IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2016-08-23

DGFT Committee Minutes

Document text

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

Para 4.7 Decision

Meeting No. 10/82/2016 of 2016-17 dated 23.08.2016 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 23.08.2016 under the Chairmanship of Shri J.V. Patil, Addl. DGFT in Room No.04, Udyog Bhawan, New Delhi. Following members were present:- Shri Nirmal Kumar, Dy. Director General of Foreign Trade Shri D.N.Mathur, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 09/82 held 10.08.2016 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 : 10/82-ALC4/2016 MEETING DATE : 23.08.2016 1

Case No.:70/4/82-

ALC4/2016 Party Name:RAKSHIT DRUGS PVT LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.07/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. 2

Case No.:15/2/82-

ALC4/2016 Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 3

Case No.:36/19/82-

ALC4/2014 Party Name:ALKALI METALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred

2 4

Case No.:38/19/82-

ALC4/2014 Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 5

Case No.:173/5/82-

ALC4/2015 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred. 6

Case No.:61/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00124/AM17/ RLA File :07/24/040/00097/AM14/ Lic.No/Date:0710096460 04.07.2013 Defer Date:28.09.2016 Decision : Deferred for want of comments from DoP. 7

Case No.:31/4/82-ALC4/2014 Party Name:UNIVERSAL

BIOFUELS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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: 28.09.2016 8

Case No.:5/4/82-ALC4/2014 Party Name:SANMAR

SPECIALITY CHEMICALS LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00253/AM15/ RLA File :04/24/040/00046/AM14/ Lic.No/Date:0410148580 05.08.2013 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.10/82 dated 05.06.2012 , 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.:41/16/82-

ALC4/2013 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 10

Case No.:140/23/82-

ALC4/2013 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016

3 11

Case No.:48/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 12

Case No.:208/3/82-

ALC4/2014 Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00212/AM15/ RLA File :09/24/040/00515/AM14/ Lic.No/Date:0910059017 22.01.2014 Defer Date: Decision : The Committee noted that information called for from the firm in NC meeting No.13/82 dated 27.11.2015 has not been furnished by the firm. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 13

Case No.:108/3/82-

ALC4/2014 Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00112/AM15/ RLA File :03/94/040/00908/AM14/ Lic.No/Date:0310767733 24.01.2014 Defer Date: No.17/82 dated 27.1.2016 has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 14

Case No.:177/3/82-

ALC4/2014 Party Name:INDO AMINES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00181/AM15/ RLA File :03/94/040/00958/AM14/ Lic.No/Date:0310768616 30.01.2014 Defer Date: No.13/82 dated 27.11.2015 which has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 15

Case No.:58/6/82-ALC4/2014 Party Name:BAYER

CROPSCIENCE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00460/AM15/ RLA File :03/94/040/00797/AM14/ Lic.No/Date:0310772503 28.02.2014 Defer Date: No.17/82 dated 27.1.2016 which has not been furnished. In absence of these information 16

Case No.:106/3/82-

ALC4/2014 Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected

4 HQ File :01/82/050/00110/AM15/ RLA File :03/95/040/00960/AM14/ Lic.No/Date:0310772411 28.02.2014 Defer Date: No.17/82 dated 27.1.2016 which has not been furnished. In absence of these information 17

Case No.:58/4/82-ALC4/2014 Party Name:IND-SWIFT

LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:
Approved HQ File :01/82/050/00306/AM15/ RLA File :22/24/040/00100/AM14/ Lic.No/Date:2210014694 14.03.2014 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/176/2016-PI(Norms) dated August 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 18

Case No.:57/3/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 19

Case No.:51/5/82-ALC4/2014 Party Name:JINDAL DRUGS

LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00368/AM15/ RLA File :03/94/040/01098/AM14/ Lic.No/Date:0310776087 27.03.2014 Defer Date: No.13/82 dated 27.11.2015 which has not been furnished. In absence of these information 20

Case No.:51/6/82-ALC4/2014 Party Name:PERFECT

INDUSTRIES PRIVATE LIMITED. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00453/AM15/ RLA File :03/95/040/01054/AM14/ Lic.No/Date:0310776759 02.04.2014 Defer Date: No.17/82 dated 27.1.2016 which has not been furnished. In absence of these information 21

Case No.:50/6/82-ALC4/2014 Party Name:V & V PHARMA

INDUSTRIES Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00452/AM15/ RLA File :03/95/040/01061/AM14/ Lic.No/Date:0310776760 02.04.2014 Defer Date: No.17/82 dated 27.01.2016 which has not been furnished. In absence of these information

5 22

Case No.:20/6/82-ALC4/2014 Party Name:ADISHANK

CHEMICALS PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00422/AM15/ RLA File :03/94/040/01140/AM14/ Lic.No/Date:0310777786 09.04.2014 Defer Date: No.17/82 dated 27.01.2016 which has not been furnished. In absence of these information 23

Case No.:49/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 24

Case No.:237/6/82-

ALC4/2014 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 25

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

PRODUCTS Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00345/AM17/ RLA File :52/21/040/00011/AM15/ Lic.No/Date:5210041026 12.05.2014 Defer Date:28.09.2016 26

Case No.:13/2/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 27

Case No.:38/8/82-

ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Copy of application has been sent to DoP. 28

Case No.:165/6/82-

ALC4/2014 Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:0210203844 Defer

6 :01/82/050/00567/AM15/ :02/24/040/00037/AM15/ 05.06.2014 Date:28.09.2016 29

Case No.:106/8/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00770/AM15/ RLA File :03/94/040/00131/AM15/ Lic.No/Date:0310785223 12.06.2014 Defer Date: No.17/82 dated 27.01.2016 has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 30

Case No.:77/8/82-

ALC4/2014 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 31

Case No.:160/6/82-

ALC4/2014 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00562/AM15/ RLA File :05/23/040/00053/AM15/ Lic.No/Date:0510388783 18.06.2014 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/437/2015-PI(Norms) dated 08.8.2016 , 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. 32

Case No.:202/6/82-

ALC4/2014 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 33

Case No.:72/10/82-

ALC4/2014 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 34

Case No.:203/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 35 Case No.:264/13/82- Party Name:BAYER Meet No/Date:10/82- Status:Deferred

7 ALC4/2014 CROPSCIENCE LIMITED ALC4/2016 23.08.2016 HQ File :01/82/050/01267/AM15/ RLA File :03/94/040/00405/AM15/ Lic.No/Date:0310788397 26.08.2014 Defer Date:28.09.2016 36

Case No.:255/13/82-

ALC4/2014 Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 37

Case No.:254/13/82-

ALC4/2014 Party Name:SEQUENT SCIENTIFIC LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01257/AM15/ RLA File :03/95/040/00459/AM15/ Lic.No/Date:0310788513 28.08.2014 Defer Date: Decision : Rejected in meeting No.08/82 38

Case No.:263/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 39

Case No.:217/13/82-

ALC4/2014 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 40

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

LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Copy of application has been sent to DoP on 29.04.2016 for comments. The Committee accordingly deferred the case. 41

Case No.:380/5/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00520/AM16/ RLA File :22/24/040/00054/AM15/ Lic.No/Date:2210015086 16.09.2014 Defer Date: No.14/82 dated 16.12.2016 which has not been furnished. In absence of these information

8 42

Case No.:57/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01060/AM15/ RLA File :05/23/040/00277/AM15/ Lic.No/Date:0510391246 19.09.2014 Defer Date: No.17/82 dated 27.01.2016 which has not been furnished. In absence of these information 43

Case No.:59/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 44

Case No.:9/15/82-

ALC4/2014 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited. The committee accordingly deferred the case. 45

Case No.:17/13/82-

ALC4/2014 Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 46

Case No.:115/13/82-

ALC4/2014 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 47

Case No.:74/13/82-

ALC4/2014 Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01077/AM15/ RLA File :05/23/040/00282/AM15/ Lic.No/Date:0510391308 24.09.2014 Defer Date:28.09.2016 48

Case No.:19/13/82-

ALC4/2014 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Copy of application has been sent to MSME for comments. The Committee

9 accordingly deferred the case. 49

Case No.:160/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01163/AM15/ RLA File :03/94/040/00544/AM15/ Lic.No/Date:0310789976 07.10.2014 Defer Date: No.17/82 dated 27.01.2016 which has not been furnished. In absence of these information 50

Case No.:35/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01038/AM15/ RLA File :05/23/040/00218/AM15/ Lic.No/Date:0510391491 08.10.2014 Defer Date: No.17/82 dated 27.01.2016 which has not been furnished. In absence of these information 51

Case No.:42/15/82-

ALC4/2014 Party Name:PVS AGRO VET Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : The firm has furnished requisite information vide letter dated 06.06.2016 and the same has been sent to DoP on 04.08.2016. The Committee accordingly deferred the case. 52

Case No.:154/13/82-

ALC4/2014 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 53

Case No.:12/20/82-

ALC4/2015 Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/01595/AM16/ RLA File :07/24/040/00255/AM15/ Lic.No/Date:0710106853 17.10.2014 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.07/82 dated 11.09.2014 , 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.:110/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:3410040635 Defer

10 :01/82/050/01113/AM15/ :34/24/040/00188/AM15/ 22.10.2014 Date:28.09.2016 55

Case No.:86/10/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 56

Case No.:266/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 57

Case No.:268/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 58

Case No.:107/13/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 59

Case No.:111/13/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01114/AM15/ RLA File :05/23/040/00352/AM15/ Lic.No/Date:0510391927 11.11.2014 Defer Date:28.09.2016 Decision : Deferred for want of comments from AYUSH. 60

Case No.:61/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 61

Case No.:100/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016

11 62

Case No.:120/13/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 63

Case No.:77/18/82-

ALC4/2014 Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01443/AM15/ RLA File :03/95/040/00629/AM14/ Lic.No/Date:0310790966 12.11.2014 Defer Date: No.17/82 dated 27.01.2016 which has not been furnished. In absence of these information 64

Case No.:65/18/82-

ALC4/2014 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01431/AM15/ RLA File :34/24/040/00199/AM15/ Lic.No/Date:3410040677 13.11.2014 Defer Date: No.13/82 dated 27.11.2015 which has not been furnished. In absence of these information 65

Case No.:42/18/82-

ALC4/2014 Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01408/AM15/ RLA File :03/95/040/00628/AM14/ Lic.No/Date:0310791049 13.11.2014 Defer Date: No.17/82 dated 27.01.2016 which has not been furnished. In absence of these information 66

Case No.:65/15/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01352/AM15/ RLA File :05/23/040/00360/AM15/ Lic.No/Date:0510392011 14.11.2014 Defer Date:28.09.2016 Decision : Deferred for want of comments from AYUSH. 67

Case No.:16/18/82-

ALC4/2014 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 68 Case No.:74/18/82- Party Name:ADESHWAR Meet No/Date:10/82- Status:Deferred

