IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

Office of Directorate General of Foreign Trade
New Delhi -0

Para 4.7 Decision

Meeting No. 14/82/2015 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, was held on 16.12.2015 under the Chairmanship of Dr. S.K. Bansal, Jt. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

Shri Nirmal Kumar, Dy.DGFT Shri A.K. Aggarwal, Addl. Indl. Advisor, DC&PC 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. 13/82 was scheduled for 27.11.2015 but actually held on 4.12.2015 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.

MEETING NUMBER
: 14/82-ALC4/2015 MEETING DATE : 16.12.2015

Case No.:14/24/82-ALC4/2010 Party Name:SAINOR

LABORATORIES PVT LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Rejected HQ File :01/82/050/00814/AM11/
RLA File :09/24/040/00210/AM11/
Lic.No/Date:0910043414 08.09.2010 Defer Date: Decision :The Committee noted that information had been called for from the firm by NC in its meeting No.18/82 dated18.2.2015 but information has not been received so far despite repeated reminders. The Committee accordingly decided to reject the case. RA concerned may take further necessary action as per decision of NC.

Case No.:173/14/82-

ALC4/2015
Party Name:NEOGEN CHEMICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01309/AM16/
RLA File :03/95/040/00881/AM10/
Lic.No/Date:0310726567 04.03.2013 Defer Date:14.01.2016 Decision :The Committee considered the case for ratification of Norms and decided defer the case for want of comments of DCPC.

Case No.:43/16/82-ALC4/2013 Party Name:SYMBIOTEC

PHARMALAB LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Rejected

HQ File :01/82/050/00856/AM14/
RLA File :56/24/040/00017/AM14/
Lic.No/Date:5610002765 03.09.2013 Defer Date: Decision : The Committee noted that information has been called for from the firm by NC in its meeting No.8/82 dated 16.09.2015 but reply has not been received so far despite repeated reminders. The Committee accordingly decided to reject the case. RA

Case No.:374/5/82-ALC4/2015 Party Name:SURVIVAL

TECHNOLOGIES PVT.LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00514/AM16/
RLA File :03/95/040/01015/AM14/
Lic.No/Date:0310775114 20.03.2014 Defer Date: Decision : The Committee decided to ratify norms for the export product based on the recommendation of D/o C&PC, forwarded vide U.O.No.14010/62/2010-Ch-II dated 2.12.2015 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.:52/6/82-ALC4/2014 Party Name:UPL LTD.

Meet No/Date:14/82- ALC4/2015 16.12.2015 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:14.01.2016 the case for want of comments of DCPC.

Case No.:71/5/82-ALC4/2014 Party Name:ARIHANTANAM

LIFECARE PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00388/AM15/
RLA File :03/94/040/00076/AM15/
Lic.No/Date:0310780901 07.05.2014 Defer Date: earlier decision taken by NC in its meeting No.3/82 dated 8.5.2014, 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.:238/6/82-

ALC4/2014
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00640/AM15/
RLA File :17/24/040/00008/AM15/
Lic.No/Date:1710005810 09.05.2014 Defer Date:14.01.2016 the case for want of comments of DCPC.

Case No.:121/14/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01257/AM16/
RLA File :17/24/040/00006/AM15/
Lic.No/Date:1710005809 09.05.2014 Defer Date:14.01.2016 the case for want of comments of DCPC.

Case No.:88/6/82-ALC4/2014 Party Name:UPL

LTD.(FORMERLY UNITED PHOSPHORUS LTD.) Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00490/AM15/
RLA File :03/95/040/00033/AM15/
Lic.No/Date:0310782129 20.05.2014 Defer Date:14.01.2016 the case for want of comments of DCPC

Case No.:61/4/82-ALC4/2014 Party Name:V & V PHARMA

INDUSTRIES Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00309/AM15/
RLA File :03/95/040/00190/AM15/
Lic.No/Date:0310785305 13.06.2014 Defer Date:14.01.2016 Decision : The Committee considered the case for ratification of Norms and decided defer the case for want of comments of DCPC

Case No.:164/6/82-

ALC4/2014
Party Name:VDH CHEM TECH PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00566/AM15/
RLA File :05/24/040/00085/AM15/
Lic.No/Date:0510388792 18.06.2014 Defer Date:14.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC, letter No.14010/58/2010-Ch-II dated 24.3.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:69/4/82-ALC4/2014 Party Name:RA CHEM

PHARMA LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00317/AM15/
RLA File :09/24/040/00175/AM15/
Lic.No/Date:0910060550 27.06.2014 Defer Date:14.01.2016 Decision :It was decided to remind RA and firm to forward a copy of application alongwith technical details to consider the case for ratification of norms.

Case No.:73/9/82-ALC4/2014 Party Name:D. R. COATS INK

& RESINS PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00870/AM15/
RLA File :03/94/040/00755/AM14/
Lic.No/Date:0310786181 30.06.2014 Defer Date:14.01.2016

the case for want of comments of DCPC.

Case No.:370/5/82-

ALC4/2015
Party Name:HETERO LABS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00510/AM16/
RLA File :09/24/040/00193/AM15/
Lic.No/Date:0910060634 09.07.2014 Defer Date:14.01.2016 the case for want of comments of DoP.

Case No.:79/9/82-ALC4/2014 Party

Name:METROPOLITAN EXIMCHEM LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00876/AM15/
RLA File :03/95/040/00337/AM15/
Lic.No/Date:0310787073 18.07.2014 Defer Date:14.01.2016 the case for want of comments of DCPC.

Case No.:24/9/82-ALC4/2014 Party Name:BRUNDAVAN

LABORATORIES PRIVATE LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Rejected HQ File :01/82/050/00821/AM15/
RLA File :09/24/040/00104/AM15/
Lic.No/Date:0910060703 22.07.2014 Defer Date: Decision :The firm vide letter No. BLPL/JDGFT/Lansulphide/2015-16 dated 10.12.2015 has informed that they are surrendering said authorisation. They have stopped manufacturing the product applied. Therefore, the Committee decided to withdraw the case.

Case No.:396/5/82-

ALC4/2015
Party Name:ESTEEM INDUSTRIES PVT. LTD, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00536/AM16/
RLA File :17/24/040/00047/AM15/
Lic.No/Date:1710005887 24.07.2014 Defer Date:14.01.2016 the case for want of comments of DCPC.

Case No.:8/6/82-ALC4/2014 Party Name:V & V PHARMA

INDUSTRIES Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00410/AM15/
RLA File :03/95/040/00331/AM15/
Lic.No/Date:0310787382 28.07.2014 Defer Date:14.01.2016 Decision :The Committee considered the case for ratification of Norms and decided to defer the case for want of comments of DCPC.

Case No.:209/13/82-

ALC4/2014
Party Name:AVA CHEMICALS PVT.LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Rejected HQ File RLA File Lic.No/Date:0310787473 Defer Date:

:01/82/050/01212/AM15/
:03/94/040/00379/AM15/
31.07.2014 Decision :The Committee noted that information has been called for from the firm by NC in its meeting No.1/82 dated 15.4.2015 followed by reminder dated 20.5.2015, reply has not been received so far. The Committee accordingly decided to reject the case. RA

Case No.:58/9/82-ALC4/2014 Party Name:G AMPHRAY

LABORATORIES, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00855/AM15/
RLA File :03/94/040/00171/AM15/
Lic.No/Date:0310787536 01.08.2014 Defer Date:14.01.2016 Decision :The Committee noted that copy of application received from the firm is incomplete. Accordingly it was decided to remind RA for forward complete set of application to consider the case for ratification of norms.

Case No.:49/9/82-ALC4/2014 Party Name:SANMAR

SPECIALITY CHEMICALS LIMITED, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00846/AM15/
RLA File :04/24/040/00106/AM15/
Lic.No/Date:0410159125 01.08.2014 Defer Date:14.01.2016 Decision :The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

Case No.:31/9/82-ALC4/2014 Party Name:AMBERNATH

ORGANICS PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00828/AM15/
RLA File :03/94/040/00074/AM15/
Lic.No/Date:0310787610 04.08.2014 Defer Date:14.01.2016 Decision :The Committee considered the case for ratification of Norms and decided send a copy of application to DCPC.

Case No.:44/9/82-ALC4/2014 Party Name:INTAS

PHARMACEUTICALS LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00841/AM15/
RLA File :08/24/040/00173/AM15/
Lic.No/Date:0810132883 04.08.2014 Defer Date:14.01.2016 Decision :The Committee noted that information call for from the firm by NC in its meeting No.08/82 dated 16.9.2015 is awaited. The Committee accordingly deferred the case.

Case No.:373/5/82-

ALC4/2015
Party Name:NECTAR LIFESCIENCES LIMITED, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00513/AM16/
RLA File :22/24/040/00039/AM15/
Lic.No/Date:2210015055 06.08.2014 Defer Date:14.01.2016 Decision :The Committee decided to defer the case for want of comments of DoP.

