISH LIFE SCIENCE PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00881/AM13/ RLA File :03/94/040/00378/AM13/ Lic.No/Date:0310709108 14.09.2012 Defer Date:13.06.2013 Decision :It was decided to give a final reminder to the firm to furnish complete details of their export product and also a copy of valid Drug Manufacturing License without any further delay otherwise their case would be closed. The case was deferred for 13.6.2013. 53

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

Party Name:VASISTA LIFE SCIENCES PVT LTD 16.05.2013 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:13.06.2013 Decision :Department of Pharmaceuticals vide their OM No. 35011/91/2013PI(Norms) dated 1.5.2013 has informed that Benzyl Magnesium Chloride 2 M in THF is a chemical used in Pharma & other industries. They have requested to obtain the comments from Department of Chemicals and Petrochemicals. It was decided to seek the comments of Department of Chemicals and Petrochemicals. The case was deferred for 13.6.2013. 54

Case No.:87/24/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00891/AM13/ RLA File :03/95/040/00466/AM13/ Lic.No/Date:0310710207 24.09.2012 Defer Date:13.06.2013 55

Case No.:85/24/82ALC4/2012

Party Name:MAKSON INDUSTRIES PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00889/AM13/ RLA File :03/95/040/00394/AM13/ Lic.No/Date:0310710561 26.09.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details sought vide minutes dated 18.4.2013. The case was deferred for 13.6.2013.

Case No.:76/24/82ALC4/2012

Party Name:ENCUBE ETHICALS PVT LTD 16.05.2013 Status:Case Approved HQ File :01/82/050/00880/AM13/ RLA File :03/94/040/00500/AM13/ Lic.No/Date:0310711014 28.09.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/177/2013PI(Norms) dated 9.5.2013, it was decided to ratify norms under Para 4.7 of HBPv 1 for export of Clotrimazole 1% Vaginal cream 35 gm tube, 100 gm tube, 20 gm tube, 50 gm tube and Clotrimazole 2% Vaginal cream 20 gm tube as per details given below or as applied by the firm whichever is less: [A] S. No Import Item For Export of 1 No. Clotrimazole Vaginal Cream

56 1%, 35 gm tube 2%, 20 gm tube 1. Clotrimazole 0.357 gm 0.408 gm 2. Octyldodecanol 4.725 gm 2.70 gm 3. Cetyl Palmated 1.05 gm 0.60 gm 4. Cetostearyl Alcohol 3.50 gm 2.00 gm 5. Empty Aluminium Collapsible Tube Relevant, as per packing policy 6. Plastic Applicator [B] S.No Import Item For Export of 1 No. Clotrimazole 1% cream, 100 gm pack 1. Clotrimazole 1.02 gm 2. Octyldodecanol 13.50 gm 3. Cetyl Palmated 3.00 gm 4. Cetostearyl Alcohol 10.00 gm 5. Empty Aluminium Collapsible Tube Relevant, as per packing policy For different pack sizes, RA may work out norms on prorata basis. RA may take appropriate action as per the decision of Norms Committee. 57

Case No.:96/24/82ALC4/2012

Party Name:TIDE INDUSTRIES 16.05.2013 Status:Case Deferred HQ File :01/82/050/00900/AM13/ RLA File :34/24/040/00158/AM13/ Lic.No/Date:3410035264 01.10.2012 Defer Date: 13.6.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Chemicals and Petrochemicals. 58

Case No.:91/24/82ALC4/2012

Party Name:SMB MEDICAL DEVICES PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00895/AM13/ RLA File :03/95/040/00446/AM13/ Lic.No/Date:0310712446 11.10.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details sought vide minutes dated 18.4.2013. The case was deferred for 13.6.2013. 59

Case No.:21/31/82ALC4/2012

Party Name:ADESHWAR MEDITEX PVT. LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01061/AM13/ RLA File :03/94/040/00597/AM13/ Lic.No/Date:0310712671 12.10.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details sought vide minutes dated 18.4.2013. The case was deferred for 13.6.2013. 60

Case No.:9/24/82ALC4/2012

Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00813/AM13/ RLA File :02/24/040/00119/AM13/ Lic.No/Date:0210183299 17 10 2012 Defer Date:13 06 2013

17.10.2012 Date:13.06.2013 61

Case No.:3/23/82ALC4/2012

Party Name:TITAN LABORATORIES PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00803/AM13/ RLA File :03/95/040/00544/AM13/ Lic.No/Date:0310713360 22.10.2012 Defer Date:13.06.2013 Decision :In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/145/2013PI(Norms) dated 9.5.2013, it was decided to call from the firm the following technical details: Copy of valid Drug Manufacturing License for the export product; and Copy of Master Batch Formula duly certified by Quality Control Incharge. The case was deferred for 13.6.2013. 62

Case No.:42/31/82ALC4/2012

Party Name:AARTI INDUSTRIES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/01082/AM13/ RLA File :03/94/040/00574/AM13/ Lic.No/Date:0310713516 23.10.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 26/82 dated 27.9.2011, 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 Benzyl((Cis,Endo)Octahydro Cyclopenta(B)Pyrrole2(S) Carboxylate Hydrochloride 1 Kg. 1. LSerine 1.50 kg 2. Benzyl Alcohol 7.02 kg 3. Palladium Catalyst 5% Dry 0.050 kg 4. Di Iso Propyl Ether 2.375 kg 63

Case No.:51/28/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01018/AM13/ RLA File :03/95/040/00495/AM13/ Lic.No/Date:0310713489 23.10.2012 Defer Date:13.06.2013 Decision :It was decided to send a copy of reply received from the firm to Department of Pharmaceuticals for their comments. The case was deferred for 13.6.2013. 64

Case No.:36/31/82ALC4/2012

Party Name:ARCH PHARMALABS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01076/AM13/ RLA File :03/94/040/00642/AM13/ Lic.No/Date:0310713679 29.10.2012 Defer Date:13.06.2013

Case No.:9/28/82ALC4/2012

Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 16.05.2013 Status:Case Approved HQ File :01/82/050/00976/AM13/ RLA File :09/24/040/00374/AM13/ Lic.No/Date:0910054204 30.10.2012 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/180/2013PI(Norms) dated 9.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed D2 Aminobutanol 1 kg 1 DL 2 Aminobutanol 2.2642 kg 2. Monosodium glutamate 1.00 kg 3. Toluene 0.709 kg 66

Case No.:105/33/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01252/AM13/ RLA File :09/24/040/00361/AM13/ Lic.No/Date:0910054229 01.11.2012 Defer Date:13.06.2013 67

Case No.:37/31/82ALC4/2012

Party Name:ARCH PHARMALABS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01077/AM13/ RLA File :03/94/040/00641/AM13/ Lic.No/Date:0310714114 01.11.2012 Defer Date:13.06.2013 68

Case No.:50/31/82ALC4/2012

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 16.05.2013 Status:Case Approved HQ File :01/82/050/01090/AM13/ RLA File :03/94/040/00495/AM13/ Lic.No/Date:0310714105 01.11.2012 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 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 Exp. Qty. Sl.No. Import items Qty. allowed 3Chloro Benzyl Chloride or Meta Chloro Benzyl Chloride 1 kg 1 Meta Chloro Toluene 0.982 kg 2. Azo Bis Isobutyro Nitrile 0.011 kg

Case No.:95/24/82ALC4/2012

Party Name:SOLARIS CHEMTECH INDUSTRIES LTD 16 05 2013 Status:Case Deferred

69 LTD. 16.05.2013 Deferred HQ File :01/82/050/00899/AM13/ RLA File :34/24/040/00188/AM13/ Lic.No/Date:3410035412 01.11.2012 Defer Date:13.06.2013 70

Case No.:7/31/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01047/AM13/ RLA File :05/24/040/00277/AM13/ Lic.No/Date:0510338116 02.11.2012 Defer Date:13.06.2013 71

Case No.:89/33/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01236/AM13/ RLA File :09/24/040/00376/AM13/ Lic.No/Date:0910054253 05.11.2012 Defer Date:13.06.2013 72

Case No.:95/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01242/AM13/ RLA File :09/24/040/00342/AM13/ Lic.No/Date:0910054286 08.11.2012 Defer Date:13.06.2013 73

Case No.:15/33/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01162/AM13/ RLA File :22/24/040/00039/AM13/ Lic.No/Date:2210013390 09.11.2012 Defer Date:13.06.2013 74

