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. 06/82/2016 of 2016-17, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products and falling under Chapter 29 and 30, held on 14.06.2016 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 05/82 held 08.06.2016 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 : 6/82-ALC4/2016 MEETING DATE : 14.06.2016 1

Case No.:132/8/82-

ALC4/2014 Party Name:PROVENTUS LIFE SCIENCES PRIVATE LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred
HQ File :01/82/050/00796/AM15/ RLA File :04/24/040/00395/AM08/ Lic.No/Date:0410094357 12.03.2008 Defer Date:27.07.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.05/AM16 is awaited. The Committee accordingly decided to await the reply and defer the case. 2

Case No.:70/4/82-

ALC4/2016 Party Name:RAKSHIT DRUGS PVT LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred for want of comments from DoP. 3

Case No.:15/2/82-

ALC4/2016 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred .

2 4

Case No.:36/19/82-

ALC4/2014 Party Name:ALKALI METALS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 5

Case No.:38/19/82-

ALC4/2014 Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred for want of comments from DoP. 6

Case No.:18/19/82-

ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01506/AM15/ RLA File :09/24/040/00085/AM13/ Lic.No/Date:0910052887 05.06.2012 Defer Date:27.07.2016 Decision : The Committee noted that information furnished by the firm is incomplete. The Committee decided to call for Central Excise Certificate for production consumption of export product and deferred the case. 7

Case No.:28/26/82-

ALC4/2012 Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00936/AM13/ RLA File :07/24/040/00268/AM13/ Lic.No/Date:0710090949 25.09.2012 Defer Date: Decision : The representative of D/o Pharmaceutical has informed in the meeting that norms for same product for same firm has been ratified by NC in its meeting No.11/AM10 dated 15.06.2010 and same norms may be given on repeat basis. There is no other application for any other firm for comparison. The Committee accordingly, decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals as mentioned above , 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. 8

Case No.:113/14/82-

ALC4/2013 Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00698/AM14/ RLA File :05/24/040/00488/AM13/ Lic.No/Date:0510350269 26.03.2013 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.11 dated 26.11.2014 in respect of same, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 9

Case No.:173/5/82-

ALC4/2015 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred. 10 Case No.:61/4/82- Party Name:ADCOCK Meet No/Date:6/82- Status:Deferred.

3 ALC4/2016 INGRAM LTD, ALC4/2016 14.06.2016 HQ File :01/82/050/00124/AM17/ RLA File :07/24/040/00097/AM14/ Lic.No/Date:0710096460 04.07.2013 Defer Date:27.07.2016 Decision : The Committee decided to send copy of application to DoP and deferred the case. 11

Case No.:31/4/82-

ALC4/2014 Party Name:UNIVERSAL BIOFUELS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00279/AM15/ RLA File :09/24/040/00155/AM14/ Lic.No/Date:0910056959 31.07.2013 Defer Date:27.07.2016 Decision :The Committee noted that information called for from the firm in NC meeting No.19/AM16 is awaited. The Committee decided to await the reply and deferred the case. 12

Case No.:41/16/82-

ALC4/2013 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : The Committee decided to send copy of application to DoP and deferred the case. 13

Case No.:140/23/82-

ALC4/2013 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 14

Case No.:48/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 15

Case No.:208/3/82-

ALC4/2014 Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 16

Case No.:108/3/82-

ALC4/2014 Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 17

Case No.:177/3/82-

ALC4/2014 Party Name:INDO AMINES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00181/AM15/ RLA File :03/94/040/00958/AM14/ Lic.No/Date:0310768616 30.01.2014 Defer Date:27.07.2016

4 18

Case No.:58/6/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 19

Case No.:106/3/82-

ALC4/2014 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 20

Case No.:58/4/82-

ALC4/2014 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :The Committee decided to send copy of application to DoP and deferred the case. 21

Case No.:57/3/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.17/AM16 dated 27.1.2016 is awaited. The Committee decided to await the reply and deferred the case. 22

Case No.:51/5/82-

ALC4/2014 Party Name:JINDAL DRUGS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 23

Case No.:51/6/82-

ALC4/2014 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 24

Case No.:50/6/82-

ALC4/2014 Party Name:V & V PHARMA INDUSTRIES Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00452/AM15/ RLA File :03/95/040/01061/AM14/ Lic.No/Date:0310776760 02.04.2014 Defer Date:27.07.2016 Decision :Deferred. 25 Case No.:20/6/82- ALC4/2014 Party Name:ADISHANK CHEMICALS PVT.LTD. Meet No/Date:6/82- ALC4/2016 Status:Deferred.

5 14.06.2016 HQ File :01/82/050/00422/AM15/ RLA File :03/94/040/01140/AM14/ Lic.No/Date:0310777786 09.04.2014 Defer Date:27.07.2016 Decision :Deferred. 26

Case No.:91/4/82-

ALC4/2016 Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00154/AM17/ RLA File :07/24/040/00441/AM14/ Lic.No/Date:0710103512 09.04.2014 Defer Date: Decision : The representative of D/o Pharmaceutical has informed in the meeting that norms for same product for same firm has been ratified by NC in its meeting No.16/AM13 dated 23.08.2012 (Case No.B-268) and same norms may be given on repeat basis. There is no other application for any other firm for comparison. The Committee accordingly, decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals as mentioned above , 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. 27

Case No.:49/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 28

Case No.:237/6/82-

ALC4/2014 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 29

Case No.:13/2/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.17/AM16 dated 27.1.2016 is awaited. The Committee decided to await the reply and deferred the case. 30

Case No.:38/8/82-

ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :The Committee decided to send a copy of application to DoP and deferred the case. 31

Case No.:165/6/82-

ALC4/2014 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred.

6 32

Case No.:106/8/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 33

Case No.:60/10/82-

ALC4/2014 Party Name:BIO-TECH OPHTHALMICS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00974/AM15/ RLA File :08/24/040/00116/AM15/ Lic.No/Date:0810132332 13.06.2014 Defer Date:27.07.2016 Decision :The Committee noted that information called for from the firm in NC meeting No.11 dated 28.10.2015 is awaited. The Committee accordingly decided to defer the case. 34

Case No.:77/8/82-

ALC4/2014 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 35

Case No.:20/8/82-

ALC4/2014 Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00684/AM15/ RLA File :09/24/040/00139/AM15/ Lic.No/Date:0910060467 17.06.2014 Defer Date:27.07.2016 Decision :The committee decided to send a copy of application to DoP and deferred the case. 36

Case No.:202/6/82-

ALC4/2014 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 37

Case No.:72/10/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00986/AM15/ RLA File :07/24/040/00112/AM15/ Lic.No/Date:0710105884 18.07.2014 Defer Date:27.07.2016 38

Case No.:203/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 39

Case No.:21/9/82-

ALC4/2014 Party Name:PI INDUSTRIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

7 40

Case No.:264/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 41

Case No.:255/13/82-

ALC4/2014 Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:12.06.2016 42

Case No.:254/13/82-

ALC4/2014 Party Name:SEQUENT SCIENTIFIC LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:
Deferred. HQ File :01/82/050/01257/AM15/ RLA File :03/95/040/00459/AM15/ Lic.No/Date:0310788513 28.08.2014 Defer Date:27.07.2016 Decision : Information called for from the firm in NC meeting No.09 dated 30.09.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case. 43

Case No.:263/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 44

Case No.:217/13/82-

ALC4/2014 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :The Committee noted that information called for from the firm in NC meeting No.02 dated 29.04.2015 is awaited. The Committee accordingly deferred the case. 45

Case No.:6/8/82-

ALC4/2014 Party Name:HONOUR LAB LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 46

Case No.:380/5/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 47 Case No.:188/13/82- ALC4/2014 Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:6/82- ALC4/2016 Status:Deferred.

