IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2016-08-10

DGFT Committee Minutes

Document text

1 Government of India Ministry of Commerce and Industry Directorate General of Foreign Trade Maulana Azad Road, New Delhi 110011 Norms Committee-III

Para 4.7 Decision

Meeting No. 09/82/2016 of 2016-17 dated to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, held on 10.08.2016 but actually held on 11.08.2016 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 08/82 held 27.07.2016 and approved the same. Note: In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned. In both these instances, the scanned copy uploaded is to be accepted. The Committee does not approve SCOMET items and all applicants are understood to have furnished a declaration to RA that the items of import/export are not SCOMET items. MEETING NUMBER : 9/82-ALC4/2016 MEETING DATE : 10.08.2016 1

Case No.:33/16/82-

ALC4/2013 Party Name:HETERO DRUGS LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00846/AM14/ RLA File :09/24/040/00278/AM14/ Lic.No/Date:0910057537 12.09.2013 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/630/2014-PI(Norms) dated 17th June 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 2

Case No.:116/23/82-

ALC4/2013 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File :01/82/050/01163/AM14/ RLA File :05/23/040/00341/AM14/ Lic.No/Date:0510372635 05.12.2013 Defer Date: 28.09.2016 Decision : Deferred 3

Case No.:30/7/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00204/AM17/ RLA File :22/24/040/00069/AM14/ Lic.No/Date:2210014463 20.12.2013 Defer Date:07.09.2016

2 Decision : The Committee noted that information called for from the firm by NC in its meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 4

Case No.:52/6/82-

ALC4/2014 Party Name:UPL LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00454/AM15/ RLA File :03/95/040/01043/AM14/ Lic.No/Date:0310776594 01.04.2014 Defer Date:07.09.2016 Decision : Deferred. 5

Case No.:88/6/82-

ALC4/2014 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00490/AM15/ RLA File :03/95/040/00033/AM15/ Lic.No/Date:0310782129 20.05.2014 Defer Date:07.09.2016 6

Case No.:61/4/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00309/AM15/ RLA File :03/95/040/00190/AM15/ Lic.No/Date:0310785305 13.06.2014 Defer Date:07.09.2016 7

Case No.:73/9/82-ALC4/2014 Party Name:D. R. COATS

INK & RESINS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File :01/82/050/00870/AM15/ RLA File :03/94/040/00755/AM14/ Lic.No/Date:0310786181 30.06.2014 Defer Date: 07.09.2016 Decision :Deferred. 8

Case No.:212/6/82-

ALC4/2014 Party Name:RAY CHEMICALS PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00614/AM15/ RLA File :07/24/040/00098/AM15/ Lic.No/Date:0710105469 30.06.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/525/2014-PI(Norms) dated March 2015 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 9

Case No.:79/9/82-

ALC4/2014 Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00876/AM15/ RLA File :03/95/040/00337/AM15/ Lic.No/Date:0310787073 18.07.2014 Defer Date:07.09.2016 10

Case No.:41/8/82-

ALC4/2014 Party Name:R L FINE CHEM Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

3 HQ File :01/82/050/00705/AM15/ RLA File :07/24/040/00130/AM15/ Lic.No/Date:0710105883 18.07.2014 Defer Date:07.09.2016 Decision :Deferred for want of comments from DoP. 11

Case No.:396/5/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00536/AM16/ RLA File :17/24/040/00047/AM15/ Lic.No/Date:1710005887 24.07.2014 Defer Date:07.09.2016 12

Case No.:63/8/82-

ALC4/2014 Party Name:ADCOCK INGRAM LTD, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00727/AM15/ RLA File :07/24/040/00148/AM15/ Lic.No/Date:0710106181 25.07.2014 Defer Date:07.09.2016 Decision : The Committee decided to send copy of application to DoP. 13

Case No.:32/9/82-

ALC4/2014 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00829/AM15/ RLA File :34/24/040/00102/AM15/ Lic.No/Date:3410040406 28.07.2014 Defer Date:07.09.2016 14

Case No.:8/6/82-ALC4/2014 Party Name:V & V

PHARMA INDUSTRIES Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00410/AM15/ RLA File :03/95/040/00331/AM15/ Lic.No/Date:0310787382 28.07.2014 Defer Date:07.09.2016 15

Case No.:49/9/82-

ALC4/2014 Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00846/AM15/ RLA File :04/24/040/00106/AM15/ Lic.No/Date:0410159125 01.08.2014 Defer Date:07.09.2016 Decision :Deferred. 16

Case No.:31/9/82-

ALC4/2014 Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00828/AM15/ RLA File :03/94/040/00074/AM15/ Lic.No/Date:0310787610 04.08.2014 Defer Date:07.09.2016 17

Case No.:2/14/82-

ALC4/2015 Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01138/AM16/ RLA File :03/95/040/00425/AM15/ Lic.No/Date:0310788055 14.08.2014 Defer Date:07.09.2016

4 Decision :Deferred for want of comments from DoP. 18

Case No.:48/5/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00188/AM16/ RLA File :09/24/040/00260/AM15/ Lic.No/Date:0910060860 18.08.2014 Defer Date:07.09.2016 Decision : The Committee noted that information called for from the firm by NC in its meeting No.05/82 dated 08.06.2016 is awaited. The Committee accordingly decided to await the reply from the firm and deferred the case. 19

Case No.:215/13/82-

ALC4/2014 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01218/AM15/ RLA File :03/94/040/00358/AM15/ Lic.No/Date:0310788338 25.08.2014 Defer Date:07.09.2016 20

Case No.:377/5/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00517/AM16/ RLA File :03/94/040/00493/AM15/ Lic.No/Date:0310788472 27.08.2014 Defer Date:07.09.2016 Decision : Deferred for want of comments from DoP. 21

Case No.:224/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01227/AM15/ RLA File :03/94/040/00391/AM15/ Lic.No/Date:0310788515 28.08.2014 Defer Date:07.09.2016 Decision :Deferred. 22

Case No.:225/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01228/AM15/ RLA File :03/94/040/00397/AM15/ Lic.No/Date:0310788514 28.08.2014 Defer Date:07.09.2016 Decision :Deferred. 23

Case No.:262/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01265/AM15/ RLA File :03/94/040/00971/AM14/ Lic.No/Date:0310788560 01.09.2014 Defer Date:07.09.2016 Decision :Deferred. 24

Case No.:223/13/82-

ALC4/2014 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01226/AM15/ RLA File :03/94/040/00508/AM15/ Lic.No/Date:0310788647 02.09.2014 Defer Date:07.09.2016

5 25

Case No.:3/7/82-ALC4/2014 Party Name:S V CHEM

INTERMEDIATES P LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00647/AM15/ RLA File :04/24/040/00139/AM15/ Lic.No/Date:0410159328 02.09.2014 Defer Date:07.09.2016 26

Case No.:400/5/82-

ALC4/2015 Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00540/AM16/ RLA File :34/24/040/00120/AM15/ Lic.No/Date:3410040554 15.09.2014 Defer Date:07.09.2016 27

Case No.:12/15/82-

ALC4/2014 Party Name:JINDAL DRUGS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01299/AM15/ RLA File :03/94/040/00460/AM15/ Lic.No/Date:0310789265 16.09.2014 Defer Date:07.09.2016 28

Case No.:15/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01018/AM15/ RLA File :34/24/040/00161/AM15/ Lic.No/Date:3410040594 30.09.2014 Defer Date:07.09.2016 29

Case No.:19/1/82-

ALC4/2015 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01545/AM15/ RLA File :03/94/040/00594/AM15/ Lic.No/Date:0310789922 01.10.2014 Defer Date:07.09.2016 30

Case No.:29/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01032/AM15/ RLA File :05/23/040/00268/AM15/ Lic.No/Date:0510391490 08.10.2014 Defer Date:07.09.2016 31

Case No.:124/13/82-

ALC4/2014 Party Name:PANACEA BIOTEC LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01127/AM15/ RLA File :05/24/040/00319/AM15/ Lic.No/Date:0510391623 17.10.2014 Defer Date:07.09.2016 Decision : Information called for in NC meeting No.03/AM17 is awaited. The Committee accordingly deferred the case. 32 Case No.:198/5/82- Party Name:SHASUN Meet No/Date:9/82- Status:Deferred

6 ALC4/2015 PHARMACEUTICALS LIMITED ALC4/2016 10.08.2016 HQ File :01/82/050/00338/AM16/ RLA File :04/24/040/00205/AM15/ Lic.No/Date:0410159704 11.11.2014 Defer Date:07.09.2016 Decision : The Committee noted that information has been called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 33

Case No.:126/8/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00922/AM16/ RLA File :03/94/040/00710/AM15/ Lic.No/Date:0310791177 18.11.2014 Defer Date:07.09.2016 34

Case No.:43/18/82-

ALC4/2014 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01409/AM15/ RLA File :03/95/040/00701/AM15/ Lic.No/Date:0310791419 26.11.2014 Defer Date:07.09.2016 35

Case No.:145/5/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00285/AM16/ RLA File :03/94/040/00877/AM15/ Lic.No/Date:0310792112 17.12.2014 Defer Date:07.09.2016 36

Case No.:127/5/82-

ALC4/2015 Party Name:EMAMI LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00267/AM16/ RLA File :02/24/040/00183/AM15/ Lic.No/Date:0210205355 18.12.2014 Defer Date:07.09.2016 Decision : The Committee decided to send copy of application to MSME and deferred the case. 37

Case No.:136/5/82-

ALC4/2015 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00276/AM16/ RLA File :03/94/040/00843/AM15/ Lic.No/Date:0310792314 23.12.2014 Defer Date:07.09.2016 38

Case No.:221/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00361/AM16/ RLA File :09/24/040/00537/AM15/ Lic.No/Date:0910061442 23.12.2014 Defer Date:07.09.2016 39 Case No.:114/5/82- Party Name:NATIONAL Meet No/Date:9/82- Status:Deferred

7 ALC4/2015 TUBE INDUSTRIES, ALC4/2016 10.08.2016 HQ File :01/82/050/00254/AM16/ RLA File :03/95/040/00756/AM15/ Lic.No/Date:0310792363 24.12.2014 Defer Date:07.09.2016 40

Case No.:218/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00358/AM16/ RLA File :09/24/040/00552/AM15/ Lic.No/Date:0910061462 29.12.2014 Defer Date:07.09.2016 41

Case No.:99/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01465/AM15/ RLA File :07/24/040/00302/AM15/ Lic.No/Date:0710107307 30.12.2014 Defer Date:07.09.2016 42

Case No.:111/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01477/AM15/ RLA File :07/24/040/00307/AM15/ Lic.No/Date:0710107306 30.12.2014 Defer Date:07.09.2016 43

Case No.:45/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00185/AM16/ RLA File :09/24/040/00558/AM15/ Lic.No/Date:0910061483 05.01.2015 Defer Date:07.09.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply 44

Case No.:102/5/82-

ALC4/2015 Party Name:ALTA LABORATORIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00242/AM16/ RLA File :03/94/040/00836/AM15/ Lic.No/Date:0310792635 07.01.2015 Defer Date:07.09.2016 45

Case No.:74/5/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00214/AM16/ RLA File :03/95/040/00833/AM15/ Lic.No/Date:0310792647 07.01.2015 Defer Date:07.09.2016 46 Case No.:149/5/82- ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:9/82- ALC4/2016 Status:Deferred

8 10.08.2016 HQ File :01/82/050/00289/AM16/ RLA File :03/94/040/00813/AM15/ Lic.No/Date:0310792673 08.01.2015 Defer Date:07.09.2016 Decision :Deferred. 47

Case No.:219/5/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00359/AM16/ RLA File :09/24/040/00549/AM15/ Lic.No/Date:0910061517 09.01.2015 Defer Date:07.09.2016 48

Case No.:112/5/82-

ALC4/2015 Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00252/AM16/ RLA File :03/95/040/00812/AM15/ Lic.No/Date:0310793039 19.01.2015 Defer Date:07.09.2016 Decision : The Committee noted that an investigation in the matter is under process. The Committee accordingly, decided to defer the case. 49

Case No.:88/5/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00228/AM16/ RLA File :05/23/040/00486/AM15/ Lic.No/Date:0510392949 21.01.2015 Defer Date:07.09.2016 Decision : Deferred for want of comments from AYUSH 50

Case No.:138/8/82-

ALC4/2015 Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00934/AM16/ RLA File :03/94/040/01099/AM14/ Lic.No/Date:0310793426 30.01.2015 Defer Date:07.09.2016 Decision : Information called for from the firm in NC meeting No.18/82 dated 10.02.2016 is awaited. The committee decided to await the reply and deferred the case. 51

Case No.:275/5/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00415/AM16/ RLA File :03/94/040/00930/AM15/ Lic.No/Date:0310793539 03.02.2015 Defer Date:07.09.2016 52

