IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2016-11-29

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. 14/82/2016 of 2016-17 dated 29.11.2016 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, scheduled to be held on 29.11.2016 but actually held on 15.12.2016 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 V.K. Tyagi, Consultant, D/o Pharmaceuticals. The committee went through the minutes of earlier meeting No. 13/82 dated 16.11.2016 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 : 14/82-ALC4/2016 MEETING DATE : 29.11.2016 1

Case No.:15/2/82-ALC4/2016 Party Name:PERFECT

INDUSTRIES PRIVATE LIMITED. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 2

Case No.:36/19/82-ALC4/2014 Party Name:ALKALI METALS

LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01524/AM15/ RLA File :09/24/040/00503/AM12/ Lic.No/Date:0910052125 12.04.2012 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the earlier decision taken by NC in its meeting No.33/82 dated 21.03.2013 , uploaded 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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Case No.:38/19/82-

ALC4/2014 Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Technical information has been received and sent to DoP on 19.09.2016. The Committee accordingly deferred the case. 4

Case No.:173/5/82-

ALC4/2015 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 5

Case No.:61/4/82-ALC4/2016 Party Name:ADCOCK

INGRAM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : The Committee noted that information has been called for from the firm by NC in its meeting No.12 dated 28.09.2016 is awaited. The committee accordingly decided to await the reply and deferred the case. 6

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

BIOFUELS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 7

Case No.:41/16/82-

ALC4/2013 Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred for want of comments from DoP. 8

Case No.:140/23/82-

ALC4/2013 Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01187/AM14/ RLA File :03/95/040/00495/AM14/ Lic.No/Date:0310758627 21.11.2013 Defer Date: Decision : Approved in meeting No.12 dated 28.09.2016 9

Case No.:48/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

3 HQ File :01/82/050/01011/AM16/ RLA File :03/94/040/00860/AM14/ Lic.No/Date:0310766718 17.01.2014 Defer Date: 28.12.2016 Decision :Deferred. 10

Case No.:57/3/82-

ALC4/2014 Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 11

Case No.:49/13/82-

ALC4/2015 Party Name:BELCHEM INDS. INDIA PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 12

Case No.:237/6/82-

ALC4/2014 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 13

Case No.:7/8/82-ALC4/2016

Party Name:MACSON PRODUCTS Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 14

Case No.:13/2/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 15

Case No.:38/8/82-

ALC4/2014 Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from DoP. 16 Case No.:165/6/82- Party Name:HALDIA Meet No/Date:14/82- Status:Deferred

4 ALC4/2014 PETROCHEMICALS LTD. ALC4/2016 29.11.2016 HQ File :01/82/050/00567/AM15/ RLA File :02/24/040/00037/AM15/ Lic.No/Date:0210203844 05.06.2014 Defer Date: 28.12.2016 Decision :Deferred. 17

Case No.:77/8/82-ALC4/2014

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00741/AM15/ RLA File :03/94/040/00196/AM15/ Lic.No/Date:0310785501 17.06.2014 Defer Date: taken by NC in its meeting No.04/82 dated 26.04.2011 , uploaded at the end of these minutes or 18

Case No.:2/14/82-ALC4/2016

Party Name:ENVEE DRUGS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00800/AM17/ RLA File :34/24/040/00067/AM15/ Lic.No/Date:3410040264 17.06.2014 Defer Date: taken by NC in its meeting No.1/82 dated -4.04.2013 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take 19

Case No.:202/6/82-

ALC4/2014 Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 20

Case No.:30/9/82-

ALC4/2014 Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00827/AM15/ RLA File :04/24/040/00033/AM15/ Lic.No/Date:0410159122 30.07.2014 Defer Date: 28.12.2016 21

Case No.:203/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : The Committee in light of the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/218/2016-PI(Norms) dated 21.10.2016 decided to call for COA of the imported details leaves from the foreign supplier and deferred the case.

5 22

Case No.:33/9/82-ALC4/2014

Party Name:TIDE INDUSTRIES Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00830/AM15/ RLA File :34/24/040/00106/AM15/ Lic.No/Date:3410040445 14.08.2014 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o C&PC forwarded earlier vide U.O.No.14010/40/2011-Ch-II dated 4.3.2016 , 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. 23

Case No.:264/13/82-

ALC4/2014 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01267/AM15/ RLA File :03/94/040/00405/AM15/ Lic.No/Date:0310788397 26.08.2014 Defer Date: 28.12.2016 Decision :Deferred. 24

Case No.:255/13/82-

ALC4/2014 Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 25

Case No.:263/13/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 26

Case No.:217/13/82-

ALC4/2014 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : It was noted that fraudulent CA certificates have been submitted in this case. The matter is under investigation. The Committee accordingly decided to defer the case. 27

Case No.:59/13/82-

ALC4/2014 Party Name:HELLO PAINTS (P) LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 28

Case No.:9/15/82-

ALC4/2014 Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

6 HQ File :01/82/050/01296/AM15/ RLA File :09/24/040/00327/AM15/ Lic.No/Date:0910061001 19.09.2014 Defer Date: 28.12.2016 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. 29

Case No.:17/13/82-

ALC4/2014 Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 30

Case No.:74/13/82-

ALC4/2014 Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 31

Case No.:19/13/82-

ALC4/2014 Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deffered HQ File :01/82/050/01022/AM15/ RLA File :04/24/040/00171/AM15/ Lic.No/Date:0410159504 29.09.2014 Defer Date:28.12.2016 Decision : The Committee decided to call for copy of DML and photograph of export and import items from the firm. The Committee accordingly decided to await the reply and deferred the case. 32

Case No.:42/15/82-

ALC4/2014 Party Name:PVS AGRO VET Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 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. 33

Case No.:154/13/82-

ALC4/2014 Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01157/AM15/ RLA File :03/94/040/00680/AM15/ Lic.No/Date:0310790351 17.10.2014 Defer Date: taken by NC in its meeting No.1/82 dated 10.04.2014 , 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 34

Case No.:110/13/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

7 HQ File :01/82/050/01113/AM15/ RLA File :34/24/040/00188/AM15/ Lic.No/Date:3410040635 22.10.2014 Defer Date: 28.12.2016 Decision :Deferred. 35

Case No.:86/10/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 36

Case No.:266/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 37

Case No.:268/13/82-

ALC4/2014 Party Name:ATUL LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 38

Case No.:107/13/82-

ALC4/2014 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 39

Case No.:111/13/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from AYUSH. 40

Case No.:61/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 41 Case No.:100/4/82- Party Name:ESTEEM Meet No/Date:14/82- Status:Deferred

8 ALC4/2015 INDUSTRIES PVT. LTD, ALC4/2016 29.11.2016 HQ File :01/82/050/00139/AM16/ RLA File :17/24/040/00125/AM15/ Lic.No/Date:1710005978 12.11.2014 Defer Date: 28.12.2016 Decision :Deferred. 42

Case No.:120/13/82-

ALC4/2014 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 43

Case No.:65/15/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from AYUSH. 44

Case No.:16/18/82-ALC4/2014 Party Name:KAIRAV

CHEMOFARBE INDUSTRIES LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01382/AM15/ RLA File :03/94/040/00789/AM15/ Lic.No/Date:0310791300 21.11.2014 Defer Date: taken by NC in its meeting No.11/82 dated 05.09.2013 Case No.B-96 , 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. 45

Case No.:74/18/82-

ALC4/2014 Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01440/AM15/ RLA File :03/94/040/00814/AM15/ Lic.No/Date:0310791373 25.11.2014 Defer Date: 28.12.2016 Decision :Deferred. 46

Case No.:18/18/82-

ALC4/2014 Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 47

Case No.:32/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310791470 Defer Date:

9 :01/82/050/00032/AM17/ :03/95/040/00617/AM15/ 27.11.2014 28.12.2016 Decision :Deferred. 48

Case No.:92/18/82-

ALC4/2014 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 49

Case No.:82/18/82-

ALC4/2014 Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from AYUSH. 50

Case No.:101/4/82-

ALC4/2015 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 51

Case No.:97/18/82-

ALC4/2014 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01463/AM15/ RLA File :30/24/040/00041/AM15/ Lic.No/Date:3010103261 11.12.2014 Defer Date: 28.12.2016 Decision :Deferred. 52

Case No.:2/18/82-

ALC4/2014 Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01368/AM15/ RLA File :29/24/040/00009/AM15/ Lic.No/Date:2910025185 17.12.2014 Defer Date: 28.12.2016 Decision :Deferred. 53

Case No.:88/18/82-

ALC4/2014 Party Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01454/AM15/ RLA File :03/95/040/00776/AM15/ Lic.No/Date:0310792133 18.12.2014 Defer Date: 28.12.2016 Decision :Deferred. 54 Case No.:69/18/82- ALC4/2014 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:14/82- ALC4/2016 Status:Deferred

10 29.11.2016 HQ File :01/82/050/01435/AM15/ RLA File :03/95/040/00649/AM15/ Lic.No/Date:0310792132 18.12.2014 Defer Date: 28.12.2016 Decision :Deferred. 55

Case No.:108/18/82-

ALC4/2014 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01474/AM15/ RLA File :05/23/040/00404/AM15/ Lic.No/Date:0510392521 19.12.2014 Defer Date: taken by NC in its meeting No.15/82 dated 09.08.2012 , uploaded at the end of these minutes or 56

Case No.:105/18/82-

ALC4/2014 Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01471/AM15/ RLA File :05/23/040/00436/AM15/ Lic.No/Date:0510392586 26.12.2014 Defer Date: 28.12.2016 Decision :Deferred. 57

Case No.:101/18/82-

ALC4/2014 Party Name:RANBAXY LABORATORIES LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01467/AM15/ RLA File :05/24/040/00439/AM15/ Lic.No/Date:0510392597 26.12.2014 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412 for export product Lamivudine 150mg tablet. Export product “ lamivudine 150mg +Zidovudine 300mg tablets”(150mg tablet)………1000 tablets Import items 1.Lamivudine…..5153mg 2.Nevirapine……204mg 3.Zidovudine……306mg RA concerned may take further necessary action as per decision of NC. 58

Case No.:84/18/82-

ALC4/2014 Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : The Committee noted that information had been called for from the firm in NC meeting No.04 dated 12.06.2015 is awaited. The Committee accordingly decided to await the reply and deferred the case. 59 Case No.:112/18/82- ALC4/2014 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:14/82- ALC4/2016 Status:Deferred

11 29.11.2016 HQ File :01/82/050/01478/AM15/ RLA File :05/24/040/00450/AM15/ Lic.No/Date:0510392619 30.12.2014 Defer Date: 28.12.2016 60

Case No.:19/4/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00058/AM16/ RLA File :03/94/040/00932/AM15/ Lic.No/Date:0310792548 01.01.2015 Defer Date: 28.12.2016 61

Case No.:137/5/82-

ALC4/2015 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00277/AM16/ RLA File :03/94/040/00931/AM15/ Lic.No/Date:0310792547 01.01.2015 Defer Date: 28.12.2016 62

Case No.:85/18/82-

ALC4/2014 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01451/AM15/ RLA File :05/24/040/00412/AM15/ Lic.No/Date:0510392654 01.01.2015 Defer Date: 28.12.2016 Decision :Deferred. 63

Case No.:28/15/82-

ALC4/2014 Party Name:DR REDDYS Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01315/AM15/ RLA File :09/24/040/00502/AM15/ Lic.No/Date:0910061479 02.01.2015 Defer Date: 28.12.2016 64

Case No.:34/15/82-ALC4/2014 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01321/AM15/ RLA File :09/24/040/00528/AM15/ Lic.No/Date:0910061522 09.01.2015 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3667 published earlier vide PN No.64 dated 17.03.2015 or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 65

Case No.:151/5/82-

ALC4/2015 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00291/AM16/ RLA File :03/94/040/00902/AM15/ Lic.No/Date:0310792875 13.01.2015 Defer Date: 28.12.2016

12 66

Case No.:92/5/82-

ALC4/2015 Party Name:ALKALOIDS CORPORATION Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : The Committee in light of the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/218/2016-PI(Norms) dated 21.10.2016 decided to call for COA of the imported details leaves from the foreign supplier and deferred the case. 67

Case No.:9/18/82-

ALC4/2014 Party Name:SAIBABA SURFACTANTS (P) LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01375/AM15/ RLA File :08/24/040/00371/AM15/ Lic.No/Date:0810134344 19.01.2015 Defer Date: 28.12.2016 Decision :Deferred. 68

Case No.:204/5/82-

ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 69

Case No.:47/18/82-ALC4/2014 Party Name:NUTRA

SPECIALITIES PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01413/AM15/ RLA File :04/24/040/00268/AM15/ Lic.No/Date:0410160068 28.01.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/213/2015-PI(Norms) dated Sept. 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. 70

Case No.:230/5/82-

ALC4/2015 Party Name:R.K.INDUSTRIES, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 71

Case No.:20/4/82-

ALC4/2015 Party Name:D. R. COATS INK & RESINS PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00059/AM16/ RLA File :03/94/040/00759/AM15/ Lic.No/Date:0310793542 03.02.2015 Defer Date: 28.12.2016 Decision :Deferred.

