IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2015-10-28

DGFT Committee Minutes

Document text

1

Office of Directorate General of Foreign Trade
New Delhi -110011

Para 4.7 Decision

Meeting No. 11/82/2015 of 2015-16, to consider the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products
and falling under Chapter 29 and 30, held on 28.10.2015 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Shri O.P.Sharma,Jt. Indl. Adviser, D/o C&PC Shri Nirmal Kumar, Dy.DGFT Shri D.N. Mathur, Consultant, Department of Pharmaceutical
Shri Mahendra Vikram Singh, Foreign Trade Development Officer

The committee went through the minutes of earlier NC –III meeting No. 10/82 was scheduled for 15.10.2015 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 U.O.No. / O.M. No. of the scanned copy is reflected in the minutes.

The following cases/issues were discussed and the committee took the decision as mentioned against each case.

MEETING NUMBER
: 11/82-ALC4/2015 MEETING DATE : 28.10.2015

1 CaseNo.:36/19/82- ALC4/2014
Party Name:ALKALI METALS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01524/AM15/
RLA File :09/24/040/00503/AM12/
Lic.No/Date:0910052125 12.04.2012 Defer date: 27.11.2015 Decision :The Committee decided to defer the case for want of comments of DC&PC(Chemical).

2 CaseNo.:38/19/82- ALC4/2014
Party Name:PORUS LABORATORIES PVT LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01526/AM15/
RLA File :09/24/040/00050/AM13/
Lic.No/Date:0910052706 21.05.2012 Defer date: 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemical).

3 Case No.:18/19/82- ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01506/AM15/
RLA File :09/24/040/00085/AM13/
Lic.No/Date:0910052887 05.06.2012 Defer date: 27.11.2015 Decision :The Committee noted that information called for from the firm is awaited. The

2

Committee accordingly decided await the reply and deferred the case.

4 Case No.:6/19/82- ALC4/2014
Party Name:BIO-TECH OPHTHALMICS PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01494/AM15/
RLA File :08/24/040/00093/AM13/
Lic.No/Date:0810112710 18.06.2012 Defer date: 27.11.2015
Decision :The Committee in light of written comments of DoP vide O.M.No.35011/19/2015- PI(Norms) dated 12.6.2015 uploaded end of these minutes decided to call for information from the firm and deferred the case.

5

Case No.:4/4/82-ALC4/2013 Party

Name:SABERO ORGANICS GUJARAT LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00045/AM14/
RLA File :03/95/040/00880/AM13/
Lic.No/Date:0310724136 14.02.2013 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemical).

6 Case No.:37/1/82- ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/01395/AM13/
RLA File :07/24/040/00487/AM13/
Lic.No/Date:0710093719 15.02.2013

Decision : The Committee decided to ratify norms for the export Tenofovir Disoproxil Fumarate product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-PI(Norms) dated 13.10.2015, uploaded along with 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.

7 Case No.:79/1/82- ALC4/2013
Party Name:STERICAT GUTSTRINGS PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01437/AM13/
RLA File :05/24/040/00420/AM13/
Lic.No/Date:0510346353 18.02.2013 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Petrochemicals).

8 Case No.:20/7/82- ALC4/2014
Party Name:DR REDDYS Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00664/AM15/
RLA File :09/24/040/00041/AM14/
Lic.No/Date:0910056000 15.05.2013 Defer date 27.11.2015 Decision : The Committee noted that information called for from the firm is awaited. The Committee accordingly decided await the reply and defer the case.

9 Case No.:211/10/82- ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File RLA File Lic.No/Date:0710095520

3

:01/82/050/00394/AM14/
:07/24/040/00037/AM14/
22.05.2013 Decision : The Committee decided to ratify norms for the export Tenofovir Disoproxil Fumarate product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-PI(Norms) dated 13.10.2015, uploaded along with 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.

10 Case No.:210/10/82- ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/00393/AM14/
RLA File :07/24/040/00034/AM14/
Lic.No/Date:0710095553 23.05.2013

Decision : The Committee decided to ratify norms for the export Tenofovir Disoproxil Fumarate product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-PI(Norms) dated 13.10.2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1.
RA concerned may take necessary action as per decision of NC.

11 Case No.:1/10/82- ALC4/2013
Party Name:MICRO LABS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00184/AM14/
RLA File :07/24/040/00111/AM14/
Lic.No/Date:0710097180 30.07.2013 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DoP.

12 Case No.:31/4/82- ALC4/2014
Party Name:UNIVERSAL BIOFUELS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00279/AM15/
RLA File :09/24/040/00155/AM14/
Lic.No/Date:0910056959 31.07.2013 Defer date 27.11.2015 DC&PC(Chemicals).

13

Case No.:45/14/82-

ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Approved HQ File :01/82/050/00630/AM14/
RLA File :07/24/040/00137/AM14/
Lic.No/Date:0710097392 06.08.2013

Date:28.10.2015

Decision : The Committee decided to ratify norms for the export product Tenofovir Disoproxil fumarate based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-PI (Norms) dated 13.10.2015 , uploaded along with 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.

14 Case No.:9/30/83- ALC1/2013
Party Name:STERICON PHARMA PVT.LTD., Meet No/Date:11/82- ALC4/2015 Status: Deferred

4

28.10.2015 HQ File :01/83/050/00471/AM14/
RLA File :07/24/040/00152/AM14/
Lic.No/Date:0710097668 22.08.2013 Defer date 27.11.2015 Decision : The Committee decided to send copy of application to DoP and deferred the case.

15 Case No.:17/4/82- ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00056/AM16/
RLA File :05/23/040/00211/AM14/
Lic.No/Date:0510364363 04.09.2013 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

16 Case No.:36/19/82- ALC4/2013
Party Name:SOHAM ORGANICS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00981/AM14/
RLA File :31/83/040/00124/AM14/
Lic.No/Date:3110060943 29.10.2013 Defer date 27.11.2015

17 Case No.:140/23/82- ALC4/2013
Party Name:UNITED PHOSPHORUS LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01187/AM14/
RLA File :03/95/040/00495/AM14/
Lic.No/Date:0310758627 21.11.2013 Defer date 27.11.2015 DC&PC(Chemicals).

18 Case No.:101/23/82- ALC4/2013
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/01148/AM14/
RLA File :07/24/040/00269/AM14/
Lic.No/Date:0710099923 25.11.2013

Decision : The Committee decided to ratify norms for the export Tenofovir Disoproxil Fumarate product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-PI(Norms) dated 13.10.2015, uploaded along with 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.

19 Case No.:181/3/82- ALC4/2014
Party Name:AKZO NOBEL INDIA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00185/AM15/
RLA File :02/24/040/00053/AM14/
Lic.No/Date:0210198392 02.01.2014

Decision : The Committee decided to ratify norms for the export product Trigonox - EHP based

5

on the recommendation of D/o C&PC, U.O. No.14010/55/2010-Ch-II dated 21.10.2015, uploaded along with 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.

20 Case No.:192/3/82- ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00196/AM15/
RLA File :09/24/040/00513/AM14/
Lic.No/Date:0910058896 10.01.2014 Defer date 27.11.2015 Decision :The Committee decided to send copy of application to DoP and deferred the case.

21 Case No.:208/3/82- ALC4/2014
Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00212/AM15/
RLA File :09/24/040/00515/AM14/
Lic.No/Date:0910059017 22.01.2014 Defer date 27.11.2015 DC&PC(Chemicals).

22 Case No.:12/21/82- ALC4/2013
Party Name:KUDOS CHEMIE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01042/AM14/
RLA File :22/21/040/00096/AM14/
Lic.No/Date:2210014544 23.01.2014 Defer date 27.11.2015 Committee accordingly decided to await the reply and defer the case.

23 Case No.:187/3/82- ALC4/2014
Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00191/AM15/
RLA File :05/23/040/00413/AM14/
Lic.No/Date:0510376990 24.01.2014 Defer date 27.11.2015

24 Case No.:108/3/82- ALC4/2014
Party Name:CROPNOSYS (INDIA) PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00112/AM15/
RLA File :03/94/040/00908/AM14/
Lic.No/Date:0310767733 24.01.2014 Defer date 27.11.2015 DC&PC(Chemicals).

25 Case No.:44/4/82- ALC4/2014
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred

6

HQ File :01/82/050/00292/AM15/
RLA File :31/83/040/00199/AM14/
Lic.No/Date:3110062387 30.01.2014 Defer date 27.11.2015 Decision :Since both the export and import items have the same description and chemical compound, the Committee decided that while fixing wastage norms it is necessary to specify the purity of import and export items in the comments of each case. DCPC may accordingly furnish revised recommendation. Accordingly, the case was deferred.

26 Case No.:177/3/82- ALC4/2014
Party Name:INDO AMINES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00181/AM15/
RLA File :03/94/040/00958/AM14/
Lic.No/Date:0310768616 30.01.2014 Defer date 27.11.2015 DC&PC(Chemicals).

27 Case No.:165/3/82- ALC4/2014
Party Name:MANGALAM ORGANICS LIMITED. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00169/AM15/
RLA File :03/94/040/00448/AM14/
Lic.No/Date:0310768928 03.02.2014 Defer date 27.11.2015 DC&PC(Chemicals).

28 Case No.:86/3/82- ALC4/2014
Party Name:AKZO NOBEL INDIA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00090/AM15/
RLA File :02/24/040/00197/AM14/
Lic.No/Date:0210200380 21.02.2014

Decision : The Committee decided to ratify norms for the export product Trigonox - EHP based on the recommendation of D/o C&PC, U.O. No.14010/55/2010-Ch-II dated 21.10.2015, uploaded along with 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.

29 Case No.:45/19/82- ALC4/2014
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01533/AM15/
RLA File :09/24/040/00600/AM14/
Lic.No/Date:0910059428 26.02.2014 Defer date 27.11.2015

30 Case No.:58/6/82- ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00460/AM15/
RLA File :03/94/040/00797/AM14/
Lic.No/Date:0310772503 28.02.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

7

31 Case No.:106/3/82- ALC4/2014
Party Name:PERFECT VITAMINS PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00110/AM15/
RLA File :03/95/040/00960/AM14/
Lic.No/Date:0310772411 28.02.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

32 Case No.:46/6/82- ALC4/2014
Party Name:NAPROD LIFE SCIENCES PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00448/AM15/
RLA File :03/95/040/00986/AM14/
Lic.No/Date:0310772962 04.03.2014 Defer date 27.11.2015

33 Case No.:34/6/82- ALC4/2014
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00436/AM15/
RLA File :03/94/040/00973/AM14/
Lic.No/Date:0310773112 05.03.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DoP

34 Case No.:58/4/82- ALC4/2014
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00306/AM15/
RLA File :22/24/040/00100/AM14/
Lic.No/Date:2210014694 14.03.2014 Defer date 27.11.2015

35 Case No.:57/3/82- ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00061/AM15/
RLA File :05/23/040/00506/AM14/
Lic.No/Date:0510382053 18.03.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

36 Case No.:42/4/82- ALC4/2014
Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00290/AM15/
RLA File :05/24/040/00480/AM14/
Lic.No/Date:0510382032 18.03.2014

Decision : The Committee decided to ratify norms for the export product Mucinex Fast-Max based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/01/2015- PI(Norms) dated 10.09.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

8

37 Case No.:51/5/82- ALC4/2014
Party Name:JINDAL DRUGS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00368/AM15/
RLA File :03/94/040/01098/AM14/
Lic.No/Date:0310776087 27.03.2014 Defer date 27.11.2015 Decision :The Committee decided to send a copy of application to PC Division and deferred the case.

38 Case No.:127/6/82- ALC4/2014
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00529/AM15/
RLA File :31/83/040/00232/AM14/
Lic.No/Date:3110063312 28.03.2014 Defer date 27.11.2015 Decision : Since both the export and import items have the same description and chemical compound, the Committee decided that while fixing wastage norms it is necessary to specify the purity of import and export items in the comments of each case. DCPC may accordingly furnish revised recommendation. Accordingly, the case was deferred.

39 Case No.:51/6/82- ALC4/2014
Party Name:PERFECT INDUSTRIES PRIVATE LIMITED. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00453/AM15/
RLA File :03/95/040/01054/AM14/
Lic.No/Date:0310776759 02.04.2014 Defer date 27.11.2015 DC&PC(Chemicals).

40 Case No.:50/6/82- ALC4/2014
Party Name:V & V PHARMA INDUSTRIES Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00452/AM15/
RLA File :03/95/040/01061/AM14/
Lic.No/Date:0310776760 02.04.2014 Defer date 27.11.2015 DC&PC(Chemicals).

