IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2016-06-08

DGFT Committee Minutes

Document text

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. 05/82/2016 of 2016-17, 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 08.06.2016 under the Chairmanship of Dr. S.K. Bansal, Jt. 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. Shri M.V. Singh, FTDO, DGFT The committee went through the minutes of earlier meeting No. 03/82 held 24.05.2016 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 : 5/82-ALC4/2016 MEETING DATE : 08.06.2016 1

Case No.:16/1/82-

ALC1/2016 Party Name:AUCTUS PHARMA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01790/AM16/ RLA File :09/24/040/00564/AM13/ Lic.No/Date:0910055281 05.03.2013 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/16/2016-PI(Norms) dated 07.06.2016 , 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.:52/6/82-

ALC4/2014 Party Name:UPL LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred

HQ File :01/82/050/00454/AM15/ RLA File :03/95/040/01043/AM14/ Lic.No/Date:0310776594 01.04.2014 Defer Date:07.07.2016 Decision :Deferred. 3

Case No.:88/6/82-

ALC4/2014 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00490/AM15/ RLA File :03/95/040/00033/AM15/ Lic.No/Date:0310782129 20.05.2014 Defer Date:07.07.2016 Decision :Deferred. 4

Case No.:61/4/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00309/AM15/ RLA File :03/95/040/00190/AM15/ Lic.No/Date:0310785305 13.06.2014 Defer Date:07.07.2016 Decision :Deferred. 5

Case No.:69/4/82-

ALC4/2014 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00317/AM15/ RLA File :09/24/040/00175/AM15/ Lic.No/Date:0910060550 27.06.2014 Defer Date:07.07.2016 Decision : Deferred for want of comments from DoP. 6

Case No.:73/9/82-

ALC4/2014 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00870/AM15/ RLA File :03/94/040/00755/AM14/ Lic.No/Date:0310786181 30.06.2014 Defer Date:07.07.2016 Decision :Deferred. 7

Case No.:79/9/82-

ALC4/2014 Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00876/AM15/ RLA File :03/95/040/00337/AM15/ Lic.No/Date:0310787073 18.07.2014 Defer Date:07.07.2016 Decision : The Committee decided to defer the case for want of comments of DoP. 8

Case No.:396/5/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00536/AM16/ RLA File :17/24/040/00047/AM15/ Lic.No/Date:1710005887 24.07.2014 Defer Date:07.07.2016 Decision :Deferred. 9

Case No.:63/8/82-

ALC4/2014 Party Name:ADCOCK INGRAM LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred

HQ File :01/82/050/00727/AM15/ RLA File :07/24/040/00148/AM15/ Lic.No/Date:0710106181 25.07.2014 Defer Date:07.07.2016 Decision : The Committee decided to defer the case for want of comments of DoP. 10

Case No.:32/9/82-

ALC4/2014 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00829/AM15/ RLA File :34/24/040/00102/AM15/ Lic.No/Date:3410040406 28.07.2014 Defer Date:07.07.2016 Decision :Deferred. 11

Case No.:8/6/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00410/AM15/ RLA File :03/95/040/00331/AM15/ Lic.No/Date:0310787382 28.07.2014 Defer Date:07.07.2016 Decision :Deferred. 12

Case No.:58/9/82-

ALC4/2014 Party Name:G AMPHRAY LABORATORIES, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00855/AM15/ RLA File :03/94/040/00171/AM15/ Lic.No/Date:0310787536 01.08.2014 Defer Date:07.07.2016 Decision : The Committee decided to defer the case for want of comments of DoP. 13

Case No.:49/9/82-

ALC4/2014 Party Name:SANMAR SPECIALITY CHEMICALS LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00846/AM15/ RLA File :04/24/040/00106/AM15/ Lic.No/Date:0410159125 01.08.2014 Defer Date:07.07.2016 Decision :Deferred. 14

Case No.:31/9/82-

ALC4/2014 Party Name:AMBERNATH ORGANICS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00828/AM15/ RLA File :03/94/040/00074/AM15/ Lic.No/Date:0310787610 04.08.2014 Defer Date:07.07.2016 Decision :Deferred. 15

Case No.:2/14/82-

ALC4/2015 Party Name:SHREE SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01138/AM16/ RLA File :03/95/040/00425/AM15/ Lic.No/Date:0310788055 14.08.2014 Defer Date:07.07.2016 Decision : The Committee decided to defer the case for want of comments of DoP. 16

Case No.:48/5/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred

HQ File :01/82/050/00188/AM16/ RLA File :09/24/040/00260/AM15/ Lic.No/Date:0910060860 18.08.2014 Defer Date:07.07.2016 Decision : It was observed that the quantities of import applied by the applicant appear to be disproportionately high. It is a necessary requirement that correct quantities be declared in the application. Whatever quantity has been applied for in the application, the firm should be in a position to justify. Accordingly, firm is to submit its version on immediate basis. 17

Case No.:215/13/82-

ALC4/2014 Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01218/AM15/ RLA File :03/94/040/00358/AM15/ Lic.No/Date:0310788338 25.08.2014 Defer Date:07.07.2016 Decision :Deferred. 18

Case No.:377/5/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00517/AM16/ RLA File :03/94/040/00493/AM15/ Lic.No/Date:0310788472 27.08.2014 Defer Date:07.07.2016 Decision : The Committee based on the written comments forwarded by D/o Pharmaceuticals vide O.M.No.35011/506/2015-PI(Norms) dated 30.12.2015, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case. 19

Case No.:224/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01227/AM15/ RLA File :03/94/040/00391/AM15/ Lic.No/Date:0310788515 28.08.2014 Defer Date:07.07.2016 Decision :Deferred. 20

Case No.:225/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01228/AM15/ RLA File :03/94/040/00397/AM15/ Lic.No/Date:0310788514 28.08.2014 Defer Date:07.07.2016 Decision :Deferred. 21

Case No.:262/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01265/AM15/ RLA File :03/94/040/00971/AM14/ Lic.No/Date:0310788560 01.09.2014 Defer Date:07.07.2016 Decision : Deferred. 22

Case No.:223/13/82-

ALC4/2014 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01226/AM15/ RLA File :03/94/040/00508/AM15/ Lic.No/Date:0310788647 02.09.2014 Defer Date:07.07.2016

Case No.:3/7/82-

ALC4/2014 Party Name:S V CHEM INTERMEDIATES P LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00647/AM15/ RLA File :04/24/040/00139/AM15/ Lic.No/Date:0410159328 02.09.2014 Defer Date:07.07.2016 24

Case No.:400/5/82-

ALC4/2015 Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00540/AM16/ RLA File :34/24/040/00120/AM15/ Lic.No/Date:3410040554 15.09.2014 Defer Date:07.07.2016 25

Case No.:12/15/82-

ALC4/2014 Party Name:JINDAL DRUGS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01299/AM15/ RLA File :03/94/040/00460/AM15/ Lic.No/Date:0310789265 16.09.2014 Defer Date:07.07.2016 26

Case No.:15/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01018/AM15/ RLA File :34/24/040/00161/AM15/ Lic.No/Date:3410040594 30.09.2014 Defer Date:07.07.2016 27

Case No.:19/1/82-

ALC4/2015 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01545/AM15/ RLA File :03/94/040/00594/AM15/ Lic.No/Date:0310789922 01.10.2014 Defer Date:07.07.2016 28

Case No.:29/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01032/AM15/ RLA File :05/23/040/00268/AM15/ Lic.No/Date:0510391490 08.10.2014 Defer Date:07.07.2016 29

Case No.:124/13/82-

ALC4/2014 Party Name:PANACEA BIOTEC LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01127/AM15/ RLA File :05/24/040/00319/AM15/ Lic.No/Date:0510391623 17.10.2014 Defer Date:07.07.2016 Decision : Information called for in NC meeting No.03/AM17 is awaited. The Committee accordingly deferred the case.

Case No.:198/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00338/AM16/ RLA File :04/24/040/00205/AM15/ Lic.No/Date:0410159704 11.11.2014 Defer Date:07.07.2016 31

Case No.:126/8/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00922/AM16/ RLA File :03/94/040/00710/AM15/ Lic.No/Date:0310791177 18.11.2014 Defer Date:07.07.2016 32

Case No.:43/18/82-

ALC4/2014 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01409/AM15/ RLA File :03/95/040/00701/AM15/ Lic.No/Date:0310791419 26.11.2014 Defer Date:07.07.2016 33

Case No.:362/5/82-

ALC4/2015 Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00502/AM16/ RLA File :05/23/040/00377/AM15/ Lic.No/Date:0510392211 28.11.2014 Defer Date:07.07.2016 34

Case No.:145/5/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00285/AM16/ RLA File :03/94/040/00877/AM15/ Lic.No/Date:0310792112 17.12.2014 Defer Date:07.07.2016 35

Case No.:127/5/82-

ALC4/2015 Party Name:EMAMI LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00267/AM16/ RLA File :02/24/040/00183/AM15/ Lic.No/Date:0210205355 18.12.2014 Defer Date:07.07.2016 36

Case No.:136/5/82-

ALC4/2015 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00276/AM16/ RLA File :03/94/040/00843/AM15/ Lic.No/Date:0310792314 23.12.2014 Defer Date:07.07.2016 37 Case No.:221/5/82- Party Name:VIVIMED Meet No/Date:5/82- Status:Case

ALC4/2015 LABS LIMITED ALC4/2016 08.06.2016 Deferred HQ File :01/82/050/00361/AM16/ RLA File :09/24/040/00537/AM15/ Lic.No/Date:0910061442 23.12.2014 Defer Date:07.07.2016 38

Case No.:114/5/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00254/AM16/ RLA File :03/95/040/00756/AM15/ Lic.No/Date:0310792363 24.12.2014 Defer Date:07.07.2016 39

Case No.:218/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00358/AM16/ RLA File :09/24/040/00552/AM15/ Lic.No/Date:0910061462 29.12.2014 Defer Date:07.07.2016 40

Case No.:99/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01465/AM15/ RLA File :07/24/040/00302/AM15/ Lic.No/Date:0710107307 30.12.2014 Defer Date:07.07.2016 41

Case No.:111/18/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01477/AM15/ RLA File :07/24/040/00307/AM15/ Lic.No/Date:0710107306 30.12.2014 Defer Date:07.07.2016 42

Case No.:28/7/82-

ALC4/2015 Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00633/AM16/ RLA File :05/24/040/00428/AM15/ Lic.No/Date:0510392678 05.01.2015 Defer Date:07.07.2016 43

Case No.:45/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00185/AM16/ RLA File :09/24/040/00558/AM15/ Lic.No/Date:0910061483 05.01.2015 Defer Date:07.07.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/1/2016-PI(Norms) dated 01.06.2016, uploaded at the end of these minutes

Case No.:102/5/82-

ALC4/2015 Party Name:ALTA LABORATORIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00242/AM16/ RLA File :03/94/040/00836/AM15/ Lic.No/Date:0310792635 07.01.2015 Defer Date:07.07.2016 Decision :Deferred for want of comments of DoP. 45

Case No.:74/5/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00214/AM16/ RLA File :03/95/040/00833/AM15/ Lic.No/Date:0310792647 07.01.2015 Defer Date:07.07.2016 Decision :Deferred. 46