13 72

Case No.:6/18/82-

ALC4/2014 Party Name:GRANULES INDIA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01372/AM15/ RLA File :09/24/040/00576/AM15/ Lic.No/Date:0910061577 03.02.2015 Defer Date: 28.12.2016 73

Case No.:11/18/82-

ALC4/2014 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01377/AM15/ RLA File :09/24/040/00561/AM15/ Lic.No/Date:0910061599 10.02.2015 Defer Date: 28.12.2016 74

Case No.:23/4/82-ALC4/2015

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00062/AM16/ RLA File :03/94/040/00949/AM15/ Lic.No/Date:0310793769 11.02.2015 Defer Date: taken by NC in its meeting No.10/82 dated 05.06.2012 , uploaded at the end of these minutes or 75

Case No.:14/18/82-ALC4/2014 Party Name:HEMMO

PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01380/AM15/ RLA File :03/94/040/01012/AM15/ Lic.No/Date:0310793763 11.02.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/233/2015-PI(Norms) dated October, 2015 , 76

Case No.:33/4/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00072/AM16/ RLA File :05/24/040/00471/AM15/ Lic.No/Date:0510393135 11.02.2015 Defer Date: 28.12.2016 Decision :Deferred. 77

Case No.:121/18/82-

ALC4/2014 Party Name:HETERO LABS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01487/AM15/ RLA File :09/24/040/00645/AM15/ Lic.No/Date:0910061606 12.02.2015 Defer Date: 28.12.2016

14 78

Case No.:91/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 79

Case No.:52/19/82-

ALC4/2014 Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 80

Case No.:24/4/82-ALC4/2015

Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00063/AM16/ RLA File :03/94/040/01052/AM15/ Lic.No/Date:0310794026 20.02.2015 Defer Date: taken by NC in its meeting No.03/82 dated 17.04.2012 , uploaded at the end of these minutes or 81

Case No.:63/4/82-

ALC4/2015 Party Name:RA CHEM PHARMA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00102/AM16/ RLA File :09/24/040/00649/AM15/ Lic.No/Date:0910061639 20.02.2015 Defer Date: 28.12.2016 82

Case No.:62/4/82-

ALC4/2015 Party Name:RAKSHIT PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00101/AM16/ RLA File :09/24/040/00644/AM15/ Lic.No/Date:0910061636 20.02.2015 Defer Date: 28.12.2016 83

Case No.:280/5/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.05.2016 is awaited. The Committee accordingly deferred the case. 84

Case No.:54/4/82-

ALC4/2015 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

15 HQ File :01/82/050/00093/AM16/ RLA File :08/24/040/00427/AM15/ Lic.No/Date:0810134665 25.02.2015 Defer Date: 28.12.2016 85

Case No.:14/2/82-ALC4/2015

SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00029/AM16/ RLA File :05/23/040/00499/AM15/ Lic.No/Date:0510393393 27.02.2015 Defer Date: taken by NC in its meeting No.03/82 dated 17.04.2012 , uploaded at the end of these minutes or 86

Case No.:72/4/82-

ALC4/2015 Party Name:LANTECH PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00111/AM16/ RLA File :09/24/040/00647/AM15/ Lic.No/Date:0910061664 04.03.2015 Defer Date: 28.12.2016 87

Case No.:444/5/82-ALC4/2015 Party Name:AARTI

INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Rejected HQ File :01/82/050/00584/AM16/ RLA File :03/94/040/01132/AM15/ Lic.No/Date:0310794412 09.03.2015 Defer Date: Decision : The Committee noted that information had been called for from firm in NC meeting No.25.06.2015 but it has not been received so far. The Committee accordingly decided to reject the case. 88

Case No.:26/4/82-ALC4/2015

Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00065/AM16/ RLA File :08/24/040/00447/AM15/ Lic.No/Date:0810134769 11.03.2015 Defer Date: taken by NC in its meeting No.13/82 dated 03.10.2013 , uploaded at the end of these minutes or 89

Case No.:85/4/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00124/AM16/ RLA File :09/24/040/00684/AM15/ Lic.No/Date:0910061681 11.03.2015 Defer Date: 28.12.2016 Decision :Deferred. 90 Case No.:53/4/82- ALC4/2015 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:14/82- ALC4/2016 Status:Deferred

16 29.11.2016 HQ File :01/82/050/00092/AM16/ RLA File :08/24/040/00451/AM15/ Lic.No/Date:0810134799 13.03.2015 Defer Date: 28.12.2016 91

Case No.:56/4/82-

ALC4/2015 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00095/AM16/ RLA File :08/24/040/00450/AM15/ Lic.No/Date:0810134798 13.03.2015 Defer Date: 28.12.2016 92

Case No.:106/7/82-

ALC4/2015 Party Name:ALCHEMIE LABORATORIES Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 93

Case No.:48/4/82-

ALC4/2015 Party Name:MAMTA POLYCOATS Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00087/AM16/ RLA File :34/24/040/00329/AM15/ Lic.No/Date:3410041054 17.03.2015 Defer Date: 28.12.2016 Decision :Deferred. 94

Case No.:50/4/82-ALC4/2015

Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00089/AM16/ RLA File :05/24/040/00590/AM15/ Lic.No/Date:0510393671 20.03.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/153/2016-PI(Norms) dated September 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. 95

Case No.:46/4/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00085/AM16/ RLA File :34/24/040/00334/AM15/ Lic.No/Date:3410041091 25.03.2015 Defer Date: 28.12.2016 Decision :Deferred. 96

Case No.:21/4/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00060/AM16/ RLA File :05/23/040/00568/AM15/ Lic.No/Date:0510393736 25.03.2015 Defer Date: 28.12.2016

17 Decision :Deferred. 97

Case No.:40/4/82-ALC4/2015

Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00079/AM16/ RLA File :31/83/040/00265/AM15/ Lic.No/Date:3110065357 27.03.2015 Defer Date: Decision : Already approved in NC Meeting No.04/82 dated 12.06.2015. 98

Case No.:431/5/82-ALC4/2015 Party Name:EUROLIFE

HEALTHCARE PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Rejected HQ File :01/82/050/00571/AM16/ RLA File :03/94/040/01086/AM15/ Lic.No/Date:0310794964 27.03.2015 Defer Date: Decision : The Committee noted that information called for firm in NC meeting No.20/82 dated 09.03.2016 has not been furnished. In absence of technical information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per the decision of NC. 99

Case No.:43/4/82-

ALC4/2015 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00082/AM16/ RLA File :34/24/040/00350/AM15/ Lic.No/Date:3410041107 30.03.2015 Defer Date: 28.12.2016 100

Case No.:30/4/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00069/AM16/ RLA File :04/24/040/00306/AM15/ Lic.No/Date:0410160363 30.03.2015 Defer Date: 28.12.2016 Decision : Information called for firm in NC meeting No.4/82 dated 12.06.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 101

Case No.:38/4/82-

ALC4/2015 Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00077/AM16/ RLA File :04/24/040/00305/AM15/ Lic.No/Date:0410160362 30.03.2015 Defer Date: 28.12.2016 Decision : Information called for firm in NC meeting No.4/82 dated 12.06.2016 is awaited. The Committee accordingly decided to await the reply and deferred the case. 102

Case No.:65/4/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00104/AM16/ RLA File :09/24/040/00662/AM15/ Lic.No/Date:0910061843 31.03.2015 Defer Date: 28.12.2016 Decision :Information has been received and forwarded to DoP for comments.

18 103

Case No.:29/4/82-ALC4/2015

Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00068/AM16/ RLA File :04/24/040/00297/AM15/ Lic.No/Date:0410160375 31.03.2015 Defer Date: Decision : The Committee decided to ratify norms on repeat basis based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/213/2015-PI(Norms) dated Sept. 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. 104

Case No.:36/4/82-

ALC4/2015 Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00075/AM16/ RLA File :04/24/040/00298/AM15/ Lic.No/Date:0410160376 31.03.2015 Defer Date: 28.12.2016 10 5

Case No.:78/4/82-

ALC4/2015 Party Name:SMILAX LABORATORIES LIMI TED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferr ed HQ File :01/82/050/00117/AM 16/ RLA File :09/24/040/00710/AM15/ Lic.No/Date:09100618 58 31.03.2015 Defer Date: 28.12.2016 106

Case No.:86/4/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00125/AM16/ RLA File :09/24/040/00721/AM15/ Lic.No/Date:0910061812 31.03.2015 Defer Date: 28.12.2016 107

Case No.:64/4/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00103/AM16/ RLA File :09/24/040/00595/AM15/ Lic.No/Date:0910061851 31.03.2015 Defer Date: 28.12.2016 Decision :Deferred. 108

Case No.:73/4/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00112/AM16/ RLA File :09/24/040/00700/AM15/ Lic.No/Date:0910061821 31.03.2015 Defer Date: 28.12.2016 Decision :Deferred.

19 109

Case No.:52/4/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00091/AM16/ RLA File :05/24/040/00562/AM15/ Lic.No/Date:0510393822 01.04.2015 Defer Date: 28.12.2016 Decision :Deferred. 110

Case No.:88/4/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00127/AM16/ RLA File :03/94/040/01218/AM15/ Lic.No/Date:0310795135 07.04.2015 Defer Date: 28.12.2016 Decision :Deferred. 111

Case No.:80/4/82-

ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00119/AM16/ RLA File :09/24/040/00652/AM15/ Lic.No/Date:0910061882 15.04.2015 Defer Date: 28.12.2016 Decision : Deferred for want of comments from DBT. 112

Case No.:5/2/82-ALC4/2015

Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00020/AM16/ RLA File :09/24/040/00689/AM15/ Lic.No/Date:0910061894 17.04.2015 Defer Date: 28.12.2016 113

Case No.:67/4/82-

ALC4/2015 Party Name:STERMONE CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00106/AM16/ RLA File :34/24/040/00336/AM15/ Lic.No/Date:3410041147 17.04.2015 Defer Date: 28.12.2016 114

Case No.:76/4/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00115/AM16/ RLA File :09/24/040/00717/AM15/ Lic.No/Date:0910061893 17.04.2015 Defer Date: 28.12.2016 Decision :Deferred. 115

Case No.:77/4/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00116/AM16/ RLA File :09/24/040/00738/AM15/ Lic.No/Date:0910061892 17.04.2015 Defer Date: 28.12.2016 Decision :Deferred.

