DGFT Committee Minutes

1

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

Para 4.7 Decision

Meeting No. 08/82/2016 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, scheduled to be held on 27.07.2016 but actually held on 04.08.2016 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 08/82 held 07.07.2016 and approved the same. Note: In certain cases the decision of the Norms Committee refers to the Recommendations/ Observations / Deficiencies received from the concerned Technical authority in the same case or a different case of another firm with the same product. A scanned copy of such document is placed at the end of the Minutes. In some cases, the scanned copy uploaded may be unsigned. In both these instances, the scanned copy uploaded is to be accepted. The Committee does not approve SCOMET items and all applicants are understood to have furnished a declaration to RA that the items of import/export are not SCOMET items. MEETING NUMBER : 8/82-ALC4/2016 MEETING DATE : 27.07.2016 1

Case No.:132/8/82-

ALC4/2014 Party Name:PROVENTUS LIFE SCIENCES PRIVATE LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00796/AM15/ RLA File :04/24/040/00395/AM08/ Lic.No/Date:0410094357 12.03.2008 Defer Date:23.08.2016 Decision :The Committee noted that information called for from the firm in NC meeting No.05/82 dated 25.06.2015 has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 2

Case No.:70/4/82-

ALC4/2016 Party Name:RAKSHIT DRUGS PVT LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00133/AM17/ RLA File :09/71/040/00061/AM12/ Lic.No/Date:0910048210 11.08.2011 Defer Date:23.08.2016 Decision :The committee decided call for information based on the recommendation of D/o

2 Pharmaceuticals forwarded vide O.M.No.35011/130/2016-PI(Norms) dated 18.07.2016 and deferred the case. 3

Case No.:15/2/82-

ALC4/2016 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00015/AM17/ RLA File :03/95/040/00554/AM12/ Lic.No/Date:0310659678 14.10.2011 Defer Date:23.08.2016 Decision :Deferred. 4

Case No.:36/19/82-

ALC4/2014 Party Name:ALKALI METALS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01524/AM15/ RLA File :09/24/040/00503/AM12/ Lic.No/Date:0910052125 12.04.2012 Defer Date:23.08.2016 Decision :Deferred. 5

Case No.:38/19/82-

ALC4/2014 Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01526/AM15/ RLA File :09/24/040/00050/AM13/ Lic.No/Date:0910052706 21.05.2012 Defer Date:23.08.2016 Decision :Deferred. 6

Case No.:18/19/82-

ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/01506/AM15/ RLA File :09/24/040/00085/AM13/ Lic.No/Date:0910052887 05.06.2012 Defer Date: Decision : The Committee noted that Central Excise Certification for production consumption called for from the firm by NC in its meeting No.09/82 dated 30.09.2015 but same has not been furnished. Firm has sent their repeated reply but Central Excise Certification for production consumption has not furnished. In absence of the above norms cannot be ratify. The Committee accordingly, decided to reject the case. RA concerned may take further necessary action as per the decision of NC. 7

Case No.:173/5/82-

ALC4/2015 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00313/AM16/ RLA File :05/23/040/00069/AM14/ Lic.No/Date:0510356983 13.06.2013 Defer Date:23.08.2016 Decision :Deferred. 8

Case No.:61/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00124/AM17/ RLA File :07/24/040/00097/AM14/ Lic.No/Date:0710096460 04.07.2013 Defer Date:23.08.2016 Decision : Deferred for want of comments from DoP. 9 Case No.:31/4/82- ALC4/2014 Party Name:UNIVERSAL BIOFUELS PRIVATE Meet No/Date:8/82- ALC4/2016 Status:Deferred

3 LIMITED 27.07.2016 HQ File :01/82/050/00279/AM15/ RLA File :09/24/040/00155/AM14/ Lic.No/Date:0910056959 31.07.2013 Defer Date:23.08.2016 Decision : Deferred. 10

Case No.:61/14/82-

ALC4/2013 Party Name:HETERO DRUGS LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00646/AM14/ RLA File :09/24/040/00206/AM14/ Lic.No/Date:0910057007 02.08.2013 Defer Date:23.08.2016 Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/630/2014-PI(Norms) dated June 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 11

Case No.:41/16/82-

ALC4/2013 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00854/AM14/ RLA File :07/24/040/00188/AM14/ Lic.No/Date:0710098283 16.09.2013 Defer Date:23.08.2016 Decision :The Committee deferred the case for want of comments from DoP. 12

Case No.:140/23/82-

ALC4/2013 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01187/AM14/ RLA File :03/95/040/00495/AM14/ Lic.No/Date:0310758627 21.11.2013 Defer Date:23.08.2016 Decision :Deferred. 13

Case No.:48/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01011/AM16/ RLA File :03/94/040/00860/AM14/ Lic.No/Date:0310766718 17.01.2014 Defer Date:23.08.2016 Decision :Deferred. 14

Case No.:208/3/82-

ALC4/2014 Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00212/AM15/ RLA File :09/24/040/00515/AM14/ Lic.No/Date:0910059017 22.01.2014 Defer Date:23.08.2016 Decision :Deferred. 15

Case No.:108/3/82-

ALC4/2014 Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00112/AM15/ RLA File :03/94/040/00908/AM14/ Lic.No/Date:0310767733 24.01.2014 Defer Date:23.08.2016 Decision :Deferred. 16 Case No.:177/3/82- Party Name:INDO AMINES Meet No/Date:8/82- Status:Deferred

4 ALC4/2014 LIMITED ALC4/2016 27.07.2016 HQ File :01/82/050/00181/AM15/ RLA File :03/94/040/00958/AM14/ Lic.No/Date:0310768616 30.01.2014 Defer Date:23.08.2016 Decision :Deferred. 17

Case No.:58/6/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00460/AM15/ RLA File :03/94/040/00797/AM14/ Lic.No/Date:0310772503 28.02.2014 Defer Date:23.08.2016 Decision :Deferred. 18

Case No.:106/3/82-

ALC4/2014 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00110/AM15/ RLA File :03/95/040/00960/AM14/ Lic.No/Date:0310772411 28.02.2014 Defer Date:23.08.2016 Decision :Deferred. 19

Case No.:58/4/82-

ALC4/2014 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00306/AM15/ RLA File :22/24/040/00100/AM14/ Lic.No/Date:2210014694 14.03.2014 Defer Date:23.08.2016 Decision :Information called for firm in NC meeting No.04/82 dated 24.5.2016 is awaited.
The Committee accordingly deferred the case. 20

Case No.:57/3/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00061/AM15/ RLA File :05/23/040/00506/AM14/ Lic.No/Date:0510382053 18.03.2014 Defer Date:23.08.2016 Decision :Deferred. 21

Case No.:51/5/82-

ALC4/2014 Party Name:JINDAL DRUGS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00368/AM15/ RLA File :03/94/040/01098/AM14/ Lic.No/Date:0310776087 27.03.2014 Defer Date:23.08.2016 Decision :Deferred. 22

Case No.:51/6/82-

ALC4/2014 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00453/AM15/ RLA File :03/95/040/01054/AM14/ Lic.No/Date:0310776759 02.04.2014 Defer Date:23.08.2016 Decision :Deferred. 23

Case No.:50/6/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

5 HQ File :01/82/050/00452/AM15/ RLA File :03/95/040/01061/AM14/ Lic.No/Date:0310776760 02.04.2014 Defer Date:23.08.2016 Decision :Deferred. 24

Case No.:20/6/82-

ALC4/2014 Party Name:ADISHANK CHEMICALS PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00422/AM15/ RLA File :03/94/040/01140/AM14/ Lic.No/Date:0310777786 09.04.2014 Defer Date:23.08.2016 Decision :Deferred. 25

Case No.:49/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01012/AM16/ RLA File :03/94/040/01118/AM14/ Lic.No/Date:0310779215 23.04.2014 Defer Date:23.08.2016 Decision :Deferred. 26

Case No.:237/6/82-

ALC4/2014 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00639/AM15/ RLA File :17/24/040/00002/AM15/ Lic.No/Date:1710005803 05.05.2014 Defer Date:23.08.2016 Decision :Deferred. 27

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

PRODUCTS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred. HQ File :01/82/050/00345/AM17/ RLA File :52/21/040/00011/AM15/ Lic.No/Date:5210041026 12.05.2014 Defer Date:23.08.2016 Decision :Deferred. 28

Case No.:13/2/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00028/AM16/ RLA File :05/23/040/00080/AM15/ Lic.No/Date:0510387607 28.05.2014 Defer Date:23.08.2016 Decision :Deferred. 29

Case No.:38/8/82-

ALC4/2014 Party Name:MYLAN Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00702/AM15/ RLA File :09/24/040/00108/AM15/ Lic.No/Date:0910060258 28.05.2014 Defer Date:23.08.2016 Decision : The Committee decided to send copy of application to DoP and deferred the case. 30

Case No.:165/6/82-

ALC4/2014 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00567/AM15/ RLA File :02/24/040/00037/AM15/ Lic.No/Date:0210203844 05.06.2014 Defer Date:23.08.2016

6 Decision :Deferred. 31

Case No.:106/8/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00770/AM15/ RLA File :03/94/040/00131/AM15/ Lic.No/Date:0310785223 12.06.2014 Defer Date:23.08.2016 Decision :Deferred. 32

Case No.:60/10/82-

ALC4/2014 Party Name:BIO-TECH OPHTHALMICS PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected
HQ File :01/82/050/00974/AM15/ RLA File :08/24/040/00116/AM15/ Lic.No/Date:0810132332 13.06.2014 Defer Date: Decision : The Committee noted that information called for from the firm in NC meeting No.11/82 dated 28.10.2015 has not been furnished. In absence of these information norms 33

Case No.:77/8/82-

ALC4/2014 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00741/AM15/ RLA File :03/94/040/00196/AM15/ Lic.No/Date:0310785501 17.06.2014 Defer Date:23.08.2016 Decision :Deferred. 34

Case No.:20/8/82-ALC4/2014 Party Name:SRINI

PHARMACEUTICALS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected
HQ File :01/82/050/00684/AM15/ RLA File :09/24/040/00139/AM15/ Lic.No/Date:0910060467 17.06.2014 Defer Date: No.02/82 dated 29.04.2015 has not been furnished by the firm. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 35

Case No.:160/6/82-

ALC4/2014 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00562/AM15/ RLA File :05/23/040/00053/AM15/ Lic.No/Date:0510388783 18.06.2014 Defer Date:23.08.2016 Decision :Deferred for want of comments from DoP. 36

Case No.:202/6/82-

ALC4/2014 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00604/AM15/ RLA File :05/23/040/00139/AM15/ Lic.No/Date:0510389232 01.07.2014 Defer Date:23.08.2016 Decision :Deferred. 37 Case No.:72/10/82- ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE Meet No/Date:8/82- ALC4/2016 Status:Deferred

7 LIMITED, 27.07.2016 HQ File :01/82/050/00986/AM15/ RLA File :07/24/040/00112/AM15/ Lic.No/Date:0710105884 18.07.2014 Defer Date:23.08.2016 Decision :Deferred. 38

Case No.:7/6/82-ALC4/2014 Party Name:AARTI DRUGS

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00409/AM15/ RLA File :03/94/040/00321/AM15/ Lic.No/Date:0310787378 28.07.2014 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 11.07.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 39

Case No.:203/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Deferred HQ File :01/82/050/00343/AM16/ RLA File :02/24/040/00080/AM15/ Lic.No/Date:0210204732 07.08.2014 Defer Date:23.08.2016 40

Case No.:21/9/82-

ALC4/2014 Party Name:PI INDUSTRIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Deferred HQ File :01/82/050/00818/AM15/ RLA File :13/24/040/00020/AM15/ Lic.No/Date:1310047575 12.08.2014 Defer Date:23.08.2016 41

Case No.:264/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01267/AM15/ RLA File :03/94/040/00405/AM15/ Lic.No/Date:0310788397 26.08.2014 Defer Date:23.08.2016 Decision :Deferred. 42

Case No.:255/13/82-

ALC4/2014 Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01258/AM15/ RLA File :03/95/040/00431/AM15/ Lic.No/Date:0310788373 26.08.2014 Defer Date:23.08.2016 Decision :Deferred. 43

Case No.:254/13/82-

ALC4/2014 Party Name:SEQUENT SCIENTIFIC LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected
HQ File :01/82/050/01257/AM15/ RLA File :03/95/040/00459/AM15/ Lic.No/Date:0310788513 28.08.2014 Defer Date: Decision : The Committee noted that information called for from the firm by NC in its meeting No.30.09.2015 has not been furnished. In absence of that information case cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take necessary action as per decision of NC.