Case No.:170/33/82ALC4/2012

Party Name:RANTUS PHARMA PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01317/AM13/ RLA File :09/24/040/00367/AM13/ Lic.No/Date:0910054294 09.11.2012 Defer Date:13.06.2013 75

Case No.:23/31/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01063/AM13/ RLA File :03/95/040/00555/AM13/ Lic.No/Date:0310714767 09.11.2012 Defer Date:13.06.2013

Decision :It was decided to send a copy of reply received from the firm to Department of Pharmaceuticals for their comments. The case was deferred for 13.6.2013. 76

Case No.:25/31/82ALC4/2012

Party Name:THINQ PHARMACRO LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01065/AM13/ RLA File :03/95/040/00602/AM13/ Lic.No/Date:0310714790 09.11.2012 Defer Date:13.06.2013 77

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

Party Name:MYLAN LABORATORIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01295/AM13/ RLA File :09/24/040/00359/AM13/ Lic.No/Date:0910054335 15.11.2012 Defer Date:13.06.2013 78

Case No.:39/31/82ALC4/2012

Party Name:CIPLA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01079/AM13/ RLA File :03/94/040/00696/AM13/ Lic.No/Date:0310715048 16.11.2012 Defer Date:13.06.2013 79

Case No.:90/33/82ALC4/2012

Party Name:SATYA DEEPTHA PHARMACEUTICALS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01237/AM13/ RLA File :09/24/040/00394/AM13/ Lic.No/Date:0910054339 19.11.2012 Defer Date:13.06.2013 80

Case No.:16/33/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01163/AM13/ RLA File :05/24/040/00308/AM13/ Lic.No/Date:0510339206 20.11.2012 Defer Date:13.06.2013 81

Case No.:179/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01326/AM13/ RLA File :09/24/040/00393/AM13/ Lic.No/Date:0910054348 20.11.2012 Defer Date:13.06.2013

Case No.:181/33/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01328/AM13/ RLA File :09/24/040/00401/AM13/ Lic.No/Date:0910054361 22.11.2012 Defer Date:13.06.2013 83

Case No.:48/31/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01088/AM13/ RLA File :03/94/040/00711/AM13/ Lic.No/Date:0310715606 23.11.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish technical details as per Appendix 33 mainly molecular weight of imported inputs and % yield on molar basis alongwith copy of relevant technical literature. The case was deferred for 13.6.2013. 84

Case No.:191/33/82ALC4/2012

Party Name:VANI PHARMA LABS LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01338/AM13/ RLA File :09/24/040/00357/AM13/ Lic.No/Date:0910054379 26.11.2012 Defer Date:13.06.2013 85

Case No.:120/33/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01267/AM13/ RLA File :09/24/040/00396/AM13/ Lic.No/Date:0910054387 27.11.2012 Defer Date:13.06.2013 86

Case No.:166/33/82ALC4/2012

Party Name:PERKIN LABORATORIES 16.05.2013 Status:Case Deferred HQ File :01/82/050/01313/AM13/ RLA File :09/24/040/00382/AM13/ Lic.No/Date:0910054386 27.11.2012 Defer Date:13.06.2013 87

Case No.:167/33/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01314/AM13/ RLA File :09/24/040/00391/AM13/ Lic.No/Date:0910054388 27.11.2012 Defer Date:13.06.2013

Case No.:50/4/82ALC4/2013

Party Name:NECTAR LIFESCIENCES LIMITED, 16.05.2013 Status:Case Deferred HQ File :01/82/050/00091/AM14/ RLA File :22/24/040/00046/AM13/ Lic.No/Date:2210013412 27.11.2012 Defer Date:13.06.2013 89

Case No.:9/31/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01049/AM13/ RLA File :04/24/040/00182/AM13/ Lic.No/Date:0410141372 29.11.2012 Defer Date:13.06.2013 90

Case No.:108/33/82ALC4/2012

Party Name:VIVIMED LABS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01255/AM13/ RLA File :09/24/040/00424/AM13/ Lic.No/Date:0910054414 30.11.2012 Defer Date:13.06.2013 91

Case No.:109/33/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01256/AM13/ RLA File :09/24/040/00409/AM13/ Lic.No/Date:0910054415 30.11.2012 Defer Date:13.06.2013 92

Case No.:1/27/82ALC4/2012

Party Name:PORUS LABORATORIES PVT LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00956/AM13/ RLA File :09/24/040/00426/AM13/ Lic.No/Date:0910054427 03.12.2012 Defer Date:13.06.2013 93

Case No.:123/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01270/AM13/ RLA File :09/24/040/00405/AM13/ Lic.No/Date:0910054430 03.12.2012 Defer Date:13.06.2013

Case No.:128/33/82ALC4/2012

16.05.2013 Status:Case Deferred

94 HQ File :01/82/050/01275/AM13/ RLA File :08/24/040/00304/AM13/ Lic.No/Date:0810116598 03.12.2012 Defer Date:13.06.2013 95

Case No.:112/33/82ALC4/2012

Party Name:STERICAT GUTSTRINGS PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01259/AM13/ RLA File :05/24/040/00304/AM13/ Lic.No/Date:0510340033 04.12.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details sought vide minutes dated 18.4.2013 immediately. The case was deferred for 13.6.2013. 96

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

Party Name:RANBAXY LABORATORIES LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01161/AM13/ RLA File :05/24/040/00324/AM13/ Lic.No/Date:0510340056 04.12.2012 Defer Date:13.06.2013 97

Case No.:18/33/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01165/AM13/ RLA File :05/24/040/00325/AM13/ Lic.No/Date:0510340057 04.12.2012 Defer Date:13.06.2013 98

Case No.:2/27/82ALC4/2012

Party Name:GOPINATH CHEMTECH LTD., 16.05.2013 Status:Case Approved HQ File :01/82/050/00957/AM13/ RLA File :08/24/040/00295/AM13/ Lic.No/Date:0810116627 04.12.2012 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 dated 22.4.2013, 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 4,4Diamino Diphenyl Amine1 Sulphonic Acid 1 kg 1 Para Nitro Aniline 0.950 kg 2. Para Nitro Chloro Benzene 1.290 kg 3. Caustic Soda Lye (100% basis) or Caustic Soda Flakes Not required in the process 4. Soda Ash 2.800 kg 99

Case No.:24/31/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 16 05 2013 Status:Case Approved

16.05.2013 Approved HQ File :01/82/050/01064/AM13/ RLA File :03/95/040/00661/AM13/ Lic.No/Date:0310716278 04.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2010Ch. II dated 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 3(4Chloro2Fluro 5MercaptoPhenyl 1Methyl6 Triflouromethyl1 HPyrimidine2,4 Dione (PDSH) 1 kg 1 Ethyl 4,4,4 Trifluoro Aceto Acetate 1.220 kg 2. 4Chloro 2 Fluoro Aniline 0.998 kg 3. Ethyl Chloroformate 1.060 kg 100

Case No.:185/33/82ALC4/2012

Party Name:S.M. HERBALS PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01332/AM13/ RLA File :05/24/040/00331/AM13/ Lic.No/Date:0510340123 05.12.2012 Defer Date:13.06.2013 101

Case No.:187/33/82ALC4/2012

Party Name:MICRO LABS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01334/AM13/ RLA File :07/24/040/00344/AM13/ Lic.No/Date:0710092287 05.12.2012 Defer Date:13.06.2013 102

Case No.:30/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01070/AM13/ RLA File :03/95/040/00670/AM13/ Lic.No/Date:0310716370 05.12.2012 Defer Date:13.06.2013 103

Case No.:57/31/82ALC4/2012

Party Name:ACTGEN PHARMA PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01097/AM13/ RLA File :03/94/040/00728/AM13/ Lic.No/Date:0310716371 05.12.2012 Defer Date:13.06.2013

Case No.:73/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 16.05.2013 Status:Case Deferred

104 HQ File :01/82/050/01220/AM13/ RLA File :09/24/040/00429/AM13/ Lic.No/Date:0910054448 05.12.2012 Defer Date:13.06.2013 105

Case No.:93/33/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01240/AM13/ RLA File :09/24/040/00237/AM13/ Lic.No/Date:0910054437 05.12.2012 Defer Date:13.06.2013 106

Case No.:127/33/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/01274/AM13/ RLA File :08/24/040/00155/AM13/ Lic.No/Date:0810116730 07.12.2012 Defer Date:13.06.2013 107

Case No.:168/33/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/01315/AM13/ RLA File :08/24/040/00253/AM13/ Lic.No/Date:0810116731 07.12.2012 Defer Date:13.06.2013 108