41 Case No.:52/6/82- ALC4/2014
Party Name:UPL LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Deferred HQ File :01/82/050/00454/AM15/
RLA File :03/95/040/01043/AM14/
Lic.No/Date:0310776594 01.04.2014 Defer date 27.11.2015 Decision :It was decided to defer the case for want of comments of Department of Chemicals..

42 Case No.:22/10/82- ALC4/2014
Party Name:OGENE SYSTEMS INDIA PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00936/AM15/
RLA File :09/24/040/00669/AM14/
Lic.No/Date:0910059697 03.04.2014 Defer date 27.11.2015

9

Decision: The Committee decided to defer the case for want of comments of DC&PC(Chemicals).

43 Case No.:20/6/82- ALC4/2014
Party Name:ADISHANK CHEMICALS PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00422/AM15/
RLA File :03/94/040/01140/AM14/
Lic.No/Date:0310777786 09.04.2014 Defer date 27.11.2015 DC&PC(Chemicals).

44

Case No.:1/2/82-ALC4/2014 Party

Name:CADILA HEALTHCARE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00003/AM15/
RLA File :08/24/040/00008/AM15/
Lic.No/Date:0810130534 11.04.2014 Defer date 27.11.2015 Decision : The Committee decided to send a copy of application to DoP and deferred the case.

45 Case No.:32/5/82- ALC4/2014
Party Name:EMCURE PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00349/AM15/
RLA File :31/83/040/00008/AM15/
Lic.No/Date:3110063481 11.04.2014 Defer date 27.11.2015

46 Case No.:34/5/82- ALC4/2014
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00351/AM15/
RLA File :34/24/040/00003/AM15/
Lic.No/Date:3410039800 15.04.2014 Defer date 27.11.2015

47 Case No.:48/10/82- ALC4/2014
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00962/AM15/
RLA File :09/24/040/00650/AM14/
Lic.No/Date:0910059803 22.04.2014 Defer date 27.11.2015

48 Case No.:183/6/82- ALC4/2014
Party Name:TIDE INDUSTRIES Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00585/AM15/
RLA File :34/24/040/00005/AM15/
Lic.No/Date:3410039854 23.04.2014 Defer date 27.11.2015

10

DC&PC(Chemicals).

49

Case No.:6/5/82-ALC4/2014 Party

Name:UNITED BIOTECH PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00323/AM15/
RLA File :05/24/040/00034/AM15/
Lic.No/Date:0510384810 24.04.2014 Defer date 27.11.2015

50 Case No.:64/5/82- ALC4/2014
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00381/AM15/
RLA File :03/95/040/00026/AM15/
Lic.No/Date:0310779504 25.04.2014 Defer date 27.11.2015 DC&PC(Chemicals).

51 Case No.:41/10/82- ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00955/AM15/
RLA File :09/24/040/00028/AM15/
Lic.No/Date:0910059852 25.04.2014 Defer date27.11.2015

52 Case No.:46/10/82- ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00960/AM15/
RLA File :09/24/040/00029/AM15/
Lic.No/Date:0910059853 25.04.2014 Defer date 27.11.2015

53 Case No.:51/10/82- ALC4/2014
Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00965/AM15/
RLA File :09/24/040/00039/AM15/
Lic.No/Date:0910059887 28.04.2014 Defer date 27.11.2015

54 Case No.:61/10/82- ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00975/AM15/
RLA File :03/95/040/00913/AM14/
Lic.No/Date:0310779831 29.04.2014 Defer date 27.11.2015

11

DC&PC(Chemicals).

55 Case No.:237/6/82- ALC4/2014
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00639/AM15/
RLA File :17/24/040/00002/AM15/
Lic.No/Date:1710005803 05.05.2014 Defer date 27.11.2015

56 Case No.:54/5/82- ALC4/2014
Party Name:NEW ALLIANCE DYE-CHEM PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00371/AM15/
RLA File :03/95/040/00077/AM15/
Lic.No/Date:0310780621 05.05.2014 Defer date 27.11.2015

57 Case No.:44/10/82- ALC4/2014
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00958/AM15/
RLA File :09/24/040/00053/AM15/
Lic.No/Date:0910060088 13.05.2014 Defer date 27.11.2015

58 Case No.:59/10/82- ALC4/2014
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00973/AM15/
RLA File :09/24/040/00045/AM15/
Lic.No/Date:0910060084 13.05.2014 Defer date 27.11.2015

59 Case No.:13/2/82- ALC4/2015
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00028/AM16/
RLA File :05/23/040/00080/AM15/
Lic.No/Date:0510387607 28.05.2014 Defer date 27.11.2015 DC&PC(Chemicals).

60 Case No.:38/8/82- ALC4/2014
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00702/AM15/
RLA File :09/24/040/00108/AM15/
Lic.No/Date:0910060258 28.05.2014 Defer date 27.11.2015 Decision :The committee decided to send a copy of application to DoP and deferred the case.

12

61 Case No.:51/8/82- ALC4/2014
Party Name:PVS LABORATORIES LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00715/AM15/
RLA File :09/24/040/00022/AM15/
Lic.No/Date:0910060267 28.05.2014 Defer date 27.11.2015

62 Case No.:165/6/82- ALC4/2014
Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00567/AM15/
RLA File :02/24/040/00037/AM15/
Lic.No/Date:0210203844 05.06.2014 Defer date 27.11.2015 Decision : The committee decided to send a copy of application to PC Division and deferred the case.

63 Case No.:106/8/82- ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00770/AM15/
RLA File :03/94/040/00131/AM15/
Lic.No/Date:0310785223 12.06.2014 Defer date 27.11.2015 DC&PC(Chemicals).

64 Case No.:60/10/82- ALC4/2014
Party Name:BIO-TECH OPHTHALMICS PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00974/AM15/
RLA File :08/24/040/00116/AM15/
Lic.No/Date:0810132332 13.06.2014 Defer date 27.11.2015 Decision : The Committee in light of written comments of DoP vide O.M.No.35011/19/2015- PI(Norms) dated 12.6.2015 uploaded end of these minutes decided to call for information from the firm and deferred the case.

65 Case No.:77/8/82- ALC4/2014
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00741/AM15/
RLA File :03/94/040/00196/AM15/
Lic.No/Date:0310785501 17.06.2014 Defer date 27.11.2015 DC&PC(Chemicals).

66 Case No.:30/8/82- ALC4/2014
Party Name:INDIAN IMMUNOLOGICALS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00694/AM15/
RLA File :09/24/040/00135/AM15/
Lic.No/Date:0910060470 17.06.2014

Decision : The Committee decided to ratify norms for the export product Raksharab Rabies Vaceine Veterinary 10 ML based on the recommendation of DBT forwarded vide letter

13

No.BT/IL/05/340/2011 PID dated 27.7.2015 , uploaded along with 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.

67 Case No.:20/8/82- ALC4/2014
Party Name:SRINI PHARMACEUTICALS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00684/AM15/
RLA File :09/24/040/00139/AM15/
Lic.No/Date:0910060467 17.06.2014 Defer date 27.11.2015

68 Case No.:19/8/82- ALC4/2014
Party Name:HETERO LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00683/AM15/
RLA File :09/24/040/00153/AM15/
Lic.No/Date:0910060486 18.06.2014 Defer date 27.11.2015

69 Case No.:83/18/82- ALC4/2014
Party Name:INDIAN IMMUNOLOGICALS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:approved HQ File :01/82/050/01449/AM15/
RLA File :09/24/040/00136/AM15/
Lic.No/Date:0910060517 20.06.2014

Decision : The Committee decided to ratify norms for the export product Raksharab Rabies Vaceine based on the recommendation of DBT forwarded vide letter No.BT/IL/05/340/2011 PID dated 13.06.2015 and e-mail communication dated 02.07.2015, uploaded along with 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.:52/8/82- ALC4/2014
Party Name:LAKE CHEMICALS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00716/AM15/
RLA File :07/24/040/00096/AM15/
Lic.No/Date:0710105418 26.06.2014 Defer date 27.11.2015 Decision :The Committee decided to send a copy of application to DoP and deferred the case.

71 Case No.:63/10/82- ALC4/2014
Party Name:SAVVY CARE & COSMETICS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00977/AM15/
RLA File :03/95/040/00254/AM15/
Lic.No/Date:0310786114 27.06.2014 Defer date 27.11.2015

72 Case No.:199/6/82- ALC4/2014
Party Name:H.J.AROCHEM PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File RLA File Lic.No/Date:0810132520 Defer date

14

:01/82/050/00601/AM15/
:08/24/040/00569/AM14/
30.06.2014 27.11.2015

73 Case No.:202/6/82- ALC4/2014
Party Name:FORACE POLYMERS (P) LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00604/AM15/
RLA File :05/23/040/00139/AM15/
Lic.No/Date:0510389232 01.07.2014 Defer date 27.11.2015 DC&PC(Petrochemicals)

74 Case No.:83/8/82- ALC4/2014
Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00747/AM15/
RLA File :03/95/040/00109/AM15/
Lic.No/Date:0310786418 04.07.2014 Defer date 27.11.2015

75 Case No.:62/10/82- ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00976/AM15/
RLA File :03/95/040/00271/AM15/
Lic.No/Date:0310786523 08.07.2014 Defer date 27.11.2015 DC&PC(Petrochemicals)

76 Case No.:44/15/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01331/AM15/
RLA File :09/24/040/00192/AM15/
Lic.No/Date:0910060635 09.07.2014 Defer date 27.11.2015 DC&PC(Petrochemicals)

77 Case No.:200/6/82- ALC4/2014
Party Name:PANACEA BIOTEC LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00602/AM15/
RLA File :05/24/040/00168/AM15/
Lic.No/Date:0510389734 16.07.2014 Defer date 27.11.2015 Decision : The Committee decided to send a copy of application to DBT and deferred the case.

78 Case No.:72/10/82- ALC4/2014
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00986/AM15/
RLA File :07/24/040/00112/AM15/
Lic.No/Date:0710105884 18.07.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

15

79 Case No.:25/15/82- ALC4/2014
Party Name:SHIVAM OILS & PROTEINS INDUSTRY, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01312/AM15/
RLA File :56/24/040/00019/AM15/
Lic.No/Date:5610004338 22.07.2014 Defer date 27.11.2015

80 Case No.:71/8/82- ALC4/2014
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00735/AM15/
RLA File :34/24/040/00099/AM15/
Lic.No/Date:3410040394 23.07.2014 Defer date 27.11.2015

81 Case No.:14/9/82- ALC4/2014
Party Name:GLAND PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00811/AM15/
RLA File :09/24/040/00219/AM15/
Lic.No/Date:0910060797 04.08.2014

Decision : The Committee decided to ratify norms for the export product pre-filled syringes based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/164/2015- PI(Norms) dated 19.10.2015 , uploaded along with 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.

82 Case No.:66/8/82- ALC4/2014
Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00730/AM15/
RLA File :05/24/040/00205/AM15/
Lic.No/Date:0510390158 06.08.2014 Defer date 27.11.2015

83 Case No.:37/9/82- ALC4/2014
Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00834/AM15/
RLA File :05/23/040/00198/AM15/
Lic.No/Date:0510390634 21.08.2014

Decision : The Committee in light of comment of the representative of D/o Pharmaceuticals in the meeting decided to ratify ad-hoc norms net to net basis without wastage under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

84 Case No.:36/9/82- ALC4/2014
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved

16

HQ File :01/82/050/00833/AM15/
RLA File :08/24/040/00202/AM15/
Lic.No/Date:0810133096 25.08.2014 Defer date
Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/306/2015-PI-(Norms) dated October 2015, uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

85 Case No.:17/15/82- ALC4/2014
Party Name:SURVIVAL TECHNOLOGIES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01304/AM15/
RLA File :03/95/040/00428/AM15/
Lic.No/Date:0310788314 25.08.2014 Defer date 27.11.2015

86 Case No.:37/7/82- ALC4/2015
Party Name:DR J PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00642/AM16/
RLA File :31/83/040/00125/AM15/
Lic.No/Date:3110064792 28.08.2014 Defer date 27.11.2015

87 Case No.:254/13/82- ALC4/2014
Party Name:SEQUENT SCIENTIFIC LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01257/AM15/
RLA File :03/95/040/00459/AM15/
Lic.No/Date:0310788513 28.08.2014 Defer date 27.11.2015

88 Case No.:217/13/82- ALC4/2014
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01220/AM15/
RLA File :03/94/040/00494/AM15/
Lic.No/Date:0310788620 02.09.2014 Defer date 27.11.2015

89 Case No.:22/13/82- ALC4/2014
Party Name:MANGALAM ORGANICS LIMITED (FORMERLY DUJODWALA Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01025/AM15/
RLA File :03/95/040/00379/AM15/
Lic.No/Date:0310788810 05.09.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

90 Case No.:196/13/82- ALC4/2014
Party Name:KOPRAN LIMITED Meet No/Date:11/82- ALC4/2015 Status: Deferred

17

28.10.2015 HQ File :01/82/050/01199/AM15/
RLA File :03/94/040/00545/AM15/
Lic.No/Date:0310788934 09.09.2014 Defer date 27.11.2015

91 Case No.:201/13/82- ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01204/AM15/
RLA File :03/94/040/00499/AM15/
Lic.No/Date:0310788928 09.09.2014 Defer date 27.11.2015

92 Case No.:27/13/82- ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01030/AM15/
RLA File :03/95/040/00494/AM15/
Lic.No/Date:0310788943 09.09.2014 Defer date 27.11.2015 Decision :The Committee decided to send copy of application to PC Division and deferred the case.