Case No.:149/5/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00289/AM16/ RLA File :03/94/040/00813/AM15/ Lic.No/Date:0310792673 08.01.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments of DoP. 47

Case No.:121/5/82-

ALC4/2015 Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00261/AM16/ RLA File :03/95/040/00835/AM15/ Lic.No/Date:0310792685 08.01.2015 Defer Date:07.07.2016 48

Case No.:219/5/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00359/AM16/ RLA File :09/24/040/00549/AM15/ Lic.No/Date:0910061517 09.01.2015 Defer Date:07.07.2016 49

Case No.:239/5/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00379/AM16/ RLA File :09/24/040/00555/AM15/ Lic.No/Date:0910061520 09.01.2015 Defer Date:07.07.2016 50

Case No.:141/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00281/AM16/ RLA File :03/94/040/00746/AM15/ Lic.No/Date:0310792870 13.01.2015 Defer Date:07.07.2016

Case No.:119/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00259/AM16/ RLA File :03/95/040/00843/AM15/ Lic.No/Date:0310792869 13.01.2015 Defer Date:07.07.2016 52

Case No.:243/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00383/AM16/ RLA File :09/24/040/00589/AM15/ Lic.No/Date:0910061530 14.01.2015 Defer Date:07.07.2016 Decision :Information called for from the firm is awaited. 53

Case No.:88/5/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00228/AM16/ RLA File :05/23/040/00486/AM15/ Lic.No/Date:0510392949 21.01.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments D/o AYUSH. 54

Case No.:138/8/82-

ALC4/2015 Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00934/AM16/ RLA File :03/94/040/01099/AM14/ Lic.No/Date:0310793426 30.01.2015 Defer Date:07.07.2016 55

Case No.:275/5/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00415/AM16/ RLA File :03/94/040/00930/AM15/ Lic.No/Date:0310793539 03.02.2015 Defer Date:07.07.2016 Decision :Deferred. 56

Case No.:284/5/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/00424/AM16/ RLA File :03/94/040/01053/AM15/ Lic.No/Date:0310793620 05.02.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/383/2015-PI(Norms) dated 17.03.2016, 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. 57

Case No.:279/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00419/AM16/ RLA File :03/94/040/01088/AM15/ Lic.No/Date:0310793983 19.02.2015 Defer Date:07.07.2016

Decision :Deferred. 58

Case No.:288/5/82-

ALC4/2015 Party Name:CROWN CHEMICALS PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00428/AM16/ RLA File :03/94/040/01089/AM15/ Lic.No/Date:0310793982 19.02.2015 Defer Date:07.07.2016 Decision :Deferred. 59

Case No.:335/5/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00475/AM16/ RLA File :03/95/040/00978/AM15/ Lic.No/Date:0310794038 20.02.2015 Defer Date:07.07.2016 Decision :deferred. 60

Case No.:309/5/82-

ALC4/2015 Party Name:SHREE VALLABH CHEMICAL Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00449/AM16/ RLA File :08/24/040/00417/AM15/ Lic.No/Date:0810134670 25.02.2015 Defer Date:07.07.2016 Decision :Deferred. 61

Case No.:1/1/82-

ALC4/2015 Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00001/AM16/ RLA File :05/24/040/00563/AM15/ Lic.No/Date:0510393385 26.02.2015 Defer Date:07.07.2016 Decision :Deferred. 62

Case No.:273/5/82-

ALC4/2015 Party Name:BHARAT SERUMS & VACCINES LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00413/AM16/ RLA File :03/94/040/01055/AM15/ Lic.No/Date:0310794262 27.02.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments of DBT. 63

Case No.:452/5/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00592/AM16/ RLA File :03/94/040/01091/AM15/ Lic.No/Date:0310794261 27.02.2015 Defer Date:07.07.2016 Decision :Deferred. 64

Case No.:295/5/82-

ALC4/2015 Party Name:PROLIFE INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00435/AM16/ RLA File :08/24/040/00395/AM15/ Lic.No/Date:0810134703 03.03.2015 Defer Date:07.07.2016

Decision :Deferred. 65

Case No.:303/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00443/AM16/ RLA File :08/24/040/00422/AM15/ Lic.No/Date:0810134739 05.03.2015 Defer Date:07.07.2016 Decision :Deferred. 66

Case No.:300/5/82-

ALC4/2015 Party Name:ADVANCE PETROCHEMICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00440/AM16/ RLA File :08/24/040/00448/AM15/ Lic.No/Date:0810134768 11.03.2015 Defer Date:07.07.2016 Decision :Deferred. 67

Case No.:447/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00587/AM16/ RLA File :03/94/040/01131/AM15/ Lic.No/Date:0310794543 12.03.2015 Defer Date:07.07.2016 68

Case No.:45/4/82-

ALC4/2015 Party Name:TIDE INDUSTRIES Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00084/AM16/ RLA File :34/24/040/00325/AM15/ Lic.No/Date:3410041050 16.03.2015 Defer Date:07.07.2016 Decision :Deferred. 69

Case No.:291/5/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00431/AM16/ RLA File :05/23/040/00544/AM15/ Lic.No/Date:0510393616 18.03.2015 Defer Date:07.07.2016 70

Case No.:183/5/82-

ALC4/2015 Party Name:SPAK ORGOCHEM (INDIA) PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00323/AM16/ RLA File :03/95/040/00964/AM15/ Lic.No/Date:0310794811 23.03.2015 Defer Date:07.07.2016 Decision :deferred. 71

Case No.:29/5/82-

ALC4/2015 Party Name:ASSOCIATED DYESTUFF PVT. LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00169/AM16/ RLA File :08/24/040/00483/AM15/ Lic.No/Date:0810134917 25.03.2015 Defer Date:07.07.2016

Case No.:16/5/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00156/AM16/ RLA File :09/24/040/00736/AM15/ Lic.No/Date:0910061856 31.03.2015 Defer Date:07.07.2016 73

Case No.:26/5/82-

ALC4/2015 Party Name:CONTINENTAL CHEMICALS Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00166/AM16/ RLA File :08/24/040/00470/AM15/ Lic.No/Date:0810134992 07.04.2015 Defer Date:07.07.2016 74

Case No.:411/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00551/AM16/ RLA File :03/95/040/01033/AM15/ Lic.No/Date:0310795186 08.04.2015 Defer Date:07.07.2016 75

Case No.:5/5/82-

ALC4/2015 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00145/AM16/ RLA File :08/24/040/00003/AM16/ Lic.No/Date:0810135051 17.04.2015 Defer Date:07.07.2016 76

Case No.:35/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00175/AM16/ RLA File :09/24/040/00739/AM15/ Lic.No/Date:0910061891 17.04.2015 Defer Date:07.07.2016 77

Case No.:132/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00737/AM16/ RLA File :03/94/040/00024/AM16/ Lic.No/Date:0310795429 20.04.2015 Defer Date:07.07.2016 78

Case No.:153/7/82-

ALC4/2015 Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00758/AM16/ RLA File :03/94/040/00039/AM16/ Lic.No/Date:0310795534 24.04.2015 Defer Date:07.07.2016

Case No.:29/7/82-

ALC4/2015 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00634/AM16/ RLA File :04/24/040/00003/AM16/ Lic.No/Date:0410160438 24.04.2015 Defer Date:07.07.2016 80

Case No.:40/8/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00836/AM16/ RLA File :09/24/040/00042/AM16/ Lic.No/Date:0910061937 27.04.2015 Defer Date:07.07.2016 81

Case No.:174/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00314/AM16/ RLA File :07/24/040/00393/AM15/ Lic.No/Date:0710108142 01.05.2015 Defer Date:07.07.2016 82

Case No.:176/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00316/AM16/ RLA File :07/24/040/00389/AM15/ Lic.No/Date:0710108141 01.05.2015 Defer Date:07.07.2016 83

Case No.:177/5/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00317/AM16/ RLA File :07/24/040/00390/AM15/ Lic.No/Date:0710108143 01.05.2015 Defer Date:07.07.2016 84

Case No.:111/7/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/00716/AM16/ RLA File :03/95/040/00058/AM16/ Lic.No/Date:0310795699 05.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/766/2015-PI(Norms) dated 26.04.2016, 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. 85

Case No.:77/8/82-

ALC4/2015 Party Name:GRANULES INDIA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/00873/AM16/ RLA File :09/24/040/00022/AM16/ Lic.No/Date:0910061978 06.05.2015 Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/648/2015-PI(Norms) dated 21.01.2016 , 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. 86

Case No.:75/8/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00871/AM16/ RLA File :09/24/040/00051/AM16/ Lic.No/Date:0910061986 06.05.2015 Defer Date:07.07.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.2 dated 26.4.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 87

Case No.:65/8/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00861/AM16/ RLA File :09/24/040/00052/AM16/ Lic.No/Date:0910061973 06.05.2015 Defer Date:07.07.2016 Decision : Information called for from the firm in NC meeting No.03/AM17 is awaited. The Committee decided to await the reply and deferred the case. 88

Case No.:7/5/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00147/AM16/ RLA File :05/23/040/00037/AM16/ Lic.No/Date:0510394177 08.05.2015 Defer Date:07.07.2016 89

Case No.:38/8/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00834/AM16/ RLA File :09/24/040/00060/AM16/ Lic.No/Date:0910061998 08.05.2015 Defer Date:07.07.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.14 dated 16.12.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case. 90

Case No.:200/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00340/AM16/ RLA File :04/24/040/00038/AM16/ Lic.No/Date:0410160569 21.05.2015 Defer Date:07.07.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.12 dated 18.11.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case. 91

Case No.:97/8/82-

ALC4/2015 Party Name:ASCENT FINECHEM PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0810135338 Defer

:01/82/050/00893/AM16/ :08/24/040/00051/AM16/ 22.05.2015 Date:07.07.2016 Decision :Deferred for want of comments from DoP. 92

Case No.:45/8/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00841/AM16/ RLA File :05/24/040/00073/AM16/ Lic.No/Date:0510394342 25.05.2015 Defer Date:07.07.2016 Decision :Information has been called for from the firm in NC meeting No.02/AM17 is awaited. 93

Case No.:86/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00882/AM16/ RLA File :09/24/040/00131/AM16/ Lic.No/Date:0910062091 29.05.2015 Defer Date:07.07.2016 Decision :Deferred. 94

Case No.:187/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00792/AM16/ RLA File :08/24/040/00057/AM16/ Lic.No/Date:0810135435 05.06.2015 Defer Date:07.07.2016 Decision :Deferred. 95

Case No.:121/8/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00917/AM16/ RLA File :03/95/040/00190/AM16/ Lic.No/Date:0310796766 23.06.2015 Defer Date:07.07.2016 Decision :Deferred. 96

Case No.:89/7/82-

ALC4/2015 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00694/AM16/ RLA File :02/24/040/00045/AM16/ Lic.No/Date:0210205925 26.06.2015 Defer Date:07.07.2016 97

Case No.:5/6/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00601/AM16/ RLA File :34/24/040/00091/AM16/ Lic.No/Date:3410041336 01.07.2015 Defer Date:07.07.2016 98

Case No.:97/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0910062271 Defer

:01/82/050/01233/AM16/ :09/24/040/00186/AM16/ 01.07.2015 Date:07.07.2016 99

Case No.:109/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01245/AM16/ RLA File :09/24/040/00195/AM16/ Lic.No/Date:0910062283 02.07.2015 Defer Date:07.07.2016 100

Case No.:7/18/82-

ALC4/2015 Party Name:SHODHANA LABORATORIES LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01472/AM16/ RLA File :09/24/040/00198/AM16/ Lic.No/Date:0910062275 02.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/833/2015-PI(Norms) dated 18.05.2016 , 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. 101

Case No.:54/8/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/00850/AM16/ RLA File :05/23/040/00150/AM16/ Lic.No/Date:0510394862 09.07.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/662/2015-PI(Norms) dated 18.05.2016 , 102

Case No.:50/8/82-

ALC4/2015 Party Name:PUSILIN BIOTECHNOLOGY PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00846/AM16/ RLA File :06/24/040/00014/AM16/ Lic.No/Date:0610038189 09.07.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments fromf DBT. 103

Case No.:54/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01190/AM16/ RLA File :09/24/040/00524/AM15/ Lic.No/Date:0910062332 15.07.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments of DBT. 104

Case No.:59/14/82-

ALC4/2015 Party Name:BIOLOGICAL E LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01195/AM16/ RLA File :09/24/040/00525/AM15/ Lic.No/Date:0910062331 15.07.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments of DBT.