Case No.:172/33/82ALC4/2012

Party Name:CADILA PHARMACEUTICALS LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01319/AM13/ RLA File :08/24/040/00303/AM13/ Lic.No/Date:0810116727 07.12.2012 Defer Date:13.06.2013 109

Case No.:176/33/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/01323/AM13/ RLA File :08/24/040/00301/AM13/ Lic.No/Date:0810116729 07.12.2012 Defer Date:13.06.2013 110

Case No.:188/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01335/AM13/ RLA File :05/23/040/00345/AM13/ Lic.No/Date:0510340432 07.12.2012 Defer Date:13.06.2013

111

Case No.:4/27/82ALC4/2012

Party Name:PORUS LABORATORIES PVT LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00959/AM13/ RLA File :09/24/040/00408/AM13/ Lic.No/Date:0910054464 07.12.2012 Defer Date:13.06.2013 112

Case No.:41/33/82ALC4/2012

Party Name:GITANJALI CHEMICALS PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01188/AM13/ RLA File :03/94/040/00747/AM13/ Lic.No/Date:0310716657 07.12.2012 Defer Date:13.06.2013 113

Case No.:43/33/82ALC4/2012

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 16.05.2013 Status:Case Deferred HQ File :01/82/050/01190/AM13/ RLA File :03/94/040/00727/AM13/ Lic.No/Date:0310716674 07.12.2012 Defer Date:13.06.2013 114

Case No.:175/33/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01322/AM13/ RLA File :05/23/040/00356/AM13/ Lic.No/Date:0510340518 10.12.2012 Defer Date:13.06.2013 115

Case No.:76/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01223/AM13/ RLA File :09/24/040/00411/AM13/ Lic.No/Date:0910054467 10.12.2012 Defer Date:13.06.2013 116

Case No.:10/27/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00965/AM13/ RLA File :09/24/040/00416/AM13/ Lic.No/Date:0910054496 12.12.2012 Defer Date:13.06.2013

117

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

Party Name:SHIVA PHARMACHEM LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/01053/AM13/ RLA File :34/24/040/00218/AM13/ Lic.No/Date:3410035633 12.12.2012 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 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed 4Chloro Butyryl Chloride Appearance: Clear Colourless Liquid 1 kg 1 Gamma Butyrolactone (Appearance: Clear Colourless Liquid) 0.753 kg 118

Case No.:66/33/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01213/AM13/ RLA File :09/24/040/00443/AM13/ Lic.No/Date:0910054499 12.12.2012 Defer Date:13.06.2013 119

Case No.:126/33/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/01273/AM13/ RLA File :08/24/040/00315/AM13/ Lic.No/Date:0810116862 13.12.2012 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the full description of the export items. The case was deferred for 13.6.2013 120

Case No.:77/33/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01224/AM13/ RLA File :09/24/040/00404/AM13/ Lic.No/Date:0910054501 13.12.2012 Defer Date: 13.6.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 121

Case No.:10/33/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/01157/AM13/ RLA File :03/95/040/00569/AM13/ Lic.No/Date:0310717225 14.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/117/2011Ch. II dated 29.5.2011, 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 2 Bromo Iso Butyric 1 kg 1 Iso Butyric Acid 0 701 kg

2Bromo Iso Butyric Iso Propyl Ester (Isopropyl2Bromo Isobutyrate/2Bromo Isobutyrate D Isopropryl) 1 kg 1. Iso Butyric Acid 0.701 kg 2. Liquid Bromine 1.276 kg 3. Iso Propanol 1.078 kg 122

Case No.:140/33/82ALC4/2012

Party Name:HETERO DRUGS LIMITED, 16.05.2013 Status:Case Deferred HQ File :01/82/050/01287/AM13/ RLA File :09/24/040/00448/AM13/ Lic.No/Date:0910054511 14.12.2012 Defer Date:13.06.2013 123

Case No.:64/31/82ALC4/2012

Party Name:CONCEPT PHARMACEUTICALS LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01104/AM13/ RLA File :03/94/040/00700/AM13/ Lic.No/Date:0310717229 14.12.2012 Defer Date:13.06.2013 124

Case No.:85/31/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01125/AM13/ RLA File :03/95/040/00465/AM13/ Lic.No/Date:0310717240 14.12.2012 Defer Date:13.06.2013 125

Case No.:11/27/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00966/AM13/ RLA File :22/24/040/00051/AM13/ Lic.No/Date:2210013450 17.12.2012 Defer Date:13.06.2013 126

Case No.:83/31/82ALC4/2012

Party Name:YASHO INDUSTRIES PVT.LTD. 16.05.2013 Status:Case Approved HQ File :01/82/050/01123/AM13/ RLA File :03/95/040/00709/AM13/ Lic.No/Date:0310717365 17.12.2012 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 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: E t d t E Qt Sl N I t it Qt ll d

Export product Exp. Qty. Sl.No. Import items Qty. allowed DiNonylated Diphenyl Amine (DND) 1 kg 1. Nonene 0.752 kg 2. Diphenylamine 0.500 kg 127

Case No.:9/33/82ALC4/2012

Party Name:NEOGEN CHEMICALS LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/01156/AM13/ RLA File :03/95/040/00683/AM13/ Lic.No/Date:0310717358 17.12.2012 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/117/2011Ch. II dated 29.5.2011, 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 2Bromo Iso Butyric Iso Propyl Ester (Isopropyl2Bromo Isobutyrate/2Bromo Isobutyrate D Isopropryl) 1 kg 1. Iso Butyric Acid 0.701 kg 2. Liquid Bromine 1.276 kg 3. Iso Propanol 1.078 kg 128

Case No.:104/33/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01251/AM13/ RLA File :05/23/040/00239/AM13/ Lic.No/Date:0510341177 18.12.2012 Defer Date:13.06.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 129

Case No.:110/33/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01257/AM13/ RLA File :08/24/040/00324/AM13/ Lic.No/Date:0810116928 18.12.2012 Defer Date:13.06.2013 130

Case No.:125/33/82ALC4/2012

Party Name:SYMBIOTEC PHARMALAB LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01272/AM13/ RLA File :56/24/040/00032/AM13/ Lic.No/Date:5610001382 18.12.2012 Defer Date:13.06.2013

Case No.:131/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT Meet No/Date:4/82ALC4/2013 Status:Case

131

Case No.:131/33/82 ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:4/82 ALC4/2013 16.05.2013 Status:Case Deferred HQ File :01/82/050/01278/AM13/ RLA File :07/24/040/00377/AM13/ Lic.No/Date:0710092564 18.12.2012 Defer Date:13.06.2013 132

Case No.:169/33/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01316/AM13/ RLA File :05/23/040/00238/AM13/ Lic.No/Date:0510341172 18.12.2012 Defer Date:13.06.2013 133

Case No.:184/33/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01331/AM13/ RLA File :05/24/040/00347/AM13/ Lic.No/Date:0510341261 19.12.2012 Defer Date:13.06.2013 134

Case No.:53/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01093/AM13/ RLA File :03/95/040/00702/AM13/ Lic.No/Date:0310717633 19.12.2012 Defer Date:13.06.2013 135

Case No.:55/31/82ALC4/2012

Party Name:S.KANT HEALTHCARE LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01095/AM13/ RLA File :03/95/040/00701/AM13/ Lic.No/Date:0310717631 19.12.2012 Defer Date:13.06.2013 136

Case No.:182/33/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01329/AM13/ RLA File :22/24/040/00055/AM13/ Lic.No/Date:2210013463 20.12.2012 Defer Date:13.06.2013 137

Case No.:186/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 16.05.2013 Status:Case Deferred HQ File :01/82/050/01333/AM13/ RLA File :07/24/040/00387/AM13/ Lic.No/Date:0710092620 20 12 2012 Defer Date:13 06 2013

20.12.2012 Date:13.06.2013 138

Case No.:45/33/82ALC4/2012

Party Name:CONCEPT PHARMACEUTICALS LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01192/AM13/ RLA File :03/94/040/00421/AM13/ Lic.No/Date:0310717803 20.12.2012 Defer Date:13.06.2013 139

Case No.:46/33/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01193/AM13/ RLA File :03/94/040/00769/AM13/ Lic.No/Date:0310717816 20.12.2012 Defer Date:13.06.2013 140

Case No.:164/33/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01311/AM13/ RLA File :05/24/040/00360/AM13/ Lic.No/Date:0510341511 21.12.2012 Defer Date:13.06.2013 141

Case No.:135/33/82ALC4/2012

Party Name:VIRAT EXPORTS P.LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01282/AM13/ RLA File :05/24/040/00365/AM13/ Lic.No/Date:0510341550 24.12.2012 Defer Date:13.06.2013 142

Case No.:113/33/82ALC4/2012

Party Name:RIDDHI PHARMA 16.05.2013 Status:Case Deferred HQ File :01/82/050/01260/AM13/ RLA File :34/24/040/00225/AM13/ Lic.No/Date:3410035749 28.12.2012 Defer Date:13.06.2013 Decision :Department of Chemicals and Petrochemicals vide their letter No. 14011/76/2010/Ch. II dated 29.4.2013 has requested to furnish the following information: Details of manufacturing process with chemical equations, molecular formula, molecular weight. Yield obtained in each step. Authentic technical literature in support of yield obtained. Material balance. CA certificate certifying the production of export item achieved by the firm for the past three years and corresponding consumption of each input.