Case No.:203/5/82-ALC4/2015 Party Name:ALKALOIDS

CORPORATION Meet No/Date:14/82- ALC4/2015 16.12.2015 Status: Case Deferred HQ File :01/82/050/00343/AM16/
RLA File :02/24/040/00080/AM15/
Lic.No/Date:0210204732 07.08.2014 Defer Date: 27.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/436/2015-PI(Norms) dated October 2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:2/14/82-ALC4/2015 Party Name:SHREE

SHIVSHANKAR DRUGS & PHARMACEUTICALS P. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01138/AM16/
RLA File :03/95/040/00425/AM15/
Lic.No/Date:0310788055 14.08.2014 Defer Date:14.01.2016 Decision :: The Committee considered the case for ratification of norms and deferred the case of want of comments of DoP.

Case No.:48/5/82-ALC4/2015 Party Name:VISION DRUGS

PVT LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00188/AM16/
RLA File :09/24/040/00260/AM15/
Lic.No/Date:0910060860 18.08.2014 Defer Date:14.01.2016

Case No.:127/14/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/01263/AM16/
RLA File :09/24/040/00267/AM15/
Lic.No/Date:0910060868 20.08.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/483/2015- PI(Norms)dated Nov. 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.:215/13/82-

ALC4/2014
Party Name:GOLD STAR CHEMICALS PVT.LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01218/AM15/
RLA File :03/94/040/00358/AM15/
Lic.No/Date:0310788338 25.08.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:264/13/82-

ALC4/2014
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01267/AM15/
RLA File :03/94/040/00405/AM15/
Lic.No/Date:0310788397 26.08.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:255/13/82-

ALC4/2014
Party Name:THE DHARAMSI MORARJI CHEMICAL CO LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01258/AM15/
RLA File :03/95/040/00431/AM15/
Lic.No/Date:0310788373 26.08.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:382/5/82-

ALC4/2015
Party Name:ALEMBIC PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00522/AM16/
RLA File :34/24/040/00129/AM15/
Lic.No/Date:3410040491 27.08.2014 Defer Date:14.01.2016

Case No.:377/5/82-

ALC4/2015
Party Name:ENCUBE ETHICALS PVT LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00517/AM16/
RLA File :03/94/040/00493/AM15/
Lic.No/Date:0310788472 27.08.2014 Defer Date:14.01.2016

Case No.:224/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01227/AM15/
RLA File :03/94/040/00391/AM15/
Lic.No/Date:0310788515 28.08.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:225/13/82-

ALC4/2014
Party Name:DELTA FINOCHEM PVT.LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01228/AM15/
RLA File :03/94/040/00397/AM15/
Lic.No/Date:0310788514 28.08.2014 Defer Date:14.01.2016 DC&PC(Chemicals).

36 Case No.:262/13/82- ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:14/82- ALC4/2015 Status:Case Deferred

16.12.2015 HQ File :01/82/050/01265/AM15/
RLA File :03/94/040/00971/AM14/
Lic.No/Date:0310788560 01.09.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:263/13/82-

ALC4/2014
Party Name:ANTHEA AROMATICS PVT.LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01266/AM15/
RLA File :03/94/040/00962/AM14/
Lic.No/Date:0310788558 01.09.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:223/13/82-

ALC4/2014
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01226/AM15/
RLA File :03/94/040/00508/AM15/
Lic.No/Date:0310788647 02.09.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:3/7/82-ALC4/2014 Party Name:S V CHEM

INTERMEDIATES P LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00647/AM15/
RLA File :04/24/040/00139/AM15/
Lic.No/Date:0410159328 02.09.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:398/5/82-ALC4/2015 Party Name:YASH RASAYAN

& CHEMICALS Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00538/AM16/
RLA File :34/24/040/00122/AM15/
Lic.No/Date:3410040555 15.09.2014 Defer Date: Decision :already approved in NC.3 meeting no. 13/82 dated 27.11.2015.

Case No.:400/5/82-

ALC4/2015
Party Name:YASH RASAYAN & CHEMICALS Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00540/AM16/
RLA File :34/24/040/00120/AM15/
Lic.No/Date:3410040554 15.09.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:12/15/82-

ALC4/2014
Party Name:JINDAL DRUGS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred

HQ File :01/82/050/01299/AM15/
RLA File :03/94/040/00460/AM15/
Lic.No/Date:0310789265 16.09.2014 Defer Date:14.01.2016 Decision : DCPC has informed that information has been called for from the firm is awaited. The Committee accordingly, decided await the reply and deferred the case.

Case No.:380/5/82-

ALC4/2015
Party Name:THEON PHARMACEUTICALS LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00520/AM16/
RLA File :22/24/040/00054/AM15/
Lic.No/Date:2210015086 16.09.2014 Defer Date:14.01.2016 Pharmaceuticals vide O.M.35011/343/2015-PI(Norms) dated November 2015, uploaded deferred the case.

Case No.:59/13/82-

ALC4/2014
Party Name:HELLO PAINTS (P) LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01062/AM15/
RLA File :05/23/040/00276/AM15/
Lic.No/Date:0510391245 19.09.2014 Defer Date:14.01.2016 Decision : It was decided to send a copy to application to DCPC.

Case No.:49/5/82-ALC4/2015 Party Name:VISION DRUGS

PVT LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00189/AM16/
RLA File :09/24/040/00336/AM15/
Lic.No/Date:0910061013 23.09.2014 Defer Date:14.01.2016

Case No.:372/5/82-

ALC4/2015
Party Name:DR J PHARMACHEM (INDIA)(PROP.ADITYA PRAMOD JOGDEO) Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00512/AM16/
RLA File :31/83/040/00154/AM15/
Lic.No/Date:3110064948 08.10.2014 Defer Date:14.01.2016 Decision :It was decided to send a copy of application to DCPC.

Case No.:29/13/82-

ALC4/2014
Party Name:JUBILANT LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01032/AM15/
RLA File :05/23/040/00268/AM15/
Lic.No/Date:0510391490 08.10.2014 Defer Date:14.01.2016 Decision :The Committee considered the case for ratification of Norms and decided to defer the case for want of comments of DCPC.

48 Case No.:356/5/82-ALC4/2015 Party Name:GLAND PHARMA Meet No/Date:14/82- Status:Case

LIMITED ALC4/2015 16.12.2015 Approved HQ File :01/82/050/00496/AM16/
RLA File :09/24/040/00350/AM15/
Lic.No/Date:0910061069 09.10.2014 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/474/2013- PI(Norms) March 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.

Case No.:350/5/82-

ALC4/2015
Party Name:AMBE PHYTOEXTRACTS PVT.LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00490/AM16/
RLA File :05/23/040/00238/AM15/
Lic.No/Date:0510391555 13.10.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:171/13/82-

ALC4/2014
Party Name:PRASOL CHEMICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01174/AM15/
RLA File :03/95/040/00588/AM15/
Lic.No/Date:0310790482 22.10.2014 Defer Date:14.01.2016 Decision : The Committee decided to defer the case for want of comments of DC&PC(Chemicals)

Case No.:352/5/82-ALC4/2015 Party Name:VIVIMED LABS

LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00492/AM16/
RLA File :09/24/040/00398/AM15/
Lic.No/Date:0910061128 22.10.2014 Defer Date: Decision : Already approved in NC.3 meeting no. 10/82 dated 15.10.2015.

Case No.:393/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00533/AM16/
RLA File :09/24/040/00387/AM15/
Lic.No/Date:0910061210 11.11.2014 Defer Date:14.01.2016 Decision :Committee decided to defer the case for want of comment from the DOP.

Case No.:198/5/82-

ALC4/2015
Party Name:SHASUN PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00338/AM16/
RLA File :04/24/040/00205/AM15/
Lic.No/Date:0410159704 11.11.2014 Defer Date:14.01.2016 Decision :The Committee decided to defer the case for want of comments of DoP

Case No.:126/8/82-

ALC4/2015
Party Name:BAYER CROPSCIENCE LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00922/AM16/
RLA File :03/94/040/00710/AM15/
Lic.No/Date:0310791177 18.11.2014 Defer Date:14.01.2016

Case No.:355/5/82-

ALC4/2015
Party Name:GRANULES INDIA LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00495/AM16/
RLA File :09/24/040/00433/AM15/
Lic.No/Date:0910061297 25.11.2014 Defer Date:14.01.2016

Case No.:94/13/82-

ALC4/2014
Party Name:HETERO DRUGS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01097/AM15/
RLA File :09/24/040/00469/AM15/
Lic.No/Date:0910061300 25.11.2014 Defer Date:14.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/143/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:126/5/82-

ALC4/2015
Party Name:IND-SWIFT LABORATORIES LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00266/AM16/
RLA File :22/24/040/00074/AM15/
Lic.No/Date:2210015136 28.11.2014 Defer Date:14.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M.35011/162/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:362/5/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00502/AM16/
RLA File :05/23/040/00377/AM15/
Lic.No/Date:0510392211 28.11.2014 Defer Date:14.01.2016

59 Case No.:154/5/82- ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:14/82- ALC4/2015 Status:Case Deferred

16.12.2015 HQ File :01/82/050/00294/AM16/
RLA File :03/95/040/00740/AM15/
Lic.No/Date:0310791735 05.12.2014 Defer Date:14.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/330/2015-PI(Norms) dated November 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:279/13/82-

ALC4/2014
Party Name:HONOUR LAB LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01282/AM15/
RLA File :09/24/040/00510/AM15/
Lic.No/Date:0910061362 09.12.2014 Defer Date:14.01.2016

Case No.:139/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00279/AM16/
RLA File :03/94/040/00872/AM15/
Lic.No/Date:0310791890 10.12.2014 Defer Date:14.01.2016

Case No.:145/5/82-

ALC4/2015
Party Name:JINDAL DRUGS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00285/AM16/
RLA File :03/94/040/00877/AM15/
Lic.No/Date:0310792112 17.12.2014 Defer Date:14.01.2016 Decision :The Committee decided to defer the case for want of comments of DCPC

Case No.:130/5/82-

ALC4/2015
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00270/AM16/
RLA File :03/95/040/00652/AM15/
Lic.No/Date:0310792103 17.12.2014 Defer Date:14.01.2016

Case No.:127/5/82-

ALC4/2015
Party Name:EMAMI LIMITED, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00267/AM16/
RLA File :02/24/040/00183/AM15/
Lic.No/Date:0210205355 18.12.2014 Defer Date:14.01.2016 Decision :The Committee decided to call for copy of DML from the firm and deferred the case.