105

Case No.:41/14/82-

ALC4/2015 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01177/AM16/ RLA File :34/24/040/00031/AM16/ Lic.No/Date:3410041376 15.07.2015 Defer Date:07.07.2016 Decision : Deferred 106

Case No.:49/8/82-

ALC4/2015 Party Name:M.L.A. INDUSTRIES Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00845/AM16/ RLA File :06/24/040/00015/AM16/ Lic.No/Date:0610038193 16.07.2015 Defer Date:07.07.2016 107

Case No.:120/8/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00916/AM16/ RLA File :03/95/040/00304/AM16/ Lic.No/Date:0310797293 16.07.2015 Defer Date:07.07.2016 108

Case No.:49/14/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01185/AM16/ RLA File :09/24/040/00205/AM16/ Lic.No/Date:0910062344 17.07.2015 Defer Date:07.07.2016 109

Case No.:39/14/82-

ALC4/2015 Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01175/AM16/ RLA File :05/23/040/00165/AM16/ Lic.No/Date:0510395004 20.07.2015 Defer Date:07.07.2016 Decision : The committee decided to call for COA from import item No.2 and deferred the case. 110

Case No.:21/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01341/AM16/ RLA File :09/24/040/00223/AM16/ Lic.No/Date:0910062361 22.07.2015 Defer Date:07.07.2016 vide letter O.M.No.35011/821/2015-PI(Norms) dated 12.05.2016 dated 27.01.2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case. 111

Case No.:22/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01342/AM16/ RLA File :09/24/040/00224/AM16/ Lic.No/Date:0910062360 22.07.2015 Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/821/2015-PI(Norms) dated 23.05.2016 , 112

Case No.:149/14/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01285/AM16/ RLA File :09/24/040/00230/AM16/ Lic.No/Date:0910062365 23.07.2015 Defer Date:07.07.2016 Decision : The Committee decided call for information as per Appendix 33 and past production consumption data vis-a-vis actual consumption of imported inputs duly certified by Central Excise Authorities. It was also observed that the quantities of import mentioned by the applicant appear to be disproportionately high. Accordingly, firm is to submit its version on immediate basis. 113

Case No.:79/8/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00875/AM16/ RLA File :05/24/040/00110/AM16/ Lic.No/Date:0510395084 24.07.2015 Defer Date:07.07.2016 114

Case No.:1/10/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00957/AM16/ RLA File :09/24/040/00211/AM16/ Lic.No/Date:0910062393 28.07.2015 Defer Date:07.07.2016 Decision :Deferred. 115

Case No.:170/14/82-

ALC4/2015 Party Name:PI INDUSTRIES LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01306/AM16/ RLA File :13/24/040/00015/AM16/ Lic.No/Date:1310047932 29.07.2015 Defer Date:07.07.2016 Decision :Deferred. 116

Case No.:131/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01267/AM16/ RLA File :09/24/040/00212/AM16/ Lic.No/Date:0910062413 30.07.2015 Defer Date:07.07.2016 Decision :Deferred. 117

Case No.:60/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01196/AM16/ RLA File :09/24/040/00256/AM16/ Lic.No/Date:0910062418 31.07.2015 Defer Date:07.07.2016

118

Case No.:84/1/82-

ALC1/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01858/AM16/ RLA File :08/91/040/00210/AM16/ Lic.No/Date:0810135770 03.08.2015 Defer Date:07.07.2016 119

Case No.:169/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01305/AM16/ RLA File :31/83/040/00018/AM16/ Lic.No/Date:3110065573 03.08.2015 Defer Date:07.07.2016 120

Case No.:17/8/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00813/AM16/ RLA File :09/24/040/00251/AM16/ Lic.No/Date:0910062426 03.08.2015 Defer Date:07.07.2016 121

Case No.:168/14/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01304/AM16/ RLA File :31/83/040/00024/AM16/ Lic.No/Date:3110065579 04.08.2015 Defer Date:07.07.2016 122

Case No.:166/13/82-

ALC4/2015 Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01129/AM16/ RLA File :05/24/040/00235/AM16/ Lic.No/Date:0510395245 07.08.2015 Defer Date:07.07.2016 123

Case No.:14/14/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01150/AM16/ RLA File :03/95/040/00356/AM16/ Lic.No/Date:0310798008 07.08.2015 Defer Date: Decision : Already approved in NC 03/AN17 124

Case No.:18/14/82-

ALC4/2015 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310798039 Defer

:01/82/050/01154/AM16/ :03/95/040/00317/AM16/ 10.08.2015 Date:07.07.2016 125

Case No.:115/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01435/AM16/ RLA File :03/95/040/00164/AM16/ Lic.No/Date:0310798051 10.08.2015 Defer Date:07.07.2016 126

Case No.:23/8/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00819/AM16/ RLA File :09/24/040/00091/AM16/ Lic.No/Date:0910062478 11.08.2015 Defer Date:07.07.2016 Decision :Information called from the firm in NC Meeting No.03/AM17 is awaited. The Committee accordingly deferred the case. 127

Case No.:155/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01291/AM16/ RLA File :05/24/040/00237/AM16/ Lic.No/Date:0510395271 11.08.2015 Defer Date:07.07.2016 128

Case No.:11/18/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01476/AM16/ RLA File :03/95/040/00327/AM16/ Lic.No/Date:0310798117 13.08.2015 Defer Date:07.07.2016 Decision :Deferred. 129

Case No.:34/14/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01170/AM16/ RLA File :34/24/040/00144/AM16/ Lic.No/Date:3410041464 17.08.2015 Defer Date:07.07.2016 130

Case No.:99/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01235/AM16/ RLA File :09/24/040/00231/AM16/ Lic.No/Date:0910062516 18.08.2015 Defer Date:07.07.2016 131

Case No.:56/13/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0510395354 Defer

:01/82/050/01019/AM16/ :05/24/040/00183/AM16/ 18.08.2015 Date:07.07.2016 Decision :Information called for from the firm in NC meeting No.03/AM17 is awaited. The committee accordingly deferred the case. 132

Case No.:154/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01290/AM16/ RLA File :05/24/040/00381/AM15/ Lic.No/Date:0510395357 19.08.2015 Defer Date:07.07.2016 133

Case No.:68/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01204/AM16/ RLA File :09/24/040/00368/AM15/ Lic.No/Date:0910062518 19.08.2015 Defer Date:07.07.2016 Decision :Deferred. 134

Case No.:30/14/82-

ALC4/2015 Party Name:BHARAT PARENTERALS LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01166/AM16/ RLA File :34/24/040/00143/AM16/ Lic.No/Date:3410041467 20.08.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments from DBT. 135

Case No.:3/14/82-

ALC4/2015 Party Name:SHIRDI CHEMICALS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01139/AM16/ RLA File :03/95/040/00401/AM16/ Lic.No/Date:0310798433 25.08.2015 Defer Date:07.07.2016 136

Case No.:54/13/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01017/AM16/ RLA File :03/94/040/00089/AM16/ Lic.No/Date:0310798493 26.08.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/824/2015-PI(Norms) dated 23.05.2016 , 137

Case No.:24/14/82-

ALC4/2015 Party Name:SHUBHAM SPECIALTY PRODUCTS Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01160/AM16/ RLA File :03/95/040/00348/AM16/ Lic.No/Date:0310798516 27.08.2015 Defer Date:07.07.2016

138

Case No.:35/14/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01171/AM16/ RLA File :22/24/040/00032/AM16/ Lic.No/Date:2210015295 27.08.2015 Defer Date:07.07.2016 139

Case No.:82/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01218/AM16/ RLA File :05/24/040/00233/AM16/ Lic.No/Date:0510395480 31.08.2015 Defer Date:07.07.2016 Decision : Deferred . 140

Case No.:89/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01225/AM16/ RLA File :05/24/040/00224/AM16/ Lic.No/Date:0510395479 31.08.2015 Defer Date:07.07.2016 141

Case No.:94/14/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01230/AM16/ RLA File :05/24/040/00202/AM16/ Lic.No/Date:0510395481 31.08.2015 Defer Date:07.07.2016 142

Case No.:116/16/82-

ALC4/2015 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01436/AM16/ RLA File :05/24/040/00181/AM16/ Lic.No/Date:0510395496 01.09.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments from DBT. 143

Case No.:93/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01229/AM16/ RLA File :05/24/040/00244/AM16/ Lic.No/Date:0510395493 01.09.2015 Defer Date:07.07.2016
Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/747/2015-PI(Norms) dated April 2016, uploaded at the end of these minutes and deferred the case. 144

Case No.:5/18/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01470/AM16/ RLA File :52/24/040/00039/AM16/ Lic.No/Date:5210041625 04.09.2015 Defer Date:07.07.2016

145

Case No.:141/14/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01277/AM16/ RLA File :17/24/040/00050/AM16/ Lic.No/Date:1710006170 04.09.2015 Defer Date:07.07.2016 146

Case No.:52/14/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01188/AM16/ RLA File :09/24/040/00323/AM16/ Lic.No/Date:0910062554 04.09.2015 Defer Date:07.07.2016 147

Case No.:10/20/82-

ALC4/2015 Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01593/AM16/ RLA File :08/24/040/00153/AM16/ Lic.No/Date:0810135975 04.09.2015 Defer Date:07.07.2016 148

Case No.:119/16/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01439/AM16/ RLA File :03/94/040/00402/AM16/ Lic.No/Date:0310798725 08.09.2015 Defer Date:07.07.2016 149

Case No.:56/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01192/AM16/ RLA File :09/24/040/00134/AM16/ Lic.No/Date:0910062560 08.09.2015 Defer Date:07.07.2016 150

Case No.:124/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01444/AM16/ RLA File :03/94/040/00399/AM16/ Lic.No/Date:0310798771 09.09.2015 Defer Date:07.07.2016 151

Case No.:46/14/82-

ALC4/2015 Party Name:MALWA OXYGEN & INDUSTRIAL GASES PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01182/AM16/ RLA File :56/24/040/00005/AM16/ Lic.No/Date:5610004674 09.09.2015 Defer Date:07.07.2016