8 14.06.2016 HQ File :01/82/050/01191/AM15/ RLA File :03/94/040/00102/AM15/ Lic.No/Date:0310789322 17.09.2014 Defer Date:27.07.2016 48

Case No.:57/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 49

Case No.:59/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01062/AM15/ RLA File :05/23/040/00276/AM15/ Lic.No/Date:0510391245 19.09.2014 Defer Date:27.07.2016 50

Case No.:9/15/82-

ALC4/2014 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Department of Pharmaceuticals have furnished their recommendation vide O.M. no. 35011/671/2015-PI (norms) dated 03.05.2016 has also pointed out to ensure the availability of valid drug manufacturing licence (DML) for commercial production. Keeping this in view, the committee decided to call for copy of valid Drug Manufacturing license from the firm. 51

Case No.:17/13/82-

ALC4/2014 Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 52

Case No.:115/13/82-

ALC4/2014 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 53

Case No.:89/4/82-

ALC4/2016 Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00152/AM17/ RLA File :09/24/040/00304/AM15/ Lic.No/Date:0910061022 24.09.2014 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.35011/72/2014-PI(Norms) dated 21.4.2014, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 54 Case No.:74/13/82- ALC4/2014 Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:6/82- ALC4/2016 Status:Deferred.

9 14.06.2016 HQ File :01/82/050/01077/AM15/ RLA File :05/23/040/00282/AM15/ Lic.No/Date:0510391308 24.09.2014 Defer Date:27.07.2016 Decision :Deferred. 55

Case No.:9/2/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00024/AM16/ RLA File :05/23/040/00261/AM15/ Lic.No/Date:0510391358 26.09.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/503/2015-PI(Norms) dated 21.03.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 56

Case No.:19/13/82-

ALC4/2014 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 57

Case No.:160/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 58

Case No.:35/13/82-

ALC4/2014 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 59

Case No.:76/13/82-

ALC4/2014 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01079/AM15/ RLA File :04/24/040/00163/AM15/ Lic.No/Date:0410159566 13.10.2014 Defer Date:27.07.2016 60

Case No.:42/15/82-

ALC4/2014 Party Name:PVS AGRO VET Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 61

Case No.:154/13/82-

ALC4/2014 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

10 62

Case No.:12/20/82-

ALC4/2015 Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 63

Case No.:110/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 64

Case No.:86/10/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 65

Case No.:266/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01269/AM15/ RLA File :08/24/040/00289/AM15/ Lic.No/Date:0810133735 05.11.2014 Defer Date:27.07.2016 66

Case No.:268/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 67

Case No.:107/13/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 68

Case No.:114/13/82-

ALC4/2014 Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01117/AM15/ RLA File :52/24/040/00042/AM15/ Lic.No/Date:5210041292 10.11.2014 Defer Date:27.07.2016 69

Case No.:111/13/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File RLA File Lic.No/Date:0510391927 Defer

11 :01/82/050/01114/AM15/ :05/23/040/00352/AM15/ 11.11.2014 Date:27.07.2016 Decision : Deferred from want of comments from AYUSH. 70

Case No.:393/5/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00533/AM16/ RLA File :09/24/040/00387/AM15/ Lic.No/Date:0910061210 11.11.2014 Defer Date:27.07.2016 71

Case No.:61/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01427/AM15/ RLA File :34/24/040/00198/AM15/ Lic.No/Date:3410040676 11.11.2014 Defer Date:27.07.2016 72

Case No.:100/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 73

Case No.:120/13/82-

ALC4/2014 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 74

Case No.:77/18/82-

ALC4/2014 Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 75

Case No.:65/18/82-

ALC4/2014 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 76

Case No.:42/18/82-

ALC4/2014 Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 77

Case No.:65/15/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred.

12 HQ File :01/82/050/01352/AM15/ RLA File :05/23/040/00360/AM15/ Lic.No/Date:0510392011 14.11.2014 Defer Date:27.07.2016 78

Case No.:52/15/82-

ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01339/AM15/ RLA File :09/24/040/00408/AM15/ Lic.No/Date:0910061280 20.11.2014 Defer Date:27.07.2016 79

Case No.:16/18/82-

ALC4/2014 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 80

Case No.:74/18/82-

ALC4/2014 Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 81

Case No.:18/18/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred . 82

Case No.:15/2/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00030/AM16/ RLA File :03/95/040/00639/AM15/ Lic.No/Date:0310791416 25.11.2014 Defer Date:27.07.2016 83

Case No.:11/2/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00026/AM16/ RLA File :05/23/040/00370/AM15/ Lic.No/Date:0510392171 27.11.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/503/2015-PI(Norms) dated 21.03.2016, uploaded 84

Case No.:32/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred .

13 85

Case No.:26/18/82-

ALC4/2014 Party Name:SADHANA NITRO CHEM LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 86

Case No.:92/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 87

Case No.:154/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00294/AM16/ RLA File :03/95/040/00740/AM15/ Lic.No/Date:0310791735 05.12.2014 Defer Date:27.07.2016 88

Case No.:82/18/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred for want of comments from AYUSH. 89

Case No.:101/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 90

Case No.:97/18/82-

ALC4/2014 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 91

Case No.:119/18/82-

ALC4/2014 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01485/AM15/ RLA File :05/24/040/00419/AM15/ Lic.No/Date:0510392414 15.12.2014 Defer Date:27.07.2016 92

Case No.:224/5/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00364/AM16/ RLA File :09/24/040/00531/AM15/ Lic.No/Date:0910061427 22.12.2014 Defer Date:27.07.2016

14 Decision : Deferred for want of comments from AYUSH. 93

Case No.:91/18/82-

ALC4/2014 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 94

Case No.:84/18/82-

ALC4/2014 Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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. 95

Case No.:3/1/82-

ALC4/2015 Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00003/AM16/ RLA File :05/23/040/00450/AM15/ Lic.No/Date:0510392649 01.01.2015 Defer Date:27.07.2016 96

Case No.:96/18/82-

ALC4/2014 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 97

Case No.:92/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 98

Case No.:59/5/82-

ALC4/2015 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 99

Case No.:72/5/82-

ALC4/2015 Party Name:MICRO INKS PRIVATE LIMITED. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00212/AM16/ RLA File :03/95/040/00658/AM15/ Lic.No/Date:0310793017 16.01.2015 Defer Date:27.07.2016 100

Case No.:10/16/82-

ALC4/2014 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File RLA File Lic.No/Date:0910061548 Defer

15 :01/82/050/01362/AM15/ :09/24/040/00529/AM15/ 21.01.2015 Date:27.07.2016 101

Case No.:12/16/82-

ALC4/2014 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 102

Case No.:86/5/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 103

Case No.:204/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 104

Case No.:31/7/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00636/AM16/ RLA File :05/24/040/00498/AM15/ Lic.No/Date:0510392987 27.01.2015 Defer Date:27.07.2016 Decision : Deferred . 105

Case No.:32/7/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 106

Case No.:25/7/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 107

Case No.:230/5/82-

ALC4/2015 Party Name:R.K.INDUSTRIES, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 108

Case No.:163/5/82-

ALC4/2015 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred.