Detailed calculations, arriving at the norms applied for Photocopy of earlier norms fixed by ALC for same export item in the recent past. It was decided to remind the firm to furnish the information immediately. The case was deferred for 13.06.2013. 143

Case No.:53/33/82ALC4/2012

Party Name:AVIGNON EXIM PVT.LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01200/AM13/ RLA File :03/94/040/00820/AM13/ Lic.No/Date:0310718503 28.12.2012 Defer Date:13.06.2013 144

Case No.:136/33/82ALC4/2012

Party Name:HETERO LABS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01283/AM13/ RLA File :09/24/040/00457/AM13/ Lic.No/Date:0910054624 31.12.2012 Defer Date:13.06.2013 145

Case No.:183/33/82ALC4/2012

Party Name:S.M. HERBALS PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01330/AM13/ RLA File :05/24/040/00366/AM13/ Lic.No/Date:0510342102 01.01.2013 Defer Date:13.06.2013 146

Case No.:33/4/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00074/AM14/ RLA File :09/24/040/00439/AM13/ Lic.No/Date:0910054647 01.01.2013 Defer Date:13.06.2013 147

Case No.:70/33/82ALC4/2012

Party Name:RAY CHEMICALS PRIVATE LIMITED, 16.05.2013 Status:Case Deferred HQ File :01/82/050/01217/AM13/ RLA File :07/24/040/00398/AM13/ Lic.No/Date:0710092831 01.01.2013 Defer Date:13.06.2013 148

Case No.:129/33/82ALC4/2012

16.05.2013 Status:Case Deferred

HQ File :01/82/050/01276/AM13/ RLA File :08/24/040/00336/AM13/ Lic.No/Date:0810117326 02.01.2013 Defer Date:13.06.2013 149

Case No.:130/33/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/01277/AM13/ RLA File :08/24/040/00161/AM13/ Lic.No/Date:0810117325 02.01.2013 Defer Date:13.06.2013 150

Case No.:165/33/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/01312/AM13/ RLA File :08/24/040/00257/AM13/ Lic.No/Date:0810117317 02.01.2013 Defer Date:13.06.2013 151

Case No.:171/33/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/01318/AM13/ RLA File :08/24/040/00256/AM13/ Lic.No/Date:0810117315 02.01.2013 Defer Date:13.06.2013 152

Case No.:74/33/82ALC4/2012

Party Name:MELZER CHEMICALS PVT. LTD 16.05.2013 Status:Case Approved HQ File :01/82/050/01221/AM13/ RLA File :31/83/040/00168/AM13/ Lic.No/Date:3110056651 02.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/72/2012Ch. 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 Exp. Qty. Sl.No. Import items Qty. allowed Benzalkonium Chloride 80% 1 kg 1 Lauryl Dimethyl Amine 0.513 kg 153

Case No.:32/4/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00073/AM14/ RLA File :09/24/040/00465/AM13/ Lic.No/Date:0910054683 03.01.2013 Defer Date:13.06.2013 Decision :It was decided to defer the case for 13 6 2013 for comments of Department of Pharmaceuticals

154

Case No.:49/4/82ALC4/2013

Party Name:ALEKHYA DRUGS PVT LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00090/AM14/ RLA File :09/24/040/00157/AM13/ Lic.No/Date:0910054675 03.01.2013 Defer Date:13.06.2013 155

Case No.:37/4/82ALC4/2013

Party Name:MYLAN LABORATORIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00078/AM14/ RLA File :09/24/040/00458/AM13/ Lic.No/Date:0910054697 04.01.2013 Defer Date:13.06.2013 156

Case No.:40/31/82ALC4/2012

Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01080/AM13/ RLA File :03/95/040/00777/AM13/ Lic.No/Date:0310719514 07.01.2013 Defer Date:13.06.2013 157

Case No.:132/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01279/AM13/ RLA File :05/23/040/00410/AM13/ Lic.No/Date:0510342696 08.01.2013 Defer Date:13.06.2013 158

Case No.:134/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01281/AM13/ RLA File :05/23/040/00408/AM13/ Lic.No/Date:0510342701 08.01.2013 Defer Date:13.06.2013 159

Case No.:31/4/82ALC4/2013

Party Name:HETERO LABS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00072/AM14/ RLA File :09/24/040/00478/AM13/ Lic.No/Date:0910054718 08.01.2013 Defer Date:13.06.2013

160

Case No.:52/31/82ALC4/2012

Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01092/AM13/ RLA File :03/95/040/00708/AM13/ Lic.No/Date:0310719783 08.01.2013 Defer Date:13.06.2013 161

Case No.:74/31/82ALC4/2012

Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01114/AM13/ RLA File :03/95/040/00724/AM13/ Lic.No/Date:0310719791 08.01.2013 Defer Date:13.06.2013 162

Case No.:96/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 16.05.2013 Status:Case Deferred HQ File :01/82/050/01243/AM13/ RLA File :07/24/040/00419/AM13/ Lic.No/Date:0710092979 08.01.2013 Defer Date:13.06.2013 163

Case No.:38/4/82ALC4/2013

Party Name:AUCTUS PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00079/AM14/ RLA File :09/24/040/00473/AM13/ Lic.No/Date:0910054734 09.01.2013 Defer Date:13.06.2013 164

Case No.:117/33/82ALC4/2012

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01264/AM13/ RLA File :08/24/040/00339/AM13/ Lic.No/Date:0810117495 10.01.2013 Defer Date:13.06.2013 165

Case No.:39/4/82ALC4/2013

Party Name:AUCTUS PHARMA LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00080/AM14/ RLA File :09/24/040/00474/AM13/ Lic.No/Date:0910054755 10.01.2013 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 Export Qty. Sl.No. Import items Qty. allowed kg/kg (2R.5R)5Hydroxy[1,3] 1 kg 1. 2,5Dihydroxy1,4diathiane 0.30

Oxathiolane2carboxylic acid, 2S Isopropyl5R Methyl1R Cyclohexyl Ester (ECE) 2 Glyoxalic Acid 0.3585 3. Toluene 0.60 4. nHexane 1.10 166

Case No.:41/4/82ALC4/2013

Party Name:MSN PHARMACHEM PRIVATE LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00082/AM14/ RLA File :09/24/040/00482/AM13/ Lic.No/Date:0910054756 10.01.2013 Defer Date:13.06.2013 167

Case No.:42/4/82ALC4/2013

Party Name:MSN LABORATORIES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00083/AM14/ RLA File :09/24/040/00481/AM13/ Lic.No/Date:0910054758 10.01.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/197/2013PI(Norms) dated 9.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Voriconazole 1 kg 1 2fluro3oxopentanoic acid methyl ester 5.00 168

Case No.:43/4/82ALC4/2013

Party Name:MSN PHARMACHEM PRIVATE LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00084/AM14/ RLA File :09/24/040/00483/AM13/ Lic.No/Date:0910054757 10.01.2013 Defer Date:13.06.2013 169

Case No.:45/4/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00086/AM14/ RLA File :09/24/040/00467/AM13/ Lic.No/Date:0910054747 10.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Export Qty. Sl.No. Import items Qty. allowed 2Aminomethyl7Chloro2,3 Dihydro5(2Fluorophenyl)1H 1 4 Benzodiazepine Dimaleate 1 Kg. 1. 2Amino5Chloro2Fluoro Benzophenone 0.932 kg 2 Chloro acetaldeh de Dimeth l 0 696 kg

1,4Benzodiazepine Dimaleate 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 RA may take appropriate action as per the decision of Norms Committee. It was also decided to revise SION A 2611 as per the above norms. 170