152

Case No.:53/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01189/AM16/ RLA File :09/24/040/00315/AM16/ Lic.No/Date:0910062581 09.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/749/2015-(PI-Norms) dated 03.05.2016 , 153

Case No.:157/14/82-

ALC4/2015 Party Name:AETHER INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01293/AM16/ RLA File :52/24/040/00042/AM16/ Lic.No/Date:5210041630 10.09.2015 Defer Date:07.07.2016 154

Case No.:78/14/82-

ALC4/2015 Party Name:AMI LIFESCIENCES P LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01214/AM16/ RLA File :34/24/040/00148/AM16/ Lic.No/Date:3410041505 11.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/825/2015(PI-Norms) dated 23.05.2016 , 155

Case No.:4/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01324/AM16/ RLA File :09/24/040/00297/AM16/ Lic.No/Date:0910062594 11.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/820/2015(PI-Norms) dated 12.05.2016 , 156

Case No.:9/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01329/AM16/ RLA File :09/24/040/00328/AM16/ Lic.No/Date:0910062593 11.09.2015 Defer Date:07.07.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/820/2015 (PI-Norms) dated 12.05.2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case. 157

Case No.:56/16/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310798876 Defer

:01/82/050/01376/AM16/ :03/94/040/00435/AM16/ 14.09.2015 Date:07.07.2016 158

Case No.:59/16/82-

ALC4/2015 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01379/AM16/ RLA File :03/94/040/00474/AM16/ Lic.No/Date:0310798877 14.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/775/2015-PI(Norms) 02.05.2016 , 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. 159

Case No.:8/14/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01144/AM16/ RLA File :03/95/040/00343/AM16/ Lic.No/Date:0310798846 14.09.2015 Defer Date:07.07.2016 160

Case No.:110/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01246/AM16/ RLA File :09/24/040/00305/AM16/ Lic.No/Date:0910062601 14.09.2015 Defer Date:07.07.2016 161

Case No.:134/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01270/AM16/ RLA File :09/24/040/00273/AM16/ Lic.No/Date:0910062602 14.09.2015 Defer Date:07.07.2016 162

Case No.:7/14/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01143/AM16/ RLA File :03/95/040/00426/AM16/ Lic.No/Date:0310798872 14.09.2015 Defer Date:07.07.2016 163

Case No.:74/14/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01210/AM16/ RLA File :34/24/040/00120/AM16/ Lic.No/Date:3410041510 15.09.2015 Defer Date:07.07.2016

164

Case No.:15/14/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01151/AM16/ RLA File :03/95/040/00360/AM16/ Lic.No/Date:0310798909 15.09.2015 Defer Date:07.07.2016 165

Case No.:9/14/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01145/AM16/ RLA File :03/95/040/00434/AM16/ Lic.No/Date:0310798944 16.09.2015 Defer Date:07.07.2016 166

Case No.:98/14/82-

ALC4/2015 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01234/AM16/ RLA File :09/24/040/00333/AM16/ Lic.No/Date:0910062625 16.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/826/2015-(PI-Norms) dated 23.05.2016 , 167

Case No.:124/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01260/AM16/ RLA File :09/24/040/00355/AM16/ Lic.No/Date:0910062622 16.09.2015 Defer Date:07.07.2016 168

Case No.:35/16/82-

ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01355/AM16/ RLA File :03/94/040/00415/AM16/ Lic.No/Date:0310798977 21.09.2015 Defer Date:07.07.2016 Decision : Deferred . 169

Case No.:34/16/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01354/AM16/ RLA File :03/94/040/00472/AM16/ Lic.No/Date:0310798979 21.09.2015 Defer Date:07.07.2016 170

Case No.:71/14/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01207/AM16/ RLA File :09/24/040/00376/AM16/ Lic.No/Date:0910062633 21.09.2015 Defer Date:

Pharmaceuticals forwarded vide O.M. No. 35011/752/2015-PI(Norms) dated 03.05.2016, 171

Case No.:64/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01769/AM16/ RLA File :08/24/040/00137/AM16/ Lic.No/Date:0810136085 22.09.2015 Defer Date:07.07.2016 172

Case No.:64/14/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01200/AM16/ RLA File :09/24/040/00375/AM16/ Lic.No/Date:0910062644 22.09.2015 Defer Date:07.07.2016 173

Case No.:117/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01253/AM16/ RLA File :04/24/040/00140/AM16/ Lic.No/Date:0410161044 22.09.2015 Defer Date:07.07.2016 174

Case No.:118/14/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01254/AM16/ RLA File :04/24/040/00139/AM16/ Lic.No/Date:0410161045 22.09.2015 Defer Date:07.07.2016 175

Case No.:103/14/82-

ALC4/2015 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred
HQ File :01/82/050/01239/AM16/ RLA File :09/24/040/00362/AM16/ Lic.No/Date:0910062635 22.09.2015 Defer Date: 07.07.2016 Decision :Information called for from the firm in NC meeting No.03/AM17 is awaited. The Committee accordingly deferred the case. 176

Case No.:25/20/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01608/AM16/ RLA File :13/24/040/00027/AM16/ Lic.No/Date:1310047981 23.09.2015 Defer Date:07.07.2016 177

Case No.:106/14/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred

HQ File :01/82/050/01242/AM16/ RLA File :09/24/040/00373/AM16/ Lic.No/Date:0910062649 23.09.2015 Defer Date:07.07.2016 178

Case No.:91/14/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01227/AM16/ RLA File :22/21/040/00029/AM16/ Lic.No/Date:2210015316 24.09.2015 Defer Date:07.07.2016 179

Case No.:5/20/82-

ALC4/2015 Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01588/AM16/ RLA File :03/94/040/00471/AM16/ Lic.No/Date:0310799047 24.09.2015 Defer Date:07.07.2016 180

Case No.:86/14/82-

ALC4/2015 Party Name:BELLAPREMIER HAPPY HYGIENECARE PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01222/AM16/ RLA File :35/24/040/00005/AM16/ Lic.No/Date:3510044794 25.09.2015 Defer Date:07.07.2016 181

Case No.:65/14/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01201/AM16/ RLA File :09/24/040/00291/AM16/ Lic.No/Date:0910062665 28.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/758/2015-PI(Norms) dated 29.04.2016 , 182

Case No.:8/16/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01328/AM16/ RLA File :09/24/040/00294/AM16/ Lic.No/Date:0910062666 28.09.2015 Defer Date:07.07.2016 183

Case No.:68/16/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01388/AM16/ RLA File :03/95/040/00454/AM16/ Lic.No/Date:0310799077 28.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/766/2015-PI(Norms) dated 26.04.2016,

184

Case No.:79/14/82-

ALC4/2015 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01215/AM16/ RLA File :05/23/040/00274/AM16/ Lic.No/Date:0510395773 30.09.2015 Defer Date:07.07.2016 Decision : Deferred for want of comments from AYUSH. 185

Case No.:6/10/82-

ALC4/2015 Party Name:ARCHIMEDIS LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/00962/AM16/ RLA File :09/24/040/00321/AM16/ Lic.No/Date:0910062670 30.09.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/762/2015-PI(Norms) dated 05.05.2016 , 186

Case No.:69/16/82-

ALC4/2015 Party Name:PIDILITE INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01389/AM16/ RLA File :03/95/040/00350/AM15/ Lic.No/Date:0310799113 30.09.2015 Defer Date:07.07.2016 187

Case No.:33/16/82-

ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01353/AM16/ RLA File :03/94/040/00483/AM16/ Lic.No/Date:0310799128 01.10.2015 Defer Date:07.07.2016 188

Case No.:55/16/82-

ALC4/2015 Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01375/AM16/ RLA File :03/94/040/00525/AM16/ Lic.No/Date:0310799188 05.10.2015 Defer Date:07.07.2016 189

Case No.:43/16/82-

ALC4/2015 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01363/AM16/ RLA File :03/94/040/00423/AM16/ Lic.No/Date:0310799184 05.10.2015 Defer Date:07.07.2016 190 Case No.:10/16/82- ALC4/2015 Party Name:SALICYLATES & Meet No/Date:5/82- ALC4/2016 Status:Case Approved

CHEMICALS PRIVATE LIMITED 08.06.2016 HQ File :01/82/050/01330/AM16/ RLA File :09/24/040/00266/AM16/ Lic.No/Date:0910062673 05.10.2015 Defer Date: Decision :Deferred. 191

Case No.:67/16/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01387/AM16/ RLA File :03/95/040/00485/AM16/ Lic.No/Date:0310799241 06.10.2015 Defer Date:07.07.2016 192

Case No.:25/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01345/AM16/ RLA File :09/24/040/00347/AM16/ Lic.No/Date:0910062681 07.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/821/2015-PI(Norms) dated 12.05.2016 , 193

Case No.:139/14/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01275/AM16/ RLA File :34/24/040/00178/AM16/ Lic.No/Date:3410041581 08.10.2015 Defer Date:07.07.2016 194

Case No.:126/16/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01446/AM16/ RLA File :03/95/040/00445/AM16/ Lic.No/Date:0310799287 08.10.2015 Defer Date:07.07.2016 195

Case No.:61/16/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01381/AM16/ RLA File :03/95/040/00483/AM16/ Lic.No/Date:0310799284 08.10.2015 Defer Date:07.07.2016 196

Case No.:62/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01382/AM16/ RLA File :03/95/040/00491/AM16/ Lic.No/Date:0310799292 08.10.2015 Defer Date:07.07.2016

197

Case No.:17/16/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01337/AM16/ RLA File :09/24/040/00402/AM16/ Lic.No/Date:0910062693 08.10.2015 Defer Date:07.07.2016 Decision : It was observed that the quantities of import mentioned by the applicant appear to be disproportionately high. Accordingly, firm is to submit its version to NC-III in DGFT on immediate basis. 198

Case No.:23/16/82-

ALC4/2015 Party Name:SHREEGEN PHARMA LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01343/AM16/ RLA File :09/24/040/00359/AM16/ Lic.No/Date:0910062695 09.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/828/2015-PI(Norms) dated 18.05.2016 , 199

Case No.:164/14/82-

ALC4/2015 Party Name:AASHA BIOCHEM Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01300/AM16/ RLA File :10/24/040/00049/AM16/ Lic.No/Date:1010059293 12.10.2015 Defer Date:07.07.2016 Decision : The Committee decided to call for DML for export product and deferred the case. 200

Case No.:140/14/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01276/AM16/ RLA File :34/24/040/00175/AM16/ Lic.No/Date:3410041586 12.10.2015 Defer Date:07.07.2016 201

Case No.:144/14/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01280/AM16/ RLA File :52/24/040/00049/AM16/ Lic.No/Date:5210041658 14.10.2015 Defer Date:07.07.2016 202

Case No.:58/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01378/AM16/ RLA File :03/94/040/00497/AM16/ Lic.No/Date:0310799433 14.10.2015 Defer Date:07.07.2016 Decision :The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/506/2015-PI(Norms) dated 30.12.2015 and deferred the case. 203 Case No.:132/14/82- Party Name:RIDDHI Meet No/Date:5/82- Status:Case

ALC4/2015 PHARMA ALC4/2016 08.06.2016 Deferred HQ File :01/82/050/01268/AM16/ RLA File :34/24/040/00180/AM16/ Lic.No/Date:3410041592 14.10.2015 Defer Date:07.07.2016 204