65 Case No.:133/5/82- Party Name:AARTI Meet No/Date:14/82- Status:Case

ALC4/2015
INDUSTRIES LIMITED ALC4/2015 16.12.2015 Deferred HQ File :01/82/050/00273/AM16/
RLA File :03/94/040/00883/AM15/
Lic.No/Date:0310792178 19.12.2014 Defer Date:14.01.2016

Case No.:224/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00364/AM16/
RLA File :09/24/040/00531/AM15/
Lic.No/Date:0910061427 22.12.2014 Defer Date:14.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/412/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:136/5/82-

ALC4/2015
Party Name:AVIGNON EXIM PVT.LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00276/AM16/
RLA File :03/94/040/00843/AM15/
Lic.No/Date:0310792314 23.12.2014 Defer Date:14.01.2016

Case No.:96/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

& PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00236/AM16/
RLA File :03/94/040/00912/AM15/
Lic.No/Date:0310792310 23.12.2014 Defer Date:14.01.2016

Case No.:221/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00361/AM16/
RLA File :09/24/040/00537/AM15/
Lic.No/Date:0910061442 23.12.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:114/5/82-

ALC4/2015
Party Name:NATIONAL TUBE INDUSTRIES, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00254/AM16/
RLA File :03/95/040/00756/AM15/
Lic.No/Date:0310792363 24.12.2014 Defer Date:14.01.2016 Decision :Information has been received and sent to DC&PC (petrochemicals). The Committee decided to defer the case for want of comments of DC&PC(Petrochemicals)

Case No.:218/5/82-

ALC4/2015
Party Name:VIVIMED LABS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00358/AM16/
RLA File :09/24/040/00552/AM15/
Lic.No/Date:0910061462 29.12.2014 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:134/5/82-ALC4/2015 Party Name:BDR

PHARMACEUTICALS INTERNATIONAL PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00274/AM16/
RLA File :03/94/040/00712/AM15/
Lic.No/Date:0310792545 01.01.2015 Defer Date:

recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/399/2015- PI(Norms) 18.12.2015 , 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.:137/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00277/AM16/
RLA File :03/94/040/00931/AM15/
Lic.No/Date:0310792547 01.01.2015 Defer Date:14.01.2016 Decision : The Committee decided to defer the case for want of comments of DOP.

Case No.:138/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00278/AM16/
RLA File :03/94/040/00920/AM15/
Lic.No/Date:0310792544 01.01.2015 Defer Date:14.01.2016 Pharmaceuticals vide O.M.35011/395/2015-PI(Norms) dated 17.12.2015 , uploaded deferred the case.

Case No.:84/5/82-ALC4/2015 Party Name:SHIVA

PHARMACHEM LTD, Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00224/AM16/
RLA File :34/24/040/00259/AM15/
Lic.No/Date:3410040852 01.01.2015 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:105/5/82-ALC4/2015 Party Name:CROWN

CHEMICALS PVT.LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00245/AM16/
RLA File :03/94/040/00864/AM15/
Lic.No/Date:0310792569 02.01.2015 Defer Date: Decision :Already approved in NC.3 meeting no. 12/82 dated 18.11.2015

Case No.:106/5/82-ALC4/2015 Party Name:CROWN

CHEMICALS PVT.LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00246/AM16/
RLA File :03/94/040/00863/AM15/
Lic.No/Date:0310792568 02.01.2015 Defer Date: Decision : Already approved in NC.3 meeting no. 12/82 dated 18.11.2015

Case No.:45/5/82-ALC4/2015 Party Name:SUVEN LIFE

SCIENCES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00185/AM16/
RLA File :09/24/040/00558/AM15/
Lic.No/Date:0910061483 05.01.2015 Defer Date:14.01.2016

Case No.:102/5/82-

ALC4/2015
Party Name:ALTA LABORATORIES LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00242/AM16/
RLA File :03/94/040/00836/AM15/
Lic.No/Date:0310792635 07.01.2015 Defer Date:14.01.2016 a copy of application to DCPC

Case No.:74/5/82-ALC4/2015 Party Name:NEW ALLIANCE

DYE-CHEM PVT. LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00214/AM16/
RLA File :03/95/040/00833/AM15/
Lic.No/Date:0310792647 07.01.2015 Defer Date:14.01.2016 a copy of application to DCPC

Case No.:149/5/82-

ALC4/2015
Party Name:ALCHEMIE LABORATORIES Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00289/AM16/
RLA File :03/94/040/00813/AM15/
Lic.No/Date:0310792673 08.01.2015 Defer Date:14.01.2016 a copy of application to DCPC

Case No.:121/5/82-

ALC4/2015
Party Name:UNIJULES LIFE SCIENCES LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred

HQ File :01/82/050/00261/AM16/
RLA File :03/95/040/00835/AM15/
Lic.No/Date:0310792685 08.01.2015 Defer Date:14.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/345/2015-PI(Norms) dated November, 2015 ,

Case No.:219/5/82-

ALC4/2015
Party Name:BHAGIRADHA CHEMICALS & INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00359/AM16/
RLA File :09/24/040/00549/AM15/
Lic.No/Date:0910061517 09.01.2015 Defer Date:14.01.2016 DC&PC(Chemicals)

Case No.:239/5/82-

ALC4/2015
Party Name:MYLAN LABORATORIES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00379/AM16/
RLA File :09/24/040/00555/AM15/
Lic.No/Date:0910061520 09.01.2015 Defer Date:14.01.2016 Decision :Information called for from the firm is awaited.

Case No.:141/5/82-

ALC4/2015
Party Name:AARTI INDUSTRIES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00281/AM16/
RLA File :03/94/040/00746/AM15/
Lic.No/Date:0310792870 13.01.2015 Defer Date:14.01.2016

Case No.:151/5/82-

ALC4/2015
Party Name:AGIO PHARMACEUTICALS LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00291/AM16/
RLA File :03/94/040/00902/AM15/
Lic.No/Date:0310792875 13.01.2015 Defer Date:14.01.2016 Decision :The committee decided to defer the case for want of comments of DoP

Case No.:119/5/82-

ALC4/2015
Party Name:SHALINA LABORATORIES PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00259/AM16/
RLA File :03/95/040/00843/AM15/
Lic.No/Date:0310792869 13.01.2015 Defer Date:14.01.2016 Decision : The Committee based on the written comments forwarded by the D/o Pharmaceuticals vide O.M. 35011/330/2015-PI(Norms) dated November 2015, uploaded deferred the case.

Case No.:59/5/82-ALC4/2015 Party Name:ANTHEA

AROMATICS PVT.LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00199/AM16/
RLA File :03/94/040/00793/AM15/
Lic.No/Date:0310792911 14.01.2015 Defer Date:14.01.2016 a copy of application to DCPC

Case No.:243/5/82-

ALC4/2015
Party Name:SUVEN LIFE SCIENCES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00383/AM16/
RLA File :09/24/040/00589/AM15/
Lic.No/Date:0910061530 14.01.2015 Defer Date:14.01.2016 Pharmaceuticals vide O.M. 35011/447/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

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

PRIVATE LIMITED. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case
Deferred HQ File :01/82/050/00212/AM16/
RLA File :03/95/040/00658/AM15/
Lic.No/Date:0310793017 16.01.2015 Defer Date:27.01.2016 Decision : The Committee decided to defer the case for want of comment of DoP.

Case No.:35/4/82-ALC4/2015 Party Name:UNICHEM

LABORATORIES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00074/AM16/
RLA File :03/95/040/00825/AM15/
Lic.No/Date:0310793002 16.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/315/2015- PI(Norms) date November 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.:52/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00192/AM16/
RLA File :03/94/040/00953/AM15/
Lic.No/Date:0310793104 20.01.2015 Defer Date:14.01.2016 Decision The Committee decided to defer the case for want of comment of DoP.