8 44

Case No.:263/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01266/AM15/ RLA File :03/94/040/00962/AM14/ Lic.No/Date:0310788558 01.09.2014 Defer Date:23.08.2016 45

Case No.:217/13/82-

ALC4/2014 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01220/AM15/ RLA File :03/94/040/00494/AM15/ Lic.No/Date:0310788620 02.09.2014 Defer Date:23.08.2016 46

Case No.:6/8/82-ALC4/2014 Party Name:HONOUR LAB

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00670/AM15/ RLA File :09/24/040/00314/AM15/ Lic.No/Date:0910060964 12.09.2014 Defer Date:23.08.2016 47

Case No.:380/5/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Deferred
HQ File :01/82/050/00520/AM16/ RLA File :22/24/040/00054/AM15/ Lic.No/Date:2210015086 16.09.2014 Defer Date:23.08.2016 Decision : The Committee based on the written com ments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/343/2015-PI(Norms) dated 17.06.2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case. 48

Case No.:188/13/82-

ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01191/AM15/ RLA File :03/94/040/00102/AM15/ Lic.No/Date:0310789322 17.09.2014 Defer Date:23.08.2016 Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.50/82 dated 15.03.2011 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. 49

Case No.:57/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01060/AM15/ RLA File :05/23/040/00277/AM15/ Lic.No/Date:0510391246 19.09.2014 Defer Date:23.08.2016 Decision :Deferred 50

Case No.:59/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

9 HQ File :01/82/050/01062/AM15/ RLA File :05/23/040/00276/AM15/ Lic.No/Date:0510391245 19.09.2014 Defer Date:23.08.2016 Decision :Deferred. 51

Case No.:9/15/82-

ALC4/2014 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01296/AM15/ RLA File :09/24/040/00327/AM15/ Lic.No/Date:0910061001 19.09.2014 Defer Date:23.08.2016 Decision :Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited. The committee accordingly deferred the case. 52

Case No.:17/13/82-

ALC4/2014 Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01020/AM15/ RLA File :34/24/040/00155/AM15/ Lic.No/Date:3410040570 23.09.2014 Defer Date:23.08.2016 Decision :Deferred. 53

Case No.:115/13/82-

ALC4/2014 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01118/AM15/ RLA File :02/24/040/00097/AM15/ Lic.No/Date:0210205008 23.09.2014 Defer Date:23.08.2016 Decision :Deferred. 54

Case No.:74/13/82-

ALC4/2014 Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01077/AM15/ RLA File :05/23/040/00282/AM15/ Lic.No/Date:0510391308 24.09.2014 Defer Date:23.08.2016 Decision :Deferred. 55

Case No.:19/13/82-

ALC4/2014 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01022/AM15/ RLA File :04/24/040/00171/AM15/ Lic.No/Date:0410159504 29.09.2014 Defer Date:23.08.2016 Decision : The committee decided to sent copy of application to MSME. 56

Case No.:160/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01163/AM15/ RLA File :03/94/040/00544/AM15/ Lic.No/Date:0310789976 07.10.2014 Defer Date:23.08.2016 Decision :Deferred. 57

Case No.:35/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01038/AM15/ RLA File :05/23/040/00218/AM15/ Lic.No/Date:0510391491 08.10.2014 Defer Date:23.08.2016

10 Decision :Deferred. 58

Case No.:76/13/82-

ALC4/2014 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/01079/AM15/ RLA File :04/24/040/00163/AM15/ Lic.No/Date:0410159566 13.10.2014 Defer Date: No.13/82 dated 27.11.2015 has not been furnished. In absence of these information norms 59

Case No.:42/15/82-

ALC4/2014 Party Name:PVS AGRO VET Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01329/AM15/ RLA File :09/24/040/00246/AM15/ Lic.No/Date:0910061105 16.10.2014 Defer Date:23.08.2016 Decision : The firm has furnished requisite information vide letter dated 06.06.2016 and the same has been sent to DoP on 04.08.2016. The Committee accordingly deferred the case. 60

Case No.:154/13/82-

ALC4/2014 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01157/AM15/ RLA File :03/94/040/00680/AM15/ Lic.No/Date:0310790351 17.10.2014 Defer Date:23.08.2016 Decision :Deferred. 61

Case No.:12/20/82-

ALC4/2015 Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01595/AM16/ RLA File :07/24/040/00255/AM15/ Lic.No/Date:0710106853 17.10.2014 Defer Date:23.08.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/846/2015-PI(Norms) dated June 2016, uploaded at the end of these minutes and deferred the case. 62

Case No.:110/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01113/AM15/ RLA File :34/24/040/00188/AM15/ Lic.No/Date:3410040635 22.10.2014 Defer Date:23.08.2016 Decision :Deferred. 63

Case No.:86/10/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01000/AM15/ RLA File :34/24/040/00194/AM15/ Lic.No/Date:3410040644 30.10.2014 Defer Date:23.08.2016 Decision :Deferred. 64 Case No.:266/13/82- Party Name:ATUL Meet No/Date:8/82- Status:Deferred

11 ALC4/2014 LIMITED, ALC4/2016 27.07.2016 HQ File :01/82/050/01269/AM15/ RLA File :08/24/040/00289/AM15/ Lic.No/Date:0810133735 05.11.2014 Defer Date:23.08.2016 Decision :Deferred. 65

Case No.:268/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01271/AM15/ RLA File :08/24/040/00283/AM15/ Lic.No/Date:0810133734 05.11.2014 Defer Date:23.08.2016 Decision :Deferred. 66

Case No.:107/13/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01110/AM15/ RLA File :34/24/040/00196/AM15/ Lic.No/Date:3410040655 05.11.2014 Defer Date:23.08.2016 Decision :Deferred. 67

Case No.:114/13/82-

ALC4/2014 Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected
HQ File :01/82/050/01117/AM15/ RLA File :52/24/040/00042/AM15/ Lic.No/Date:5210041292 10.11.2014 Defer Date: No.09/82 dated 30.09.2015 has not been furnished. In absence of these information norms 68

Case No.:111/13/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01114/AM15/ RLA File :05/23/040/00352/AM15/ Lic.No/Date:0510391927 11.11.2014 Defer Date:23.08.2016 Decision :Deferred for want of comments from AYUSH. 69

Case No.:393/5/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00533/AM16/ RLA File :09/24/040/00387/AM15/ Lic.No/Date:0910061210 11.11.2014 Defer Date: No.12/82 dated 18.11.2015 has not been furnished. In their reply firm has sent repeated information but Central Excise Certification for production consumption has not been furnished so far. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 70

Case No.:61/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

12 HQ File :01/82/050/01427/AM15/ RLA File :34/24/040/00198/AM15/ Lic.No/Date:3410040676 11.11.2014 Defer Date:23.08.2016 Decision :Deferred. 71

Case No.:100/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00139/AM16/ RLA File :17/24/040/00125/AM15/ Lic.No/Date:1710005978 12.11.2014 Defer Date:23.08.2016 Decision :Deferred. 72

Case No.:120/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01123/AM15/ RLA File :05/23/040/00325/AM15/ Lic.No/Date:0510391947 12.11.2014 Defer Date:23.08.2016 Decision :Deferred. 73

Case No.:77/18/82-

ALC4/2014 Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01443/AM15/ RLA File :03/95/040/00629/AM14/ Lic.No/Date:0310790966 12.11.2014 Defer Date:23.08.2016 Decision :Deferred.. 74

Case No.:65/18/82-

ALC4/2014 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01431/AM15/ RLA File :34/24/040/00199/AM15/ Lic.No/Date:3410040677 13.11.2014 Defer Date:23.08.2016 Decision :Deferred. 75

Case No.:42/18/82-

ALC4/2014 Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01408/AM15/ RLA File :03/95/040/00628/AM14/ Lic.No/Date:0310791049 13.11.2014 Defer Date:23.08.2016 Decision :Deferred. 76

Case No.:65/15/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01352/AM15/ RLA File :05/23/040/00360/AM15/ Lic.No/Date:0510392011 14.11.2014 Defer Date:23.08.2016 Decision :Deferred for want of comments from AYUSH. 77

Case No.:52/15/82-

ALC4/2014 Party Name:MYLAN Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected
HQ File :01/82/050/01339/AM15/ RLA File :09/24/040/00408/AM15/ Lic.No/Date:0910061280 20.11.2014 Defer Date:

13 No.09/82 dated 30.09.2015 has not been furnished. In their reply firm has sent repeated information but Central Excise Certification for production consumption has not been furnished so far. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 78

Case No.:16/18/82-

ALC4/2014 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01382/AM15/ RLA File :03/94/040/00789/AM15/ Lic.No/Date:0310791300 21.11.2014 Defer Date:23.08.2016 Decision :Deferred. 79

Case No.:74/18/82-

ALC4/2014 Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01440/AM15/ RLA File :03/94/040/00814/AM15/ Lic.No/Date:0310791373 25.11.2014 Defer Date:23.08.2016 Decision :Deferred. 80

Case No.:18/18/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01384/AM15/ RLA File :03/94/040/00792/AM15/ Lic.No/Date:0310791374 25.11.2014 Defer Date:23.08.2016 Decision :Deferred. 81

Case No.:15/2/82-ALC4/2015 Party Name:SHALINA

LABORATORIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00030/AM16/ RLA File :03/95/040/00639/AM15/ Lic.No/Date:0310791416 25.11.2014 Defer Date: No.17/82 dated 27.01.2016 has not been furnished. In absence of these information norms 82

Case No.:32/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00032/AM17/ RLA File :03/95/040/00617/AM15/ Lic.No/Date:0310791470 27.11.2014 Defer Date:23.08.2016 Decision :Deferred. 83

Case No.:26/18/82-

ALC4/2014 Party Name:SADHANA NITRO CHEM LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01392/AM15/ RLA File :03/95/040/00714/AM15/ Lic.No/Date:0310791516 28.11.2014 Defer Date:23.08.2016 Decision :Deferred.

14 84

Case No.:92/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01458/AM15/ RLA File :34/24/040/00224/AM15/ Lic.No/Date:3410040732 28.11.2014 Defer Date:23.08.2016 Decision :Deferred. 85

Case No.:154/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00294/AM16/ RLA File :03/95/040/00740/AM15/ Lic.No/Date:0310791735 05.12.2014 Defer Date: No.14/82 dated 16.12.2015 has not been furnished. In absence of these information norms 86

Case No.:279/13/82-

ALC4/2014 Party Name:HONOUR LAB LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01282/AM15/ RLA File :09/24/040/00510/AM15/ Lic.No/Date:0910061362 09.12.2014 Defer Date:23.08.2016 Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/692/2015-PI(Norms) dated 26.02.2016 , 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. 87

Case No.:82/18/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Deferred
HQ File :01/82/050/01448/AM15/ RLA File :05/23/040/00413/AM15/ Lic.No/Date:0510392368 10.12.2014 Defer Date:23.08.2016 Decision : The Committee decided call for approved composition from the Drug Controller and deferred the case.. 88

Case No.:101/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00140/AM16/ RLA File :17/24/040/00144/AM15/ Lic.No/Date:1710005998 10.12.2014 Defer Date:23.08.2016 Decision :Deferred. 89

Case No.:97/18/82-

ALC4/2014 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/01463/AM15/ RLA File :30/24/040/00041/AM15/ Lic.No/Date:3010103261 11.12.2014 Defer Date:23.08.2016 Decision :Deferred. 90

Case No.:119/18/82-

ALC4/2014 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

15 HQ File :01/82/050/01485/AM15/ RLA File :05/24/040/00419/AM15/ Lic.No/Date:0510392414 15.12.2014 Defer Date:23.08.2016 Decision :Deferred. 91

Case No.:224/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00364/AM16/ RLA File :09/24/040/00531/AM15/ Lic.No/Date:0910061427 22.12.2014 Defer Date: No.12/82 dated 18.11.2015 has not been furnished. In absence of these information norms 92

Case No.:91/18/82-

ALC4/2014 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01457/AM15/ RLA File :05/23/040/00449/AM15/ Lic.No/Date:0510392602 29.12.2014 Defer Date:23.08.2016 93

Case No.:84/18/82-

ALC4/2014 Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Deferred HQ File :01/82/050/01450/AM15/ RLA File :08/24/040/00362/AM15/ Lic.No/Date:0810134170 30.12.2014 Defer Date: 27.07.2016 Decision : Deferred for want of comments from DBT. 94

Case No.:3/1/82-ALC4/2015 Party Name:JAGSONPAL

PHARMACEUTICALS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected
HQ File :01/82/050/00003/AM16/ RLA File :05/23/040/00450/AM15/ Lic.No/Date:0510392649 01.01.2015 Defer Date: No.11/82 dated 28.10.2015 has not been furnished. In absence of these information norms 95

Case No.:96/18/82-

ALC4/2014 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01462/AM15/ RLA File :04/24/040/00248/AM15/ Lic.No/Date:0410159986 07.01.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited. The Committee accordingly deferred the case. 96

Case No.:92/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00232/AM16/ RLA File :02/24/040/00203/AM15/ Lic.No/Date:0210205448 14.01.2015 Defer Date:23.08.2016 Decision : The Committee decided to call for copy of COA of the import items from