20 116

Case No.:6/2/82-ALC4/2015

Party Name:ALMELO PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00021/AM16/ RLA File :09/24/040/00001/AM16/ Lic.No/Date:0910061899 20.04.2015 Defer Date: 28.12.2016 117

Case No.:22/4/82-ALC4/2015

Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00061/AM16/ RLA File :04/24/040/00335/AM15/ Lic.No/Date:0410160421 20.04.2015 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/511/2014-PI(Norms) dated 17.02 2015 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 118

Case No.:25/4/82-ALC4/2015

Party Name:BALAJI AMINES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00064/AM16/ RLA File :31/83/040/00268/AM15/ Lic.No/Date:3110065387 21.04.2015 Defer Date: Decision : recommendation of D/o C&PC U.O.No.14010/122/2011-Ch-II dated 26.02.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 119

Case No.:27/4/82-ALC4/2015

Party Name:BALAJI AMINES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00066/AM16/ RLA File :31/83/040/00269/AM15/ Lic.No/Date:3110065385 21.04.2015 Defer Date: taken by NC in its meeting No.15/82 dated 31.10.2013 , uploaded at the end of these minutes or 120

Case No.:66/4/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00105/AM16/ RLA File :34/24/040/00010/AM16/ Lic.No/Date:3410041157 22.04.2015 Defer Date: 28.12.2016 Decision :Deferred. 121

Case No.:69/4/82-

ALC4/2015 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File RLA File Lic.No/Date:3410041158 Defer Date:

21 :01/82/050/00108/AM16/ :34/24/040/00012/AM16/ 22.04.2015 28.12.2016 Decision :Deferred. 122

Case No.:84/4/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00123/AM16/ RLA File :22/24/040/00119/AM15/ Lic.No/Date:2210015225 23.04.2015 Defer Date: 28.12.2016 123

Case No.:83/4/82-

ALC4/2015 Party Name:CONTINENTAL CHEMICALS Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00122/AM16/ RLA File :08/24/040/00005/AM16/ Lic.No/Date:0810135094 24.04.2015 Defer Date: 28.12.2016 Decision :Deferred. 124

Case No.:74/4/82-ALC4/2015

Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00113/AM16/ RLA File :05/24/040/00018/AM16/ Lic.No/Date:0510393982 24.04.2015 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/318/2015-PI(Norms) dated 05.11.2015 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 125

Case No.:70/4/82-ALC4/2015

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00109/AM16/ RLA File :34/24/040/00019/AM16/ Lic.No/Date:3410041191 29.04.2015 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/580/2015-PI(Norms) dated 09.03.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 126

Case No.:71/4/82-

ALC4/2015 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00110/AM16/ RLA File :34/24/040/00025/AM16/ Lic.No/Date:3410041192 29.04.2015 Defer Date: 28.12.2016 127

Case No.:50/7/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

22 HQ File :01/82/050/00655/AM16/ RLA File :09/24/040/00041/AM16/ Lic.No/Date:0910061976 06.05.2015 Defer Date: 28.12.2016 Decision : Information called for from the firm in NC meeting No.19/82 dated 25.2.2016 is awaited. The Committee deferred the case. 128

Case No.:15/7/82-

ALC4/2015 Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 129

Case No.:129/7/82-

ALC4/2015 Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from DMSME. 130

Case No.:164/7/82-ALC4/2015 Party Name:ETERNIS FINE

CHEMICALS LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00769/AM16/ RLA File :03/94/040/00026/AM16/ Lic.No/Date:0310795971 18.05.2015 Defer Date: Decision : recommendation of D/o C&PC forwarded videU.O.No.14010/90/2011-Ch-II dated 10.09.2015, 131

Case No.:102/7/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 132

Case No.:55/13/82-

ALC4/2015 Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 133

Case No.:8/4/82-ALC4/2015

Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00047/AM16/ RLA File :09/24/040/00048/AM16/ Lic.No/Date:0910062074 26.05.2015 Defer Date: 28.12.2016

23 134

Case No.:124/7/82-

ALC4/2015 Party Name:PRIVI ORGANICS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 135

Case No.:100/7/82-

ALC4/2015 Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Approved HQ File :01/82/050/00705/AM16/ RLA File :34/24/040/00024/AM16/ Lic.No/Date:3410041261 28.05.2015 Defer Date: taken by NC in its meeting No.46/82 dated 14.02.2012 , uploaded at the end of these minutes or 136

Case No.:92/4/82-

ALC4/2015 Party Name:ALMELO PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00131/AM16/ RLA File :09/24/040/00115/AM16/ Lic.No/Date:0910062107 01.06.2015 Defer Date: 28.12.2016 137

Case No.:93/4/82-ALC4/2015

Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00132/AM16/ RLA File :52/24/040/00008/AM16/ Lic.No/Date:5210041536 01.06.2015 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/434/2014-PI(Norms) dated February 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. 138

Case No.:94/4/82-

ALC4/2015 Party Name:ALMELO PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00133/AM16/ RLA File :09/24/040/00113/AM16/ Lic.No/Date:0910062119 02.06.2015 Defer Date: 28.12.2016 139

Case No.:95/4/82-

ALC4/2015 Party Name:ALMELO PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00134/AM16/ RLA File :09/24/040/00114/AM16/ Lic.No/Date:0910062120 02.06.2015 Defer Date: 28.12.2016

24 140

Case No.:99/4/82-

ALC4/2015 Party Name:INTAS PHARMACEUTICALS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00138/AM16/ RLA File :08/24/040/00072/AM16/ Lic.No/Date:0810135427 03.06.2015 Defer Date: 28.12.2016 Decision : The representative of D/o Pharmaceuticals stated in the meeting that DML and master Batch Formula is required for ratification of norms. The Committee accordingly decided to call for copy of DML and Master Batch Formula from the firm and deferred the case. 141

Case No.:110/7/82-

ALC4/2015 Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00715/AM16/ RLA File :03/95/040/00051/AM16/ Lic.No/Date:0310796383 03.06.2015 Defer Date: 28.12.2016 Decision :Deferred. 142

Case No.:17/7/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 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. 143

Case No.:67/7/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 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. 144

Case No.:60/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No,12/82 dated 28.09.2016 is awaited. The Committee accordingly defer the case. 145

Case No.:66/7/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00671/AM16/ RLA File :09/24/040/00162/AM16/ Lic.No/Date:0910062162 10.06.2015 Defer Date: 28.12.2016 Decision :Deferred.

25 146

Case No.:159/7/82-

ALC4/2015 Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 147

Case No.:42/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.12 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 148

Case No.:48/19/82-

ALC4/2015 Party Name:RAJ DHANVANTRY PHARMACY Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 149

Case No.:41/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 150

Case No.:52/7/82-

ALC4/2015 Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00657/AM16/ RLA File :05/23/040/00107/AM16/ Lic.No/Date:0510394590 17.06.2015 Defer Date: 28.12.2016 Decision : The committee as per the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/696/2015-PI(Norms) dated 22.3.2016 uploaded at the end of these minutes, decided to call for information from the firm. The Committee accordingly deferred the case. 151

Case No.:43/13/82-

ALC4/2015 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 152 Case No.:15/9/82- Party Name:KDAC CHEM Meet No/Date:14/82- Status:Deferred

26 ALC4/2015 PVT LTD ALC4/2016 29.11.2016 HQ File :01/82/050/00951/AM16/ RLA File :34/24/040/00069/AM16/ Lic.No/Date:3410041310 22.06.2015 Defer Date: 28.12.2016 Decision :Deferred. 153

Case No.:83/13/82-

ALC4/2015 Party Name:RIDDHI PHARMA Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 154

Case No.:75/7/82-

ALC4/2015 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 155

Case No.:78/7/82-ALC4/2015

Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Rejected HQ File :01/82/050/00683/AM16/ RLA File :02/24/040/00028/AM16/ Lic.No/Date:0210205920 25.06.2015 Defer Date: Decision : The Committee noted that information called for from the firm in NC meeting No.19/82 dated 25.02.2016 has not been furnished. In absence of technical information norms cannot be decided. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per the decision of NC. 156

Case No.:108/14/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 157

Case No.:10/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 158

Case No.:11/13/82-

ALC4/2015 Party Name:AMINES & PLASTICIZERS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File RLA File Lic.No/Date:0310797020 Defer Date:

27 :01/82/050/00974/AM16/ :03/94/040/00228/AM16/ 02.07.2015 28.12.2016 Decision :Deferred. 159

Case No.:24/13/82-

ALC4/2015 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 160

Case No.:20/16/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Information has been received and forwarded to DoP. 161

Case No.:22/13/82-

ALC4/2015 Party Name:BLISS INDASI LIFESCIENCES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No,02/82 dated 2.04.2016 is awaited. The Committee accordingly defer the case. 162

Case No.:115/13/82-

ALC4/2015 Party Name:FERMENTA BIOTECH LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No,06/82 dated 14.06.2016 is awaited. The Committee accordingly defer the case. 163

Case No.:73/8/82-

ALC4/2015 Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 164

Case No.:116/13/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred.

28 165

Case No.:112/13/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 166

Case No.:109/13/82-

ALC4/2015 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 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. 167

Case No.:12/18/82-

ALC4/2015 Party Name:OMTECH CHEMICAL INDUSTRIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01477/AM16/ RLA File :03/95/040/00345/AM16/ Lic.No/Date:0310797967 05.08.2015 Defer Date: 28.12.2016 Decision :Deferred. 168

Case No.:50/13/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 169

Case No.:2/21/82-ALC4/2015

Party Name:AUROLAB Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01707/AM16/ RLA File :35/24/040/00022/AM16/ Lic.No/Date:3510044782 06.08.2015 Defer Date: Decision : The Committee decided ratify norms as per packaging policy. RA concerned take necessary action as per the decision of NC. 170

Case No.:111/13/82-

ALC4/2015 Party Name:HEMA DYE CHEM PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 171

Case No.:127/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

29 HQ File :01/82/050/01090/AM16/ RLA File :03/94/040/00878/AM15/ Lic.No/Date:0310798205 17.08.2015 Defer Date: 28.12.2016 172

Case No.:126/13/82-

ALC4/2015 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 173

Case No.:61/13/82-

ALC4/2015 PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC 08/82 dated 27.07.2016 is awaited. The Committee accordingly deferred the case. 174

Case No.:161/13/82-

ALC4/2015 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 175

Case No.:77/13/82-

ALC4/2015 Party Name:ARKRAY HEALTHCARE PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC 10/82 dated 23.08.2016 is awaited. The Committee accordingly deferred the case. 176

Case No.:84/14/82-

ALC4/2015 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : The Committee noted that information called for from the firm in NC meeting No.06/82 dated 24.05.2016 is awaited. The Committee accordingly deferred the case. 177

Case No.:59/4/82-

ALC4/2016 Party Name:ADCOCK INGRAM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00122/AM17/ RLA File :07/24/040/00180/AM16/ Lic.No/Date:0710108694 07.09.2015 Defer Date: 28.12.2016 Decision : The Committee noted that information called for from the firm in NC meeting

30 No.12/82 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 178

Case No.:10/9/82-ALC4/2015

Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00946/AM16/ RLA File :03/94/040/00355/AM16/ Lic.No/Date:0310798806 10.09.2015 Defer Date: taken by NC in its meeting No.17/82 dated 26.07.2011, uploaded at the end of these minutes or 179

Case No.:8/16/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01328/AM16/ RLA File :09/24/040/00294/AM16/ Lic.No/Date:0910062666 28.09.2015 Defer Date: 28.12.2016 Decision :Deferred. 180

Case No.:12/19/82-

ALC4/2015 Party Name:ARJUN CHEMICALS PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 181

Case No.:44/4/82-

ALC4/2016 Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred. 182

Case No.:130/14/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01266/AM16/ RLA File :05/24/040/00317/AM16/ Lic.No/Date:0510395874 09.10.2015 Defer Date: 28.12.2016 Decision :Deferred. 183