Case No.:147/5/82-ALC4/2015 Party Name:INDOCO

REMEDIES LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved

HQ File :01/82/050/00287/AM16/
RLA File :03/94/040/00964/AM15/
Lic.No/Date:0310793105 20.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/377/2015- PI(Norms) date 7th November 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.:88/5/82-ALC4/2015 Party Name:ABEERS

PHARMACEUTICALS PVT LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00228/AM16/
RLA File :05/23/040/00486/AM15/
Lic.No/Date:0510392949 21.01.2015 Defer Date:14.01.2016 Decision :The committee decided to defer the case for want of comments of AYUSH

Case No.:131/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00271/AM16/
RLA File :03/94/040/00988/AM15/
Lic.No/Date:0310793181 21.01.2015 Defer Date:14.01.2016 Decision : The Committee decided to defer the case for want of comment of DoP.

Case No.:10/16/82-ALC4/2014 Party Name:JODAS EXPOIM

PVT.LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01362/AM15/
RLA File :09/24/040/00529/AM15/
Lic.No/Date:0910061548 21.01.2015 Defer Date: 27.01.2016 Pharmaceuticals vide O.M. 35011/295/2015-PI(Norms) dated Oct. 2015 , uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

Case No.:76/5/82-ALC4/2015 Party Name:MELOG

SPECIALITY CHEMICALS PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00216/AM16/
RLA File :03/95/040/00891/AM15/
Lic.No/Date:0310793255 23.01.2015 Defer Date: recommendation of D/o C&PC forwarded vide U.O.No.14010/22/2012-Ch-II date
04.12.2015 , 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.

98 Case No.:204/5/82-ALC4/2015 Party Name:VIVIMED LABS LIMITED Meet No/Date:14/82- ALC4/2015 Status:Case deferred

16.12.2015 HQ File :01/82/050/00344/AM16/
RLA File :09/24/040/00596/AM15/
Lic.No/Date:0910061555 23.01.2015 Defer Date: 27.01.2016 Decision :The Committee decided to send a copy of application to DCPC.

Case No.:269/5/82-

ALC4/2015
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00409/AM16/
RLA File :03/94/040/01006/AM15/
Lic.No/Date:0310793301 27.01.2015 Defer Date:14.01.2016 Pharmaceuticals vide O.M.No.35011/396/2015-PI(Norms) dated 17.12.2015, uploaded deferred the case.

100

Case No.:13/4/82-ALC4/2015 Party Name:METROCHEM

API PVT. LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/00052/AM16/
RLA File :09/24/040/00586/AM15/
Lic.No/Date:0910061559 27.01.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/169/2015- PI(Norms) dated 16.09.2015, uploaded along with these minutes or as applied by the

101

Case No.:85/5/82-ALC4/2015 Party Name:V.D.H.

ORGANICS PVT. LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00225/AM16/
RLA File :05/24/040/00500/AM15/
Lic.No/Date:0510392989 27.01.2015 Defer Date:14.01.2016 Decision : The Committee based on the written comments forwarded by the D/o C&PC vide U.O.No. 14010/58/2010-Ch-II dated 14.08.2015, uploaded along with these minutes decided to call for technical information from the firm and deferred the case.

102

Case No.:163/5/82-

ALC4/2015
Party Name:RANBAXY LABORATORIES LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00303/AM16/
RLA File :05/24/040/00503/AM15/
Lic.No/Date:0510393026 29.01.2015 Defer Date:14.01.2016 Pharmaceuticals vide O.M.No.35011/338/2015-PI(Norms) dated November 2015,

103

Case No.:138/8/82-

ALC4/2015
Party Name:HEMMO PHARMACEUTICALS PRIVATE LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/00934/AM16/
RLA File :03/94/040/01099/AM14/
Lic.No/Date:0310793426 30.01.2015 Defer Date:14.01.2016 Decision :The committee deferred the case for want of comments of DoP.

104

Case No.:143/14/82-

ALC4/2015
Party Name:MOREPEN LABORATORIES LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/01279/AM16/
RLA File :05/24/040/00330/AM16/
Lic.No/Date:0510395931 15.10.2015 Defer Date: recommendation of D/o Pharmaceuticals forwarded vide O.M. No.35011/487/2015-PI(Norms) dated 14th November 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.

455

Case No.:119/14/82-

ALC4/2015
Party Name:VERVE HUMAN CARE LABORATORIES Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Rejected HQ File :01/82/050/01255/AM16/
RLA File :61/24/040/00012/AM16/
Lic.No/Date:6110001323 15.10.2015 Defer Date: Decision : The Committee noted that import item not mention in the application. The Committee decided to reject the case. RA concerned may take necessary action as per decision of NC.

456

Case No.:158/14/82-

ALC4/2015
Party Name:JODAS EXPOIM PVT.LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01294/AM16/
RLA File :05/23/040/00305/AM16/
Lic.No/Date:0510395945 16.10.2015 Defer Date:14.01.2016

457

Case No.:137/14/82-

ALC4/2015
Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01273/AM16/
RLA File :05/23/040/00275/AM16/
Lic.No/Date:0510395972 19.10.2015 Defer Date:14.01.2016

458

Case No.:156/14/82-

ALC4/2015
Party Name:SOFTGEL HEALTH CARE PVT. LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01292/AM16/
RLA File :04/24/040/00158/AM16/
Lic.No/Date:0410161133 20.10.2015 Defer Date:14.01.2016

459

Case No.:161/14/82-

ALC4/2015
Party Name:KAIRAV CHEMOFARBE INDUSTRIES LTD. Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01297/AM16/
RLA File :03/94/040/01226/AM15/
Lic.No/Date:0310799680 26.10.2015 Defer Date:14.01.2016

460

Case No.:146/14/82-

ALC4/2015
Party Name:KLJ PLASTICIZERS LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01282/AM16/
RLA File :05/23/040/00308/AM16/
Lic.No/Date:0510396019 26.10.2015 Defer Date:14.01.2016 recommendation of DCPC forwarded vide O.M. No.1401036/2011.CH-II 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.

461

Case No.:145/14/82-

ALC4/2015
Party Name:PAYAL PETROCHEM PRIVATE LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01281/AM16/
RLA File :05/24/040/00250/AM16/
Lic.No/Date:0510396054 29.10.2015 Defer Date:14.01.2016

462 Case No.:151/14/82- Party Name:PAYAL Meet No/Date:14/82- Status:Case

ALC4/2015
PETROCHEM PRIVATE LIMITED ALC4/2015 16.12.2015 Deferred HQ File :01/82/050/01287/AM16/
RLA File :05/24/040/00308/AM16/
Lic.No/Date:0510396056 29.10.2015 Defer Date:14.01.2016

463

Case No.:136/14/82-

ALC4/2015
Party Name:FRESENIUS KABI ONCOLOGY LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01272/AM16/
RLA File :05/23/040/00293/AM16/
Lic.No/Date:0510396078 30.10.2015 Defer Date:14.01.2016

464

Case No.:159/14/82-

ALC4/2015
Party Name:SUN PHARMACEUTICAL INDUSTRIES LTD., Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01295/AM16/
RLA File :05/24/040/00343/AM16/
Lic.No/Date:0510396075 30.10.2015 Defer Date:14.01.2016

465

Case No.:1/14/82-ALC4/2015 Party Name:HONOUR LAB

LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01137/AM16/
RLA File :09/24/040/00516/AM16/
Lic.No/Date:0910062901 26.11.2015 Defer Date:14.01.2016

466

Case No.:171/14/82-

ALC4/2015
Party Name:ALKYL AMINES CHEMICALS LTD Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01307/AM16/
RLA File :03/94/040/00533/AM16/
Lic.No/Date:0310800496 30.11.2015 Defer Date:16.12.2015

467

Case No.:172/14/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01308/AM16/
RLA File :09/24/040/00480/AM16/
Lic.No/Date:0910062921 02.12.2015 Defer Date: Decision : The Committee decided to defer the case for want of comments of DOP..

468

Case No.:174/14/82-

ALC4/2015
Party Name:AUROBINDO PHARMA LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Deferred HQ File :01/82/050/01310/AM16/
RLA File :09/24/040/00515/AM16/
Lic.No/Date:0910062931 03.12.2015 Defer Date:14.01.2016

469

Case No.:175/14/82-

ALC4/2015
Party Name:COVALENT LABORATORIES PRIVATE LIMITED Meet No/Date:14/82- ALC4/2015 16.12.2015 Status:Case Approved HQ File :01/82/050/01311/AM16/
RLA File :09/24/040/00471/AM16/
Lic.No/Date:0910062934 04.12.2015 Defer Date:14.01.2016 recommendation of DOP forwarded vide O.M. No.14010/360/2014.CH-II dated January, 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.

Manual Agenda of NC Meeting No.14/82/2015 Scheduled to be held on 16.12.2015

Case No. B- 01

M.No.14/AM-16 Date 16.12.2015

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 ratification of norms as per agenda. The Committee decided to ratify norms for the export product based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/36/2011-Ch-II 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.

Case No. B- 02

M.No.14/AM-16 Date 16.12.2015

M/s. Micro Lab Ltd File No. 01/82/50/00015/AM-15 RLA No.07/24/040/00318/AM14 Adv.Auth. No. 0710100791 dt. 23.12.2013

Decision: The Committee considered the case for ratification of norms as per agenda. The Committee decided to ratify norms for the export product as per SION or as applied by the firm whichever is less under para 4.07 of HBP Vol.1 as per details given below.