Case No.:133/7/82-

ALC4/2016 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00307/AM17/ RLA File :03/95/040/00911/AM15/ Lic.No/Date:0310793837 12.02.2015 Defer Date:07.09.2016 Decision : Information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The committee decided to await the reply and deferred the case. 53 Case No.:285/5/82- ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS Meet No/Date:9/82- ALC4/2016 Status:Deferred

9 LIMITED, 10.08.2016 HQ File :01/82/050/00425/AM16/ RLA File :03/94/040/01092/AM15/ Lic.No/Date:0310793985 19.02.2015 Defer Date:07.09.2016 54

Case No.:279/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00419/AM16/ RLA File :03/94/040/01088/AM15/ Lic.No/Date:0310793983 19.02.2015 Defer Date:07.09.2016 Decision :Deferred. 55

Case No.:288/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00428/AM16/ RLA File :03/94/040/01089/AM15/ Lic.No/Date:0310793982 19.02.2015 Defer Date:07.09.2016 Decision :Deferred. 56

Case No.:335/5/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00475/AM16/ RLA File :03/95/040/00978/AM15/ Lic.No/Date:0310794038 20.02.2015 Defer Date:07.09.2016 57

Case No.:334/5/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00474/AM16/ RLA File :03/95/040/00862/AM15/ Lic.No/Date:0310794100 24.02.2015 Defer Date:07.09.2016 58

Case No.:309/5/82-

ALC4/2015 Party Name:SHREE VALLABH CHEMICAL Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00449/AM16/ RLA File :08/24/040/00417/AM15/ Lic.No/Date:0810134670 25.02.2015 Defer Date:07.09.2016 59

Case No.:273/5/82-

ALC4/2015 Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00413/AM16/ RLA File :03/94/040/01055/AM15/ Lic.No/Date:0310794262 27.02.2015 Defer Date:07.09.2016 60

Case No.:452/5/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00592/AM16/ RLA File :03/94/040/01091/AM15/ Lic.No/Date:0310794261 27.02.2015 Defer Date:07.09.2016

10 61

Case No.:295/5/82-

ALC4/2015 Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00435/AM16/ RLA File :08/24/040/00395/AM15/ Lic.No/Date:0810134703 03.03.2015 Defer Date:07.09.2016 Decision :Deferred. 62

Case No.:303/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00443/AM16/ RLA File :08/24/040/00422/AM15/ Lic.No/Date:0810134739 05.03.2015 Defer Date:07.09.2016 63

Case No.:300/5/82-

ALC4/2015 Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00440/AM16/ RLA File :08/24/040/00448/AM15/ Lic.No/Date:0810134768 11.03.2015 Defer Date:07.09.2016 64

Case No.:447/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00587/AM16/ RLA File :03/94/040/01131/AM15/ Lic.No/Date:0310794543 12.03.2015 Defer Date:07.09.2016 Decision : Committee decided to sent copy of application to DoP and deferred the case. 65

Case No.:45/4/82-

ALC4/2015 Party Name:TIDE INDUSTRIES Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00084/AM16/ RLA File :34/24/040/00325/AM15/ Lic.No/Date:3410041050 16.03.2015 Defer Date:07.09.2016 66

Case No.:291/5/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00431/AM16/ RLA File :05/23/040/00544/AM15/ Lic.No/Date:0510393616 18.03.2015 Defer Date:07.09.2016 67

Case No.:183/5/82-

ALC4/2015 Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00323/AM16/ RLA File :03/95/040/00964/AM15/ Lic.No/Date:0310794811 23.03.2015 Defer Date:07.09.2016 68 Case No.:29/5/82- Party Name:ASSOCIATED Meet No/Date:9/82- Status:Deferred

11 ALC4/2015 DYESTUFF PVT. LTD ALC4/2016 10.08.2016 HQ File :01/82/050/00169/AM16/ RLA File :08/24/040/00483/AM15/ Lic.No/Date:0810134917 25.03.2015 Defer Date:07.09.2016 69

Case No.:26/5/82-

ALC4/2015 Party Name:CONTINENTAL CHEMICALS Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00166/AM16/ RLA File :08/24/040/00470/AM15/ Lic.No/Date:0810134992 07.04.2015 Defer Date:07.09.2016 70

Case No.:35/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00175/AM16/ RLA File :09/24/040/00739/AM15/ Lic.No/Date:0910061891 17.04.2015 Defer Date:07.09.2016 Decision : The Committee decided to call for a complete set of application from the firm and defer the case. 71

Case No.:132/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00737/AM16/ RLA File :03/94/040/00024/AM16/ Lic.No/Date:0310795429 20.04.2015 Defer Date:07.09.2016 Decision : Information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 72

Case No.:153/7/82-

ALC4/2015 Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Case Approved HQ File :01/82/050/00758/AM16/ RLA File :03/94/040/00039/AM16/ Lic.No/Date:0310795534 24.04.2015 Defer Date: Decision :This case was already approved in NC 07/82 dated 07.07.2016 73

Case No.:40/8/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00836/AM16/ RLA File :09/24/040/00042/AM16/ Lic.No/Date:0910061937 27.04.2015 Defer Date:07.09.2016 74

Case No.:174/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00314/AM16/ RLA File :07/24/040/00393/AM15/ Lic.No/Date:0710108142 01.05.2015 Defer Date:07.09.2016 75 Case No.:176/5/82- ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE Meet No/Date:9/82- ALC4/2016 Status:Deferred

12 LIMITED, 10.08.2016 HQ File :01/82/050/00316/AM16/ RLA File :07/24/040/00389/AM15/ Lic.No/Date:0710108141 01.05.2015 Defer Date:07.09.2016 76

Case No.:177/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00317/AM16/ RLA File :07/24/040/00390/AM15/ Lic.No/Date:0710108143 01.05.2015 Defer Date:07.09.2016 77

Case No.:75/8/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00871/AM16/ RLA File :09/24/040/00051/AM16/ Lic.No/Date:0910061986 06.05.2015 Defer Date:07.09.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly deferred the case. 78

Case No.:65/8/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00861/AM16/ RLA File :09/24/040/00052/AM16/ Lic.No/Date:0910061973 06.05.2015 Defer Date:07.09.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 79

Case No.:7/5/82-ALC4/2015 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00147/AM16/ RLA File :05/23/040/00037/AM16/ Lic.No/Date:0510394177 08.05.2015 Defer Date:07.09.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 80

Case No.:97/8/82-

ALC4/2015 Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00893/AM16/ RLA File :08/24/040/00051/AM16/ Lic.No/Date:0810135338 22.05.2015 Defer Date:07.09.2016 81

Case No.:45/8/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00841/AM16/ RLA File :05/24/040/00073/AM16/ Lic.No/Date:0510394342 25.05.2015 Defer Date:07.09.2016 Decision : The Committee noted that Information has been called for from the firm in NC

13 meeting No.20 dated 09.03.2016 is awaited. The Committee accordingly deferred the case. 82

Case No.:86/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00882/AM16/ RLA File :09/24/040/00131/AM16/ Lic.No/Date:0910062091 29.05.2015 Defer Date:07.09.2016 83

Case No.:187/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00792/AM16/ RLA File :08/24/040/00057/AM16/ Lic.No/Date:0810135435 05.06.2015 Defer Date:07.09.2016 84

Case No.:121/8/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00917/AM16/ RLA File :03/95/040/00190/AM16/ Lic.No/Date:0310796766 23.06.2015 Defer Date:07.09.2016 85

Case No.:41/7/82-

ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00215/AM17/ RLA File :34/24/040/00082/AM16/ Lic.No/Date:3410041319 24.06.2015 Defer Date:07.09.2016 86

Case No.:89/7/82-

ALC4/2015 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00694/AM16/ RLA File :02/24/040/00045/AM16/ Lic.No/Date:0210205925 26.06.2015 Defer Date:07.09.2016 87

Case No.:97/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01233/AM16/ RLA File :09/24/040/00186/AM16/ Lic.No/Date:0910062271 01.07.2015 Defer Date:07.09.2016 88

Case No.:109/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01245/AM16/ RLA File :09/24/040/00195/AM16/ Lic.No/Date:0910062283 02.07.2015 Defer Date:07.09.2016 Decision :

14 89

Case No.:54/8/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00850/AM16/ RLA File :05/23/040/00150/AM16/ Lic.No/Date:0510394862 09.07.2015 Defer Date:07.09.2016 Decision : The Committee noted that Information has been called for from the firm in NC meeting No.03 dated 12.05.2016 is awaited. The Committee accordingly deferred the case. 90

Case No.:50/8/82-

ALC4/2015 Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00846/AM16/ RLA File :06/24/040/00014/AM16/ Lic.No/Date:0610038189 09.07.2015 Defer Date:07.09.2016 Decision :Deferred for want of comments from DoP. 91

Case No.:54/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01190/AM16/ RLA File :09/24/040/00524/AM15/ Lic.No/Date:0910062332 15.07.2015 Defer Date:07.09.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply 92

Case No.:59/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01195/AM16/ RLA File :09/24/040/00525/AM15/ Lic.No/Date:0910062331 15.07.2015 Defer Date:07.09.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply 93

Case No.:41/14/82-

ALC4/2015 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01177/AM16/ RLA File :34/24/040/00031/AM16/ Lic.No/Date:3410041376 15.07.2015 Defer Date:07.09.2016 94

Case No.:49/8/82-

ALC4/2015 Party Name:M.L.A. INDUSTRIES Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00845/AM16/ RLA File :06/24/040/00015/AM16/ Lic.No/Date:0610038193 16.07.2015 Defer Date:07.09.2016 95

Case No.:120/8/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File RLA File Lic.No/Date:0310797293 Defer

15 :01/82/050/00916/AM16/ :03/95/040/00304/AM16/ 16.07.2015 Date:07.09.2016 96

Case No.:49/14/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01185/AM16/ RLA File :09/24/040/00205/AM16/ Lic.No/Date:0910062344 17.07.2015 Defer Date:07.09.2016 97

Case No.:39/14/82-

ALC4/2015 Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01175/AM16/ RLA File :05/23/040/00165/AM16/ Lic.No/Date:0510395004 20.07.2015 Defer Date:07.09.2016 meeting No.07 dated 07.07.2016 is awaited. The Committee decided to await the reply 98

Case No.:21/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01341/AM16/ RLA File :09/24/040/00223/AM16/ Lic.No/Date:0910062361 22.07.2015 Defer Date:07.09.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 99

Case No.:149/14/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01285/AM16/ RLA File :09/24/040/00230/AM16/ Lic.No/Date:0910062365 23.07.2015 Defer Date:07.09.2016 meeting No.03 dated 12.05.2016 is awaited. The Committee decided to await the reply 100

Case No.:1/10/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00957/AM16/ RLA File :09/24/040/00211/AM16/ Lic.No/Date:0910062393 28.07.2015 Defer Date:07.09.2016 101

Case No.:170/14/82-

ALC4/2015 Party Name:PI INDUSTRIES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01306/AM16/ RLA File :13/24/040/00015/AM16/ Lic.No/Date:1310047932 29.07.2015 Defer Date:07.09.2016

16 102

Case No.:131/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01267/AM16/ RLA File :09/24/040/00212/AM16/ Lic.No/Date:0910062413 30.07.2015 Defer Date:07.09.2016 103

Case No.:60/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01196/AM16/ RLA File :09/24/040/00256/AM16/ Lic.No/Date:0910062418 31.07.2015 Defer Date:07.09.2016 Decision :Deferred. 104

Case No.:84/1/82-

ALC1/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01858/AM16/ RLA File :08/91/040/00210/AM16/ Lic.No/Date:0810135770 03.08.2015 Defer Date:07.09.2016 105

Case No.:169/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01305/AM16/ RLA File :31/83/040/00018/AM16/ Lic.No/Date:3110065573 03.08.2015 Defer Date:07.09.2016 106

Case No.:17/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00813/AM16/ RLA File :09/24/040/00251/AM16/ Lic.No/Date:0910062426 03.08.2015 Defer Date:07.09.2016 107

Case No.:168/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01304/AM16/ RLA File :31/83/040/00024/AM16/ Lic.No/Date:3110065579 04.08.2015 Defer Date:07.09.2016 108

Case No.:18/14/82-

ALC4/2015 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01154/AM16/ RLA File :03/95/040/00317/AM16/ Lic.No/Date:0310798039 10.08.2015 Defer Date:07.09.2016 109

Case No.:115/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

17 HQ File :01/82/050/01435/AM16/ RLA File :03/95/040/00164/AM16/ Lic.No/Date:0310798051 10.08.2015 Defer Date:07.09.2016 meeting No.07 dated 07.07.2016 is awaited. The Committee decided to await the reply 110

