← Archive
IN FORCE Advance Authorisation

DGFT Minutes

Reliability

In force — no superseding record on file.

Document text

Government of India Ministry of CommerceandIndustry Department of Commerce DIRECTORATE GENERAL OF FOREIGN TRADE

MINUTES OF MEETING OF PERSONAL HEARING

Meeting No. NC/3/MEET/Dec/202324/17 Dated: 13/12/2023


Minutes of the Norms Committee –3 Meeting No.NC/3/MEET/Dec/202324/17 dated 13/12/2023 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2023 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

Following members were present in the Meeting:

S.N. Name & Designation Department
1 Shri Shaish Kumar, Technical Consultant (Pharma)
2 Shri D.N. Mathur, Technical Consultant (Chemical)
3 Shri Nand Lal, Technical Consultant (Chemical)
In attendance
1 Shri Raman Kumar Deputy DGFT DGFT
2 Shri Uttam Dey Sarkar, ASO DGFT
  1. The Norms Committee has taken decision only with respect to technical aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularization of the case.

Manual Cases of Personal Hearing

those in policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularization of the case.

Manual Cases of Personal Hearing

CaseNo. **A-1 **
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Inchem Laboratories Private Limited
HQ F. No. HQRNORMREVIW00004197/AM24/DES-III<br>(Earlier F. No. 01/82/050/01275/AM12/DES-III)
RLA F. No. 09/24/040/00413/AM12
Advance AuthorizationNo.and Date 0910050238 dated 15/12/2011
Subject Request of M/s Inchem Laboratories Private Limited<br>for enhancement in the quantity of import item in<br>respect of ad-hoc norms fixed against Advance<br>Authorization issued to the firm.
Decision:The Committee considered the request of firm for review of ad-hoc norms and it was observed<br>that the firm had neither attended the Personal Hearing nor intimated to committee. Hence, it was decided<br>torejectthe case maintaining thestatus quo.

-hoc norms and it was observed<br>that the firm had neither attended the Personal Hearing nor intimated to committee. Hence, it was decided<br>torejectthe case maintaining thestatus quo.||

CaseNo. **A-2 **
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Inchem Laboratories Private Limited
HQ F. No. HQRNORMREVIW00003005/AM24/DES-III<br>(Earlier F. No. 01/82/050/00910/AM14/DES-III)
RLA F. No. 09/24/040/00287/AM14
Advance AuthorizationNo.and Date 0910057785 dated 01/10/2013
Subject Request of M/s Inchem Laboratories Private Limited<br>for enhancement in the quantity of import item in<br>respect of ad-hoc norms fixed against Advance<br>Authorization issued to the firm.
Decision:The Committee considered the request of firm for review of ad-hoc norms and it was observed<br>that the firm had neither attended the Personal Hearing nor intimated to committee. Hence, it was decided<br>torejectthe case maintaining thestatus quo.

-hoc norms and it was observed<br>that the firm had neither attended the Personal Hearing nor intimated to committee. Hence, it was decided<br>torejectthe case maintaining thestatus quo.||

CaseNo. **A-3 **
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Inchem Laboratories Private Limited
HQ F. No. HQRNORMREVIW00002967/AM23/DES-III<br>(Earlier F. No01/82/050/00934/AM15/DES-III)
RLA F. No. 09/24/040/00044/AM15
Advance AuthorizationNo.and Date 0910059969 dated 01.05.2014.
Subject Request of M/s Inchem Laboratories Private Limited<br>for enhancement in the quantity of import item in<br>respect of ad-hoc norms fixed against Advance<br>Authorization issued to the firm.
Decision:The Committee considered the request of firm for review of ad-hoc norms and it was observed that<br>the firm had neither attended the Personal Hearing nor intimated to committee. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.

hoc norms and it was observed that<br>the firm had neither attended the Personal Hearing nor intimated to committee. Hence, it was decided to<br>rejectthe case maintaining thestatus quo.||