16 HQ File :01/82/050/00303/AM16/ RLA File :05/24/040/00503/AM15/ Lic.No/Date:0510393026 29.01.2015 Defer Date:27.07.2016 109

Case No.:166/5/82-

ALC4/2015 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00306/AM16/ RLA File :08/24/040/00386/AM15/ Lic.No/Date:0810134454 30.01.2015 Defer Date:27.07.2016 110

Case No.:169/5/82-

ALC4/2015 Party Name:TIDE INDUSTRIES Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 111

Case No.:91/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 112

Case No.:52/19/82-

ALC4/2014 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 113

Case No.:38/7/82-

ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 114

Case No.:332/5/82-

ALC4/2015 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00472/AM16/ RLA File :03/95/040/00991/AM15/ Lic.No/Date:0310794000 19.02.2015 Defer Date:27.07.2016 115

Case No.:280/5/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 116 Case No.:298/5/82- ALC4/2015 Party Name:MEDICEF PHARMA, Meet No/Date:6/82- ALC4/2016 Status: Approved

17 14.06.2016 HQ File :01/82/050/00438/AM16/ RLA File :22/24/040/00095/AM15/ Lic.No/Date:2210015200 27.02.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/502/2015-PI(Norms) dated 28.12.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 117

Case No.:444/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00584/AM16/ RLA File :03/94/040/01132/AM15/ Lic.No/Date:0310794412 09.03.2015 Defer Date:27.07.2016 118

Case No.:413/5/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 119

Case No.:106/7/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 120

Case No.:16/1/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01542/AM15/ RLA File :09/24/040/00703/AM15/ Lic.No/Date:0910061716 17.03.2015 Defer Date:27.07.2016 121

Case No.:427/5/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00567/AM16/ RLA File :03/95/040/01071/AM15/ Lic.No/Date:0310794916 26.03.2015 Defer Date:27.07.2016 122

Case No.:431/5/82-

ALC4/2015 Party Name:EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 123

Case No.:9/1/82-

ALC4/2015 Party Name:VIVIMED LABS ( ALATHUR) PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00009/AM16/ RLA File :04/24/040/00292/AM15/ Lic.No/Date:0410160364 30.03.2015 Defer Date:27.07.2016

18 124

Case No.:448/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 125

Case No.:12/7/82-

ALC4/2015 Party Name:SHILPA MEDICARE LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved. HQ File :01/82/050/00617/AM16/ RLA File :07/24/040/00002/AM16/ Lic.No/Date:0710108028 15.04.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/640/2015-PI(Norms) dated 01.06.2016, uploaded 126

Case No.:32/5/82-

ALC4/2015 Party Name:LANTECH PHARMACEUTICALS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00172/AM16/ RLA File :09/24/040/00011/AM16/ Lic.No/Date:0910061900 20.04.2015 Defer Date:27.07.2016 127

Case No.:8/2/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00023/AM16/ RLA File :09/24/040/00043/AM16/ Lic.No/Date:0910061906 21.04.2015 Defer Date:27.07.2016 128

Case No.:174/7/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred . 129

Case No.:62/8/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00858/AM16/ RLA File :09/24/040/00028/AM16/ Lic.No/Date:0910061955 01.05.2015 Defer Date:27.07.2016 130

Case No.:50/7/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00655/AM16/ RLA File :09/24/040/00041/AM16/ Lic.No/Date:0910061976 06.05.2015 Defer Date:27.07.2016 131 Case No.:3/3/82- Party Name:RA CHEM Meet No/Date:6/82- Status:Deferred.

19 ALC4/2015 PHARMA LIMITED ALC4/2016 14.06.2016 HQ File :01/82/050/00033/AM16/ RLA File :09/24/040/00077/AM16/ Lic.No/Date:0910061994 07.05.2015 Defer Date:27.07.2016 132

Case No.:108/7/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00713/AM16/ RLA File :03/95/040/00003/AM16/ Lic.No/Date:0310795745 07.05.2015 Defer Date:27.07.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 133

Case No.:15/7/82-

ALC4/2015 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 134

Case No.:129/7/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 135

Case No.:6/7/82-

ALC4/2015 Party Name:SIMPEX PHARMA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00611/AM16/ RLA File :05/24/040/00564/AM15/ Lic.No/Date:0510394266 15.05.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/698/2015-PI(Norms) dated 21.03.2016, 136

Case No.:164/7/82-

ALC4/2015 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 137

Case No.:109/7/82-

ALC4/2015 Party Name:ZIM LABORATORIES LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00714/AM16/ RLA File :03/95/040/00103/AM16/ Lic.No/Date:0310795994 18.05.2015 Defer Date:27.07.2016 Decision : The Committee decided to defer the case for want of comments of DoP. 138 Case No.:133/7/82- ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 Status:Deferred.

20 14.06.2016 HQ File :01/82/050/00738/AM16/ RLA File :03/94/040/00085/AM16/ Lic.No/Date:0310796048 20.05.2015 Defer Date:27.07.2016 139

Case No.:102/7/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 140

Case No.:199/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 141

Case No.:55/13/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 142

Case No.:5/4/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00044/AM16/ RLA File :09/24/040/00116/AM16/ Lic.No/Date:0910062066 25.05.2015 Defer Date:27.07.2016 143

Case No.:176/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 144

Case No.:124/7/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00729/AM16/ RLA File :03/95/040/00114/AM16/ Lic.No/Date:0310796233 27.05.2015 Defer Date:27.07.2016 145

Case No.:100/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 146 Case No.:188/7/82- Party Name:ATUL Meet No/Date:6/82- Status:Deferred.

21 ALC4/2015 LIMITED, ALC4/2016 14.06.2016 HQ File :01/82/050/00793/AM16/ RLA File :08/24/040/00034/AM16/ Lic.No/Date:0810135421 02.06.2015 Defer Date:27.07.2016 Decision :Deferred. 147

Case No.:142/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 148

Case No.:110/7/82-

ALC4/2015 Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 149

Case No.:17/7/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 150

Case No.:67/7/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 151

Case No.:13/9/82-

ALC4/2015 Party Name:SHILPA MEDICARE LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00949/AM16/ RLA File :07/24/040/00081/AM16/ Lic.No/Date:0710108327 05.06.2015 Defer Date:27.07.2016 152

Case No.:121/7/82-

ALC4/2015 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 153

Case No.:123/7/82-

ALC4/2015 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

22 Decision : The Committee noted that information had been called for from the firm in NC meeting No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 154

Case No.:60/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 155

Case No.:14/9/82-

ALC4/2015 Party Name:SHILPA MEDICARE LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00950/AM16/ RLA File :07/24/040/00078/AM16/ Lic.No/Date:0710108349 10.06.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/640/2015-PI(Norms) dated 01.06.2016, uploaded 156

Case No.:65/7/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00670/AM16/ RLA File :09/24/040/00164/AM16/ Lic.No/Date:0910062163 10.06.2015 Defer Date:27.07.2016 Decision :Deferred. 157

Case No.:66/7/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 158

Case No.:20/13/82-

ALC4/2015 Party Name:JAYANT AGRO ORGANICS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 159

Case No.:159/7/82-

ALC4/2015 Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 160

Case No.:87/7/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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: 27.07.2016 Decision : The Committee decided to call for information as per Appendix 33 and past production

23 consumption data vis-a-vis actual consumption of imported inputs duly certified by Central Excise Authorities. It was also observed that the quantities of import mentioned by the applicant appear to be disproportionately high. Accordingly, firm is to submit its version on immediate basis. 161

Case No.:42/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 162

Case No.:48/19/82-

ALC4/2015 Party Name:RAJ DHANVANTRY PHARMACY Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 163

Case No.:41/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 164

Case No.:52/7/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 165

Case No.:43/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 166

Case No.:15/9/82-

ALC4/2015 Party Name:KDAC CHEM PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 167

Case No.:83/13/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 168 Case No.:15/13/82- Party Name:ALIVIRA Meet No/Date:6/82- Status:Deferred.