12 ALC4/2014 MEDITEX PVT. LTD ALC4/2016 23.08.2016 HQ File :01/82/050/01440/AM15/ RLA File :03/94/040/00814/AM15/ Lic.No/Date:0310791373 25.11.2014 Defer Date:28.09.2016 69

Case No.:18/18/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 70

Case No.:32/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 71

Case No.:26/18/82-

ALC4/2014 Party Name:SADHANA NITRO CHEM LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01392/AM15/ RLA File :03/95/040/00714/AM15/ Lic.No/Date:0310791516 28.11.2014 Defer Date: No.13/82 dated 27.11.2015 which has not been furnished. In absence of these information 72

Case No.:92/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 73

Case No.:82/18/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred for want of comments from AYUSH. 74

Case No.:101/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 75 Case No.:97/18/82- Party Name:DYNAMIC Meet No/Date:10/82- Status:Deferred

13 ALC4/2014 SPECIALITY CHEMICALS LIMITED ALC4/2016 23.08.2016 HQ File :01/82/050/01463/AM15/ RLA File :30/24/040/00041/AM15/ Lic.No/Date:3010103261 11.12.2014 Defer Date:28.09.2016 76

Case No.:119/18/82-

ALC4/2014 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01485/AM15/ RLA File :05/24/040/00419/AM15/ Lic.No/Date:0510392414 15.12.2014 Defer Date: No.13/82 dated 27.11.2015 which has not been furnished. In absence of these information 77

Case No.:91/18/82-

ALC4/2014 Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/01457/AM15/ RLA File :05/23/040/00449/AM15/ Lic.No/Date:0510392602 29.12.2014 Defer Date:
Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/437/2015-PI(Norms) dated 08.8.2016 , 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. 78

Case No.:84/18/82-

ALC4/2014 Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred for want of comments from DBT. 79

Case No.:96/18/82-

ALC4/2014 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01462/AM15/ RLA File :04/24/040/00248/AM15/ Lic.No/Date:0410159986 07.01.2015 Defer Date: No.13/82 dated 27.11.2015 which has not been furnished. In absence of these information 80

Case No.:92/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : The Committee decided to call for copy of COA of the import items from foreign supplier and deferred the case. 81 Case No.:59/5/82- Party Name:ANTHEA Meet No/Date:10/82- Status:Deferred

14 ALC4/2015 AROMATICS PVT.LTD., ALC4/2016 23.08.2016 HQ File :01/82/050/00199/AM16/ RLA File :03/94/040/00793/AM15/ Lic.No/Date:0310792911 14.01.2015 Defer Date:28.09.2016 82

Case No.:12/16/82-

ALC4/2014 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Copy of application has been sent to DoP. 83

Case No.:86/5/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 84

Case No.:204/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 85

Case No.:31/7/82-ALC4/2015 Party Name:V.D.H.

ORGANICS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00636/AM16/ RLA File :05/24/040/00498/AM15/ Lic.No/Date:0510392987 27.01.2015 Defer Date: No.13/82 dated 27.11.2015 which has not been furnished. In absence of these information 86

Case No.:32/7/82-ALC4/2015 Party Name:V.D.H.

ORGANICS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00637/AM16/ RLA File :05/24/040/00499/AM15/ Lic.No/Date:0510392988 27.01.2015 Defer Date: Decision : The Committee noted that information called for from the firm in NC meeting No.07/82 dated 24.07.2015 which has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 87

Case No.:25/7/82-ALC4/2015

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00630/AM16/ RLA File :31/83/040/00144/AM15/ Lic.No/Date:3110065235 28.01.2015 Defer Date: Decision : The Committee noted that information called for from the firm in NC meeting No.13/82

15 dated 27.11.2015 which has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 88

Case No.:230/5/82-ALC4/2015 Party Name:R.K.INDUSTRIES,

Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 89

Case No.:169/5/82-ALC4/2015

Party Name:TIDE INDUSTRIES Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00309/AM16/ RLA File :34/24/040/00290/AM15/ Lic.No/Date:3410040927 05.02.2015 Defer Date: Decision : The Committee decided ratify norms on repeat basis as per the earlier decision taken by NC in its meeting No.34/82 dated23.11.2010, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 90

Case No.:91/7/82-ALC4/2015

Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 91

Case No.:52/19/82-ALC4/2014

Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 92

Case No.:38/7/82-ALC4/2015

Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 93

Case No.:280/5/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 94

Case No.:444/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :

16 95

Case No.:413/5/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00553/AM16/ RLA File :03/94/040/01145/AM15/ Lic.No/Date:0310794545 12.03.2015 Defer Date: No.05/82 dated 25.06.2015 which has not been furnished. In absence of these information 96

Case No.:106/7/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 97

Case No.:431/5/82-

ALC4/2015 Party Name:EUROLIFE HEALTHCARE PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for firm in NC meeting No.20/82 dated 09.03.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 98

Case No.:448/5/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00588/AM16/ RLA File :03/94/040/01211/AM15/ Lic.No/Date:0310795048 31.03.2015 Defer Date: No.08/82 dated 16.09.2015 which has not been furnished. In absence of these information 99

Case No.:174/7/82-

ALC4/2015 Party Name:S M B CORPORATION OF INDIA Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00779/AM16/ RLA File :03/95/040/00039/AM16/ Lic.No/Date:0310795601 28.04.2015 Defer Date: No.107/82 dated 24.07.2015 has not been furnished. In absence of these information 100

Case No.:50/7/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.19/82 dated 25.2.2016

17 is awaited. The Committee deferred the case. 101

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

PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00033/AM16/ RLA File :09/24/040/00077/AM16/ Lic.No/Date:0910061994 07.05.2015 Defer Date:28.09.2016 Decision : Copy of application has not been received in DGFT so far. Therefore, firm/RA may be requested to send a complete set of application for ratification of norms. The committee accordingly deferred the case. 102

Case No.:15/7/82-

ALC4/2015 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 103

Case No.:129/7/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : A set of application has been sent to MSME for comments and deferred the case. 104

Case No.:164/7/82-

ALC4/2015 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information received and sent to DoP for comments. 105

Case No.:133/7/82-

ALC4/2015 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Deferred HQ File :01/82/050/00738/AM16/ RLA File :03/94/040/00085/AM16/ Lic.No/Date:0310796048 20.05.2015 Defer Date:28.09.2016 Decision : Copy of application has been sent to DoP. 106

Case No.:102/7/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 107

Case No.:199/5/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File RLA File Lic.No/Date:0410160570 Defer Date:

18 :01/82/050/00339/AM16/ :04/24/040/00040/AM16/ 21.05.2015 No.05/82 dated 25.06.2015 which has not been furnished. In absence of these information 108

Case No.:55/13/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 109

Case No.:176/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 110

Case No.:124/7/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 111

Case No.:100/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 112

Case No.:188/7/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00793/AM16/ RLA File :08/24/040/00034/AM16/ Lic.No/Date:0810135421 02.06.2015 Defer Date:28.09.2016 113

Case No.:142/7/82-

ALC4/2015 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : : Information called for from the firm in NC meeting No.21/82 dated 22.03.2016 is awaited. The Committee accordingly defer the case. 114

Case No.:110/7/82-

ALC4/2015 Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred

19 HQ File :01/82/050/00715/AM16/ RLA File :03/95/040/00051/AM16/ Lic.No/Date:0310796383 03.06.2015 Defer Date:28.09.2016 115

Case No.:17/7/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No,04/82 dated 24.05.2016 is awaited. The Committee accordingly defer the case. 116

Case No.:67/7/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.21/82 dated 22.03.2016 is awaited. The Committee accordingly defer the case. 117

Case No.:121/7/82-

ALC4/2015 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00726/AM16/ RLA File :03/95/040/00715/AM15/ Lic.No/Date:0310796458 05.06.2015 Defer Date: No.17/82 dated 17.01.2016 which has not been furnished. In absence of these information 118

Case No.:123/7/82-

ALC4/2015 Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00728/AM16/ RLA File :03/95/040/00582/AM15/ Lic.No/Date:0310796457 05.06.2015 Defer Date: No.17/82 dated 17.01.2016 which has not been furnished. In absence of these information 119

Case No.:60/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 120

Case No.:66/7/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred

20 HQ File :01/82/050/00671/AM16/ RLA File :09/24/040/00162/AM16/ Lic.No/Date:0910062162 10.06.2015 Defer Date:28.09.2016 121

Case No.:20/13/82-

ALC4/2015 Party Name:JAYANT AGRO ORGANICS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00983/AM16/ RLA File :03/94/040/00169/AM16/ Lic.No/Date:0310796563 11.06.2015 Defer Date: No.17/82 dated 17.01.2016 which has not been furnished. In absence of these information 122

Case No.:159/7/82-

ALC4/2015 Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : 123

Case No.:87/7/82-

ALC4/2015 Party Name:VISION DRUGS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.04/82 dated
24.05.2016 is awaited. The Committee accordingly defer the case. 124

Case No.:42/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 125

Case No.:48/19/82-

ALC4/2015 Party Name:RAJ DHANVANTRY PHARMACY Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 126

Case No.:41/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 127 Case No.:52/7/82- ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 Status:Deferred

21 23.08.2016 HQ File :01/82/050/00657/AM16/ RLA File :05/23/040/00107/AM16/ Lic.No/Date:0510394590 17.06.2015 Defer Date:28.09.2016 Decision : DML called for from the firm is awaited. The Committee accordingly deferred the case. 128

Case No.:43/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 129

Case No.:15/9/82-

ALC4/2015 Party Name:KDAC CHEM PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 130

Case No.:83/13/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred 131

Case No.:72/7/82-ALC4/2015 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00677/AM16/ RLA File :05/24/040/00104/AM16/ Lic.No/Date:0510394704 25.06.2015 Defer Date: No.09/82 dated 30.09.2015 which has not been furnished. In absence of these information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC. 132

Case No.:76/7/82-ALC4/2015 Party Name:PCL OIL &

SOLVENTS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00681/AM16/ RLA File :05/24/040/00103/AM16/ Lic.No/Date:0510394703 25.06.2015 Defer Date: No.09/82 dated 30.09.2015 which has not been furnished. In absence of these information 133

Case No.:75/7/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016

22 Decision :Deferred for want of comments from DoP. 134

Case No.:78/7/82-

ALC4/2015 Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 No.19/82 dated 25.02.2016 is awaited. The Committee accordingly deferred the case. 135

Case No.:108/14/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01244/AM16/ RLA File :09/24/040/00183/AM16/ Lic.No/Date:0910062267 01.07.2015 Defer Date:28.09.2016 Decision :Deferred. 136

Case No.:10/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 137

Case No.:11/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 138

Case No.:105/14/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01241/AM16/ RLA File :09/24/040/00191/AM16/ Lic.No/Date:0910062299 03.07.2015 Defer Date: Decision : Rejected in the meeting No.08/82 dated 27.07.2016. 139