CaseNo. **A-4 **
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Inchem Laboratories Private Limited
HQ F. No. HQRNORMREVIW00003004/AM24/DES-III<br>(Earlier F. No. 01/82/050/01094/AM15 /DES-III)
RLA F. No. 09/24/040/00421/AM15
Advance AuthorizationNo.and Date 0910061287 dated 21.11.2014
Subject Request of M/s Inchem Laboratories Private Limited for<br>enhancement in the quantity of import item in respect of ad-<br>hoc norms fixed against Advance Authorization issued to<br>the firm.
Decision:The Committee considered the request of firm for review of ad-hoc norms and it was<br>observed that the firm had neither attended the Personal Hearing nor intimated to committee.<br>Hence,it was decided torejectthe case maintainingthestatusquo.

ad-hoc norms and it was<br>observed that the firm had neither attended the Personal Hearing nor intimated to committee.<br>Hence,it was decided torejectthe case maintainingthestatusquo.||

CaseNo. **A-5 **
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Natco Pharma
HQ F. No. HQRNORMREVIW00004490/AM24/DES-III<br>(Earlier F. No. HQRNORMAPPLY00001280/AM23 /DES-III)<br>HQRNORMREVIW00004488AM24/DES-III<br>(Earlier F. No.HQRNORMAPPLY00293027AM22/DES-III)
RLA F. No. 09/AX/040/00174/AM23<br>09/AX/040/00043/AM22
Advance Authorization No. and Date 0911003150 dated 08.06.2022<br>0911002121 dated 21.12.2022
Subject Request of M/s Natco Pharma for enhancement of quantity<br>of import item in respect of ad-hoc norms fixed against<br>Advance Authorization issued to the firm.
**Decision:**Dr. B. Krishna Murthy, Vice-President and Shri P. Gopala Krishnam Raju, Sr. Manager of<br>the firm had attended the Personal Hearing and explained the case. The Committee heard the<br>explanation of Representative of the firm and after due deliberation it was directed to firm to furnish<br>the following information/documents for further consideration:-<br>1. Copy of CoA of import item from foreign supplier.<br>2. Data for production/consumption certificate duly endorsed by GST.<br>3. Copy of Drug Manufacturing License (DML).<br>4. Master Batch Formula (MBF).

tem from foreign supplier.**<br>2. Data for production/consumption certificate duly endorsed by GST.<br>3. Copy of Drug Manufacturing License (DML).<br>4. Master Batch Formula (MBF).||

CaseNo. **A-6 **
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Cipla Limited
HQ F. No. HQRNORMREVIW00002990/AM24/DES-III<br>(Earlier F. No. HQRNORMAPPLY00224766/AM22/DES-III)<br>F. No. HQRNORMREVIW00002991/AM24/DES-III<br>(Earlier F. No.HQRNORMAPPLY00005573/AM23 /DES-III)
RLA F. No. 03/AA/040/110548/AM22<br>03/AX/040/04890/AM23
Advance Authorization No. and<br>Date 0311007891dated 25.10.2021<br>0311020522 dated 06.01.2023

Subject

Request of M/s Cipla Limited for enhancement in the quantity of import item in respect of ad-hoc norms fixed against Advance Authorization issued to the firm.

Decision: Shri Jivan C. Patil, Director (Taxation)of the firm had attended the Personal Hearing and explained the case. The Committee heard the explanation of Representative of the firm and after due deliberation it was advised to the firm to appear before norms committee again for Personal Hearing alongwith following information/documents for further consideration:-

2. Master Batch Formula (MBF).

3. Production/consumption data endorsed by GST.

4. Substantial documents showing the process loss.

5. Drug Manufacturing License (DML).

6. CoA of import item from foreign supplier.

Case No. **A-7 **
MeetingNo. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Cipla Limited
HQ F. No. HQRNORMREVIW00000259/AM24/DES-III<br>(Earlier F. No. HQRNORMAPPLY00001629/AM23/DES-III)
RLA F. No. 03/AX/040/01871/AM23
Advance Authorization No. and Date 0311015826 dated 24.06.2022
Subject Request of M/s Cipla Limited for enhancement in the<br>quantity of import item in respect of adhoc norms fixed<br>against Advance Authorization issued to the firm.
**Decision:**Shri Jivan C. Patil, Director (Taxation)of the firm had attended the Personal Hearing and<br>explained the case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation it was advised to the firm to appear before norms committee again for Personal Hearing<br>alongwith following information/documents for further consideration:-<br>1. Contractual Papers.<br>2. Master Batch Formula (MBF).<br>3. Production/consumption data endorsed by GST.<br>4. Substantial documents showing the process loss.<br>5. Drug Manufacturing License (DML).<br>6. CoA of import item from foreign supplier.