Case No.:23/8/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00819/AM16/ RLA File :09/24/040/00091/AM16/ Lic.No/Date:0910062478 11.08.2015 Defer Date:07.09.2016 111

Case No.:155/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01291/AM16/ RLA File :05/24/040/00237/AM16/ Lic.No/Date:0510395271 11.08.2015 Defer Date:07.09.2016 112

Case No.:11/18/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01476/AM16/ RLA File :03/95/040/00327/AM16/ Lic.No/Date:0310798117 13.08.2015 Defer Date:07.09.2016 113

Case No.:34/14/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01170/AM16/ RLA File :34/24/040/00144/AM16/ Lic.No/Date:3410041464 17.08.2015 Defer Date:07.09.2016 114

Case No.:99/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01235/AM16/ RLA File :09/24/040/00231/AM16/ Lic.No/Date:0910062516 18.08.2015 Defer Date:07.09.2016 meeting No20/82 dated 09.03.2016 is awaited. The Committee decided to await the reply 115

Case No.:56/13/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01019/AM16/ RLA File :05/24/040/00183/AM16/ Lic.No/Date:0510395354 18.08.2015 Defer Date:07.09.2016

18 116

Case No.:154/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01290/AM16/ RLA File :05/24/040/00381/AM15/ Lic.No/Date:0510395357 19.08.2015 Defer Date:07.09.2016 117

Case No.:68/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01204/AM16/ RLA File :09/24/040/00368/AM15/ Lic.No/Date:0910062518 19.08.2015 Defer Date:07.09.2016 118

Case No.:24/14/82-

ALC4/2015 Party Name:SHUBHAM SPECIALTY PRODUCTS Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01160/AM16/ RLA File :03/95/040/00348/AM16/ Lic.No/Date:0310798516 27.08.2015 Defer Date:07.09.2016 119

Case No.:82/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01218/AM16/ RLA File :05/24/040/00233/AM16/ Lic.No/Date:0510395480 31.08.2015 Defer Date:07.09.2016 120

Case No.:89/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01225/AM16/ RLA File :05/24/040/00224/AM16/ Lic.No/Date:0510395479 31.08.2015 Defer Date:07.09.2016 Decision :Deferred. 121

Case No.:94/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01230/AM16/ RLA File :05/24/040/00202/AM16/ Lic.No/Date:0510395481 31.08.2015 Defer Date:07.09.2016 122

Case No.:116/16/82-

ALC4/2015 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01436/AM16/ RLA File :05/24/040/00181/AM16/ Lic.No/Date:0510395496 01.09.2015 Defer Date:07.09.2016 Decision :Deferred for want of comments from DBT.

19 123

Case No.:93/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01229/AM16/ RLA File :05/24/040/00244/AM16/ Lic.No/Date:0510395493 01.09.2015 Defer Date:07.09.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 124

Case No.:124/7/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00298/AM17/ RLA File :03/94/040/00424/AM16/ Lic.No/Date:0310798671 04.09.2015 Defer Date:07.09.2016 125

Case No.:5/18/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01470/AM16/ RLA File :52/24/040/00039/AM16/ Lic.No/Date:5210041625 04.09.2015 Defer Date:07.09.2016 126

Case No.:141/14/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01277/AM16/ RLA File :17/24/040/00050/AM16/ Lic.No/Date:1710006170 04.09.2015 Defer Date:07.09.2016 127

Case No.:52/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01188/AM16/ RLA File :09/24/040/00323/AM16/ Lic.No/Date:0910062554 04.09.2015 Defer Date:07.09.2016 128

Case No.:56/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01192/AM16/ RLA File :09/24/040/00134/AM16/ Lic.No/Date:0910062560 08.09.2015 Defer Date:07.09.2016 129

Case No.:124/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

20 HQ File :01/82/050/01444/AM16/ RLA File :03/94/040/00399/AM16/ Lic.No/Date:0310798771 09.09.2015 Defer Date:07.09.2016 130

Case No.:46/14/82-

ALC4/2015 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01182/AM16/ RLA File :56/24/040/00005/AM16/ Lic.No/Date:5610004674 09.09.2015 Defer Date:07.09.2016 131

Case No.:53/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01189/AM16/ RLA File :09/24/040/00315/AM16/ Lic.No/Date:0910062581 09.09.2015 Defer Date:07.09.2016 132

Case No.:157/14/82-

ALC4/2015 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01293/AM16/ RLA File :52/24/040/00042/AM16/ Lic.No/Date:5210041630 10.09.2015 Defer Date:07.09.2016 133

Case No.:9/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01329/AM16/ RLA File :09/24/040/00328/AM16/ Lic.No/Date:0910062593 11.09.2015 Defer Date:07.09.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 134

Case No.:56/16/82-

ALC4/2015 INDUSTRIES PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01376/AM16/ RLA File :03/94/040/00435/AM16/ Lic.No/Date:0310798876 14.09.2015 Defer Date:07.09.2016 135

Case No.:8/14/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01144/AM16/ RLA File :03/95/040/00343/AM16/ Lic.No/Date:0310798846 14.09.2015 Defer Date:07.09.2016 136 Case No.:110/14/82- ALC4/2015 & CHEMICALS PRIVATE Meet No/Date:9/82- ALC4/2016 Status:Deferred

21 LIMITED 10.08.2016 HQ File :01/82/050/01246/AM16/ RLA File :09/24/040/00305/AM16/ Lic.No/Date:0910062601 14.09.2015 Defer Date:07.09.2016 137

Case No.:134/14/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01270/AM16/ RLA File :09/24/040/00273/AM16/ Lic.No/Date:0910062602 14.09.2015 Defer Date:07.09.2016 138

Case No.:7/14/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01143/AM16/ RLA File :03/95/040/00426/AM16/ Lic.No/Date:0310798872 14.09.2015 Defer Date:07.09.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.07 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 139

Case No.:74/14/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01210/AM16/ RLA File :34/24/040/00120/AM16/ Lic.No/Date:3410041510 15.09.2015 Defer Date:07.09.2016 140

Case No.:15/14/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01151/AM16/ RLA File :03/95/040/00360/AM16/ Lic.No/Date:0310798909 15.09.2015 Defer Date:07.09.2016 141

Case No.:9/14/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01145/AM16/ RLA File :03/95/040/00434/AM16/ Lic.No/Date:0310798944 16.09.2015 Defer Date:07.09.2016 142

Case No.:124/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01260/AM16/ RLA File :09/24/040/00355/AM16/ Lic.No/Date:0910062622 16.09.2015 Defer Date:07.09.2016 143

Case No.:35/16/82-

ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

22 HQ File :01/82/050/01355/AM16/ RLA File :03/94/040/00415/AM16/ Lic.No/Date:0310798977 21.09.2015 Defer Date:07.09.2016 144

Case No.:34/16/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01354/AM16/ RLA File :03/94/040/00472/AM16/ Lic.No/Date:0310798979 21.09.2015 Defer Date:07.09.2016 145

Case No.:64/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01769/AM16/ RLA File :08/24/040/00137/AM16/ Lic.No/Date:0810136085 22.09.2015 Defer Date:07.09.2016 146

Case No.:64/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01200/AM16/ RLA File :09/24/040/00375/AM16/ Lic.No/Date:0910062644 22.09.2015 Defer Date:07.09.2016 meeting No.20 dated 09.03.2016 is awaited. The Committee decided to await the reply 147

Case No.:117/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01253/AM16/ RLA File :04/24/040/00140/AM16/ Lic.No/Date:0410161044 22.09.2015 Defer Date:07.09.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 148

Case No.:103/14/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01239/AM16/ RLA File :09/24/040/00362/AM16/ Lic.No/Date:0910062635 22.09.2015 Defer Date:07.09.2016 149

Case No.:25/20/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01608/AM16/ RLA File :13/24/040/00027/AM16/ Lic.No/Date:1310047981 23.09.2015 Defer Date:07.09.2016

23 150

Case No.:106/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01242/AM16/ RLA File :09/24/040/00373/AM16/ Lic.No/Date:0910062649 23.09.2015 Defer Date:07.09.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 151

Case No.:91/14/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01227/AM16/ RLA File :22/21/040/00029/AM16/ Lic.No/Date:2210015316 24.09.2015 Defer Date:07.09.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 152

Case No.:86/14/82-

ALC4/2015 Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred
HQ File :01/82/050/01222/AM16/ RLA File :35/24/040/00005/AM16/ Lic.No/Date:3510044794 25.09.2015 Defer Date:07.09.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/793/2015-PI(Norms) dated 03.08 2016 , uploaded at the end of these minutes and deferred the case. 153

Case No.:8/16/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01328/AM16/ RLA File :09/24/040/00294/AM16/ Lic.No/Date:0910062666 28.09.2015 Defer Date:07.09.2016 154

Case No.:79/14/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01215/AM16/ RLA File :05/23/040/00274/AM16/ Lic.No/Date:0510395773 30.09.2015 Defer Date:07.09.2016 Decision : Deferred for want of comments from AYUSH. 155

Case No.:69/16/82-

ALC4/2015 Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01389/AM16/ RLA File :03/95/040/00350/AM15/ Lic.No/Date:0310799113 30.09.2015 Defer Date:07.09.2016 156 Case No.:43/16/82- Party Name:INDOFIL Meet No/Date:9/82- Status:Deferred

24 ALC4/2015 INDUSTRIES LTD. ALC4/2016 10.08.2016 HQ File :01/82/050/01363/AM16/ RLA File :03/94/040/00423/AM16/ Lic.No/Date:0310799184 05.10.2015 Defer Date:07.09.2016 157

Case No.:67/16/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01387/AM16/ RLA File :03/95/040/00485/AM16/ Lic.No/Date:0310799241 06.10.2015 Defer Date:07.09.2016 158

Case No.:139/14/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01275/AM16/ RLA File :34/24/040/00178/AM16/ Lic.No/Date:3410041581 08.10.2015 Defer Date:07.09.2016 159

Case No.:126/16/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01446/AM16/ RLA File :03/95/040/00445/AM16/ Lic.No/Date:0310799287 08.10.2015 Defer Date:07.09.2016 160

Case No.:61/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01381/AM16/ RLA File :03/95/040/00483/AM16/ Lic.No/Date:0310799284 08.10.2015 Defer Date:07.09.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 161

Case No.:62/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01382/AM16/ RLA File :03/95/040/00491/AM16/ Lic.No/Date:0310799292 08.10.2015 Defer Date:07.09.2016 162

Case No.:17/16/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01337/AM16/ RLA File :09/24/040/00402/AM16/ Lic.No/Date:0910062693 08.10.2015 Defer Date:07.09.2016

25 163

Case No.:164/14/82-

ALC4/2015 Party Name:AASHA BIOCHEM Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01300/AM16/ RLA File :10/24/040/00049/AM16/ Lic.No/Date:1010059293 12.10.2015 Defer Date:07.09.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 164

Case No.:140/14/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01276/AM16/ RLA File :34/24/040/00175/AM16/ Lic.No/Date:3410041586 12.10.2015 Defer Date:07.09.2016 165

Case No.:144/14/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01280/AM16/ RLA File :52/24/040/00049/AM16/ Lic.No/Date:5210041658 14.10.2015 Defer Date:07.09.2016 Decision : Deferred. 166

Case No.:58/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01378/AM16/ RLA File :03/94/040/00497/AM16/ Lic.No/Date:0310799433 14.10.2015 Defer Date:07.09.2016 meeting No.05 dated 08.06.2016 is awaited. The Committee decided to await the reply 167

Case No.:132/14/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01268/AM16/ RLA File :34/24/040/00180/AM16/ Lic.No/Date:3410041592 14.10.2015 Defer Date:07.09.2016 168

Case No.:60/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01380/AM16/ RLA File :03/94/040/00486/AM16/ Lic.No/Date:0310799460 15.10.2015 Defer Date:07.09.2016 169

Case No.:92/16/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01412/AM16/ RLA File :34/24/040/00185/AM16/ Lic.No/Date:3410041600 15.10.2015 Defer Date:07.09.2016

26 170

Case No.:72/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01392/AM16/ RLA File :03/95/040/00102/AM16/ Lic.No/Date:0310799579 21.10.2015 Defer Date:07.09.2016 171

Case No.:73/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01393/AM16/ RLA File :03/95/040/00087/AM16/ Lic.No/Date:0310799578 21.10.2015 Defer Date:07.09.2016 172

Case No.:29/16/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01349/AM16/ RLA File :09/24/040/00379/AM16/ Lic.No/Date:0910062768 23.10.2015 Defer Date:07.09.2016 173

Case No.:30/16/82-

ALC4/2015 & CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01350/AM16/ RLA File :09/24/040/00383/AM16/ Lic.No/Date:0910062767 23.10.2015 Defer Date:07.09.2016 174