16 foreign supplier and deferred the case. 97

Case No.:59/5/82-

ALC4/2015 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00199/AM16/ RLA File :03/94/040/00793/AM15/ Lic.No/Date:0310792911 14.01.2015 Defer Date:23.08.2016 Decision :Deferred. 98

Case No.:72/5/82-ALC4/2015 Party Name:MICRO INKS

PRIVATE LIMITED. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00212/AM16/ RLA File :03/95/040/00658/AM15/ Lic.No/Date:0310793017 16.01.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.12/82 dated 19.09.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 99

Case No.:10/16/82-

ALC4/2014 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected
HQ File :01/82/050/01362/AM15/ RLA File :09/24/040/00529/AM15/ Lic.No/Date:0910061548 21.01.2015 Defer Date: No.09/82 dated 30.09.2015 has not been furnished. In absence of these information norms 100

Case No.:12/16/82-

ALC4/2014 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01364/AM15/ RLA File :09/24/040/00592/AM15/ Lic.No/Date:0910061552 21.01.2015 Defer Date:23.08.2016 Decision : The committee decided to send copy of application to DoP and deferred the case. 101

Case No.:86/5/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00226/AM16/ RLA File :05/24/040/00489/AM15/ Lic.No/Date:0510392966 22.01.2015 Defer Date:23.08.2016 102

Case No.:204/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00344/AM16/ RLA File :09/24/040/00596/AM15/ Lic.No/Date:0910061555 23.01.2015 Defer Date:23.08.2016 Decision :Deferred. 103 Case No.:31/7/82- Party Name:V.D.H. Meet No/Date:8/82- Status:Deferred

17 ALC4/2015 ORGANICS PVT. LTD ALC4/2016 27.07.2016 HQ File :01/82/050/00636/AM16/ RLA File :05/24/040/00498/AM15/ Lic.No/Date:0510392987 27.01.2015 Defer Date:23.08.2016 Decision :Deferred. 104

Case No.:32/7/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00637/AM16/ RLA File :05/24/040/00499/AM15/ Lic.No/Date:0510392988 27.01.2015 Defer Date:23.08.2016 Decision :Deferred. 105

Case No.:25/7/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00630/AM16/ RLA File :31/83/040/00144/AM15/ Lic.No/Date:3110065235 28.01.2015 Defer Date:23.08.2016 Decision :Deferred. 106

Case No.:230/5/82-

ALC4/2015 Party Name:R.K.INDUSTRIES, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00370/AM16/ RLA File :08/24/040/00394/AM15/ Lic.No/Date:0810134414 28.01.2015 Defer Date:23.08.2016 Decision :Deferred. 107

Case No.:163/5/82-

ALC4/2015 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00303/AM16/ RLA File :05/24/040/00503/AM15/ Lic.No/Date:0510393026 29.01.2015 Defer Date: No.12/82 dated 18.11.2015 has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 108

Case No.:166/5/82-

ALC4/2015 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00306/AM16/ RLA File :08/24/040/00386/AM15/ Lic.No/Date:0810134454 30.01.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/450/2015-PI(Norms) dated 20.06.2016, uploaded 109

Case No.:169/5/82-

ALC4/2015 Party Name:TIDE INDUSTRIES Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00309/AM16/ RLA File :34/24/040/00290/AM15/ Lic.No/Date:3410040927 05.02.2015 Defer Date:23.08.2016

18 Decision :Deferred. 110

Case No.:10/18/82-

ALC4/2014 Party Name:HONOUR LAB LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01376/AM15/ RLA File :09/24/040/00628/AM15/ Lic.No/Date:0910061598 10.02.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/692/2015-PI(Norms) dated 26.02.2016 , 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. 111

Case No.:91/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00696/AM16/ RLA File :34/24/040/00295/AM15/ Lic.No/Date:3410040965 16.02.2015 Defer Date:23.08.2016 Decision :Deferred. 112

Case No.:52/19/82-

ALC4/2014 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01540/AM15/ RLA File :05/24/040/00273/AM15/ Lic.No/Date:0510393248 17.02.2015 Defer Date:23.08.2016 Decision :Deferred. 113

Case No.:38/7/82-

ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00643/AM16/ RLA File :09/24/040/00640/AM15/ Lic.No/Date:0910061628 18.02.2015 Defer Date:23.08.2016 Decision : The Committee decided to send copy of application to DoP. 114

Case No.:332/5/82-

ALC4/2015 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00472/AM16/ RLA File :03/95/040/00991/AM15/ Lic.No/Date:0310794000 19.02.2015 Defer Date:23.08.2016 Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.33/82 dated 21.03.2013, uploaded as 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. 115

Case No.:280/5/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00420/AM16/ RLA File :03/94/040/01110/AM15/ Lic.No/Date:0310794101 24.02.2015 Defer Date:23.08.2016 116 Case No.:444/5/82- ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 Status:Deferred

19 27.07.2016 HQ File :01/82/050/00584/AM16/ RLA File :03/94/040/01132/AM15/ Lic.No/Date:0310794412 09.03.2015 Defer Date:23.08.2016 117

Case No.:413/5/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00553/AM16/ RLA File :03/94/040/01145/AM15/ Lic.No/Date:0310794545 12.03.2015 Defer Date:23.08.2016 Decision :Deferred. 118

Case No.:106/7/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00711/AM16/ RLA File :03/94/040/00812/AM15/ Lic.No/Date:0310794612 16.03.2015 Defer Date:23.08.2016 Decision :Deferred. 119

Case No.:16/1/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01542/AM15/ RLA File :09/24/040/00703/AM15/ Lic.No/Date:0910061716 17.03.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/231/2015-PI(Norms) dated 17.06.2016, uploaded 120

Case No.:427/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00567/AM16/ RLA File :03/95/040/01071/AM15/ Lic.No/Date:0310794916 26.03.2015 Defer Date: Decision :The Committee noted that information called for from the firm in NC meeting No.12/82 dated 18.11.2015 has not been furnished. In absence of these information norms cannot decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 121

Case No.:431/5/82-

ALC4/2015 Party Name:EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00571/AM16/ RLA File :03/94/040/01086/AM15/ Lic.No/Date:0310794964 27.03.2015 Defer Date:23.08.2016 Decision : Information called for firm in NC meeting No.20/82 dated 09.03.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 122

Case No.:9/1/82-ALC4/2015 Party Name:VIVIMED LABS

( ALATHUR) PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00009/AM16/ RLA File :04/24/040/00292/AM15/ Lic.No/Date:0410160364 30.03.2015 Defer Date:

20 No.13/82 dated 27.11.2015 has not been furnished. In absence of these information norms cannot decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 123

Case No.:448/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00588/AM16/ RLA File :03/94/040/01211/AM15/ Lic.No/Date:0310795048 31.03.2015 Defer Date:23.08.2016 Decision :Deferred. 124

Case No.:32/5/82-

ALC4/2015 Party Name:LANTECH PHARMACEUTICALS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected
HQ File :01/82/050/00172/AM16/ RLA File :09/24/040/00011/AM16/ Lic.No/Date:0910061900 20.04.2015 Defer Date:23.08.2016 No.12/82 dated 18.11.2015 has not been furnished. In absence of these information norms cannot decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 125

Case No.:8/2/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00023/AM16/ RLA File :09/24/040/00043/AM16/ Lic.No/Date:0910061906 21.04.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/231/2015-PI(Norms) dated 17.06.2016, uploaded 126

Case No.:174/7/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00779/AM16/ RLA File :03/95/040/00039/AM16/ Lic.No/Date:0310795601 28.04.2015 Defer Date:23.08.2016 127

Case No.:62/8/82-ALC4/2015 Party Name:OPTIMUS

DRUGS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00858/AM16/ RLA File :09/24/040/00028/AM16/ Lic.No/Date:0910061955 01.05.2015 Defer Date: No.14/82 dated 16.12.2015 has not been furnished. In absence of these information norms cannot decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 128

Case No.:50/7/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

21 HQ File :01/82/050/00655/AM16/ RLA File :09/24/040/00041/AM16/ Lic.No/Date:0910061976 06.05.2015 Defer Date:23.08.2016 Decision :Information called for from the firm in NC meeting No.19/82 dated 25.2.2016 is awaited. The Committee deferred the case. 129

Case No.:3/3/82-ALC4/2015 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00033/AM16/ RLA File :09/24/040/00077/AM16/ Lic.No/Date:0910061994 07.05.2015 Defer Date:23.08.2016 130

Case No.:108/7/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00713/AM16/ RLA File :03/95/040/00003/AM16/ Lic.No/Date:0310795745 07.05.2015 Defer Date: No.13/82 dated 27.11.2015 has not been furnished. In absence of these information norms cannot decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 131

Case No.:15/7/82-

ALC4/2015 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00620/AM16/ RLA File :52/24/040/00007/AM16/ Lic.No/Date:5210041517 11.05.2015 Defer Date:23.08.2016 Decision :Deferred. 132

Case No.:129/7/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00734/AM16/ RLA File :03/95/040/00073/AM16/ Lic.No/Date:0310795930 14.05.2015 Defer Date:23.08.2016 Decision :Deferred. 133

Case No.:164/7/82-

ALC4/2015 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00769/AM16/ RLA File :03/94/040/00026/AM16/ Lic.No/Date:0310795971 18.05.2015 Defer Date:23.08.2016 Decision :Deferred. 134

Case No.:109/7/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00714/AM16/ RLA File :03/95/040/00103/AM16/ Lic.No/Date:0310795994 18.05.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/513/2015-PI(Norms) dated 30.12.2016, uploaded Vol.1. RA concerned may take necessary action as per decision of NC..

22 135

Case No.:133/7/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00738/AM16/ RLA File :03/94/040/00085/AM16/ Lic.No/Date:0310796048 20.05.2015 Defer Date:23.08.2016 136

Case No.:102/7/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00707/AM16/ RLA File :30/24/040/00006/AM16/ Lic.No/Date:3010103498 21.05.2015 Defer Date:23.08.2016 Decision :Deferred. 137

Case No.:199/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Deferred HQ File :01/82/050/00339/AM16/ RLA File :04/24/040/00040/AM16/ Lic.No/Date:0410160570 21.05.2015 Defer Date:23.08.2016 Decision : Information called for from the firm is awaited. The Committee accordingly decided to await the reply and deferred the case. 138

Case No.:55/13/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01018/AM16/ RLA File :07/24/040/00036/AM16/ Lic.No/Date:0710108251 22.05.2015 Defer Date:23.08.2016 Decision :Deferred. 139

Case No.:5/4/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00044/AM16/ RLA File :09/24/040/00116/AM16/ Lic.No/Date:0910062066 25.05.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/605/2-15-PI(Norms) dated July, 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 140

Case No.:176/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00781/AM16/ RLA File :03/94/040/00124/AM16/ Lic.No/Date:0310796194 26.05.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.21/82 dated22.03.2016 is awaited. The Committee accordingly defer the case. 141

Case No.:124/7/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File RLA File Lic.No/Date:0310796233 Defer

23 :01/82/050/00729/AM16/ :03/95/040/00114/AM16/ 27.05.2015 Date:23.08.2016 Decision :Deferred. 142

Case No.:100/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00705/AM16/ RLA File :34/24/040/00024/AM16/ Lic.No/Date:3410041261 28.05.2015 Defer Date:23.08.2016 Decision :Deferred. 143

Case No.:188/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00793/AM16/ RLA File :08/24/040/00034/AM16/ Lic.No/Date:0810135421 02.06.2015 Defer Date:23.08.2016 Decision :Deferred. 144

Case No.:142/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00747/AM16/ RLA File :03/94/040/00159/AM16/ Lic.No/Date:0310796401 03.06.2015 Defer Date:23.08.2016 145

Case No.:110/7/82-

ALC4/2015 Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00715/AM16/ RLA File :03/95/040/00051/AM16/ Lic.No/Date:0310796383 03.06.2015 Defer Date:23.08.2016 Decision :Deferred. 146

Case No.:17/7/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00622/AM16/ RLA File :05/24/040/00078/AM16/ Lic.No/Date:0510394418 03.06.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No,04/82 dated 24.05.2016 is awaited. The Committee accordingly defer the case. 147

Case No.:67/7/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00672/AM16/ RLA File :09/24/040/00105/AM16/ Lic.No/Date:0910062138 05.06.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.21/82 dated 22.03.2016 is awaited. The Committee accordingly defer the case. 148

Case No.:13/9/82-ALC4/2015 Party Name:SHILPA

MEDICARE LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00949/AM16/ RLA File :07/24/040/00081/AM16/ Lic.No/Date:0710108327 05.06.2015 Defer Date:

24 Pharmaceuticals forwarded vide O.M. No.35011/715/2015-PI(Norms) dated 15.07.2016, uploaded 149

Case No.:121/7/82-

ALC4/2015 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00726/AM16/ RLA File :03/95/040/00715/AM15/ Lic.No/Date:0310796458 05.06.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.17/82 dated 27.01.2016 is awaited. The Committee accordingly defer the case. 150

Case No.:123/7/82-

ALC4/2015 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00728/AM16/ RLA File :03/95/040/00582/AM15/ Lic.No/Date:0310796457 05.06.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.17/82 dated 27.01.2016 is awaited. The Committee accordingly defer the case. 151

Case No.:60/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00123/AM17/ RLA File :07/24/040/00071/AM16/ Lic.No/Date:0710108351 10.06.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is awaited. The Committee accordingly deferred the case. 152

Case No.:65/7/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/00670/AM16/ RLA File :09/24/040/00164/AM16/ Lic.No/Date:0910062163 10.06.2015 Defer Date: No.07/82 dated 24.07.2015 has not furnished. In absence of these information norms 153

Case No.:66/7/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00671/AM16/ RLA File :09/24/040/00162/AM16/ Lic.No/Date:0910062162 10.06.2015 Defer Date:23.08.2016 Decision :Deferred. 154

Case No.:20/13/82-

ALC4/2015 Party Name:JAYANT AGRO ORGANICS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00983/AM16/ RLA File :03/94/040/00169/AM16/ Lic.No/Date:0310796563 11.06.2015 Defer Date:23.08.2016 Decision :Deferred.