Amoxicillin 250 mg /caps SION A-54 Flucloxacilline 250 mg caps SION A-235 Amoxicillin 125 Oral suspension (125mg/5ml) SION A-56 Flucloxacillin 125 Oral suspension (125mg/5ml) SION A-237

RA concerned may take necessary action as per decision of NC.

Case No. B- 03

M.No.14/AM-16 Date 16.12.2015

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 norms as per agenda. The Committee decided to ratify norms for the export product based on the recommendation of D/o C&PC forwarded vide U.O.No.14010/70/2015-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.

Case No. B- 04

M.No.14/AM-16 Date 16.12.2015

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 defer the case for want of comment of DCPC

Case No. B- 05

M.No.14/AM-16 Date 16.12.2015

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 correction in ratified norms as per agenda. The Committee decided to defer the case for want of comments of DCPC.

Case No. B- 06

M.No.14/AM-16 Date 16.12.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/01098/AM 14 RLA No.03/94/040/00715/AM14 Adv.Auth. No.0310762311 dt. 18.12.2013

Decision: The Committee considered the case for correction in the description of export product as per agenda. The Committee decided to amend the description of import item no.2 to be read as ‘S-Propylene Oxide’ without any change in quantity.

Case No. B- 07

M.No.14/AM-16 Date 16.12.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/00950/AM 14 RLA No.03/94/040/00626/AM14 Adv.Auth. No.0310754842 dt. 22.10.2013

Decision: The Committee considered the case for correction in the description of export product as per agenda. The Committee decided to correct the description of export product to read as Astromusk concentrate (Astromusk Content: 100%) without any change in the quantity. RA

Case No. B- 08

M.No.14/AM-16 Date 16.12.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/00741/AM 13 RLA No.03/94/040/00222/AM13 Adv.Auth. No.0310706272 dt. 24.08.2012

Decision: The Committee considered the case for correction in the description of export product as per agenda. The Committee decided to send copy of representation of DCPC and deferred the case.

Case No. B- 09

M.No.14/AM-16 Date 16.12.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/00623/AM 13 RLA No.03/94/040/00363/AM13 Adv.Auth. No.0310704836 dt. 10.08.2012

Decision: The Committee considered the case for correction in the description of export product as per agenda. The Committee decided to send copy of representation of DCPC and deferred the case.

Case No. B- 10

M.No.14/AM-16 Date 16.12.2015

M/s. Camphor & Allied Products Ltd File No.01/82/050/01071/AM 13 RLA No.03/94/040/00543/AM13 Adv.Auth. No.0310712193 dt. 9.10.2012

Decision: The Committee considered the case for correction in the description of export product as per agenda. The Committee decided to send copy of representation of DCPC and deferred the case.

tQ lr+m;e ら |・≠ ヽ　）

Subject: Advance Authorization applications from M/s Survival Technologies pvt. Ltd for

the import of raw material against the export of rRlFLUoRoMErnnug sulFotttc ANHYDRTDE (TRtFLtc ANHYDRTDE) Ref: U.O. No. 01tA2l0SOh3O4,4tO,S14t AM_ 1s/DES_ily351, dated 3.7.2015 (Advance Authorization No.o3'r0788314dated 25.8.2015, 0310775114 dated2}.3.201 4 and 03 1 079389 1 dated 1 6.2.20 1 5) M/s survival rechnologies pvt. Ltd have submitted present apprication for the import of raw material against the export of TRTFLUoRoMETHANE sulFoNlc ANHYDRIDE (TRrFLlc ANHYDRTDE). The application has been examined and the Department recommends the following norms for the present Advance Authorization applications. Government of lndia Ministry of Chemicals and Fertilizers Department of Chemicals and petrochemicals 1 . ltem of Export Qty Item of lmport Qty TRIFLUOROMETHANE SULFONIC ANHYDRIDE ■TR FLIC ANHYDRIDE) l kg l TRIFLIC ACID (TRIFLUORO METHANE 壺 ∪LFONIC ACID) 2 425 kg L This issues with the approval of competent authority. (A K AGARWAL) Addl lndustrial Adviser Tel No 011-23381430 Deptt of C&Pc U o No 14010/62/2010-CH― ll dated 2122015

′[1 9,ハイ ⌒

Case No.:100/3/82¨ ALC4/2014 Party Name:ARIHANTANAM Mcet No/Date:3/82- Status:Case

LIFECARE PVT LTD ALC4/2014 Approved 08.052014 HQ File RLA Flle Lic_No/Date:0310768439 1Defer Date: :01/82/050/00104/AM15/ :03/94/040/00970/AM14/ 29012014 Decision:In the light of earHer decision taken in lnecting no.3/82 dated 02.05.2013,it 296 was dccided to ratitt nollllS under Para 4.7 of HBP vl as per details g市 en bclow or as applied by thc flrln,、vhichcver is less: Export product Exp Qtv SI No lmport items Qty. allowed Artemether l Kq Artemisinin 1 235 kq RA rnay take appropriate action as per the decision of Norms Committee.

1句|ろ “ ^)わ F No 14010/58/2010-CH― || Government ofindia Ministry of Chemicals and Fert‖ izers Department of Chemicals and Petrochemicals Shastri Bhavan,New Delhi-110001 Dated: 24th,March,2015 To, VDH Chem Tech Pvt Ltd, H-5,Near Saniay Park, Shakarpur, Delh卜110092 Sublecti Applicalon frOm M/s VDH Chem Tech Pvt Ltd fOr the import of raw― matenals againstthe export of BHT(Butylated Hydroxy Toluene) 1 I am directed to refer to your Advance Authorization application received through office of DGFT on the subject mentioned above.

of raw― matenals againstthe export of BHT(Butylated Hydroxy Toluene) 1 I am directed to refer to your Advance Authorization application received through office of DGFT on the subject mentioned above. ln this connection, you are requested to submit the following information within 15 days of the issue of this letter' Detailed manufacturing process with balanced chemical reactions indicating numuer ot moles oi all the reactants, products and by-products with corre+onOing molecular Formula, structurai formula, molecular weight and process flow diagram. 5i;;;:il; p;dntage yield with respect of each of the reactants and products ;ilih; relivant luitification enctosing therewith authentic printed technical literature in support of yield/ quantity of items for impgrt li"i"ifi "t OypioOucts fbrmed'during the process and their recovery in terms of ３　４ quantity and value. Details'of production of export product under reference -onsumption of raw material in the year 2013-14 and Septembefl duly certified by CA may be furnished Any other relevant information, if any and corresponding 2014-15(Apnl to 5 Coov tO:― 郎鼈 Addl lndustria!Adviser Tel No 011‐23381430 Shn Mahender Vikram Singh,FTDO(DES-3),in reference to DGFTノUONo― 01/82/050′ 566ノAM‐ 15/DES― |‖/1210,dated 3 03 2015

F. No.350l 1143612015-PI (Norms) Government of India Ministry of Chemical & Fertilizers Depaftment of Pharmaceutical s Udyog Bhawan, New Delhi. the October, 2015 Office Memorandum

Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case

of M/s Alkaloids Corporation Ltd. The undersigned is directed to refer to DGFT U.O.No. 01182/50/343/AM-16/DES-3/609 dated the l5lO7l15 vide which application from M/s. Alkaloids Corporation Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Digoxin (Digitalis Extract). This department has examined the matter and it is requested that DGFT may call following technical details from the firm viz:- (a) Actual content of Digoxin in Imported Digitalis Leares Supported by COA from Foreign Supplier. (b) Assay of Export Product. (c) Past production vis-ir-vis Actual consumption of Leares for last 3 years duly certified by Central Excise Authorities. (Raj Kumar) Under Secretary to the Government of India Phone:23071162 Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi クスを′ダ

uthorities. (Raj Kumar) Under Secretary to the Government of India Phone:23071162 Directorate General of Foreign Trade, Department of Commerce, (Shri M.V. Singh, FTDO), Udyog Bhawan, New Delhi クスを′ダ

F. No.350 I | /48312015-PI (Norms) Government of India Department of Pharmaceutical s Ne、v Delhi,the Udyog Bhawan, November. 2015 Office Memorandum Sub.iect: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501346/AM-l6|DES-31470 dated the 07107115 vide which application from lv{/s. Suven Life Sciences Ltd was sent to this Deparlment for fixation of norms under para: 4.7 for the export of 2r4-Dichloro Pyrimidine. 'fhis department has examined the matter and the following norms are furnished under para4.7 of Hand Book of Procedures (Vol.l) 2009-14:- つ４ (Raj Kumar) Phone:23071162 Directorate General of Foreign Trade. Department of Comrnerce, Udyog Bhawan. New Delhi ぐ//る― ,ぁ S,No. Import Item Qty. Recommended kg/kg. l Uraci [ (2.a-Dihydroxy Pyrimidine) 1.12 つ４ Phosphorous Oxychloride 1.53 3. Iriethylarnine 1.01

Sl, *t"- 43 F. No.3 50 | | 13431201 5-PI (Norms) Govemment of India Department of Pharmaceuticals New Delhi, the Udyog Bhawan, November, 2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l)