tion/consumption data endorsed by GST.**<br>4. Substantial documents showing the process loss.<br>5. Drug Manufacturing License (DML).<br>6. CoA of import item from foreign supplier.||

Case No. **A-8 **
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Syntho Chirals Private Limited
HQ F. No. HQRNORMREVIW00001514/AM24/DES-III<br>(Earlier F. No.HQRNORMAPPLY00059741/AM21/DES-III)<br>F. No. HQRNORMREVIW00001518/AM24/DES-III<br>(Earlier F. No.HQRNORMAPPLY00136591/AM22/DES-III)
RLA F. No. 09/AA/040/07265/AM22<br>09/AA/040/03656/AM21
Advance Authorization No. and Date 0911000173 dated 11.01.2021<br>0911001194 dated 12.07.2021
Subject Request of M/s Syntho Chirals Private Limited for<br>enhancement in the quantity of import item in respect of<br>ad-hoc norms fixed against Advance Authorization issued<br>to the firm.

Decision: The Committee considered the case as per agenda and it has been observed the firm could not attend the PH and requested vide e-mail dated 15/10/2023 to give one more opportunity to attend Personal Hearing. Therefore, the committee has decided to grant the permission for again Personal Hearing with relevant documents/information.

15/10/2023 to give one more opportunity to attend Personal Hearing. Therefore, the committee has decided to grant the permission for again Personal Hearing with relevant documents/information.

CaseNo. CaseNo. CaseNo. **A-9 ** **A-9 ** **A-9 ** **A-9 **
MeetingNo. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Syntho Chirals Private Limited
HQ F. No. HQRNORMREVIW00001504/AM24/DES-III
(Earlier F. NoQ RNORMAPPLY00038802/A M21/DES-III)
RLA F. No. 09/AA/0 40/027 48/AM21
Advance AuthorizationNo.and Date 0911000 023 d ated 15.12.2020
Subject Request<br>fixation<br>issued to of M<br>of ad-<br>firm. /s Syntho Chirals Privat<br>hoc norms against Advance e Limited for<br>Authorization
**Decision:**The Committee considered the case as per agenda and it has been observed the firm could<br>not attend the PH and requested vide e-mail dated 15/10/2023to give one more opportunity to<br>attend Personal Hearing. Therefore, the committee has decided to grant the permission for again<br>Personal Hearing with relevant documents/information.

give one more opportunity to<br>attend Personal Hearing. Therefore, the committee has decided to grant the permission for again<br>Personal Hearing with relevant documents/information.|||||||

CaseNo. A-10
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Torrent Pharmaceuticals Ltd
HQF. No. HQRNORMAPPLY00002509AM24
RLA F. No. 08/AX/040/00510/AM24
Advance AuthorizationNo.and Date 0811008516 dated 26.06.2023
Subject Request of M/sTorrent Pharmaceuticals Ltd for
fixation of ad-hoc norms against Advance Authorization
issued to firm.
**Decision:**Shri Sisir Kumar Bera, General Manager, Shri Vivek Bobde, Assistant Manager and Shri
Sanjay Patel, Assistant Managerof the firm had attended the Personal Hearing and explained the case.
The Committee heard the explanation of Representative of the firm and after due deliberation it was
advised to the firm to furnish following information/documents for further consideration:-
1. Shipping Bills showing the overages.
2. CoA of import item from foreign supplier.
3. Drug Manufacturing License (DML).
4. Label claimed showing the overages.

ion:-|| |1. Shipping Bills showing the overages.|| |2. CoA of import item from foreign supplier.|| |3. Drug Manufacturing License (DML).|| |4. Label claimed showing the overages.||

CaseNo. A-11
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/s Morepen Laboratories Limited
HQ F. No. HQRNORMREVIW000006470/AM23/DES-III
(Earlier F. No. 01/82/050/00153/AM15/DES-III)
RLA F. No. 05/24/040/00420/AM14
Advance AuthorizationNo.and Date 0510378413 dated 05.02.2014
Subject Request of M/s Morepen Laboratories Limited for fixation
of ad-hoc norms against Advance Authorization issued to
the firm.