24 ALC4/2015 ANIMAL HEALTH LIMITED ALC4/2016 14.06.2016 HQ File :01/82/050/00978/AM16/ RLA File :03/94/040/00219/AM16/ Lic.No/Date:0310796797 24.06.2015 Defer Date:27.07.2016 Decision :Deferred. 169

Case No.:82/19/82-

ALC4/2015 Party Name:SIDDHARTH CARBOCHEM PRODUCTS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01563/AM16/ RLA File :03/95/040/00667/AM15/ Lic.No/Date:0310796830 24.06.2015 Defer Date:27.07.2016 Decision : Information called for from the firm in NC meeting No.04 dated24.05.2016 is awaited.
The Committee accordingly deferred the case. 170

Case No.:72/7/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 171

Case No.:76/7/82-

ALC4/2015 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 172

Case No.:75/7/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00680/AM16/ RLA File :05/24/040/00122/AM16/ Lic.No/Date:0510394696 25.06.2015 Defer Date:27.07.2016 173

Case No.:78/7/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 174

Case No.:109/8/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00905/AM16/ RLA File :03/95/040/00038/AM16/ Lic.No/Date:0310796997 01.07.2015 Defer Date:27.07.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 175

Case No.:108/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File RLA File Lic.No/Date:0910062267 Defer

25 :01/82/050/01244/AM16/ :09/24/040/00183/AM16/ 01.07.2015 Date:27.07.2016 176

Case No.:10/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 177

Case No.:11/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 178

Case No.:105/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01241/AM16/ RLA File :09/24/040/00191/AM16/ Lic.No/Date:0910062299 03.07.2015 Defer Date:27.07.2016 Decision The Committee noted that information had been called for from the firm in NC meeting No.20 dated 09.032016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 179

Case No.:24/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 180

Case No.:82/13/82-

ALC4/2015 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.15 dated 30.12.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case.. 181

Case No.:23/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 182

Case No.:20/16/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

26 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/822/2015-PI(Norms) dated 12.05.2016, uploaded at the end of these minutes decided to call for technical information from the firm and deferred the case. 183

Case No.:22/13/82-

ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.2 dated 24.04.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 184

Case No.:119/8/82-

ALC4/2015 Party Name:SI GROUP INDIA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00915/AM16/ RLA File :03/95/040/00322/AM16/ Lic.No/Date:0310797595 23.07.2015 Defer Date:27.07.2016 Decision :Deferred. 185

Case No.:115/13/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 vide O.M.No.35011/761/2015-PI(Norms) dated 05.05.2016, uploaded at the end of these minutes 186

Case No.:73/8/82-

ALC4/2015 Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 187

Case No.:69/13/82-

ALC4/2015 Party Name:PI INDUSTRIES LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred.. 188

Case No.:116/13/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 189

Case No.:114/13/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

27 Decision :Deferred. 190

Case No.:113/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01076/AM16/ RLA File :03/94/040/00335/AM16/ Lic.No/Date:0310797897 03.08.2015 Defer Date:27.07.2016 Decision :Deferred. 191

Case No.:112/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 192

Case No.:75/13/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01038/AM16/ RLA File :05/24/040/00215/AM16/ Lic.No/Date:0510395160 04.08.2015 Defer Date:27.07.2016 193

Case No.:78/13/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01041/AM16/ RLA File :05/24/040/00219/AM16/ Lic.No/Date:0510395169 04.08.2015 Defer Date:27.07.2016 194

Case No.:109/13/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deffered
HQ File :01/82/050/01072/AM16/ RLA File :03/94/040/00170/AM16/ Lic.No/Date:0310797954 05.08.2015 Defer Date:27.07.2016 vide O.M.No.35011/773/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes 195

Case No.:12/18/82-

ALC4/2015 Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 196

Case No.:50/13/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 197 Case No.:2/21/82- ALC4/2015 Party Name:AUROLAB Meet No/Date:6/82- ALC4/2016 Status:Deferred.

28 14.06.2016 HQ File :01/82/050/01707/AM16/ RLA File :35/24/040/00022/AM16/ Lic.No/Date:3510044782 06.08.2015 Defer Date:27.07.2016 198

Case No.:110/13/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 199

Case No.:111/13/82-

ALC4/2015 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 200

Case No.:79/13/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 201

Case No.:57/13/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01020/AM16/ RLA File :22/24/040/00013/AM16/ Lic.No/Date:2210015284 14.08.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/784/2015-PI(Norms) dated 29.04.2016, uploaded 202

Case No.:127/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred for Chemicals. 203

Case No.:60/13/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred, 204

Case No.:126/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

29 Decision :Deferred. 205

Case No.:61/13/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 206

Case No.:62/13/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01025/AM16/ RLA File :05/23/040/00212/AM16/ Lic.No/Date:0510395383 20.08.2015 Defer Date:27.07.2016 207

Case No.:161/13/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 208

Case No.:77/13/82-

ALC4/2015 Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 209

Case No.:120/13/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 210

Case No.:84/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 vide O.M.No.35011/781/2015-PI(Norms) dated 26.04.2016, uploaded at the end of these minutes 211

Case No.:59/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 212 Case No.:8/9/82- ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:6/82- ALC4/2016 Status:Deferred.

30 14.06.2016 HQ File :01/82/050/00944/AM16/ RLA File :34/24/040/00155/AM16/ Lic.No/Date:3410041496 09.09.2015 Defer Date:27.07.2016 Decision :Deferred. 213

Case No.:10/9/82-

ALC4/2015 Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 214

Case No.:20/9/82-

ALC4/2015 Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 215

Case No.:51/19/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.17 dated 27.1.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 216

Case No.:12/19/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 217

Case No.:44/4/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 218

Case No.:130/14/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 219

Case No.:56/2/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

31 Decision :Deferred. 220

Case No.:135/13/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :The Committee decided to send application to DoP and deferred the case. 221

Case No.:24/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 222

Case No.:136/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 223

Case No.:46/19/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01527/AM16/ RLA File :09/24/040/00438/AM16/ Lic.No/Date:0910062744 19.10.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/811/2015-PI(Norms) dated 07.06.2016 , 224

Case No.:77/16/82-

ALC4/2015 Party Name:LACTOSE (INDIA) LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 225

Case No.:140/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 226

Case No.:141/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

32 227

Case No.:142/13/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 228

Case No.:73/19/82-

ALC4/2015 Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 229

Case No.:147/13/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 230

Case No.:64/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 231

Case No.:65/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 232

Case No.:153/13/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 233

Case No.:66/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 234

Case No.:54/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

33 235

Case No.:67/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01548/AM16/ RLA File :03/94/040/00553/AM16/ Lic.No/Date:0310799932 02.11.2015 Defer Date:27.07.2016 236

Case No.:70/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01551/AM16/ RLA File :03/94/040/00481/AM16/ Lic.No/Date:0310799926 02.11.2015 Defer Date:27.07.2016 237

Case No.:154/13/82-

ALC4/2015 Party Name:DR REDDYS LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 238

Case No.:156/13/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 239

Case No.:38/21/82-

ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred for want of comments from DBT. 240

Case No.:159/13/82-

ALC4/2015 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 241

Case No.:57/19/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 242

Case No.:163/13/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved

34 HQ File :01/82/050/01126/AM16/ RLA File :09/24/040/00479/AM16/ Lic.No/Date:0910062838 06.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 24.05.2016, uploaded 243

Case No.:18/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 244

Case No.:2/6/82-

ALC4/2016 Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00164/AM17/ RLA File :05/24/040/00350/AM16/ Lic.No/Date:0510396257 06.11.2015 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.35011/370/2012-PI(Norms) dated Sept. 2012 , 245

Case No.:55/19/82-

ALC4/2015 Party Name:BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Deferred HQ File :01/82/050/01536/AM16/ RLA File :03/94/040/00600/AM16/ Lic.No/Date:0310800148 09.11.2015 Defer Date: 27.07.2016 246

Case No.:23/21/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deffered
HQ File :01/82/050/01728/AM16/ RLA File :09/24/040/00481/AM16/ Lic.No/Date:0910062849 10.11.2015 Defer Date:27.07.2016 vide O.M.No.35011/03/2016-PI(Norms) dated 01.06.2016, uploaded at the end of these minutes 247

Case No.:165/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 248

Case No.:71/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred.