93 Case No.:23/13/82- ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01026/AM15/
RLA File :03/95/040/00496/AM15/
Lic.No/Date:0310788911 09.09.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

94 Case No.:250/13/82- ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01253/AM15/
RLA File :03/95/040/00490/AM15/
Lic.No/Date:0310788892 09.09.2014 Defer date 27.11.2015 DC&PC(Chemicals/Petrochemicals)/

95 Case No.:53/13/82- ALC4/2014
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01056/AM15/
RLA File :09/24/040/00240/AM15/
Lic.No/Date:0910060930 10.09.2014 Defer date 27.11.2015

96 Case No.:64/13/82- ALC4/2014
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved

18

HQ File :01/82/050/01067/AM15/
RLA File :09/24/040/00247/AM15/
Lic.No/Date:0910060929 10.09.2014

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/85/2015-PI-(Norms) dated Sept.2015 , uploaded along with 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.

97 Case No.:197/13/82- ALC4/2014
Party Name:KOPRAN LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01200/AM15/
RLA File :03/94/040/00547/AM15/
Lic.No/Date:0310789054 11.09.2014 Defer date 27.11.2015

98 Case No.:45/15/82- ALC4/2014
Party Name:GLAND PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/01332/AM15/
RLA File :09/24/040/00305/AM15/
Lic.No/Date:0910060957 12.09.2014

Decision : The Committee decided to ratify norms for the export product pre-filled syringes based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/110/2015- PI(Norms) dated 19.10.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

99

Case No.:4/8/82-ALC4/2014 Party Name:HONOUR LAB

LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00668/AM15/
RLA File :09/24/040/00318/AM15/
Lic.No/Date:0910060963 12.09.2014 Defer date 27.11.2015

100 Case No.:6/8/82- ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00670/AM15/
RLA File :09/24/040/00314/AM15/
Lic.No/Date:0910060964 12.09.2014 Defer date 27.11.2015

101 Case No.:8/8/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00672/AM15/
RLA File :09/24/040/00315/AM15/
Lic.No/Date:0910060966 12.09.2014 Defer date 27.11.2015

102 Case No.:28/13/82- Party Name:TITAN Meet No/Date:11/82- Status:

19

ALC4/2014
LABORATORIES PVT. LTD. ALC4/2015 28.10.2015 Deferred
HQ File :01/82/050/01031/AM15/
RLA File :03/95/040/00398/AM15/
Lic.No/Date:0310789099 12.09.2014 Defer date 27.11.2015

103 Case No.:188/13/82- ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01191/AM15/
RLA File :03/94/040/00102/AM15/
Lic.No/Date:0310789322 17.09.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DCPC.

104 Case No.:57/13/82- ALC4/2014
Party Name:HELLO PAINTS (P) LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01060/AM15/
RLA File :05/23/040/00277/AM15/
Lic.No/Date:0510391246 19.09.2014 Defer date 27.11.2015 DC&PC(Chemicals)

105 Case No.:59/13/82- ALC4/2014
Party Name:HELLO PAINTS (P) LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01062/AM15/
RLA File :05/23/040/00276/AM15/
Lic.No/Date:0510391245 19.09.2014 Defer Date:27.11.2015 DC&PC(Chemicals)

106 Case No.:125/8/82- ALC4/2014
Party Name:HETERO DRUGS LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00789/AM15/
RLA File :09/24/040/00345/AM15/
Lic.No/Date:0910061000 19.09.2014 Defer date 27.11.2015

107 Case No.:9/15/82- ALC4/2014
Party Name:VIRCHOW BIOTECH PV T LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01296/AM15/
RLA File :09/24/040/00327/AM15/
Lic.No/Date:0910061001 19.09.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DBT.

108 Case No.:60/15/82- ALC4/2014
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01347/AM15/
RLA File :31/83/040/00136/AM15/
Lic.No/Date:3110064915 22.09.2014 Defer date 27.11.2015

20

DC&PC(Chemicals)

109 Case No.:128/8/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00792/AM15/
RLA File :09/24/040/00341/AM15/
Lic.No/Date:0910061003 22.09.2014 Defer date 27.11.2015

110 Case No.:129/8/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00793/AM15/
RLA File :09/24/040/00338/AM15/
Lic.No/Date:0910061004 22.09.2014 Defer date 27.11.2015

111 Case No.:17/13/82- ALC4/2014
Party Name:GRASIM INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01020/AM15/
RLA File :34/24/040/00155/AM15/
Lic.No/Date:3410040570 23.09.2014 Defer date 27.11.2015 DC&PC(Chemicals)

112 Case No.:115/13/82- ALC4/2014
Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01118/AM15/
RLA File :02/24/040/00097/AM15/
Lic.No/Date:0210205008 23.09.2014 Defer date 27.11.2015 DC&PC(Chemicals)

113 Case No.:74/13/82- ALC4/2014
Party Name:CONSTECH ENTERPRISES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 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 27.11.2015 DC&PC(Chemicals)

114 Case No.:9/2/82- ALC4/2015
Party Name:JUBILANT GENERICS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00024/AM16/
RLA File :05/23/040/00261/AM15/
Lic.No/Date:0510391358 26.09.2014 Defer date 27.11.2015

21

115 Case No.:21/13/82- ALC4/2014
Party Name:JUBILANT GENERICS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01024/AM15/
RLA File :05/23/040/00260/AM15/
Lic.No/Date:0510391357 26.09.2014 Defer date 27.11.2015

116 Case No.:19/13/82- ALC4/2014
Party Name:SANO MEDICAL KITS PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01022/AM15/
RLA File :04/24/040/00171/AM15/
Lic.No/Date:0410159504 29.09.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DBT.

117 Case No.:177/13/82- ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01180/AM15/
RLA File :03/94/040/00586/AM15/
Lic.No/Date:0310789849 30.09.2014 Defer date 27.11.2015 DC&PC(Chemicals)

118 Case No.:15/13/82- ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01018/AM15/
RLA File :34/24/040/00161/AM15/
Lic.No/Date:3410040594 30.09.2014 Defer date 27.11.2015 DC&PC(Chemicals)

119 Case No.:29/18/82- ALC4/2014
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01395/AM15/
RLA File :03/94/040/00596/AM15/
Lic.No/Date:0310789917 01.10.2014 Defer date 27.11.2015 DC&PC(Chemicals)

120 Case No.:19/1/82- ALC4/2015
Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01545/AM15/
RLA File :03/94/040/00594/AM15/
Lic.No/Date:0310789922 01.10.2014 Defer date 27.11.2015 DC&PC(Chemicals)

121 Case No.:77/13/82- ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred

22

HQ File :01/82/050/01080/AM15/
RLA File :04/24/040/00164/AM15/
Lic.No/Date:0410159520 01.10.2014 Defer date 27.11.2015

122 Case No.:160/13/82- ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01163/AM15/
RLA File :03/94/040/00544/AM15/
Lic.No/Date:0310789976 07.10.2014 Defer date 27.11.2015 DC&PC(Chemicals)

123 Case No.:5/9/82- ALC4/2014
Party Name:HETERO DRUGS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00802/AM15/
RLA File :09/24/040/00362/AM15/
Lic.No/Date:0910061060 07.10.2014 Defer date 27.11.2015

124 Case No.:35/13/82- ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01038/AM15/
RLA File :05/23/040/00218/AM15/
Lic.No/Date:0510391491 08.10.2014 Defer date 27.11.2015 DC&PC(Chemicals)

125 Case No.:46/15/82- ALC4/2014
Party Name:PORUS LABORATORIES PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01333/AM15/
RLA File :09/24/040/00372/AM15/
Lic.No/Date:0910061072 09.10.2014 Defer date 27.11.2015 DC&PC(Chemicals).

126 Case No.:76/13/82- ALC4/2014
Party Name:CAPLIN POINT LABORATORIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01079/AM15/
RLA File :04/24/040/00163/AM15/
Lic.No/Date:0410159566 13.10.2014 Defer date 27.11.2015

127 Case No.:140/13/82- ALC4/2014
Party Name:MICRO LABS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/01143/AM15/
RLA File :07/24/040/00228/AM15/
Lic.No/Date:0710106816 13.10.2014

Decision : The Committee decided to ratify norms for the export product Amoxicillin based on

23

the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/11/2015-PI(Norms) dated 23.10.2015 , uploaded along with 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.

128 Case No.:184/13/82- ALC4/2014
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01187/AM15/
RLA File :03/94/040/00675/AM15/
Lic.No/Date:0310790237 14.10.2014 Defer date 27.11.2015

129 Case No.:272/13/82- ALC4/2014
Party Name:SAIBABA SURFACTANTS (P) LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01275/AM15/
RLA File :08/24/040/00249/AM15/
Lic.No/Date:0810133587 14.10.2014 Defer date 27.11.2015

130 Case No.:114/9/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00911/AM15/
RLA File :09/24/040/00386/AM15/
Lic.No/Date:0910061094 15.10.2014 Defer date 27.11.2015

131 Case No.:42/15/82- ALC4/2014
Party Name:PVS AGRO VET Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01329/AM15/
RLA File :09/24/040/00246/AM15/
Lic.No/Date:0910061105 16.10.2014 Defer date 27.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/14/2015-PI(Norms) dated 08.06.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

132 Case No.:13/15/82- ALC4/2014
Party Name:VINS BIOPRODUCTS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/01300/AM15/
RLA File :09/24/040/00290/AM15/
Lic.No/Date:0910061111 16.10.2014

recommendation of DBT forwarded vide O.M. No.BT/IL/05/410/2015-PID dated 10.3.2015 , uploaded along with 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.

24

133 Case No.:136/13/82- ALC4/2014
Party Name:DHANUKA LABORATORIES LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/01139/AM15/
RLA File :05/23/040/00309/AM15/
Lic.No/Date:0510391614 17.10.2014

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/426/2015-PI(Norms) date 14.10.2015 , uploaded along with 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.

134 Case No.:154/13/82- ALC4/2014
Party Name:GEM AROMATICS PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01157/AM15/
RLA File :03/94/040/00680/AM15/
Lic.No/Date:0310790351 17.10.2014 Defer date 27.11.2015 DC&PC(Chemicals/Petrochemicals)

135 Case No.:124/13/82- ALC4/2014
Party Name:PANACEA BIOTEC LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01127/AM15/
RLA File :05/24/040/00319/AM15/
Lic.No/Date:0510391623 17.10.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DBT.

136 Case No.:139/13/82- ALC4/2014
Party Name:RECKITT BENCKISER HEALTHCARE INDIA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/01142/AM15/ RLA File :05/24/040/00325/AM15/ Lic.No/Date:0510391645 20.10.2014

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/01/2015-PI(Norms) date 10.09.2015 , uploaded along with 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.