Case No.:56/2/82-ALC4/2016

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00056/AM17/ RLA File :07/24/040/00123/AM16/ Lic.No/Date:0710108886 13.10.2015 Defer Date: Decision:The Committee decided to ratify norms on repeat basis on the basis of the earlier decision taken by NC in its meeting No.06/82 dated 29.08.2014, uploaded at the

31 end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action taken as per decision taken by NC. 184

Case No.:135/13/82-

ALC4/2015 Party Name:MYLAN Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information has been received and forwarded to DoP for comments. 185

Case No.:24/16/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 186

Case No.:136/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 187

Case No.:77/16/82-

ALC4/2015 Party Name:LACTOSE (INDIA) LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 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. 188

Case No.:140/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 189

Case No.:141/13/82-

ALC4/2015 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01104/AM16/ RLA File :03/95/040/00504/AM16/ Lic.No/Date:0310799629 23.10.2015 Defer Date: 28.12.2016 Decision :Deferred. 190 Case No.:142/13/82- Party Name:SYNTHO Meet No/Date:14/82- Status:Deferred

32 ALC4/2015 CHIRALS PVT. LTD ALC4/2016 29.11.2016 HQ File :01/82/050/01105/AM16/ RLA File :09/24/040/00443/AM16/ Lic.No/Date:0910062774 27.10.2015 Defer Date: 28.12.2016 Decision :Deferred. 191

Case No.:73/19/82-ALC4/2015 Party Name:GALAXY

SURFACTANTS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01554/AM16/ RLA File :03/94/040/00575/AM16/ Lic.No/Date:0310799849 29.10.2015 Defer Date: Decision : recommendation of D/o C&PC forwarded earlier vide U.O.No.14010/148/2011-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. 192

Case No.:147/13/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 193

Case No.:64/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 194

Case No.:65/19/82-

ALC4/2015 Party Name:INDO AMINES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 195

Case No.:66/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01547/AM16/ RLA File :03/94/040/00582/AM16/ Lic.No/Date:0310799943 02.11.2015 Defer Date: 28.12.2016 Decision :Deferred. 196

Case No.:156/13/82-

ALC4/2015 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File RLA File Lic.No/Date:0910062832 Defer Date:

33 :01/82/050/01119/AM16/ :09/24/040/00464/AM16/ 03.11.2015 Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/505/2013-PI(Norms) dated 21st October, 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. 197

Case No.:38/21/82-

ALC4/2015 Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from DBT. 198

Case No.:159/13/82-

ALC4/2015 Party Name:CHEMCON SPECIALITY CHEMICALS P LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 199

Case No.:57/19/82-

ALC4/2015 Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01538/AM16/ RLA File :03/94/040/00443/AM16/ Lic.No/Date:0310800060 05.11.2015 Defer Date: 28.12.2016 Decision :Deferred. 200

Case No.:18/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 201

Case No.:23/21/82-

ALC4/2015 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. The Committee accordingly deferred the case. 202

Case No.:165/13/82-

ALC4/2015 Party Name:ATUL LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016

34 Decision :Deferred. 203

Case No.:71/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 204

Case No.:72/19/82-

ALC4/2015 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 205

Case No.:58/19/82-

ALC4/2015 Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01539/AM16/ RLA File :03/94/040/00572/AM16/ Lic.No/Date:0310800324 19.11.2015 Defer Date: 28.12.2016 Decision :Deferred. 206

Case No.:75/19/82-

ALC4/2015 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 207

Case No.:60/19/82-

ALC4/2015 Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 208

Case No.:20/19/82-

ALC4/2015 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 209

Case No.:59/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

35 HQ File :01/82/050/01540/AM16/ RLA File :03/94/040/00251/AM16/ Lic.No/Date:0310800536 01.12.2015 Defer Date: 28.12.2016 210

Case No.:62/19/82-

ALC4/2015 Party Name:EXCEL INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 211

Case No.:61/19/82-

ALC4/2015 Party Name:K V AROCHEM PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 212

Case No.:17/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 213

Case No.:1/8/82-ALC4/2016

Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 213A

Case No.:84/20/82-

ALC4/2015 Party Name:SIRMAXO CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01667/AM16/ RLA File :03/95/040/00730/AM16/ Lic.No/Date:0310801411 30.12.2015 Defer Date: Decision: This case has already been approved in NC meeting No.13/82 dt. 16.11.2016 at Sl. No.246 on repeat basis based on the earlier decision taken by NC in its meeting No.06/82 dated 29.08.2014, copy uploaded at the end of these minutes. RA may take action as per decision of NC. 214

Case No.:90/19/82-

ALC4/2015 Party Name:VENUS REMEDIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :

36 215

Case No.:40/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 216

Case No.:88/19/82-

ALC4/2015 Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 217

Case No.:94/19/82-ALC4/2015 Party Name:THEON

PHARMACEUTICALS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01575/AM16/ RLA File :22/24/040/00080/AM16/ Lic.No/Date:2210015366 10.12.2015 Defer Date: Decision : The Committee decided ratify norms as per earlier SION A-3647 published vide PN No.64 dated 17.03.2016. RA concerned may calculate the quantity on pro-rata basis. 218

Case No.:42/21/82-ALC4/2015 Party Name:NATCO PHARMA

LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: withdrawn HQ File :01/82/050/01747/AM16/ RLA File :09/24/040/00520/AM16/ Lic.No/Date:0910062967 11.12.2015 Defer Date: Decision : Already approved in NC meeting No.12 dated 28.09.2016. 219

Case No.:56/21/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 220

Case No.:30/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 221

Case No.:31/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File RLA File Lic.No/Date:0510396609 Defer Date:

37 :01/82/050/01511/AM16/ :05/24/040/00375/AM16/ 14.12.2015 28.12.2016 Decision :Deferred. 222

Case No.:32/19/82-

ALC4/2015 Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01513/AM16/ RLA File :05/24/040/00381/AM16/ Lic.No/Date:0510396610 14.12.2015 Defer Date: 28.12.2016 Decision :Deferred. 223

Case No.:10/19/82-

ALC4/2015 Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 224

Case No.:39/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 225

Case No.:41/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 226

Case No.:42/19/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 227

Case No.:9/15/82-ALC4/2015

Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01320/AM16/ RLA File :09/24/040/00530/AM16/ Lic.No/Date:0910062986 17.12.2015 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/429/2012-PI(Norms) dated 06.06.2012, uploaded at the end of these minutes or as applied by the firm whichever is NC.

38 228

Case No.:36/19/82-

ALC4/2015 Party Name:PANACEA BIOTEC LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01517/AM16/ RLA File :05/24/040/00439/AM16/ Lic.No/Date:0510396670 18.12.2015 Defer Date: 28.12.2016 Decision : Deferred for want of comments from DBT. 229

Case No.:35/19/82-

ALC4/2015 Party Name:HELLO PAINTS (P) LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred 230

Case No.:33/19/82-

ALC4/2015 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 231

Case No.:54/21/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 232

Case No.:61/21/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 233

Case No.:55/21/82-

ALC4/2015 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 234

Case No.:34/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016

39 Decision :Deferred. 235

Case No.:22/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 236

Case No.:23/19/82-

ALC4/2015 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.06/82 dated 14.06.2016 is awaited. 237

Case No.:13/19/82-

ALC4/2015 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.04/82 dated 24.05.2016 is awaited. 238

Case No.:47/21/82-

ALC4/2015 Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 239

Case No.:35/21/82-

ALC4/2015 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 240

Case No.:2/17/82-

ALC4/2015 Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited.

40 241

Case No.:5/17/82-

ALC4/2015 Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 242

Case No.:60/21/82-

ALC4/2015 Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 243

Case No.:37/2/82-

ALC4/2016 Party Name:ALKALOIDS CORPORATION Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. 244

Case No.:31/21/82-ALC4/2015 Party Name:BALAJI AMINES

LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01736/AM16/ RLA File :31/83/040/00148/AM16/ Lic.No/Date:3110065887 25.01.2016 Defer Date: Decision :The Committee decided to ratify norms based on the earlier recommendation of D/oC&PC forwarded vide U.O.No.14010/122/2011-Ch-II dated 11.02.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 245

Case No.:24/21/82-

ALC4/2015 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 246

Case No.:17/10/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00363/AM17/ RLA File :22/24/040/00104/AM16/ Lic.No/Date:2210015407 01.02.2016 Defer Date: 28.12.2016 Decision :Deferred.

41 247

Case No.:8/21/82-

ALC4/2015 Party Name:JUBILANT GENERICS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 248

Case No.:13/21/82-

ALC4/2015 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 249

Case No.:1/19/82-

ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 250

Case No.:4/19/82-

ALC4/2015 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01484/AM16/ RLA File :09/24/040/00628/AM16/ Lic.No/Date:0910063226 05.02.2016 Defer Date: 28.12.2016 Decision : Information called for from the firm in NC meeting No.08/82 dated 27.07.2016 is awaited. 251

Case No.:25/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from DoP 252

Case No.:26/21/82-

ALC4/2015 Party Name:RONAK CHEMICALS Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from DoP 253

Case No.:14/21/82-

ALC4/2015 Party Name:DHAMPUR SUGAR MILLS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016

42 Decision :Deferred. 254

Case No.:5/19/82-

ALC4/2015 Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 255

Case No.:62/4/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 256

Case No.:85/19/82-

ALC4/2015 Party Name:ANUPAM RASAYAN (INDIA) LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 257

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

Party Name:GULBRANDSEN CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 258

Case No.:15/10/82-

ALC4/2016 Party Name:INFINITY LABORATORIES PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00361/AM17/ RLA File :22/24/040/00107/AM16/ Lic.No/Date:2210015412 10.02.2016 Defer Date: 28.12.2016 Decision : Deferred for want of comments from DoP 259

Case No.:30/21/82-

ALC4/2015 PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from DoP 260

Case No.:97/19/82-ALC4/2015 Party Name:AUROBINDO

PHARMA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved

43 HQ File :01/82/050/01578/AM16/ RLA File :09/24/040/00652/AM16/ Lic.No/Date:0910063248 11.02.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/605/2014-PI(Norms) dated April, 2015 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 261

Case No.:36/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 262

Case No.:35/4/82-ALC4/2016

Party Name:INDOCO REMEDIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00098/AM17/ RLA File :03/94/040/00952/AM16/ Lic.No/Date:0310802542 12.02.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412 or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 263

Case No.:101/19/82-

ALC4/2015 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/01582/AM16/ RLA File :09/24/040/00668/AM16/ Lic.No/Date:0910063275 16.02.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/552/2014-PI(Norms) dated January, 2015 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 264

Case No.:5/2/82-ALC4/2016

Party Name:MAMTA POLYCOATS Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 265

Case No.:13/10/82-

ALC4/2016 Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00359/AM17/ RLA File :22/24/040/00109/AM16/ Lic.No/Date:2210015417 17.02.2016 Defer Date: 28.12.2016 Decision : Deferred for want of comments from DoP

44 266

Case No.:55/2/82-

ALC4/2016 Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 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. 267

Case No.:35/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 268

Case No.:102/19/82-

ALC4/2015 LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 269

Case No.:20/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 270

Case No.:23/4/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00086/AM17/ RLA File :05/23/040/00470/AM16/ Lic.No/Date:0510397643 18.02.2016 Defer Date: 28.12.2016 Decision :Deferred. 271

Case No.:34/2/82-

ALC4/2016 Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 272

Case No.:9/2/82-ALC4/2016

Party Name:DEEPAK NITRITE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00009/AM17/ RLA File :34/24/040/00161/AM16/ Lic.No/Date:3410041915 22.02.2016 Defer Date:

45 Decision : The Committee decided to ratify norms based on the earlier decision taken by NC in its meeting No.14/82 dated 05.07.2011, 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. 273

Case No.:27/2/82-

ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 274

Case No.:22/2/82-

ALC4/2016 Party Name:SANJIVANI PARANTERAL LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 275