25 155

Case No.:159/7/82-

ALC4/2015 Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00764/AM16/ RLA File :03/95/040/00985/AM15/ Lic.No/Date:0310796576 11.06.2015 Defer Date:23.08.2016 Decision :Deferred. 156

Case No.:87/7/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00692/AM16/ RLA File :09/24/040/00102/AM16/ Lic.No/Date:0910062168 11.06.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited. The Committee accordingly defer the case. 157

Case No.:42/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01005/AM16/ RLA File :03/94/040/00177/AM16/ Lic.No/Date:0310796604 15.06.2015 Defer Date:23.08.2016 Decision :Deferred. 158

Case No.:48/19/82-

ALC4/2015 Party Name:RAJ DHANVANTRY PHARMACY Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01529/AM16/ RLA File :24/24/040/00007/AM16/ Lic.No/Date:2410041748 15.06.2015 Defer Date:23.08.2016 Decision :Deferred. 159

Case No.:41/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01004/AM16/ RLA File :03/94/040/00111/AM16/ Lic.No/Date:0310796667 16.06.2015 Defer Date:23.08.2016 Decision :Deferred. 160

Case No.:52/7/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00657/AM16/ RLA File :05/23/040/00107/AM16/ Lic.No/Date:0510394590 17.06.2015 Defer Date:23.08.2016 Decision : The Committee based on the recommendation of DoP forwarded vide O.M.No.35011/696/2015-PI(Norms) dated 22.3.2016 decide to call for copy of DML from the firm and deferred the case. 161

Case No.:43/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01006/AM16/ RLA File :03/94/040/00178/AM16/ Lic.No/Date:0310796712 18.06.2015 Defer Date:23.08.2016 Decision: Deferred.

26 162

Case No.:15/9/82-

ALC4/2015 Party Name:KDAC CHEM PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00951/AM16/ RLA File :34/24/040/00069/AM16/ Lic.No/Date:3410041310 22.06.2015 Defer Date:23.08.2016 Decision :Deferred. 163

Case No.:83/13/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01046/AM16/ RLA File :34/24/040/00087/AM16/ Lic.No/Date:3410041313 23.06.2015 Defer Date:23.08.2016 Decision :Deferred. 164

Case No.:15/13/82-

ALC4/2015 Party Name:ALIVIRA ANIMAL HEALTH LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/00978/AM16/ RLA File :03/94/040/00219/AM16/ Lic.No/Date:0310796797 24.06.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/706/2015-PI(Norms) dated June, 2016, uploaded 165

Case No.:82/19/82-

ALC4/2015 Party Name:SIDDHARTH CARBOCHEM PRODUCTS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01563/AM16/ RLA File :03/95/040/00667/AM15/ Lic.No/Date:0310796830 24.06.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/874/2015-PI(Norms) dated 25.07.2016, uploaded 166

Case No.:72/7/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00677/AM16/ RLA File :05/24/040/00104/AM16/ Lic.No/Date:0510394704 25.06.2015 Defer Date:23.08.2016 Decision :Deferred. 167

Case No.:76/7/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00681/AM16/ RLA File :05/24/040/00103/AM16/ Lic.No/Date:0510394703 25.06.2015 Defer Date:23.08.2016 Decision :Deferred. 168

Case No.:75/7/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

27 HQ File :01/82/050/00680/AM16/ RLA File :05/24/040/00122/AM16/ Lic.No/Date:0510394696 25.06.2015 Defer Date:23.08.2016 169

Case No.:78/7/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00683/AM16/ RLA File :02/24/040/00028/AM16/ Lic.No/Date:0210205920 25.06.2015 Defer Date:23.08.2016 Decision :The Committee noted that information called for from the firm in NC meeting No.19/82 dated 25.02.2016 is awaited. The Committee accordingly deferred the case. 170

Case No.:109/8/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Rejected HQ File :01/82/050/00905/AM16/ RLA File :03/95/040/00038/AM16/ Lic.No/Date:0310796997 01.07.2015 Defer Date: Decision : The Committee observed that technical information has been called for from the firm by NC in its meeting No.14/82 dated 16.12.2015 but reply has not been received so far. In absence of these information norms cannot be decided. The Committee accordingly, decided to reject the case. RA concerned may take further necessary action as per decision of NC. 171

Case No.:108/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01244/AM16/ RLA File :09/24/040/00183/AM16/ Lic.No/Date:0910062267 01.07.2015 Defer Date:23.08.2016 Decision :Deferred. 172

Case No.:10/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00973/AM16/ RLA File :03/94/040/00229/AM16/ Lic.No/Date:0310797018 02.07.2015 Defer Date:23.08.2016 Decision :Deferred. 173

Case No.:11/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00974/AM16/ RLA File :03/94/040/00228/AM16/ Lic.No/Date:0310797020 02.07.2015 Defer Date:23.08.2016 Decision :Deferred. 174

Case No.:105/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Rejected HQ File :01/82/050/01241/AM16/ RLA File :09/24/040/00191/AM16/ Lic.No/Date:0910062299 03.07.2015 Defer Date: Decision : The representative of D/o Pharmaceuticals stated in the meeting that both export and import items are the same and firm has not furnished COA of export and import item from foreign supplier. The Committee accordingly decided to reject the case.

28 175

Case No.:24/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00987/AM16/ RLA File :03/94/040/00226/AM16/ Lic.No/Date:0310797092 07.07.2015 Defer Date:23.08.2016 Decision :Deferred. 176

Case No.:82/13/82-

ALC4/2015 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01045/AM16/ RLA File :34/24/040/00084/AM16/ Lic.No/Date:3410041360 07.07.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is awaited. The Committee accordingly deferred the case. 177

Case No.:23/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00986/AM16/ RLA File :03/94/040/00284/AM16/ Lic.No/Date:0310797268 15.07.2015 Defer Date:23.08.2016 Decision :Deferred. 178

Case No.:20/16/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01340/AM16/ RLA File :09/24/040/00032/AM16/ Lic.No/Date:0910062338 15.07.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is awaited. The Committee accordingly deferred the case. 179

Case No.:22/13/82-

ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00985/AM16/ RLA File :03/94/040/00282/AM16/ Lic.No/Date:0310797355 17.07.2015 Defer Date:23.08.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.2 /82 dated 24.04.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 180

Case No.:1/8/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/00797/AM16/ RLA File :09/24/040/00236/AM16/ Lic.No/Date:0910062367 23.07.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/723/2015-PI(Norms) dated 08.03.2016, uploaded 181

Case No.:119/8/82-

ALC4/2015 Party Name:SI GROUP INDIA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Deferred

29 HQ File :01/82/050/00915/AM16/ RLA File :03/95/040/00322/AM16/ Lic.No/Date:0310797595 23.07.2015 Defer Date:23.08.2016 182

Case No.:115/13/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01078/AM16/ RLA File :03/94/040/00038/AM16/ Lic.No/Date:0310797627 24.07.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is awaited. The Committee accordingly deferred the case. 183

Case No.:73/8/82-

ALC4/2015 Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00869/AM16/ RLA File :05/24/040/00213/AM16/ Lic.No/Date:0510395102 28.07.2015 Defer Date:23.08.2016 184

Case No.:69/13/82-

ALC4/2015 Party Name:PI INDUSTRIES LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01032/AM16/ RLA File :13/24/040/00016/AM16/ Lic.No/Date:1310047933 29.07.2015 Defer Date:23.08.2016 Decision :Deferred. 185

Case No.:116/13/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01079/AM16/ RLA File :03/94/040/00215/AM16/ Lic.No/Date:0310797864 31.07.2015 Defer Date:23.08.2016 Decision :Deferred. 186

Case No.:114/13/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01077/AM16/ RLA File :03/94/040/00258/AM16/ Lic.No/Date:0310797898 03.08.2015 Defer Date:23.08.2016 Decision :Deferred. 187

Case No.:112/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01075/AM16/ RLA File :03/94/040/00345/AM16/ Lic.No/Date:0310797937 04.08.2015 Defer Date:23.08.2016 Decision :Deferred. 188

Case No.:75/13/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File RLA File Lic.No/Date:0510395160 Defer

30 :01/82/050/01038/AM16/ :05/24/040/00215/AM16/ 04.08.2015 Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/778/2015-PI(Norms) dated 27.06.2016, uploaded 189

Case No.:78/13/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01041/AM16/ RLA File :05/24/040/00219/AM16/ Lic.No/Date:0510395169 04.08.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/778/2015-PI(Norms) dated 27.06.2016, uploaded 190

Case No.:109/13/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01072/AM16/ RLA File :03/94/040/00170/AM16/ Lic.No/Date:0310797954 05.08.2015 Defer Date:23.08.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.6/82 dated 14.06.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 191

Case No.:12/18/82-

ALC4/2015 Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01477/AM16/ RLA File :03/95/040/00345/AM16/ Lic.No/Date:0310797967 05.08.2015 Defer Date:23.08.2016 Decision :Deferred. 192

Case No.:50/13/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01013/AM16/ RLA File :04/24/040/00095/AM16/ Lic.No/Date:0410160884 06.08.2015 Defer Date:23.08.2016 Decision :Deferred. 193

Case No.:2/21/82-

ALC4/2015 Party Name:AUROLAB Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01707/AM16/ RLA File :35/24/040/00022/AM16/ Lic.No/Date:3510044782 06.08.2015 Defer Date:23.08.2016 194

Case No.:110/13/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01073/AM16/ RLA File :03/94/040/00350/AM16/ Lic.No/Date:0310798096 12.08.2015 Defer Date:23.08.2016 Decision :Deferred.

31 195

Case No.:111/13/82-

ALC4/2015 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01074/AM16/ RLA File :03/94/040/00305/AM16/ Lic.No/Date:0310798134 13.08.2015 Defer Date:23.08.2016 Decision :Deferred. 196

Case No.:79/13/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01042/AM16/ RLA File :52/24/040/00034/AM16/ Lic.No/Date:5210041610 14.08.2015 Defer Date:23.08.2016 197

Case No.:127/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01090/AM16/ RLA File :03/94/040/00878/AM15/ Lic.No/Date:0310798205 17.08.2015 Defer Date:23.08.2016 Decision :Deferred. 198

Case No.:60/13/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01023/AM16/ RLA File :05/23/040/00204/AM16/ Lic.No/Date:0510395351 18.08.2015 Defer Date:23.08.2016 Decision :Deferred. 199

Case No.:126/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01089/AM16/ RLA File :03/94/040/00879/AM15/ Lic.No/Date:0310798319 20.08.2015 Defer Date:23.08.2016 Decision :Deferred. 200

Case No.:61/13/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01024/AM16/ RLA File :05/23/040/00218/AM16/ Lic.No/Date:0510395388 20.08.2015 Defer Date:23.08.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/789/2015-PI(Norms) dated 18.07.2016, uploaded at the end of these minutes decided to call for detail of the export product as well as the raw material to be imported along with a copy of valid DML indicating approved composition from the firm and deferred the case. 201

Case No.:62/13/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01025/AM16/ RLA File :05/23/040/00212/AM16/ Lic.No/Date:0510395383 20.08.2015 Defer Date:23.08.2016 Decision The Committee decided to ratify norms based on the recommendation of D/o

32 Pharmaceuticals forwarded vide O.M. No.35011/789/2015-PI(Norms) dated 18.07.2016, uploaded 202

Case No.:161/13/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01124/AM16/ RLA File :03/95/040/00274/AM16/ Lic.No/Date:0310798374 21.08.2015 Defer Date:23.08.2016 Decision :Deferred. 203

Case No.:77/13/82-

ALC4/2015 Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01040/AM16/ RLA File :52/24/040/00038/AM16/ Lic.No/Date:5210041620 27.08.2015 Defer Date:23.08.2016 Decision :Deferred. 204