137 Case No.:152/13/82- ALC4/2014
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/01155/AM15/
RLA File :03/94/040/00692/AM15/
Lic.No/Date:0310790392 20.10.2014

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/12/2015-PI(Norms) date 08.06.2015 , uploaded along with 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.:78/10/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File RLA File Lic.No/Date:0910061130 Defer date

25

:01/82/050/00992/AM15/
:09/24/040/00393/AM15/
22.10.2014 27.11.2015

139 Case No.:80/10/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00994/AM15/
RLA File :09/24/040/00394/AM15/
Lic.No/Date:0910061132 22.10.2014 Defer date 27.11.2015 Pharmaceuticals vide O.M. 35011/145/2015-PI-(Norms) dt. Sept. 2015, uploaded along with

140 Case No.:81/10/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00995/AM15/
RLA File :09/24/040/00407/AM15/
Lic.No/Date:0910061133 22.10.2014 Defer date 27.11.2015

141 Case No.:171/13/82- ALC4/2014
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01174/AM15/
RLA File :03/95/040/00588/AM15/
Lic.No/Date:0310790482 22.10.2014 Defer Date:27.11.2015

142 Case No.:172/13/82- ALC4/2014
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01175/AM15/
RLA File :03/95/040/00362/AM15/
Lic.No/Date:0310790480 22.10.2014 Defer date 27.11.2015 DC&PC(Chemicals).

143 Case No.:170/13/82- ALC4/2014
Party Name:SAVLA CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01173/AM15/
RLA File :03/95/040/00619/AM15/
Lic.No/Date:0310790490 22.10.2014 Defer date 27.11.2015 DC&PC(Chemicals).

144 Case No.:110/13/82- ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01113/AM15/
RLA File :34/24/040/00188/AM15/
Lic.No/Date:3410040635 22.10.2014 Defer date 27.11.2015

26

DC&PC(Chemicals).

145 Case No.:36/18/82- ALC4/2014
Party Name:APEX PHARMA, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/01402/AM15/
RLA File :03/94/040/00551/AM15/
Lic.No/Date:0310790531 27.10.2014

Decision : The Committee decided withdraw this case as it has already been approved in NC.3 meeting no. 9/82-ALC4/2015 dated 30.09.2015.

146 Case No.:83/10/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00997/AM15/
RLA File :09/24/040/00402/AM15/
Lic.No/Date:0910061139 27.10.2014 Defer date 27.11.2015 Decision :The committee decided to send a copy of application to DoP and deferred the case.

147 Case No.:87/13/82- ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/01090/AM15/
RLA File :04/24/040/00196/AM15/
Lic.No/Date:0410159624 27.10.2014

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/6/2015-PI(Norms) dated Oct.2015, uploaded along with 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.

148 Case No.:86/10/82- ALC4/2014
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01000/AM15/
RLA File :34/24/040/00194/AM15/
Lic.No/Date:3410040644 30.10.2014 Defer date 27.11.2015 DC&PC(Chemicals)

149 Case No.:104/13/82- ALC4/2014
Party Name:AMOL PHARMACEUTICALS PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01107/AM15/
RLA File :13/24/040/00029/AM15/
Lic.No/Date:1310047687 05.11.2014 Defer date 27.11.2015 Decision :The Committee decided to send a copy of application to DoP and deferred the case.

150 Case No.:266/13/82- ALC4/2014
Party Name:ATUL LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File RLA File Lic.No/Date:0810133735 Defer date

27

:01/82/050/01269/AM15/
:08/24/040/00289/AM15/
05.11.2014 27.11.2015 Decision : The Committee decided to send a copy of application to PC Division and deferred the case.

151 Case No.:268/13/82- ALC4/2014
Party Name:ATUL LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01271/AM15/
RLA File :08/24/040/00283/AM15/
Lic.No/Date:0810133734 05.11.2014 Defer date 27.11.2015 Decision : The Committee decided to send a copy of application to PC Division and deferred the case.

152 Case No.:39/7/82- ALC4/2015
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00644/AM16/
RLA File :09/24/040/00371/AM15/
Lic.No/Date:0910061181 05.11.2014 Defer date 27.11.2015

153 Case No.:107/13/82- ALC4/2014
Party Name:SHIVA PHARMACHEM LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01110/AM15/
RLA File :34/24/040/00196/AM15/
Lic.No/Date:3410040655 05.11.2014 Defer date 27.11.2015 DC&PC(Chemicals)

154 Case No.:121/13/82- ALC4/2014
Party Name:AKZO NOBEL INDIA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/01124/AM15/
RLA File :02/24/040/00111/AM15/
Lic.No/Date:0210205126 07.11.2014

Decision : The Committee decided to ratify norms for the export product Trigonox - EHP based on the recommendation of D/o C&PC, U.O. No.14010/55/2010-Ch-II dated 21.10.2015, uploaded along with 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.

155 Case No.:23/15/82- ALC4/2014
Party Name:VENUS REMEDIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01310/AM15/
RLA File :22/24/040/00065/AM15/
Lic.No/Date:2210015115 07.11.2014 Defer date 27.11.2015

156 Case No.:265/13/82- ALC4/2014
Party Name:H.J.AROCHEM PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01268/AM15/
RLA File :08/24/040/00265/AM15/
Lic.No/Date:0810133768 10.11.2014 Defer date 27.11.2015

28

157 Case No.:114/13/82- ALC4/2014
Party Name:VIRDEV INTERMEDIATES PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01117/AM15/
RLA File :52/24/040/00042/AM15/
Lic.No/Date:5210041292 10.11.2014 Defer date 27.11.2015

158 Case No.:111/13/82- ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 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 27.11.2015 Decision : Reply dated 29.07.2015 to the deficiency letter has been received from the firm and send to Department of Ayush. The case is deferred for want of comments from the Department of Ayush.

159 Case No.:19/15/82- ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01306/AM15/
RLA File :04/24/040/00206/AM15/
Lic.No/Date:0410159706 11.11.2014 Defer date 27.11.2015

160 Case No.:20/15/82- ALC4/2014
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01307/AM15/
RLA File :04/24/040/00207/AM15/
Lic.No/Date:0410159705 11.11.2014 Defer date 27.11.2015

161 Case No.:112/13/82- ALC4/2014
Party Name:SOLARIS CHEMTECH INDUSTRIES LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/01115/AM15/
RLA File :34/24/040/00193/AM15/
Lic.No/Date:3410040672 11.11.2014

Decision : The Committee decided to ratify norms for the export product 4-Bromomethyl-2- biphenyl-carbonitrile based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/337/2015-PI(Norms) dated 1.4.2013, uploaded along with 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.

162 Case No.:61/18/82- ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred

29

HQ File :01/82/050/01427/AM15/
RLA File :34/24/040/00198/AM15/
Lic.No/Date:3410040676 11.11.2014 Defer date 27.11.2015 DC&PC(Chemicals/Petrochemicals)

163 Case No.:100/4/82- ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00139/AM16/
RLA File :17/24/040/00125/AM15/
Lic.No/Date:1710005978 12.11.2014 Defer date 27.11.2015 DC&PC(Chemicals)

164 Case No.:120/13/82- ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01123/AM15/
RLA File :05/23/040/00325/AM15/
Lic.No/Date:0510391947 12.11.2014 Defer date 27.11.2015 DC&PC(Chemicals)

165 Case No.:98/18/82- ALC4/2014
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/01464/AM15/
RLA File :07/24/040/00272/AM15/
Lic.No/Date:0710106948 12.11.2014

recommendation of PC, D/o Pharmaceuticals forwarded vide O.M. No.35011/296/2015- PI(Norms) dated 13.10.2015 , uploaded along with 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.

166 Case No.:77/18/82- ALC4/2014
Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01443/AM15/
RLA File :03/95/040/00629/AM14/
Lic.No/Date:0310790966 12.11.2014 Defer date 27.11.2015 DC&PC(Chemicals).

167 Case No.:65/18/82- ALC4/2014
Party Name:DEEPAK NITRITE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01431/AM15/
RLA File :34/24/040/00199/AM15/
Lic.No/Date:3410040677 13.11.2014 Defer date 27.11.2015 DC&PC(Chemicals)

168 Case No.:72/18/82- ALC4/2014
Party Name:J.B. CHEMICALS & Meet No/Date:11/82- ALC4/2015 Status: Deferred

30

PHARMACEUTICALS LIMITED 28.10.2015 HQ File :01/82/050/01438/AM15/
RLA File :03/94/040/00773/AM15/
Lic.No/Date:0310791044 13.11.2014 Defer date 27.11.2015

169 Case No.:42/18/82- ALC4/2014
Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01408/AM15/
RLA File :03/95/040/00628/AM14/
Lic.No/Date:0310791049 13.11.2014 Defer date 27.11.2015 DC&PC(Chemicals)

170 Case No.:65/15/82- ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 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 27.11.2015 Decision : Reply dated 29.07.2015 to the deficiency letter has been received from the firm and send to Department of Ayush. The case is deferred for want of comments from the Department of Ayush.

171 Case No.:119/13/82- ALC4/2014
Party Name:JUBILANT GENERICS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01122/AM15/
RLA File :05/23/040/00304/AM15/
Lic.No/Date:0510392008 14.11.2014 Defer date 27.11.2015

172 Case No.:23/18/82- ALC4/2014
Party Name:LAKELAND CHEMICALS (INDIA) LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/01389/AM15/
RLA File :03/95/040/00697/AM14/
Lic.No/Date:0310791253 20.11.2014

Decision : This case has already been approved in NC-09/AM-16. Accordingly decided to withdraw this case.

173 Case No.:52/15/82- ALC4/2014
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01339/AM15/
RLA File :09/24/040/00408/AM15/
Lic.No/Date:0910061280 20.11.2014 Defer date 27.11.2015

31

174 Case No.:34/18/82- ALC4/2014
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01400/AM15/
RLA File :03/94/040/00803/AM15/
Lic.No/Date:0310791303 21.11.2014 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DoP.

175 Case No.:16/18/82- ALC4/2014
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01382/AM15/
RLA File :03/94/040/00789/AM15/
Lic.No/Date:0310791300 21.11.2014 Defer date 27.11.2015 DC&PC(Chemicals).

176 Case No.:74/18/82- ALC4/2014
Party Name:ADESHWAR MEDITEX PVT. LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01440/AM15/
RLA File :03/94/040/00814/AM15/
Lic.No/Date:0310791373 25.11.2014 Defer date 27.11.2015 Decision : The Committee decided to send a copy of application to DC&PC(Petrochemicals) and defer the case.

177 Case No.:18/18/82- ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01384/AM15/
RLA File :03/94/040/00792/AM15/
Lic.No/Date:0310791374 25.11.2014 Defer date 27.11.2015 DC&PC(Chemicals)

178 Case No.:53/18/82- ALC4/2014
Party Name:CATAPHARMA CHEMICALS PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01419/AM15/
RLA File :31/83/040/00057/AM15/
Lic.No/Date:3110065095 25.11.2014 Defer date 27.11.2015 Decision : Since both the export and import items have the same description and chemical compound, the Committee decided that while fixing wastage norms it is necessary to specify the purity of import and export items in the comments of each case. DCPC may accordingly furnish revised recommendation. Accordingly, the case was deferred.

179 Case No.:15/2/82- ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00030/AM16/
RLA File :03/95/040/00639/AM15/
Lic.No/Date:0310791416 25.11.2014 Defer date 27.11.2015

32

180 Case No.:99/13/82- ALC4/2014
Party Name:HETERO DRUGS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01102/AM15/
RLA File :09/24/040/00472/AM15/
Lic.No/Date:0910061318 26.11.2014 Defer date 27.11.2015

181 Case No.:43/18/82- ALC4/2014
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01409/AM15/
RLA File :03/95/040/00701/AM15/
Lic.No/Date:0310791419 26.11.2014 Defer date 27.11.2015

182 Case No.:103/18/82- ALC4/2014
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/01469/AM15/
RLA File :34/24/040/00197/AM15/
Lic.No/Date:3410040726 27.11.2014

Decision : The Committee decided to ratify norms for the export product Alemplint and Pactum Injection based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No. 35011/73/2015-PI(Norms) date Sept. 2015, uploaded along with 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.

183 Case No.:10/2/82- ALC4/2015
Party Name:JUBILANT GENERICS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00025/AM16/
RLA File :05/23/040/00211/AM15/
Lic.No/Date:0510392167 27.11.2014 Defer date 27.11.2015

184 Case No.:11/2/82- ALC4/2015
Party Name:JUBILANT GENERICS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00026/AM16/
RLA File :05/23/040/00370/AM15/
Lic.No/Date:0510392171 27.11.2014 Defer date 27.11.2015 Decision :The Committee decided to call for Master Batch Formula from the firm and deferred the case.

185 Case No.:114/18/82- ALC4/2014
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01480/AM15/
RLA File :22/24/040/00073/AM15/
Lic.No/Date:2210015135 28.11.2014 Defer date 27.11.2015

33

Pharmaceuticals vide O.M. 35011/162/2015-PI(Norms) dt. October 2015, uploaded along with

186 Case No.:26/18/82- ALC4/2014
Party Name:SADHANA NITRO CHEM LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01392/AM15/
RLA File :03/95/040/00714/AM15/
Lic.No/Date:0310791516 28.11.2014 Defer date 27.11.2015 DC&PC(Chemicals).