Case No.:129/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01449/AM16/ RLA File :03/95/040/00505/AM16/ Lic.No/Date:0310799628 23.10.2015 Defer Date:07.09.2016 175

Case No.:161/14/82-

ALC4/2015 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01297/AM16/ RLA File :03/94/040/01226/AM15/ Lic.No/Date:0310799680 26.10.2015 Defer Date:07.09.2016 176

Case No.:78/16/82-

ALC4/2015 Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01398/AM16/ RLA File :03/95/040/00777/AM15/ Lic.No/Date:0310799666 26.10.2015 Defer Date:07.09.2016 177 Case No.:53/20/82- ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 Status:Deferred

27 10.08.2016 HQ File :01/82/050/01636/AM16/ RLA File :03/95/040/00529/AM16/ Lic.No/Date:0310799675 26.10.2015 Defer Date:07.09.2016 178

Case No.:93/16/82-

ALC4/2015 Party Name:JAINEX SPECIALITY CHEMICAL Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01413/AM16/ RLA File :34/24/040/00196/AM16/ Lic.No/Date:3410041626 28.10.2015 Defer Date:07.09.2016 179

Case No.:31/16/82-

ALC4/2015 Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01351/AM16/ RLA File :09/24/040/00423/AM16/ Lic.No/Date:0910062790 28.10.2015 Defer Date:07.09.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 180

Case No.:74/16/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01394/AM16/ RLA File :03/95/040/00518/AM16/ Lic.No/Date:0310799705 28.10.2015 Defer Date:07.09.2016 181

Case No.:75/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01395/AM16/ RLA File :03/95/040/00525/AM16/ Lic.No/Date:0310799704 28.10.2015 Defer Date:07.09.2016 182

Case No.:47/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01367/AM16/ RLA File :03/95/040/00526/AM16/ Lic.No/Date:0310799853 29.10.2015 Defer Date:07.09.2016 183

Case No.:136/14/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01272/AM16/ RLA File :05/23/040/00293/AM16/ Lic.No/Date:0510396078 30.10.2015 Defer Date:07.09.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 184 Case No.:159/14/82- Party Name:SUN Meet No/Date:9/82- Status:Deferred

28 ALC4/2015 PHARMACEUTICAL INDUSTRIES LTD., ALC4/2016 10.08.2016 HQ File :01/82/050/01295/AM16/ RLA File :05/24/040/00343/AM16/ Lic.No/Date:0510396075 30.10.2015 Defer Date:07.09.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 185

Case No.:118/16/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01438/AM16/ RLA File :05/24/040/00345/AM16/ Lic.No/Date:0510396076 30.10.2015 Defer Date:07.09.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 186

Case No.:84/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01404/AM16/ RLA File :22/24/040/00055/AM16/ Lic.No/Date:2210015339 30.10.2015 Defer Date:07.09.2016 meeting No.03 dated 08.06.2016 is awaited. The Committee decided to await the reply 187

Case No.:112/16/82-

ALC4/2015 Party Name:BELCO PHARMA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01432/AM16/ RLA File :05/23/040/00273/AM16/ Lic.No/Date:0510396205 03.11.2015 Defer Date:07.09.2016 188

Case No.:107/16/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01427/AM16/ RLA File :05/23/040/00326/AM16/ Lic.No/Date:0510396204 03.11.2015 Defer Date:07.09.2016 189

Case No.:19/16/82-

ALC4/2015 Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01339/AM16/ RLA File :04/24/040/00181/AM16/ Lic.No/Date:0410161279 04.11.2015 Defer Date:07.09.2016 190

Case No.:90/16/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01410/AM16/ RLA File :34/24/040/00207/AM16/ Lic.No/Date:3410041662 05.11.2015 Defer Date:07.09.2016

29 191

Case No.:88/16/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01408/AM16/ RLA File :34/24/040/00202/AM16/ Lic.No/Date:3410041663 05.11.2015 Defer Date:07.09.2016 192

Case No.:37/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01357/AM16/ RLA File :03/94/040/00561/AM16/ Lic.No/Date:0310800114 06.11.2015 Defer Date:07.09.2016 193

Case No.:53/16/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01373/AM16/ RLA File :03/95/040/00540/AM16/ Lic.No/Date:0310800090 06.11.2015 Defer Date:07.09.2016 194

Case No.:89/16/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01409/AM16/ RLA File :34/24/040/00203/AM16/ Lic.No/Date:3410041666 09.11.2015 Defer Date:07.09.2016 195

Case No.:2/16/82-

ALC4/2015 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01322/AM16/ RLA File :04/24/040/00175/AM16/ Lic.No/Date:0410161296 09.11.2015 Defer Date:07.09.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.18/82 dated 10.02.2016 is awaited. The Committee accordingly deferred the case. 196

Case No.:34/1/82-

ALC1/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01808/AM16/ RLA File :09/24/040/00469/AM16/ Lic.No/Date:0910062848 10.11.2015 Defer Date:07.09.2016 197

Case No.:114/16/82-

ALC4/2015 Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01434/AM16/ RLA File :50/24/040/00017/AM16/ Lic.No/Date:5010002240 16.11.2015 Defer Date:07.09.2016

30 198

Case No.:104/16/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01424/AM16/ RLA File :05/23/040/00339/AM16/ Lic.No/Date:0510396384 20.11.2015 Defer Date:07.07.2016 199

Case No.:4/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01587/AM16/ RLA File :03/94/040/00656/AM16/ Lic.No/Date:0310800363 23.11.2015 Defer Date:07.09.2016 Decision :Deferred. 200

Case No.:31/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01805/AM16/ RLA File :05/24/040/00347/AM16/ Lic.No/Date:0510396399 23.11.2015 Defer Date:07.09.2016 201

Case No.:2/20/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01585/AM16/ RLA File :05/24/040/00400/AM16/ Lic.No/Date:0510396400 23.11.2015 Defer Date:07.09.2016 202

Case No.:24/19/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/01504/AM16/ RLA File :31/83/040/00115/AM16/ Lic.No/Date:3110065769 26.11.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
RA concerned may take necessary action as per decision of NC. 203

Case No.:33/1/82-

ALC1/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01807/AM16/ RLA File :09/24/040/00486/AM16/ Lic.No/Date:0910062902 26.11.2015 Defer Date:07.09.2016 204

Case No.:32/16/82-

ALC4/2015 Party Name:INTERMED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01352/AM16/ RLA File :04/24/040/00177/AM16/ Lic.No/Date:0410161343 26.11.2015 Defer Date:07.09.2016

31 205

Case No.:2/1/82-ALC1/2016 Party Name:UNIJULES LIFE

SCIENCES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01776/AM16/ RLA File :03/95/040/00632/AM16/ Lic.No/Date:0310800416 26.11.2015 Defer Date:07.09.2016 206

Case No.:23/1/82-

ALC1/2016 Party Name:UNILINK PHARMA PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01797/AM16/ RLA File :04/24/040/00170/AM16/ Lic.No/Date:0410161342 26.11.2015 Defer Date:07.09.2016 207

Case No.:58/20/82-

ALC4/2015 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01641/AM16/ RLA File :03/95/040/00182/AM15/ Lic.No/Date:0310800550 01.12.2015 Defer Date:07.09.2016 208

Case No.:3/1/82-ALC1/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01777/AM16/ RLA File :03/95/040/00529/AM15/ Lic.No/Date:0310800547 01.12.2015 Defer Date:07.09.2016 209

Case No.:5/1/82-ALC1/2016 Party Name:NEOGEN

CHEMICALS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01779/AM16/ RLA File :03/95/040/00239/AM15/ Lic.No/Date:0310800551 01.12.2015 Defer Date:07.09.2016 210

Case No.:33/20/82-

ALC4/2015 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01616/AM16/ RLA File :03/94/040/00532/AM16/ Lic.No/Date:0310800597 02.12.2015 Defer Date:07.09.2016 211

Case No.:54/20/82-

ALC4/2015 Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01637/AM16/ RLA File :03/95/040/00631/AM16/ Lic.No/Date:0310800619 03.12.2015 Defer Date:07.09.2016 212

Case No.:112/20/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

32 HQ File :01/82/050/01695/AM16/ RLA File :03/95/040/00646/AM16/ Lic.No/Date:0310800620 03.12.2015 Defer Date:07.09.2016 213

Case No.:87/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01670/AM16/ RLA File :03/95/040/00605/AM16/ Lic.No/Date:0310800715 07.12.2015 Defer Date:07.09.2016 214

Case No.:127/16/82-

ALC4/2015 Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01447/AM16/ RLA File :07/24/040/00267/AM16/ Lic.No/Date:0710109146 08.12.2015 Defer Date:07.09.2016 Decision : Information called for from the firm in NC meeting No.03/AM17 dated 12.05.2016 is awaited. The committee accordingly deferred the case. 215

Case No.:36/20/82-

ALC4/2015 Party Name:BAYER VAPI PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01619/AM16/ RLA File :03/94/040/00651/AM16/ Lic.No/Date:0310800833 09.12.2015 Defer Date:07.09.2016 216

Case No.:67/20/82-

ALC4/2015 Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01650/AM16/ RLA File :03/95/040/00054/AM16/ Lic.No/Date:0310800865 10.12.2015 Defer Date:07.09.2016 217

Case No.:110/20/82-

ALC4/2015 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01693/AM16/ RLA File :56/24/040/00040/AM16/ Lic.No/Date:5610004767 10.12.2015 Defer Date:07.09.2016 218

Case No.:39/20/82-

ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01622/AM16/ RLA File :03/94/040/00088/AM16/ Lic.No/Date:0310800889 11.12.2015 Defer Date:07.09.2016 219

Case No.:41/20/82-

ALC4/2015 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310800905 Defer

33 :01/82/050/01624/AM16/ :03/94/040/00648/AM16/ 11.12.2015 Date:07.09.2016 220

Case No.:9/1/82-ALC1/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01783/AM16/ RLA File :03/94/040/00490/AM16/ Lic.No/Date:0310800912 11.12.2015 Defer Date:07.09.2016 221

Case No.:66/20/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01649/AM16/ RLA File :03/95/040/00633/AM16/ Lic.No/Date:0310800935 11.12.2015 Defer Date:07.09.2016 222

Case No.:45/20/82-

ALC4/2015 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01628/AM16/ RLA File :03/94/040/00736/AM16/ Lic.No/Date:0310800992 14.12.2015 Defer Date:07.09.2016 223

Case No.:24/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01607/AM16/ RLA File :03/95/040/00088/AM16/ Lic.No/Date:0310800991 14.12.2015 Defer Date:07.09.2016 224

Case No.:49/20/82-

ALC4/2015 INDUSTRIES PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01632/AM16/ RLA File :03/94/040/00714/AM16/ Lic.No/Date:0310801093 16.12.2015 Defer Date:07.09.2016 225

Case No.:10/1/82-

ALC1/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01784/AM16/ RLA File :03/94/040/00630/AM16/ Lic.No/Date:0310801130 16.12.2015 Defer Date:07.09.2016 226

Case No.:46/20/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01629/AM16/ RLA File :03/94/040/00692/AM16/ Lic.No/Date:0310801111 16.12.2015 Defer Date:07.09.2016

34 227

Case No.:23/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01606/AM16/ RLA File :03/95/040/00697/AM16/ Lic.No/Date:0310801116 16.12.2015 Defer Date:07.09.2016 228

Case No.:8/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01591/AM16/ RLA File :05/24/040/00427/AM16/ Lic.No/Date:0510396637 16.12.2015 Defer Date:07.09.2016 229

Case No.:8/1/82-ALC1/2016 Party Name:CAMPHOR &

ALLIED PRODUCTS LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01782/AM16/ RLA File :03/94/040/00754/AM16/ Lic.No/Date:0310801214 18.12.2015 Defer Date:07.09.2016 230

Case No.:83/1/82-

ALC1/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01857/AM16/ RLA File :03/94/040/00752/AM16/ Lic.No/Date:0310801211 18.12.2015 Defer Date:07.09.2016 231

Case No.:14/20/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01597/AM16/ RLA File :03/94/040/00728/AM16/ Lic.No/Date:0310801252 21.12.2015 Defer Date:07.09.2016 Decision : Deferred for want of comments from DoP. 232

Case No.:19/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01602/AM16/ RLA File :03/95/040/00009/AM16/ Lic.No/Date:0310801275 22.12.2015 Defer Date:07.09.2016 233

Case No.:20/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01603/AM16/ RLA File :03/95/040/00267/AM16/ Lic.No/Date:0310801273 22.12.2015 Defer Date:07.09.2016 234 Case No.:48/20/82- ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:9/82- ALC4/2016 Status:Deferred

35 10.08.2016 HQ File :01/82/050/01631/AM16/ RLA File :03/94/040/00683/AM16/ Lic.No/Date:0310801362 28.12.2015 Defer Date:07.09.2016 meeting No.07/82 dated 07.07.2016 is awaited. The Committee decided to await the reply and deferred the case. 235

Case No.:7/7/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00181/AM17/ RLA File :08/24/040/00333/AM16/ Lic.No/Date:0810136798 29.12.2015 Defer Date:07.09.2016 236

Case No.:80/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01663/AM16/ RLA File :03/95/040/00736/AM16/ Lic.No/Date:0310801389 29.12.2015 Defer Date:07.09.2016 237

Case No.:81/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01664/AM16/ RLA File :03/95/040/00735/AM16/ Lic.No/Date:0310801388 29.12.2015 Defer Date:07.09.2016 238

Case No.:32/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/01737/AM16/ RLA File :31/83/040/00135/AM16/ Lic.No/Date:3110065815 30.12.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
RA concerned may take necessary action as per decision of NC. 239

Case No.:22/20/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01605/AM16/ RLA File :03/95/040/00738/AM16/ Lic.No/Date:0310801409 30.12.2015 Defer Date:07.09.2016 Decision : 240

Case No.:84/20/82-

ALC4/2015 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File :01/82/050/01667/AM16/ RLA File :03/95/040/00730/AM16/ Lic.No/Date:0310801411 30.12.2015 Defer Date:07.09.2016 Decision : Information called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The committee decided to await the reply and deferred the case.