Case No.:147/33/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 16.05.2013 Status:Case Deferred HQ File :01/82/050/01294/AM13/ RLA File :07/24/040/00429/AM13/ Lic.No/Date:0710093054 11.01.2013 Defer Date:13.06.2013 171

Case No.:203/33/82ALC4/2012

Party Name:SUBHASH CHEMICAL INDUSTRIES PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01350/AM13/ RLA File :31/83/040/00137/AM13/ Lic.No/Date:3110056802 11.01.2013 Defer Date:13.06.2013 Decision :Department of Chemicals and Petrochemicals vide their letter NO. 14010/4/2013Ch. II dated 9.4.2013 has requested the firm to furnish the following information Manufacturing process with chemical equations, molecular formula, molecular weights. Composition of the product Stagewise percentage yield Material Balance Authentic technical literature in support of norms applied. It was decided to remind the firm to furnish the above information. The case was deferred for 13.6.2013. 172

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

Party Name:GLAND PHARMA LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01036/AM13/ RLA File :09/24/040/00497/AM13/ Lic.No/Date:0910054771 11.01.2013 Defer Date:13.06.2013 173

Case No.:44/4/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00085/AM14/ RLA File :09/24/040/00480/AM13/ Lic.No/Date:0910054759 11.01.2013 Defer Date:13.06.2013

Case No.:48/4/82ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:4/82ALC4/2013 Status:Case

174

Case No.:48/4/82 ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:4/82 ALC4/2013 16.05.2013 Status:Case Deferred HQ File :01/82/050/00089/AM14/ RLA File :09/24/040/00463/AM13/ Lic.No/Date:0910054762 11.01.2013 Defer Date:13.06.2013 175

Case No.:56/33/82ALC4/2012

Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01203/AM13/ RLA File :03/95/040/00801/AM13/ Lic.No/Date:0310720417 11.01.2013 Defer Date:13.06.2013 176

Case No.:58/33/82ALC4/2012

Party Name:METROPOLITAN EXIMCHEM LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01205/AM13/ RLA File :03/95/040/00788/AM13/ Lic.No/Date:0310720530 14.01.2013 Defer Date:13.06.2013 177

Case No.:199/33/82ALC4/2012

Party Name:INDO AMINES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/01346/AM13/ RLA File :03/94/040/00630/AM13/ Lic.No/Date:0310720784 15.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/81/2010/Ch. II dated 23.4.2013, 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 Di Iso Butyl Carbinol 1 kg 1 Di Iso Butyl Ketone 1.048 kg 178

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

Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01171/AM13/ RLA File :03/95/040/00806/AM13/ Lic.No/Date:0310720729 15.01.2013 Defer Date:13.06.2013 179

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

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01051/AM13/ RLA File :04/24/040/00217/AM13/ Lic.No/Date:0410142687 18.01.2013 Defer Date:13.06.2013

180

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

Party Name:YASHO INDUSTRIES PVT.LTD. 16.05.2013 Status:Case Approved HQ File :01/82/050/01169/AM13/ RLA File :03/95/040/00815/AM13/ Lic.No/Date:0310721364 18.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011/Ch. II dated 23.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Export Qty. Sl.No. Import items Qty. allowed Methyl Iso Eugenol 1 kg 1 Clove Leaf Oil 1.51 kg 181

Case No.:99/33/82ALC4/2012

Party Name:PARAMOUNT AROMACHEM PVT.LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01246/AM13/ RLA File :05/24/040/00381/AM13/ Lic.No/Date:0510343720 18.01.2013 Defer Date:13.06.2013 182

Case No.:34/4/82ALC4/2013

Party Name:CHORUS LABS LIMITED, 16.05.2013 Status:Case Approved HQ File :01/82/050/00075/AM14/ RLA File :09/24/040/00462/AM13/ Lic.No/Date:0910054812 21.01.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/184/2013PI(norms) dated 9.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Etodolac 1 kg 1. 7Ethyl Tryptophol 0.72 kg 2. Methyl3Oxopentonoate 0.54 kg 183

Case No.:87/33/82ALC4/2012

Party Name:R L FINE CHEM 16.05.2013 Status:Case Deferred HQ File :01/82/050/01234/AM13/ RLA File :07/24/040/00428/AM13/ Lic.No/Date:0710093201 21.01.2013 Defer Date:13.06.2013

Case No.:88/33/82ALC4/2012

Party Name:R L FINE CHEM Status:Case

184 y 16.05.2013 Deferred HQ File :01/82/050/01235/AM13/ RLA File :07/24/040/00425/AM13/ Lic.No/Date:0710093199 21.01.2013 Defer Date:13.06.2013 185

Case No.:91/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01238/AM13/ RLA File :05/23/040/00415/AM13/ Lic.No/Date:0510343812 21.01.2013 Defer Date:13.06.2013 186

Case No.:102/33/82ALC4/2012

Party Name:SHIVA PHARMACHEM LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/01249/AM13/ RLA File :34/24/040/00239/AM13/ Lic.No/Date:3410035900 22.01.2013 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 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed 4Chloro Butyryl Chloride Appearance: Clear Colourless Liquid 1 kg 1 Gamma Butyrolactone (Appearance: Clear Colourless Liquid) 0.753 kg 187

Case No.:145/33/82ALC4/2012

Party Name:SHILPA MEDICARE LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01292/AM13/ RLA File :07/24/040/00454/AM13/ Lic.No/Date:0710093290 23.01.2013 Defer Date:13.06.2013 188

Case No.:146/33/82ALC4/2012

Party Name:SHILPA MEDICARE LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01293/AM13/ RLA File :07/24/040/00453/AM13/ Lic.No/Date:0710093292 23.01.2013 Defer Date:13.06.2013 189

Case No.:193/33/82ALC4/2012

Party Name:GLENMARK GENERICS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01340/AM13/ RLA File :03/94/040/00800/AM13/ Lic.No/Date:0310721794 Defer

Q 23.01.2013 Date:13.06.2013 190

Case No.:158/33/82ALC4/2012

Party Name:FERMENTA BIOTECH LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01305/AM13/ RLA File :03/94/040/00683/AM13/ Lic.No/Date:0310721893 24.01.2013 Defer Date:13.06.2013 191

Case No.:38/33/82ALC4/2012

Party Name:R L FINE CHEM 16.05.2013 Status:Case Deferred HQ File :01/82/050/01185/AM13/ RLA File :07/24/040/00449/AM13/ Lic.No/Date:0710093355 28.01.2013 Defer Date:13.06.2013 192

Case No.:153/33/82ALC4/2012

Party Name:ZYTEX BIOTECH PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01300/AM13/ RLA File :03/95/040/00816/AM13/ Lic.No/Date:0310722230 29.01.2013 Defer Date:13.06.2013 193

Case No.:197/33/82ALC4/2012

Party Name:FERMENTA BIOTECH LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/01344/AM13/ RLA File :03/94/040/00917/AM13/ Lic.No/Date:0310722266 29.01.2013 Defer Date:13.06.2013 Decision :It was decided to remind the firm to furnish the details as sought vide minutes dated 18.4.2013 immediately. The case was deferred for 13.6.2013. 194

Case No.:201/33/82ALC4/2012

Party Name:ENALTEC LABS PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01348/AM13/ RLA File :03/94/040/00933/AM13/ Lic.No/Date:0310722303 29.01.2013 Defer Date:13.06.2013 195

Case No.:79/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01226/AM13/ RLA File :05/23/040/00430/AM13/ Lic.No/Date:0510344338 29.01.2013 Defer Date:13.06.2013

196

Case No.:154/33/82ALC4/2012

Party Name:SATYAM PHARMA CHEM PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01301/AM13/ RLA File :03/95/040/00787/AM13/ Lic.No/Date:0310722449 30.01.2013 Defer Date:13.06.2013 197

Case No.:60/33/82ALC4/2012

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 16.05.2013 Status:Case Deferred HQ File :01/82/050/01207/AM13/ RLA File :07/24/040/00430/AM13/ Lic.No/Date:0710093432 30.01.2013 Defer Date:13.06.2013 198

Case No.:152/33/82ALC4/2012

16.05.2013 Status:Case Deferred HQ File :01/82/050/01299/AM13/ RLA File :08/24/040/00363/AM13/ Lic.No/Date:0810117991 31.01.2013 Defer Date:13.06.2013 199

Case No.:35/4/82ALC4/2013

Party Name:RAMPEX LABS PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00076/AM14/ RLA File :09/24/040/00490/AM13/ Lic.No/Date:0910054869 31.01.2013 Defer Date:13.06.2013 200