187 Case No.:92/18/82- ALC4/2014
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01458/AM15/
RLA File :34/24/040/00224/AM15/
Lic.No/Date:3410040732 28.11.2014 Defer date 27.11.2015 DC&PC(Chemicals).

188 Case No.:67/18/82- ALC4/2014
Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved HQ File :01/82/050/01433/AM15/
RLA File :03/94/040/00328/AM15/
Lic.No/Date:0310791619 02.12.2014

Decision : The Committee decided to ratify norms for the export product 2-(N,N dimethylamino)- 2-Phenyl-1-Butanol based on the recommendation of D/o C&PC forwarded vide U.O. No.14010/29/2011-Ch-II dated 20.10.2015, uploaded along with 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.

189 Case No.:36/7/82- ALC4/2015
Party Name:HEPTACHEM & PHARMA (INDIA) PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00641/AM16/
RLA File :09/24/040/00406/AM15/
Lic.No/Date:0910061331 02.12.2014 Defer date 27.11.2015 DC&PC(Chemicals).

190 Case No.:102/13/82- ALC4/2014
Party Name:DR REDDYS Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:
Approved HQ File :01/82/050/01105/AM15/
RLA File :09/24/040/00487/AM15/
Lic.No/Date:0910061336 04.12.2014 Defer date 28.10.2015 Decision : Approved in NC09/AM16

191 Case No.:87/18/82- ALC4/2014
Party Name:STERLING AUXILIARIES PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred

34

HQ File :01/82/050/01453/AM15/
RLA File :03/95/040/00755/AM15/
Lic.No/Date:0310791744 05.12.2014 Defer date 27.11.2015 DC&PC(Chemicals).

192 Case No.:82/18/82- ALC4/2014
Party Name:ABEERS PHARMACEUTICALS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01448/AM15/
RLA File :05/23/040/00413/AM15/
Lic.No/Date:0510392368 10.12.2014 Defer date 27.11.2015 Decision : Reply dated 29.07.2015 to the deficiency letter has been received from the firm and send to Department of Ayush. The case is deferred for want of comments from the Department of Ayush.

193 Case No.:101/4/82- ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00140/AM16/
RLA File :17/24/040/00144/AM15/
Lic.No/Date:1710005998 10.12.2014 Defer date 27.11.2015

194 Case No.:97/18/82- ALC4/2014
Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01463/AM15/
RLA File :30/24/040/00041/AM15/
Lic.No/Date:3010103261 11.12.2014 Defer date 27.11.2015

195 Case No.:119/18/82- ALC4/2014
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01485/AM15/
RLA File :05/24/040/00419/AM15/
Lic.No/Date:0510392414 15.12.2014 Defer date 27.11.2015 DC&PC(Chemicals).

196 Case No.:118/18/82- ALC4/2014
Party Name:H.J.AROCHEM PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01484/AM15/
RLA File :08/24/040/00341/AM15/
Lic.No/Date:0810134067 16.12.2014 Defer date 27.11.2015

197 Case No.:106/18/82- ALC4/2014
Party Name:PANACEA BIOTEC LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01472/AM15/
RLA File :05/24/040/00424/AM15/
Lic.No/Date:0510392443 16.12.2014 Defer date 27.11.2015

35

198 Case No.:91/18/82- ALC4/2014
Party Name:ALCHEM INTERNATIONAL LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01457/AM15/
RLA File :05/23/040/00449/AM15/
Lic.No/Date:0510392602 29.12.2014 Defer date 27.11.2015

199 Case No.:84/18/82- ALC4/2014
Party Name:HESTER BIOSCIENCES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01450/AM15/
RLA File :08/24/040/00362/AM15/
Lic.No/Date:0810134170 30.12.2014 Defer date 27.11.2015 Decision : The Committee based on the written comments forwarded by the D/o Bio Technology forwarded vide letter No.BT/IL/05/391/2013-PID dt.29.08.2013 2015, uploaded along with

200 Case No.:3/1/82- ALC4/2015
Party Name:JAGSONPAL PHARMACEUTICALS LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00003/AM16/
RLA File :05/23/040/00450/AM15/
Lic.No/Date:0510392649 01.01.2015 Defer date 27.11.2015 Pharmaceuticals vide O.M.35011/289/2015-PI(Norms) dt. October 2015, uploaded along with

201 Case No.:28/7/82- ALC4/2015
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00633/AM16/
RLA File :05/24/040/00428/AM15/
Lic.No/Date:0510392678 05.01.2015 Defer date 27.11.2015 DC&PC(Chemicals)

202 Case No.:29/15/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01316/AM15/
RLA File :09/24/040/00543/AM15/
Lic.No/Date:0910061501 07.01.2015 Defer date 27.11.2015 DC&PC(Chemicals)

203 Case No.:96/18/82- ALC4/2014
Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File RLA File Lic.No/Date:0410159986 Defer date

36

:01/82/050/01462/AM15/
:04/24/040/00248/AM15/
07.01.2015 27.11.2015 Pharmaceuticals vide O.M.35011/268/2015-PI(Norms) Dt.08 October 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

204 Case No.:92/7/82- ALC4/2015
Party Name:RIDDHI PHARMA Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00697/AM16/
RLA File :34/24/040/00266/AM15/
Lic.No/Date:3410040864 12.01.2015 Defer date 27.11.2015

205 Case No.:24/7/82- ALC4/2015
Party Name:YASHASHVI RASAYAN PVT.LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00629/AM16/
RLA File :52/24/040/00056/AM15/
Lic.No/Date:5210041389 12.01.2015 Defer date 27.11.2015 DC&PC(Chemicals)

206 Case No.:11/16/82- ALC4/2014
Party Name:DR REDDYS Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01363/AM15/
RLA File :09/24/040/00580/AM15/
Lic.No/Date:0910061549 21.01.2015 Defer date 27.11.2015

207 Case No.:10/16/82- ALC4/2014
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01362/AM15/
RLA File :09/24/040/00529/AM15/
Lic.No/Date:0910061548 21.01.2015 Defer date 27.11.2015 Pharmaceuticals vide O.M.35011/309/2015-PI(Norms) dt. October 2015, uploaded along with

208 Case No.:12/16/82- ALC4/2014
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01364/AM15/
RLA File :09/24/040/00592/AM15/
Lic.No/Date:0910061552 21.01.2015 Defer date 27.11.2015

209 Case No.:14/1/82- ALC4/2015
Party Name:ANUH PHARMA LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00014/AM16/
RLA File :03/94/040/00985/AM15/
Lic.No/Date:0310793308 27.01.2015 Defer date 27.11.2015

37

210 Case No.:107/7/82- ALC4/2015
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00712/AM16/
RLA File :03/94/040/00992/AM15/
Lic.No/Date:0310793305 27.01.2015 Defer date 27.11.2015

211 Case No.:31/7/82- ALC4/2015
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00636/AM16/
RLA File :05/24/040/00498/AM15/
Lic.No/Date:0510392987 27.01.2015 Defer date 27.11.2015 DC&PC(Chemicals ).

212 Case No.:32/7/82- ALC4/2015
Party Name:V.D.H. ORGANICS PVT. LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00637/AM16/
RLA File :05/24/040/00499/AM15/
Lic.No/Date:0510392988 27.01.2015 Defer date 27.11.2015

213 Case No.:25/7/82- ALC4/2015
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00630/AM16/
RLA File :31/83/040/00144/AM15/
Lic.No/Date:3110065235 28.01.2015 Defer date 27.11.2015 DC&PC(Chemicals ).

214 Case No.:12/1/82- ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Approved
HQ File :01/82/050/00012/AM16/
RLA File :03/94/040/01005/AM15/
Lic.No/Date:0310793729 09.02.2015 Defer date 28.10.2015 Decision : Already approved in NC 09/AM16

215 Case No.:91/7/82- ALC4/2015
Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00696/AM16/
RLA File :34/24/040/00295/AM15/
Lic.No/Date:3410040965 16.02.2015 Defer date 27.11.2015 DC&PC(Chemicals ).

216 Case No.:52/19/82- ALC4/2014
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:11/82- ALC4/2015 Status: Deferred

38

28.10.2015 HQ File :01/82/050/01540/AM15/
RLA File :05/24/040/00273/AM15/
Lic.No/Date:0510393248 17.02.2015 Defer date 27.11.2015

217 Case No.:38/7/82- ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00643/AM16/
RLA File :09/24/040/00640/AM15/
Lic.No/Date:0910061628 18.02.2015 Defer date 27.11.2015

218 Case No.:35/7/82- ALC4/2015
Party Name:MAHARSHI PHARMA CHEM PVT.LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00640/AM16/
RLA File :08/24/040/00425/AM15/
Lic.No/Date:0810134658 24.02.2015 Defer date 27.11.2015

219 Case No.:1/1/82- ALC4/2015
Party Name:PARAMOUNT AROMACHEM PVT.LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00001/AM16/
RLA File :05/24/040/00563/AM15/
Lic.No/Date:0510393385 26.02.2015 Defer date 27.11.2015 DC&PC(Chemicals ).

220 Case No.:47/19/82- ALC4/2014
Party Name:RUBY FRAGRANCE PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01535/AM15/
RLA File :35/24/040/00006/AM15/
Lic.No/Date:3510044692 27.02.2015 Defer date 27.11.2015 DC&PC(Chemicals).

221 Case No.:444/5/82- ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00584/AM16/
RLA File :03/94/040/01132/AM15/
Lic.No/Date:0310794412 09.03.2015 Defer date 27.11.2015 Decision : The Committee noted that the export item is bulk drug and accordingly, decided to send a copy of application to DoP and deferred the case.

222 Case No.:6/1/82- ALC4/2015
Party Name:MICRO LABS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00006/AM16/
RLA File :07/24/040/00446/AM15/
Lic.No/Date:0710107776 10.03.2015 Defer date 27.11.2015

39

Decision : The Committee decided to defer the case for want of comments of DoP .

223 Case No.:15/1/82- ALC4/2015
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00015/AM16/
RLA File :04/24/040/00272/AM15/
Lic.No/Date:0410160273 11.03.2015

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/433/2015-PI(Norms) dated 15.10.2015 , uploaded along with 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.

224 Case No.:50/19/82- ALC4/2014
Party Name:HETERO DRUGS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Deferred HQ File :01/82/050/01538/AM15/
RLA File :09/24/040/00679/AM15/
Lic.No/Date:0910061693 12.03.2015

Pharmaceuticals vide O.M.35011/236/2015-PI(Norm) dt. October 2015, uploaded along with

225 Case No.:53/19/82- ALC4/2014
Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:11 /82- ALC4/2015 28.10.2015 Status:Case Approved HQ File :01/82/050/01541/AM15/
RLA File :09/24/040/00558/AM14/
Lic.No/Date:0910061704 13.03.2015 Defer Date: Decision :Already approved in NC09/AM16-withdrawn.

226 Case No.:51/19/82- ALC4/2014
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01539/AM15/
RLA File :09/24/040/00693/AM15/
Lic.No/Date:0910061695 12.03.2015 Defer date 27.11.2015 DC&PC(Chemicals)

227 Case No.:40/7/82- ALC4/2015
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00645/AM16/
RLA File :07/24/040/00351/AM15/
Lic.No/Date:0710107812 13.03.2015 Defer date 27.11.2015 DC&PC(Chemicals)

228 Case No.:106/7/82- Party Name:ALCHEMIE Meet No/Date:11/82- Status:

40

ALC4/2015
LABORATORIES ALC4/2015 28.10.2015 Deferred
HQ File :01/82/050/00711/AM16/
RLA File :03/94/040/00812/AM15/
Lic.No/Date:0310794612 16.03.2015 Defer date 27.11.2015 DC&PC(Chemicals)

229 Case No.:16/1/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01542/AM15/
RLA File :09/24/040/00703/AM15/
Lic.No/Date:0910061716 17.03.2015 Defer date 27.11.2015 Pharmaceuticals vide O.M.35011/231/2015-PI(Norms) dt. Sept. 2015, uploaded along with

230 Case No.:103/7/82- ALC4/2015
Party Name:VADIVARHE SPECIALITY CHEMICALS LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00708/AM16/
RLA File :03/95/040/01041/AM15/
Lic.No/Date:0310794641 17.03.2015 Defer date 27.11.2015

231 Case No.:315/5/82- ALC4/2015
Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00455/AM16/
RLA File :07/24/040/00461/AM15/
Lic.No/Date:0710107895 20.03.2015

Decision : The Committee decided to ratify norms for the export Tenofovir Disoproxil Fumarate product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/434/2015-PI(Norms) dated 13.10.2015, uploaded along with 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.