Case No.:120/13/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01083/AM16/ RLA File :03/94/040/00279/AM16/ Lic.No/Date:0310798629 03.09.2015 Defer Date:23.08.2016 205

Case No.:84/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01220/AM16/ RLA File :05/24/040/00262/AM16/ Lic.No/Date:0510395506 03.09.2015 Defer Date:23.08.2016 Decision :The Committee noted that information called for from the firm in NC meeting No.06/82 dated 24.05.2016 is awaited. The Committee accordingly deferred the case. 206

Case No.:59/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00122/AM17/ RLA File :07/24/040/00180/AM16/ Lic.No/Date:0710108694 07.09.2015 Defer Date:23.08.2016 207

Case No.:8/9/82-ALC4/2015 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00944/AM16/ RLA File :34/24/040/00155/AM16/ Lic.No/Date:3410041496 09.09.2015 Defer Date:23.08.2016 Decision :Deferred. 208

Case No.:10/9/82-

ALC4/2015 Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00946/AM16/ RLA File :03/94/040/00355/AM16/ Lic.No/Date:0310798806 10.09.2015 Defer Date:23.08.2016

33 Decision :Deferred. 209

Case No.:20/9/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00956/AM16/ RLA File :03/95/040/00424/AM16/ Lic.No/Date:0310798995 22.09.2015 Defer Date:23.08.2016 Decision :Deferred. 210

Case No.:51/19/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01532/AM16/ RLA File :03/95/040/00430/AM16/ Lic.No/Date:0310799076 28.09.2015 Defer Date:23.08.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.19 dated 25.02.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 211

Case No.:12/19/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01492/AM16/ RLA File :04/24/040/00154/AM16/ Lic.No/Date:0410161070 01.10.2015 Defer Date:23.08.2016 Decision :Deferred. 212

Case No.:44/4/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00107/AM17/ RLA File :03/94/040/00468/AM16/ Lic.No/Date:0310799183 05.10.2015 Defer Date:23.08.2016 Decision :Deferred. 213

Case No.:130/14/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01266/AM16/ RLA File :05/24/040/00317/AM16/ Lic.No/Date:0510395874 09.10.2015 Defer Date:23.08.2016 Decision :Deferred. 214

Case No.:56/2/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00056/AM17/ RLA File :07/24/040/00123/AM16/ Lic.No/Date:0710108886 13.10.2015 Defer Date:23.08.2016 Decision :Deferred. 215

Case No.:135/13/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01098/AM16/ RLA File :09/24/040/00408/AM16/ Lic.No/Date:0910062740 14.10.2015 Defer Date:23.08.2016

34 Decision :The committee decided to send copy of application to DoP. 216

Case No.:24/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01344/AM16/ RLA File :09/24/040/00380/AM16/ Lic.No/Date:0910062727 14.10.2015 Defer Date:23.08.2016 Decision :Deferred. 217

Case No.:136/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01099/AM16/ RLA File :08/24/040/00207/AM16/ Lic.No/Date:0810136320 16.10.2015 Defer Date:23.08.2016 Decision :Deferred. 218

Case No.:77/16/82-

ALC4/2015 Party Name:LACTOSE (INDIA) LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01397/AM16/ RLA File :03/95/040/00481/AM16/ Lic.No/Date:0310799561 20.10.2015 Defer Date:23.08.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/785/2015-PI(Norms) dated 11.4.2016, uploaded at the end of these minutes and deferred the case. 219

Case No.:140/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01103/AM16/ RLA File :03/95/040/00503/AM16/ Lic.No/Date:0310799583 21.10.2015 Defer Date:23.08.2016 Decision :Deferred. 220

Case No.:141/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01104/AM16/ RLA File :03/95/040/00504/AM16/ Lic.No/Date:0310799629 23.10.2015 Defer Date:23.08.2016 Decision :Deferred. 221

Case No.:142/13/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01105/AM16/ RLA File :09/24/040/00443/AM16/ Lic.No/Date:0910062774 27.10.2015 Defer Date:23.08.2016 Decision :Deferred. 222

Case No.:73/19/82-

ALC4/2015 Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01554/AM16/ RLA File :03/94/040/00575/AM16/ Lic.No/Date:0310799849 29.10.2015 Defer Date:23.08.2016 Decision :Deferred.

35 223

Case No.:147/13/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01110/AM16/ RLA File :08/24/040/00241/AM16/ Lic.No/Date:0810136382 29.10.2015 Defer Date:23.08.2016 Decision :Deferred. 224

Case No.:64/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01545/AM16/ RLA File :03/94/040/00240/AM16/ Lic.No/Date:0310799907 30.10.2015 Defer Date:23.08.2016 Decision :Deferred. 225

Case No.:65/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01546/AM16/ RLA File :03/94/040/00059/AM16/ Lic.No/Date:0310799906 30.10.2015 Defer Date:23.08.2016 Decision :Deferred. 226

Case No.:153/13/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01116/AM16/ RLA File :34/24/040/00199/AM16/ Lic.No/Date:3410041644 02.11.2015 Defer Date:23.08.2016 Decision :Deferred. 227

Case No.:66/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01547/AM16/ RLA File :03/94/040/00582/AM16/ Lic.No/Date:0310799943 02.11.2015 Defer Date:23.08.2016 Decision :Deferred. 228

Case No.:54/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01535/AM16/ RLA File :03/94/040/00590/AM16/ Lic.No/Date:0310799952 02.11.2015 Defer Date:23.08.2016 229

Case No.:67/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01548/AM16/ RLA File :03/94/040/00553/AM16/ Lic.No/Date:0310799932 02.11.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/804/2015-PI(Norms) dated 25.07.2016, uploaded

36 230

Case No.:70/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01551/AM16/ RLA File :03/94/040/00481/AM16/ Lic.No/Date:0310799926 02.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/804/2015-PI(Norms) dated 25.06.2016, uploaded 231

Case No.:154/13/82-

ALC4/2015 Party Name:DR REDDYS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01117/AM16/ RLA File :09/24/040/00460/AM16/ Lic.No/Date:0910062821 03.11.2015 Defer Date:23.08.2016 232

Case No.:156/13/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01119/AM16/ RLA File :09/24/040/00464/AM16/ Lic.No/Date:0910062832 03.11.2015 Defer Date:23.08.2016 Decision :The Committee decided to send copy of application to DoP. 233

Case No.:38/21/82-

ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01743/AM16/ RLA File :09/24/040/00442/AM16/ Lic.No/Date:0910062831 03.11.2015 Defer Date:23.08.2016 Decision : Deferred for want of comments from DBT. 234

Case No.:159/13/82-

ALC4/2015 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01122/AM16/ RLA File :34/24/040/00205/AM16/ Lic.No/Date:3410041650 04.11.2015 Defer Date:23.08.2016 Decision :Deferred. 235

Case No.:57/19/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01538/AM16/ RLA File :03/94/040/00443/AM16/ Lic.No/Date:0310800060 05.11.2015 Defer Date:23.08.2016 Decision :Deferred. 236

Case No.:18/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01723/AM16/ RLA File :09/24/040/00487/AM16/ Lic.No/Date:0910062841 06.11.2015 Defer Date:23.08.2016 Decision :Deferred.

37 237

Case No.:55/19/82-

ALC4/2015 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01536/AM16/ RLA File :03/94/040/00600/AM16/ Lic.No/Date:0310800148 09.11.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/805/2015-PI(Norms) dated 10.06.2016, 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. 238

Case No.:23/21/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01728/AM16/ RLA File :09/24/040/00481/AM16/ Lic.No/Date:0910062849 10.11.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. The Committee accordingly deferred the case. 239

Case No.:165/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01128/AM16/ RLA File :52/24/040/00050/AM16/ Lic.No/Date:5210041688 12.11.2015 Defer Date:23.08.2016 Decision :Deferred. 240

Case No.:71/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01552/AM16/ RLA File :03/94/040/00613/AM16/ Lic.No/Date:0310800272 17.11.2015 Defer Date:23.08.2016 Decision :Deferred. 241

Case No.:72/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01553/AM16/ RLA File :03/94/040/00612/AM16/ Lic.No/Date:0310800271 17.11.2015 Defer Date:23.08.2016 Decision :Deferred. 242

Case No.:74/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01555/AM16/ RLA File :03/94/040/00641/AM16/ Lic.No/Date:0310800285 17.11.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/807/2015-PI(Norms) dated 26.07.2016, uploaded 243 Case No.:167/13/82- ALC4/2015 PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 Status:Deferred

38 27.07.2016 HQ File :01/82/050/01130/AM16/ RLA File :09/24/040/00493/AM16/ Lic.No/Date:0910062862 19.11.2015 Defer Date:23.08.2016 Decision : : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. The Committee accordingly deferred the case. 244

Case No.:58/19/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01539/AM16/ RLA File :03/94/040/00572/AM16/ Lic.No/Date:0310800324 19.11.2015 Defer Date:23.08.2016 Decision :Deferred. 245

Case No.:75/19/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01556/AM16/ RLA File :03/94/040/00450/AM16/ Lic.No/Date:0310800347 20.11.2015 Defer Date:23.08.2016 Decision :deferred. 246

Case No.:60/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01541/AM16/ RLA File :03/94/040/00661/AM16/ Lic.No/Date:0310800340 20.11.2015 Defer Date:23.08.2016 Decision :Deferred. 247

Case No.:11/19/82-

ALC4/2015 Party Name:SURNI LABS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01491/AM16/ RLA File :34/24/040/00214/AM16/ Lic.No/Date:3410041688 20.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/791/2015-PI(Norms) dated 15.07.2016, uploaded 248

Case No.:20/19/82-

ALC4/2015 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01500/AM16/ RLA File :05/24/040/00369/AM16/ Lic.No/Date:0510396413 24.11.2015 Defer Date:23.08.2016 Decision :Deferred. 249

Case No.:1/14/82-

ALC4/2015 Party Name:HONOUR LAB LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01137/AM16/ RLA File :09/24/040/00516/AM16/ Lic.No/Date:0910062901 26.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/17/2016-PI(Norms) dated 10.06.2016, uploaded

39 250

Case No.:59/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01540/AM16/ RLA File :03/94/040/00251/AM16/ Lic.No/Date:0310800536 01.12.2015 Defer Date:23.08.2016 Decision :Deferred. 251

Case No.:62/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01543/AM16/ RLA File :03/94/040/00252/AM16/ Lic.No/Date:0310800539 01.12.2015 Defer Date:23.08.2016 Decision :Deferred. 252

Case No.:61/19/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01542/AM16/ RLA File :03/94/040/00440/AM16/ Lic.No/Date:0310800529 01.12.2015 Defer Date:23.08.2016 Decision :Deferred. 253

Case No.:81/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01562/AM16/ RLA File :03/94/040/00660/AM16/ Lic.No/Date:0310800594 02.12.2015 Defer Date:23.08.2016 254

Case No.:19/19/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01499/AM16/ RLA File :05/23/040/00370/AM16/ Lic.No/Date:0510396479 02.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/789/2015-PI(Norms) dated 18.07.2016, uploaded 255

Case No.:16/19/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01496/AM16/ RLA File :05/23/040/00362/AM16/ Lic.No/Date:0510396503 03.12.2015 Defer Date:23.08.2016 Decision :Deferred. 256

Case No.:17/19/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01497/AM16/ RLA File :05/23/040/00002/AM16/ Lic.No/Date:0510396500 03.12.2015 Defer Date:23.08.2016

40 Decision :Deferred. 257

Case No.:38/19/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01519/AM16/ RLA File :52/24/040/00062/AM16/ Lic.No/Date:5210041707 04.12.2015 Defer Date:23.08.2016 Decision : The Committee decided to send copy of application to DoP and Deferred the case. 258

Case No.:63/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01544/AM16/ RLA File :03/94/040/00673/AM16/ Lic.No/Date:0310800674 04.12.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/807/2015-PI(Norms) dated 25.07.2016, uploaded 259

Case No.:1/8/82-ALC4/2016 Party Name:SWATI

MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Case Added HQ File :01/82/050/00339/AM17/ RLA File :29/24/040/00007/AM16/ Lic.No/Date:2910025232 04.12.2015 Defer Date: Decision :Deferred. 260

Case No.:90/19/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01571/AM16/ RLA File :22/24/040/00082/AM16/ Lic.No/Date:2210015359 07.12.2015 Defer Date:23.08.2016 Decision :Deferred for want of comments from DBT. 261

Case No.:64/4/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00127/AM17/ RLA File :03/94/040/00671/AM16/ Lic.No/Date:0310800767 08.12.2015 Defer Date:23.08.2016 Decision :Deferred. 262

Case No.:5/15/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01316/AM16/ RLA File :34/24/040/00215/AM16/ Lic.No/Date:3410041722 10.12.2015 Defer Date:23.08.2016 Decision :Deferred. 263