Case No.:24/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred 140

Case No.:82/13/82-

ALC4/2015 Party Name:PAB ORGANICS PVT.LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016

23 141

Case No.:23/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/00986/AM16/ RLA File :03/94/040/00284/AM16/ Lic.No/Date:0310797268 15.07.2015 Defer Date: No.17/82 dated 17.01.2016 which has not been furnished. In absence of these information 142

Case No.:20/16/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 143

Case No.:22/13/82-

ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.2 /82 dated 24.04.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 144

Case No.:119/8/82-

ALC4/2015 Party Name:SI GROUP INDIA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00915/AM16/ RLA File :03/95/040/00322/AM16/ Lic.No/Date:0310797595 23.07.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.06/82 dated 29.08.2014 , 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. 145

Case No.:115/13/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 146

Case No.:79/8/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510395084 Defer

24 :01/82/050/00875/AM16/ :05/24/040/00110/AM16/ 24.07.2015 Date:28.09.2016 Decision :Deferred for want of comments from DoP. 147

Case No.:73/8/82-

ALC4/2015 Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred for want of comments from DoP. 148

Case No.:69/13/82-

ALC4/2015 Party Name:PI INDUSTRIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:
Approved
HQ File :01/82/050/01032/AM16/ RLA File :13/24/040/00016/AM16/ Lic.No/Date:1310047933 29.07.2015 Defer Date: C&PC forwarded vide U.O.No.15022/28/2012-Ch-II dated 10.08.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 149

Case No.:116/13/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 150

Case No.:114/13/82-

ALC4/2015 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 151

Case No.:112/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 152

Case No.:109/13/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01072/AM16/ RLA File :03/94/040/00170/AM16/ Lic.No/Date:0310797954 05.08.2015 Defer Date:28.09.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.6/82 dated 14.06.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 153 Case No.:12/18/82- Party Name:OMTECH Meet No/Date:10/82- Status:Deferred

25 ALC4/2015 CHEMICAL INDUSTRIES PVT.LTD. ALC4/2016 23.08.2016 HQ File :01/82/050/01477/AM16/ RLA File :03/95/040/00345/AM16/ Lic.No/Date:0310797967 05.08.2015 Defer Date:28.09.2016 Decision :Deferred. 154

Case No.:50/13/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 155

Case No.:2/21/82-

ALC4/2015 Party Name:AUROLAB Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01707/AM16/ RLA File :35/24/040/00022/AM16/ Lic.No/Date:3510044782 06.08.2015 Defer Date:28.09.2016 156

Case No.:110/13/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01073/AM16/ RLA File :03/94/040/00350/AM16/ Lic.No/Date:0310798096 12.08.2015 Defer Date: No.17/82 dated 17.01.2016 which has not been furnished. In absence of these information 157

Case No.:111/13/82-

ALC4/2015 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 158

Case No.:127/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 159

Case No.:60/13/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01023/AM16/ RLA File :05/23/040/00204/AM16/ Lic.No/Date:0510395351 18.08.2015 Defer Date: No.17/82 dated 17.01.2016 which has not been furnished. In absence of these information

26 160

Case No.:126/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 161

Case No.:61/13/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC 08/82 dated 27.07.2016 is awaited.
The Committee accordingly deferred the case. 162

Case No.:161/13/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 163

Case No.:77/13/82-

ALC4/2015 Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/713/2015-PI(Norms) dated 12.04.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 164

Case No.:120/13/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 165

Case No.:84/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 No.06/82 dated 24.05.2016 is awaited. The Committee accordingly deferred the case. 166

Case No.:59/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:0710108694 Defer

27 :01/82/050/00122/AM17/ :07/24/040/00180/AM16/ 07.09.2015 Date:28.09.2016 Decision :Deferred for want of comments from DoP. 167

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

CHEM PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00944/AM16/ RLA File :34/24/040/00155/AM16/ Lic.No/Date:3410041496 09.09.2015 Defer Date:28.09.2016 Decision :Deferred. 168

Case No.:10/9/82-

ALC4/2015 Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 169

Case No.:20/9/82-ALC4/2015 Party Name:SUPREET

CHEMICALS PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00956/AM16/ RLA File :03/95/040/00424/AM16/ Lic.No/Date:0310798995 22.09.2015 Defer Date:
Decision : The Committee decided to ratify norms on repeat basis as per the earlier decision taken by NC in its meeting No.02/82 dated 18.04.2013, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 170

Case No.:51/19/82-

ALC4/2015 Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.19 dated 25.02.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 171

Case No.:12/19/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 172

Case No.:44/4/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 173 Case No.:130/14/82- Party Name:V.D.H. Meet No/Date:10/82- Status:Deferred

28 ALC4/2015 ORGANICS PVT. LTD ALC4/2016 23.08.2016 HQ File :01/82/050/01266/AM16/ RLA File :05/24/040/00317/AM16/ Lic.No/Date:0510395874 09.10.2015 Defer Date:28.09.2016 174

Case No.:56/2/82-

ALC4/2016 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 175

Case No.:135/13/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Copy of application has been sent to DoP. 176

Case No.:24/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 177

Case No.:136/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 178

Case No.:77/16/82-

ALC4/2015 Party Name:LACTOSE (INDIA) LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 179

Case No.:140/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 180

Case No.:141/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred

29 HQ File :01/82/050/01104/AM16/ RLA File :03/95/040/00504/AM16/ Lic.No/Date:0310799629 23.10.2015 Defer Date:28.09.2016 181

Case No.:142/13/82-

ALC4/2015 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Rejected HQ File :01/82/050/01105/AM16/ RLA File :09/24/040/00443/AM16/ Lic.No/Date:0910062774 27.10.2015 Defer Date: No.17/82 dated 17.01.2016 which has not been furnished. In absence of these information 182

Case No.:73/19/82-

ALC4/2015 Party Name:GALAXY SURFACTANTS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 183

Case No.:147/13/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 184

Case No.:64/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 185

Case No.:65/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 186

Case No.:153/13/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 187

Case No.:66/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred

30 HQ File :01/82/050/01547/AM16/ RLA File :03/94/040/00582/AM16/ Lic.No/Date:0310799943 02.11.2015 Defer Date:28.09.2016 188

Case No.:54/19/82-

ALC4/2015 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 189

Case No.:70/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/01551/AM16/ RLA File :03/94/040/00481/AM16/ Lic.No/Date:0310799926 02.11.2015 Defer Date: Decision : Approved in the meeting No.08/82 dated 27.07.2016 190

Case No.:154/13/82-

ALC4/2015 Party Name:DR REDDYS Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/01117/AM16/ RLA File :09/24/040/00460/AM16/ Lic.No/Date:0910062821 03.11.2015 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/44/2016-PI(Norms) dated 29.08.2016 , 191

Case No.:156/13/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 192

Case No.:38/21/82-

ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred for want of comments from DBT. 193

Case No.:159/13/82-

ALC4/2015 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 194 Case No.:57/19/82- ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:10/82- ALC4/2016 Status:Deferred

31 23.08.2016 HQ File :01/82/050/01538/AM16/ RLA File :03/94/040/00443/AM16/ Lic.No/Date:0310800060 05.11.2015 Defer Date:28.09.2016 Decision :Deferred. 195

Case No.:18/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
196

Case No.:23/21/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01728/AM16/ RLA File :09/24/040/00481/AM16/ Lic.No/Date:0910062849 10.11.2015 Defer Date:28.09.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 197

Case No.:165/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : : Deferred
198

Case No.:71/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : : Deferred
199

Case No.:72/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
200

Case No.:167/13/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01130/AM16/ RLA File :09/24/040/00493/AM16/ Lic.No/Date:0910062862 19.11.2015 Defer Date:28.09.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 201

Case No.:58/19/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred

32 HQ File :01/82/050/01539/AM16/ RLA File :03/94/040/00572/AM16/ Lic.No/Date:0310800324 19.11.2015 Defer Date:28.09.2016 Decision : Deferred
202

Case No.:75/19/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
203

Case No.:60/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
204

Case No.:20/19/82-

ALC4/2015 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
205

Case No.:59/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
206

Case No.:62/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
207

Case No.:61/19/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
208

Case No.:81/19/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016

33 209

Case No.:19/19/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/01499/AM16/ RLA File :05/23/040/00370/AM16/ Lic.No/Date:0510396479 02.12.2015 Defer Date: Decision :Approved in NC 08/82 Sl.No. 254. 210

Case No.:16/19/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
211

Case No.:17/19/82-

ALC4/2015 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
212

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

MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00339/AM17/ RLA File :29/24/040/00007/AM16/ Lic.No/Date:2910025232 04.12.2015 Defer Date:28.09.2016 Decision : Deferred
213

Case No.:90/19/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred for want of comments from DBT. 214

Case No.:64/4/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
215

Case No.:5/15/82-ALC4/2015 Party

Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/01316/AM16/ RLA File :34/24/040/00215/AM16/ Lic.No/Date:3410041722 10.12.2015 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/49/2011-Ch-II dated 10.09.2015 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP

34 Vol.1. RA concerned may take necessary action as per decision of NC. 216

Case No.:40/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
217

Case No.:88/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
218

Case No.:94/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
219

Case No.:42/21/82-

ALC4/2015 Party Name:NATCO PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
220

Case No.:56/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
221

Case No.:30/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
222

Case No.:31/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
223 Case No.:32/19/82- Party Name:PAYAL Meet No/Date:10/82- Status:Deferred

35 ALC4/2015 PETROCHEM PRIVATE LIMITED ALC4/2016 23.08.2016 HQ File :01/82/050/01513/AM16/ RLA File :05/24/040/00381/AM16/ Lic.No/Date:0510396610 14.12.2015 Defer Date:28.09.2016 Decision : Deferred
224

Case No.:10/19/82-

ALC4/2015 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
225

Case No.:39/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
226

Case No.:41/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
227

Case No.:42/19/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
228

Case No.:8/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 229

Case No.:9/15/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Copy of application has been sent to DoP. 230

Case No.:36/19/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred

36 HQ File :01/82/050/01517/AM16/ RLA File :05/24/040/00439/AM16/ Lic.No/Date:0510396670 18.12.2015 Defer Date:28.09.2016 Decision : Deferred for want of comments from DBT. 231

Case No.:35/19/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
232

Case No.:33/19/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
233

Case No.:54/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
234

Case No.:61/21/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
235

Case No.:93/19/82-

ALC4/2015 Party Name:CURETECH SKINCARE Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 236

Case No.:55/21/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Deferred HQ File :01/82/050/01760/AM16/ RLA File :09/24/040/00573/AM16/ Lic.No/Date:0910063035 28.12.2015 Defer Date: 28.09.2016 237