Case No.:60/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01380/AM16/ RLA File :03/94/040/00486/AM16/ Lic.No/Date:0310799460 15.10.2015 Defer Date:07.07.2016 205

Case No.:92/16/82-

ALC4/2015 Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01412/AM16/ RLA File :34/24/040/00185/AM16/ Lic.No/Date:3410041600 15.10.2015 Defer Date:07.07.2016 206

Case No.:158/14/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01294/AM16/ RLA File :05/23/040/00305/AM16/ Lic.No/Date:0510395945 16.10.2015 Defer Date:07.07.2016 207

Case No.:26/16/82-

ALC4/2015 Party Name:NEULAND LABORATORIES LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01346/AM16/ RLA File :09/24/040/00370/AM16/ Lic.No/Date:0910062746 20.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/830/2015-PI(Norms) dated 18.05.2016 , 208

Case No.:11/16/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01331/AM16/ RLA File :09/24/040/00425/AM16/ Lic.No/Date:0910062758 20.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/820/2015-PI(Norms) dated 12.05.2016 , 209

Case No.:27/16/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File RLA File Lic.No/Date:0910062753 Defer Date:

:01/82/050/01347/AM16/ :09/24/040/00420/AM16/ 20.10.2015 Pharmaceuticals forwarded vide O.M. No.35011/827/2015-PI(Norms) dated 18.05.2016 , 210

Case No.:72/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01392/AM16/ RLA File :03/95/040/00102/AM16/ Lic.No/Date:0310799579 21.10.2015 Defer Date:07.07.2016 211

Case No.:73/16/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01393/AM16/ RLA File :03/95/040/00087/AM16/ Lic.No/Date:0310799578 21.10.2015 Defer Date:07.07.2016 212

Case No.:29/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01349/AM16/ RLA File :09/24/040/00379/AM16/ Lic.No/Date:0910062768 23.10.2015 Defer Date:07.07.2016 Decision :Deferred. 213

Case No.:30/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01350/AM16/ RLA File :09/24/040/00383/AM16/ Lic.No/Date:0910062767 23.10.2015 Defer Date:07.07.2016 214

Case No.:129/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01449/AM16/ RLA File :03/95/040/00505/AM16/ Lic.No/Date:0310799628 23.10.2015 Defer Date:07.07.2016 215

Case No.:161/14/82-

ALC4/2015 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01297/AM16/ RLA File :03/94/040/01226/AM15/ Lic.No/Date:0310799680 26.10.2015 Defer Date:07.07.2016

216

Case No.:78/16/82-

ALC4/2015 Party Name:MOHINI ORGANICS PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01398/AM16/ RLA File :03/95/040/00777/AM15/ Lic.No/Date:0310799666 26.10.2015 Defer Date:07.07.2016 217

Case No.:53/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01636/AM16/ RLA File :03/95/040/00529/AM16/ Lic.No/Date:0310799675 26.10.2015 Defer Date:07.07.2016 218

Case No.:93/16/82-

ALC4/2015 Party Name:JAINEX SPECIALITY CHEMICAL Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01413/AM16/ RLA File :34/24/040/00196/AM16/ Lic.No/Date:3410041626 28.10.2015 Defer Date:07.07.2016 219

Case No.:31/16/82-

ALC4/2015 Party Name:MSN LABORATORIES PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01351/AM16/ RLA File :09/24/040/00423/AM16/ Lic.No/Date:0910062790 28.10.2015 Defer Date:07.07.2016 vide O.M.No.35011/837/2015-PI(Norms) dated 18.05.2016, uploaded at the end of these minutes 220

Case No.:74/16/82-

ALC4/2015 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01394/AM16/ RLA File :03/95/040/00518/AM16/ Lic.No/Date:0310799705 28.10.2015 Defer Date:07.07.2016 Decision :Deferred. 221

Case No.:75/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01395/AM16/ RLA File :03/95/040/00525/AM16/ Lic.No/Date:0310799704 28.10.2015 Defer Date:07.07.2016 Decision :Deferred. 222

Case No.:9/20/82-

ALC4/2015 Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01592/AM16/ RLA File :08/24/040/00237/AM16/ Lic.No/Date:0810136380 28.10.2015 Defer Date:07.07.2016

223

Case No.:47/16/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01367/AM16/ RLA File :03/95/040/00526/AM16/ Lic.No/Date:0310799853 29.10.2015 Defer Date:07.07.2016 Decision :Deferred. 224

Case No.:136/14/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01272/AM16/ RLA File :05/23/040/00293/AM16/ Lic.No/Date:0510396078 30.10.2015 Defer Date:07.07.2016 Decision :Information called for from the firm in NC meeting No.03/AM17 is awaited and deferred the case. 225

Case No.:48/16/82-

ALC4/2015 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01368/AM16/ RLA File :03/95/040/00549/AM16/ Lic.No/Date:0310799873 30.10.2015 Defer Date:07.07.2016 226

Case No.:87/16/82-

ALC4/2015 Party Name:SCOTT-EDIL PHARMACIA LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01407/AM16/ RLA File :22/24/040/00020/AM16/ Lic.No/Date:2210015341 30.10.2015 Defer Date:07.07.2016 227

Case No.:159/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01295/AM16/ RLA File :05/24/040/00343/AM16/ Lic.No/Date:0510396075 30.10.2015 Defer Date:07.07.2016 Decision : 228

Case No.:118/16/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01438/AM16/ RLA File :05/24/040/00345/AM16/ Lic.No/Date:0510396076 30.10.2015 Defer Date:07.07.2016 vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes 229

Case No.:84/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:5/82-AL
C4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01404/AM16/ RLA File :22/24/040/00055/AM16/ Lic.No/Date:2210015339 30.10.2015 Defer Date:

Decision : The Committee decided to ratify norms based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/784/2015-PI(Norms) dated 29.04.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per decision of NC. 230

Case No.:67/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01772/AM16/ RLA File :08/24/040/00258/AM16/ Lic.No/Date:0810136406 02.11.2015 Defer Date:07.07.2016 231

Case No.:112/16/82-

ALC4/2015 Party Name:BELCO PHARMA Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01432/AM16/ RLA File :05/23/040/00273/AM16/ Lic.No/Date:0510396205 03.11.2015 Defer Date:07.07.2016 232

Case No.:107/16/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01427/AM16/ RLA File :05/23/040/00326/AM16/ Lic.No/Date:0510396204 03.11.2015 Defer Date:07.07.2016 233

Case No.:19/16/82-

ALC4/2015 Party Name:MEDICLONE BIO-TECH PRIVATE LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01339/AM16/ RLA File :04/24/040/00181/AM16/ Lic.No/Date:0410161279 04.11.2015 Defer Date:07.07.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/799/2015-PI(Norms) dated 13.06.2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case. 234

Case No.:90/16/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01410/AM16/ RLA File :34/24/040/00207/AM16/ Lic.No/Date:3410041662 05.11.2015 Defer Date:07.07.2016 235

Case No.:88/16/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01408/AM16/ RLA File :34/24/040/00202/AM16/ Lic.No/Date:3410041663 05.11.2015 Defer Date:07.07.2016

236

Case No.:37/16/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01357/AM16/ RLA File :03/94/040/00561/AM16/ Lic.No/Date:0310800114 06.11.2015 Defer Date:07.07.2016 237

Case No.:53/16/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01373/AM16/ RLA File :03/95/040/00540/AM16/ Lic.No/Date:0310800090 06.11.2015 Defer Date:07.07.2016 238

Case No.:89/16/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01409/AM16/ RLA File :34/24/040/00203/AM16/ Lic.No/Date:3410041666 09.11.2015 Defer Date:07.07.2016 239

Case No.:2/16/82-

ALC4/2015 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01322/AM16/ RLA File :04/24/040/00175/AM16/ Lic.No/Date:0410161296 09.11.2015 Defer Date:07.07.2016 240

Case No.:34/1/82-

ALC1/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01808/AM16/ RLA File :09/24/040/00469/AM16/ Lic.No/Date:0910062848 10.11.2015 Defer Date:07.07.2016 241

Case No.:110/16/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01430/AM16/ RLA File :05/23/040/00329/AM16/ Lic.No/Date:0510396325 13.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/339/2015-PI(Norms) dated 12.4.2016 , 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. 242

Case No.:106/16/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01426/AM16/ RLA File :05/24/040/00384/AM16/ Lic.No/Date:0510396340 16.11.2015 Defer Date:

Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/801/2015-PI(Norms) dated 13.06.2016 , 243

Case No.:114/16/82-

ALC4/2015 Party Name:SHIVA BIOCHEM INDUSTRIES Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01434/AM16/ RLA File :50/24/040/00017/AM16/ Lic.No/Date:5010002240 16.11.2015 Defer Date:07.07.2016 Decision : Deferred . 244

Case No.:52/20/82-

ALC4/2015 Party Name:RELIANCE INDUSTRIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01635/AM16/ RLA File :03/95/040/00551/AM16/ Lic.No/Date:0310800331 19.11.2015 Defer Date:07.07.2016 Decision :Deferred. 245

Case No.:104/16/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case 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 246

Case No.:4/20/82-

ALC4/2015 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01587/AM16/ RLA File :03/94/040/00656/AM16/ Lic.No/Date:0310800363 23.11.2015 Defer Date:07.07.2016 247

Case No.:31/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01805/AM16/ RLA File :05/24/040/00347/AM16/ Lic.No/Date:0510396399 23.11.2015 Defer Date:07.07.2016 248

Case No.:2/20/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01585/AM16/ RLA File :05/24/040/00400/AM16/ Lic.No/Date:0510396400 23.11.2015 Defer Date:07.07.2016 249

Case No.:79/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred

HQ File :01/82/050/01399/AM16/ RLA File :22/24/040/00074/AM16/ Lic.No/Date:2210015349 23.11.2015 Defer Date:07.07.2016 250

Case No.:81/16/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01401/AM16/ RLA File :22/24/040/00075/AM16/ Lic.No/Date:2210015348 23.11.2015 Defer Date:07.07.2016 251

Case No.:105/16/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01425/AM16/ RLA File :05/23/040/00356/AM16/ Lic.No/Date:0510396410 24.11.2015 Defer Date:07.07.2016 252

Case No.:33/1/82-

ALC1/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01807/AM16/ RLA File :09/24/040/00486/AM16/ Lic.No/Date:0910062902 26.11.2015 Defer Date:07.07.2016 253

Case No.:32/16/82-

ALC4/2015 Party Name:INTERMED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01352/AM16/ RLA File :04/24/040/00177/AM16/ Lic.No/Date:0410161343 26.11.2015 Defer Date:07.07.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/800/2015-PI(Norms) dated 13.06.2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case. 254

Case No.:2/1/82-

ALC1/2016 Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01776/AM16/ RLA File :03/95/040/00632/AM16/ Lic.No/Date:0310800416 26.11.2015 Defer Date:07.07.2016 255

Case No.:23/1/82-

ALC1/2016 Party Name:UNILINK PHARMA PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01797/AM16/ RLA File :04/24/040/00170/AM16/ Lic.No/Date:0410161342 26.11.2015 Defer Date:07.07.2016 256 Case No.:57/20/82- Party Name:WANBURY Meet No/Date:5/82- Status:Case