Case No.:40/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510396587 Defer

41 :01/82/050/01521/AM16/ :05/23/040/00240/AM16/ 10.12.2015 Date:23.08.2016 264

Case No.:87/19/82-

ALC4/2015 Party Name:SAURAV CHEMICALS LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01568/AM16/ RLA File :22/24/040/00087/AM16/ Lic.No/Date:2210015368 10.12.2015 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/813/2015-PI(Norms) dated 15.07.2016, uploaded 265

Case No.:88/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01569/AM16/ RLA File :22/24/040/00081/AM16/ Lic.No/Date:2210015365 10.12.2015 Defer Date:23.08.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/817/2015-PI(Norms) dated 17.06.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 266

Case No.:94/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01575/AM16/ RLA File :22/24/040/00080/AM16/ Lic.No/Date:2210015366 10.12.2015 Defer Date:23.08.2016 Decision : The Committee decided to based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/343/2015-PI(Norms) dated June 2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 267

Case No.:42/21/82-

ALC4/2015 Party Name:NATCO PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01747/AM16/ RLA File :09/24/040/00520/AM16/ Lic.No/Date:0910062967 11.12.2015 Defer Date:23.08.2016 268

Case No.:56/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01761/AM16/ RLA File :09/24/040/00523/AM16/ Lic.No/Date:0910062965 11.12.2015 Defer Date:23.08.2016 Decision :Deferred. 269

Case No.:30/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01510/AM16/ RLA File :05/24/040/00401/AM16/ Lic.No/Date:0510396611 14.12.2015 Defer Date:23.08.2016

42 270

Case No.:31/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01511/AM16/ RLA File :05/24/040/00375/AM16/ Lic.No/Date:0510396609 14.12.2015 Defer Date:23.08.2016 271

Case No.:32/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01513/AM16/ RLA File :05/24/040/00381/AM16/ Lic.No/Date:0510396610 14.12.2015 Defer Date:23.08.2016 272

Case No.:10/19/82-

ALC4/2015 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01490/AM16/ RLA File :34/24/040/00223/AM16/ Lic.No/Date:3410041732 14.12.2015 Defer Date:23.08.2016 273

Case No.:18/19/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01498/AM16/ RLA File :52/24/040/00064/AM16/ Lic.No/Date:5210041711 15.12.2015 Defer Date:23.08.2016 Decision : The committee decided to send copy of application to DoP. 274

Case No.:39/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01520/AM16/ RLA File :05/23/040/00360/AM16/ Lic.No/Date:0510396634 16.12.2015 Defer Date:23.08.2016 275

Case No.:41/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01522/AM16/ RLA File :05/23/040/00001/AM16/ Lic.No/Date:0510396632 16.12.2015 Defer Date:23.08.2016 276

Case No.:42/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01523/AM16/ RLA File :05/23/040/00192/AM16/ Lic.No/Date:0510396633 16.12.2015 Defer Date:23.08.2016 277

Case No.:8/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

43 HQ File :01/82/050/01319/AM16/ RLA File :09/24/040/00536/AM16/ Lic.No/Date:0910062985 17.12.2015 Defer Date:23.08.2016 Decision : The Committee decided to based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 24.05.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 278

Case No.:9/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01320/AM16/ RLA File :09/24/040/00530/AM16/ Lic.No/Date:0910062986 17.12.2015 Defer Date:23.08.2016 Decision :The Committee decided to send copy of application to DoP. 279

Case No.:36/19/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01517/AM16/ RLA File :05/24/040/00439/AM16/ Lic.No/Date:0510396670 18.12.2015 Defer Date:23.08.2016 Decision : Deferred for want of comments from DBT. 280

Case No.:35/19/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01516/AM16/ RLA File :05/23/040/00396/AM16/ Lic.No/Date:0510396751 21.12.2015 Defer Date:23.08.2016 281

Case No.:33/19/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01514/AM16/ RLA File :05/24/040/00448/AM16/ Lic.No/Date:0510396777 21.12.2015 Defer Date:23.08.2016 282

Case No.:54/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01759/AM16/ RLA File :09/24/040/00525/AM16/ Lic.No/Date:0910063015 21.12.2015 Defer Date:23.08.2016 Decision :Deferred. 283

Case No.:61/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01766/AM16/ RLA File :09/24/040/00547/AM16/ Lic.No/Date:0910063018 21.12.2015 Defer Date:23.08.2016 Decision :Deferred. 284

Case No.:93/19/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File RLA File Lic.No/Date:2210015392 Defer

44 :01/82/050/01574/AM16/ :22/24/040/00051/AM16/ 23.12.2015 Date:23.08.2016 Decision : The Committee decided to based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/792/2015-PI(Norms) dated June 2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 285

Case No.:55/21/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01760/AM16/ RLA File :09/24/040/00573/AM16/ Lic.No/Date:0910063035 28.12.2015 Defer Date:23.08.2016 286

Case No.:21/19/82-

ALC4/2015 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01501/AM16/ RLA File :05/23/040/00391/AM16/ Lic.No/Date:0510397095 29.12.2015 Defer Date:23.08.2016 287

Case No.:34/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01739/AM16/ RLA File :31/83/040/00128/AM16/ Lic.No/Date:3110065816 30.12.2015 Defer Date:23.08.2016 288

Case No.:22/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01502/AM16/ RLA File :05/23/040/00244/AM16/ Lic.No/Date:0510397137 30.12.2015 Defer Date:23.08.2016 Decision :Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 289

Case No.:23/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01503/AM16/ RLA File :05/23/040/00260/AM16/ Lic.No/Date:0510397138 30.12.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 290

Case No.:13/19/82-

ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01493/AM16/ RLA File :04/24/040/00213/AM16/ Lic.No/Date:0410161479 30.12.2015 Defer Date:23.08.2016 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited.

45 291

Case No.:40/21/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01745/AM16/ RLA File :09/24/040/00559/AM16/ Lic.No/Date:0910063056 30.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/69/2016-PI(Norms) dated June 2016, uploaded 292

Case No.:47/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01752/AM16/ RLA File :09/24/040/00570/AM16/ Lic.No/Date:0910063087 01.01.2016 Defer Date:23.08.2016 293

Case No.:35/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01740/AM16/ RLA File :31/83/040/00094/AM16/ Lic.No/Date:3110065843 01.01.2016 Defer Date:23.08.2016 294

Case No.:33/21/82-

ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01738/AM16/ RLA File :31/83/040/00117/AM16/ Lic.No/Date:3110065848 05.01.2016 Defer Date:23.08.2016 295

Case No.:137/16/82-

ALC4/2015 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01457/AM16/ RLA File :34/24/040/00245/AM16/ Lic.No/Date:3410041783 05.01.2016 Defer Date:23.08.2016 296

Case No.:68/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01773/AM16/ RLA File :08/24/040/00350/AM16/ Lic.No/Date:0810136965 06.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/65/2016-PI(Norms) dated June 2016, uploaded 297

Case No.:2/17/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01462/AM16/ RLA File :09/24/040/00571/AM16/ Lic.No/Date:0910063114 08.01.2016 Defer Date:23.08.2016

46 Decision :The Committee decided to send copy of application to DoP. 298

Case No.:5/17/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01465/AM16/ RLA File :30/24/040/00035/AM16/ Lic.No/Date:3010103695 11.01.2016 Defer Date:23.08.2016 299

Case No.:33/2/82-

ALC4/2016 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00033/AM17/ RLA File :03/95/040/00737/AM16/ Lic.No/Date:0310801688 11.01.2016 Defer Date:23.08.2016 300

Case No.:60/21/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01765/AM16/ RLA File :09/24/040/00581/AM16/ Lic.No/Date:0910063135 13.01.2016 Defer Date:23.08.2016 301

Case No.:37/2/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00037/AM17/ RLA File :02/24/040/00181/AM16/ Lic.No/Date:0210206452 19.01.2016 Defer Date:23.08.2016 302

Case No.:36/21/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01741/AM16/ RLA File :13/24/040/00038/AM16/ Lic.No/Date:1310048100 20.01.2016 Defer Date:23.08.2016 303

Case No.:2/18/82-ALC4/2015 Party Name:HETERO LABS

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01467/AM16/ RLA File :09/24/040/00617/AM16/ Lic.No/Date:0910063157 22.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/180/2016-PI(Norms) dated 18.07.2016, uploaded 304

Case No.:4/21/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01709/AM16/ RLA File :05/24/040/00521/AM16/ Lic.No/Date:0510397403 22.01.2016 Defer Date:23.08.2016

47 305

Case No.:31/21/82-

ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01736/AM16/ RLA File :31/83/040/00148/AM16/ Lic.No/Date:3110065887 25.01.2016 Defer Date:23.08.2016 306

Case No.:24/21/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01729/AM16/ RLA File :34/24/040/00267/AM16/ Lic.No/Date:3410041832 28.01.2016 Defer Date:23.08.2016 307

Case No.:8/21/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01713/AM16/ RLA File :05/23/040/00438/AM16/ Lic.No/Date:0510397455 01.02.2016 Defer Date:23.08.2016 308

Case No.:13/21/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01718/AM16/ RLA File :05/23/040/00439/AM16/ Lic.No/Date:0510397481 03.02.2016 Defer Date:23.08.2016 309

Case No.:1/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01481/AM16/ RLA File :09/24/040/00634/AM16/ Lic.No/Date:0910063213 04.02.2016 Defer Date:23.08.2016 310

Case No.:12/21/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01717/AM16/ RLA File :05/24/040/00543/AM16/ Lic.No/Date:0510397506 04.02.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/778/2015-PI(Norms) dated June 2016, uploaded 311

Case No.:4/19/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01484/AM16/ RLA File :09/24/040/00628/AM16/ Lic.No/Date:0910063226 05.02.2016 Defer Date:23.08.2016

48 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/690/2015-PI(Norms) dated 21.03.2016, uploaded at the end of these minutes and deferred the case. 312

Case No.:25/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01730/AM16/ RLA File :34/24/040/00274/AM16/ Lic.No/Date:3410041858 05.02.2016 Defer Date:23.08.2016 313

Case No.:26/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01731/AM16/ RLA File :34/24/040/00273/AM16/ Lic.No/Date:3410041857 05.02.2016 Defer Date:23.08.2016 314

Case No.:14/21/82-

ALC4/2015 Party Name:DHAMPUR SUGAR MILLS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01719/AM16/ RLA File :05/23/040/00456/AM16/ Lic.No/Date:0510397521 08.02.2016 Defer Date:23.08.2016 315

Case No.:5/19/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01485/AM16/ RLA File :08/24/040/00291/AM16/ Lic.No/Date:0810137155 08.02.2016 Defer Date:23.08.2016 316

Case No.:62/4/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00125/AM17/ RLA File :03/95/040/00568/AM16/ Lic.No/Date:0310802284 08.02.2016 Defer Date:23.08.2016 317

Case No.:11/21/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01716/AM16/ RLA File :05/24/040/00534/AM16/ Lic.No/Date:0510397525 08.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/18/2016-PI(Norms) dated 27.06.2016, uploaded 318

Case No.:85/19/82-

ALC4/2015 Party Name:ANUPAM RASAYAN (INDIA) LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

49 HQ File :01/82/050/01566/AM16/ RLA File :52/24/040/00076/AM16/ Lic.No/Date:5210041759 09.02.2016 Defer Date:23.08.2016 Decision :Deferred. 319

Case No.:84/19/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01565/AM16/ RLA File :09/24/040/00654/AM16/ Lic.No/Date:0910063231 09.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/180/2016-PI(Norms) dated 18.07.2016, uploaded 320

Case No.:95/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01576/AM16/ RLA File :09/24/040/00639/AM16/ Lic.No/Date:0910063233 10.02.2016 Defer Date:23.08.2016 321

Case No.:8/2/82-ALC4/2016 Party

Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00008/AM17/ RLA File :34/24/040/00284/AM16/ Lic.No/Date:3410041870 10.02.2016 Defer Date:23.08.2016 Decision :Deferred. 322

Case No.:30/21/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01735/AM16/ RLA File :05/23/040/00467/AM16/ Lic.No/Date:0510397580 10.02.2016 Defer Date:23.08.2016 323

Case No.:34/4/82-ALC4/2016 Party Name:ANUH

PHARMA LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00097/AM17/ RLA File :03/94/040/00862/AM16/ Lic.No/Date:0310802461 11.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/119/2016-PI(Norms) dated 11.07.2016, uploaded 324

Case No.:97/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01578/AM16/ RLA File :09/24/040/00652/AM16/ Lic.No/Date:0910063248 11.02.2016 Defer Date:23.08.2016

50 325

Case No.:36/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00036/AM17/ RLA File :03/95/040/00870/AM16/ Lic.No/Date:0310802475 11.02.2016 Defer Date:23.08.2016 Decision :Deferred. 326

Case No.:35/4/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00098/AM17/ RLA File :03/94/040/00952/AM16/ Lic.No/Date:0310802542 12.02.2016 Defer Date:23.08.2016 327

Case No.:101/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01582/AM16/ RLA File :09/24/040/00668/AM16/ Lic.No/Date:0910063275 16.02.2016 Defer Date:23.08.2016 328