2009-14 Case of \zVs Theon Pharma Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215015201All4- l6IDES-3/189 dated the29106115 vide which application from M/s. Theon Pharma I-td was sent to this Department for fixation of norms under para: 4.7 for the export of Amoxicillin & Clavulanate Potassium Tablets USP. This department has examined the matter and it is requested that DGFT may call copy of valid DML from the firm for above export product. 2. (Raj Kumar) Phone:23071162 Departrrent of Commerce, Lldyog Bhawan, New Delhi

(1.*to 43 F. No.350'l 1147412O13-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated: March 10,2015 Office Memorandum Sub: Fixation of norms under para 4.7 of Hand Book of Procedures Application of M/s Gland Pharma Ltd. The undersigned is directed to refer to DGFT U.O. No. 01/82/50/01036/AM13/DES-3/146 dated the '14.05.20'13 vide which an application from M/s Gland Pharma Ltd. was fonauarded to this Department for fixation of norms for the export Nadroparin Calcium lnjections (Low Molecular Weight Heparin) 57001U/0.6m1 in Pre-Filled-Syringes. The matter has been examined and based upon the additional information fonararded by DGFT following observations are made:- The application is for import of 16 different raw materials against the export product referred above.

d and based upon the additional information fonararded by DGFT following observations are made:- The application is for import of 16 different raw materials against the export product referred above. Out of 16, there is one APl, 7 components and I reagents test kits or columns or reference standards that are used to carry out analysis as a part of quality control regime. As per the Foreign Trade Policy Advance Authorizations are issued to allow duty free impoft of inputs which are physically in expott product (making normal allowance for wastage). ln addition fuel, oil, energy and catalyst which are consumed utilized to obtain expott product may also be allowed. As such 8 raw materials to be used in analysis of the export product do not qualify to be allowed against present application. .....2t-

tttltb qg -2- 2. Based on the above, following norms are recommended against export of one pre-filled syringe of Nadroparin Calcium lnjections (Low Molecular Weight Heparin) 57001U/0.5m1 :- Ｌ　ｏＳＮ lmport ltems Qty. applied/ injection Qty.

wing norms are recommended against export of one pre-filled syringe of Nadroparin Calcium lnjections (Low Molecular Weight Heparin) 57001U/0.5m1 :- Ｌ　ｏＳＮ lmport ltems Qty. applied/ injection Qty. recommended Nadroparin Calcium 88 mg 52 25 rTlg 2. Barrel Syrinqes 1.28 nos. 1 0534 Nos 3. Needle Shield 1_28 nos. 1 0451 Nos. 4 Plunqer Stoppers 1 28 nos 1.1091 Nos. 5 Plunqer Rods 1.08 nos 1.0294 Nos. 6. Preventis 1.05 nos. 1.0500 Nos. 7 Anti― Factor Xa 丁est Kits 0 0001 nos. Not admissible 8 Anti― Factor‖ a ttest Kits 0 0001 nos. Not admissible 9 Analvtical Columns 0.00025 nos. Not admissible 10. Analytical Guard Columns 0 00025 nos. Not admissible Medical Grade Paper 09gm 0.9 gram 12. Tubing 0 02925 cms 0.02925 cms 13 Anti― Factor Xa 0 0000125 nos Not admissible 14 Anti― Factor‖ a 0.0000125 nos. Not admissible 15. N.M.R Standard 0 0000125 nos. Not adnlissible 16 Mol 1/Vt.Standard 0.0000125 nos. Not admissible 3. This issues with the approval of Director (Pharma lndustry). (Barnali Khastgir) Under Secretary to the Government of lndia Phone: 23385765 Directorate(3eneral of Forelgn Trade, Depattment of Commerce, (Shri M∨Singh,FTDO), Udyog Bhawan,New Delhi.

ma lndustry). (Barnali Khastgir) Under Secretary to the Government of lndia Phone: 23385765 Directorate(3eneral of Forelgn Trade, Depattment of Commerce, (Shri M∨Singh,FTDO), Udyog Bhawan,New Delhi.

（　　　（、Цヽμ― |も F. No.350 1 I I 1 4312015-PI (Norms) Government of India Ministry of Chemicals & Fertilizers Deparlnrent of Pharmaceuticals Udyog Bhawan"Nelr' Delhi. Dated the Octobcr. 201 5 Olllce Mernorandum Sub.iect: - Fixation of nornrs under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 (lase' of M/s Hetero l)rugs Ltd. 'f'lre undersignecl is directed to refbr to DGFT U.O.No. 0118215011097/nM-15/DES- 311293 dated the 0410311-5 vidc which application fiom M/s. Fletero Drugs Ltd was serrt to tlris Departrnent for flxation ol nonrls uncler para: 4.7 fbr the export of Pantoprazole Sodium Sesquihydrate. This departntent has examined the r.natter and it is recluestcd that DGIrT ntal' call fbllor.r'ing technical dctails fiom tlic f-irm viz:- (a) Cmplete techr-rical detail as per Appendix-33 showing Mol.wt. of input and outpttt products, Requirement & Recovery of solvents at each step of manufacturing process. (b) The yield in last step is very low. Technical.iustification alongwith copy of technical literature may be furnished in support of their yield. (c) Past production vis-ir-vis Actual consumption of all inported input duly certified by Central Excise Authorities. (Bamali Khastgir) Under Secretary to the Governntent of India Phone:23071 162 Department of Commerce. (Shri M.V. Singh, FTDO).

ion of all inported input duly certified by Central Excise Authorities. (Bamali Khastgir) Under Secretary to the Governntent of India Phone:23071 162 Department of Commerce. (Shri M.V. Singh, FTDO).

F. No.350 1 1 I 16212015-PI (Norms) Government of lndia Ministry ol- Chemicals & Fertilizers Department of Pharmacer,rticals el "b- ,V Udyog Bharvan.Nerv Delhi. Dated the Octobcr. 201 5 OI'llce Mentorartdunt Subject: - l--ixation cll'nornrs uncler pirra 4.7 ol'Hancl llook of I)roccdltres (Vol.l)l(X)()-l'l ('lse of Mis Ind-Sr.i'ili Labs [,tc1. 'l'lre unclersignccl is clircctccl to rcl'er to DGIfT LJ.O.No. 0118215011'+u0/Alvl-15/l)l:S- 311452 rlared the lll03ll-i vicle rvhich application f}onr M/s. Incl-Sw'iti l-abs Ltcl u'as sctlt to this Departrlent lbr flxation ol'nun.rrs r.rncler para:4.7 lbr the export ol'Clarithl'ontvcin (,lranules. 1'his dcpartntent has cxLulinccl the ntattcr uncl it is requesteci that DGIrT rttal call coltlplcte sct of application fi'onr the 1lrnr. (Barr-rali Khastgir) Under Secretary to the Governtlent of India Phone:23071 162 Directorate Gerteral of lroreign 'fracle. Departrlent of Cotlmerce. LJdyog Bllawan, New Delhi \r

on fi'onr the 1lrnr. (Barr-rali Khastgir) Under Secretary to the Governtlent of India Phone:23071 162 Directorate Gerteral of lroreign 'fracle. Departrlent of Cotlmerce. LJdyog Bllawan, New Delhi \r

⌒ l t4い円レlι F. No.350 1 1 13301201 5-PI (-l'iorms) Government of India New Delhi. the Udyog Bhawan, November. 2015 Office Memorandum Sub.iect: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Shalina Labs Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0118215012941AM-I6|DES-31147 dated the 17106115 vide which application from M/s. Shalina Labs Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Betasol Lotion 30m1. This departprent has examined the matter and it is requested that DGFT may call copy of Master- Batch fonnula duly authenticated by their Quality-control Incharge. (Raj Kumar) Phone:23071162 ..re

^ ′hl″ `´′ 6 9, tt"- 6e F. No.3 50 I I l4l2l20l5-Pl (Norms) Govemment of India Udyog Bhawan,New Delhi, Dated the October, 2015 Office Memorandum 2009-14 Case of IWs Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501383/AM- l61DE,S-31339 dated the O2lo7ll5 vide which application from M/s. Suven Life Sciences Ltd was sent to this Department for fixation of norms under para'. 4-7 fot the export of Penicillamine.

01383/AM- l61DE,S-31339 dated the O2lo7ll5 vide which application from M/s. Suven Life Sciences Ltd was sent to this Department for fixation of norms under para'. 4-7 fot the export of Penicillamine. This department has examined the matter and it is requesied that DGFT may call Past production vis-d-vis Actual consumption of all irnported inputs duly certified by Central Excise Authorities for the last 3 years period. (Barnali Khastgir) IJnder Secretary to the Governrtent of India Phone:23071162 udyog Bhawan, New Delhi .<

⌒ ) h)q'r-16 9/ ,h q-2-- F No.3501 1/399/201 5-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated the 1 8th December, 2015 Office Memorandum

subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-

14:Application fom M/s BDR Pharma lnternational Pvt Ltd The undersigned is directed to refer to DGFT U.O.No. O1l82l50l274lAM- 16/DES-3/488 dated the o8lo7t15 vide which application from M/s BDR Pharma lnternationaPvt. Ltd was sent to this Department for fixation of norms for the export of L-Asparaginase for injection, 1O,0OO lU per vial. This department has examined the matter and following norms are recommended against this application' sr No. Raw material to be imPorted Quantity Recommended 1 L-Asparaginase 50 mg per injection of '10,000 lU Phone:-23071162 (Shri M V. Singh, FTDO),

ヽ

r'|' -!( I L{ 14,", F. No 3501113951201s-Pl (Norms) Government of lndia Depa rtment of Pha rmaceutica ls ノ′外へ力 tr Shastri Bhawan, New Delhi, Dated the 17th December , 2O1S Office Memorandum Subject. - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009- 14 : Application from M/s J. B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01t82t5Ot27BtAM- 16/DES-3/410 dated the 07107115 vide an application from M/s J B Chemicals & Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the.export of Medi-keel an OTC range of products.