36 241

Case No.:47/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01630/AM16/ RLA File :03/94/040/00792/AM16/ Lic.No/Date:0310801428 31.12.2015 Defer Date:07.09.2016 242

Case No.:98/20/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01681/AM16/ RLA File :05/23/040/00338/AM16/ Lic.No/Date:0510397164 31.12.2015 Defer Date:07.09.2016 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 is awaited. The committee accordingly deferred the case. 243

Case No.:99/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01682/AM16/ RLA File :05/23/040/00389/AM16/ Lic.No/Date:0510397158 31.12.2015 Defer Date:07.09.2016 244

Case No.:101/20/82-

ALC4/2015 Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01684/AM16/ RLA File :34/24/040/00226/AM16/ Lic.No/Date:3410041775 31.12.2015 Defer Date:07.09.2016 245

Case No.:119/20/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01702/AM16/ RLA File :09/24/040/00582/AM16/ Lic.No/Date:0910063066 31.12.2015 Defer Date:07.09.2016 246

Case No.:104/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01687/AM16/ RLA File :34/24/040/00253/AM16/ Lic.No/Date:3410041778 04.01.2016 Defer Date:07.09.2016 247

Case No.:82/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01665/AM16/ RLA File :03/95/040/00750/AM16/ Lic.No/Date:0310801522 04.01.2016 Defer Date:07.09.2016 248 Case No.:83/20/82- Party Name:YASHO Meet No/Date:9/82- Status:Deferred

37 ALC4/2015 INDUSTRIES PVT.LTD. ALC4/2016 10.08.2016 HQ File :01/82/050/01666/AM16/ RLA File :03/95/040/00749/AM16/ Lic.No/Date:0310801521 04.01.2016 Defer Date:07.09.2016 249

Case No.:105/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01688/AM16/ RLA File :34/24/040/00252/AM16/ Lic.No/Date:3410041782 05.01.2016 Defer Date:07.09.2016 250

Case No.:78/20/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01661/AM16/ RLA File :03/95/040/00652/AM16/ Lic.No/Date:0310801554 05.01.2016 Defer Date:07.09.2016 251

Case No.:26/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01609/AM16/ RLA File :03/94/040/00802/AM16/ Lic.No/Date:0310801601 06.01.2016 Defer Date:07.09.2016 252

Case No.:7/1/82-ALC1/2016 Party Name:PRIVI

ORGANICS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01781/AM16/ RLA File :03/95/040/00688/AM16/ Lic.No/Date:0310801600 06.01.2016 Defer Date:07.09.2016 253

Case No.:76/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01659/AM16/ RLA File :03/94/040/00790/AM16/ Lic.No/Date:0310801644 07.01.2016 Defer Date:07.09.2016 Decision :Deferred. 254

Case No.:103/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01686/AM16/ RLA File :05/23/040/00404/AM16/ Lic.No/Date:0510397232 07.01.2016 Defer Date:07.09.2016 255

Case No.:6/1/82-ALC1/2016 Party Name:MEDISPRAY

LABORATORIES PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310801634 Defer

38 :01/82/050/01780/AM16/ :03/95/040/00676/AM16/ 07.01.2016 Date:07.09.2016 256

Case No.:32/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01806/AM16/ RLA File :05/24/040/00431/AM16/ Lic.No/Date:0510397230 07.01.2016 Defer Date:07.09.2016 257

Case No.:95/20/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01678/AM16/ RLA File :05/24/040/00499/AM16/ Lic.No/Date:0510397256 08.01.2016 Defer Date:07.09.2016 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 is awaited. The committee accordingly deferred the case. 258

Case No.:79/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01662/AM16/ RLA File :03/95/040/00765/AM16/ Lic.No/Date:0310801655 08.01.2016 Defer Date:07.09.2016 259

Case No.:21/20/82-

ALC4/2015 Party Name:SHREE LIFE SCIENCES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01604/AM16/ RLA File :03/95/040/00762/AM16/ Lic.No/Date:0310801691 11.01.2016 Defer Date:07.09.2016 Decision : Information called for from the firm in NC meeting No.07/AM17 dated 07.07.2016 is awaited. The committee accordingly deferred the case. 260

Case No.:19/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01793/AM16/ RLA File :04/24/040/00214/AM16/ Lic.No/Date:0410161494 11.01.2016 Defer Date:07.09.2016 261

Case No.:60/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01834/AM16/ RLA File :03/94/040/00828/AM16/ Lic.No/Date:0310801732 12.01.2016 Defer Date:07.09.2016 262

Case No.:61/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

39 HQ File :01/82/050/01835/AM16/ RLA File :03/94/040/00820/AM16/ Lic.No/Date:0310801731 12.01.2016 Defer Date:07.09.2016 263

Case No.:48/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01822/AM16/ RLA File :03/94/040/00785/AM16/ Lic.No/Date:0310801728 12.01.2016 Defer Date:07.09.2016 264

Case No.:82/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01856/AM16/ RLA File :03/95/040/00690/AM16/ Lic.No/Date:0310801719 12.01.2016 Defer Date:07.09.2016 265

Case No.:62/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01836/AM16/ RLA File :03/94/040/00833/AM16/ Lic.No/Date:0310801811 15.01.2016 Defer Date:07.09.2016 266

Case No.:66/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01840/AM16/ RLA File :03/94/040/00831/AM16/ Lic.No/Date:0310801850 18.01.2016 Defer Date:07.09.2016 267

Case No.:64/1/82-

ALC1/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01838/AM16/ RLA File :03/94/040/00840/AM16/ Lic.No/Date:0310801857 18.01.2016 Defer Date:07.09.2016 268

Case No.:79/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01853/AM16/ RLA File :03/95/040/00689/AM16/ Lic.No/Date:0310801831 18.01.2016 Defer Date:07.09.2016 269

Case No.:80/1/82-

ALC1/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01854/AM16/ RLA File :03/95/040/00771/AM16/ Lic.No/Date:0310801856 18.01.2016 Defer Date:07.09.2016

40 Decision :Deferred. 270

Case No.:63/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01837/AM16/ RLA File :03/94/040/00846/AM16/ Lic.No/Date:0310801882 19.01.2016 Defer Date:07.09.2016 271

Case No.:65/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01839/AM16/ RLA File :03/94/040/00857/AM16/ Lic.No/Date:0310801883 19.01.2016 Defer Date:07.09.2016 Decision : 272

Case No.:70/7/82-ALC4/2016 Party Name:EYTAN LABS

LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00244/AM17/ RLA File :09/24/040/00543/AM16/ Lic.No/Date:0910063146 19.01.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/183/2016-PI(Norms) dated 10.08.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 273

Case No.:59/1/82-

ALC1/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01833/AM16/ RLA File :03/94/040/00589/AM16/ Lic.No/Date:0310801896 19.01.2016 Defer Date:07.09.2016 Decision : Information has been called for from the firm in NC meeting No.05 dated 08.06.2016 is awaited. The Committee accordingly deferred the case. 274

Case No.:114/20/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01697/AM16/ RLA File :34/24/040/00263/AM16/ Lic.No/Date:3410041814 19.01.2016 Defer Date:07.09.2016 275

Case No.:77/1/82-

ALC1/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01851/AM16/ RLA File :03/95/040/00657/AM16/ Lic.No/Date:0310801888 19.01.2016 Defer Date:07.09.2016 276 Case No.:76/1/82- ALC1/2016 Party Name:TITAN LABORATORIES PVT. Meet No/Date:9/82- ALC4/2016 Status:Deferred

41 LTD. 10.08.2016 HQ File :01/82/050/01850/AM16/ RLA File :03/95/040/00790/AM16/ Lic.No/Date:0310801892 19.01.2016 Defer Date:07.09.2016 277

Case No.:50/1/82-

ALC1/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01824/AM16/ RLA File :03/94/040/00861/AM16/ Lic.No/Date:0310801928 20.01.2016 Defer Date:07.09.2016 278

Case No.:68/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01842/AM16/ RLA File :03/94/040/00834/AM16/ Lic.No/Date:0310801927 20.01.2016 Defer Date:07.09.2016 279

Case No.:106/20/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01689/AM16/ RLA File :05/24/040/00515/AM16/ Lic.No/Date:0510397367 20.01.2016 Defer Date:07.09.2016 280

Case No.:38/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01812/AM16/ RLA File :03/95/040/00798/AM16/ Lic.No/Date:0310801923 20.01.2016 Defer Date:07.09.2016 281

Case No.:49/1/82-

ALC1/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01823/AM16/ RLA File :03/94/040/00869/AM16/ Lic.No/Date:0310801950 21.01.2016 Defer Date:07.09.2016 282

Case No.:47/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01821/AM16/ RLA File :03/94/040/00864/AM16/ Lic.No/Date:0310801994 22.01.2016 Defer Date:07.09.2016 283

Case No.:67/1/82-

ALC1/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310802014 Defer

42 :01/82/050/01841/AM16/ :03/94/040/00880/AM16/ 22.01.2016 Date:07.09.2016 284

Case No.:24/1/82-

ALC1/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01798/AM16/ RLA File :04/24/040/00210/AM16/ Lic.No/Date:0410161548 22.01.2016 Defer Date:07.09.2016 Decision : Information has been called for from the firm in NC meeting No.07/82 dated 07.07.2016 is awaited. The Committee accordingly deferred the case. 285

Case No.:83/7/82-ALC4/2016 Party Name:METROCHEM

API PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00257/AM17/ RLA File :09/24/040/00610/AM16/ Lic.No/Date:0910063152 22.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/557/2015-PI(Norms) dated July 2016 , 286

Case No.:81/7/82-ALC4/2016 Party Name:NEULAND

LABORATORIES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00255/AM17/ RLA File :09/24/040/00621/AM16/ Lic.No/Date:0910063150 22.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/147/2016-PI(Norms) dated 25.07.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under

para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

287

Case No.:72/7/82-

ALC4/2016 Party Name:OGENE SYSTEMS INDIA LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00246/AM17/ RLA File :09/24/040/00620/AM16/ Lic.No/Date:0910063151 22.01.2016 Defer Date:07.09.2016 288

Case No.:71/7/82-ALC4/2016 Party Name:SATYA

DEEPTHA PHARMACEUTICALS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00245/AM17/ RLA File :09/24/040/00626/AM16/ Lic.No/Date:0910063149 22.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/135/2016-PI(Norms) dated 25.07.2016 , 289

Case No.:97/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

43 HQ File :01/82/050/01680/AM16/ RLA File :05/24/040/00522/AM16/ Lic.No/Date:0510397405 22.01.2016 Defer Date:07.09.2016 290

Case No.:96/20/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01679/AM16/ RLA File :02/24/040/00178/AM16/ Lic.No/Date:0210206458 22.01.2016 Defer Date:07.09.2016 291

Case No.:51/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01825/AM16/ RLA File :03/94/040/00877/AM16/ Lic.No/Date:0310802029 25.01.2016 Defer Date:07.09.2016 292

Case No.:52/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01826/AM16/ RLA File :03/94/040/00888/AM16/ Lic.No/Date:0310802024 25.01.2016 Defer Date:07.09.2016 293

Case No.:89/7/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00263/AM17/ RLA File :09/24/040/00623/AM16/ Lic.No/Date:0910063196 29.01.2016 Defer Date:07.09.2016 294

Case No.:88/7/82-

ALC4/2016 & CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00262/AM17/ RLA File :09/24/040/00304/AM16/ Lic.No/Date:0910063190 29.01.2016 Defer Date:07.09.2016 295