Case No.:5/2/82-ALC4/2016 Party Name:MAMTA

POLYCOATS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00005/AM17/ RLA File :34/24/040/00293/AM16/ Lic.No/Date:3410041887 16.02.2016 Defer Date:23.08.2016 329

Case No.:55/2/82-

ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00055/AM17/ RLA File :08/24/040/00392/AM16/ Lic.No/Date:0810137224 17.02.2016 Defer Date:23.08.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/95/2016-PI(Norms) dated July 2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 330

Case No.:35/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00035/AM17/ RLA File :03/95/040/00868/AM16/ Lic.No/Date:0310802660 17.02.2016 Defer Date:23.08.2016 331

Case No.:102/19/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01583/AM16/ RLA File :09/24/040/00666/AM16/ Lic.No/Date:0910063280 17.02.2016 Defer Date:23.08.2016 Decision :Deferred. 332 Case No.:52/2/82- Party Name:HPL Meet No/Date:8/82- Status:Deferred

51 ALC4/2016 ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER ALC4/2016 27.07.2016 HQ File :01/82/050/00052/AM17/ RLA File :05/23/040/00426/AM16/ Lic.No/Date:0510397651 18.02.2016 Defer Date:23.08.2016 333

Case No.:54/2/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00054/AM17/ RLA File :05/23/040/00487/AM16/ Lic.No/Date:0510397639 18.02.2016 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/85/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 334

Case No.:20/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00083/AM17/ RLA File :05/23/040/00469/AM16/ Lic.No/Date:0510397644 18.02.2016 Defer Date:23.08.2016 335

Case No.:23/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00086/AM17/ RLA File :05/23/040/00470/AM16/ Lic.No/Date:0510397643 18.02.2016 Defer Date:23.08.2016 336

Case No.:34/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00034/AM17/ RLA File :03/95/040/00888/AM16/ Lic.No/Date:0310802715 19.02.2016 Defer Date:23.08.2016 337

Case No.:9/2/82-ALC4/2016 Party Name:DEEPAK

NITRITE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00009/AM17/ RLA File :34/24/040/00161/AM16/ Lic.No/Date:3410041915 22.02.2016 Defer Date:23.08.2016 338

Case No.:28/2/82-

ALC4/2016 Party Name:MAC CHEM PRODUCTS (INDIA) PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/00028/AM17/ RLA File :03/95/040/00858/AM16/ Lic.No/Date:0310802836 24.02.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/74/2016-PI(Norms) dated June 2016, uploaded

52 339

Case No.:27/2/82-

ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00027/AM17/ RLA File :03/95/040/00874/AM16/ Lic.No/Date:0310802827 24.02.2016 Defer Date:23.08.2016 340

Case No.:22/2/82-

ALC4/2016 Party Name:SANJIVANI PARANTERAL LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00022/AM17/ RLA File :03/95/040/00897/AM16/ Lic.No/Date:0310802826 24.02.2016 Defer Date:23.08.2016 341

Case No.:18/4/82-

ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00081/AM17/ RLA File :05/24/040/00550/AM16/ Lic.No/Date:0510397711 24.02.2016 Defer Date:23.08.2016 342

Case No.:15/4/82-ALC4/2016 Party Name:FRESENIUS

KABI ONCOLOGY LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00078/AM17/ RLA File :05/23/040/00485/AM16/ Lic.No/Date:0510397721 25.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/116/2016-PI(Norms) dated July 2016, uploaded 343

Case No.:19/4/82-

ALC4/2016 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00082/AM17/ RLA File :05/24/040/00582/AM16/ Lic.No/Date:0510397715 25.02.2016 Defer Date:23.08.2016 344

Case No.:53/2/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/00053/AM17/ RLA File :08/24/040/00409/AM16/ Lic.No/Date:0810137314 26.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/86/2016-PI(Norms) dated June, 2016, uploaded 345

Case No.:24/4/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred

53 HQ File :01/82/050/00087/AM17/ RLA File :05/23/040/00491/AM16/ Lic.No/Date:0510397731 26.02.2016 Defer Date:23.08.2016 346

Case No.:4/2/82-ALC4/2016 Party Name:RIDDHI

PHARMA Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00004/AM17/ RLA File :34/24/040/00301/AM16/ Lic.No/Date:3410041924 26.02.2016 Defer Date:23.08.2016 Decision :Deferred . 347

Case No.:84/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00147/AM17/ RLA File :09/24/040/00648/AM16/ Lic.No/Date:0910063326 26.02.2016 Defer Date:23.08.2016 348

Case No.:43/2/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00043/AM17/ RLA File :03/95/040/00948/AM16/ Lic.No/Date:0310802906 29.02.2016 Defer Date:23.08.2016 349

Case No.:6/2/82-ALC4/2016 Party Name:BEST VALUE

CHEM PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00006/AM17/ RLA File :34/24/040/00308/AM16/ Lic.No/Date:3410041932 01.03.2016 Defer Date:23.08.2016 350

Case No.:42/4/82-

ALC4/2016 Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00105/AM17/ RLA File :03/94/040/01001/AM16/ Lic.No/Date:0310802950 01.03.2016 Defer Date:23.08.2016 351

Case No.:42/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00042/AM17/ RLA File :03/95/040/00939/AM16/ Lic.No/Date:0310802934 01.03.2016 Defer Date:23.08.2016 Decision :Deferred. 352

Case No.:14/2/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00014/AM17/ RLA File :34/24/040/00221/AM16/ Lic.No/Date:3410041935 01.03.2016 Defer Date:23.08.2016 Decision :Deferred.

54 353

Case No.:38/2/82-

ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00038/AM17/ RLA File :03/95/040/00920/AM16/ Lic.No/Date:0310802986 02.03.2016 Defer Date:23.08.2016 354

Case No.:28/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00091/AM17/ RLA File :03/94/040/00959/AM16/ Lic.No/Date:0310803032 03.03.2016 Defer Date:23.08.2016 Decision :Deferred. 355

Case No.:29/4/82-

ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00092/AM17/ RLA File :03/94/040/01004/AM16/ Lic.No/Date:0310803038 03.03.2016 Defer Date:23.08.2016 Decision :Deferred. 356

Case No.:1/21/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/01706/AM16/ RLA File :09/24/040/00702/AM16/ Lic.No/Date:0910063354 03.03.2016 Defer Date:23.08.2016 Pharmaceuticals forwarded vide O.M. No.35011/14/2016-PI(Norms) dated 11.07.2016, uploaded 357

Case No.:3/4/82-ALC4/2016 Party Name:JAGSONPAL

PHARMACEUTICALS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00066/AM17/ RLA File :05/23/040/00502/AM16/ Lic.No/Date:0510397820 04.03.2016 Defer Date:23.08.2016 Decision :Deferred. 358

Case No.:50/2/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00050/AM17/ RLA File :05/24/040/00597/AM16/ Lic.No/Date:0510397827 04.03.2016 Defer Date:23.08.2016 Decision :Deferred for want of comments from DBT. 359

Case No.:66/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00129/AM17/ RLA File :04/24/040/00257/AM16/ Lic.No/Date:0410161685 04.03.2016 Defer Date:23.08.2016

55 360

Case No.:67/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00130/AM17/ RLA File :04/24/040/00256/AM16/ Lic.No/Date:0410161684 04.03.2016 Defer Date:23.08.2016 361

Case No.:68/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00131/AM17/ RLA File :04/24/040/00255/AM16/ Lic.No/Date:0410161683 04.03.2016 Defer Date:23.08.2016 362

Case No.:40/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00103/AM17/ RLA File :03/94/040/01017/AM16/ Lic.No/Date:0310803105 07.03.2016 Defer Date:23.08.2016 Decision :Deferred. 363

Case No.:41/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00104/AM17/ RLA File :03/94/040/01018/AM16/ Lic.No/Date:0310803103 07.03.2016 Defer Date:23.08.2016 364

Case No.:57/4/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00120/AM17/ RLA File :03/94/040/01041/AM16/ Lic.No/Date:0310803137 08.03.2016 Defer Date:23.08.2016 Decision :Deferred. 365

Case No.:26/2/82-

ALC4/2016 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/00026/AM17/ RLA File :03/95/040/00672/AM16/ Lic.No/Date:0310803128 08.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/94/2016-PI(Norms) dated July 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 366

Case No.:23/2/82-ALC4/2016 Party Name:MERCK

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00023/AM17/ RLA File :03/95/040/00936/AM16/ Lic.No/Date:0310803135 08.03.2016 Defer Date:

56 Pharmaceuticals forwarded vide O.M. No.35011/96/2016-PI(Norms) dated July 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 367

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

SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00007/AM17/ RLA File :34/24/040/00323/AM16/ Lic.No/Date:3410041954 08.03.2016 Defer Date:23.08.2016 Decision :Deferred. 368

Case No.:56/4/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00119/AM17/ RLA File :03/94/040/01040/AM16/ Lic.No/Date:0310803170 09.03.2016 Defer Date:23.08.2016 Decision :Deferred. 369

Case No.:55/4/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00118/AM17/ RLA File :03/94/040/01044/AM16/ Lic.No/Date:0310803171 09.03.2016 Defer Date:23.08.2016 370

Case No.:30/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00030/AM17/ RLA File :03/95/040/00940/AM16/ Lic.No/Date:0310803176 09.03.2016 Defer Date:23.08.2016 Decision :Deferred. 371

Case No.:31/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00031/AM17/ RLA File :03/95/040/00931/AM16/ Lic.No/Date:0310803177 09.03.2016 Defer Date:23.08.2016 Decision :Deferred. 372

Case No.:3/2/82-ALC4/2016 Party Name:RONAK

CHEMICALS Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00003/AM17/ RLA File :34/24/040/00329/AM16/ Lic.No/Date:3410041957 09.03.2016 Defer Date:23.08.2016 Decision :Deferred. 373

Case No.:29/2/82-

ALC4/2016 Party Name:RUSAN PHARMA LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00029/AM17/ RLA File :03/95/040/00924/AM16/ Lic.No/Date:0310803186 09.03.2016 Defer Date:23.08.2016

57 374

Case No.:39/4/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00102/AM17/ RLA File :03/94/040/00973/AM16/ Lic.No/Date:0310803223 10.03.2016 Defer Date:23.08.2016 375

Case No.:58/2/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00058/AM17/ RLA File :22/24/040/00115/AM16/ Lic.No/Date:2210015444 11.03.2016 Defer Date:23.08.2016 376

Case No.:59/2/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00059/AM17/ RLA File :22/24/040/00112/AM16/ Lic.No/Date:2210015443 11.03.2016 Defer Date:23.08.2016 377

Case No.:24/2/82-

ALC4/2016 Party Name:SCOPE CHEMICALS PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00024/AM17/ RLA File :03/95/040/00955/AM16/ Lic.No/Date:0310803229 11.03.2016 Defer Date:23.08.2016 Decision :Deferred. 378

Case No.:38/4/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00101/AM17/ RLA File :03/94/040/01049/AM16/ Lic.No/Date:0310803267 14.03.2016 Defer Date:23.08.2016 Decision :Deferred. 379

Case No.:25/4/82-ALC4/2016 Party Name:ENVEE DRUGS

PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00088/AM17/ RLA File :34/24/040/00334/AM16/ Lic.No/Date:3410041974 14.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/123/2016-PI(Norms) dated 11.07.2016, uploaded 380

Case No.:27/4/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00090/AM17/ RLA File :03/94/040/00981/AM16/ Lic.No/Date:0310803290 14.03.2016 Defer Date:23.08.2016 Decision :Deferred.