Case No.:74/4/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/00115/AM14/ RLA File :17/24/040/00081/AM13/ Lic.No/Date:1710005221 31.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 5/82 dated 3.5.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed Product SSC90 (Polyethylene Glycol Stearyl Ether Sulphosuccinate 50% Solution) 1 KG. 1. Ethylene Oxide (Colourless clear liquid) 0.228 kg

Case No.:75/4/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, Status:Case

201 16.05.2013 Deferred HQ File :01/82/050/00116/AM14/ RLA File :17/24/040/00080/AM13/ Lic.No/Date:1710005220 31.01.2013 Defer Date:13.06.2013 202

Case No.:76/4/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/00117/AM14/ RLA File :17/24/040/00079/AM13/ Lic.No/Date:1710005219 31.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 49/82 dated 8.3.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed Product ASO1315 (Tridecyl Alcohol 15 Mole Ethoxylate) 1 KG. 1. Ethylene Oxide 0.767 kg 2. Tridecyl Alcohol (Iso Tridecanol) 0.232 kg 203

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

Party Name:GOPALDAS VISRAM & CO.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00051/AM14/ RLA File :03/94/040/00940/AM13/ Lic.No/Date:0310722706 01.02.2013 Defer Date: 13.06.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 204

Case No.:47/4/82ALC4/2013

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 16.05.2013 Status:Case Deferred HQ File :01/82/050/00088/AM14/ RLA File :07/24/040/00465/AM13/ Lic.No/Date:0710093504 01.02.2013 Defer Date:13.06.2013 205

Case No.:9/4/82ALC4/2013

Party Name:GOPALDAS VISRAM & CO.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00050/AM14/ RLA File :03/94/040/00945/AM13/ Lic.No/Date:0310722715 01.02.2013 Defer Date: 13.06.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 206

Case No.:209/33/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01356/AM13/ RLA File :03/95/040/00804/AM13/ Lic.No/Date:0310722788 04.02.2013 Defer Date:13.06.2013

207

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

Party Name:GEM AROMATICS PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00042/AM14/ RLA File :03/94/040/00953/AM13/ Lic.No/Date:0310722934 05.02.2013 Defer Date:13.06.2013 208

Case No.:27/4/82ALC4/2013

Party Name:NEULAND LABORATORIES LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00068/AM14/ RLA File :09/24/040/00519/AM13/ Lic.No/Date:0910054938 05.02.2013 Defer Date:13.06.2013 209

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

Party Name:MYLAN LABORATORIES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00069/AM14/ RLA File :09/24/040/00520/AM13/ Lic.No/Date:0910054940 05.02.2013 Defer Date:13.06.2013 210

Case No.:61/33/82ALC4/2012

Party Name:DISHMAN PHARMACEUTICALS & CHEMICALS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/01208/AM13/ RLA File :08/24/040/00184/AM13/ Lic.No/Date:0810118080 05.02.2013 Defer Date:13.06.2013 211

Case No.:67/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 16.05.2013 Status:Case Deferred HQ File :01/82/050/01214/AM13/ RLA File :07/24/040/00461/AM13/ Lic.No/Date:0710093544 05.02.2013 Defer Date:13.06.2013 212

Case No.:151/33/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01298/AM13/ RLA File :05/23/040/00459/AM13/ Lic.No/Date:0510345208 07.02.2013 Defer Date:13.06.2013 Decision :It was decided to defer the case for 13.6.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals.

213

Case No.:210/33/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/01357/AM13/ RLA File :03/95/040/00836/AM13/ Lic.No/Date:0310723378 07.02.2013 Defer Date:13.06.2013 214

Case No.:30/4/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00071/AM14/ RLA File :09/24/040/00516/AM13/ Lic.No/Date:0910054978 07.02.2013 Defer Date:13.06.2013 215

Case No.:93/31/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/01133/AM13/ RLA File :03/94/040/00926/AM13/ Lic.No/Date:0310723236 07.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2011Ch. II dated 10.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Qty. Sl.No. Import items Qty. allowed Menthanol (4Isopropryl Cyclohexyl Methanol) 1 kg 1. Cuminique aldehyde 1.185 kg 2. 5% Ruthenium on Carbon Catalyst 0.0035 kg 216

Case No.:57/4/82ALC4/2013

Party Name:POLYDRUG LABORATORIES PVT.LTD. 16.05.2013 Status:Case Approved HQ File :01/82/050/00098/AM14/ RLA File :03/95/040/00890/AM13/ Lic.No/Date:0310723645 11.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Metaprolol Base Min. 98% (metoprolol Base) 1 kg 1. 4Methoxy ethyl Phenol 0.665 kg 2. Epichlorohydrin 0.52 kg 3. Methyl Isopropyl amine 0.509 kg 217

Case No.:26/4/82ALC4/2013

Party Name:S M S PHARMACEUTICALS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00067/AM14/ RLA File :09/24/040/00501/AM13/ Lic.No/Date:0910055023 12 02 2013 Defer Date:13 06 2013

12.02.2013 Date:13.06.2013 218

Case No.:14/4/82ALC4/2013

Party Name:ADCOCK INGRAM LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/00055/AM14/ RLA File :07/24/040/00478/AM13/ Lic.No/Date:0710093696 13.02.2013 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed Syndol Tabs – Paracetamol 450 mg + Caffeine 30 mg + Doxylamine Succinate 5 mg +Codeine Phosphate 10 mg Tablets 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phsophate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 1.632 kg Adco Dol Tab – Paracetamol 450 mg+ Codeine Phosphate 10 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 2.43 kg 4. Colour Quinoline Yellow WS (spectracol) 4.56 kg Betapyn Tabs – Tablets containing Paracetamol 450 mg +Caffeine 50 mg +Doxylamine Succinate 5 mg+ Codeine Phsophate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 IH Do not match with MBF Pynstop Tabs – tablets containing Paracetamol 450 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg+Codeine Phosphate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 219

Case No.:163/33/82ALC4/2012

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/01310/AM13/ RLA File :03/94/040/00972/AM13/ Lic.No/Date:0310724040 13.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/90/2011Ch. II dated 10.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Para Tertiary Butyl Cyclohexyl Acetate 1 kg 1. Para Tertiary Butyl Phenol 0.820 kg 2. 5% Ruthenium on Carbon Catalyst 0.00003 kg

y g 3. Acetic Acid 0.300 kg 4. Methanol 0.330 kg 220

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

Party Name:SABERO ORGANICS GUJARAT LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00045/AM14/ RLA File :03/95/040/00880/AM13/ Lic.No/Date:0310724136 14.02.2013 Defer Date:13.06.2013 221

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

Party Name:ARIHANTANAM LIFECARE PVT. LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00049/AM14/ RLA File :03/94/040/00986/AM13/ Lic.No/Date:0310724200 14.02.2013 Defer Date:13.06.2013 222

Case No.:7/4/82ALC4/2013

Party Name:POLYDRUG LABORATORIES PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00048/AM14/ RLA File :03/95/040/00892/AM13/ Lic.No/Date:0310724239 15.02.2013 Defer Date:13.06.2013 223

Case No.:36/4/82ALC4/2013

Party Name:ASTRIX LABORATORIES LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00077/AM14/ RLA File :09/24/040/00532/AM13/ Lic.No/Date:0910055090 19.02.2013 Defer Date:13.06.2013 224

Case No.:2/4/82ALC4/2013

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 16.05.2013 Status:Case Approved HQ File :01/82/050/00043/AM14/ RLA File :03/94/040/00937/AM13/ Lic.No/Date:0310725118 21.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2012Ch. II dated 13.3.2013, 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 Camphor USP 1 kg 1 Alpha Pinene 1.146 kg

Case No :3/4/82 ALC4/2013

Party Name:CAMPHOR & ALLIED PRODUCTS Meet No/Date:4/82 ALC4/2013 Status:Case

225

Case No.:3/4/82ALC4/2013

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 16.05.2013 Status:Case Approved HQ File :01/82/050/00044/AM14/ RLA File :03/94/040/00936/AM13/ Lic.No/Date:0310725122 21.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2012Ch. II dated 11.3.2013, 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 Astrolide (IPM/BB) (Astrolide in Isopropryl Myristate/Benzyl Benzoate Main. Total Astrolide content 62.5%) 1 kg 1. Isoamylene 0.380 kg 2. Propylene Oxide 0.280 kg 3. Alpha Methyl Styrene 0.500 kg 4. Paraformaldehyde 0.088 kg 5. Isopropryl Myristate 0.350 kg 226

