IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-11-24

DGFT Committee Minutes

Document text

UDIN00274142AM23

Government of India / भारत सरकार

Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / व्यापार महकमा Directorate General of Foreign Trade / िवदेश व्यापार महािनदेशालय Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD,NEW DELHI / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777

(DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Nov/202223/13 DATED: 24/11/2022

Please Note

  • I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address: nc3.dgft@nic.in

  • II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, 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 EODC.

  • III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.

Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022 of Norms Committee - III for the year 2022-23 was held on 24/11/2022 under the Chairmanship of Rajiv Soni ,Joint DGFT to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.

The following members were present in the meeting:-

S.No. Name and Designation of Representatives Department
1 AJAY KUMAR,Deputy Director Directorate General of Foreign Trade, Delhi
2 SHAISH KUMAR,Technical Authority Technical Consultant,DGFT
3 DINESHNARAIN MATHUR,Technical<br>Authority Technical Consultant,DGFT

This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-12-2022 17:49:44.

1

UDIN00274142AM23

Case Details and Decision(s):

Case No. 1 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number 018205000672AM20
RA File Number 039504000625 AM20
Licence No and<br>Date 0310831873/27/09/2019
Norms Committee Decision:
Shri Amjad Sayyad, Export Executive - Logistics had attended the Personal Hearing and explained firm’s case. The
Committee after hearing explanation of Representative of the firm decided to call for following information /
documents from the firm:
The quantity asked / unit in the licence is different than request letter submitted later on. Please clarify it.<br>i.
For Export<br>ii. Product No. 2 – PALLADIUM METAL SPONGE, justification for asking raw material since it is
generated as a By-Product for Export Product No. 1 – 3-METHYL PYRIDAZINE (3-MP).
iii Any Published Literature for yield of 65% in second stage of reaction.
Case No.<br>2 / NC/3/MEET/Nov/202223/13
Case Status<br>Case Deferred
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number<br>018205001022AM20
RA File Number<br>052404000669 AM20
Licence No and<br>Date<br>0510413373/17/01/2020
Norms Committee Decision:
Shri Karan Singh, Manager, Shri Pranay Patel, Sr. Manager, Shri Diptesh Panoli, Sr. Manager and Shri
Lokesh Kr. Jangid, Sr. Executive had attended the Personal Hearing and explained firm’s case. The Committee
after hearing the explanation of the Representatives of the firm decided to call for following information / documents
from the firm:
Complete technical details, chemistry, molecular weight and percentage yield on molar basis for API and wastage
details alongwith Master Batch Formula for formulations.
Case No. 3 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED

This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-12-2022 17:49:44.

2

UDIN00274142AM23

Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number 018205001136AM20
RA File Number 052404000749 AM20
Licence No and<br>Date 0510413850/12/03/2020
Norms Committee Decision:<br>Shri Karan Singh, Manager, Shri Pranay Patel, Sr. Manager, Shri Diptesh Panoli, Sr. Manager and Shri<br>Lokesh Kr. Jangid, Sr. Executive had attended the Personal Hearing and explained firm’s case. The Committee<br>after hearing the explanation of the Representatives of the firm decided to call for following information / documents<br>from the firm:<br>Complete technical details, chemistry, molecular weight and percentage yield on molar basis for API and wastage<br>details alongwith Master Batch Formula for formulations.
Case No. 4 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name CONCORD BIOTECH LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number 018205001614AM21
RA File Number 082404000395 AM20
Licence No and<br>Date 0810148478/03/09/2020
Norms Committee Decision:<br>Shri Lalit Shethi, CEO, Shri Anand Dhiman, General Manager (R&D) and Shri Mayur Kansara, Manager Finance had<br>attended the Personal Hearing and explained firm’s case. The Committee after hearing the explanation of the<br>Representatives of the firm decided to call for additional information as discussed during Personal Hearing with the<br>Representatives of firm.
Case No. 5 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number 018205001829AM21
RA File Number 052304000263 AM21
Licence No and<br>Date 0510415769/06/11/2020
Norms Committee Decision:<br>Shri Deepak Kumar Mishra, AGM (A&F), Shri Deepesh Kumar Mishra, Sr. Executive- Export item and Shri Suneel<br>Kumar Singh, GM Technical had attended the Personal Hearing and explained firm’s case. The Committee after<br>hearing the explanation of the Representatives of the firm decided to call for following information / documents from

This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-12-2022 17:49:44.

3

UDIN00274142AM23

the firm:

To get the unit and quantity of import item amended as per their COA for actual import.