Case No.:18/4/82-

ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 276

Case No.:24/4/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00087/AM17/ RLA File :05/23/040/00491/AM16/ Lic.No/Date:0510397731 26.02.2016 Defer Date: 28.12.2016 Decision :Deferred. 277

Case No.:4/2/82-ALC4/2016

Party Name:RIDDHI PHARMA Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 278

Case No.:84/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 279 Case No.:43/2/82- Party Name:YASHO Meet No/Date:14/82- Status:Deferred

46 ALC4/2016 INDUSTRIES PVT.LTD. ALC4/2016 29.11.2016 HQ File :01/82/050/00043/AM17/ RLA File :03/95/040/00948/AM16/ Lic.No/Date:0310802906 29.02.2016 Defer Date: 28.12.2016 Decision :Deferred. 280

Case No.:6/2/82-ALC4/2016

Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 281

Case No.:42/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 282

Case No.:14/2/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00014/AM17/ RLA File :34/24/040/00221/AM16/ Lic.No/Date:3410041935 01.03.2016 Defer Date: 28.12.2016 Decision :Deferred. 283

Case No.:28/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 284

Case No.:67/7/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00241/AM17/ RLA File :09/24/040/00714/AM16/ Lic.No/Date:0910063353 03.03.2016 Defer Date: 28.12.2016 Decision :Deferred for want of comments from DBT. 285

Case No.:29/4/82-ALC4/2016

Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00092/AM17/ RLA File :03/94/040/01004/AM16/ Lic.No/Date:0310803038 03.03.2016 Defer Date: taken by NC in its meeting No.20/82 dated 20.09.2012, uploaded at the end of these minutes or

47 286

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

Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00066/AM17/ RLA File :05/23/040/00502/AM16/ Lic.No/Date:0510397820 04.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412 or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 287

Case No.:50/2/82-

ALC4/2016 Party Name:PANERA BIOTEC PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Deferred for want of comments from DBT. 288

Case No.:66/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 289

Case No.:67/4/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00130/AM17/ RLA File :04/24/040/00256/AM16/ Lic.No/Date:0410161684 04.03.2016 Defer Date: 28.12.2016 Decision : Information called for from the firm in NC meeting No.12/82 dated 28.09.2016 is awaited. The Committee accordingly deferred the case. 290

Case No.:40/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : The Committee as recommendation of D/O Pharmaceuticals forwarded vide O.M.No.35011/207/2016-PI(Norms) dated 08.09.2016 decided to call for following information from the firm: 1. Copy of valid drug manufacturing license for the export product with approved composition. 2. Firm has shown 5% wastage in one application and 22% wastage in another application. Justification for such variation may be furnished. 3. Firm has shown use of 50 liters of stearyl alcohol with 1000kg ascorbic acid in flow diagram. However, in the CA certificate, it is shown as 1:1 by content of stearyl alcohol in export product may be furnished.

48 4. CoA/Test report of the export product vis-a-avis specification given in British Pharmacopoeia may be furnished. 5. Past production vis-a-vis actual consumption of import item duly certified by Central Excise Authorities may be furnished. The Committee accordingly deferred the case. 291

Case No.:41/4/82-

ALC4/2016 Party Name:BTL EXPORTS PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : The Committee as recommendation of D/O Pharmaceuticals forwarded vide O.M.No.35011/207/2016-PI(Norms) dated 08.09.2016 decided to call for following information from the firm: 6. Copy of valid drug manufacturing license for the export product with approved composition. 7. Firm has shown 5% wastage in one application and 22% wastage in another application. Justification for such variation may be furnished. 8. Firm has shown use of 50 liters of stearyl alcohol with 1000kg ascorbic acid in flow diagram. However, in the CA certificate, it is shown as 1:1 by content of stearyl alcohol in export product may be furnished. 9. CoA/Test report of the export product vis-a-avis specification given in British Pharmacopoeia may be furnished. 10. Past production vis-a-vis actual consumption of import item duly certified by Central Excise Authorities may be furnished. The Committee accordingly deferred the case. 292

Case No.:57/4/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 293

Case No.:7/2/82-ALC4/2016

Party Name:SONGWON SPECIALTY CHEMICALS INDIA PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 294

Case No.:56/4/82-ALC4/2016

Party Name:CLARIANT INDIA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00119/AM17/ RLA File :03/94/040/01040/AM16/ Lic.No/Date:0310803170 09.03.2016 Defer Date: taken by NC for same product in Meeting No.06/82 dt.29.08.2014, upl oaded 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.

49 295

Case No.:55/4/82-

ALC4/2016 Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 296

Case No.:30/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 297

Case No.:31/2/82-

ALC4/2016 Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 298

Case No.:3/2/82-ALC4/2016

Party Name:RONAK CHEMICALS Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 299

Case No.:39/4/82-ALC4/2016

Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00102/AM17/ RLA File :03/94/040/00973/AM16/ Lic.No/Date:0310803223 10.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-412 or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 300

Case No.:58/2/82-ALC4/2016

Party Name:CHIROS PHARMA Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00058/AM17/ RLA File :22/24/040/00115/AM16/ Lic.No/Date:2210015444 11.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3648 published earlier vide PN No.64 dated 17.03.2016. RA concerned may calculate quantity on pro-rata basis as per decision. 301 Case No.:59/2/82-ALC4/2016 Party Name:CHIROS PHARMA Meet No/Date:14/82- ALC4/2016 Status: Approved

50 29.11.2016 HQ File :01/82/050/00059/AM17/ RLA File :22/24/040/00112/AM16/ Lic.No/Date:2210015443 11.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3648 published earlier vide PN No.64 dated 17.03.2016. RA concerned may calculate quantity on pro-rata basis as per decision. 302

Case No.:176/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00522/AM17/ RLA File :31/83/040/00178/AM16/ Lic.No/Date:3110066046 14.03.2016 Defer Date: 28.12.2016 Decision :Deferred. 303

Case No.:13/1/82-

ALC1/2016 Party Name:ONEIRO CHEMICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/01787/AM16/ RLA File :34/24/040/00286/AM16/ Lic.No/Date:3410041972 14.03.2016 Defer Date: 28.12.2016 Decision :Deferred. 304

Case No.:37/4/82-

ALC4/2016 Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :The Committee decided to call for copy of DML from the firm and deferred the case. 305

Case No.:144/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00490/AM17/ RLA File :09/24/040/00727/AM16/ Lic.No/Date:0910063417 15.03.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/69/2016-PI(Norms) dated June 2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 306

Case No.:26/4/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 307 Case No.:168/10/82- Party Name:RA CHEM Meet No/Date:14/82- Status:

51 ALC4/2016 PHARMA LIMITED ALC4/2016 29.11.2016 Approved HQ File :01/82/050/00514/AM17/ RLA File :09/24/040/00741/AM16/ Lic.No/Date:0910063422 16.03.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/811/2015-PI(Norms) dated 07.06.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 308

Case No.:7/4/82-ALC4/2016

SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 309

Case No.:13/4/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 310

Case No.:145/10/82-

ALC4/2016 Party Name:MSN PHARMACHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00491/AM17/ RLA File :09/24/040/00725/AM16/ Lic.No/Date:0910063424 17.03.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/871/2015-PI(Norms) dated 24.05.2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 311

Case No.:5/4/82-ALC4/2016

PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00068/AM17/ RLA File :05/23/040/00544/AM16/ Lic.No/Date:0510397982 18.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION published for injection for above 5ml. RA may calculation quantity on pro-rata basis as per decision of NC. 312

Case No.:8/4/82-ALC4/2016

PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00071/AM17/ RLA File :05/23/040/00541/AM16/ Lic.No/Date:0510397985 18.03.2016 Defer Date: 28.12.2016

52 313

Case No.:153/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00499/AM17/ RLA File :09/24/040/00738/AM16/ Lic.No/Date:0910063433 18.03.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/3/2016-PI(Norms) dated 01.06.2016 , uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 314

Case No.:85/4/82-

ALC4/2016 Party Name:SYNTHO CHIRALS PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 315

Case No.:36/4/82-

ALC4/2016 Party Name:INDOFIL INDUSTRIES LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 316

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

PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00067/AM17/ RLA File :05/23/040/00543/AM16/ Lic.No/Date:0510397989 21.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION A-3667 published earlier vide PN No.64 dated 17.03.2016 for export product No.1 and for export product No.2 may be calculated on pro-rata basis. RA concerned may calculate quantity on pro-rata basis as per decision. 317

Case No.:6/4/82-ALC4/2016

PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00069/AM17/ RLA File :05/23/040/00542/AM16/ Lic.No/Date:0510397988 21.03.2016 Defer Date: Decision : The Committee decided to ratify norms as per SION published for injection for 5ml published and quantity to be calculated for 100 vial. RA concerned may take action as per the decision of NC. 318

Case No.:81/4/82-

ALC4/2016 Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016

53 Decision :Deferred. 319

Case No.:50/4/82-

ALC4/2016 Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 320

Case No.:108/7/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00282/AM17/ RLA File :05/23/040/00518/AM16/ Lic.No/Date:0510398017 23.03.2016 Defer Date: 28.12.2016 321

Case No.:47/4/82-ALC4/2016

Party Name:HUBERGROUP INDIA PRIVATE LIMITED. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00110/AM17/ RLA File :03/94/040/01078/AM16/ Lic.No/Date:0310803568 28.03.2016 Defer Date: taken by NC in its meeting No.21/82 dated 06.02.2014 , uploaded at the end of these minutes or 322

Case No.:80/4/82-ALC4/2016

Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00143/AM17/ RLA File :03/95/040/01007/AM16/ Lic.No/Date:0310803591 29.03.2016 Defer Date: taken by NC in its meeting No.2/82 dated 18.04.2013 , uploaded at the end of these minutes or 323

Case No.:186/10/82-

ALC4/2016 Party Name:VOVANTIS LABORATORIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00532/AM17/ RLA File :34/24/040/00290/AM16/ Lic.No/Date:3410042021 30.03.2016 Defer Date: 28.12.2016 324

Case No.:43/4/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016

54 325

Case No.:69/4/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision : Information has been called for from the firm in NC meeting No.10/82 dated 23.08.2016 is awaited. The Committee accordingly deferred the case. 326

Case No.:76/4/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 327

Case No.:8/10/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00354/AM17/ RLA File :03/94/040/00645/AM16/ Lic.No/Date:0310803722 01.04.2016 Defer Date: 28.12.2016 Decision :Deferred. 328

Case No.:7/10/82-

ALC4/2016 Party Name:FERMENTA BIOTECH LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Approved HQ File :01/82/050/00353/AM17/ RLA File :03/94/040/01125/AM16/ Lic.No/Date:0310803764 04.04.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/577/2015-PI(Norms) dated December 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. 329

Case No.:77/4/82-ALC4/2016

Party Name:TITAN LABORATORIES PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00140/AM17/ RLA File :03/95/040/00001/AM17/ Lic.No/Date:0310803752 04.04.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/564/2012-PI(Norms) dated 21.12.2012 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 330 Case No.:92/4/82- ALC4/2016 Party Name:SWATI MENTHOL & ALLIED Meet No/Date:14/82- ALC4/2016 Status:Deferred

55 CHEMICALS LTD., 29.11.2016 HQ File :01/82/050/00155/AM17/ RLA File :29/24/040/00010/AM16/ Lic.No/Date:2910025244 06.04.2016 Defer Date: 28.12.2016 Decision :Deferred. 331

Case No.:74/4/82-ALC4/2016

Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00137/AM17/ RLA File :03/95/040/00021/AM17/ Lic.No/Date:0310803871 11.04.2016 Defer Date: taken by NC in its meeting No.03/82 dated 08.05.2014 , uploaded at the end of these minutes or 332

Case No.:66/2/82-

ALC4/2016 Party Name:ENCEE AROMATICS PVT. LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 333

Case No.:167/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00513/AM17/ RLA File :09/24/040/00777/AM16/ Lic.No/Date:0910063505 15.04.2016 Defer Date: 28.12.2016 334