232 Case No.:29/1/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/01555/AM15/
RLA File :09/24/040/00722/AM15/
Lic.No/Date:0910061789 30.03.2015 Defer date 27.11.2015

233 Case No.:51/4/82- ALC4/2015
Party Name:PANACEA BIOTEC LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00090/AM16/
RLA File :05/24/040/00607/AM15/
Lic.No/Date:0510393789 30.03.2015 Defer date 27.11.2015

41

Decision : The Committee decided to defer the case for want of comments of DBT.

234 Case No.:9/1/82- ALC4/2015
Party Name:VIVIMED LABS (ALATHUR) PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00009/AM16/
RLA File :04/24/040/00292/AM15/
Lic.No/Date:0410160364 30.03.2015 Defer date 27.11.2015

235 Case No.:104/7/82- ALC4/2015
Party Name:ANUH PHARMA LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00709/AM16/
RLA File :03/94/040/01192/AM15/
Lic.No/Date:0310795054 31.03.2015 Defer date 27.11.2015

236 Case No.:12/7/82- ALC4/2015
Party Name:SHILPA MEDICARE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Deferred HQ File :01/82/050/00617/AM16/
RLA File :07/24/040/00002/AM16/
Lic.No/Date:0710108028 15.04.2015 Defer Date: 27.11.2015 Decision :The Committee decided to defer the case for want of comments of DoP.

237 Case No.:144/7/82- ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00749/AM16/
RLA File :03/94/040/01200/AM15/
Lic.No/Date:0310795391 17.04.2015 Defer date 27.11.2015 DCPC(Chemicals).

238 Case No.:152/7/82- ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00757/AM16/
RLA File :03/94/040/01210/AM15/
Lic.No/Date:0310795394 17.04.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC.

239 Case No.:132/7/82- ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Deferred HQ File :01/82/050/00737/AM16/
RLA File :03/94/040/00024/AM16/
Lic.No/Date:0310795429 20.04.2015 Defer Date:18.11.2015 Decision :The Committee decided to defer the case for want of comments of DoP.

240 Case No.:147/7/82- Party Name:INDOCO Meet No/Date:11/82- Status:

42

ALC4/2015
REMEDIES LIMITED ALC4/2015 28.10.2015 Deferred
HQ File :01/82/050/00752/AM16/
RLA File :03/94/040/00036/AM16/
Lic.No/Date:0310795446 21.04.2015 Defer date 27.11.2015

241 Case No.:29/7/82- ALC4/2015
Party Name:NUTRA SPECIALITIES PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00634/AM16/
RLA File :04/24/040/00003/AM16/
Lic.No/Date:0410160438 24.04.2015 Defer date 27.11.2015 Pharmaceuticals vide O.M.35011/268/2015-PI(Norms) Dt.08 October 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

242 Case No.:173/7/82- ALC4/2015
Party Name:UNIMAX LABORATORIES PVT.LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00778/AM16/
RLA File :03/95/040/00031/AM16/
Lic.No/Date:0310795525 24.04.2015 Defer date 27.11.2015

243 Case No.:155/7/82- ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00760/AM16/
RLA File :03/94/040/00035/AM16/
Lic.No/Date:0310795581 28.04.2015 Defer date 27.11.2015

244 Case No.:153/7/82- ALC4/2015
Party Name:DR. ACHARYA LABORATORIES PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Deferred HQ File :01/82/050/00758/AM16/
RLA File :03/94/040/00039/AM16/
Lic.No/Date:0310795534 24.04.2015 Defer Date:18.11.2015 Decision :The Committee decided to defer the case for want of comments of DC&PC

245 Case No.:174/7/82- ALC4/2015
Party Name:S M B CORPORATION OF INDIA Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00779/AM16/
RLA File :03/95/040/00039/AM16/
Lic.No/Date:0310795601 28.04.2015 Defer date 27.11.2015

246 Case No.:151/7/82- ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred

43

LIMITED HQ File :01/82/050/00756/AM16/
RLA File :03/94/040/01216/AM15/
Lic.No/Date:0310795663 30.04.2015 Defer date 27.11.2015 Decision :The Committee decided to call for DML and Mater Batch Formula from the firm and deferred the case.

247 Case No.:50/7/82- ALC4/2015
Party Name:ARENE LIFE SCIENCES LIMITED. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00655/AM16/
RLA File :09/24/040/00041/AM16/
Lic.No/Date:0910061976 06.05.2015 Defer date 27.11.2015

248 Case No.:4/7/82- ALC4/2015
Party Name:POSY PHARMACHEM PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00609/AM16/
RLA File :08/24/040/00006/AM16/
Lic.No/Date:0810135194 06.05.2015 Defer date 27.11.2015 DC&PC(Chemicals)

249 Case No.:11/7/82- ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00616/AM16/
RLA File :08/24/040/00016/AM16/
Lic.No/Date:0810135204 07.05.2015 Defer date 27.11.2015

250 Case No.:23/7/82- ALC4/2015
Party Name:CADILA HEALTHCARE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00628/AM16/
RLA File :08/24/040/00028/AM16/
Lic.No/Date:0810135220 07.05.2015 Defer date 27.11.2015

251 Case No.:3/3/82- ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00033/AM16/
RLA File :09/24/040/00077/AM16/
Lic.No/Date:0910061994 07.05.2015 Defer date 27.11.2015

252 Case No.:108/7/82- ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00713/AM16/
RLA File :03/95/040/00003/AM16/
Lic.No/Date:0310795745 07.05.2015 Defer date 27.11.2015

253 Case No.:191/7/82- Party Name:SURVIVAL Meet No/Date:11/82- Status:

44

ALC4/2015
TECHNOLOGIES PVT.LTD. ALC4/2015 28.10.2015 Deferred
HQ File :01/82/050/00796/AM16/
RLA File :03/95/040/00065/AM16/
Lic.No/Date:0310795759 07.05.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC (Chemicals)

254 Case No.:7/7/82- ALC4/2015
Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00612/AM16/
RLA File :08/24/040/00017/AM16/
Lic.No/Date:0810135225 08.05.2015 Defer date 27.11.2015

255 Case No.:8/7/82- ALC4/2015
Party Name:SWISS PARENTERALS PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00613/AM16/
RLA File :08/24/040/00018/AM16/
Lic.No/Date:0810135226 08.05.2015 Defer date 27.11.2015

256 Case No.:117/7/82- ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00722/AM16/
RLA File :03/95/040/00079/AM16/
Lic.No/Date:0310795788 08.05.2015 Defer date 27.11.2015

257 Case No.:30/7/82- ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00635/AM16/
RLA File :05/23/040/00033/AM16/
Lic.No/Date:0510394185 11.05.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC.

258 Case No.:15/7/82- ALC4/2015
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00620/AM16/
RLA File :52/24/040/00007/AM16/
Lic.No/Date:5210041517 11.05.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC.

259 Case No.:99/7/82- ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00704/AM16/
RLA File :34/24/040/00040/AM16/
Lic.No/Date:3410041221 12.05.2015

Decision : The Committee decided to ratify norms for the export product Azithromycin Step-4 based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/153/2014- PI(Norms) dated October 2015 , uploaded along with these minutes or as applied by the firm

45

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

260 Case No.:139/7/82- ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00744/AM16/
RLA File :03/95/040/00068/AM16/
Lic.No/Date:0310795837 12.05.2015 Defer date 27.11.2015

261 Case No.:140/7/82- ALC4/2015
Party Name:LUPIN LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00745/AM16/
RLA File :03/95/040/00067/AM16/
Lic.No/Date:0310795839 12.05.2015 Defer date 27.11.2015

262 Case No.:49/7/82- ALC4/2015
Party Name:BRUNDAVAN LABORATORIES PRIVATE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00654/AM16/
RLA File :09/24/040/00059/AM16/
Lic.No/Date:0910062011 13.05.2015 Defer date 27.11.2015

263 Case No.:146/7/82- ALC4/2015
Party Name:DORF- KETAL CHEMICALS INDIA PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00751/AM16/
RLA File :03/94/040/00047/AM16/
Lic.No/Date:0310795883 13.05.2015

Decision : The Committee decided to ratify norms for the export product Antipolymerant based on the recommendation of D/o C&PC, forwarded vide U.O.No.14010/176/2011-Ch-II dated 20.10.2015 , uploaded along with 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.

264 Case No.:5/3/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00035/AM16/
RLA File :09/24/040/00081/AM16/
Lic.No/Date:0910062019 14.05.2015 Defer date 27.11.2015

265 Case No.:129/7/82- ALC4/2015
Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00734/AM16/
RLA File :03/95/040/00073/AM16/
Lic.No/Date:0310795930 14.05.2015 Defer date 27.11.2015

46

266 Case No.:6/7/82- ALC4/2015
Party Name:SIMPEX PHARMA PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00611/AM16/
RLA File :05/24/040/00564/AM15/
Lic.No/Date:0510394266 15.05.2015 Defer date 27.11.2015

267 Case No.:164/7/82- ALC4/2015
Party Name:ETERNIS FINE CHEMICALS LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00769/AM16/
RLA File :03/94/040/00026/AM16/
Lic.No/Date:0310795971 18.05.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DC&PC (Chemical).

268 Case No.:126/7/82- ALC4/2015
Party Name:SANDOZ PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00731/AM16/
RLA File :03/95/040/00071/AM16/
Lic.No/Date:0310795986 18.05.2015 Defer date 27.11.2015

269 Case No.:109/7/82- ALC4/2015
Party Name:ZIM LABORATORIES LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00714/AM16/
RLA File :03/95/040/00103/AM16/
Lic.No/Date:0310795994 18.05.2015 Defer date 27.11.2015

270 Case No.:133/7/82- ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00738/AM16/
RLA File :03/94/040/00085/AM16/
Lic.No/Date:0310796048 20.05.2015 Defer date 27.11.2015

271 Case No.:41/7/82- ALC4/2015
Party Name:KORES (INDIA) LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00646/AM16/
RLA File :31/83/040/00196/AM15/
Lic.No/Date:3110065441 20.05.2015 Defer date 27.11.2015 DC&PC(Chemicals)

272 Case No.:102/7/82- ALC4/2015
Party Name:DYNAMIC SPECIALITY CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00707/AM16/
RLA File :30/24/040/00006/AM16/
Lic.No/Date:3010103498 21.05.2015 Defer date 27.11.2015

47

DC&PC(Petrochemicals)

273 Case No.:51/7/82- ALC4/2015
Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00656/AM16/
RLA File :09/24/040/00096/AM16/
Lic.No/Date:0910062060 22.05.2015 Defer date 27.11.2015 DC&PC(Petrochemicals)

274 Case No.:167/7/82- ALC4/2015
Party Name:IPCA Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00772/AM16/
RLA File :03/94/040/00041/AM16/
Lic.No/Date:0310796129 22.05.2015 Defer date 27.11.2015

275 Case No.:112/7/82- ALC4/2015
Party Name:YASHO INDUSTRIES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00717/AM16/
RLA File :03/95/040/00121/AM16/
Lic.No/Date:0310796157 22.05.2015

recommendation of D/o Pharmaceuticals forwarded vide U.O.No.14010/95/2011-CH-II dated 20.10.2015, uploaded along with 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.

276 Case No.:3/4/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00042/AM16/
RLA File :09/24/040/00104/AM16/
Lic.No/Date:0910062064 25.05.2015 Defer date 27.11.2015 Pharmaceuticals vide O.M. 35011/145/2015-PI-(Norms) dt. Sept. 2015, uploaded along with

277 Case No.:13/7/82- ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00618/AM16/
RLA File :05/24/040/00074/AM16/
Lic.No/Date:0510394343 25.05.2015 Defer date 27.11.2015

278 Case No.:170/7/82- ALC4/2015
Party Name:FERMENTA BIOTECH LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00775/AM16/
RLA File :03/94/040/00009/AM16/
Lic.No/Date:0310796191 26.05.2015 Defer date 27.11.2015

48

279 Case No.:46/7/82- ALC4/2015
Party Name:GLAND PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00651/AM16/
RLA File :09/24/040/00709/AM15/
Lic.No/Date:0910062070 26.05.2015

Decision : The Committee decided to ratify norms for the export product pre-filled syringes based on the recommendation of

D/o Pharmaceuticals forwarded vide O.M. No.35011/110/2015-PI(Norms) dated 19.10.2015 , uploaded along with 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.