Case No.:86/7/82-ALC4/2016 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00260/AM17/ RLA File :09/24/040/00633/AM16/ Lic.No/Date:0910063191 29.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/139/2016-PI(Norms) dated 02.08.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under

para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

296 Case No.:27/1/82- ALC1/2016 Party Name:BODAL CHEMICALS LTD Meet No/Date:9/82- ALC4/2016 Status:Deferred

44 10.08.2016 HQ File :01/82/050/01801/AM16/ RLA File :08/24/040/00325/AM16/ Lic.No/Date:0810137105 01.02.2016 Defer Date:07.09.2016 297

Case No.:44/1/82-

ALC1/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01818/AM16/ RLA File :03/94/040/00886/AM16/ Lic.No/Date:0310802172 02.02.2016 Defer Date:07.09.2016 298

Case No.:40/1/82-

ALC1/2016 Party Name:MAGNOLIA LIMITED. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01814/AM16/ RLA File :03/95/040/01074/AM15/ Lic.No/Date:0310802175 02.02.2016 Defer Date:07.09.2016 299

Case No.:19/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/01724/AM16/ RLA File :31/83/040/00153/AM16/ Lic.No/Date:3110065906 03.02.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.03/82 dated 08.05.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 300

Case No.:3/5/82-ALC4/2016 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00162/AM17/ RLA File :05/24/040/00537/AM16/ Lic.No/Date:0510397479 03.02.2016 Defer Date:07.09.2016 301

Case No.:35/1/82-

ALC1/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01809/AM16/ RLA File :31/82/040/00270/AM16/ Lic.No/Date:3110065907 04.02.2016 Defer Date:07.09.2016 302

Case No.:37/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01811/AM16/ RLA File :03/95/040/00639/AM16/ Lic.No/Date:0310802231 04.02.2016 Defer Date:07.09.2016 303 Case No.:43/1/82- ALC1/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 Status:Deferred

45 10.08.2016 HQ File :01/82/050/01817/AM16/ RLA File :03/94/040/00882/AM16/ Lic.No/Date:0310802261 05.02.2016 Defer Date:07.09.2016 304

Case No.:58/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01832/AM16/ RLA File :03/95/040/00819/AM16/ Lic.No/Date:0310802266 05.02.2016 Defer Date:07.09.2016 305

Case No.:69/1/82-

ALC1/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01843/AM16/ RLA File :03/94/040/00922/AM16/ Lic.No/Date:0310802291 08.02.2016 Defer Date:07.09.2016 306

Case No.:74/1/82-

ALC1/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01848/AM16/ RLA File :03/94/040/00810/AM16/ Lic.No/Date:0310802333 08.02.2016 Defer Date:07.09.2016 307

Case No.:39/1/82-

ALC1/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01813/AM16/ RLA File :03/95/040/00847/AM16/ Lic.No/Date:0310802292 08.02.2016 Defer Date:07.09.2016 308

Case No.:60/7/82-ALC4/2016 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00234/AM17/ RLA File :09/24/040/00643/AM16/ Lic.No/Date:0910063227 08.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/146/2016-PI(Norms) dated 25th July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 309

Case No.:45/1/82-

ALC1/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01819/AM16/ RLA File :03/94/040/00859/AM16/ Lic.No/Date:0310802380 09.02.2016 Defer Date:07.09.2016 310 Case No.:114/7/82- Party Name:VENUS Meet No/Date:9/82- Status:Deferred

46 ALC4/2016 REMEDIES LTD., ALC4/2016 10.08.2016 HQ File :01/82/050/00288/AM17/ RLA File :22/24/040/00101/AM16/ Lic.No/Date:2210015410 09.02.2016 Defer Date:07.09.2016 311

Case No.:20/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/01725/AM16/ RLA File :31/83/040/00155/AM16/ Lic.No/Date:3110065933 10.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/19/2016-PI(Norms) dated June 2016 , 312

Case No.:70/1/82-

ALC1/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01844/AM16/ RLA File :03/94/040/00935/AM16/ Lic.No/Date:0310802452 10.02.2016 Defer Date:07.09.2016 313

Case No.:79/7/82-ALC4/2016 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00253/AM17/ RLA File :09/24/040/00586/AM16/ Lic.No/Date:0910063240 10.02.2016 Defer Date:07.09.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/138/2016-PI(Norms) dated 02.08.2016 , uploaded at the end of these minutes and deferred the case. 314

Case No.:41/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01815/AM16/ RLA File :03/95/040/00826/AM16/ Lic.No/Date:0310802395 10.02.2016 Defer Date:07.09.2016 315

Case No.:78/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01852/AM16/ RLA File :03/95/040/00752/AM16/ Lic.No/Date:0310802451 10.02.2016 Defer Date:07.09.2016 316

Case No.:77/7/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00251/AM17/ RLA File :09/24/040/00664/AM16/ Lic.No/Date:0910063251 11.02.2016 Defer Date:07.09.2016

47 317

Case No.:80/7/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00254/AM17/ RLA File :09/24/040/00646/AM16/ Lic.No/Date:0910063250 11.02.2016 Defer Date:07.09.2016 318

Case No.:2/7/82-ALC4/2016 Party Name:COVALENT

LABORATORIES PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00176/AM17/ RLA File :09/24/040/00647/AM16/ Lic.No/Date:0910063256 12.02.2016 Defer Date:07.09.2016 319

Case No.:90/7/82-

ALC4/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00
AM17/ RLA File :09/24/040/00653/AM16/ Lic.No/Date:0910063257 12.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/184/2016-PI(Norms) dated 10th August 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 320

Case No.:73/1/82-

ALC1/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01847/AM16/ RLA File :03/94/040/00953/AM16/ Lic.No/Date:0310802552 12.02.2016 Defer Date:07.09.2016 321

Case No.:26/1/82-

ALC1/2016 Party Name:UMA ENTERPRISE Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01800/AM16/ RLA File :08/24/040/00396/AM16/ Lic.No/Date:0810137202 15.02.2016 Defer Date:07.09.2016 322

Case No.:84/7/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00258/AM17/ RLA File :09/24/040/00663/AM16/ Lic.No/Date:0910063276 16.02.2016 Defer Date:07.09.2016 323

Case No.:56/1/82-

ALC1/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01830/AM16/ RLA File :03/95/040/00887/AM16/ Lic.No/Date:0310802649 16.02.2016 Defer Date:07.09.2016

48 324

Case No.:17/1/82-

ALC1/2016 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01791/AM16/ RLA File :04/24/040/00229/AM16/ Lic.No/Date:0410161613 17.02.2016 Defer Date:07.09.2016 325

Case No.:57/1/82-

ALC1/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01831/AM16/ RLA File :03/95/040/00895/AM16/ Lic.No/Date:0310802676 17.02.2016 Defer Date:07.09.2016 326

Case No.:63/7/82-ALC4/2016 Party Name:NIFTY LABS

PVT LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00237/AM17/ RLA File :09/24/040/00660/AM16/ Lic.No/Date:0910063291 17.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/144/2016-PI(Norms) dated July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under

para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

327

Case No.:64/7/82-ALC4/2016 Party Name:NIFTY LABS

PVT LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00238/AM17/ RLA File :09/24/040/00658/AM16/ Lic.No/Date:0910063293 17.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/144/2016-PI(Norms) dated July 2016 , 328

Case No.:65/7/82-ALC4/2016 Party Name:NIFTY LABS

PVT LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00239/AM17/ RLA File :09/24/040/00661/AM16/ Lic.No/Date:0910063292 17.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/144/2016-PI(Norms) dated July 2016 , 329

Case No.:85/7/82-ALC4/2016 Party Name:NIFTY LABS

PVT LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00259/AM17/ RLA File :09/24/040/00659/AM16/ Lic.No/Date:0910063294 17.02.2016 Defer Date:

49 Pharmaceuticals forwarded vide O.M. No.35011/144/2016-PI(Norms) dated July 2016 , 330

Case No.:73/7/82-ALC4/2016 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00247/AM17/ RLA File :09/24/040/00671/AM16/ Lic.No/Date:0910063289 17.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/139/2016-PI(Norms) dated 02.08.2016 , 331

Case No.:56/1/83-

ALC1/2016 Party Name:ORCH LABORATORIES INDIA PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Case Added HQ File :01/83/050/00905/AM16/ RLA File :09/24/040/00692/AM16/ Lic.No/Date:0910063297 19.02.2016 Defer Date: 332

Case No.:87/7/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00261/AM17/ RLA File :09/24/040/00696/AM16/ Lic.No/Date:0910063310 22.02.2016 Defer Date:07.09.2016 333

Case No.:56/7/82-ALC4/2016 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00230/AM17/ RLA File :09/24/040/00677/AM16/ Lic.No/Date:0910063309 22.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/146/2016-PI(Norms) dated 25th July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 334

Case No.:68/7/82-ALC4/2016 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00242/AM17/ RLA File :09/24/040/00683/AM16/ Lic.No/Date:0910063308 22.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/146/2016-PI(Norms) dated July 2016 , 335 Case No.:78/7/82- Party Name:VIVIMED Meet No/Date:9/82- Status:Deferred

50 ALC4/2016 LABS LIMITED ALC4/2016 10.08.2016 HQ File :01/82/050/00252/AM17/ RLA File :09/24/040/00592/AM16/ Lic.No/Date:0910063303 22.02.2016 Defer Date:07.09.2016 336

Case No.:97/7/82-

ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00271/AM17/ RLA File :09/24/040/00694/AM16/ Lic.No/Date:0910063328 26.02.2016 Defer Date:07.09.2016 Pharmaceuticals forwarded vide O.M. No.35011/148/2016-PI(Norms) dated 25th July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 337

Case No.:116/7/82-

ALC4/2016 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00290/AM17/ RLA File :22/24/040/00111/AM16/ Lic.No/Date:2210015421 26.02.2016 Defer Date:07.09.2016 338

Case No.:12/7/82-

ALC4/2016 Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00186/AM17/ RLA File :04/24/040/00250/AM16/ Lic.No/Date:0410161677 01.03.2016 Defer Date:07.09.2016 Decision : Deferred for want of comments from DBT. 339

Case No.:18/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01792/AM16/ RLA File :04/24/040/00248/AM16/ Lic.No/Date:0410161671 01.03.2016 Defer Date:07.09.2016 340

Case No.:20/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01794/AM16/ RLA File :04/24/040/00247/AM16/ Lic.No/Date:0410161672 01.03.2016 Defer Date:07.09.2016 341

Case No.:21/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01795/AM16/ RLA File :04/24/040/00246/AM16/ Lic.No/Date:0410161670 01.03.2016 Defer Date:07.09.2016

51 342

Case No.:67/7/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00241/AM17/ RLA File :09/24/040/00714/AM16/ Lic.No/Date:0910063353 03.03.2016 Defer Date:07.09.2016 Decision : Deferred for want of comments from DBT. 343

Case No.:82/7/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00256/AM17/ RLA File :09/24/040/00721/AM16/ Lic.No/Date:0910063357 03.03.2016 Defer Date:07.09.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/138/2016-PI(Norms) dated 02.08.2016 , uploaded at the end of these minutes and deferred the case. 344

Case No.:119/7/82-

ALC4/2016 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00293/AM17/ RLA File :22/24/040/00121/AM16/ Lic.No/Date:2210015426 04.03.2016 Defer Date:07.09.2016 345

Case No.:118/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00292/AM17/ RLA File :22/24/040/00114/AM16/ Lic.No/Date:2210015440 09.03.2016 Defer Date:07.09.2016 346

Case No.:120/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00294/AM17/ RLA File :22/24/040/00113/AM16/ Lic.No/Date:2210015441 09.03.2016 Defer Date:07.09.2016 347

Case No.:59/7/82-

ALC4/2016 Party Name:RUCHI SOYA INDUSTRIES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00233/AM17/ RLA File :56/24/040/00054/AM16/ Lic.No/Date:5610004864 11.03.2016 Defer Date:07.09.2016 348

Case No.:24/2/82-

ALC4/2016 Party Name:SCOPE CHEMICALS PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00024/AM17/ RLA File :03/95/040/00955/AM16/ Lic.No/Date:0310803229 11.03.2016 Defer Date:27.07.2016 349 Case No.:100/7/82- Party Name:CATAPHARMA Meet No/Date:9/82- Status:Deferred

52 ALC4/2016 CHEMICALS PVT. LTD., ALC4/2016 10.08.2016 HQ File :01/82/050/00274/AM17/ RLA File :31/83/040/00174/AM16/ Lic.No/Date:3110066051 14.03.2016 Defer Date:07.09.2016 350