Case No.:127/10/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00473/AM17/ RLA File :09/24/040/00008/AM17/ Lic.No/Date:0910063506 18.04.2016 Defer Date: 28.12.2016 335

Case No.:3/10/82-

ALC4/2016 Party Name:INDOCO REMEDIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00349/AM17/ RLA File :03/94/040/00042/AM17/ Lic.No/Date:0310804024 20.04.2016 Defer Date: 28.12.2016 336

Case No.:69/2/82-

ALC4/2016 Party Name:ALMELO PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016

56 337

Case No.:98/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00444/AM17/ RLA File :17/24/040/00006/AM17/ Lic.No/Date:1710006305 21.04.2016 Defer Date: 28.12.2016 Decision :Deferred. 338

Case No.:99/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00445/AM17/ RLA File :17/24/040/00005/AM17/ Lic.No/Date:1710006311 22.04.2016 Defer Date: 28.12.2016 Decision :Deferred. 339

Case No.:164/10/82-

ALC4/2016 Party Name:GLAND PHARMA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00510/AM17/ RLA File :09/24/040/00767/AM16/ Lic.No/Date:0910063540 22.04.2016 Defer Date: 28.12.2016 340

Case No.:125/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00471/AM17/ RLA File :09/24/040/00033/AM17/ Lic.No/Date:0910063570 29.04.2016 Defer Date: 28.12.2016 341

Case No.:7/6/82-ALC4/2016

Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 342

Case No.:107/10/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00453/AM17/ RLA File :31/83/040/00001/AM17/ Lic.No/Date:3110066134 04.05.2016 Defer Date: 28.12.2016 Decision : Approved in Meeting No.12/82 dated 28.09.2016. 343

Case No.:108/10/82-

ALC4/2016 Party Name:BALAJI AMINES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved

57 HQ File :01/82/050/00454/AM17/ RLA File :31/83/040/00182/AM16/ Lic.No/Date:3110066133 04.05.2016 Defer Date: Decision : The Committee decided to ratify norms based on the earlier recommendation of D/oC&PC forwarded vide U.O.No.14010/122/2011-Ch-II dated 11.02.2016, uploaded at the end of these minutes or as applied by the firm whichever is less. RA concerned may take further necessary action as per the decision of NC. 344

Case No.:174/10/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00520/AM17/ RLA File :05/23/040/00038/AM17/ Lic.No/Date:0510398377 04.05.2016 Defer Date: 28.12.2016 345

Case No.:175/10/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00521/AM17/ RLA File :05/23/040/00032/AM17/ Lic.No/Date:0510398379 04.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 346

Case No.:132/10/82-

ALC4/2016 Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00478/AM17/ RLA File :09/24/040/00040/AM17/ Lic.No/Date:0910063583 04.05.2016 Defer Date: 28.12.2016 347

Case No.:181/10/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00527/AM17/ RLA File :34/24/040/00021/AM17/ Lic.No/Date:3410042142 05.05.2016 Defer Date: 28.12.2016 348

Case No.:9/10/82-

ALC4/2016 Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00355/AM17/ RLA File :03/94/040/00077/AM17/ Lic.No/Date:0310804424 05.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 349

Case No.:6/10/82-

ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00352/AM17/ RLA File :05/24/040/00054/AM17/ Lic.No/Date:0510398413 06.05.2016 Defer Date: 28.12.2016

58 Decision :Deferred. 350

Case No.:146/10/82-

ALC4/2016 Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00492/AM17/ RLA File :09/24/040/00044/AM17/ Lic.No/Date:0910063608 09.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 351

Case No.:178/10/82-

ALC4/2016 Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00524/AM17/ RLA File :34/24/040/00354/AM16/ Lic.No/Date:3410042154 10.05.2016 Defer Date: 28.12.2016 352

Case No.:77/10/82-

ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00423/AM17/ RLA File :13/24/040/00004/AM17/ Lic.No/Date:1310048244 11.05.2016 Defer Date: 28.12.2016 353

Case No.:71/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00417/AM17/ RLA File :05/24/040/00056/AM17/ Lic.No/Date:0510398495 13.05.2016 Defer Date: 28.12.2016 354

Case No.:169/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00515/AM17/ RLA File :09/24/040/00007/AM17/ Lic.No/Date:0910063629 17.05.2016 Defer Date: 28.12.2016 Decision : Deferred for want of comments from DBT. 355

Case No.:94/10/82-

ALC4/2016 Party Name:KLJ PLASTICIZERS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00440/AM17/ RLA File :05/23/040/00067/AM17/ Lic.No/Date:0510398541 18.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 356

Case No.:126/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

59 HQ File :01/82/050/00472/AM17/ RLA File :09/24/040/00306/AM15/ Lic.No/Date:0910063657 19.05.2016 Defer Date: 28.12.2016 Decision : Deferred for want of comments from DBT. 357

Case No.:149/10/82-

ALC4/2016 Party Name:BIOLOGICAL E LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00495/AM17/ RLA File :09/24/040/00546/AM16/ Lic.No/Date:0910063659 19.05.2016 Defer Date: 28.12.2016 Decision : Deferred for want of comments from DBT. 358

Case No.:72/10/82-

ALC4/2016 Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00418/AM17/ RLA File :05/24/040/00080/AM17/ Lic.No/Date:0510398561 19.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 359

Case No.:73/10/82-

ALC4/2016 Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00419/AM17/ RLA File :05/24/040/00067/AM17/ Lic.No/Date:0510398560 19.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 360

Case No.:130/10/82-

ALC4/2016 Party Name:SRINI PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00476/AM17/ RLA File :09/24/040/00078/AM17/ Lic.No/Date:0910063664 23.05.2016 Defer Date: 28.12.2016 361

Case No.:83/10/82-

ALC4/2016 Party Name:STERILE INDIA PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00429/AM17/ RLA File :05/24/040/00633/AM16/ Lic.No/Date:0510398574 23.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 362

Case No.:79/10/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00425/AM17/ RLA File :05/23/040/00075/AM17/ Lic.No/Date:0510398581 24.05.2016 Defer Date: 28.12.2016 363 Case No.:80/10/82-ALC4/2016 Party Name:INDO PHYTO Meet No/Date:14/82- Status:

60 CHEMICALS PVT LTD ALC4/2016 29.11.2016 Approved HQ File :01/82/050/00426/AM17/ RLA File :05/23/040/00027/AM17/ Lic.No/Date:0510398587 24.05.2016 Defer Date: Decision : The Committee decided to ratify norms based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/254/2016-PI(Norms) dated 18.11.2016, 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. 364

Case No.:81/10/82-ALC4/2016 Party Name:INDO PHYTO

CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00427/AM17/ RLA File :05/23/040/00028/AM17/ Lic.No/Date:0510398588 24.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/254/2016-PI(Norms) dated 08.11.2016, 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. 365

Case No.:74/10/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00420/AM17/ RLA File :05/23/040/00078/AM17/ Lic.No/Date:0510398583 24.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 366

Case No.:75/10/82-

ALC4/2016 Party Name:JUBILANT GENERICS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00421/AM17/ RLA File :05/23/040/00076/AM17/ Lic.No/Date:0510398582 24.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 367

Case No.:136/10/82-

ALC4/2016 Party Name:METROCHEM API PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00482/AM17/ RLA File :09/24/040/00100/AM17/ Lic.No/Date:0910063676 25.05.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/210/2016-PI(Norms) dated Sept. 2016 , uploaded at the end of these minutes or as applied by the firm whichever is NC. 368

Case No.:185/10/82-

ALC4/2016 Party Name:PAUSHAK LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00531/AM17/ RLA File :34/24/040/00037/AM17/ Lic.No/Date:3410042207 25.05.2016 Defer Date: 28.12.2016

61 369

Case No.:87/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00433/AM17/ RLA File :05/24/040/00058/AM17/ Lic.No/Date:0510398614 25.05.2016 Defer Date: 28.12.2016 370

Case No.:102/10/82-

ALC4/2016 Party Name:IKRISH HEALTHCARE PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00448/AM17/ RLA File :05/23/040/00091/AM17/ Lic.No/Date:0510398628 26.05.2016 Defer Date: 28.12.2016 371

Case No.:68/10/82-

ALC4/2016 PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00414/AM17/ RLA File :05/23/040/00088/AM17/ Lic.No/Date:0510398631 26.05.2016 Defer Date: 28.12.2016 372

Case No.:65/10/82-

ALC4/2016 Party Name:KORES (INDIA) LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00411/AM17/ RLA File :31/83/040/00014/AM17/ Lic.No/Date:3110066163 26.05.2016 Defer Date: 28.12.2016 373

Case No.:88/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00434/AM17/ RLA File :05/24/040/00083/AM17/ Lic.No/Date:0510398625 26.05.2016 Defer Date: 28.12.2016 374

Case No.:147/10/82-

ALC4/2016 Party Name:SHREEGEN PHARMA LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00493/AM17/ RLA File :09/24/040/00091/AM17/ Lic.No/Date:0910063692 26.05.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/555/2015-PI(Norms) dated December, 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.

62 375

Case No.:91/10/82-

ALC4/2016 Party Name:VIC INDUSTRIES, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00437/AM17/ RLA File :17/24/040/00028/AM17/ Lic.No/Date:1710006343 26.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 376

Case No.:117/10/82-

ALC4/2016 Party Name:DR. REDDYS Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00463/AM17/ RLA File :09/24/040/00089/AM17/ Lic.No/Date:0910063705 27.05.2016 Defer Date: 28.12.2016 377

Case No.:92/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00438/AM17/ RLA File :17/24/040/00030/AM17/ Lic.No/Date:1710006345 27.05.2016 Defer Date: 28.12.2016 378

Case No.:112/10/82-

ALC4/2016 Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00458/AM17/ RLA File :05/23/040/00094/AM17/ Lic.No/Date:0510398655 27.05.2016 Defer Date: 28.12.2016 379

Case No.:45/10/82-ALC4/2016 Party Name:YASHO

INDUSTRIES PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00391/AM17/ RLA File :03/95/040/00157/AM17/ Lic.No/Date:0310804995 27.05.2016 Defer Date: taken by NC in its meeting No.03/82 dated 8.05.2014 , uploaded at the end of these minutes or 380

Case No.:36/10/82-

ALC4/2016 Party Name:FRESENIUS KABI INDIA PRIVATE LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00382/AM17/ RLA File :03/94/040/00145/AM17/ Lic.No/Date:0310805018 30.05.2016 Defer Date: 28.12.2016 381

Case No.:34/10/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred

63 HQ File :01/82/050/00380/AM17/ RLA File :03/94/040/00048/AM17/ Lic.No/Date:0310805010 30.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 382

Case No.:35/10/82-

ALC4/2016 Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00381/AM17/ RLA File :03/94/040/00030/AM17/ Lic.No/Date:0310805009 30.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 383

Case No.:123/10/82-

ALC4/2016 Party Name:NIFTY LABS PVT LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00469/AM17/ RLA File :09/24/040/00102/AM17/ Lic.No/Date:0910063716 30.05.2016 Defer Date: 28.12.2016 384

Case No.:44/10/82-

ALC4/2016 Party Name:PRIVI ORGANICS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00390/AM17/ RLA File :03/95/040/00128/AM17/ Lic.No/Date:0310805023 30.05.2016 Defer Date: 28.12.2016 Decision :Deferred. 385

Case No.:103/10/82-

ALC4/2016 Party Name:AGSON GLOBAL PRIVATE LIMITED. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00449/AM17/ RLA File :05/23/040/00095/AM17/ Lic.No/Date:0510398680 31.05.2016 Defer Date: 28.12.2016 386

Case No.:33/10/82-

ALC4/2016 Party Name:KOPRAN RESEARCH LABORATORIES LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00379/AM17/ RLA File :03/94/040/00044/AM17/ Lic.No/Date:0310805039 31.05.2016 Defer Date: 28.12.2016 387