Case No.:21/19/82-

ALC4/2015 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510397095 Defer

37 :01/82/050/01501/AM16/ :05/23/040/00391/AM16/ 29.12.2015 Date:28.09.2016 Decision : Deferred
238

Case No.:34/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred
239

Case No.:22/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01502/AM16/ RLA File :05/23/040/00244/AM16/ Lic.No/Date:0510397137 30.12.2015 Defer Date:28.09.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 240

Case No.:23/19/82-

ALC4/2015 KABI ONCOLOGY LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/01503/AM16/ RLA File :05/23/040/00260/AM16/ Lic.No/Date:0510397138 30.12.2015 Defer Date:28.09.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 241

Case No.:13/19/82-

ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited. 242

Case No.:47/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 243

Case No.:35/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 244

Case No.:33/21/82-

ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred

38 HQ File :01/82/050/01738/AM16/ RLA File :31/83/040/00117/AM16/ Lic.No/Date:3110065848 05.01.2016 Defer Date:28.09.2016 245

Case No.:137/16/82-

ALC4/2015 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 246

Case No.:2/17/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Copy of application has been sent to DoP. 247

Case No.:5/17/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 248

Case No.:33/2/82-

ALC4/2016 Party Name:UPL LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 249

Case No.:60/21/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 250

Case No.:37/2/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 251

Case No.:36/21/82-

ALC4/2015 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016

39 252

Case No.:4/21/82-

ALC4/2015 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 253

Case No.:31/21/82-

ALC4/2015 Party Name:BALAJI AMINES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 254

Case No.:24/21/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 255

Case No.:17/10/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00363/AM17/ RLA File :22/24/040/00104/AM16/ Lic.No/Date:2210015407 01.02.2016 Defer Date:28.09.2016 256

Case No.:8/21/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 257

Case No.:13/21/82-

ALC4/2015 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 258

Case No.:1/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 259 Case No.:4/19/82- ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:10/82- ALC4/2016 Status:Deferred

40 23.08.2016 HQ File :01/82/050/01484/AM16/ RLA File :09/24/040/00628/AM16/ Lic.No/Date:0910063226 05.02.2016 Defer Date:28.09.2016 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. 260

Case No.:25/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 261

Case No.:26/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 262

Case No.:14/21/82-

ALC4/2015 Party Name:DHAMPUR SUGAR MILLS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 263

Case No.:5/19/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 264

Case No.:62/4/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 265

Case No.:85/19/82-

ALC4/2015 Party Name:ANUPAM RASAYAN (INDIA) LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 266

Case No.:95/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File RLA File Lic.No/Date:0910063233 Defer

41 :01/82/050/01576/AM16/ :09/24/040/00639/AM16/ 10.02.2016 Date:28.09.2016 267

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

Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 268

Case No.:15/10/82-

ALC4/2016 Party Name:INFINITY LABORATORIES PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00361/AM17/ RLA File :22/24/040/00107/AM16/ Lic.No/Date:2210015412 10.02.2016 Defer Date:28.09.2016 269

Case No.:30/21/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 270

Case No.:97/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 271

Case No.:36/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 272

Case No.:35/4/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 273

Case No.:101/19/82-

ALC4/2015 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016

42 274

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

POLYCOATS Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 275

Case No.:13/10/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00359/AM17/ RLA File :22/24/040/00109/AM16/ Lic.No/Date:2210015417 17.02.2016 Defer Date:28.09.2016 Decision : Deferred 276

Case No.:55/2/82-

ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 277

Case No.:35/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 278

Case No.:102/19/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 279

Case No.:52/2/82-

ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 280

Case No.:20/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 281 Case No.:23/4/82- Party Name:JUBILANT Meet No/Date:10/82- Status:Deferred

43 ALC4/2016 GENERICS LTD ALC4/2016 23.08.2016 HQ File :01/82/050/00086/AM17/ RLA File :05/23/040/00470/AM16/ Lic.No/Date:0510397643 18.02.2016 Defer Date:28.09.2016 Decision : Deferred 282

Case No.:34/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 283

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

NITRITE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00009/AM17/ RLA File :34/24/040/ 03/95/040/00161/AM16/ Lic.No/Date:3410041915 22.02.2016 Defer Date:28.09.2016 284

Case No.:27/2/82-

ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 285

Case No.:22/2/82-

ALC4/2016 Party Name:SANJIVANI PARANTERAL LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 286

Case No.:18/4/82-

ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 287

Case No.:19/4/82-ALC4/2016 Party Name:SHREE

BANKEY BEHARI LAL AROMATICS Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00082/AM17/ RLA File :05/24/040/00582/AM16/ Lic.No/Date:0510397715 25.02.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier recommendation of D/o C&PC forwarded vide U.O.No.14010/28/2012-Ch-II dated 30.09.2015, 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. 288 Case No.:24/4/82- Party Name:JUBILANT Meet No/Date:10/82- Status:Deferred

44 ALC4/2016 ALC4/2016 23.08.2016 HQ File :01/82/050/00087/AM17/ RLA File :05/23/040/00491/AM16/ Lic.No/Date:0510397731 26.02.2016 Defer Date:28.09.2016 Decision : Deferred 289

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

PHARMA Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 290

Case No.:84/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 291

Case No.:43/2/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 292

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

CHEM PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 293

Case No.:42/4/82-ALC4/2016 Party Name:FINE ORGANIC

INDUSTRIES PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:
Approved HQ File :01/82/050/00105/AM17/ RLA File :03/94/040/01001/AM16/ Lic.No/Date:0310802950 01.03.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/129/2011-Ch-II dated 04.30.2016 , 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. 294

Case No.:42/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 295 Case No.:14/2/82- Party Name:SHIVA Meet No/Date:10/82- Status:Deferred

45 ALC4/2016 PHARMACHEM LTD, ALC4/2016 23.08.2016 HQ File :01/82/050/00014/AM17/ RLA File :34/24/040/00221/AM16/ Lic.No/Date:3410041935 01.03.2016 Defer Date:28.09.2016 Decision : Deferred 296

Case No.:38/2/82-

ALC4/2016 Party Name:WANBURY LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 297

Case No.:28/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 298

Case No.:29/4/82-

ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:10/82-ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 299

Case No.:3/4/82-ALC4/2016

Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/769/2015-PI(Norms) dated June 2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 300

Case No.:50/2/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred for want of comments from DBT. 301

Case No.:66/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 302 Case No.:67/4/82- ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:10/82- ALC4/2016 Status:Deferred

46 23.08.2016 HQ File :01/82/050/00130/AM17/ RLA File :04/24/040/00256/AM16/ Lic.No/Date:0410161684 04.03.2016 Defer Date:28.09.2016 303

Case No.:68/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 304

Case No.:40/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred . 305

Case No.:41/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 306

Case No.:57/4/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 307

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

SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 308

Case No.:56/4/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 309

Case No.:55/4/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016

47 310

Case No.:30/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 311

Case No.:31/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 312

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

CHEMICALS Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 313

Case No.:29/2/82-

ALC4/2016 Party Name:RUSAN PHARMA LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 314

Case No.:16/10/82-

ALC4/2016 Party Name:SAURAV CHEMICALS LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00362/AM17/ RLA File :22/24/040/00122/AM16/ Lic.No/Date:2210015442 09.03.2016 Defer Date:28.09.2016 315

Case No.:39/4/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00102/AM17/ RLA File :03/94/040/00973/AM16/ Lic.No/Date:0310803223 10.03.2016 Defer Date:28.09.2016 316

Case No.:58/2/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016

48 317

Case No.:59/2/82-

ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 318

Case No.:38/4/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 319

Case No.:176/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00522/AM17/ RLA File :31/83/040/00178/AM16/ Lic.No/Date:3110066046 14.03.2016 Defer Date:28.09.2016 320

Case No.:27/4/82-

ALC4/2016 Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 321

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

CHEMICALS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00145/AM17/ RLA File :03/95/040/00967/AM16/ Lic.No/Date:0310803283 14.03.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/107/2010-Ch-II dated 27.6.2015 dated June 2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 322

Case No.:37/4/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 323

Case No.:143/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00489/AM17/ RLA File :09/24/040/00726/AM16/ Lic.No/Date:0910063418 15.03.2016 Defer Date:28.09.2016

49 324

Case No.:144/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00490/AM17/ RLA File :09/24/040/00727/AM16/ Lic.No/Date:0910063417 15.03.2016 Defer Date:28.09.2016 325

Case No.:26/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 326

Case No.:168/10/82-

ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00514/AM17/ RLA File :09/24/040/00741/AM16/ Lic.No/Date:0910063422 16.03.2016 Defer Date:28.09.2016 327

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

Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 328

Case No.:13/4/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 329

Case No.:145/10/82-

ALC4/2016 Party Name:MSN PHARMACHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00491/AM17/ RLA File :09/24/040/00725/AM16/ Lic.No/Date:0910063424 17.03.2016 Defer Date:28.09.2016 330

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

EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 331 Case No.:8/4/82-ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 Status:Deferred

50 23.08.2016 HQ File :01/82/050/00071/AM17/ RLA File :05/23/040/00541/AM16/ Lic.No/Date:0510397985 18.03.2016 Defer Date:28.09.2016 332

Case No.:153/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00499/AM17/ RLA File :09/24/040/00738/AM16/ Lic.No/Date:0910063433 18.03.2016 Defer Date:28.09.2016 333

Case No.:85/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 334

Case No.:46/2/82-ALC4/2016 Party Name:CADILA

HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00046/AM17/ RLA File :08/24/040/00431/AM16/ Lic.No/Date:0810137474 21.03.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/78/2016-PI(Norms) dated 29.08.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 335

Case No.:36/4/82-

ALC4/2016 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 336

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

EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 337

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

EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 338 Case No.:53/4/82-ALC4/2016 Party Name:ANUH PHARMA LTD. Meet No/Date:10/82- ALC4/2016 Status: Approved

51 23.08.2016 HQ File :01/82/050/00116/AM17/ RLA File :03/94/040/01066/AM16/ Lic.No/Date:0310803494 22.03.2016 Defer Date:
Decision : Approved in meeting No.08/82 dated 27.07.2016 Sl.No.399. 339

Case No.:81/4/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Deferred. 340

Case No.:49/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 341

Case No.:50/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 342

Case No.:142/10/82-

ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00488/AM17/ RLA File :09/24/040/00756/AM16/ Lic.No/Date:0910063439 23.03.2016 Defer Date:28.09.2016 343

Case No.:63/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 344

Case No.:171/10/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00517/AM17/ RLA File :08/24/040/00442/AM16/ Lic.No/Date:0810137503 28.03.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.24/82 dated 15.11.2011, 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. 345 Case No.:47/4/82- ALC4/2016 Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:10/82- ALC4/2016 Status:Deferred