Case No.:13/1/82-ALC1/2016 Party Name:ONEIRO

CHEMICALS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File :01/82/050/01787/AM16/ RLA File :34/24/040/00286/AM16/ Lic.No/Date:3410041972 14.03.2016 Defer Date: 28.09.2016 351

Case No.:15/1/82-

ALC1/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01789/AM16/ RLA File :09/24/040/00713/AM16/ Lic.No/Date:0910063416 15.03.2016 Defer Date:07.09.2016 Decision : The Committee decided to send copy of application to DoP. 352

Case No.:14/1/82-

ALC1/2016 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01788/AM16/ RLA File :09/24/040/00716/AM16/ Lic.No/Date:0910063414 15.03.2016 Defer Date:07.09.2016 353

Case No.:110/7/82-

ALC4/2016 Party Name:TIDE INDUSTRIES Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00284/AM17/ RLA File :34/24/040/00338/AM16/ Lic.No/Date:3410041981 16.03.2016 Defer Date:07.09.2016 354

Case No.:107/7/82-

ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00281/AM17/ RLA File :34/24/040/00345/AM16/ Lic.No/Date:3410041995 21.03.2016 Defer Date:07.09.2016 355

Case No.:109/7/82-

ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00283/AM17/ RLA File :34/24/040/00336/AM16/ Lic.No/Date:3410041989 21.03.2016 Defer Date:10.07.2016 356

Case No.:111/7/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:3410041992 Defer

53 :01/82/050/00285/AM17/ :34/24/040/00346/AM16/ 21.03.2016 Date:07.09.2016 357

Case No.:122/7/82-

ALC4/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00296/AM17/ RLA File :03/94/040/01019/AM16/ Lic.No/Date:0310803499 22.03.2016 Defer Date:07.09.2016 358

Case No.:48/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00111/AM17/ RLA File :03/94/040/01067/AM16/ Lic.No/Date:0310803525 23.03.2016 Defer Date:07.09.2016 359

Case No.:57/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00231/AM17/ RLA File :22/24/040/00125/AM16/ Lic.No/Date:2210015455 23.03.2016 Defer Date:07.09.2016 360

Case No.:61/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00235/AM17/ RLA File :22/24/040/00127/AM16/ Lic.No/Date:2210015457 23.03.2016 Defer Date:07.09.2016 361

Case No.:62/7/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00236/AM17/ RLA File :22/24/040/00128/AM16/ Lic.No/Date:2210015456 23.03.2016 Defer Date:07.09.2016 362

Case No.:85/1/82-

ALC1/2016 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/01859/AM16/ RLA File :09/24/040/00730/AM16/ Lic.No/Date:0910063440 23.03.2016 Defer Date:07.09.2016 Decision : The Committee decided to send copy of application to DoP. 363

Case No.:108/7/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File :01/82/050/00282/AM17/ RLA File :05/23/040/00518/AM16/ Lic.No/Date:0510398017 23.03.2016 Defer Date: 28.09.2016

54 364

Case No.:3/7/82-ALC4/2016 Party Name:DHANUKA

LABORATORIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00177/AM17/ RLA File :05/23/040/00551/AM16/ Lic.No/Date:0510398033 28.03.2016 Defer Date:07.09.2016 365

Case No.:5/7/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00179/AM17/ RLA File :08/24/040/00466/AM16/ Lic.No/Date:0810137553 30.03.2016 Defer Date:07.09.2016 366

Case No.:95/7/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Approved HQ File :01/82/050/00269/AM17/ RLA File :22/24/040/00132/AM16/ Lic.No/Date:2210015462 30.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/176/2016-PI(Norms) dated 08.08.2016 , 367

Case No.:39/7/82-

ALC4/2016 Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00213/AM17/ RLA File :08/24/040/00426/AM16/ Lic.No/Date:0810137551 30.03.2016 Defer Date:07.09.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/142/2016-PI(Norms) dated 08.08.2016 , uploaded at the end of these minutes and deferred the case. 368

Case No.:58/7/82-

ALC4/2016 Party Name:VENUS REMEDIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00232/AM17/ RLA File :22/24/040/00133/AM16/ Lic.No/Date:2210015463 31.03.2016 Defer Date:07.09.2016 369

Case No.:138/7/82-

ALC4/2016 Party Name:ALTA LABORATORIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00312/AM17/ RLA File :03/94/040/01112/AM16/ Lic.No/Date:0310803707 01.04.2016 Defer Date:07.09.2016 370

Case No.:103/7/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00277/AM17/ RLA File :05/23/040/00555/AM16/ Lic.No/Date:0510398126 01.04.2016 Defer Date:07.09.2016

55 371

Case No.:104/7/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00278/AM17/ RLA File :05/23/040/00556/AM16/ Lic.No/Date:0510398125 01.04.2016 Defer Date:07.09.2016 372

Case No.:121/7/82-

ALC4/2016 Party Name:VARUN MEDIMPEX INC. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00295/AM17/ RLA File :05/24/040/00632/AM16/ Lic.No/Date:0510398119 01.04.2016 Defer Date:07.09.2016 373

Case No.:4/7/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00178/AM17/ RLA File :08/24/040/00001/AM17/ Lic.No/Date:0810137612 05.04.2016 Defer Date:07.09.2016 374

Case No.:6/7/82-ALC4/2016 Party Name:CADILA

PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00180/AM17/ RLA File :08/24/040/00470/AM16/ Lic.No/Date:0810137611 05.04.2016 Defer Date:07.09.2016 375

Case No.:24/7/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00198/AM17/ RLA File :31/83/040/00186/AM16/ Lic.No/Date:3110066111 05.04.2016 Defer Date:07.09.2016 376

Case No.:38/7/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00212/AM17/ RLA File :05/23/040/00571/AM16/ Lic.No/Date:0510398134 05.04.2016 Defer Date:07.09.2016 377

Case No.:105/7/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00279/AM17/ RLA File :05/23/040/00573/AM16/ Lic.No/Date:0510398133 05.04.2016 Defer Date:07.09.2016 378 Case No.:106/7/82- Party Name:JODAS Meet No/Date:9/82- Status:Deferred

56 ALC4/2016 EXPOIM PVT.LTD., ALC4/2016 10.08.2016 HQ File :01/82/050/00280/AM17/ RLA File :05/23/040/00570/AM16/ Lic.No/Date:0510398132 05.04.2016 Defer Date:07.09.2016 379

Case No.:123/7/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00297/AM17/ RLA File :03/94/040/01038/AM16/ Lic.No/Date:0310803819 06.04.2016 Defer Date:07.09.2016 380

Case No.:42/7/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00216/AM17/ RLA File :34/24/040/00325/AM16/ Lic.No/Date:3410042036 07.04.2016 Defer Date:07.09.2016 381

Case No.:43/7/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00217/AM17/ RLA File :34/24/040/00355/AM16/ Lic.No/Date:3410042037 07.04.2016 Defer Date:07.09.2016 382

Case No.:150/7/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00324/AM17/ RLA File :03/94/040/00003/AM17/ Lic.No/Date:0310803875 11.04.2016 Defer Date:07.09.2016 383

Case No.:151/7/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00325/AM17/ RLA File :03/94/040/00002/AM17/ Lic.No/Date:0310803873 11.04.2016 Defer Date:07.09.2016 384

Case No.:52/7/82-

ALC4/2016 Party Name:FINE CURE PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00226/AM17/ RLA File :08/24/040/00460/AM16/ Lic.No/Date:0810137652 11.04.2016 Defer Date:07.09.2016 385

Case No.:45/7/82-

ALC4/2016 Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:3410042064 Defer

57 :01/82/050/00219/AM17/ :34/24/040/00009/AM17/ 13.04.2016 Date:07.09.2016 386

Case No.:50/7/82-

ALC4/2016 Party Name:BODAL CHEMICALS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00224/AM17/ RLA File :08/24/040/00005/AM17/ Lic.No/Date:0810137692 18.04.2016 Defer Date:07.09.2016 387

Case No.:10/7/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00184/AM17/ RLA File :04/24/040/00002/AM17/ Lic.No/Date:0410161814 18.04.2016 Defer Date:07.09.2016 388

Case No.:11/7/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00185/AM17/ RLA File :04/24/040/00003/AM17/ Lic.No/Date:0410161815 18.04.2016 Defer Date:07.09.2016 389

Case No.:13/7/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00187/AM17/ RLA File :04/24/040/00004/AM17/ Lic.No/Date:0410161816 18.04.2016 Defer Date:07.09.2016 390

Case No.:98/7/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00272/AM17/ RLA File :08/24/040/00015/AM17/ Lic.No/Date:0810137712 21.04.2016 Defer Date:07.09.2016 391

Case No.:35/7/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Approved HQ File :01/82/050/00209/AM17/ RLA File :05/24/040/00016/AM17/ Lic.No/Date:0510398257 21.04.2016 Defer Date:07.09.2016 Pharmaceuticals forwarded vide O.M. No.35011/141/2016-PI(Norms) dated 25th July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 392

Case No.:33/7/82-

ALC4/2016 Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

58 HQ File :01/82/050/00207/AM17/ RLA File :05/23/040/00018/AM17/ Lic.No/Date:0510398279 22.04.2016 Defer Date:07.09.2016 393

Case No.:29/7/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00203/AM17/ RLA File :05/24/040/00028/AM17/ Lic.No/Date:0510398295 25.04.2016 Defer Date:07.09.2016 394

Case No.:31/7/82-ALC4/2016 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File :01/82/050/00205/AM17/ RLA File :05/24/040/00030/AM17/ Lic.No/Date:0510398296 25.04.2016 Defer Date: 28.09.2016 395

Case No.:15/7/82-ALC4/2016 Party Name:SUPREET

CHEMICALS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File :01/82/050/00189/AM17/ RLA File :52/24/040/00006/AM17/ Lic.No/Date:5210041869 25.04.2016 Defer Date: 07.09.2016 396

Case No.:99/7/82-ALC4/2016 Party Name:SUPREET

CHEMICALS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00273/AM17/ RLA File :52/24/040/00007/AM17/ Lic.No/Date:5210041868 25.04.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.08/82 dated 11.07.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 397

Case No.:125/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00299/AM17/ RLA File :03/95/040/00061/AM17/ Lic.No/Date:0310804144 25.04.2016 Defer Date:07.09.2016 398

Case No.:126/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00300/AM17/ RLA File :03/95/040/00064/AM17/ Lic.No/Date:0310804154 25.04.2016 Defer Date:07.09.2016 399

Case No.:145/7/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

59 HQ File :01/82/050/00319/AM17/ RLA File :03/94/040/00072/AM17/ Lic.No/Date:0310804202 26.04.2016 Defer Date:07.09.2016 400

Case No.:144/7/82-

ALC4/2016 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00318/AM17/ RLA File :03/94/040/01042/AM16/ Lic.No/Date:0310804172 26.04.2016 Defer Date:07.09.2016 401

Case No.:148/7/82-

ALC4/2016 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00322/AM17/ RLA File :03/94/040/00055/AM17/ Lic.No/Date:0310804211 26.04.2016 Defer Date:07.09.2016 402

Case No.:127/7/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00301/AM17/ RLA File :03/95/040/00048/AM17/ Lic.No/Date:0310804183 26.04.2016 Defer Date:07.09.2016 403

Case No.:128/7/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00302/AM17/ RLA File :03/95/040/00049/AM17/ Lic.No/Date:0310804184 26.04.2016 Defer Date:07.09.2016 404

Case No.:32/7/82-

ALC4/2016 Party Name:HELLO PAINTS (P) LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00206/AM17/ RLA File :05/23/040/00036/AM17/ Lic.No/Date:0510398321 27.04.2016 Defer Date:07.09.2016 405

Case No.:130/7/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00304/AM17/ RLA File :03/95/040/00068/AM17/ Lic.No/Date:0310804238 27.04.2016 Defer Date:07.09.2016 406

Case No.:146/7/82-

ALC4/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

60 HQ File :01/82/050/00320/AM17/ RLA File :03/94/040/00012/AM17/ Lic.No/Date:0310804283 29.04.2016 Defer Date:07.09.2016 407

Case No.:147/7/82-

ALC4/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00321/AM17/ RLA File :03/94/040/00063/AM17/ Lic.No/Date:0310804284 29.04.2016 Defer Date:07.09.2016 408

Case No.:143/7/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00317/AM17/ RLA File :03/94/040/00064/AM17/ Lic.No/Date:0310804295 29.04.2016 Defer Date:07.09.2016 409

Case No.:36/7/82-ALC4/2016 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00210/AM17/ RLA File :22/24/040/00004/AM17/ Lic.No/Date:2210015474 29.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/176/2016-PI(Norms) dated 08.08.2016 , 410

Case No.:142/7/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00316/AM17/ RLA File :03/94/040/01101/AM16/ Lic.No/Date:0310804342 02.05.2016 Defer Date:07.09.2016 411