/DES-3/410 dated the 07107115 vide an application from M/s J B Chemicals & Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the.export of Medi-keel an OTC range of products. This department has examined the matter and it is requested that DGFT may call following document from the applicant:- Justification for classifying the export product under HS code 30049087. A copy of valid Drug Manufacturing License of FSSAI registration issued by the respective State Drug Controller or FSSAI indicating the composition of each Lozenge. Copy of Master Batch Formula for each export product. The justification about very high percentage claimed indicating the possibility of recycling the material stated to be lost during the manufacturing operations by the automatic Lozenges making machine. (Raj'Kumar) Phone:-23071162 ¨ ＝　Ｖ

,h I A"f4-t6 9, rto '! z- F. No.3501 I 1345 l20l 5-PI (Norms) Govemment of India New Delhi, the IJdyog Bhawan, November,2015 Office Memorandum 2009-14 Case of IWs lJnijeles Lifesciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501261/AM- l6lDES-31206 dated the 29106115 vide which application from M/s. Unijeles Lifesciences Ltd was sent to this Department for fixation of norms under pata: 4.7 for the export of Novatrizoate 76oh (Diatrizoate Sodium and Diatrizoate Meglumine Injection USP),20m1 Vial Kg.1000kg. This department has examined the matter and it is requested that DGFT may call copy of valid DML for the expott product. 2. l'his issues with the approval of competent authority. (Raj Kumar) Phone:23071162

artment has examined the matter and it is requested that DGFT may call copy of valid DML for the expott product. 2. l'his issues with the approval of competent authority. (Raj Kumar) Phone:23071162

F. No.350l 1133012015-Pl (Norms) Government of India New Delhi, the Udyog Bhawan, November,20l5 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case

of M/s Shalina Labs Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501294/AM-l61DES-31147 dated the 17106115 vide which application from iWs. Shalina Labs Pvt Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Betasol Lotion 30ml' This department has examined the matter and it is requested that DGFT may call copy of Master- Batch formula duly authenticated by their Quality-Control Incharge. (Raj Kumar) Phone:23071162 9,t/o BT

I ,', I t- -16 ″効‐89 F. No.350 I I l4l2l20l5-Pl (Norms) Govemment of India Udyog Bhawan,New Delhi, Dated the October, 2015 Office Memorandum 2009-14 Case of IWs Suven Life Sciences Ltd. The undersigned is directed to refer to DGFT U.O.No. 011821501383/AM- 16iDES-31339 dated the 02107115 vide which application from M/s. Suven Life Sciences Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Penicillamine. This department has examined the matter and it is requested that DGFT may call Past production vis-d-vis Actual consumption of all irnported inputs duly certified by Central Excise Authorities for the last 3 years period. (Barnali Khastgir) Phone:23071162

ハ ′ Ir. No.350I 1131512015-PI (Norms) Government of lndia Ministry of C'hemical & Fertilizers Departnrerrt of Pharmaceurticals ≦ヨヶノ 6‐ New Delhi. the Udyog Bhawan. November. 2015 Office Memorandurn

Subject: - Fixation of nornrs under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case

of M/s Unichem Labs Ltd. The undersigned is directed to ret'er to DGFT U.O.No. 01182150173/AM-16/DES-3/41 dated the 11106115 vide which application from M/s. Unichem Labs Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Clopidogrel 75mg'fablet. Tlris department has examined the matter ar-rd the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14:- (l{ai I(unrar) Under Secretary to the Govertttttettt ol- Inclia I'}hone:2i07l 1 62 Departnrent of Comrnerce. (Shri M.V. Singh, IrTDO). S.No. Imporl Itenr Qty. [{ecorn nrcrrclcrl. l Clopidogrel I lydrogen Sulphate 99.82rng/tablct ③

1切|めρ。 |ど /t F. No.3501 1137712015-PI (Nornts) (iovernment of lndia Ministry ol' Chemical & Fertilizers New Delhi. ttre ?fi gl xt, 41 I.Jdyog Bhawau. December. 201 5 Of1ice Memorandum Subiect: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case of M/s Indoco ltenredies Ltd. The undersigned is directed to refbr to DGFT U.O.No. 011821501287/AM-16/DES-3/45ti dated the O7l17ll5 vide which applicatiorr fiom M/s. Indoco Remedies Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Losartan Potassium 'I'ablet in i5mg, 50mg and 100mg.

O7l17ll5 vide which applicatiorr fiom M/s. Indoco Remedies Ltd was sent to this Department for fixation of norms under para: 4.7 for the export of Losartan Potassium 'I'ablet in i5mg, 50mg and 100mg. This department has examined the matter and the tbllowing rlornrs are frrrnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 - Export products Norms Recommendecl fbr onc tablet l-osartan Potassiunr 25 nrg f ilm coated tablets 25.5 nrg Losartan PotassiLrtll l-osartan Potassium 50 rlrg fllrn coatecl tablets 5l.00 mg Losartatr Potassiunr l-osartan Potassium l00 mg lllru coatccl tablets 102 nrg Losartatt Potassirttl-t n つ一 This issues with the approval ol'conlpetent authority. (t{a.i KLrnrar) Under Secretary to the Governmetrt o1-lndia Phonc:23071162 (Shri M.V. Singh. FTDO). LJdyog Bhawan. New Delhi

⌒ rr.r )A u*\L Government of lndia

Subject: Advance Authorization application from M/s MELOG SPECIALITY CHEMICALS P.

Ltd. for the import of raw material against the export of PHENIX ACID (Advance Authorization No. 0310793255 dated 23.01.2015) M/s. MELOG SPECIALITY CHEMICALS P. Ltd.have submitted present applications for the import of raw material against the export of PHENIX ACID The applications have been examined and the Department recommends the following norms for the present Advance Authorization applications,

ltem of Export Qtv. Item of lmport Qty PHENIX ACID l kg 1.2,6 Di-Tert Butyl Phenol 1.285 kg. 2.Methanol 1.104 kg (A.K AGARWAL) Addl.lndustrial Advlser Tel.No.011-23381430 Shtt Mahender Vikram Singh,FTDO,(DES¨ |||)Oノo DGFT,Udvog Bhawan,New Delhi-11. Deptt.of C&PC UoO.No.14010/22/2012-CH― |l dated 4.12.2015

F. No.3501'l /39612015-Pl (Norms) Government of lndia Shastri Bhawan, New Delhi, Dated the 17th December,2015 Office Memorandum

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-

Application from M/s J. B. Chemicals & Pharmaceuticals Ltd. The undersigned is directed to refer to DGFT U.O.No. 01/82l50/409/AM- 16iDES-3/407 dated the 07107115 vide an application from M/s J B Chemicals & Pharmaceuticals Ltd. was sent to this Department for fixation of norms for the export of Difflam AAA sugar free flavored lozenges. This department has examined the matt5r and it is requested that DGFT may call following document from the applicant:- i) Justification for classifying the export product under HS code

ii) A copy of valid Drug Manufacturing License of FSSAI registration issued by the respective State Drug Controller or FSSAI indicating the composition of each Lozenge. iii) Copy of Master Batch Formula for each export product. iv) The justification about very high percentage claimed indicating the possibility of recycling the material stated to be lost during the manufacturing operations by the automatic Lozenges making mach ine. (Raj KumaQ Phone:-2307'1 162 (Shri MV Singh,FTDO),

a) F. No.350l t/2g5l2Ol5-PI fi'6rms) Government of Indla Udyog Bhawan, New Delhi, the October,2015 Office Mgmgrand.um

Subject: - Fixation of norms under para 4.7 of Hand Book of Procedures (Vol.l) 2009-14 Case

of IWs Jodas Expoim Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l1367lAM-L51DES-3/24 dated the 0l/05/15 vide which application from IWs. Jodas Expoim Pvt Ltd was sent to this Department for fixation of norms under para:4.7 for the export of Meropenem Injection Vial. lgm. This department has examined the matter and it is requested that DGFT may call following technical details from the firm viz:- (a) Exact deseription of lmport item and norrns applied thereof. (b) COA of Imported item from Foreign Supplier. (Barnali Khastgir) Under Secretary to the Govemment of India Phone:23071162 gハ●qA