35 249

Case No.:72/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Defered. 250

Case No.:74/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01555/AM16/ RLA File :03/94/040/00641/AM16/ Lic.No/Date:0310800285 17.11.2015 Defer Date:27.07.2016 251

Case No.:167/13/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deffered
HQ File :01/82/050/01130/AM16/ RLA File :09/24/040/00493/AM16/ Lic.No/Date:0910062862 19.11.2015 Defer Date:27.07.2016 vide O.M.No.35011/860/2015-PI(Norms) dated 24.05.2016, uploaded at the end of these minutes 252

Case No.:58/19/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 253

Case No.:77/19/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01558/AM16/ RLA File :03/94/040/00653/AM16/ Lic.No/Date:0310800320 19.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/808/2015-PI(Norms) dated 07.06.2016, uploaded 254

Case No.:75/19/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 255

Case No.:60/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 256 Case No.:11/19/82- Party Name:SURNI LABS Meet No/Date:6/82- Status:Deferred.

36 ALC4/2015 ALC4/2016 14.06.2016 HQ File :01/82/050/01491/AM16/ RLA File :34/24/040/00214/AM16/ Lic.No/Date:3410041688 20.11.2015 Defer Date:27.07.2016 257

Case No.:20/19/82-

ALC4/2015 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 258

Case No.:24/19/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01504/AM16/ RLA File :31/83/040/00115/AM16/ Lic.No/Date:3110065769 26.11.2015 Defer Date:27.07.2016 259

Case No.:59/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 260

Case No.:62/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 261

Case No.:61/19/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 262

Case No.:81/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 263

Case No.:19/19/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01499/AM16/ RLA File :05/23/040/00370/AM16/ Lic.No/Date:0510396479 02.12.2015 Defer Date:27.07.2016

37 264

Case No.:16/19/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 265

Case No.:17/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 266

Case No.:38/19/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 267

Case No.:63/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01544/AM16/ RLA File :03/94/040/00673/AM16/ Lic.No/Date:0310800674 04.12.2015 Defer Date:27.07.2016 268

Case No.:22/21/82-

ALC4/2015 Party Name:NIFTY LABS PVT LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: approved HQ File :01/82/050/01727/AM16/ RLA File :09/24/040/00519/AM16/ Lic.No/Date:0910062938 07.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/15/2016-PI(Norms) dated 07.06.2016 , uploaded 269

Case No.:90/19/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 270

Case No.:64/4/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 271 Case No.:27/21/82- ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 Status: Approved

38 14.06.2016 HQ File :01/82/050/01732/AM16/ RLA File :09/24/040/00482/AM16/ Lic.No/Date:0910062947 08.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/003/2016-PI(Norms) dated 01.06.2016 , 272

Case No.:43/21/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:
Approved HQ File :01/82/050/01748/AM16/ RLA File :09/24/040/00518/AM16/ Lic.No/Date:0910062943 08.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/001/2016-PI(Norms) dated 01.06.2016 , uploaded 273

Case No.:89/19/82-

ALC4/2015 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01570/AM16/ RLA File :22/24/040/00085/AM16/ Lic.No/Date:2210015363 09.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/790/2015-PI(Norms) dated 22.03.2016, 274

Case No.:5/15/82-

ALC4/2015 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 275

Case No.:40/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01521/AM16/ RLA File :05/23/040/00240/AM16/ Lic.No/Date:0510396587 10.12.2015 Defer Date:27.07.2016 Decision :Deferred. 276

Case No.:87/19/82-

ALC4/2015 Party Name:SAURAV CHEMICALS LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01568/AM16/ RLA File :22/24/040/00087/AM16/ Lic.No/Date:2210015368 10.12.2015 Defer Date:27.07.2016 Decision :Deferred. 277

Case No.:88/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred.

39 278

Case No.:94/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 279

Case No.:42/21/82-

ALC4/2015 Party Name:NATCO PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 280

Case No.:50/21/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01755/AM16/ RLA File :09/24/040/00490/AM16/ Lic.No/Date:0910062966 11.12.2015 Defer Date: Decision : The Committee decided to approve the case on net to net basis without wastage. However, the Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.No.35011/01/2016-PI(Norms) dated 01.06.2016, uploaded at the end of these minutes decided to call for technical information from the firm. RA may take further necessary action as per the decision of NC. 281

Case No.:43/19/82-

ALC4/2015 Party Name:U SQUARE LIFESCIENCE PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01524/AM16/ RLA File :08/24/040/00306/AM16/ Lic.No/Date:0810136712 11.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/816/2015-PI(Norms) dated June 2016, uploaded 282

Case No.:56/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 283

Case No.:30/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 284

Case No.:31/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred.

40 285

Case No.:32/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 286

Case No.:10/19/82-

ALC4/2015 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 287

Case No.:18/19/82-

ALC4/2015 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 288

Case No.:48/21/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/01753/AM16/ RLA File :09/24/040/00508/AM16/ Lic.No/Date:0910062971 15.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/05/2016-PI(Norms) dated 6.6.2016 , 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. 289

Case No.:39/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 290

Case No.:41/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 291

Case No.:42/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 292 Case No.:6/15/82- ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 Status:Approved

41 14.06.2016 HQ File :01/82/050/01317/AM16/ RLA File :09/24/040/00540/AM16/ Lic.No/Date:0910062982 17.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 24.05.2016 , 293

Case No.:7/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01318/AM16/ RLA File :09/24/040/00531/AM16/ Lic.No/Date:0910062983 17.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 24.05.2016 , 294

Case No.:8/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Deferred. HQ File :01/82/050/01319/AM16/ RLA File :09/24/040/00536/AM16/ Lic.No/Date:0910062985 17.12.2015 Defer Date:27.07.2016 vide O.M.No.35011/860/2015-PI(Norms) dated 24.05.2016, uploaded at the end of these minutes 295

Case No.:9/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 296

Case No.:136/16/82-

ALC4/2015 Party Name:METROCHEM API PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01456/AM16/ RLA File :09/24/040/00533/AM16/ Lic.No/Date:0910062980 17.12.2015 Defer Date: Decision :Already approved in NC 03/AM17 297

Case No.:45/21/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01750/AM16/ RLA File :09/24/040/00392/AM16/ Lic.No/Date:0910062991 17.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/822/2015-PI(Norms) dated 23,05.2016, uploaded 298

Case No.:36/19/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Deffered
HQ File :01/82/050/01517/AM16/ RLA File :05/24/040/00439/AM16/ Lic.No/Date:0510396670 18.12.2015 Defer Date:27.07.2016

42 Decision : Information has been called for from the firm by NC in its meeting No.02/Am17 and reply is awaited. The Committee accordingly deferred the case. 299

Case No.:90/4/82-

ALC4/2016 Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00153/AM17/ RLA File :09/24/040/00556/AM16/ Lic.No/Date:0910063002 21.12.2015 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.35011/72/2014-PI(Norms) dated 21.4.2014, 300

Case No.:35/19/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 301

Case No.:37/19/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01518/AM16/ RLA File :05/23/040/00388/AM16/ Lic.No/Date:0510396753 21.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/806/2015-PI(Norms) dated 10.06.2016 , 302

Case No.:33/19/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 303

Case No.:54/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 304

Case No.:61/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 305

Case No.:93/19/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01574/AM16/ RLA File :22/24/040/00051/AM16/ Lic.No/Date:2210015392 23.12.2015 Defer Date:27.07.2016

43 306

Case No.:132/16/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01452/AM16/ RLA File :09/24/040/00563/AM16/ Lic.No/Date:0910063042 28.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 24.05.2016 , 307

Case No.:55/21/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deffered
HQ File :01/82/050/01760/AM16/ RLA File :09/24/040/00573/AM16/ Lic.No/Date:0910063035 28.12.2015 Defer Date:27.07.2016 Decision :
D/o Pharmaceuticals forwarded vide O.M. No.35011/2/2016-PI(Norms) dated 01.06.2016 , uploaded at the end of these minutes has informed that DoP is not concerned. The Committee accordingly deferred the case for want of comment from C&PC 308

Case No.:21/19/82-

ALC4/2015 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 309

Case No.:34/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 310

Case No.:32/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01737/AM16/ RLA File :31/83/040/00135/AM16/ Lic.No/Date:3110065815 30.12.2015 Defer Date:27.07.2016 311

Case No.:22/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deffered
HQ File :01/82/050/01502/AM16/ RLA File :05/23/040/00244/AM16/ Lic.No/Date:0510397137 30.12.2015 Defer Date:27.07.2016 vide O.M.No.35011/870/2015-PI(Norms) dated 24.05.2016, uploaded at the end of these minutes 312

Case No.:23/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Deferred.