Case No.:129/7/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00303/AM17/ RLA File :03/95/040/00004/AM17/ Lic.No/Date:0310804339 02.05.2016 Defer Date:07.09.2016 412

Case No.:14/7/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00188/AM17/ RLA File :08/24/040/00035/AM17/ Lic.No/Date:0810137832 03.05.2016 Defer Date:07.09.2016 413

Case No.:75/7/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred

61 HQ File :01/82/050/00249/AM17/ RLA File :02/24/040/00016/AM17/ Lic.No/Date:0210206661 04.05.2016 Defer Date:07.09.2016 414

Case No.:21/7/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00195/AM17/ RLA File :08/24/040/00049/AM17/ Lic.No/Date:0810137835 04.05.2016 Defer Date:07.09.2016 415

Case No.:46/7/82-ALC4/2016 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00220/AM17/ RLA File :05/24/040/00041/AM17/ Lic.No/Date:0510398375 04.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/141/2016-PI(Norms) dated 25th July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 416

Case No.:49/7/82-

ALC4/2016 Party Name:PANACEA BIOTEC LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00223/AM17/ RLA File :05/24/040/00009/AM17/ Lic.No/Date:0510398392 05.05.2016 Defer Date:07.09.2016 Decision : Deferred for want of comments from DBT 417

Case No.:8/7/82-ALC4/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00182/AM17/ RLA File :04/24/040/00009/AM17/ Lic.No/Date:0410161871 05.05.2016 Defer Date:07.09.2016 418

Case No.:9/7/82-ALC4/2016 Party Name:STRIDES

SHASUN LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00183/AM17/ RLA File :04/24/040/00010/AM17/ Lic.No/Date:0410161872 05.05.2016 Defer Date:07.09.2016 419

Case No.:163/7/82-

ALC4/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00337/AM17/ RLA File :03/94/040/00090/AM17/ Lic.No/Date:0310804480 09.05.2016 Defer Date:07.09.2016 420 Case No.:141/7/82- ALC4/2016 INDUSTRIES PRIVATE Meet No/Date:9/82- ALC4/2016 Status:Deferred

62 LIMITED, 10.08.2016 HQ File :01/82/050/00315/AM17/ RLA File :03/94/040/00041/AM17/ Lic.No/Date:0310804465 09.05.2016 Defer Date:07.09.2016 421

Case No.:17/7/82-

ALC4/2016 Party Name:CONTINENTAL CHEMICALS Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00191/AM17/ RLA File :08/24/040/00045/AM17/ Lic.No/Date:0810137878 09.05.2016 Defer Date:07.09.2016 422

Case No.:18/7/82-

ALC4/2016 Party Name:CONTINENTAL CHEMICALS Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00192/AM17/ RLA File :08/24/040/00044/AM17/ Lic.No/Date:0810137877 09.05.2016 Defer Date:07.09.2016 423

Case No.:161/7/82-

ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00335/AM17/ RLA File :03/94/040/00026/AM17/ Lic.No/Date:0310804504 09.05.2016 Defer Date:07.09.2016 424

Case No.:51/7/82-

ALC4/2016 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00225/AM17/ RLA File :05/23/040/00539/AM16/ Lic.No/Date:0510398432 09.05.2016 Defer Date:07.09.2016 425

Case No.:159/7/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00333/AM17/ RLA File :03/94/040/00061/AM17/ Lic.No/Date:0310804534 10.05.2016 Defer Date:07.09.2016 426

Case No.:160/7/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00334/AM17/ RLA File :03/94/040/00036/AM17/ Lic.No/Date:0310804533 10.05.2016 Defer Date:07.09.2016 427

Case No.:76/7/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00250/AM17/ RLA File :05/23/040/00031/AM17/ Lic.No/Date:0510398443 10.05.2016 Defer Date:07.09.2016

63 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/200/2016-PI(Norms) dated 10.08.2016, uploaded at the end of these minutes and deferred the case. 428

Case No.:47/7/82-ALC4/2016 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Deferred HQ File :01/82/050/00221/AM17/ RLA File :05/24/040/00053/AM17/ Lic.No/Date:0510398448 10.05.2016 Defer Date: 28.09.2016 429

Case No.:137/7/82-

ALC4/2016 Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00311/AM17/ RLA File :03/95/040/00763/AM16/ Lic.No/Date:0310804513 10.05.2016 Defer Date:07.09.2016 430

Case No.:157/7/82-

ALC4/2016 Party Name:APEX PHARMA, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00331/AM17/ RLA File :03/94/040/00122/AM17/ Lic.No/Date:0310804628 12.05.2016 Defer Date:07.09.2016 431

Case No.:74/7/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00248/AM17/ RLA File :05/23/040/00050/AM17/ Lic.No/Date:0510398481 12.05.2016 Defer Date:07.09.2016 432

Case No.:158/7/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00332/AM17/ RLA File :03/94/040/01064/AM16/ Lic.No/Date:0310804642 12.05.2016 Defer Date:07.09.2016 433

Case No.:20/7/82-ALC4/2016 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00194/AM17/ RLA File :22/24/040/00011/AM17/ Lic.No/Date:2210015481 13.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/176/2016-PI(Norms) dated 08.08.2016 , 434 Case No.:131/7/82- ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM Meet No/Date:9/82- ALC4/2016 Status:Deferred

64 PVT. LTD., 10.08.2016 HQ File :01/82/050/00305/AM17/ RLA File :03/95/040/00016/AM17/ Lic.No/Date:0310804666 13.05.2016 Defer Date:07.09.2016 435

Case No.:135/7/82-

ALC4/2016 Party Name:UNIMAX CHEMICALS PVT LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:
Approved HQ File :01/82/050/00309/AM17/ RLA File :03/95/040/00093/AM17/ Lic.No/Date:0310804670 13.05.2016 Defer Date Pharmaceuticals forwarded vide O.M. No.35011/143/2016-PI(Norms) dated 25th July 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 436

Case No.:136/7/82-

ALC4/2016 Party Name:ROYAL PHARMA Meet No/Date:9/82- ALC4/2016 10.08.2016 Status: Approved HQ File :01/82/050/00310/AM17/ RLA File :03/95/040/00098/AM17/ Lic.No/Date:0310804724 17.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/140/2016-PI(Norms) dated 02.08.2016 , 437

Case No.:54/7/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00228/AM17/ RLA File :05/23/040/00064/AM17/ Lic.No/Date:0510398544 18.05.2016 Defer Date:07.09.2016 438

Case No.:55/7/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00229/AM17/ RLA File :05/23/040/00063/AM17/ Lic.No/Date:0510398543 18.05.2016 Defer Date:07.09.2016 439

Case No.:53/7/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00227/AM17/ RLA File :08/24/040/00069/AM17/ Lic.No/Date:0810137950 19.05.2016 Defer Date:07.09.2016 440

Case No.:1/5/82-ALC4/2016 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00160/AM17/ RLA File :09/24/040/00083/AM17/ Lic.No/Date:0910063660 20.05.2016 Defer Date:07.09.2016

65 441

Case No.:132/7/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00306/AM17/ RLA File :03/95/040/00118/AM17/ Lic.No/Date:0310804885 20.05.2016 Defer Date:07.09.2016 442

Case No.:156/7/82-

ALC4/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00330/AM17/ RLA File :03/94/040/00147/AM17/ Lic.No/Date:0310804903 23.05.2016 Defer Date:07.09.2016 Decision :Deferred. 443

Case No.:139/7/82-

ALC4/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00313/AM17/ RLA File :03/94/040/00149/AM17/ Lic.No/Date:0310804914 23.05.2016 Defer Date:07.09.2016 Decision :Deferred. 444

Case No.:140/7/82-

ALC4/2016 Party Name:GANGWAL CHEMICALS (P) LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00314/AM17/ RLA File :03/94/040/00148/AM17/ Lic.No/Date:0310804913 23.05.2016 Defer Date:07.09.2016 445

Case No.:153/7/82-

ALC4/2016 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00327/AM17/ RLA File :03/94/040/00115/AM17/ Lic.No/Date:0310804948 24.05.2016 Defer Date:07.09.2016 446

Case No.:152/7/82-

ALC4/2016 INDUSTRIES PRIVATE LIMITED, Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00326/AM17/ RLA File :03/94/040/00152/AM17/ Lic.No/Date:0310804950 24.05.2016 Defer Date:07.09.2016 447

Case No.:134/7/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00308/AM17/ RLA File :03/95/040/00069/AM17/ Lic.No/Date:0310804944 24.05.2016 Defer Date:07.09.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/145/2016-PI(Norms) dated July 2016 , uploaded at the end of these minutes and deferred the case.

66 448

Case No.:3/6/82-ALC4/2016 Party Name:INTAS

PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00165/AM17/ RLA File :08/24/040/00086/AM17/ Lic.No/Date:0810138080 02.06.2016 Defer Date:07.09.2016 449

Case No.:4/6/82-ALC4/2016 Party Name:INTAS

PHARMACEUTICALS LTD. Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00166/AM17/ RLA File :08/24/040/00089/AM17/ Lic.No/Date:0810138086 02.06.2016 Defer Date:07.09.2016 450

Case No.:1/7/82-ALC4/2016 Party Name:NEULAND

LABORATORIES LTD Meet No/Date:9/82- ALC4/2016 10.08.2016 Status:Deferred HQ File :01/82/050/00175/AM17/ RLA File :09/24/040/00139/AM17/ Lic.No/Date:0910063809 21.06.2016 Defer Date:07.09.2016 Decision :Deferred for want of comments from DoP. Manual Agenda of NC Meeting No. 9/82/2017 Scheduled to be held on 10/11.08.2016

Case No. B- 01

M.No.9/AM-17 Date 10.08.2016 M/s. Coral Drugs Pvt Ltd File No. 01/82/050/01445/AM12 RLA No 05/23/040/00457/AM12 Adv.Auth. No. 0510319267 dated 02.03.2012 Decision: The Committee considered this case for correction/amendment in the description of export product “ Fluticasone Propionate” to “Fluticasone Propionate BP/EP/USP”as per agenda. The Committee decided to amend the description of export product to read as to “Fluticasone Propionate BP/EP/USP”. RA concerned may take further necessary action as per decision of NC.

Case No. B- 02

M.No.9/AM-17 Date 10.08.2016 M/s. Alembic Pharmaceuticals Ltd File No. 01/82/050/00579/AM15 RLA No 34/24/040/00320/AM14 Adv.Auth. No. 3410039702 dated 01.04.2014 Decision: The Committee considered this case for revision of norms under Para 4.07 of HBP as per agenda. The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals

67 forwarded vide O.M. No.35011/497/2015-PI(Norms) dated 23.12.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No. B- 03

M.No.9/AM-17 Date 10.08.2016 M/s. Alembic Pharmaceuticals Ltd File No. 01/82/050/00717/AM15 RLA No 34/24/040/00090/AM15 Adv.Auth. No. 3410040353 dated 10.07.2014 Decision: The Committee considered this case for revision of norms under Para 4.07 of HBP as per agenda. The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/497/2015-PI(Norms) dated 23.12.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No. B- 04

M.No.9/AM-17 Date 10.08.2016 M/s. Alembic Pharmaceuticals Ltd File No. 01/82/050/00537/AM16 RLA No 34/24/040/00128/AM15 Adv.Auth. No. 3410040471 dated 21.08.2014 Decision: The Committee considered this case for revision of norms under Para 4.07 of HBP as per agenda. The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/497/2015-PI(Norms) dated 23.12.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No. B- 05

M.No.9/AM-17 Date 10.08.2016 M/s. Ipca Laboratories Ltd File No. 01/82/050/01221/AM12 RLA No 03/94/040/00712/AM12 Adv.Auth. No. 0310665724 dated 17.11.2011 Decision: The Committee considered this case for revision of norms under Para 4.07 of HBP as per agenda. The Committee decided to revise norms based on the earlier decision taken by NC in its meeting No.54/82 dated 31.03.2009 (case No.B-551), uploaded at the end of these minutes under para

Case No. B- 06

M.No.9/AM-17 Date 10.08.2016 M/s. Reliance Industries Ltd File No. 01/82/050/01358/AM15 Adv.Auth. No. 0310792858 dated 13.01.2015 Adv.Auth. No. 0310792860 dated 13.01.2015 Adv.Auth. No. 0310792863 dated 13.01.2015

Decision: The Committee considered this case correction in the norms already ratified as per agenda. The Committee deferred the case.

Case No. B- 07

M.No.9/AM-17 Date 10.08.2016 M/s. Reliance Industries Ltd File No. 01/82/050/01385/AM16 Adv.Auth. No. 0310799215 dated 06.10.2015

68 Decision: The Committee considered this case correction in the norms already ratified as per agenda. The Committee deferred the case.


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