280 Case No.:47/7/82- ALC4/2015
Party Name:GLAND PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00652/AM16/
RLA File :09/24/040/00712/AM15/
Lic.No/Date:0910062071 26.05.2015

Decision : The Committee decided to ratify norms for the export product pre-filled syringes based on the recommendation of

D/o Pharmaceuticals forwarded vide O.M. No.35011/110/2015-PI(Norms) dated 19.10.2015 , uploaded along with 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.

281 Case No.:166/7/82- ALC4/2015
Party Name:IPCA Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00771/AM16/
RLA File :03/94/040/00063/AM16/
Lic.No/Date:0310796196 26.05.2015 Defer date 27.11.2015

282 Case No.:162/7/82- ALC4/2015
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00767/AM16/
RLA File :03/94/040/00107/AM16/
Lic.No/Date:0310796189 26.05.2015 Defer date 27.11.2015 DC&PC(Chemicals)

283 Case No.:124/7/82- ALC4/2015
Party Name:PRIVI ORGANICS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00729/AM16/
RLA File :03/95/040/00114/AM16/
Lic.No/Date:0310796233 27.05.2015 Defer date 27.11.2015 DC&PC(Chemicals)

284 Case No.:96/7/82- ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Approved HQ File :01/82/050/00701/AM16/
RLA File :34/24/040/00035/AM16/
Lic.No/Date:3410041255 28.05.2015

49

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/304/2015-PI(Norms) dated October 2015 , uploaded along with 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.

285 Case No.:176/7/82- ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Deferred HQ File :01/82/050/00781/AM16/
RLA File :03/94/040/00124/AM16/
Lic.No/Date:0310796194 26.05.2015 Defer Date:27.11.2015 Decision :it was decided to defer the case for want of comments of DoP.

286 Case No.:180/7/82- ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Approved HQ File :01/82/050/00785/AM16/
RLA File :22/24/040/00007/AM16/
Lic.No/Date:2210015238 25.05.2015

Decision: The Committee decided to ratify norms for the export product based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/407/2015-PI(Norms) dated October, 2015 , uploaded along with 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.

287 Case No.:100/7/82- ALC4/2015
Party Name:SHREE GANESH REMEDIES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00705/AM16/
RLA File :34/24/040/00024/AM16/
Lic.No/Date:3410041261 28.05.2015 Defer date 27.11.2015 DC&PC(Chemicals)

288 Case No.:184/7/82- ALC4/2015
Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00789/AM16/
RLA File :22/24/040/00009/AM16/
Lic.No/Date:2210015246 28.05.2015 Defer date 27.11.2015

289 Case No.:188/7/82- ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00793/AM16/
RLA File :08/24/040/00034/AM16/
Lic.No/Date:0810135421 02.06.2015 Defer date 27.11.2015 DC&PC(Chemicals)

290 Case No.:14/7/82- Party Name:DHANUKA Meet No/Date:11/82- Status:

50

ALC4/2015
LABORATORIES LTD. ALC4/2015 28.10.2015 Deferred
HQ File :01/82/050/00619/AM16/
RLA File :05/23/040/00075/AM16/
Lic.No/Date:0510394413 02.06.2015 Defer date 27.11.2015

291 Case No.:113/7/82- ALC4/2015
Party Name:S.M. CHEMICALS Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Deferred HQ File :01/82/050/00718/AM16/
RLA File :03/95/040/00115/AM16/
Lic.No/Date:0310796312 29.05.2015 Defer Date: 18.11.2015 Decision :it was decided to defer the case for want of comments of DC&PC(Chemicals).

292 Case No.:5/7/82- ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00610/AM16/
RLA File :05/24/040/00090/AM16/
Lic.No/Date:0510394416 02.06.2015 Defer date 27.11.2015

293 Case No.:142/7/82- ALC4/2015
Party Name:GLOBE TROTTERS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00747/AM16/
RLA File :03/94/040/00159/AM16/
Lic.No/Date:0310796401 03.06.2015 Defer date 27.11.2015

294 Case No.:134/7/82- ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00739/AM16/
RLA File :03/94/040/00154/AM16/
Lic.No/Date:0310796399 03.06.2015 Defer date 27.11.2015

295 Case No.:110/7/82- ALC4/2015
Party Name:RISHABH METALS & CHEMICALS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00715/AM16/
RLA File :03/95/040/00051/AM16/
Lic.No/Date:0310796383 03.06.2015 Defer date 27.11.2015 DC&PC(Petrochemicals)

296 Case No.:16/7/82- ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00621/AM16/
RLA File :05/24/040/00084/AM16/
Lic.No/Date:0510394419 03.06.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DoP

51

297 Case No.:17/7/82- ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00622/AM16/
RLA File :05/24/040/00078/AM16/
Lic.No/Date:0510394418 03.06.2015 Defer date 27.11.2015

298 Case No.:105/7/82- ALC4/2015
Party Name:SAVLA CHEMICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00710/AM16/
RLA File :03/95/040/00159/AM16/
Lic.No/Date:0310796432 04.06.2015 Defer date 27.11.2015 DC&PC(Petrochemicals)

299 Case No.:187/7/82- ALC4/2015
Party Name:ATUL LIMITED, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00792/AM16/
RLA File :08/24/040/00057/AM16/
Lic.No/Date:0810135435 05.06.2015 Defer date 27.11.2015 DC&PC(Chemical)

300 Case No.:62/7/82- ALC4/2015
Party Name:EYTAN LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00667/AM16/
RLA File :09/24/040/00598/AM15/
Lic.No/Date:0910062137 05.06.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DoP.

301 Case No.:135/7/82- ALC4/2015
Party Name:INDOCO REMEDIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00740/AM16/
RLA File :03/94/040/00153/AM16/
Lic.No/Date:0310796471 05.06.2015 Defer date 27.11.2015

302 Case No.:67/7/82- ALC4/2015
Party Name:OPTIMUS DRUGS PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00672/AM16/
RLA File :09/24/040/00105/AM16/
Lic.No/Date:0910062138 05.06.2015 Defer date 27.11.2015

303 Case No.:13/9/82- ALC4/2015
Party Name:SHILPA MEDICARE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00949/AM16/
RLA File :07/24/040/00081/AM16/
Lic.No/Date:0710108327 05.06.2015 Defer date 27.11.2015

52

304 Case No.:121/7/82- ALC4/2015
Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00726/AM16/
RLA File :03/95/040/00715/AM15/
Lic.No/Date:0310796458 05.06.2015 Defer date 27.11.2015

305 Case No.:123/7/82- ALC4/2015
Party Name:UNIMARK REMEDIES LIMITED., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00728/AM16/
RLA File :03/95/040/00582/AM15/
Lic.No/Date:0310796457 05.06.2015 Defer date 27.11.2015

306 Case No.:97/7/82- ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00702/AM16/
RLA File :34/24/040/00062/AM16/
Lic.No/Date:3410041281 09.06.2015 Defer date 27.11.2015

307 Case No.:136/7/82- ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00741/AM16/
RLA File :03/94/040/00032/AM16/
Lic.No/Date:0310796511 09.06.2015 Defer date 27.11.2015

308 Case No.:85/7/82- ALC4/2015
Party Name:SHREEGEN PHARMA LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00690/AM16/
RLA File :09/24/040/00130/AM16/
Lic.No/Date:0910062145 09.06.2015 Defer date 27.11.2015

309 Case No.:60/7/82- ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00665/AM16/
RLA File :09/24/040/00126/AM16/
Lic.No/Date:0910062150 10.06.2015 Defer date 27.11.2015

310 Case No.:61/7/82- ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00666/AM16/
RLA File :09/24/040/00141/AM16/
Lic.No/Date:0910062149 10.06.2015 Defer date 27.11.2015

53

311 Case No.:137/7/82- ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00742/AM16/
RLA File :03/94/040/00074/AM16/
Lic.No/Date:0310796546 10.06.2015 Defer date 27.11.2015

312 Case No.:182/7/82- ALC4/2015
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00787/AM16/
RLA File :22/24/040/00006/AM16/
Lic.No/Date:2210015251 10.06.2015 Defer date 27.11.2015

313 Case No.:14/9/82- ALC4/2015
Party Name:SHILPA MEDICARE LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00950/AM16/
RLA File :07/24/040/00078/AM16/
Lic.No/Date:0710108349 10.06.2015 Defer date 27.11.2015

314 Case No.:65/7/82- ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00670/AM16/
RLA File :09/24/040/00164/AM16/
Lic.No/Date:0910062163 10.06.2015 Defer date 27.11.2015

315 Case No.:66/7/82- ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00671/AM16/
RLA File :09/24/040/00162/AM16/
Lic.No/Date:0910062162 10.06.2015 Defer date 27.11.2015 DC&PC(Chemicals).

316 Case No.:159/7/82- ALC4/2015
Party Name:VIJAY PERFUMES PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00764/AM16/
RLA File :03/95/040/00985/AM15/
Lic.No/Date:0310796576 11.06.2015 Defer date 27.11.2015 DC&PC(Chemicals).

54

317 Case No.:87/7/82- ALC4/2015
Party Name:VISION DRUGS PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00692/AM16/
RLA File :09/24/040/00102/AM16/
Lic.No/Date:0910062168 11.06.2015 Defer date 27.11.2015

318 Case No.:171/7/82- ALC4/2015
Party Name:MAKSON INDUSTRIES PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00776/AM16/
RLA File :03/95/040/01080/AM15/
Lic.No/Date:0310796624 15.06.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of MSME.

319 Case No.:172/7/82- ALC4/2015
Party Name:MAKSON INDUSTRIES PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00777/AM16/
RLA File :03/95/040/01079/AM15/
Lic.No/Date:0310796623 15.06.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of MSME.

320 Case No.:54/7/82- ALC4/2015
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00659/AM16/
RLA File :05/23/040/00065/AM16/
Lic.No/Date:0510394575 16.06.2015 Defer date 27.11.2015

321 Case No.:55/7/82- ALC4/2015
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00660/AM16/
RLA File :05/23/040/00030/AM16/
Lic.No/Date:0510394579 16.06.2015 Defer date 27.11.2015

322 Case No.:177/7/82- ALC4/2015
Party Name:S.M. CHEMICALS Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Deferred HQ File RLA File Lic.No/Date:0310796577 Defer

55

:01/82/050/00782/AM16/ :03/95/040/00124/AM16/ 11.06.2015 Date:27.11.2015 Decision :it was decided to defer the case for want of comments of DC&PC(Chemicals).

323 Case No.:52/7/82- ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00657/AM16/
RLA File :05/23/040/00107/AM16/
Lic.No/Date:0510394590 17.06.2015 Defer date 27.11.2015

324 Case No.:53/7/82- ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:approved HQ File :01/82/050/00658/AM16/
RLA File :05/23/040/00115/AM16/
Lic.No/Date:0510394591 17.06.2015

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/298/2015-PI(Norms , uploaded along with 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.

325 Case No.:86/7/82- ALC4/2015
Party Name:RA CHEM PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00691/AM16/
RLA File :09/24/040/00160/AM16/
Lic.No/Date:0910062204 17.06.2015 Defer date 27.11.2015

326 Case No.:190/7/82- ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00795/AM16/
RLA File :05/24/040/00105/AM16/
Lic.No/Date:0510394617 17.06.2015 Defer date 27.11.2015

327 Case No.:15/9/82- ALC4/2015
Party Name:KDAC CHEM PVT LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00951/AM16/
RLA File :34/24/040/00069/AM16/
Lic.No/Date:3410041310 22.06.2015 Defer date 27.11.2015 DC&PC(Chemicals).

328 Case No.:183/7/82- ALC4/2015
Party Name:SAURAV CHEMICALS LTD, Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00788/AM16/
RLA File :22/24/040/00010/AM16/
Lic.No/Date:2210015259 22.06.2015 Defer date 27.11.2015

56

DC&PC(Chemicals).

329 Case No.:45/7/82- ALC4/2015
Party Name:EYTAN LABS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00650/AM16/
RLA File :09/24/040/00135/AM16/
Lic.No/Date:0910062250 24.06.2015 Defer date 27.11.2015

330 Case No.:64/7/82- ALC4/2015
Party Name:TRIMAX BIO SCIENCES PRIVATE LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00669/AM16/
RLA File :09/24/040/00133/AM16/
Lic.No/Date:0910062246 24.06.2015 Defer date 27.11.2015 DC&PC(Chemicals).