ALC4/2015 LIMITED(FORMERLY PEARL ORGANICS LTD) ALC4/2016 08.06.2016 Approved HQ File :01/82/050/01640/AM16/ RLA File :03/95/040/00628/AM16/ Lic.No/Date:0310800470 30.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/865/2015-PI(Norms) dated 24.05.2016, 257

Case No.:58/20/82-

ALC4/2015 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01641/AM16/ RLA File :03/95/040/00182/AM15/ Lic.No/Date:0310800550 01.12.2015 Defer Date:07.07.2016 258

Case No.:3/1/82-

ALC1/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01777/AM16/ RLA File :03/95/040/00529/AM15/ Lic.No/Date:0310800547 01.12.2015 Defer Date:07.07.2016 259

Case No.:5/1/82-

ALC1/2016 Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01779/AM16/ RLA File :03/95/040/00239/AM15/ Lic.No/Date:0310800551 01.12.2015 Defer Date:07.07.2016 260

Case No.:90/20/82-

ALC4/2015 Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01673/AM16/ RLA File :03/95/040/00629/AM16/ Lic.No/Date:0310800552 01.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/865/2015-PI(Norms) dated 24.05.2016, 261

Case No.:33/20/82-

ALC4/2015 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01616/AM16/ RLA File :03/94/040/00532/AM16/ Lic.No/Date:0310800597 02.12.2015 Defer Date:07.07.2016 262

Case No.:54/20/82-

ALC4/2015 Party Name:MELOG SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred

HQ File :01/82/050/01637/AM16/ RLA File :03/95/040/00631/AM16/ Lic.No/Date:0310800619 03.12.2015 Defer Date:07.07.2016 263

Case No.:112/20/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01695/AM16/ RLA File :03/95/040/00646/AM16/ Lic.No/Date:0310800620 03.12.2015 Defer Date:07.07.2016 264

Case No.:86/20/82-

ALC4/2015 Party Name:REANNON PHARMACEUTICALS Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01669/AM16/ RLA File :03/95/040/00494/AM16/ Lic.No/Date:0310800662 04.12.2015 Defer Date:07.07.2016 265

Case No.:62/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01645/AM16/ RLA File :03/95/040/00522/AM16/ Lic.No/Date:0310800711 07.12.2015 Defer Date: Decision :Already approved in NC03/AM17. 266

Case No.:87/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01670/AM16/ RLA File :03/95/040/00605/AM16/ Lic.No/Date:0310800715 07.12.2015 Defer Date:07.07.2016 Decision :Deferred. 267

Case No.:127/16/82-

ALC4/2015 Party Name:BLUELINE FOODS (INDIA) PVT.LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01447/AM16/ RLA File :07/24/040/00267/AM16/ Lic.No/Date:0710109146 08.12.2015 Defer Date:07.07.2016 vide O.M.No.35011/656/2015-PI(Norms) dated 27.04.2016, uploaded at the end of these minutes 268

Case No.:85/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01668/AM16/ RLA File :03/95/040/00201/AM16/ Lic.No/Date:0310800751 08.12.2015 Defer Date: Decision :Already approved in NC 03/Am17

269

Case No.:36/20/82-

ALC4/2015 Party Name:BAYER VAPI PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01619/AM16/ RLA File :03/94/040/00651/AM16/ Lic.No/Date:0310800833 09.12.2015 Defer Date:07.07.2016 Decision :Deferred. 270

Case No.:67/20/82-

ALC4/2015 Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01650/AM16/ RLA File :03/95/040/00054/AM16/ Lic.No/Date:0310800865 10.12.2015 Defer Date:07.07.2016 Decision :Deferred. 271

Case No.:108/20/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01691/AM16/ RLA File :09/24/040/00506/AM16/ Lic.No/Date:0910062961 10.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/5/2016-PI(Norms) dated 06.06.2016, 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. 272

Case No.:110/20/82-

ALC4/2015 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01693/AM16/ RLA File :56/24/040/00040/AM16/ Lic.No/Date:5610004767 10.12.2015 Defer Date:07.07.2016 Decision :Deferred. 273

Case No.:9/1/82-

ALC1/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01783/AM16/ RLA File :03/94/040/00490/AM16/ Lic.No/Date:0310800912 11.12.2015 Defer Date:07.07.2016 Decision :Deferred. 274

Case No.:66/20/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01649/AM16/ RLA File :03/95/040/00633/AM16/ Lic.No/Date:0310800935 11.12.2015 Defer Date:07.07.2016 Decision :Deferred. 275

Case No.:45/20/82-

ALC4/2015 Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310800992 Defer

:01/82/050/01628/AM16/ :03/94/040/00736/AM16/ 14.12.2015 Date:07.07.2016 Decision :Deferred. 276

Case No.:24/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01607/AM16/ RLA File :03/95/040/00088/AM16/ Lic.No/Date:0310800991 14.12.2015 Defer Date:07.07.2016 Decision :Deferred. 277

Case No.:69/20/82-

ALC4/2015 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01652/AM16/ RLA File :03/95/040/00661/AM16/ Lic.No/Date:0310800980 14.12.2015 Defer Date: Decision :Already approved in NC 03/Am17 278

Case No.:4/1/82-

ALC1/2016 Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01778/AM16/ RLA File :03/95/040/00660/AM16/ Lic.No/Date:0310800993 14.12.2015 Defer Date: Decision : Already approved in NC 03/Am17 279

Case No.:49/20/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01632/AM16/ RLA File :03/94/040/00714/AM16/ Lic.No/Date:0310801093 16.12.2015 Defer Date:07.07.2016 Decision :Deferred. 280

Case No.:10/1/82-

ALC1/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01784/AM16/ RLA File :03/94/040/00630/AM16/ Lic.No/Date:0310801130 16.12.2015 Defer Date:07.07.2016 Decision :Deferred. 281

Case No.:44/20/82-

ALC4/2015 Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01627/AM16/ RLA File :03/94/040/00720/AM16/ Lic.No/Date:0310801132 16.12.2015 Defer Date:07.07.2016 282 Case No.:46/20/82- ALC4/2015 Party Name:JINDAL DRUGS PRIVATE Meet No/Date:5/82- ALC4/2016 Status:Case Deferred

LIMITED 08.06.2016 HQ File :01/82/050/01629/AM16/ RLA File :03/94/040/00692/AM16/ Lic.No/Date:0310801111 16.12.2015 Defer Date:07.07.2016 Decision :Deferred. 283

Case No.:120/20/82-

ALC4/2015 Party Name:MAITHRI LABORATORIES (P) LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01703/AM16/ RLA File :09/24/040/00524/AM16/ Lic.No/Date:0910062974 16.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/743/2015-PI(NORMS) dated, 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. 284

Case No.:23/20/82-

ALC4/2015 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01606/AM16/ RLA File :03/95/040/00697/AM16/ Lic.No/Date:0310801116 16.12.2015 Defer Date:07.07.2016 Decision :Deferred. 285

Case No.:8/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01591/AM16/ RLA File :05/24/040/00427/AM16/ Lic.No/Date:0510396637 16.12.2015 Defer Date:07.07.2016 Decision :Deferred. 286

Case No.:135/16/82-

ALC4/2015 Party Name:METROCHEM API PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01455/AM16/ RLA File :09/24/040/00534/AM16/ Lic.No/Date:0910062981 17.12.2015 Defer Date: Decision : This case already approve in NC 03/AN17 287

Case No.:8/1/82-

ALC1/2016 Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01782/AM16/ RLA File :03/94/040/00754/AM16/ Lic.No/Date:0310801214 18.12.2015 Defer Date:07.07.2016 Decision :Deferred. 288

Case No.:83/1/82-

ALC1/2016 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01857/AM16/ RLA File :03/94/040/00752/AM16/ Lic.No/Date:0310801211 18.12.2015 Defer Date:07.07.2016 Decision :Deferred.

289

Case No.:14/20/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01597/AM16/ RLA File :03/94/040/00728/AM16/ Lic.No/Date:0310801252 21.12.2015 Defer Date:07.07.2016 vide O.M.No.35011/866/2015-PI(Norms) dated 18.05.2016, uploaded at the end of these minutes 290

Case No.:15/20/82-

ALC4/2015 Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01598/AM16/ RLA File :03/94/040/00721/AM16/ Lic.No/Date:0310801298 22.12.2015 Defer Date:07.07.2016 291

Case No.:19/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01602/AM16/ RLA File :03/95/040/00009/AM16/ Lic.No/Date:0310801275 22.12.2015 Defer Date:07.07.2016 Decision :Deferred. 292

Case No.:20/20/82-

ALC4/2015 Party Name:LAXMI ORGANIC INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01603/AM16/ RLA File :03/95/040/00267/AM16/ Lic.No/Date:0310801273 22.12.2015 Defer Date:07.07.2016 Decision :Deferred. 293

Case No.:111/20/82-

ALC4/2015 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01694/AM16/ RLA File :56/24/040/00045/AM16/ Lic.No/Date:5610004780 22.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/803/2015-PI(Norms) dated 13.06.2016, 294

Case No.:48/20/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01631/AM16/ RLA File :03/94/040/00683/AM16/ Lic.No/Date:0310801362 28.12.2015 Defer Date:07.07.2016 295

Case No.:102/20/82-

ALC4/2015 Party Name:STERMONE CHEMICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File RLA File Lic.No/Date:3410041764 Defer Date:

:01/82/050/01685/AM16/ :34/24/040/00243/AM16/ 29.12.2015 Pharmaceuticals forwarded vide O.M. No.35011/868/2015-PI(Norms) dated 24.05.2016 , 296

Case No.:80/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01663/AM16/ RLA File :03/95/040/00736/AM16/ Lic.No/Date:0310801389 29.12.2015 Defer Date:07.07.2016 297

Case No.:81/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01664/AM16/ RLA File :03/95/040/00735/AM16/ Lic.No/Date:0310801388 29.12.2015 Defer Date:07.07.2016 298

Case No.:22/20/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01605/AM16/ RLA File :03/95/040/00738/AM16/ Lic.No/Date:0310801409 30.12.2015 Defer Date:07.07.2016 299

Case No.:84/20/82-

ALC4/2015 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01667/AM16/ RLA File :03/95/040/00730/AM16/ Lic.No/Date:0310801411 30.12.2015 Defer Date:07.07.2016 300

Case No.:116/20/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01699/AM16/ RLA File :05/24/040/00463/AM16/ Lic.No/Date:0510397108 30.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/867/2015-PI(Norms) dated 24.05.2016 , 301

Case No.:47/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01630/AM16/ RLA File :03/94/040/00792/AM16/ Lic.No/Date:0310801428 31.12.2015 Defer Date:07.07.2016

302

Case No.:98/20/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01681/AM16/ RLA File :05/23/040/00338/AM16/ Lic.No/Date:0510397164 31.12.2015 Defer Date:07.07.2016 303

Case No.:99/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01682/AM16/ RLA File :05/23/040/00389/AM16/ Lic.No/Date:0510397158 31.12.2015 Defer Date:07.07.2016 304

Case No.:101/20/82-

ALC4/2015 Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01684/AM16/ RLA File :34/24/040/00226/AM16/ Lic.No/Date:3410041775 31.12.2015 Defer Date:07.07.2016 305