52 23.08.2016 HQ File :01/82/050/00110/AM17/ RLA File :03/94/040/01078/AM16/ Lic.No/Date:0310803568 28.03.2016 Defer Date:28.09.2016 346

Case No.:60/2/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 347

Case No.:46/4/82-

ALC4/2016 Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 348

Case No.:173/10/82-

ALC4/2016 Party Name:CURETECH SKINCARE Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00519/AM17/ RLA File :22/24/040/00108/AM16/ Lic.No/Date:2210015458 29.03.2016 Defer Date:28.09.2016 349

Case No.:80/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 350

Case No.:163/10/82-

ALC4/2016 Party Name:METROCHEM API PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00509/AM17/ RLA File :09/24/040/00755/AM16/ Lic.No/Date:0910063468 30.03.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/776/2013-PI(Norms) dated 04.03.2014, 351

Case No.:165/10/82-

ALC4/2016 Party Name:METROCHEM API PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00511/AM17/ RLA File :09/24/040/00751/AM16/ Lic.No/Date:0910063467 30.03.2016 Defer Date:28.09.2016 352 Case No.:186/10/82- ALC4/2016 Party Name:VOVANTIS LABORATORIES PVT LTD Meet No/Date:10/82- ALC4/2016 Status:Case Deferred

53 23.08.2016 HQ File :01/82/050/00532/AM17/ RLA File :34/24/040/00290/AM16/ Lic.No/Date:3410042021 30.03.2016 Defer Date:28.09.2016 353

Case No.:43/4/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 354

Case No.:69/4/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : The Committee based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/66/2016-PI(Norms) dated 27.06.2016, uploaded at the end of these minutes decided to call for information from the firm and deferred the case. 355

Case No.:76/4/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Deferred 356

Case No.:8/10/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00354/AM17/ RLA File :03/94/040/00645/AM16/ Lic.No/Date:0310803722 01.04.2016 Defer Date:28.09.2016 Decision : Deferred 357

Case No.:65/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 358

Case No.:7/10/82-

ALC4/2016 Party Name:FERMENTA BIOTECH LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00353/AM17/ RLA File :03/94/040/01125/AM16/ Lic.No/Date:0310803764 04.04.2016 Defer Date:28.09.2016 359 Case No.:77/4/82- Party Name:TITAN Meet No/Date:10/82- Status:Deferred

54 ALC4/2016 LABORATORIES PVT. LTD. ALC4/2016 23.08.2016 HQ File :01/82/050/00140/AM17/ RLA File :03/95/040/00001/AM17/ Lic.No/Date:0310803752 04.04.2016 Defer Date:28.09.2016 360

Case No.:162/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00508/AM17/ RLA File :09/24/040/00761/AM16/ Lic.No/Date:0910063495 05.04.2016 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.35011/132/2016- PI(Norms) dated July 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 361

Case No.:92/4/82-

ALC4/2016 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 362

Case No.:74/4/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00137/AM17/ RLA File :03/95/040/00021/AM17/ Lic.No/Date:0310803871 11.04.2016 Defer Date:28.09.2016 363

Case No.:66/2/82-

ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 364

Case No.:5/10/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00351/AM17/ RLA File :03/94/040/00024/AM17/ Lic.No/Date:0310803926 13.04.2016 Defer Date:28.09.2016 365

Case No.:167/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00513/AM17/ RLA File :09/24/040/00777/AM16/ Lic.No/Date:0910063505 15.04.2016 Defer Date:28.09.2016

55 366

Case No.:140/10/82-

ALC4/2016 Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00486/AM17/ RLA File :09/24/040/00784/AM16/ Lic.No/Date:0910063504 15.04.2016 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.35011/136/2016- PI(Norms) dated July 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 367

Case No.:141/10/82-

ALC4/2016 Party Name:VIRUPAKSHA ORGANICS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00487/AM17/ RLA File :09/24/040/00003/AM17/ Lic.No/Date:0910063503 15.04.2016 Defer Date:28.09.2016 368

Case No.:161/10/82-

ALC4/2016 Party Name:SATYADEVA PHARMACEUTICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00507/AM17/ RLA File :09/24/040/00009/AM17/ Lic.No/Date:0910063508 18.04.2016 Defer Date:28.09.2016 369

Case No.:127/10/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00473/AM17/ RLA File :09/24/040/00008/AM17/ Lic.No/Date:0910063506 18.04.2016 Defer Date:28.09.2016 370

Case No.:166/10/82-

ALC4/2016 Party Name:AKTINOS PHARMA PVT LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00512/AM17/ RLA File :09/24/040/00775/AM16/ Lic.No/Date:0910063518 19.04.2016 Defer Date:28.09.2016 371

Case No.:67/2/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision : Copy of application has been sent to TA. 372

Case No.:68/2/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 Decision :Copy of application has been sent to TA.

56 373

Case No.:3/10/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00349/AM17/ RLA File :03/94/040/00042/AM17/ Lic.No/Date:0310804024 20.04.2016 Defer Date:28.09.2016 374

Case No.:69/2/82-

ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 375

Case No.:98/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00444/AM17/ RLA File :17/24/040/00006/AM17/ Lic.No/Date:1710006305 21.04.2016 Defer Date:28.09.2016 376

Case No.:172/10/82-

ALC4/2016 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00518/AM17/ RLA File :05/24/040/00628/AM16/ Lic.No/Date:0510398255 21.04.2016 Defer Date:28.09.2016 377

Case No.:99/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00445/AM17/ RLA File :17/24/040/00005/AM17/ Lic.No/Date:1710006311 22.04.2016 Defer Date:28.09.2016 378

Case No.:164/10/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00510/AM17/ RLA File :09/24/040/00767/AM16/ Lic.No/Date:0910063540 22.04.2016 Defer Date:28.09.2016 379

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

PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00350/AM17/ RLA File :03/94/040/00059/AM17/ Lic.No/Date:0310804159 25.04.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/739/2015-PI(Norms) dated 26.04.2016,

57 380

Case No.:125/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00471/AM17/ RLA File :09/24/040/00033/AM17/ Lic.No/Date:0910063570 29.04.2016 Defer Date:28.09.2016 381

Case No.:118/10/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00464/AM17/ RLA File :09/24/040/00001/AM17/ Lic.No/Date:0910063572 03.05.2016 Defer Date:28.09.2016 382

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

ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00174/AM17/ RLA File :03/95/040/00013/AM17/ Lic.No/Date:0310804365 03.05.2016 Defer Date:28.09.2016 383

Case No.:107/10/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00453/AM17/ RLA File :31/83/040/00001/AM17/ Lic.No/Date:3110066134 04.05.2016 Defer Date:28.09.2016 384

Case No.:108/10/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00454/AM17/ RLA File :31/83/040/00182/AM16/ Lic.No/Date:3110066133 04.05.2016 Defer Date:28.09.2016 385

Case No.:174/10/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00520/AM17/ RLA File :05/23/040/00038/AM17/ Lic.No/Date:0510398377 04.05.2016 Defer Date:28.09.2016 386

Case No.:175/10/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00521/AM17/ RLA File :05/23/040/00032/AM17/ Lic.No/Date:0510398379 04.05.2016 Defer Date:28.09.2016 Decision : Deferred . 387 Case No.:132/10/82- Party Name:SUVEN LIFE Meet No/Date:10/82- Status:Case

58 ALC4/2016 SCIENCES LIMITED ALC4/2016 23.08.2016 Deferred HQ File :01/82/050/00478/AM17/ RLA File :09/24/040/00040/AM17/ Lic.No/Date:0910063583 04.05.2016 Defer Date:28.09.2016 388

Case No.:181/10/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00527/AM17/ RLA File :34/24/040/00021/AM17/ Lic.No/Date:3410042142 05.05.2016 Defer Date:28.09.2016 389

Case No.:9/10/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00355/AM17/ RLA File :03/94/040/00077/AM17/ Lic.No/Date:0310804424 05.05.2016 Defer Date:28.09.2016 390

Case No.:116/10/82-

ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:
Approved HQ File :01/82/050/00462/AM17/ RLA File :09/24/040/00049/AM17/ Lic.No/Date:0910063597 06.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/146/2016-PI(Norms) dated July 2016, 391

Case No.:6/10/82-

ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00352/AM17/ RLA File :05/24/040/00054/AM17/ Lic.No/Date:0510398413 06.05.2016 Defer Date:28.09.2016 392

Case No.:146/10/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00492/AM17/ RLA File :09/24/040/00044/AM17/ Lic.No/Date:0910063608 09.05.2016 Defer Date:28.09.2016 393

Case No.:178/10/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00524/AM17/ RLA File :34/24/040/00354/AM16/ Lic.No/Date:3410042154 10.05.2016 Defer Date:28.09.2016 394 Case No.:77/10/82- Party Name:AMOL Meet No/Date:10/82- Status:Case

59 ALC4/2016 PHARMACEUTICALS PVT. LTD. ALC4/2016 23.08.2016 Deferred HQ File :01/82/050/00423/AM17/ RLA File :13/24/040/00004/AM17/ Lic.No/Date:1310048244 11.05.2016 Defer Date:28.09.2016 395

Case No.:95/4/82-

ALC4/2016 Party Name:AIMS IMPEX PVT. LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 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:28.09.2016 396

Case No.:71/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00417/AM17/ RLA File :05/24/040/00056/AM17/ Lic.No/Date:0510398495 13.05.2016 Defer Date:28.09.2016 397

Case No.:169/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00515/AM17/ RLA File :09/24/040/00007/AM17/ Lic.No/Date:0910063629 17.05.2016 Defer Date:28.09.2016 398

Case No.:156/10/82-

ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00502/AM17/ RLA File :09/24/040/00051/AM17/ Lic.No/Date:0910063627 17.05.2016 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.35011/695/2015- PI(Norms) dated January 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. 399

Case No.:159/10/82-

ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00505/AM17/ RLA File :09/24/040/00035/AM17/ Lic.No/Date:0910063628 17.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/174/2016-PI(Norms) dated July 2016, 400

Case No.:170/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File RLA File Lic.No/Date:0910063646 Defer Date:

60 :01/82/050/00516/AM17/ :09/24/040/00071/AM17/ 17.05.2016 Decision : The Committee decided to ratify norms on based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/132/2016-PI(Norms) dated July 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 401

Case No.:148/10/82-

ALC4/2016 Party Name:VINDHYA PHARMA (INDIA)PVT LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00494/AM17/ RLA File :09/24/040/00062/AM17/ Lic.No/Date:0910063625 17.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/215/2016-PI(Norms) dated Sept. 2016, 402

Case No.:94/10/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00440/AM17/ RLA File :05/23/040/00067/AM17/ Lic.No/Date:0510398541 18.05.2016 Defer Date:28.09.2016 403

Case No.:126/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00472/AM17/ RLA File :09/24/040/00306/AM15/ Lic.No/Date:0910063657 19.05.2016 Defer Date:28.09.2016 404