44 HQ File :01/82/050/01503/AM16/ RLA File :05/23/040/00260/AM16/ Lic.No/Date:0510397138 30.12.2015 Defer Date:27.07.2016 vide O.M.No.35011/870/2015-PI(Norms) dated 24.05.2016, uploaded at the end of these minutes 313

Case No.:13/19/82-

ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 vide O.M.No.35011/839/2015-PI(Norms) dated 18.05.2016, uploaded at the end of these minutes 314

Case No.:40/21/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Deferred HQ File :01/82/050/01745/AM16/ RLA File :09/24/040/00559/AM16/ Lic.No/Date:0910063056 30.12.2015 Defer Date: 27.07.2016 Decision : Deferred for want of comments from DoP. 315

Case No.:49/21/82-

ALC4/2015 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01754/AM16/ RLA File :09/24/040/00560/AM16/ Lic.No/Date:0910063055 30.12.2015 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/05/2016-PI(Norms) dated 06.06.2016 , uploaded 316

Case No.:47/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 317

Case No.:35/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 318

Case No.:33/21/82-

ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred.

45 319

Case No.:137/16/82-

ALC4/2015 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 320

Case No.:68/21/82-

ALC4/2015 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01773/AM16/ RLA File :08/24/040/00350/AM16/ Lic.No/Date:0810136965 06.01.2016 Defer Date:27.07.2016 321

Case No.:2/17/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 322

Case No.:1/17/82-

ALC4/2015 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01461/AM16/ RLA File :09/24/040/00565/AM16/ Lic.No/Date:0910063113 08.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/08/2016-PI(Norms) dated 06.06.2016, uploaded 323

Case No.:44/21/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved. HQ File :01/82/050/01749/AM16/ RLA File :09/24/040/00588/AM16/ Lic.No/Date:0910063107 08.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/01/2016-PI(Norms) dated 01.01.2016 , uploaded 324

Case No.:4/17/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: approved HQ File :01/82/050/01464/AM16/ RLA File :09/24/040/00598/AM16/ Lic.No/Date:0910063124 11.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 24.05.2016 , 325

Case No.:5/17/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

46 Decision :Deferred. 326

Case No.:33/2/82-

ALC4/2016 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 327

Case No.:6/21/82-

ALC4/2015 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/01711/AM16/ RLA File :09/24/040/00602/AM16/ Lic.No/Date:0910063139 13.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/8/2016-PI(Norms) dated 06.06.2016 , uploaded 328

Case No.:60/21/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 329

Case No.:37/2/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 330

Case No.:36/21/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 331

Case No.:4/21/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 332

Case No.:31/21/82-

ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred.

47 333

Case No.:24/21/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 334

Case No.:88/4/82-

ALC4/2016 Party Name:VAYA JAYANTHI DRUGS(P) LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00151/AM17/ RLA File :09/24/040/00630/AM16/ Lic.No/Date:0910063185 29.01.2016 Defer Date: Pharmaceuticals forwarded vide O.M.35011/848/2015-PI(Norms) dated 14th June, 2016, 335

Case No.:8/21/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 336

Case No.:39/21/82-

ALC4/2015 Party Name:VISCUS OILS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Rejected HQ File :01/82/050/01744/AM16/ RLA File :56/24/040/00042/AM16/ Lic.No/Date:5610004823 01.02.2016 Defer Date: Decision : The O/o Jt. DGFT, Bhopal has informed the Committee that firm has not utilised the authorisation and are surrendering it. They have requested to withdraw the case. The Committee accordingly decided to withdraw the case from the agenda of the Committee. 337

Case No.:19/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01724/AM16/ RLA File :31/83/040/00153/AM16/ Lic.No/Date:3110065906 03.02.2016 Defer Date:27.07.2016 338

Case No.:13/21/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 339

Case No.:1/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

48 340

Case No.:12/21/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01717/AM16/ RLA File :05/24/040/00543/AM16/ Lic.No/Date:0510397506 04.02.2016 Defer Date:27.07.2016 341

Case No.:4/19/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 342

Case No.:25/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 343

Case No.:26/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 344

Case No.:14/21/82-

ALC4/2015 Party Name:DHAMPUR SUGAR MILLS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 345

Case No.:5/19/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 346

Case No.:62/4/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :deferred. 347

Case No.:11/21/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01716/AM16/ RLA File :05/24/040/00534/AM16/ Lic.No/Date:0510397525 08.02.2016 Defer Date:27.07.2016

49 348

Case No.:85/19/82-

ALC4/2015 Party Name:ANUPAM RASAYAN (INDIA) LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01566/AM16/ RLA File :52/24/040/00076/AM16/ Lic.No/Date:5210041759 09.02.2016 Defer Date:27.07.2016 349

Case No.:84/19/82-

ALC4/2015 Party Name:HETERO LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01565/AM16/ RLA File :09/24/040/00654/AM16/ Lic.No/Date:0910063231 09.02.2016 Defer Date:27.07.2016 Decision : The committee decided to send a copy of application to DoP and deferred the case. 350

Case No.:95/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 351

Case No.:96/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/01577/AM16/ RLA File :09/24/040/00638/AM16/ Lic.No/Date:0910063234 10.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/860/2015-PI(Norms) dated 24.05.2016 , 352

Case No.:20/21/82-

ALC4/2015 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01725/AM16/ RLA File :31/83/040/00155/AM16/ Lic.No/Date:3110065933 10.02.2016 Defer Date:27.07.2016 353

Case No.:8/2/82-

ALC4/2016 Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 354

Case No.:30/21/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 355 Case No.:34/4/82- ALC4/2016 Party Name:ANUH PHARMA LTD. Meet No/Date:6/82- ALC4/2016 Status:Deferred.

50 14.06.2016 HQ File :01/82/050/00097/AM17/ RLA File :03/94/040/00862/AM16/ Lic.No/Date:0310802461 11.02.2016 Defer Date:27.07.2016 356

Case No.:97/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 357

Case No.:36/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 358

Case No.:13/2/82-

ALC4/2016 Party Name:AMI LIFESCIENCES P LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00013/AM17/ RLA File :34/24/040/00289/AM16/ Lic.No/Date:3410041874 12.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/825/2015-PI(Norms) dated 01.06.2016 , 359

Case No.:35/4/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 360

Case No.:101/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 361

Case No.:5/2/82-

ALC4/2016 Party Name:MAMTA POLYCOATS Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 362

Case No.:55/2/82-

ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

51 363

Case No.:35/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 364

Case No.:102/19/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 365

Case No.:52/2/82-

ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00052/AM17/ RLA File :05/23/040/00426/AM16/ Lic.No/Date:0510397651 18.02.2016 Defer Date:27.07.2016 Decision :Deferred. 366

Case No.:54/2/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00054/AM17/ RLA File :05/23/040/00487/AM16/ Lic.No/Date:0510397639 18.02.2016 Defer Date:27.07.2016 Decision :Deferred. 367

Case No.:20/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 368

Case No.:22/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00085/AM17/ RLA File :05/23/040/00471/AM16/ Lic.No/Date:0510397645 18.02.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/503/2015-PI(Norms) dated 21.03.2016, uploaded 369