Case No.:119/20/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01702/AM16/ RLA File :09/24/040/00582/AM16/ Lic.No/Date:0910063066 31.12.2015 Defer Date:07.07.2016 306

Case No.:77/20/82-

ALC4/2015 Party Name:CIPLA LIMITED. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01660/AM16/ RLA File :03/94/040/00788/AM16/ Lic.No/Date:0310801491 01.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/861/2015-PI(Norms) dated 10.05.2016, 307

Case No.:118/20/82-

ALC4/2015 Party Name:AMI LIFESCIENCES P LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01701/AM16/ RLA File :34/24/040/00256/AM16/ Lic.No/Date:3410041779 04.01.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/825/2015-PI(Norms) dated 01.06.2016, 308 Case No.:104/20/82- ALC4/2015 Party Name:BEST VALUE CHEM PVT. Meet No/Date:5/82- ALC4/2016 Status:Case Deferred

LTD. 08.06.2016 HQ File :01/82/050/01687/AM16/ RLA File :34/24/040/00253/AM16/ Lic.No/Date:3410041778 04.01.2016 Defer Date:07.07.2016 Decision :Deferred. 309

Case No.:82/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01665/AM16/ RLA File :03/95/040/00750/AM16/ Lic.No/Date:0310801522 04.01.2016 Defer Date:07.07.2016 Decision :Deferred. 310

Case No.:83/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01666/AM16/ RLA File :03/95/040/00749/AM16/ Lic.No/Date:0310801521 04.01.2016 Defer Date:07.07.2016 Decision :Deferred. 311

Case No.:105/20/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01688/AM16/ RLA File :34/24/040/00252/AM16/ Lic.No/Date:3410041782 05.01.2016 Defer Date:07.07.2016 Decision :Deferred. 312

Case No.:78/20/82-

ALC4/2015 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01661/AM16/ RLA File :03/95/040/00652/AM16/ Lic.No/Date:0310801554 05.01.2016 Defer Date:07.07.2016 Decision :Deferred. 313

Case No.:26/20/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01609/AM16/ RLA File :03/94/040/00802/AM16/ Lic.No/Date:0310801601 06.01.2016 Defer Date:07.07.2016 Decision :Deferred. 314

Case No.:7/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01781/AM16/ RLA File :03/95/040/00688/AM16/ Lic.No/Date:0310801600 06.01.2016 Defer Date:07.07.2016 Decision :Deferred. 315 Case No.:76/20/82- ALC4/2015 Party Name:AIMS IMPEX PVT. LTD Meet No/Date:5/82- ALC4/2016 Status:Case Deferred

08.06.2016 HQ File :01/82/050/01659/AM16/ RLA File :03/94/040/00790/AM16/ Lic.No/Date:0310801644 07.01.2016 Defer Date:07.07.2016 Decision :Deferred. 316

Case No.:103/20/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01686/AM16/ RLA File :05/23/040/00404/AM16/ Lic.No/Date:0510397232 07.01.2016 Defer Date:07.07.2016 Decision :Deferred. 317

Case No.:6/1/82-

ALC1/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01780/AM16/ RLA File :03/95/040/00676/AM16/ Lic.No/Date:0310801634 07.01.2016 Defer Date:07.07.2016 318

Case No.:32/1/82-

ALC1/2016 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01806/AM16/ RLA File :05/24/040/00431/AM16/ Lic.No/Date:0510397230 07.01.2016 Defer Date:07.07.2016 Decision :Deferred. 319

Case No.:95/20/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01678/AM16/ RLA File :05/24/040/00499/AM16/ Lic.No/Date:0510397256 08.01.2016 Defer Date:07.07.2016 320

Case No.:79/20/82-

ALC4/2015 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01662/AM16/ RLA File :03/95/040/00765/AM16/ Lic.No/Date:0310801655 08.01.2016 Defer Date:07.07.2016 Decision :Deferred. 321

Case No.:21/20/82-

ALC4/2015 Party Name:SHREE LIFE SCIENCES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01604/AM16/ RLA File :03/95/040/00762/AM16/ Lic.No/Date:0310801691 11.01.2016 Defer Date:07.07.2016 322

Case No.:19/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred

HQ File :01/82/050/01793/AM16/ RLA File :04/24/040/00214/AM16/ Lic.No/Date:0410161494 11.01.2016 Defer Date:07.07.2016 323

Case No.:60/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01834/AM16/ RLA File :03/94/040/00828/AM16/ Lic.No/Date:0310801732 12.01.2016 Defer Date:07.07.2016 324

Case No.:61/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01835/AM16/ RLA File :03/94/040/00820/AM16/ Lic.No/Date:0310801731 12.01.2016 Defer Date:07.07.2016 325

Case No.:48/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01822/AM16/ RLA File :03/94/040/00785/AM16/ Lic.No/Date:0310801728 12.01.2016 Defer Date:07.07.2016 Decision :Deferred. 326

Case No.:82/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01856/AM16/ RLA File :03/95/040/00690/AM16/ Lic.No/Date:0310801719 12.01.2016 Defer Date:07.07.2016 Decision :Deferred. 327

Case No.:62/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01836/AM16/ RLA File :03/94/040/00833/AM16/ Lic.No/Date:0310801811 15.01.2016 Defer Date:07.07.2016 Decision :Deferred. 328

Case No.:66/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01840/AM16/ RLA File :03/94/040/00831/AM16/ Lic.No/Date:0310801850 18.01.2016 Defer Date:07.07.2016 329 Case No.:64/1/82- Party Name:ETERNIS Meet No/Date:5/82- Status:Case

ALC1/2016 FINE CHEMICALS LIMITED, ALC4/2016 08.06.2016 Deferred HQ File :01/82/050/01838/AM16/ RLA File :03/94/040/00840/AM16/ Lic.No/Date:0310801857 18.01.2016 Defer Date:07.07.2016 330

Case No.:22/1/82-

ALC1/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01796/AM16/ RLA File :04/24/040/00220/AM16/ Lic.No/Date:0410161521 18.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/839/2015-PI(Norms) dated 18.05.2016 , 331

Case No.:79/1/82-

ALC1/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01853/AM16/ RLA File :03/95/040/00689/AM16/ Lic.No/Date:0310801831 18.01.2016 Defer Date:07.07.2016 Decision :Deferred. 332

Case No.:80/1/82-

ALC1/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01854/AM16/ RLA File :03/95/040/00771/AM16/ Lic.No/Date:0310801856 18.01.2016 Defer Date:07.07.2016 Decision :Deferred. 333

Case No.:63/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01837/AM16/ RLA File :03/94/040/00846/AM16/ Lic.No/Date:0310801882 19.01.2016 Defer Date:07.07.2016 334

Case No.:65/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01839/AM16/ RLA File :03/94/040/00857/AM16/ Lic.No/Date:0310801883 19.01.2016 Defer Date:07.07.2016 335

Case No.:59/1/82-

ALC1/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0310801896 Defer

:01/82/050/01833/AM16/ :03/94/040/00589/AM16/ 19.01.2016 Date:07.07.2016 vide O.M.No.35011/11/2016-PI(Norms) dated 07.06.2016, uploaded at the end of these minutes 336

Case No.:114/20/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01697/AM16/ RLA File :34/24/040/00263/AM16/ Lic.No/Date:3410041814 19.01.2016 Defer Date:07.07.2016 337

Case No.:77/1/82-

ALC1/2016 Party Name:MEDISPRAY LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01851/AM16/ RLA File :03/95/040/00657/AM16/ Lic.No/Date:0310801888 19.01.2016 Defer Date:07.07.2016 338

Case No.:36/1/82-

ALC1/2016 Party Name:SI GROUP INDIA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01810/AM16/ RLA File :03/95/040/00779/AM16/ Lic.No/Date:0310801890 19.01.2016 Defer Date:07.07.2016 339

Case No.:113/20/82-

ALC4/2015 Party Name:STERMONE CHEMICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/01696/AM16/ RLA File :34/24/040/00177/AM16/ Lic.No/Date:3410041821 19.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/868/2015-(PI-Norms) dated 24.05.2016 , 340

Case No.:76/1/82-

ALC1/2016 Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01850/AM16/ RLA File :03/95/040/00790/AM16/ Lic.No/Date:0310801892 19.01.2016 Defer Date:07.07.2016 341

Case No.:50/1/82-

ALC1/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01824/AM16/ RLA File :03/94/040/00861/AM16/ Lic.No/Date:0310801928 20.01.2016 Defer Date:07.07.2016

342

Case No.:68/1/82-

ALC1/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01842/AM16/ RLA File :03/94/040/00834/AM16/ Lic.No/Date:0310801927 20.01.2016 Defer Date:07.07.2016 343

Case No.:106/20/82-

ALC4/2015 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01689/AM16/ RLA File :05/24/040/00515/AM16/ Lic.No/Date:0510397367 20.01.2016 Defer Date:07.07.2016 vide O.M.No.35011/4/2016-PI(Norms) dated 01.06.2016, uploaded at the end of these minutes 344

Case No.:38/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01812/AM16/ RLA File :03/95/040/00798/AM16/ Lic.No/Date:0310801923 20.01.2016 Defer Date:07.07.2016 345

Case No.:115/20/82-

ALC4/2015 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01698/AM16/ RLA File :34/24/040/00268/AM16/ Lic.No/Date:3410041823 21.01.2016 Defer Date:07.07.2016 346

Case No.:49/1/82-

ALC1/2016 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01823/AM16/ RLA File :03/94/040/00869/AM16/ Lic.No/Date:0310801950 21.01.2016 Defer Date:07.07.2016 347

Case No.:47/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01821/AM16/ RLA File :03/94/040/00864/AM16/ Lic.No/Date:0310801994 22.01.2016 Defer Date:07.07.2016 348

Case No.:67/1/82-

ALC1/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01841/AM16/ RLA File :03/94/040/00880/AM16/ Lic.No/Date:0310802014 22.01.2016 Defer Date:07.07.2016

349

Case No.:24/1/82-

ALC1/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01798/AM16/ RLA File :04/24/040/00210/AM16/ Lic.No/Date:0410161548 22.01.2016 Defer Date:07.07.2016 350

Case No.:97/20/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01680/AM16/ RLA File :05/24/040/00522/AM16/ Lic.No/Date:0510397405 22.01.2016 Defer Date:07.07.2016 351

Case No.:96/20/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01679/AM16/ RLA File :02/24/040/00178/AM16/ Lic.No/Date:0210206458 22.01.2016 Defer Date:07.07.2016 352

Case No.:51/1/82-

ALC1/2016 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01825/AM16/ RLA File :03/94/040/00877/AM16/ Lic.No/Date:0310802029 25.01.2016 Defer Date:07.07.2016 353

Case No.:52/1/82-

ALC1/2016 Party Name:INDO AMINES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01826/AM16/ RLA File :03/94/040/00888/AM16/ Lic.No/Date:0310802024 25.01.2016 Defer Date:07.07.2016 354

Case No.:53/1/82-

ALC1/2016 Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01827/AM16/ RLA File :03/94/040/00881/AM16/ Lic.No/Date:0310802057 27.01.2016 Defer Date:07.07.2016 355