Case No.:149/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00495/AM17/ RLA File :09/24/040/00546/AM16/ Lic.No/Date:0910063659 19.05.2016 Defer Date:28.09.2016 405

Case No.:133/10/82-

ALC4/2016 Party Name:CHANDRA LIFE SCIENCES PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00479/AM17/ RLA File :09/24/040/00063/AM17/ Lic.No/Date:0910063652 19.05.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.18/82 dated 19.12.2013 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. 406

Case No.:72/10/82-

ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred

61 HQ File :01/82/050/00418/AM17/ RLA File :05/24/040/00080/AM17/ Lic.No/Date:0510398561 19.05.2016 Defer Date:28.09.2016 407

Case No.:73/10/82-

ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00419/AM17/ RLA File :05/24/040/00067/AM17/ Lic.No/Date:0510398560 19.05.2016 Defer Date:28.09.2016 408

Case No.:130/10/82-

ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00476/AM17/ RLA File :09/24/040/00078/AM17/ Lic.No/Date:0910063664 23.05.2016 Defer Date:28.09.2016 409

Case No.:83/10/82-

ALC4/2016 Party Name:STERILE INDIA PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00429/AM17/ RLA File :05/24/040/00633/AM16/ Lic.No/Date:0510398574 23.05.2016 Defer Date:28.09.2016 410

Case No.:177/10/82-

ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00523/AM17/ RLA File :34/24/040/00039/AM17/ Lic.No/Date:3410042198 24.05.2016 Defer Date:28.09.2016 411

Case No.:180/10/82-

ALC4/2016 Party Name:DEEPAK NITRITE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00526/AM17/ RLA File :34/24/040/00042/AM17/ Lic.No/Date:3410042199 24.05.2016 Defer Date:28.09.2016 412

Case No.:79/10/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00425/AM17/ RLA File :05/23/040/00075/AM17/ Lic.No/Date:0510398581 24.05.2016 Defer Date:28.09.2016 413

Case No.:80/10/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00426/AM17/ RLA File :05/23/040/00027/AM17/ Lic.No/Date:0510398587 24.05.2016 Defer Date:28.09.2016

62 414

Case No.:81/10/82-

ALC4/2016 Party Name:INDO PHYTO CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00427/AM17/ RLA File :05/23/040/00028/AM17/ Lic.No/Date:0510398588 24.05.2016 Defer Date:28.09.2016 415

Case No.:74/10/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00420/AM17/ RLA File :05/23/040/00078/AM17/ Lic.No/Date:0510398583 24.05.2016 Defer Date:28.09.2016 416

Case No.:75/10/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00421/AM17/ RLA File :05/23/040/00076/AM17/ Lic.No/Date:0510398582 24.05.2016 Defer Date:28.09.2016 417

Case No.:76/10/82-

ALC4/2016 Party Name:PI INDUSTRIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00422/AM17/ RLA File :13/24/040/00006/AM17/ Lic.No/Date:1310048249 24.05.2016 Defer Date: C&PC forwarded vide U.O.No.15022/6/2012-Ch-II dated 30.09.2015 , 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.:136/10/82-

ALC4/2016 Party Name:METROCHEM API PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00482/AM17/ RLA File :09/24/040/00100/AM17/ Lic.No/Date:0910063676 25.05.2016 Defer Date:28.09.2016 419

Case No.:115/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00461/AM17/ RLA File :09/24/040/00088/AM17/ Lic.No/Date:0910063685 25.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/132/2016-PI(Norms) dated July 2016, 420

Case No.:185/10/82-

ALC4/2016 Party Name:PAUSHAK LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred

63 HQ File :01/82/050/00531/AM17/ RLA File :34/24/040/00037/AM17/ Lic.No/Date:3410042207 25.05.2016 Defer Date:28.09.2016 421

Case No.:84/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00430/AM17/ RLA File :05/24/040/00059/AM17/ Lic.No/Date:0510398615 25.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/778/2015-PI(Norms) dated June 2016, 422

Case No.:87/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00433/AM17/ RLA File :05/24/040/00058/AM17/ Lic.No/Date:0510398614 25.05.2016 Defer Date:28.09.2016 423

Case No.:102/10/82-

ALC4/2016 Party Name:IKRISH HEALTHCARE PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00448/AM17/ RLA File :05/23/040/00091/AM17/ Lic.No/Date:0510398628 26.05.2016 Defer Date:28.09.2016 424

Case No.:68/10/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00414/AM17/ RLA File :05/23/040/00088/AM17/ Lic.No/Date:0510398631 26.05.2016 Defer Date:28.09.2016 425

Case No.:65/10/82-

ALC4/2016 Party Name:KORES (INDIA) LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00411/AM17/ RLA File :31/83/040/00014/AM17/ Lic.No/Date:3110066163 26.05.2016 Defer Date:28.09.2016 426

Case No.:88/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00434/AM17/ RLA File :05/24/040/00083/AM17/ Lic.No/Date:0510398625 26.05.2016 Defer Date:28.09.2016 427

Case No.:147/10/82-

ALC4/2016 Party Name:SHREEGEN PHARMA LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred

64 HQ File :01/82/050/00493/AM17/ RLA File :09/24/040/00091/AM17/ Lic.No/Date:0910063692 26.05.2016 Defer Date:28.09.2016 428

Case No.:91/10/82-

ALC4/2016 Party Name:VIC INDUSTRIES, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00437/AM17/ RLA File :17/24/040/00028/AM17/ Lic.No/Date:1710006343 26.05.2016 Defer Date:28.09.2016 429

Case No.:160/10/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00506/AM17/ RLA File :09/24/040/00096/AM17/ Lic.No/Date:0910063702 27.05.2016 Defer Date:28.09.2016 430

Case No.:155/10/82-

ALC4/2016 Party Name:DIVIS LABORATORIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00501/AM17/ RLA File :09/24/040/00073/AM17/ Lic.No/Date:0910063701 27.05.2016 Defer Date:28.09.2016 431

Case No.:117/10/82-

ALC4/2016 Party Name:DR. REDDYS Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00463/AM17/ RLA File :09/24/040/00089/AM17/ Lic.No/Date:0910063705 27.05.2016 Defer Date:28.09.2016 432

Case No.:92/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00438/AM17/ RLA File :17/24/040/00030/AM17/ Lic.No/Date:1710006345 27.05.2016 Defer Date:28.09.2016 433

Case No.:112/10/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00458/AM17/ RLA File :05/23/040/00094/AM17/ Lic.No/Date:0510398655 27.05.2016 Defer Date:28.09.2016 434

Case No.:113/10/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00459/AM17/ RLA File :05/23/040/00093/AM17/ Lic.No/Date:0510398654 27.05.2016 Defer Date:28.09.2016

65 435

Case No.:45/10/82-

ALC4/2016 Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00391/AM17/ RLA File :03/95/040/00157/AM17/ Lic.No/Date:0310804995 27.05.2016 Defer Date:28.09.2016 436

Case No.:36/10/82-

ALC4/2016 KABI INDIA PRIVATE LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00382/AM17/ RLA File :03/94/040/00145/AM17/ Lic.No/Date:0310805018 30.05.2016 Defer Date:28.09.2016 437

Case No.:34/10/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00380/AM17/ RLA File :03/94/040/00048/AM17/ Lic.No/Date:0310805010 30.05.2016 Defer Date:28.09.2016 438

Case No.:35/10/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00381/AM17/ RLA File :03/94/040/00030/AM17/ Lic.No/Date:0310805009 30.05.2016 Defer Date:28.09.2016 439

Case No.:139/10/82-

ALC4/2016 Party Name:NATCO PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00485/AM17/ RLA File :09/24/040/00110/AM17/ Lic.No/Date:0910063712 30.05.2016 Defer Date:28.09.2016 440

Case No.:123/10/82-

ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00469/AM17/ RLA File :09/24/040/00102/AM17/ Lic.No/Date:0910063716 30.05.2016 Defer Date:28.09.2016 441

Case No.:44/10/82-

ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00390/AM17/ RLA File :03/95/040/00128/AM17/ Lic.No/Date:0310805023 30.05.2016 Defer Date:28.09.2016 442 Case No.:42/10/82- ALC4/2016 Party Name:SUPRIYA LIFESCIENCE LTD Meet No/Date:10/82- ALC4/2016 Status:Case Deferred

66 23.08.2016 HQ File :01/82/050/00388/AM17/ RLA File :03/95/040/00154/AM17/ Lic.No/Date:0310805017 30.05.2016 Defer Date:28.09.2016 443

Case No.:103/10/82-

ALC4/2016 Party Name:AGSON GLOBAL PRIVATE LIMITED. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00449/AM17/ RLA File :05/23/040/00095/AM17/ Lic.No/Date:0510398680 31.05.2016 Defer Date:28.09.2016 444

Case No.:33/10/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00379/AM17/ RLA File :03/94/040/00044/AM17/ Lic.No/Date:0310805039 31.05.2016 Defer Date:28.09.2016 445

Case No.:95/10/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00441/AM17/ RLA File :05/24/040/00091/AM17/ Lic.No/Date:0510398694 31.05.2016 Defer Date:28.09.2016 446

Case No.:20/10/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00366/AM17/ RLA File :05/24/040/00072/AM17/ Lic.No/Date:0510398691 31.05.2016 Defer Date:28.09.2016 447

Case No.:96/10/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00442/AM17/ RLA File :05/24/040/00063/AM17/ Lic.No/Date:0510398692 31.05.2016 Defer Date:28.09.2016 448

Case No.:97/10/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00443/AM17/ RLA File :05/24/040/00066/AM17/ Lic.No/Date:0510398693 31.05.2016 Defer Date:28.09.2016 449

Case No.:10/10/82-

ALC4/2016 Party Name:CADILA HEALTHCARE LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00356/AM17/ RLA File :08/24/040/00075/AM17/ Lic.No/Date:0810138075 01.06.2016 Defer Date:

67 Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.12/82 dated 19.09.2013, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 450

Case No.:43/10/82-

ALC4/2016 Party Name:O C SPECIALITIES PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00389/AM17/ RLA File :03/95/040/00169/AM17/ Lic.No/Date:0310805124 01.06.2016 Defer Date:28.09.2016 451

Case No.:124/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00470/AM17/ RLA File :09/24/040/00107/AM17/ Lic.No/Date:0910063720 01.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M. No.35011/132/2016-PI(Norms) dated July 2016, 452

Case No.:119/10/82-

ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00465/AM17/ RLA File :09/24/040/00113/AM17/ Lic.No/Date:0910063721 01.06.2016 Defer Date:28.09.2016 453

Case No.:187/10/82-

ALC4/2016 Party Name:WINDLAS HEALTH CARE PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00533/AM17/ RLA File :61/24/040/00001/AM17/ Lic.No/Date:6110001350 01.06.2016 Defer Date:28.09.2016 454