Case No.:23/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

52 370

Case No.:34/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 371

Case No.:9/2/82-

ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 372

Case No.:58/4/82-

ALC4/2016 Party Name:AARTI DRUGS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00121/AM17/ RLA File :03/94/040/00911/AM16/ Lic.No/Date:0310802757 23.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/824/2015-PI(Norms) dated 06.06.2016 , 373

Case No.:16/4/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00079/AM17/ RLA File :05/24/040/00570/AM16/ Lic.No/Date:0510397697 23.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/4/2016-PI(Norms) dated 01.06.2016 , uploaded 374

Case No.:17/4/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00080/AM17/ RLA File :05/24/040/00571/AM16/ Lic.No/Date:0510397698 23.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/818/2015-PI(Norms) dated 05.05.2016 , 375

Case No.:33/4/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00096/AM17/ RLA File :03/94/040/00940/AM16/ Lic.No/Date:0310802838 24.02.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/824/2015-PI(Norms) dated 06.06.2016 , 376 Case No.:28/2/82- ALC4/2016 Party Name:MAC CHEM PRODUCTS (INDIA) Meet No/Date:6/82- ALC4/2016 Status:Deferred.

53 PRIVATE LIMITED 14.06.2016 HQ File :01/82/050/00028/AM17/ RLA File :03/95/040/00858/AM16/ Lic.No/Date:0310802836 24.02.2016 Defer Date:27.07.2016 377

Case No.:27/2/82-

ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 378

Case No.:22/2/82-

ALC4/2016 Party Name:SANJIVANI PARANTERAL LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 379

Case No.:21/4/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved. HQ File :01/82/050/00084/AM17/ RLA File :05/24/040/00581/AM16/ Lic.No/Date:0510397709 24.02.2016 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.35011/412/2014-PI(Norms) dated 21.01.2015, 380

Case No.:18/4/82-

ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 381

Case No.:15/4/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00078/AM17/ RLA File :05/23/040/00485/AM16/ Lic.No/Date:0510397721 25.02.2016 Defer Date:27.07.2016 Decision :Deferred. 382

Case No.:19/4/82-

ALC4/2016 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 383

Case No.:53/2/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00053/AM17/ RLA File :08/24/040/00409/AM16/ Lic.No/Date:0810137314 26.02.2016 Defer Date:27.07.2016

54 384

Case No.:24/4/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00087/AM17/ RLA File :05/23/040/00491/AM16/ Lic.No/Date:0510397731 26.02.2016 Defer Date:27.07.2016 385

Case No.:4/2/82-

ALC4/2016 Party Name:RIDDHI PHARMA Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 386

Case No.:84/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 387

Case No.:43/2/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 388

Case No.:6/2/82-

ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 389

Case No.:42/4/82-

ALC4/2016 Party Name:FINE ORGANIC INDUSTRIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 390

Case No.:42/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 391

Case No.:14/2/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File RLA File Lic.No/Date:3410041935 Defer

55 :01/82/050/00014/AM17/ :34/24/040/00221/AM16/ 01.03.2016 Date:27.07.2016 Decision :Deferred. 392

Case No.:38/2/82-

ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 393

Case No.:28/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 394

Case No.:29/4/82-

ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 395

Case No.:1/21/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01706/AM16/ RLA File :09/24/040/00702/AM16/ Lic.No/Date:0910063354 03.03.2016 Defer Date:27.07.2016 396

Case No.:30/4/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00093/AM17/ RLA File :03/94/040/01022/AM16/ Lic.No/Date:0310803061 04.03.2016 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.35011/471/2013-PI(Norms) dated 21.10.2013 , 397

Case No.:3/4/82-

ALC4/2016 Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 398

Case No.:50/2/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision : Deferred for want of comments from DBT.

56 399

Case No.:66/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 400

Case No.:67/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 401

Case No.:68/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 402

Case No.:40/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 403

Case No.:41/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 404

Case No.:57/4/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 405

Case No.:26/2/82-

ALC4/2016 Party Name:MANGALAM DRUGS & ORGANICS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00026/AM17/ RLA File :03/95/040/00672/AM16/ Lic.No/Date:0310803128 08.03.2016 Defer Date:27.07.2016 406

Case No.:23/2/82-

ALC4/2016 Party Name:MERCK LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00023/AM17/ RLA File :03/95/040/00936/AM16/ Lic.No/Date:0310803135 08.03.2016 Defer Date:27.07.2016 Decision :The committee decided to send a copy of application to DoP.

57 407

Case No.:7/2/82-

ALC4/2016 Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 408

Case No.:56/4/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 409

Case No.:55/4/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 410

Case No.:30/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 411

Case No.:31/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 412

Case No.:3/2/82-

ALC4/2016 Party Name:RONAK CHEMICALS Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 413

Case No.:29/2/82-

ALC4/2016 Party Name:RUSAN PHARMA LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 414

Case No.:39/4/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File RLA File Lic.No/Date:0310803223 Defer

58 :01/82/050/00102/AM17/ :03/94/040/00973/AM16/ 10.03.2016 Date:27.07.2016 415

Case No.:58/2/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 416

Case No.:59/2/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 417

Case No.:25/2/82-

ALC4/2016 Party Name:PREGNA INTERNATIONAL LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00025/AM17/ RLA File :03/95/040/00953/AM16/ Lic.No/Date:0310803237 11.03.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.07/2015 dated 24.07.2015 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 418

Case No.:24/2/82-

ALC4/2016 Party Name:SCOPE CHEMICALS PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00024/AM17/ RLA File :03/95/040/00955/AM16/ Lic.No/Date:0310803229 11.03.2016 Defer Date:27.07.2016 Decision :Deferred. 419

Case No.:38/4/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 420

Case No.:25/4/82-

ALC4/2016 Party Name:ENVEE DRUGS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00088/AM17/ RLA File :34/24/040/00334/AM16/ Lic.No/Date:3410041974 14.03.2016 Defer Date:27.07.2016 Decision :Deferred. 421

Case No.:27/4/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred.

59 422

Case No.:82/4/82-

ALC4/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 423

Case No.:51/2/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00051/AM17/ RLA File :08/24/040/00440/AM16/ Lic.No/Date:0810137433 15.03.2016 Defer Date:27.07.2016 424

Case No.:37/4/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 425

Case No.:26/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 426

Case No.:7/4/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 427

Case No.:13/4/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 428

Case No.:12/4/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00075/AM17/ RLA File :05/24/040/00613/AM16/ Lic.No/Date:0510397962 17.03.2016 Defer Date:27.07.2016 429

Case No.:9/4/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00072/AM17/ RLA File :05/24/040/00603/AM16/ Lic.No/Date:0510397956 17.03.2016 Defer Date:27.07.2016

60 430

Case No.:10/4/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00073/AM17/ RLA File :05/24/040/00554/AM16/ Lic.No/Date:0510397955 17.03.2016 Defer Date:27.07.2016 431

Case No.:14/4/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00077/AM17/ RLA File :05/23/040/00526/AM16/ Lic.No/Date:0510397978 18.03.2016 Defer Date:27.07.2016 Decision :Deferred. 432

Case No.:52/4/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00115/AM17/ RLA File :03/94/040/01085/AM16/ Lic.No/Date:0310803441 18.03.2016 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.35011/636/2015-PI(Norms) dated 14.03.2016, 433

Case No.:5/4/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 434

Case No.:8/4/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 435

Case No.:85/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 436

Case No.:46/2/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 437 Case No.:48/2/82- Party Name:CADILA Meet No/Date:6/82- Status:Deferred.