Case No.:5/4/82ALC4/2013

Party Name:ZIM LABORATORIES LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00046/AM14/ RLA File :03/95/040/00692/AM13/ Lic.No/Date:0310725029 21.02.2013 Defer Date:13.06.2013 Decision : It was decided to defer the case for 13.6.2013 for comments of Department of Pharmaceuticals. 227

Case No.:6/4/82ALC4/2013

Party Name:ZIM LABORATORIES LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00047/AM14/ RLA File :03/95/040/00600/AM13/ Lic.No/Date:0310725026 21.02.2013 Defer Date:13.06.2013 228

Case No.:25/4/82ALC4/2013

Party Name:ALKYL AMINES CHEMICALS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00066/AM14/ RLA File :03/94/040/00761/AM13/ Lic.No/Date:0310725325 22.02.2013 Defer Date:13.06.2013

Case No.:15/4/82ALC4/2013

Party Name:ADCOCK INGRAM LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/00056/AM14/ RLA File :07/24/040/00486/AM13/ Lic.No/Date:0710093907 22.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 30/82 dated 7.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Neulin 125 mg tablets 1 no of 1 Theophylline BP/EP/USP Ph 127 5 mg

229 Neulin 125 mg tablets Theophylline 125 mg+Guar gum 4.375 mg 1 no. of Neulin Tablet 1. Theophylline BP/EP/USP Ph. EUR Anhydrous powder 127.5 mg 2. Guar Gum, 1 H (BP/EP/USP/PH. EUR) 4.375 mg Neulin 200 mg tablets Theophylline 200 mg+ Guar Gum 7.00 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 204.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 7.00 mg Neulin 250 mg tablets Theophylline 250 mg+ Guar Gum 8.750 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 255.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 8.75 mg Neulin 300 mg tablets Theophylline 300 mg+ Guar Gum 10.5 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 306.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 10.5 mg 230

Case No.:18/4/82ALC4/2013

Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 16.05.2013 Status:Case Approved HQ File :01/82/050/00059/AM14/ RLA File :03/94/040/01002/AM13/ Lic.No/Date:0310725345 22.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O no. 14010/176/2011Ch. II dated 29.11.2012, 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 Chemicals – Organic Mixture, Trade Name SR 8114 R 1 kg 1 Glyoxylic Acid 50% 0.713 kg 231

Case No.:21/4/82ALC4/2013

Party Name:ALKYL AMINES CHEMICALS LTD 16.05.2013 Status:Case Approved HQ File :01/82/050/00062/AM14/ RLA File :03/94/040/00790/AM13/ Lic.No/Date:0310725341 22.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export S No Import Product Quantity Allowed

Export Product Export Quantity S.No Import Product Quantity Allowed Acetonitrile 1 kg 1 Acetic Acid 1.460 kg 232

Case No.:23/4/82ALC4/2013

Party Name:GLENMARK GENERICS LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00064/AM14/ RLA File :03/94/040/00893/AM13/ Lic.No/Date:0310725666 26.02.2013 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 v1 as Export product Export Qty. Sl.No. Import item Qty. allowed Glimepiride 1 Kg. 1. 4(23 Ethyl4Methyl2Oxo3Pyrroline1 Carboxamido Ethyl Phenyl Sulfonamide) 0.80 kg 2. Trans4Methyl Cyclohexyl Iso Cyanate 0.39 kg 3. Acetone 2.50 kg 4. Methanol 2.50 kg 233

Case No.:24/4/82ALC4/2013

Party Name:GLENMARK GENERICS LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00065/AM14/ RLA File :03/94/040/00892/AM13/ Lic.No/Date:0310725673 26.02.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/483/2012PI(Norms) dated 12.11.2012, 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 Export Qty. Sl.No. Import items Qty. allowed kg/kg Cilostazol 1 kg 1. [5(4Chlorobutyl)1Cyclohexyl1H Tetrazole] {CBT Cilostazol} 0.88 2. 6Hydroxy3,4Dihydroquinolinone [HCS Cilostazol] 0.59 234

Case No.:17/4/82ALC4/2013

Party Name:CROWN CHEMICALS PVT.LTD., 16.05.2013 Status:Case Approved HQ File :01/82/050/00058/AM14/ RLA File :03/94/040/01022/AM13/ Lic.No/Date:0310726283 28.02.2013 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperonal Min. Purity 98% 1 kg 1. Catechol (Min. Purity 99%) 0.862 kg 2. Dichloromethane (Min. Purity 99%) 0.703 kg 3. Dimethylsulfoxide (Min. Purity 99%) 0.875 kg

Dimethylsulfoxide (Min. Purity 99%) 0.875 kg 4. Hexamine (Min. Purity 96%) 1.000 kg 5. Toluene (Min. Purity 97%) 0.430 kg 6. Isopropyl Alcohol (Min. Purity 99%) 0.220 kg 235

Case No.:46/4/82ALC4/2013

Party Name:ADCOCK INGRAM LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/00087/AM14/ RLA File :07/24/040/00499/AM13/ Lic.No/Date:0710093975 28.02.2013 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 Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Calcium Carbonate 1250 mg+Glycine 535.7 mg tablets (no. of Tabs 4000000) (Glycine2142.800 kgs+Calcium – 5000.000 kgs) 1000 tablets 1 Glycine USP/BP Not shown in DML 2. Calcium Carbonate Dense BP/USP 1.25 kg 236

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

Party Name:AVA CHEMICALS PVT.LTD., 16.05.2013 Status:Case Approved HQ File :01/82/050/00057/AM14/ RLA File :03/94/040/01008/AM13/ Lic.No/Date:0310726493 01.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 3.4.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed Disodium Zinc EDTA Content 15% (=/ 0.5%) 1 kg Ethylene Diamine Tetra Acetic Acid (EDTA) 0.690 kg 237

Case No.:3/33/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/01150/AM13/ RLA File :05/24/040/00448/AM13/ Lic.No/Date:0510347967 01.03.2013 Defer Date:13.06.2013

Case No.:19/4/82ALC4/2013

Party Name:CIPLA LIMITED Meet No/Date:4/82ALC4/2013 Status:Case

238

Case No.:19/4/82 ALC4/2013

Party Name:CIPLA LIMITED Meet No/Date:4/82 ALC4/2013 16.05.2013 Status:Case Approved HQ File :01/82/050/00060/AM14/ RLA File :03/94/040/01033/AM13/ Lic.No/Date:0310726647 04.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 19.4.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export Product Export Qty. Sl.No. Import items Qty. allowed Vetpro 60%/Ropiodol 60 percent Amprolium 60% Powder (Each pack 100 gms) (Each 30 gm of powder contain Amprolium HCL 18 gm) 1 Kg. 1. Amprolium Hcl 0.606 kg. 239

Case No.:59/4/82ALC4/2013

Party Name:SUPREET CHEMICALS PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00100/AM14/ RLA File :03/95/040/00965/AM13/ Lic.No/Date:0310726554 04.03.2013 Defer Date:13.06.2013 240

Case No.:20/4/82ALC4/2013

Party Name:CIPLA LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00061/AM14/ RLA File :03/94/040/01036/AM13/ Lic.No/Date:0310726881 05.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxicillin & Clavulanate Potassium for Suspension USP 75 ml pack 1. Amoxycillin Trihydrate 4.200 gm 2. Clavulanate Potassium Syloid 2.3444 gm 3. Silicon Dioxide (Syloid AL 1FP)NF 1.500 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) As per packing policy 5 Cap 28/400 WHT CRC W/FS M1 As per packing policy Amoxicillin & Clavulanate Potassium for Suspension USP 100 ml pack 1. Amoxycillin Trihydrate 5.649 gm 2. Clavulanate Potassium Syloid 3.126 gm 3. Silicon Dioxide (Syloid AL 1FP)NF 2.00 gm 4. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) As per packing policy 5 Cap 28/400 WHT CRC W/FS As per packing

Cap 28/400 WHT CRC W/FS M1 As per packing policy Amoxicillin & Clavulanate Potassium for Suspension USP 150 ml pack 1. Amoxycillin Trihydrate 8.274 gm 2. Clavulanate Potassium Syloid 4.6888 gm 3. Silicon Dioxide (Syloid AL 1FP)NF 3.00 gm 4 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) As per packing policy 5. Cap 28/400 WHT CRC W/FS M1 As per packing policy 241