58 381

Case No.:82/4/82-

ALC4/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00145/AM17/ RLA File :03/95/040/00967/AM16/ Lic.No/Date:0310803283 14.03.2016 Defer Date:23.08.2016 Decision :Deferred. 382

Case No.:51/2/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/00051/AM17/ RLA File :08/24/040/00440/AM16/ Lic.No/Date:0810137433 15.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/92/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 383

Case No.:37/4/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00100/AM17/ RLA File :03/94/040/00962/AM16/ Lic.No/Date:0310803341 15.03.2016 Defer Date:23.08.2016 384

Case No.:26/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00089/AM17/ RLA File :03/94/040/01057/AM16/ Lic.No/Date:0310803376 16.03.2016 Defer Date:23.08.2016 Decision :Deferred. 385

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

Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00070/AM17/ RLA File :05/23/040/00468/AM16/ Lic.No/Date:0510397952 17.03.2016 Defer Date:23.08.2016 Decision :Deferred 386

Case No.:13/4/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00076/AM17/ RLA File :05/23/040/00390/AM16/ Lic.No/Date:0510397953 17.03.2016 Defer Date:23.08.2016 Decision :Deferred. 387

Case No.:12/4/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Approved HQ File :01/82/050/00075/AM17/ RLA File :05/24/040/00613/AM16/ Lic.No/Date:0510397962 17.03.2016 Defer Date:

59 Pharmaceuticals forwarded vide O.M. No.35011/778/2015-PI(Norms) dated June 2016, uploaded 388

Case No.:9/4/82-ALC4/2016 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00072/AM17/ RLA File :05/24/040/00603/AM16/ Lic.No/Date:0510397956 17.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/129/2016-PI(Norms) dated 18.07.2016, uploaded 389

Case No.:10/4/82-ALC4/2016 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00073/AM17/ RLA File :05/24/040/00554/AM16/ Lic.No/Date:0510397955 17.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/125/2016-PI(Norms) dated 11.07.2016, uploaded 390

Case No.:14/4/82-ALC4/2016 Party Name:INDO PHYTO

CHEMICALS PVT LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00077/AM17/ RLA File :05/23/040/00526/AM16/ Lic.No/Date:0510397978 18.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/85/2016-PI(Norms) dated June 2016, uploaded 391

Case No.:5/4/82-ALC4/2016 Party Name:JODAS

EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00068/AM17/ RLA File :05/23/040/00544/AM16/ Lic.No/Date:0510397982 18.03.2016 Defer Date:23.08.2016 392

Case No.:8/4/82-ALC4/2016 Party Name:JODAS

EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00071/AM17/ RLA File :05/23/040/00541/AM16/ Lic.No/Date:0510397985 18.03.2016 Defer Date:23.08.2016 393

Case No.:85/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00148/AM17/ RLA File :09/24/040/00742/AM16/ Lic.No/Date:0910063432 18.03.2016 Defer Date:23.08.2016

60 Decision :Deferred. 394

Case No.:46/2/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00046/AM17/ RLA File :08/24/040/00431/AM16/ Lic.No/Date:0810137474 21.03.2016 Defer Date:23.08.2016 395

Case No.:48/2/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00048/AM17/ RLA File :08/24/040/00430/AM16/ Lic.No/Date:0810137473 21.03.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.01/82 dated 04.04.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 396

Case No.:36/4/82-

ALC4/2016 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00099/AM17/ RLA File :03/94/040/01056/AM16/ Lic.No/Date:0310803468 21.03.2016 Defer Date:23.08.2016 Decision :Deferred. 397

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

EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00067/AM17/ RLA File :05/23/040/00543/AM16/ Lic.No/Date:0510397989 21.03.2016 Defer Date:23.08.2016 Decision :Deferred. 398

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

EXPOIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00069/AM17/ RLA File :05/23/040/00542/AM16/ Lic.No/Date:0510397988 21.03.2016 Defer Date:23.08.2016 Decision :Deferred. 399

Case No.:53/4/82-ALC4/2016 Party Name:ANUH

PHARMA LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:
Approved HQ File :01/82/050/00116/AM17/ RLA File :03/94/040/01066/AM16/ Lic.No/Date:0310803494 22.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/119/2016-PI(Norms) dated 11.07.2016, uploaded 400 Case No.:47/2/82-ALC4/2016 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:8/82- ALC4/2016 Status: Approved

61 27.07.2016 HQ File :01/82/050/00047/AM17/ RLA File :08/24/040/00444/AM16/ Lic.No/Date:0810137475 22.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/84/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 401

Case No.:81/4/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00144/AM17/ RLA File :03/95/040/00984/AM16/ Lic.No/Date:0310803500 22.03.2016 Defer Date:23.08.2016 Decision :Deferred. 402

Case No.:49/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00112/AM17/ RLA File :03/94/040/01046/AM16/ Lic.No/Date:0310803524 23.03.2016 Defer Date:23.08.2016 Decision :Deferred. 403

Case No.:50/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00113/AM17/ RLA File :03/94/040/01070/AM16/ Lic.No/Date:0310803526 23.03.2016 Defer Date:23.08.2016 Decision :Deferred. 404

Case No.:63/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00126/AM17/ RLA File :03/94/040/01037/AM16/ Lic.No/Date:0310803569 28.03.2016 Defer Date:23.08.2016 Decision :Deferred. 405

Case No.:47/4/82-

ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00110/AM17/ RLA File :03/94/040/01078/AM16/ Lic.No/Date:0310803568 28.03.2016 Defer Date:23.08.2016 Decision :Deferred. 406

Case No.:60/2/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/01863/AM16/ RLA File :09/24/040/00710/AM16/ Lic.No/Date:0910063454 29.03.2016 Defer Date:23.08.2016 407 Case No.:46/4/82- ALC4/2016 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:8/82- ALC4/2016 Status:Deferred

62 27.07.2016 HQ File :01/82/050/00109/AM17/ RLA File :03/94/040/01109/AM16/ Lic.No/Date:0310803597 29.03.2016 Defer Date:23.08.2016 Decision : The committee decided to call for COA from foreign supplier for export and import items and deferred the case. 408

Case No.:80/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00143/AM17/ RLA File :03/95/040/01007/AM16/ Lic.No/Date:0310803591 29.03.2016 Defer Date:23.08.2016 Decision :Deferred. 409

Case No.:63/2/82-ALC4/2016 Party Name:HETERO

DRUGS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/01866/AM16/ RLA File :09/24/040/00769/AM16/ Lic.No/Date:0910063463 30.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/630/2015-PI(Norms) dated June 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 410

Case No.:43/4/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00106/AM17/ RLA File :03/94/040/01108/AM16/ Lic.No/Date:0310803663 31.03.2016 Defer Date:23.08.2016 411

Case No.:69/4/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00132/AM17/ RLA File :04/24/040/00275/AM16/ Lic.No/Date:0410161762 31.03.2016 Defer Date:23.08.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/66/2016-PI(Norms) dated 27.06.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 412

Case No.:76/4/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00139/AM17/ RLA File :03/95/040/01015/AM16/ Lic.No/Date:0310803674 31.03.2016 Defer Date:23.08.2016 Decision :Deferred. 413

Case No.:65/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File RLA File Lic.No/Date:0410161772 Defer

63 :01/82/050/00128/AM17/ :04/24/040/00283/AM16/ 01.04.2016 Date:23.08.2016 414

Case No.:79/4/82-ALC4/2016 Party Name:MAKSON

INDUSTRIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00142/AM17/ RLA File :03/95/040/01000/AM16/ Lic.No/Date:0310803763 04.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of Development Commissioner (MSME) forwarded vide 23(2) 2014-Chem-718 dated 4.1.2016 , 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. 415

Case No.:77/4/82-

ALC4/2016 Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00140/AM17/ RLA File :03/95/040/00001/AM17/ Lic.No/Date:0310803752 04.04.2016 Defer Date:23.08.2016 416

Case No.:92/4/82-

ALC4/2016 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00155/AM17/ RLA File :29/24/040/00010/AM16/ Lic.No/Date:2910025244 06.04.2016 Defer Date:23.08.2016 Decision :Deferred. 417

Case No.:72/4/82-ALC4/2016 Party Name:PRASOL

CHEMICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00135/AM17/ RLA File :03/95/040/00981/AM16/ Lic.No/Date:0310803838 07.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/107/2011-Ch-II dated 12.01.2016, 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. 418

Case No.:83/4/82-ALC4/2016 Party Name:PRASOL

CHEMICALS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00146/AM17/ RLA File :03/95/040/00982/AM16/ Lic.No/Date:0310803855 07.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/107/2011-Ch-II dated 12.01.2016, 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. 419

Case No.:71/4/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00134/AM17/ RLA File :03/95/040/00020/AM17/ Lic.No/Date:0310803870 11.04.2016 Defer Date:

64 Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 23.11.2015 dated 27.06.2016, 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. 420

Case No.:74/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00137/AM17/ RLA File :03/95/040/00021/AM17/ Lic.No/Date:0310803871 11.04.2016 Defer Date:23.08.2016 Decision :Deferred. 421

Case No.:78/4/82-ALC4/2016 Party Name:MAKSON

INDUSTRIES PVT. LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00141/AM17/ RLA File :03/95/040/00999/AM16/ Lic.No/Date:0310803899 12.04.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of Development Commissioner (MSME) forwarded vide 23(2) 2014-Chem-718 dated 4.1.2016 , 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. 422

Case No.:66/2/82-

ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00060/AM17/ RLA File :32/24/040/00043/AM16/ Lic.No/Date:3210077862 13.04.2016 Defer Date:23.08.2016 Decision :Deferred. 423

Case No.:87/4/82-ALC4/2016 Party Name:PI INDUSTRIES

LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Approved HQ File :01/82/050/00150/AM17/ RLA File :13/24/040/00054/AM16/ Lic.No/Date:1310048210 13.04.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.07/82 dated 27.06.2013 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 424

Case No.:86/4/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00149/AM17/ RLA File :52/24/040/00001/AM17/ Lic.No/Date:5210041862 19.04.2016 Defer Date:23.08.2016 Decision :The Committee decided to send copy of application to DoP. 425

Case No.:67/2/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00061/AM17/ RLA File :09/24/040/00014/AM17/ Lic.No/Date:0910063515 19.04.2016 Defer Date:23.08.2016

65 426

Case No.:68/2/82-ALC4/2016 Party Name:HETERO LABS

LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status: Deferred HQ File :01/82/050/00062/AM17/ RLA File :09/24/040/00019/AM17/ Lic.No/Date:0910063520 19.04.2016 Defer Date: 27.07.2016 427

Case No.:69/2/82-

ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00063/AM17/ RLA File :09/24/040/00739/AM16/ Lic.No/Date:0910063533 21.04.2016 Defer Date:23.08.2016 428

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

ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00174/AM17/ RLA File :03/95/040/00013/AM17/ Lic.No/Date:0310804365 03.05.2016 Defer Date:23.08.2016 Decision :Deferred. 429

Case No.:95/4/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred
HQ File :01/82/050/00158/AM17/ RLA File :03/94/040/00129/AM17/ Lic.No/Date:0310804639 12.05.2016 Defer Date:23.08.2016 Decision :Deferred 430

Case No.:3/8/82-ALC4/2016 Party Name:ALEMBIC

PHARMACEUTICALS LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Case Deferred HQ File :01/82/050/00341/AM17/ RLA File :34/24/040/00079/AM17/ Lic.No/Date:3410042326 05.07.2016 Defer Date:23.08.2016 431

Case No.:2/8/82-ALC4/2016 Party Name:HELLO PAINTS

(P) LTD Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Case Deferred HQ File :01/82/050/00340/AM17/ RLA File :05/23/040/00139/AM17/ Lic.No/Date:0510398996 05.07.2016 Defer Date:23.08.2016 Decision :Deferred. 432

Case No.:4/8/82-ALC4/2016 Party Name:GOPINATH

CHEM-TECH LTD., Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Case Deferred HQ File :01/82/050/00342/AM17/ RLA File :08/24/040/00132/AM17/ Lic.No/Date:0810138237 07.07.2016 Defer Date:23.08.2016 Decision :Deferred. 433 Case No.:5/8/82-ALC4/2016 Party Name:MYLAN Meet No/Date:8/82- Status:Case

66 LABORATORIES LIMITED ALC4/2016 27.07.2016 Deferred HQ File :01/82/050/00343/AM17/ RLA File :09/24/040/00197/AM17/ Lic.No/Date:0910063918 14.07.2016 Defer Date:23.08.2016 Decision :Deferred. 434

Case No.:6/8/82-ALC4/2016 Party Name:ATUL

LIMITED, Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Case
Deferred HQ File :01/82/050/00344/AM17/ RLA File :08/24/040/00134/AM17/ Lic.No/Date:0810138308 18.07.2016 Defer Date:23.08.2016 Decision :Deferred. 435

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

PHARMA LIMITED Meet No/Date:8/82- ALC4/2016 27.07.2016 Status:Deferred HQ File :01/82/050/00346/AM17/ RLA File :09/24/040/00198/AM17/ Lic.No/Date:0910063961 20.07.2016 Defer Date:23.08.2016 Outside Agenda of NC Meeting No. 08/2016 Scheduled to be held on 27.07.2016

Case No. B- 01

M.No.08/AM-17 Date 27.07.2016 M/s. Yasho Industries Pvt. Ltd. File No. 01/82/050/1121/AM13 RLA No 03/95/040/00735/AM13 Adv.Auth. No. 0310718082 dated 24.12.2012 Decision: The Committee considered this case for correction in the quantity of import item No.1 Hydroquinone............0.1.247kg as mentioned in the recommendation of D/o D&PC forwarded vide U.O.No.14010/95/2011-Ch-II dated 23.11.2015 as per agenda.
The Committee has examined the matter in detail and it is seen that in the earlier recommendation provided by D/o C&PC vide U.O.No.14010/95/2011-Ch-II dated 12.6.2013, uploaded at the end of these minutes wherein the quantity of import item No.1 Hydroquinone.......1.247kg is mentioned. The Committee also calculate the quantity of import item applied by the firm. Accordingly, the Committee in view of the above decided to correct the quantity of import item to read as Hydroquinone.......... 1.247kg. RA may take further necessary action as per the decision of NC.

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