ｒ、 F. No.350 1 1 I 16912015-PI (Norms) Government of India 9/ r/ o' / Oo

Udyog Bhawan,New Delhi, Daled the l6 September. 2015 Office Memorandum

Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.t) 2009-14 Case

of M/s Metrochem API Pvt Ltd. The undersigned is directed to refer to DGFT U.O.No. 0ll82l50l52lAM-161DES-3/536 dated the 09107115 vide which application from M/s. Metrochem API Pvt Ltd was sent to this Department for fixatior-r of norms under para: 4.7 for the export of 2-Chloromethyl-4-(3- methoxy propoxy)-3-methyl pyridine hydrochloride. This department has examined the matter and the following norms are furnished under para 4.7 of Hand Book of Procedures (Vol.l) 2009-t4:- S. No. lmport Item 1 2,3 Dimethylpyridine (2,3 Lutidine) 1.00 つ４ )-Methoxy-1-propanol 1.187 {ktu^aot+,r (Barnali Khastgir) Phone:23071 I 62 Directorate General of Foreign 'Irade,

lt(い“ 一16 F No 14010/58ノ2010-CH― || Government oflndia Ministry Of Chemica:s and Fert‖ izers g/勺んらヽノοノ Shastri Bhavan, New Delhi-l10001 Dated: 14th,August,2015 To, M/s V.D.H. Organics Pvt. Ltd. 654, Kabool Nagar, Shahadra, Delhi-110032

Subject: - Advance Authorization Application for the import of raw-materials against the export

of Thymol Crystal (3- Hydroxy-Cymene) (Advance Authorization No. 05'l0392988 dated 27 .O1.2015.) I am directed to refer to your Advance Authorization application received through Office of DGFT on the subject mentioned above. In this connection, you are requested to submit the following information within 15 days of the issue of this letter. 1. Detailed manufacturing process, material balance with balanced chemical reactions indicating all the reactants and products and by-products with corresponding molecular Formulae, structural formulae, molecular weight and process flow diagram. 2. Stage-wise percentage yield with respect of each of the reactants and products and the relevant justification enclosing therewith authentic printed technical literature in support of yield / quantity of items for import. 3. Details of production of export product under reference and corresponding consumption of raw material in lhe year 2013-14,2014-15 and 2015-16 (April to June) duly certified by CA may be furnished. 4. Any other relevant information 体K絣け Addl lndustria:Adviser Tel No 011‐23381430 Copv tol― ShH Mahender Vikram Singh,FTDO(DES‐ 3),in reference to DGFT/UO No― 01/82ノ050/637/メヽM-16/DES― ‖:/677,dated 30 07 2015

^ tr. No.350 | | 133812015-Pl (Nornts) Governntent of India Ministly of Cher-nical & Fertilizers Departntent of Pharmaceuticals New Delhi. 91 . N, /o2-

Iic1rog l]ltawart. the Novcntbe r'. 20I .5 Oftce Memorandum

Subject: - Fixation of norms under para4.7 of Hand Book of Procedures (Vol.l) 20rJ9-14 Case

of M/s Ranbaxy Labs Ltd. ,The undersigned is directed to ref-er to DGFT U.O.No. 011821501303/AM-l 6IDES-31179 dated ilre 29106115 vide which applicatior-r from M/s. Ranbaxy Labs Ltd was sent to this Deparlment for fixation of norms under para: 4.7 for the export of Clarithromycin Carbomer Granules 43.75"/". This department hers examined the matter and it is requested that DGFT may call fbllowing technical details fiorn the firrn viz:- (a) Copy o1'valicl l)M1.. (b) Copy of Mastcr-Batch lbrntula c'lLrly certilred by Qr.raliti' Control Inchargc. -fhis issr,res with thc aplrroval ol'conrpetent authoritir. (l{a j l(Lunar) L-lnder Secrctary to thc Govcrtttttettt o{'Irldia I'honc:2i071 l(rl

F No 14010/106/2011‐ CH‐ il Government oflndia Ministry of Chemicals and Fert‖ izers Reminder タスな′クz Shastri Bhavan, New Delhi-1 10001 Dated: 2nd December, 2015 To, Jindal Drugs Pvt. Ltd., Bakhtawar, 6hFloor, B&C, 229, Nariman Point, Mumbai, Maharashtra - 400021

Subject: - Advance Authorization Application for the import of raw-materials against the export

of Anethol (pure) (Advance Authorization No. 0310776081 dated 2Z .3.2014 and Advance Authorization No. 031 0789265 dated 1 6.9.2014) I am directed to refer to your Advance Authorization applications received through Office of DGFT on the subject mentioned above. ln this connection, you are advised to submit additional information vide this office letter of even number dated 14.7.2o1s (copy enclosed) but no information has been received so far, you are again being advised to submit the information within 15 days of the issue of this letter. 1. Technical specifications, certificate of Analysis (coA) and copy of export order for the Anethole (Pure) to be exported. ２　３４　５６ Detailed manufacturing process along with technical justification for wastage at each stage and on each ofthe raw materiars to be used in the manufacturing proless. Details of other indigenous inputs to be used in the manufacture of expJrt product. complete material balance indicating .input and output material at each stage of manufacturing process and basis of applied quantity of raw materials . Details of by-products generated in the process along with their quantity and value. D_etails _of production o

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 generated for this document yet (analysis runs over brief docs + on-demand). Run build_analysis.py --ids 7875 --apply.

DGFT Minutes

Office of Directorate General of Foreign Trade New Delhi -0

Para 4.7 Decision

Case No.:14/24/82-ALC4/2010 Party Name:SAINOR

Case No.:173/14/82-

Case No.:43/16/82-ALC4/2013 Party Name:SYMBIOTEC

Case No.:374/5/82-ALC4/2015 Party Name:SURVIVAL

Case No.:52/6/82-ALC4/2014 Party Name:UPL LTD.

Case No.:71/5/82-ALC4/2014 Party Name:ARIHANTANAM

Case No.:238/6/82-

Case No.:121/14/82-

Case No.:88/6/82-ALC4/2014 Party Name:UPL

Case No.:61/4/82-ALC4/2014 Party Name:V & V PHARMA

Case No.:164/6/82-

Case No.:69/4/82-ALC4/2014 Party Name:RA CHEM

Case No.:73/9/82-ALC4/2014 Party Name:D. R. COATS INK

Case No.:370/5/82-

Case No.:79/9/82-ALC4/2014 Party

Case No.:24/9/82-ALC4/2014 Party Name:BRUNDAVAN

Case No.:396/5/82-

Case No.:8/6/82-ALC4/2014 Party Name:V & V PHARMA

Case No.:209/13/82-

Case No.:58/9/82-ALC4/2014 Party Name:G AMPHRAY

Case No.:49/9/82-ALC4/2014 Party Name:SANMAR

Case No.:31/9/82-ALC4/2014 Party Name:AMBERNATH

Case No.:44/9/82-ALC4/2014 Party Name:INTAS

Case No.:373/5/82-

Case No.:203/5/82-ALC4/2015 Party Name:ALKALOIDS

Case No.:2/14/82-ALC4/2015 Party Name:SHREE

Case No.:48/5/82-ALC4/2015 Party Name:VISION DRUGS

Case No.:127/14/82-

Case No.:215/13/82-

Case No.:264/13/82-

Case No.:255/13/82-

Case No.:382/5/82-

Case No.:377/5/82-

Case No.:224/13/82-

Case No.:225/13/82-

Case No.:263/13/82-

Case No.:223/13/82-

Case No.:3/7/82-ALC4/2014 Party Name:S V CHEM

Case No.:398/5/82-ALC4/2015 Party Name:YASH RASAYAN

Case No.:400/5/82-

Case No.:12/15/82-

Case No.:380/5/82-

Case No.:59/13/82-

Case No.:49/5/82-ALC4/2015 Party Name:VISION DRUGS

Case No.:372/5/82-

Case No.:29/13/82-

Case No.:350/5/82-

Case No.:171/13/82-

Case No.:352/5/82-ALC4/2015 Party Name:VIVIMED LABS

Case No.:393/5/82-

Case No.:198/5/82-

Case No.:126/8/82-

Case No.:355/5/82-

Case No.:94/13/82-

Case No.:126/5/82-

Case No.:362/5/82-

Case No.:279/13/82-

Case No.:139/5/82-

Case No.:145/5/82-

Case No.:130/5/82-

Case No.:127/5/82-

Case No.:224/5/82-

Case No.:136/5/82-

Case No.:96/5/82-ALC4/2015 Party Name:J.B. CHEMICALS

Case No.:221/5/82-

Case No.:114/5/82-

Case No.:218/5/82-

Case No.:134/5/82-ALC4/2015 Party Name:BDR

Case No.:137/5/82-

Case No.:138/5/82-

Case No.:84/5/82-ALC4/2015 Party Name:SHIVA

Case No.:105/5/82-ALC4/2015 Party Name:CROWN

Case No.:106/5/82-ALC4/2015 Party Name:CROWN

Case No.:45/5/82-ALC4/2015 Party Name:SUVEN LIFE

Case No.:102/5/82-

Case No.:74/5/82-ALC4/2015 Party Name:NEW ALLIANCE

Case No.:149/5/82-

Office of Directorate General of Foreign Trade
New Delhi -0

ｒ、 F. No.350 1 1 I 16912015-PI (Norms) Government of India 9/ r/ o' / Oo