Case No.:96/10/82-ALC4/2016 Party Name:SUN

PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00442/AM17/ RLA File :05/24/040/00063/AM17/ Lic.No/Date:0510398692 31.05.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/867/2015-PI(Norms) dated 24.05.2016,

64 388

Case No.:97/10/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00443/AM17/ RLA File :05/24/040/00066/AM17/ Lic.No/Date:0510398693 31.05.2016 Defer Date: 28.12.2016 389

Case No.:187/10/82-

ALC4/2016 Party Name:WINDLAS HEALTH CARE PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00533/AM17/ RLA File :61/24/040/00001/AM17/ Lic.No/Date:6110001350 01.06.2016 Defer Date: 28.12.2016 390

Case No.:54/10/82-ALC4/2016 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Deferred HQ File :01/82/050/00400/AM17/ RLA File :04/24/040/00038/AM17/ Lic.No/Date:0410162004 02.06.2016 Defer Date: 29.11.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/255/2016-PI(Norms) dated 17.11.2016, uploaded at the end of these minutes and deferred the case. 391

Case No.:69/10/82-

ALC4/2016 PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00415/AM17/ RLA File :05/23/040/00108/AM17/ Lic.No/Date:0510398724 03.06.2016 Defer Date: 28.12.2016 392

Case No.:70/10/82-

ALC4/2016 PVT.LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00416/AM17/ RLA File :05/23/040/00109/AM17/ Lic.No/Date:0510398725 03.06.2016 Defer Date: 28.12.2016 393

Case No.:48/10/82-

ALC4/2016 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00394/AM17/ RLA File :03/94/040/00051/AM17/ Lic.No/Date:0310805268 07.06.2016 Defer Date: 28.12.2016 394 Case No.:50/10/82- ALC4/2016 Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 Status:Deferred

65 29.11.2016 HQ File :01/82/050/00396/AM17/ RLA File :03/94/040/00065/AM17/ Lic.No/Date:0310805269 07.06.2016 Defer Date: 28.12.2016 395

Case No.:51/10/82-

ALC4/2016 Party Name:BLUE CIRCLE ORGANICS PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00397/AM17/ RLA File :03/94/040/00196/AM17/ Lic.No/Date:0310805264 07.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 396

Case No.:11/10/82-

ALC4/2016 Party Name:CADILA PHARMACEUTICALS LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00357/AM17/ RLA File :08/24/040/00088/AM17/ Lic.No/Date:0810138109 07.06.2016 Defer Date: 28.12.2016 397

Case No.:157/10/82-

ALC4/2016 Party Name:MAITHRI DRUGS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00503/AM17/ RLA File :09/24/040/00112/AM17/ Lic.No/Date:0910063749 07.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/63/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 398

Case No.:131/10/82-

ALC4/2016 Party Name:MSN PHARMACHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00477/AM17/ RLA File :09/24/040/00117/AM17/ Lic.No/Date:0910063750 07.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/70/2010-PI(Norms) dated 25.10.2010, 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.:129/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Deferred HQ File :01/82/050/00475/AM17/ RLA File :09/24/040/00045/AM17/ Lic.No/Date:0910063759 07.06.2016 Defer Date:28.12.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/188/2015-PI(Norms) dated August 2015, uploaded at the end of these minutes and deferred the case. 400 Case No.:59/10/82- Party Name:NECTAR Meet No/Date:14/82- Status:Approved

66 ALC4/2016 LIFESCIENCES LIMITED, ALC4/2016 29.11.2016 HQ File :01/82/050/00405/AM17/ RLA File :22/24/040/00016/AM17/ Lic.No/Date:2210015489 07.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/597/2012-PI(Norms) dated 06.02.2013, 401

Case No.:128/10/82-

ALC4/2016 Party Name:SHODHANA LABORATORIES LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00474/AM17/ RLA File :09/24/040/00127/AM17/ Lic.No/Date:0910063760 07.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/833/2015-PI(Norms) dated 18.05.2016, 402

Case No.:134/10/82-

ALC4/2016 Party Name:ALPHAMED FORMULATIONS P LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00480/AM17/ RLA File :09/24/040/00087/AM17/ Lic.No/Date:0910063771 08.06.2016 Defer Date: 28.12.2016 Decision : The Committee decided to call for copy of Master Batch formula duly authenticated by Q.C. in-charge and deferred the case. 403

Case No.:18/10/82-

ALC4/2016 Party Name:ARJUN CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00364/AM17/ RLA File :04/24/040/00041/AM17/ Lic.No/Date:0410162023 08.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 404

Case No.:53/10/82-ALC4/2016 Party Name:FDC LTD

Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00399/AM17/ RLA File :03/94/040/00172/AM17/ Lic.No/Date:0310805303 08.06.2016 Defer Date: Decision : Already approved in NC 12/82 dated 28.09.2016. 405

Case No.:121/10/82-

ALC4/2016 Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00467/AM17/ RLA File :09/24/040/00032/AM17/ Lic.No/Date:0910063765 08.06.2016 Defer Date: 28.12.2016 406 Case No.:150/10/82- Party Name:INCHEM Meet No/Date:14/82- Status:

67 ALC4/2016 LABORATORIES PRIVATE LIMITED ALC4/2016 29.11.2016 Approved HQ File :01/82/050/00496/AM17/ RLA File :09/24/040/00122/AM17/ Lic.No/Date:0910063779 09.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/20/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC. 407

Case No.:151/10/82-

ALC4/2016 Party Name:INCHEM LABORATORIES PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00497/AM17/ RLA File :09/24/040/00123/AM17/ Lic.No/Date:0910063778 09.06.2016 Defer Date: 28.12.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/70/2016-PI(Norms) dated June 2016, uploaded at the end of these minutes and deferred the case. 408

Case No.:49/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00395/AM17/ RLA File :03/94/040/00181/AM17/ Lic.No/Date:0310805345 09.06.2016 Defer Date: 28.12.2016 409

Case No.:179/10/82-

ALC4/2016 Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00525/AM17/ RLA File :34/24/040/00064/AM17/ Lic.No/Date:3410042257 10.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 410

Case No.:12/10/82-

ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00358/AM17/ RLA File :04/24/040/00043/AM17/ Lic.No/Date:0410162034 10.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 411

Case No.:89/10/82-

ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00435/AM17/ RLA File :17/24/040/00037/AM17/ Lic.No/Date:1710006358 10.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 412 Case No.:90/10/82- ALC4/2016 Party Name:ESTEEM INDUSTRIES PRIVATE Meet No/Date:14/82- ALC4/2016 Status:Deferred

68 LIMITED 29.11.2016 HQ File :01/82/050/00436/AM17/ RLA File :17/24/040/00039/AM17/ Lic.No/Date:1710006359 10.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 413

Case No.:46/10/82-

ALC4/2016 Party Name:NOCIL LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00392/AM17/ RLA File :03/95/040/00134/AM17/ Lic.No/Date:0310805363 10.06.2016 Defer Date: 28.12.2016 414

Case No.:47/10/82-

ALC4/2016 Party Name:SUNSHIELD CHEMICALS LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00393/AM17/ RLA File :03/95/040/00196/AM17/ Lic.No/Date:0310805364 10.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 415

Case No.:64/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00410/AM17/ RLA File :31/83/040/00195/AM16/ Lic.No/Date:3110066174 13.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 416

Case No.:14/10/82-

ALC4/2016 Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00360/AM17/ RLA File :04/24/040/00049/AM17/ Lic.No/Date:0410162041 14.06.2016 Defer Date: 28.12.2016 417

Case No.:52/10/82-

ALC4/2016 Party Name:CLARIANT INDIA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00398/AM17/ RLA File :03/94/040/00223/AM17/ Lic.No/Date:0310805476 14.06.2016 Defer Date: 28.12.2016 418

Case No.:26/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00372/AM17/ RLA File :03/94/040/00217/AM17/ Lic.No/Date:0310805452 14.06.2016 Defer Date: 28.12.2016

69 419

Case No.:27/10/82-

ALC4/2016 Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00373/AM17/ RLA File :03/94/040/00218/AM17/ Lic.No/Date:0310805451 14.06.2016 Defer Date: 28.12.2016 420

Case No.:137/10/82-

ALC4/2016 Party Name:PROCESS AGROCHEM INDUSTRIES PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00483/AM17/ RLA File :56/24/040/00009/AM17/ Lic.No/Date:5610004930 14.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 421

Case No.:19/10/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00365/AM17/ RLA File :05/24/040/00117/AM17/ Lic.No/Date:0510398800 14.06.2016 Defer Date: 28.12.2016 422

Case No.:60/10/82-

ALC4/2016 Party Name:VENUS REMEDIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00406/AM17/ RLA File :22/24/040/00014/AM17/ Lic.No/Date:2210015501 14.06.2016 Defer Date: 28.12.2016 423

Case No.:61/10/82-

ALC4/2016 Party Name:ANUJA HEALTHCARE LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00407/AM17/ RLA File :22/24/040/00013/AM17/ Lic.No/Date:2210015504 15.06.2016 Defer Date: 28.12.2016 424

Case No.:25/10/82-

ALC4/2016 Party Name:ASTEC LIFESCIENCES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00371/AM17/ RLA File :03/94/040/00132/AM17/ Lic.No/Date:0310805494 15.06.2016 Defer Date: 28.12.2016 425

Case No.:154/10/82-

ALC4/2016 Party Name:MYLAN Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File RLA File Lic.No/Date:0910063799 Defer Date:

70 :01/82/050/00500/AM17/ :09/24/040/00084/AM17/ 15.06.2016 28.12.2016 426

Case No.:23/10/82-

ALC4/2016 Party Name:RECKITT BENCKISER ( INDIA) PRIVATE LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00369/AM17/ RLA File :05/24/040/00128/AM17/ Lic.No/Date:0510398826 16.06.2016 Defer Date: 28.12.2016 427

Case No.:57/10/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00403/AM17/ RLA File :05/23/040/00054/AM17/ Lic.No/Date:0510398839 17.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 428

Case No.:40/10/82-

ALC4/2016 Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00386/AM17/ RLA File :03/95/040/00191/AM17/ Lic.No/Date:0310805570 17.06.2016 Defer Date: 28.12.2016 429

Case No.:30/10/82-

ALC4/2016 Party Name:DANOPHARM CHEMICALS PRIVATE LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00376/AM17/ RLA File :03/94/040/00150/AM17/ Lic.No/Date:0310805606 20.06.2016 Defer Date: 28.12.2016 430

Case No.:21/10/82-ALC4/2016 Party Name:MOREPEN

LABORATORIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00367/AM17/ RLA File :05/24/040/00129/AM17/ Lic.No/Date:0510398847 20.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/657/2015-PI(Norms) dated 12.02.2016, 431

Case No.:29/10/82-

ALC4/2016 Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00375/AM17/ RLA File :03/94/040/00208/AM17/ Lic.No/Date:0310805623 21.06.2016 Defer Date: 28.12.2016

71 432

Case No.:55/10/82-ALC4/2016 Party Name:MALLADI

DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00401/AM17/ RLA File :04/24/040/00052/AM17/ Lic.No/Date:0410162053 21.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/255/2016-PI(Norms) dated 21.11.2016, 433

Case No.:78/10/82-

ALC4/2016 Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00424/AM17/ RLA File :13/24/040/00009/AM17/ Lic.No/Date:1310048295 22.06.2016 Defer Date: 28.12.2016 434

Case No.:56/10/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00402/AM17/ RLA File :04/24/040/00051/AM17/ Lic.No/Date:0410162058 22.06.2016 Defer Date:29.1.2016 Decision : The Committee decided to call for information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/255/2016-PI(Norms) dated 17.11.2016, uploaded at the end of these minutes and deferred the case. 435

Case No.:105/10/82-

ALC4/2016 Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00451/AM17/ RLA File :05/24/040/00133/AM17/ Lic.No/Date:0510398872 22.06.2016 Defer Date: 28.12.2016 436

Case No.:109/10/82-

ALC4/2016 Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00455/AM17/ RLA File :22/24/040/00022/AM17/ Lic.No/Date:2210015511 23.06.2016 Defer Date: 28.12.2016 Decision : The Committee decided to call for following information based on the recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/259/2016-PI(Norms) dated 21.11.2016 from the firm:- 1. Complete technical detail as per appendix-33 2. Past production vis-a-vis actual consumption of all imported inputs duly certified by Central Excise Authorities. The committee accordingly deferred the case.