Case No.:56/4/82ALC4/2013

Party Name:DIVIS LABORATORIES LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00097/AM14/ RLA File :09/24/040/00577/AM13/ Lic.No/Date:0910055286 05.03.2013 Defer Date:13.06.2013 242

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

Party Name:SHREE GANESH REMEDIES PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00096/AM14/ RLA File :34/24/040/00287/AM13/ Lic.No/Date:3410036329 06.03.2013 Defer Date:13.06.2013 243

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

Party Name:NECTAR LIFESCIENCES LIMITED, 16.05.2013 Status:Case Deferred HQ File :01/82/050/00099/AM14/ RLA File :22/24/040/00077/AM13/ Lic.No/Date:2210013693 06.03.2013 Defer Date:13.06.2013

Case No.:67/4/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00108/AM14/ RLA File :31/83/040/00193/AM13/ Lic.No/Date:3110057349 06.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Morpholine 1 kg 1 Dieth lene Gl col 1 354 kg

244 Morpholine 1 kg 1. Diethylene Glycol 1.354 kg 2 Ammonia Anhydrous 0.217 kg 3. Hydrogen Not an importable commodity 4. Morpholine Catalyst Details of catalysts not given 245

Case No.:69/4/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00110/AM14/ RLA File :31/83/040/00166/AM13/ Lic.No/Date:3110057355 06.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 12.4.2013, 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 kg/kg NMethyl2 Pyrrolidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg 246

Case No.:66/4/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00107/AM14/ RLA File :31/83/040/00183/AM13/ Lic.No/Date:3110057356 07.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 12.4.2013, 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 kg/kg NMethyl2 Pyrrolidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg RA may take appropriate action as per the decision of Norms Committee

Case No.:11/4/82ALC4/2013

Party Name:AARTI INDUSTRIES LIMITED 16.05.2013 Status:Case Deferred

247 HQ File :01/82/050/00052/AM14/ RLA File :03/94/040/01027/AM13/ Lic.No/Date:0310727436 08.03.2013 Defer Date:13.06.2013 248

Case No.:12/4/82ALC4/2013

16.05.2013 Status:Case Approved HQ File :01/82/050/00053/AM14/ RLA File :08/24/040/00438/AM13/ Lic.No/Date:0810119175 08.03.2013 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 Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Azithromycin 250 mg Tablets (Cristers) Active ingredient Azithromycin Dihydrate 142.15 kgs) 1 tablet 1 Azithromycin Dihydrate 259.50 mg 249

Case No.:22/4/82ALC4/2013

Party Name:GLENMARK GENERICS LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00063/AM14/ RLA File :03/94/040/01026/AM13/ Lic.No/Date:0310727454 08.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Amiodarone HCL 1 kg 1. 2Butyl3(3,5 Diiodo4 Hydroxy Benzoyl) Benzofuran 0.9135 2. N, N Diethyl2 Chloroethylamine HCL 0.315 3. Potassium Carbonate 0.694 4. Isopropyl Alcohol 2.70 250

Case No.:62/4/82ALC4/2013

Party Name:UNITED PHOSPHORUS LTD. 16.05.2013 Status:Case Approved HQ File :01/82/050/00103/AM14/ RLA File :03/95/040/00955/AM13/ Lic.No/Date:0310727648 11.03.2013 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 per details given below or as applied by the firm whichever is less:

250 per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed Phenyl Chloroformate 1 kg 1. Phenol 0.666 kg 2. Ethylene Dichloride 0.292 kg 251

Case No.:13/4/82ALC4/2013

Party Name:CONTINENTAL CHEMICALS 16.05.2013 Status:Case Deferred HQ File :01/82/050/00054/AM14/ RLA File :08/24/040/00432/AM13/ Lic.No/Date:0810119295 12.03.2013 Defer Date:13.06.2013 252

Case No.:61/4/82ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00102/AM14/ RLA File :03/95/040/01003/AM13/ Lic.No/Date:0310727951 13.03.2013 Defer Date:13.06.2013 253

Case No.:63/4/82ALC4/2013

Party Name:GOPINATH CHEMTECH LTD., 16.05.2013 Status:Case Deferred HQ File :01/82/050/00104/AM14/ RLA File :08/24/040/00436/AM13/ Lic.No/Date:0810119304 13.03.2013 Defer Date:13.06.2013 254

Case No.:60/4/82ALC4/2013

Party Name:SATYAM PHARMA CHEM PVT LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00101/AM14/ RLA File :03/95/040/01005/AM13/ Lic.No/Date:0310728189 14.03.2013 Defer Date:13.06.2013 255

Case No.:65/4/82ALC4/2013

Party Name:MELZER CHEMICALS PVT. LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00106/AM14/ RLA File :31/83/040/00204/AM13/ Lic.No/Date:3110057485 18.03.2013 Defer Date:13.06.2013 2 6

Case No.:52/4/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 16.05.2013 Status:Case Deferred HQ Fil 01/82/050/00093/AM14/ RLA Fil 24/24/040/00017/AM13/ Li N /D 2410038507 D f

256 HQ File :01/82/050/00093/AM14/ RLA File :24/24/040/00017/AM13/ Lic.No/Date:2410038507 20.03.2013 Defer Date:13.06.2013 257

Case No.:53/4/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 16.05.2013 Status:Case Deferred HQ File :01/82/050/00094/AM14/ RLA File :24/24/040/00014/AM13/ Lic.No/Date:2410038508 20.03.2013 Defer Date:13.06.2013 258

Case No.:54/4/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00095/AM14/ RLA File :31/83/040/00198/AM13/ Lic.No/Date:3110057554 21.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 12.4.2013, 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 kg/kg NMethyl2 Pyrrolidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg RA may take appropriate action as per the decision of Norms Committee 259

Case No.:64/4/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 16.05.2013 Status:Case Approved HQ File :01/82/050/00105/AM14/ RLA File :31/83/040/00190/AM13/ Lic.No/Date:3110057555 21.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 12.4.2013, 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 kg/kg NMethyl2 Pyrrolidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg RA may take appropriate action as per the decision of Norms Committee

Case No.:51/4/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 16.05.2013 Status:Case Deferred

260 HQ File :01/82/050/00092/AM14/ RLA File :04/24/040/00281/AM13/ Lic.No/Date:0410144356 22.03.2013 Defer Date:13.06.2013 261

Case No.:70/4/82ALC4/2013

Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 16.05.2013 Status:Case Deferred HQ File :01/82/050/00111/AM14/ RLA File :04/24/040/00279/AM13/ Lic.No/Date:0410144366 25.03.2013 Defer Date:13.06.2013 262

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

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 16.05.2013 Status:Case Deferred HQ File :01/82/050/01480/AM13/ RLA File :05/24/040/00481/AM13/ Lic.No/Date:0510350279 26.03.2013 Defer Date:13.06.2013 263

Case No.:71/4/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 16.05.2013 Status:Case Deferred HQ File :01/82/050/00112/AM14/ RLA File :24/24/040/00001/AM14/ Lic.No/Date:2410038645 09.04.2013 Defer Date:13.06.2013 264

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

Party Name:HALDIA PETROCHEMICALS LTD. 16.05.2013 Status:Case Deferred HQ File :01/82/050/00109/AM14/ RLA File :02/24/040/00002/AM14/ Lic.No/Date:0210188734 17.04.2013 Defer Date:13.06.2013 Decision :It was decided to defer the case for 13.6.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals. 265

Case No.:72/4/82ALC4/2013

Party Name:MICRO LABS LTD 16.05.2013 Status:Case Deferred HQ File :01/82/050/00113/AM14/ RLA File :07/24/040/00020/AM14/ Lic.No/Date:0710095227 06.05.2013 Defer Date:13.06.2013

Case No.:73/4/82ALC4/2013

Party Name:SHIVA PHARMACHEM LTD, 16.05.2013 Status:Case Approved HQ File :01/82/050/00114/AM14/ RLA File :34/24/040/00024/AM14/ Lic.No/Date:3410036789 06.05.2013 Defer Date: D i i I h li h f i i d f D f Ch i l d P h i l id h i U O N 14010/65/2007 Ch II

266 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/65/2007Ch. II dated 7.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product Export Quantity S.No Import Product Quantity Allowed Iso Nonanoyl Chloride (Appearance: Clear Colourless Liquid) 1 kg 1 Iso Nonanoic Acid (Appearance: Clear colourless liquid) 0.942 kg ‘RA may take appropriate action as per the decision of Norms Committee. Date:20.05.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer

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Para 4.7 Decision(DRAFT)

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