Decision: Shri Rajeev Kumar Vashisth, Head (Logistic), Shri V.K. Mishra, DGM (Production), Shri Avinash Aggarwal, DM (R&D) and Shri Tarun Bansal, Exim of the firm had attended the Personal Hearing and informed that they have been issued Show Cause Notice (SCN) by concerned RA. Therefore, the committee has decided to call a status report on SCN from concerned RA before taking a decision. Also call the following documents and information:-

1. Complete and balance chemical reactions especially step-1 alongwith mol wt. of each reactant their molar requirements.

  1. % yield on molar basis for each step

  2. Past 3-year production vis-à-vis actual consumption of all imported inputs duly certified by Central GST.

. of each reactant their molar requirements.

  1. % yield on molar basis for each step

  2. Past 3-year production vis-à-vis actual consumption of all imported inputs duly certified by Central GST.

CaseNo. A-12
Meeting No. NC/3/MEET/Dec/202324/17
Date 13.12.2023
Firm’sName M/s Morepen Laboratories Limited
HQ F. No. HQRNORMREVIW000006437/AM23/DES-III<br>(Earlier F. No. 01/82/050/00841/AM16/DES-III)
RLA F. No. 05/24/040/00073/AM16
Advance AuthorizationNo.and Date 0510394342 dated 25.05.2015
Subject Request ofM/s Morepen Laboratories Limitedfor<br>fixation of ad-hoc norms against Advance Authorization<br>issued to the firm.
**Decision:**Shri Rajeev Kumar Vashisth, Head (Logistic), Shri V.K. Mishra, DGM (Production), Shri<br>Avinash Aggarwal, DM (R&D) and Shri Tarun Bansal, Exim of the firm had attended the Personal<br>Hearing and informed that they have been issued Show Cause Notice (SCN) by concerned RA.<br>Therefore, the committee has decided to call a status report on SCN from concerned RA before taking a<br>decision. Also call the following documents and information:-<br>1. Complete and balance chemical reactions especially step-1 alongwith mol wt. of each reactant<br>their molar requirements.<br>2. % yield on molar basis for each step<br>3. Past 3-year production vis-à-vis actual consumption of all imported inputs duly certified by<br>Central GST.

ir molar requirements.**<br>2. % yield on molar basis for each step<br>3. Past 3-year production vis-à-vis actual consumption of all imported inputs duly certified by<br>Central GST.||

CaseNo. A-13
Meeting No. NC/3/MEET/Dec/202324/17
Date 13/12/2023
Firm’sName M/S Supriya Lifescience Limited
HQF. No. HQRNORMAPPLY00006357AM24
RLA F. No. 03/AX/040/03085/AM24
Advance AuthorizationNo.and Date 0311028054 dated 19.10.2023
Subject Request ofM/s Supriya Lifescience Limitedfor fixation<br>of ad-hoc norms against Advance Authorization issued to<br>the firm.
**Decision:**Dr.Shireesh Ambhaikar, Technical (Lead) and Shri Deepak Maduskarof the firm had<br>attended the Personal Hearing and explained the case. The committee has observedthat export product<br>is of USP/EP Grade, whereas, the firm explained the case for (EP 11.2). It isadvised to the firm to get<br>amend the Advance Authorisation accordingly from concerned RA. Subsequently, given the following<br>documents along with the amended license:-<br>1.Step wise process details with percentage yield on molar basis.<br>2. Recycle/reuse of crude product generated during purification process.<br>3. Batch record of product from manufacturer

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 8039 --apply.

Citation copied