Case No.:32/10/82-

ALC4/2016 Party Name:IPCA Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00378/AM17/ RLA File :03/94/040/00180/AM17/ Lic.No/Date:0310805161 02.06.2016 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.54/82 AM09 dated31.3.2009 Case No. B-551, 455

Case No.:54/10/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00400/AM17/ RLA File :04/24/040/00038/AM17/ Lic.No/Date:0410162004 02.06.2016 Defer Date:28.09.2016

68 456

Case No.:106/10/82-

ALC4/2016 Party Name:GRANULES INDIA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00452/AM17/ RLA File :09/24/040/00115/AM17/ Lic.No/Date:0910063743 03.06.2016 Defer Date:28.09.2016 457

Case No.:69/10/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00415/AM17/ RLA File :05/23/040/00108/AM17/ Lic.No/Date:0510398724 03.06.2016 Defer Date:28.09.2016 458

Case No.:70/10/82-

ALC4/2016 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00416/AM17/ RLA File :05/23/040/00109/AM17/ Lic.No/Date:0510398725 03.06.2016 Defer Date:28.09.2016 459

Case No.:48/10/82-

ALC4/2016 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00394/AM17/ RLA File :03/94/040/00051/AM17/ Lic.No/Date:0310805268 07.06.2016 Defer Date:28.09.2016 460

Case No.:50/10/82-

ALC4/2016 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00396/AM17/ RLA File :03/94/040/00065/AM17/ Lic.No/Date:0310805269 07.06.2016 Defer Date:28.09.2016 461

Case No.:51/10/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00397/AM17/ RLA File :03/94/040/00196/AM17/ Lic.No/Date:0310805264 07.06.2016 Defer Date:28.09.2016 462

Case No.:11/10/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00357/AM17/ RLA File :08/24/040/00088/AM17/ Lic.No/Date:0810138109 07.06.2016 Defer Date:28.09.2016 463 Case No.:157/10/82- Party Name:MAITHRI Meet No/Date:10/82- Status:Case

69 ALC4/2016 DRUGS PVT LTD ALC4/2016 23.08.2016 Deferred HQ File :01/82/050/00503/AM17/ RLA File :09/24/040/00112/AM17/ Lic.No/Date:0910063749 07.06.2016 Defer Date:28.09.2016 464

Case No.:131/10/82-

ALC4/2016 Party Name:MSN PHARMACHEM PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00477/AM17/ RLA File :09/24/040/00117/AM17/ Lic.No/Date:0910063750 07.06.2016 Defer Date:28.09.2016 465

Case No.:129/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00475/AM17/ RLA File :09/24/040/00045/AM17/ Lic.No/Date:0910063759 07.06.2016 Defer Date:28.09.2016 466

Case No.:59/10/82-

ALC4/2016 Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00405/AM17/ RLA File :22/24/040/00016/AM17/ Lic.No/Date:2210015489 07.06.2016 Defer Date:28.09.2016 467

Case No.:128/10/82-

ALC4/2016 Party Name:SHODHANA LABORATORIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00474/AM17/ RLA File :09/24/040/00127/AM17/ Lic.No/Date:0910063760 07.06.2016 Defer Date:28.09.2016 468

Case No.:134/10/82-

ALC4/2016 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00480/AM17/ RLA File :09/24/040/00087/AM17/ Lic.No/Date:0910063771 08.06.2016 Defer Date:28.09.2016 469

Case No.:18/10/82-

ALC4/2016 Party Name:ARJUN CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00364/AM17/ RLA File :04/24/040/00041/AM17/ Lic.No/Date:0410162023 08.06.2016 Defer Date:28.09.2016 470

Case No.:158/10/82-

ALC4/2016 PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File RLA File Lic.No/Date:0910063769 Defer

70 :01/82/050/00504/AM17/ :09/24/040/00137/AM17/ 08.06.2016 Date:28.09.2016 471

Case No.:53/10/82-

ALC4/2016 Party Name:FDC LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00399/AM17/ RLA File :03/94/040/00172/AM17/ Lic.No/Date:0310805303 08.06.2016 Defer Date:28.09.2016 472

Case No.:111/10/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00457/AM17/ RLA File :05/24/040/00110/AM17/ Lic.No/Date:0510398753 08.06.2016 Defer Date:28.09.2016 473

Case No.:121/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00467/AM17/ RLA File :09/24/040/00032/AM17/ Lic.No/Date:0910063765 08.06.2016 Defer Date:28.09.2016 474

Case No.:120/10/82-

ALC4/2016 Party Name:HETERO DRUGS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00466/AM17/ RLA File :09/24/040/00133/AM17/ Lic.No/Date:0910063783 09.06.2016 Defer Date:28.09.2016 475

Case No.:122/10/82-

ALC4/2016 Party Name:HETERO LABS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00468/AM17/ RLA File :09/24/040/00136/AM17/ Lic.No/Date:0910063784 09.06.2016 Defer Date:28.09.2016 476

Case No.:150/10/82-

ALC4/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00496/AM17/ RLA File :09/24/040/00122/AM17/ Lic.No/Date:0910063779 09.06.2016 Defer Date:28.09.2016 477

Case No.:151/10/82-

ALC4/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00497/AM17/ RLA File :09/24/040/00123/AM17/ Lic.No/Date:0910063778 09.06.2016 Defer Date:28.09.2016

71 478

Case No.:49/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00395/AM17/ RLA File :03/94/040/00181/AM17/ Lic.No/Date:0310805345 09.06.2016 Defer Date:28.09.2016 479

Case No.:114/10/82-

ALC4/2016 Party Name:SHREE BANKEY BEHARI LAL AROMATICS Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00460/AM17/ RLA File :05/24/040/00092/AM17/ Lic.No/Date:0510398757 09.06.2016 Defer Date:28.09.2016 480

Case No.:179/10/82-

ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00525/AM17/ RLA File :34/24/040/00064/AM17/ Lic.No/Date:3410042257 10.06.2016 Defer Date:28.09.2016 481

Case No.:12/10/82-

ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00358/AM17/ RLA File :04/24/040/00043/AM17/ Lic.No/Date:0410162034 10.06.2016 Defer Date:28.09.2016 482

Case No.:89/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00435/AM17/ RLA File :17/24/040/00037/AM17/ Lic.No/Date:1710006358 10.06.2016 Defer Date:28.09.2016 483

Case No.:90/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00436/AM17/ RLA File :17/24/040/00039/AM17/ Lic.No/Date:1710006359 10.06.2016 Defer Date:28.09.2016 484

Case No.:31/10/82-

ALC4/2016 Party Name:GLENMARK PHARMACEUTICALS LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00377/AM17/ RLA File :03/94/040/00216/AM17/ Lic.No/Date:0310805373 10.06.2016 Defer Date:28.09.2016 485

Case No.:46/10/82-

ALC4/2016 Party Name:NOCIL LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred

72 HQ File :01/82/050/00392/AM17/ RLA File :03/95/040/00134/AM17/ Lic.No/Date:0310805363 10.06.2016 Defer Date:28.09.2016 486

Case No.:47/10/82-

ALC4/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00393/AM17/ RLA File :03/95/040/00196/AM17/ Lic.No/Date:0310805364 10.06.2016 Defer Date:28.09.2016 487

Case No.:64/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00410/AM17/ RLA File :31/83/040/00195/AM16/ Lic.No/Date:3110066174 13.06.2016 Defer Date:28.09.2016 488

Case No.:152/10/82-

ALC4/2016 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00498/AM17/ RLA File :09/24/040/00130/AM17/ Lic.No/Date:0910063793 13.06.2016 Defer Date:28.09.2016 489

Case No.:14/10/82-

ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00360/AM17/ RLA File :04/24/040/00049/AM17/ Lic.No/Date:0410162041 14.06.2016 Defer Date:28.09.2016 490

Case No.:52/10/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00398/AM17/ RLA File :03/94/040/00223/AM17/ Lic.No/Date:0310805476 14.06.2016 Defer Date:28.09.2016 491

Case No.:26/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00372/AM17/ RLA File :03/94/040/00217/AM17/ Lic.No/Date:0310805452 14.06.2016 Defer Date:28.09.2016 492

Case No.:27/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00373/AM17/ RLA File :03/94/040/00218/AM17/ Lic.No/Date:0310805451 14.06.2016 Defer Date:28.09.2016

73 493

Case No.:137/10/82-

ALC4/2016 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00483/AM17/ RLA File :56/24/040/00009/AM17/ Lic.No/Date:5610004930 14.06.2016 Defer Date:28.09.2016 494

Case No.:19/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00365/AM17/ RLA File :05/24/040/00117/AM17/ Lic.No/Date:0510398800 14.06.2016 Defer Date:28.09.2016 495

Case No.:41/10/82-

ALC4/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00387/AM17/ RLA File :03/95/040/00195/AM17/ Lic.No/Date:0310805433 14.06.2016 Defer Date: Decision : The Committee decided to ratify norms repeat basis based on the earlier decision taken by NC in its meeting No.08/82 dated 25.09.2014 , 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. 496

Case No.:60/10/82-

ALC4/2016 Party Name:VENUS REMEDIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00406/AM17/ RLA File :22/24/040/00014/AM17/ Lic.No/Date:2210015501 14.06.2016 Defer Date:28.09.2016 497

Case No.:61/10/82-

ALC4/2016 Party Name:ANUJA HEALTHCARE LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00407/AM17/ RLA File :22/24/040/00013/AM17/ Lic.No/Date:2210015504 15.06.2016 Defer Date:28.09.2016 498

Case No.:25/10/82-

ALC4/2016 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00371/AM17/ RLA File :03/94/040/00132/AM17/ Lic.No/Date:0310805494 15.06.2016 Defer Date:28.09.2016 499

Case No.:154/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00500/AM17/ RLA File :09/24/040/00084/AM17/ Lic.No/Date:0910063799 15.06.2016 Defer Date:28.09.2016

74 500

Case No.:23/10/82-

ALC4/2016 Party Name:RECKITT BENCKISER ( INDIA) PRIVATE LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00369/AM17/ RLA File :05/24/040/00128/AM17/ Lic.No/Date:0510398826 16.06.2016 Defer Date:28.09.2016 501

Case No.:62/10/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00408/AM17/ RLA File :52/24/040/00019/AM17/ Lic.No/Date:5210041935 17.06.2016 Defer Date:28.09.2016 502

Case No.:57/10/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00403/AM17/ RLA File :05/23/040/00054/AM17/ Lic.No/Date:0510398839 17.06.2016 Defer Date:28.09.2016 503

Case No.:40/10/82-

ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00386/AM17/ RLA File :03/95/040/00191/AM17/ Lic.No/Date:0310805570 17.06.2016 Defer Date:28.09.2016 504