331 Case No.:48/7/82- ALC4/2015
Party Name:MYLAN Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00653/AM16/
RLA File :09/24/040/00118/AM16/
Lic.No/Date:0910062253 25.06.2015 Defer date 27.11.2015

332 Case No.:27/7/82- ALC4/2015
Party Name:PANACEA BIOTEC LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00632/AM16/
RLA File :05/24/040/00146/AM16/
Lic.No/Date:0510394710 25.06.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DBT.

333 Case No.:72/7/82- ALC4/2015
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00677/AM16/
RLA File :05/24/040/00104/AM16/
Lic.No/Date:0510394704 25.06.2015 Defer date 27.11.2015

334 Case No.:76/7/82- ALC4/2015
Party Name:PCL OIL & SOLVENTS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00681/AM16/
RLA File :05/24/040/00103/AM16/
Lic.No/Date:0510394703 25.06.2015 Defer date 27.11.2015

335 Case No.:75/7/82- ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:11/82- ALC4/2015 Status: Deferred

57

28.10.2015 HQ File :01/82/050/00680/AM16/
RLA File :05/24/040/00122/AM16/
Lic.No/Date:0510394696 25.06.2015 Defer date 27.11.2015

336 Case No.:78/7/82- ALC4/2015
Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00683/AM16/
RLA File :02/24/040/00028/AM16/
Lic.No/Date:0210205920 25.06.2015 Defer date 27.11.2015 DC&PC(Chemicals).

337 Case No.:89/7/82- ALC4/2015
Party Name:HALDIA PETROCHEMICALS LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00694/AM16/
RLA File :02/24/040/00045/AM16/
Lic.No/Date:0210205925 26.06.2015 Defer date 27.11.2015 DC&PC(petrochemicals).

338 Case No.:77/7/82- ALC4/2015
Party Name:SENTISS PHARMA PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00682/AM16/
RLA File :05/24/040/00130/AM16/
Lic.No/Date:0510394732 26.06.2015 Defer date 27.11.2015

339 Case No.:26/7/82- ALC4/2015
Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00631/AM16/
RLA File :04/24/040/00072/AM16/
Lic.No/Date:0410160709 26.06.2015 Defer date 27.11.2015

340 Case No.:181/7/82- ALC4/2015
Party Name:CLARION DRUGS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00786/AM16/
RLA File :50/24/040/00002/AM16/
Lic.No/Date:5010002211 29.06.2015 Defer date 27.11.2015

341 Case No.:57/7/82- ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00662/AM16/
RLA File :05/23/040/00112/AM16/
Lic.No/Date:0510394740 29.06.2015 Defer date 27.11.2015 DC&PC(Chemical)

58

342 Case No.:44/7/82- ALC4/2015
Party Name:LEE PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00649/AM16/
RLA File :09/24/040/00201/AM16/
Lic.No/Date:0910062263 30.06.2015 Defer date 27.11.2015

343 Case No.:42/7/82- ALC4/2015
Party Name:CLEAN SCIENCE AND TECHNOLOGY PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00647/AM16/
RLA File :31/83/040/00030/AM16/
Lic.No/Date:3110065521 01.07.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of CCPC (Chemicals).

344 Case No.:2/7/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00607/AM16/
RLA File :09/24/040/00213/AM16/
Lic.No/Date:0910062316 08.07.2015 Defer date 27.11.2015

345 Case No.:185/7/82- ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00790/AM16/
RLA File :09/24/040/00219/AM16/
Lic.No/Date:0910062355 21.07.2015 Defer date 27.11.2015

346 Case No.:7/9/82- ALC4/2015
Party Name:DR REDDYS Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00943/AM16/
RLA File :09/24/040/00312/AM16/
Lic.No/Date:0910062574 08.09.2015 Defer date 27.11.2015

347 Case No.:58/7/82- ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:11/82- ALC4/2015 28.10.2015 Status:Case Deferred HQ File :01/82/050/00663/AM16/
RLA File :05/23/040/00111/AM16/
Lic.No/Date:0510394739 29.06.2015 Defer Date:27.11.2015

Decision : The Committee decided to defer the case for want of comments of DCPC.

348 Case No.:3/9/82- ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00939/AM16/
RLA File :09/24/040/00341/AM16/
Lic.No/Date:0910062565 08.09.2015 Defer date 27.11.2015

59

349 Case No.:4/9/82- ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00940/AM16/
RLA File :09/24/040/00338/AM16/
Lic.No/Date:0910062566 08.09.2015 Defer date 27.11.2015

350 Case No.:5/9/82- ALC4/2015
Party Name:HETERO DRUGS LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00941/AM16/
RLA File :09/24/040/00337/AM16/
Lic.No/Date:0910062567 08.09.2015 Defer date 27.11.2015

351 Case No.:2/9/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00938/AM16/
RLA File :09/24/040/00344/AM16/
Lic.No/Date:0910062564 08.09.2015 Defer date 27.11.2015

350 Case No.:8/9/82- ALC4/2015
Party Name:BEST VALUE CHEM PVT. LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00944/AM16/
RLA File :34/24/040/00155/AM16/
Lic.No/Date:3410041496 09.09.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DCPC (Chemicals).

351 Case No.:10/9/82- ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00946/AM16/
RLA File :03/94/040/00355/AM16/
Lic.No/Date:0310798806 10.09.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DCPC (Chemicals).

352 Case No.:12/9/82- ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00948/AM16/
RLA File :03/94/040/00372/AM16/
Lic.No/Date:0310798878 14.09.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DCPC (Chemicals).

353 Case No.:16/9/82- ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:11/82- ALC4/2015 Status: Deferred

60

28.10.2015 HQ File :01/82/050/00952/AM16/
RLA File :03/94/040/00265/AM16/
Lic.No/Date:0310798923 16.09.2015 Defer date 27.11.2015 Decision : The Committee decided to defer the case for want of comments of DCPC (Chemicals).

354 Case No.:18/9/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00954/AM16/
RLA File :09/24/040/00368/AM16/
Lic.No/Date:0910062629 16.09.2015 Defer date 27.11.2015

355 Case No.:19/9/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00955/AM16/
RLA File :09/24/040/00369/AM16/
Lic.No/Date:0910062630 16.09.2015 Defer date 27.11.2015

356 Case No.:17/9/82- ALC4/2015
LIMITED Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00953/AM16/
RLA File :09/24/040/00371/AM16/
Lic.No/Date:0910062628 16.09.2015 Defer date 27.11.2015 Pharmaceuticals vide O.M.35011/245/2015-PI(Norms) Dt.29 September 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

357 Case No.:20/9/82- ALC4/2015
Party Name:SUPREET CHEMICALS PVT.LTD. Meet No/Date:11/82- ALC4/2015 28.10.2015 Status: Deferred
HQ File :01/82/050/00956/AM16/
RLA File :03/95/040/00424/AM16/
Lic.No/Date:0310798995 22.09.2015 Defer date 27.11.2015 DC&PC(Chemicals)


Manual Agenda of NC Meeting No. 11/82/2015 Scheduled to be held on 28.10.2015

Case No. B- 01

M.No.11/16 Date 28.10.2015

M/s. Divi’s Laboratories Ltd File No. 01/82/050/00491/AM 15 RLA No.09/24/040/00150/AM 15 Adv.Auth. No. 0910060536 dt. 25.06.2014 Decision: The Committee considered the case for revision of norms as per agenda and decided to defer the case for want of comments of DoP.

61

Case No. B- 02

M.No.11/16 Date 28.10.2015

M/s. Divi’s Laboratories Ltd File No. 01/82/050/00514/AM 15 RLA No.09/24/040/00658/AM 14 Adv.Auth. No. 0910059678 dt. 28.03.2014 Decision: The Committee considered the case for revision of norms as per agenda and decided to defer the case for want of comments of DoP.

Case No. B- 03

M.No.11/16 Date 28.10.2015

M/s. KLJ Plasticizers Ltd File No. 01/82/050/01128/AM 15 RLA No.05/23/040/00313/AM 15 Adv.Auth. No. 0510391766 dt. 28.10.2014

Decision: The Committee considered the case for revision of norms as per agenda and decided to defer the case for want of comments of DC&PC (Chemicals).

Case No. B- 04

M.No.11/16 Date 28.10.2015

M/s. KLJ Plasticizers Ltd File No. 01/82/050/01036/AM 15 RLA No.05/23/040/00256/AM 15 Adv.Auth. No. 0510391459 dt. 07.10.2014 Decision: The Committee considered the case for revision of norms as per agenda and decided to defer the case for want of comments of DC&PC (Chemicals).

Case No. B- 05

M.No.11/16 Date 28.10.2015

M/s. Metropolitan Eximchem Ltd File No. 01/82/050/01085/AM 14 RLA No.03/95/040/00736/AM 14 Adv.Auth. No. 0310762602 dt. 19.12.2013 Decision: The Committee considered the case for revision of norms as per agenda and decided to defer the case for want of comments of DC&PC (Chemicals).

Case No. B- 06

M.No.11/16 Date 28.10.2015

M/s. FDC Ltd File No. 01/82/050/01203/AM 15 RLA No.03/94/040/00231/AM 15 Adv.Auth. No. 0310788027 dt. 14.08.2014

Decision: The Committee decided to ratify norms for the export product Chloramphenicol Eye Drops based on the recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/149/2015-PI(Norms) dated Sept.2015 , uploaded along with these minutes or as applied by the firm whichever is less under para 4.07 of HBP Vol.1. RA concerned may take necessary action as per decision of NC.

Case No. B- 07

M.No.11/16 Date 28.10.2015

M/s. India Glyools Ltd File No. 01/82/050/01012/AM 12 RLA No.05/23/040/00237/AM 12 Adv.Auth. No. 0510305501 dt. 17.10.2011 Decision: The Committee considered the case for revision of norms as per agenda and decided to send a copy of application to the DCPC (Petrochemical).

Case No. B- 08

M.No.11/16 Date 28.10.2015

M/s. Jubilant Life Sciences Ltd File No. 01/82/162/00371/AM 14

Decision: The Committee considered the case for revision of norms as per agenda and decided to defer the case for want of comments of DC&PC (Chemicals).

62

Case No. B- 09

M.No.11/16 Date 28.10.2015

M/s. Adcock Ingram Ltd File No. 01/82/050/00666/AM 09 RLA No.07/24/040/00142/AM 09 Adv.Auth. No. 0710058154 dt. 26.06.2008

Decision: The Committee considered the case for revision of norms as per agenda and decided to examine the case on file.

Case No. B- 10

M.No.11/16 Date 28.10.2015

M/s. Beloor Bayir Biotech Ltd File No. 01/82/050/00151/AM 12 RLA No.07/24/040/00317/AM 12 Adv.Auth. No. 0710084045 dt. 18.11.2011

Decision: The Committee considered the case for ratification of norms as per agenda and noted that export product not cover under Chapter 29 & 30. The committee accordingly decided to transfer this case to DES- VI as earlier considered by them.

Case No. B- 11

M.No.11/16 Date 28.10.2015

M/s. Beloor Bayir Biotech Ltd File No. 01/82/050/00113/AM 14 RLA No.07/24/040/00150/AM 14 Adv.Auth. No. 0710097664 dt. 22.08.2013

Decision: The Committee considered the case for ratification of norms as per agenda. Based on the written comments received from DoP vide their O.M. No. 35011/122/2015-PI (Norms) dated September 2015, uploaded along with these minutes, the committee decided to transfer this case to the concerned Section i.e. DES-VI.

Case No. B- 12

M.No.11/16 Date 28.10.2015

M/s. Piramal Healthcare Ltd File No. 01/82/050/00056/AM 12 RLA No.03/95/040/00949/AM 11 Adv.Auth. No. 0310620143 dt. 08.03.2011

Decision: The Committee considered the case for ratification of norms as per agenda and decided to defer the case for want of comments of DoP.

Case No. B- 13

M.No.11/16 Date 28.10.2015

M/s. KLJ Plasticizers Ltd File No. 01/82/050/00831/AM 15 RLA No.05/23/040/00214/AM 15 Adv.Auth. No. 0510390804 dt. 28.08.2014

Decision: The Committee considered the case for revision of norms and decided to defer the case for want of comments of DC&PC (Chemicals).


Verbatim extracted text (OCR/PDF). Older scans and tables may show extraction artifacts — verify against the original for anything you act on.

Analysis

No analysis has been generated for this document yet.

Citation copied