Case No.:27/1/82-

ALC1/2016 Party Name:BODAL CHEMICALS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01801/AM16/ RLA File :08/24/040/00325/AM16/ Lic.No/Date:0810137105 01.02.2016 Defer Date:07.07.2016

356

Case No.:44/1/82-

ALC1/2016 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01818/AM16/ RLA File :03/94/040/00886/AM16/ Lic.No/Date:0310802172 02.02.2016 Defer Date:07.07.2016 357

Case No.:40/1/82-

ALC1/2016 Party Name:MAGNOLIA LIMITED. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01814/AM16/ RLA File :03/95/040/01074/AM15/ Lic.No/Date:0310802175 02.02.2016 Defer Date:07.07.2016 358

Case No.:3/5/82-

ALC4/2016 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00162/AM17/ RLA File :05/24/040/00537/AM16/ Lic.No/Date:0510397479 03.02.2016 Defer Date:07.07.2016 359

Case No.:35/1/82-

ALC1/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01809/AM16/ RLA File :31/82/040/00270/AM16/ Lic.No/Date:3110065907 04.02.2016 Defer Date:07.07.2016 360

Case No.:37/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01811/AM16/ RLA File :03/95/040/00639/AM16/ Lic.No/Date:0310802231 04.02.2016 Defer Date:07.07.2016 361

Case No.:43/1/82-

ALC1/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01817/AM16/ RLA File :03/94/040/00882/AM16/ Lic.No/Date:0310802261 05.02.2016 Defer Date:07.07.2016 362

Case No.:58/1/82-

ALC1/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01832/AM16/ RLA File :03/95/040/00819/AM16/ Lic.No/Date:0310802266 05.02.2016 Defer Date:07.07.2016

363

Case No.:42/1/82-

ALC1/2016 Party Name:CELOGEN PHARMA PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01816/AM16/ RLA File :03/94/040/00929/AM16/ Lic.No/Date:0310802331 08.02.2016 Defer Date:07.07.2016 364

Case No.:69/1/82-

ALC1/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01843/AM16/ RLA File :03/94/040/00922/AM16/ Lic.No/Date:0310802291 08.02.2016 Defer Date:07.07.2016 365

Case No.:74/1/82-

ALC1/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01848/AM16/ RLA File :03/94/040/00810/AM16/ Lic.No/Date:0310802333 08.02.2016 Defer Date:07.07.2016 366

Case No.:39/1/82-

ALC1/2016 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01813/AM16/ RLA File :03/95/040/00847/AM16/ Lic.No/Date:0310802292 08.02.2016 Defer Date:07.07.2016 367

Case No.:75/1/82-

ALC1/2016 Party Name:BLISS GVS PHARMA LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01849/AM16/ RLA File :03/94/040/00948/AM16/ Lic.No/Date:0310802382 09.02.2016 Defer Date:07.07.2016 368

Case No.:71/1/82-

ALC1/2016 Party Name:HALCYON LABS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01845/AM16/ RLA File :03/94/040/00916/AM16/ Lic.No/Date:0310802390 09.02.2016 Defer Date:07.07.2016 369

Case No.:72/1/82-

ALC1/2016 Party Name:HALCYON LABS PVT. LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01846/AM16/ RLA File :03/94/040/00915/AM16/ Lic.No/Date:0310802387 09.02.2016 Defer Date:07.07.2016 Decision :

370

Case No.:45/1/82-

ALC1/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01819/AM16/ RLA File :03/94/040/00859/AM16/ Lic.No/Date:0310802380 09.02.2016 Defer Date:07.07.2016 371

Case No.:70/1/82-

ALC1/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01844/AM16/ RLA File :03/94/040/00935/AM16/ Lic.No/Date:0310802452 10.02.2016 Defer Date:07.07.2016 372

Case No.:41/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01815/AM16/ RLA File :03/95/040/00826/AM16/ Lic.No/Date:0310802395 10.02.2016 Defer Date:07.07.2016 373

Case No.:78/1/82-

ALC1/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01852/AM16/ RLA File :03/95/040/00752/AM16/ Lic.No/Date:0310802451 10.02.2016 Defer Date:07.07.2016 374

Case No.:73/1/82-

ALC1/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01847/AM16/ RLA File :03/94/040/00953/AM16/ Lic.No/Date:0310802552 12.02.2016 Defer Date:07.07.2016 375

Case No.:26/1/82-

ALC1/2016 Party Name:UMA ENTERPRISE Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01800/AM16/ RLA File :08/24/040/00396/AM16/ Lic.No/Date:0810137202 15.02.2016 Defer Date:07.07.2016 376

Case No.:56/1/82-

ALC1/2016 Party Name:ZIM LABORATORIES LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01830/AM16/ RLA File :03/95/040/00887/AM16/ Lic.No/Date:0310802649 16.02.2016 Defer Date:07.07.2016

377

Case No.:17/1/82-

ALC1/2016 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01791/AM16/ RLA File :04/24/040/00229/AM16/ Lic.No/Date:0410161613 17.02.2016 Defer Date:07.07.2016 378

Case No.:57/1/82-

ALC1/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01831/AM16/ RLA File :03/95/040/00895/AM16/ Lic.No/Date:0310802676 17.02.2016 Defer Date:07.07.2016 379

Case No.:1/20/82-

ALC4/2015 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01584/AM16/ RLA File :09/24/040/00689/AM16/ Lic.No/Date:0910063311 22.02.2016 Defer Date:07.07.2016 380

Case No.:18/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01792/AM16/ RLA File :04/24/040/00248/AM16/ Lic.No/Date:0410161671 01.03.2016 Defer Date:07.07.2016 381

Case No.:20/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01794/AM16/ RLA File :04/24/040/00247/AM16/ Lic.No/Date:0410161672 01.03.2016 Defer Date:07.07.2016 382

Case No.:21/1/82-

ALC1/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01795/AM16/ RLA File :04/24/040/00246/AM16/ Lic.No/Date:0410161670 01.03.2016 Defer Date:07.07.2016 383

Case No.:13/1/82-

ALC1/2016 Party Name:ONEIRO CHEMICALS LTD Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01787/AM16/ RLA File :34/24/040/00286/AM16/ Lic.No/Date:3410041972 14.03.2016 Defer Date:07.07.2016

384

Case No.:15/1/82-

ALC1/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01789/AM16/ RLA File :09/24/040/00713/AM16/ Lic.No/Date:0910063416 15.03.2016 Defer Date:07.07.2016 385

Case No.:14/1/82-

ALC1/2016 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01788/AM16/ RLA File :09/24/040/00716/AM16/ Lic.No/Date:0910063414 15.03.2016 Defer Date:07.07.2016 386

Case No.:85/1/82-

ALC1/2016 Party Name:DIVIS LABORATORIES LTD., Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/01859/AM16/ RLA File :09/24/040/00730/AM16/ Lic.No/Date:0910063440 23.03.2016 Defer Date:07.07.2016 387

Case No.:2/5/82-

ALC4/2016 Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Approved HQ File :01/82/050/00161/AM17/ RLA File :07/24/040/00036/AM17/ Lic.No/Date:0710109851 20.05.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/12/2016-(PI-Norms) dated 07.06.2016 , 388

Case No.:1/5/82-

ALC4/2016 Party Name:RA CHEM
PHARMA LIMITED Meet No/Date:5/82- ALC4/2016 08.06.2016 Status:Case Deferred HQ File :01/82/050/00160/AM17/ RLA File :09/24/040/00083/AM17/ Lic.No/Date:0910063660 20.05.2016 Defer Date:07.07.2016 Manual Agenda for NC-3 Meeting No. 5/82AM-17 held on 08.06.2016

Case No. B- 01

M.No.5/AM-17 M/s. KLJ Plasticizers Ltd File No. 01/82/050/01036/AM15

Date 08.06.2016 RLA No 05/23/040/00256/AM15 Adv.Auth. No. 0510391459 dated 07.0.2014 Decision: The Committee considered this case for amendment in description of import from ethyl hexanol to 2-ethyl hexanol as agenda. The Committee decided to amend the description of import item No.2 to read as 2-Ethyl hexanol. The export product name is Brand name and the chemical name in support should also be mentioned. This aspect would be commented upon by the applicant.

Case No. B- 02

M.No.5/AM-17 Date 08.06.2016 M/s. Herbo chem File No. 01/82/050/01366/AM15 RLA No 09/24/040/00572/AM15 Adv.Auth. No. 0910061552 dated 21.01.2015 Decision: The Committee considered this case for revision of quantity of import item “Ipecacuanha Roots” as per agenda. The representative the firm appeared for personal hearing before the Committee. He gave technical justification for reconsideration of their case. In support of his claim he produced COA issued by the foreign supplier/university which shows the content of active ingredient as 2.03 & 2.11. Accordingly the Committee noticed that the minimum requirement on pro-rata basis will be 1kg/kg on content basis. Allowing the nominal wastage for extraction and purification. The Committee unanimously decided to allow the wastage in line with earlier MSME report and it will be as under:- Export product Qty. Import item Qty. Extract Ipecacuanha (Ipecac Conc having 2% Alkaloids 1kg Ipecacuanha (Ipecac) Roots (Dry Roots) containing maximum 1.10% Alkaloids 1.10kg As the time of closure applicant will submit copy of COA to RA showing content of active ingredient 2% (+/- 10%).

Case No. B- 03

M.No.5/AM-17 Date 08.06.2016 M/s. Best Value Chem Pvt Ltd File No. 01/82/050/00230/AM16 RLA No 34/24/040/00254/AM15 Adv.Auth. No. 3410040841 dated 29.12.2014 Decision: The Committee considered this case for correction the decision of norms committee taken earlier as per agenda. The Committee noted that the comments from DCPC have not been received so far. Therefore, the Committee decided to defer the case.

Case No. B- 04

M.No.5/AM-17 Date 08.06.2016 M/s. Eternis Fine Chemicals Ltd Formaly Hindustan Polyamides & Fibres Ltd File No. 01/82/050/00769/AM16 RLA No 03/94/040/00026/AM16 Adv.Auth. No. 0310795971dated 18.05.2015 Decision: The Committee considered this case for ratification of norms as per agenda. The Committee decided to ratify the norms based on the written comments provided by C&PC vide U.O.No.14010/90/2011-Ch-II dated 10.09.2015, uploaded at the end of these minutes or as applied by the firm whichever is less. RA may taken necessary action as per decision of NC.

Case No. B- 05

M.No.5/AM-17 Date 08.06.2016 M/s. Micro Labs Ltd File No. 01/82/050/00322/AM16 RLA No 07/24/040/00398/AM15 Adv.Auth. No. 0710107559 dated 05.02.2015 Decision: The Committee considered this case for revision of Norms as per agenda.
The Committee considered this case for ratification of norms as per agenda. The Committee

decided to ratify the norms based on the written comments provided by D/o Pharmaceuticals vide 35011/518/2015-PI(Norms) dated 15.01.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA may taken necessary action as per decision of NC.

Case No. B- 06

M.No.5/AM-17 Date 08.06.2016 M/s. SMB Corporation of India File No. 01/82/050/01016/AM13 RLA No 03/95/040/00568/AM13 Adv.Auth. No. 0310713614 dated 25.10.2012 Decision: The Committee considered this case for amendment UOM of export item from kg. To Number as per agenda. The Committee decided to amend the UOM of export to read as Number instead of kg.

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