72 437

Case No.:66/10/82-ALC4/2016 Party Name:EMCURE

PHARMACEUTICALS LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00412/AM17/ RLA File :31/83/040/00030/AM17/ Lic.No/Date:3110066188 23.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/258/2016-PI(Norms) dated 21.11.2016, 438

Case No.:28/10/82-

ALC4/2016 Party Name:GITANJALI CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00374/AM17/ RLA File :03/94/040/00202/AM17/ Lic.No/Date:0310805671 23.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 439

Case No.:110/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00456/AM17/ RLA File :31/83/040/00027/AM17/ Lic.No/Date:3110066198 27.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 440

Case No.:104/10/82-

ALC4/2016 Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Approved HQ File :01/82/050/00450/AM17/ RLA File :05/24/040/00130/AM17/ Lic.No/Date:0510398918 27.06.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/810/2015-PI(Norms) dated 07.06.2016, 441

Case No.:37/10/82-

ALC4/2016 Party Name:METROPOLITAN EXIMCHEM PRIVATE LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00383/AM17/ RLA File :03/95/040/00258/AM17/ Lic.No/Date:0310805756 28.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 442

Case No.:38/10/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00384/AM17/ RLA File :03/95/040/00234/AM17/ Lic.No/Date:0310805748 28.06.2016 Defer Date: 28.12.2016

73 443

Case No.:39/10/82-

ALC4/2016 Party Name:ORBIT LIFE SCIENCE PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00385/AM17/ RLA File :03/95/040/00235/AM17/ Lic.No/Date:0310805747 28.06.2016 Defer Date: 28.12.2016 444

Case No.:138/10/82-

ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00484/AM17/ RLA File :56/24/040/00051/AM16/ Lic.No/Date:5610004939 30.06.2016 Defer Date: 28.12.2016 445

Case No.:182/10/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00528/AM17/ RLA File :34/24/040/00095/AM17/ Lic.No/Date:3410042315 30.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 446

Case No.:183/10/82-

ALC4/2016 Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00529/AM17/ RLA File :34/24/040/00094/AM17/ Lic.No/Date:3410042314 30.06.2016 Defer Date: 28.12.2016 Decision :Deferred. 447

Case No.:85/10/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00431/AM17/ RLA File :05/23/040/00172/AM17/ Lic.No/Date:0510398972 04.07.2016 Defer Date: 28.12.2016 Decision :Deferred. 448

Case No.:86/10/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00432/AM17/ RLA File :05/23/040/00146/AM17/ Lic.No/Date:0510398970 04.07.2016 Defer Date: 28.12.2016 Decision :Deferred. 449

Case No.:101/10/82-

ALC4/2016 SCIENCES LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00447/AM17/ RLA File :05/23/040/00173/AM17/ Lic.No/Date:0510398971 04.07.2016 Defer Date: 28.12.2016 Decision :Deferred.

74 450

Case No.:135/10/82-

ALC4/2016 Party Name:PARENTRAL DRUGS INDIA LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00481/AM17/ RLA File :56/24/040/00014/AM17/ Lic.No/Date:5610004941 04.07.2016 Defer Date: 28.12.2016 451

Case No.:3/8/82-ALC4/2016

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 452

Case No.:5/14/82-ALC4/2016

Party Name:ASTRAL STERITECH PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00803/AM17/ RLA File :34/24/040/00099/AM17/ Lic.No/Date:3410042324 05.07.2016 Defer Date: 453

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

Party Name:HELLO PAINTS (P) LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 454

Case No.:4/8/82-ALC4/2016

Party Name:GOPINATH CHEM-TECH LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 455

Case No.:63/10/82-

ALC4/2016 Party Name:STRIDES SHASUN LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00409/AM17/ RLA File :04/24/040/00058/AM17/ Lic.No/Date:0410162083 08.07.2016 Defer Date: 28.12.2016 456

Case No.:10/14/82-ALC4/2016 Party Name:GLOBAL

MEDICINES LTD, Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00808/AM17/ RLA File :34/24/040/00101/AM17/ Lic.No/Date:3410042344 12.07.2016 Defer Date:

75 Decision :Deferred. 457

Case No.:82/10/82-

ALC4/2016 Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00428/AM17/ RLA File :31/83/040/00041/AM17/ Lic.No/Date:3110066246 14.07.2016 Defer Date: 28.12.2016 Decision :Deferred. 458

Case No.:5/8/82-ALC4/2016

Party Name:MYLAN Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00343/AM17/ RLA File :09/24/040/00197/AM17/ Lic.No/Date:0910063918 14.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/752/2015-PI(Norms) dated 03.05.2016, 459

Case No.:6/8/82-ALC4/2016

Party Name:ATUL LIMITED, Meet No/Date:14/82- ALC4/2016 29.11.2016 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: 28.12.2016 Decision :Deferred. 460

Case No.:4/14/82-ALC4/2016

Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00802/AM17/ RLA File :34/24/040/00109/AM17/ Lic.No/Date:3410042360 19.07.2016 Defer Date: Decision :Deferred. 461

Case No.:12/14/82-ALC4/2016 Party Name:ESTEEM

INDUSTRIES PRIVATE LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00810/AM17/ RLA File :17/24/040/00065/AM17/ Lic.No/Date:1710006408 19.07.2016 Defer Date: Decision :Deferred. 462

Case No.:11/14/82-ALC4/2016 Party Name:TRANSPEK

INDUSTRY LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00809/AM17/ RLA File :34/24/040/00114/AM17/ Lic.No/Date:3410042366 19.07.2016 Defer Date: taken by NC in its meeting No.12/82 dated 03.07.2012, uploaded at the end of these minutes or

76 463

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

Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00346/AM17/ RLA File :09/24/040/00198/AM17/ Lic.No/Date:0910063961 20.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/720/2013-PI(Norms) dated 24.12.2013, 464

Case No.:1/14/82-ALC4/2016

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00799/AM17/ RLA File :34/24/040/00106/AM17/ Lic.No/Date:3410042370 21.07.2016 Defer Date: Decision :Deferred. 465

Case No.:3/14/82-ALC4/2016

Party Name:TRANSPEK INDUSTRY LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00801/AM17/ RLA File :34/24/040/00124/AM17/ Lic.No/Date:3410042372 22.07.2016 Defer Date: 466

Case No.:1/10/82-ALC4/2016

Party Name:INTAS PHARMACEUTICALS LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00347/AM17/ RLA File :08/24/040/00127/AM17/ Lic.No/Date:0810138359 25.07.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/161/2014-PI(Norms) dated August 2014, 467

Case No.:9/14/82-ALC4/2016

Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00807/AM17/ RLA File :34/24/040/00133/AM17/ Lic.No/Date:3410042403 04.08.2016 Defer Date: 468

Case No.:8/14/82-

ALC4/2016 Party Name:STERMONE CHEMICALS PVT LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Approved HQ File :01/82/050/00806/AM17/ RLA File :34/24/040/00137/AM17/ Lic.No/Date:3410042427 11.08.2016 Defer Date:

77 Pharmaceuticals forwarded vide O.M.No.35011/868/2015-PI(Norms) dated 24.05.2016, 469

Case No.:7/14/82-ALC4/2016

Party Name:AMI LIFESCIENCES P LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00805/AM17/ RLA File :34/24/040/00057/AM17/ Lic.No/Date:3410042468 24.08.2016 Defer Date: Pharmaceuticals forwarded vide O.M.No.35011/825/2015-PI(Norms) dated 01.06.2016, 470

Case No.:1/12/82-

ALC4/2016 Party Name:INTAS PHARMACEUTICALS LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00625/AM17/ RLA File :08/24/040/00236/AM17/ Lic.No/Date:0810138639 09.09.2016 Defer Date: 28.12.2016 471

Case No.:2/12/82-ALC4/2016

Party Name:ARIHANTANAM LIFECARE PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status: Approved HQ File :01/82/050/00626/AM17/ RLA File :52/24/040/00039/AM17/ Lic.No/Date:5210042021 15.09.2016 Defer Date: Decision : recommendation of D/o Pharmaceuticals forwarded vide O.M.No.35011/434/2014-PI(Norms) dated February 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. 472

Case No.:3/12/82-

ALC4/2016 Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00627/AM17/ RLA File :05/24/040/00255/AM17/ Lic.No/Date:0510399725 15.09.2016 Defer Date: 28.12.2016 473

Case No.:4/12/82-

ALC4/2016 Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Deferred HQ File :01/82/050/00628/AM17/ RLA File :09/24/040/00290/AM17/ Lic.No/Date:0910064145 16.09.2016 Defer Date: 28.12.2016 474

Case No.:6/14/82-ALC4/2016

Party Name:SWATI MENTHOL & ALLIED CHEMICALS LTD., Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred

78 HQ File :01/82/050/00804/AM17/ RLA File :29/24/040/00002/AM17/ Lic.No/Date:2910025262 23.09.2016 Defer Date: 28.12.2016 Decision :Deferred. 475

Case No.:13/14/82-ALC4/2016 Party Name:ARIHANTANAM

LIFECARE PVT. LTD. Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00811/AM17/ RLA File :52/24/040/00047/AM17/ Lic.No/Date:5210042055 25.10.2016 Defer Date: 28.12.2016 476

Case No.:14/14/82-ALC4/2016 Party Name:CONCORD

BIOTECH LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00812/AM17/ RLA File :08/24/040/00264/AM17/ Lic.No/Date:0810138999 28.10.2016 Defer Date: 28.12.2016 Decision :Deferred for want of comments from DBT. 477

Case No.:15/14/82-

ALC4/2016 Party Name:MICRO LABS LTD Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00813/AM17/ RLA File :07/24/040/00255/AM17/ Lic.No/Date:0710110609 02.11.2016 Defer Date: 28.12.2016 478

Case No.:16/14/82-

ALC4/2016 Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2016 29.11.2016 Status:Case Deferred HQ File :01/82/050/00814/AM17/ RLA File :04/24/040/00133/AM17/ Lic.No/Date:0410162482 10.11.2016 Defer Date: 28.12.2016 Cases considered out of agenda

Case No. B- 01

M.No.14/AM-17 Date 29.11.2016 M/s. Hemmo Pharma Pvt. Ltd. F.No.01/82/50/373/AM12 RLA File No.03/94/040/1111/AM11 Adv.Auth.No.0310635238 dated 09.06.2011 Decision: The Committee considered this for amendment of norms as per agenda. The Committee in light of the recommendation of D/o Pharmaceuticals forwarded earlier vide O.M.No.35011/438/2012-PI(Norms) dated Sept. 2012, 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.

79

Case No. B- 02

M.No.14/AM-17 Date 29.11.2016 M/s. Reliance Industries Ltd File No. 01/82/050/01385/AM16 Adv.Auth. No. 0310799215 dated 06.10.2015 Decision: The Committee considered firm’s representation dated 02.12.2016 for correction in the description of import item as “Reformate Relevant Catalyst and Chemicals used in manufacture of Paraxylene as per agenda. The Committee decided to correct the description of import item to read as “Relevant Catalyst and Chemicals used in manufacture of Paraxylene without any other change. RA concerned may take further necessary action as per the decision of NC.


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