Case No.:58/10/82-

ALC4/2016 Party Name:AMI ORGANICS PVT LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00404/AM17/ RLA File :52/24/040/00018/AM17/ Lic.No/Date:5210041937 20.06.2016 Defer Date:28.09.2016 505

Case No.:67/10/82-

ALC4/2016 Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status: Approved HQ File :01/82/050/00413/AM17/ RLA File :31/83/040/00025/AM17/ Lic.No/Date:3110066183 20.06.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o C&PC) forwarded vide U.O.No.14010/3/2012-Ch-II dated 16.02..2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 506

Case No.:30/10/82-

ALC4/2016 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00376/AM17/ RLA File :03/94/040/00150/AM17/ Lic.No/Date:0310805606 20.06.2016 Defer Date:28.09.2016

75 507

Case No.:21/10/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00367/AM17/ RLA File :05/24/040/00129/AM17/ Lic.No/Date:0510398847 20.06.2016 Defer Date:28.09.2016 508

Case No.:22/10/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00368/AM17/ RLA File :05/24/040/00112/AM17/ Lic.No/Date:0510398846 20.06.2016 Defer Date:28.09.2016 509

Case No.:29/10/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00375/AM17/ RLA File :03/94/040/00208/AM17/ Lic.No/Date:0310805623 21.06.2016 Defer Date:28.09.2016 510

Case No.:24/10/82-

ALC4/2016 Party Name:IPCA Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00370/AM17/ RLA File :03/94/040/00230/AM17/ Lic.No/Date:0310805622 21.06.2016 Defer Date:28.09.2016 511

Case No.:55/10/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00401/AM17/ RLA File :04/24/040/00052/AM17/ Lic.No/Date:0410162053 21.06.2016 Defer Date:28.09.2016 512

Case No.:78/10/82-

ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00424/AM17/ RLA File :13/24/040/00009/AM17/ Lic.No/Date:1310048295 22.06.2016 Defer Date:28.09.2016 513

Case No.:56/10/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00402/AM17/ RLA File :04/24/040/00051/AM17/ Lic.No/Date:0410162058 22.06.2016 Defer Date:28.09.2016

76 514

Case No.:105/10/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00451/AM17/ RLA File :05/24/040/00133/AM17/ Lic.No/Date:0510398872 22.06.2016 Defer Date:28.09.2016 515

Case No.:109/10/82-

ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00455/AM17/ RLA File :22/24/040/00022/AM17/ Lic.No/Date:2210015511 23.06.2016 Defer Date:28.09.2016 516

Case No.:66/10/82-

ALC4/2016 Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00412/AM17/ RLA File :31/83/040/00030/AM17/ Lic.No/Date:3110066188 23.06.2016 Defer Date:28.09.2016 517

Case No.:28/10/82-

ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00374/AM17/ RLA File :03/94/040/00202/AM17/ Lic.No/Date:0310805671 23.06.2016 Defer Date:28.09.2016 518

Case No.:184/10/82-

ALC4/2016 Party Name:TIDE INDUSTRIES Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00530/AM17/ RLA File :34/24/040/00074/AM17/ Lic.No/Date:3410042297 23.06.2016 Defer Date:28.09.2016 519

Case No.:110/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00456/AM17/ RLA File :31/83/040/00027/AM17/ Lic.No/Date:3110066198 27.06.2016 Defer Date:28.09.2016 520

Case No.:104/10/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00450/AM17/ RLA File :05/24/040/00130/AM17/ Lic.No/Date:0510398918 27.06.2016 Defer Date:28.09.2016 521 Case No.:37/10/82- Party Meet No/Date:10/82- Status:Case

77 ALC4/2016 Name:METROPOLITAN EXIMCHEM PRIVATE LTD. ALC4/2016 23.08.2016 Deferred HQ File :01/82/050/00383/AM17/ RLA File :03/95/040/00258/AM17/ Lic.No/Date:0310805756 28.06.2016 Defer Date:28.09.2016 522

Case No.:38/10/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00384/AM17/ RLA File :03/95/040/00234/AM17/ Lic.No/Date:0310805748 28.06.2016 Defer Date:28.09.2016 523

Case No.:39/10/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00385/AM17/ RLA File :03/95/040/00235/AM17/ Lic.No/Date:0310805747 28.06.2016 Defer Date:28.09.2016 524

Case No.:138/10/82-

ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00484/AM17/ RLA File :56/24/040/00051/AM16/ Lic.No/Date:5610004939 30.06.2016 Defer Date:28.09.2016 525

Case No.:182/10/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00528/AM17/ RLA File :34/24/040/00095/AM17/ Lic.No/Date:3410042315 30.06.2016 Defer Date:28.09.2016 526

Case No.:183/10/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00529/AM17/ RLA File :34/24/040/00094/AM17/ Lic.No/Date:3410042314 30.06.2016 Defer Date:28.09.2016 527

Case No.:100/10/82-

ALC4/2016 KABI ONCOLOGY LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00446/AM17/ RLA File :05/23/040/00169/AM17/ Lic.No/Date:0510398969 04.07.2016 Defer Date:28.09.2016 528

Case No.:93/10/82-

ALC4/2016 Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred

78 HQ File :01/82/050/00439/AM17/ RLA File :05/23/040/00097/AM17/ Lic.No/Date:0510398980 04.07.2016 Defer Date:28.09.2016 529

Case No.:85/10/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00431/AM17/ RLA File :05/23/040/00172/AM17/ Lic.No/Date:0510398972 04.07.2016 Defer Date:28.09.2016 530

Case No.:86/10/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00432/AM17/ RLA File :05/23/040/00146/AM17/ Lic.No/Date:0510398970 04.07.2016 Defer Date:28.09.2016 531

Case No.:101/10/82-

ALC4/2016 Party Name:JUBILANT Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00447/AM17/ RLA File :05/23/040/00173/AM17/ Lic.No/Date:0510398971 04.07.2016 Defer Date:28.09.2016 532

Case No.:135/10/82-

ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00481/AM17/ RLA File :56/24/040/00014/AM17/ Lic.No/Date:5610004941 04.07.2016 Defer Date:28.09.2016 533

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

PHARMACEUTICALS LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00341/AM17/ RLA File :34/24/040/00079/AM17/ Lic.No/Date:3410042326 05.07.2016 Defer Date:28.09.2016 534

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

(P) LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00340/AM17/ RLA File :05/23/040/00139/AM17/ Lic.No/Date:0510398996 05.07.2016 Defer Date:28.09.2016 535

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

CHEM-TECH LTD., Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00342/AM17/ RLA File :08/24/040/00132/AM17/ Lic.No/Date:0810138237 07.07.2016 Defer Date:28.09.2016

79 536

Case No.:63/10/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00409/AM17/ RLA File :04/24/040/00058/AM17/ Lic.No/Date:0410162083 08.07.2016 Defer Date:28.09.2016 537

Case No.:82/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00428/AM17/ RLA File :31/83/040/00041/AM17/ Lic.No/Date:3110066246 14.07.2016 Defer Date:28.09.2016 538

Case No.:5/8/82-ALC4/2016 Party Name:MYLAN

Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00343/AM17/ RLA File :09/24/040/00197/AM17/ Lic.No/Date:0910063918 14.07.2016 Defer Date:28.09.2016 539

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

LIMITED, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00344/AM17/ RLA File :08/24/040/00134/AM17/ Lic.No/Date:0810138308 18.07.2016 Defer Date:28.09.2016 540

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

PHARMA LIMITED Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Deferred HQ File :01/82/050/00346/AM17/ RLA File :09/24/040/00198/AM17/ Lic.No/Date:0910063961 20.07.2016 Defer Date:28.09.2016 541

Case No.:1/10/82-

ALC4/2016 Party Name:INTAS PHARMACEUTICALS LTD. Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00347/AM17/ RLA File :08/24/040/00127/AM17/ Lic.No/Date:0810138359 25.07.2016 Defer Date:28.09.2016 542

Case No.:2/10/82-

ALC4/2016 Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:10/82- ALC4/2016 23.08.2016 Status:Case Deferred HQ File :01/82/050/00348/AM17/ RLA File :07/24/040/00115/AM17/ Lic.No/Date:0710110184 29.07.2016 Defer Date:28.09.2016 543 Case No.:188/10/82- ALC4/2016 Party Name:SAURAV CHEMICALS LTD, Meet No/Date:10/82- ALC4/2016 Status:Case Deferred

80 23.08.2016 HQ File :01/82/050/00534/AM17/ RLA File :22/24/040/00040/AM17/ Lic.No/Date:2210015536 11.08.2016 Defer Date:28.09.2016 Minutes of cases considered outside agenda

Case No. B- 01

M.No.10/AM-17 Date 23.08.2016 M/s. AVA Chemicals Pvt Ltd File No. 01/82/050/01017/AM14 RLA No 03/94/040/00786/AM14 Adv.Auth. No. 0310763107 dated 23.03.2013 Decision: The Committee considered this for correction in the quantity of import item Ethylene diamine Tetra Acetic Acid.....0.0730kg as per agenda. The Committee in light of written comment forwarded by D/o C&PC forwarded in the earlier vide U.O.No.14010/157/2011-Ch-II dated 29.10.2013, uploaded at the end of these minutes, decided to correct the quantity of import item to read as “Ethylene Diamine Tetra Acetic Acid..... 0.730kg”. RA concerned may take necessary action as per decision of NC.

Case No. B- 02

M.No.10/AM-17 Date 23.08.2016 M/s. Gland Pharma Ltd File No. 01/82/050/01477/AM13 Adv.Auth. No. 0910054887 dated 01.02.2013 Adv.Auth. No. 0910058221 dated 13.11.2013 Adv.Auth. No. 0910058310 dated 25.11.2013 Adv.Auth. No. 0910058454 dated 04.12.2013 Adv.Auth. No. 0910060220 dated 26.05.2013 Adv.Auth. No. 0910060413 dated 10.06.2014 Adv.Auth. No. 0910060946 dated 11.09.2014 Adv.Auth. No. 0910061067 dated 09.10.2014 Decision: The Committee considered this case for ratification of Norms under Para 4.07 of HBP as per agenda. The Committee decided to ratify norms based on recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/164/2015-PI(Norms) dated 19.10.2015, uploaded at the end of these minutes or as applied by the firm whichever is less under

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

Case No. B- 03

M.No.10/AM-17 Date 23.08.2016 M/s. Pace Pharmatech Pvt Ltd File No. 01/82/050/00875/AM15 RLA No 03/95/040/00347/AM15

81 Adv.Auth. No. 0310787160 dated 22.07.2014 Decision: The Committee considered this case for ratification of Norms under Para 4.07 of HBP as per agenda. The Committee decided to ratify norms based on recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/583/2014-PI(Norms) dated 19.05.2016, uploaded at the end of these minutes or as applied by the firm whichever is less under

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


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