61 ALC4/2016 HEALTHCARE LTD., ALC4/2016 14.06.2016 HQ File :01/82/050/00048/AM17/ RLA File :08/24/040/00430/AM16/ Lic.No/Date:0810137473 21.03.2016 Defer Date:27.07.2016 438

Case No.:36/4/82-

ALC4/2016 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 439

Case No.:51/4/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status: Approved HQ File :01/82/050/00114/AM17/ RLA File :03/94/040/01086/AM16/ Lic.No/Date:0310803470 21.03.2016 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.35011/708/2015-PI(Norms) dated 17.03.2016 , 440

Case No.:4/4/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 441

Case No.:6/4/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 442

Case No.:11/4/82-

ALC4/2016 Party Name:OTSUKA CHEMICAL INDIA PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:approved HQ File :01/82/050/00074/AM17/ RLA File :05/24/040/00612/AM16/ Lic.No/Date:0510397994 21.03.2016 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.35011/370/2012-PI(Norms) dated Sept. 2012 , 443

Case No.:53/4/82-

ALC4/2016 Party Name:ANUH PHARMA LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00116/AM17/ RLA File :03/94/040/01066/AM16/ Lic.No/Date:0310803494 22.03.2016 Defer Date:27.07.2016

62 444

Case No.:47/2/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00047/AM17/ RLA File :08/24/040/00444/AM16/ Lic.No/Date:0810137475 22.03.2016 Defer Date:27.07.2016 445

Case No.:81/4/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 446

Case No.:48/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00111/AM17/ RLA File :03/94/040/01067/AM16/ Lic.No/Date:0310803525 23.03.2016 Defer Date:27.07.2016 447

Case No.:49/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 448

Case No.:50/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 449

Case No.:63/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 450

Case No.:47/4/82-

ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 451

Case No.:60/2/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016

63 452

Case No.:46/4/82-

ALC4/2016 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00109/AM17/ RLA File :03/94/040/01109/AM16/ Lic.No/Date:0310803597 29.03.2016 Defer Date:27.07.2016 453

Case No.:80/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 454

Case No.:63/2/82-

ALC4/2016 Party Name:HETERO DRUGS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/01866/AM16/ RLA File :09/24/040/00769/AM16/ Lic.No/Date:0910063463 30.03.2016 Defer Date:27.07.2016 455

Case No.:43/4/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 456

Case No.:69/4/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 vide O.M.No.35011/839/2015-PI(Norms) dated 18.05.2016, uploaded at the end of these minutes 457

Case No.:76/4/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred. 458

Case No.:65/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00128/AM17/ RLA File :04/24/040/00283/AM16/ Lic.No/Date:0410161772 01.04.2016 Defer Date:27.07.2016 459 Case No.:79/4/82- Party Name:MAKSON Meet No/Date:6/82- Status:Deferred.

64 ALC4/2016 INDUSTRIES PVT. LTD. ALC4/2016 14.06.2016 HQ File :01/82/050/00142/AM17/ RLA File :03/95/040/01000/AM16/ Lic.No/Date:0310803763 04.04.2016 Defer Date:27.07.2016 Decision : Deferred for want of comments from MSME. 460

Case No.:77/4/82-

ALC4/2016 Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 461

Case No.:92/4/82-

ALC4/2016 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 462

Case No.:72/4/82-

ALC4/2016 Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00135/AM17/ RLA File :03/95/040/00981/AM16/ Lic.No/Date:0310803838 07.04.2016 Defer Date:27.07.2016 463

Case No.:83/4/82-

ALC4/2016 Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00146/AM17/ RLA File :03/95/040/00982/AM16/ Lic.No/Date:0310803855 07.04.2016 Defer Date:27.07.2016 464

Case No.:73/4/82-

ALC4/2016 Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00136/AM17/ RLA File :03/95/040/00301/AM16/ Lic.No/Date:0310803874 11.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/9/2016-PI(Norms) dated 07.06.2016 , uploaded 465

Case No.:71/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00134/AM17/ RLA File :03/95/040/00020/AM17/ Lic.No/Date:0310803870 11.04.2016 Defer Date:27.07.2016 466

Case No.:74/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File RLA File Lic.No/Date:0310803871 Defer

65 :01/82/050/00137/AM17/ :03/95/040/00021/AM17/ 11.04.2016 Date:27.07.2016 467

Case No.:78/4/82-

ALC4/2016 Party Name:MAKSON INDUSTRIES PVT. LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00141/AM17/ RLA File :03/95/040/00999/AM16/ Lic.No/Date:0310803899 12.04.2016 Defer Date:27.07.2016 Decision : Deferred for want of comments from MSME. 468

Case No.:66/2/82-

ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 469

Case No.:87/4/82-

ALC4/2016 Party Name:PI INDUSTRIES LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Deferred. HQ File :01/82/050/00150/AM17/ RLA File :13/24/040/00054/AM16/ Lic.No/Date:1310048210 13.04.2016 Defer Date:27.07.2016 470

Case No.:86/4/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 471

Case No.:67/2/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 472

Case No.:68/2/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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 473

Case No.:69/2/82-

ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 474

Case No.:7/6/82-

ALC4/2016 Party Name:MANGALAM ORGANICS LIMITED (FORMERLY Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Case Deferred

66 DUJODWALA HQ File :01/82/050/00174/AM17/ RLA File :03/95/040/00013/AM17/ Lic.No/Date:0310804365 03.05.2016 Defer Date27.07.2016: Decision :Deferred. 475

Case No.:95/4/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:6/82- ALC4/2016 14.06.2016 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:27.07.2016 Decision :Deferred 476

Case No.:94/4/82-

ALC4/2016 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00157/AM17/ RLA File :09/24/040/00018/AM17/ Lic.No/Date:0910063620 12.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/822/2015-PI(Norms) dated 23.05.2016, 477

Case No.:1/6/82-

ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00163/AM17/ RLA File :22/24/040/00015/AM17/ Lic.No/Date:2210015487 01.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/790/2015-PI(Norms) dated 22.03.2016, 478

Case No.:3/6/82-

ALC4/2016 Party Name:INTAS PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Case Deferred. HQ File :01/82/050/00165/AM17/ RLA File :08/24/040/00086/AM17/ Lic.No/Date:0810138080 02.06.2016 Defer Date 27.07.2016 479

Case No.:4/6/82-

ALC4/2016 Party Name:INTAS PHARMACEUTICALS LTD. Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Case Deferred HQ File :01/82/050/00166/AM17/ RLA File :08/24/040/00089/AM17/ Lic.No/Date:0810138086 02.06.2016 Defer Date: 27.07.2016 480

Case No.:6/6/82-

ALC4/2016 Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00173/AM17/ RLA File :09/24/040/00106/AM17/ Lic.No/Date:0910063758 07.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/08/2016-PI(Norms) dated 06.06.2016, uploaded

67 481

Case No.:5/6/82-

ALC4/2016 Party Name:SATYADEVA PHARMACEUTICALS PVT LTD Meet No/Date:6/82- ALC4/2016 14.06.2016 Status:Approved HQ File :01/82/050/00172/AM17/ RLA File :09/24/040/00114/AM17/ Lic.No/Date:0910063748 07.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No. 35011/829/2015-PI(Norms) dated 18.05.2016, Manual Agenda of NC Meeting No. 6/2016 AM-2017 Scheduled to be held on 14.06.2016

Case No. B- 01

M.No.6/AM-17 Date 14.06.2016 M/s. Indian Immunological Ltd File No. 01/82/050/01449/AM15 RLA No 09/24/040/00136/AM15 Adv.Auth. No. 0910060517 dated 20.06.2014 Decision: The Committee considered this case for correction the date of written comments mentioned in the minutes as per agenda. The committee deferred the case.

Case No. B- 02

M.No.6/AM-17 Date 14.06.2016 M/s. Gland Pharma Ltd File No. 01/82/050/01477/AM13 RLA No 09/24/040/00518/AM13 Adv.Auth. No. 0910054887 dated 01.02.2013 Decision: The Committee considered this case for ratification of norms per agenda. The Committee deferred the case for want of comments from DoP.