Case No. 6 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number 018205001832AM21
RA File Number 052404000405 AM21
Licence No and<br>Date 0510415761/06/11/2020
Norms Committee Decision:<br>Shri Karan Singh, Manager, Shri Pranay Patel, Sr. Manager, Shri Diptesh Panoli, Sr. Manager and Shri<br>Lokesh Kr. Jangid, Sr. Executive had attended the Personal Hearing and explained firm’s case. The Committee<br>after hearing the explanation of the Representatives of the firm decided to call for following information / documents<br>from the firm:<br>Complete technical details, chemistry, molecular weight and percentage yield on molar basis for API and wastage<br>details alongwith Master Batch Formula for formulations.
Case No. 7 / NC/3/MEET/Nov/202223/13
Case Status Case Rejected
Party Name MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number HQRNORM APPLY 00080306AM21
RA File Number 05AA04029372 AM21
Licence No and<br>Date 0511001191/09/02/2021
Norms Committee Decision:<br>Shri Vinod, Accountant and Ms. Ritu, Analytical Chemist had attended the Personal Hearing and explained firm’s<br>case. The Committee after hearing explanation of the Representatives of firm observed that they could not explain<br>the query raised regarding process, purity and impurity profile of import and export item and the fact that import item<br>has a superior purity than export item on which firm could not give satisfactory explanation.<br>Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-12-2022 17:49:44.

4

UDIN00274142AM23

Case No. 8 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number HQRNORM APPLY 00094103AM21
RA File Number 34AA04002716 AM21
Licence No and<br>Date 3411000254/01/03/2021
Norms Committee Decision:
Shri Paibal Mukherjee, General Manager had attended the Personal Hearing and explained firm’s case. The
Committee after hearing the explanation of the Representative of the firm decided to call for following information /
documents from the firm:
To get the export quantity and / or import quantity amended in line with DML for each export item.
Case No.<br>9 / NC/3/MEET/Nov/202223/13
Case Status<br>Case Deferred
Party Name<br>SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number<br>HQRNORM APPLY 00004824AM22
RA File Number<br>05AA04000952 AM22
Licence No and<br>Date<br>0511002092/06/04/2021
Norms Committee Decision:
Shri Karan Singh, Manager, Shri Pranay Patel, Sr. Manager, Shri Diptesh Panoli, Sr. Manager and Shri
Lokesh Kr. Jangid, Sr. Executive had attended the Personal Hearing and explained firm’s case. The Committee
after hearing the explanation of the Representatives of the firm decided to call for following information / documents
from the firm:
Complete technical details, chemistry, molecular weight and percentage yield on molar basis for API and wastage
details alongwith Master Batch Formula for formulations.
Case No. 10 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number HQRNORM APPLY 00039055AM22
RA File Number 05AA04009662 AM22
Licence No and<br>Date 0511002560/12/05/2021

This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-12-2022 17:49:44.

5

UDIN00274142AM23

Norms Committee Decision:

Shri Deepak Kumar Mishra, AGM (A&F), Shri Deepesh Kumar Mishra, Sr. Executive- Export item and Shri Suneel Kumar Singh, GM Technical had attended the Personal Hearing and explained firm’s case. The Committee after hearing the explanation of the Representatives of the firm decided to call for following information / documents from the firm:

To get the unit and quantity of import item amended as per their COA for actual import.

Case No. 11 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number HQRNORM APPLY 00208798AM22
RA File Number 05AA04089568 AM22
Licence No and<br>Date 0511005321/11/10/2021
Norms Committee Decision:<br>Shri Karan Singh, Manager, Shri Pranay Patel, Sr. Manager, Shri Diptesh Panoli, Sr. Manager and Shri<br>Lokesh Kr. Jangid, Sr. Executive had attended the Personal Hearing and explained firm’s case. The Committee<br>after hearing the explanation of the Representatives of the firm decided to call for following information / documents<br>from the firm:<br>Complete technical details, chemistry, molecular weight and percentage yield on molar basis for API and wastage<br>details alongwith Master Batch Formula for formulations.
Case No. 12 / NC/3/MEET/Nov/202223/13
Case Status Case Deferred
Party Name EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date NC/ 3/ MEET/ Nov/ 202223/ 13 and 24/11/2022
HQ File Number HQRNORM APPLY 00211838AM22
RA File Number 05AA04081672 AM22
Licence No and<br>Date 0511005408/13/10/2021
Norms Committee Decision:<br>Shri Deepak Kumar Mishra, AGM (A&F), Shri Deepesh Kumar Mishra, Sr. Executive- Export item and Shri Suneel<br>Kumar Singh, GM Technical had attended the Personal Hearing and explained firm’s case. The Committee after<br>hearing the explanation of the Representatives of the firm decided to call for following information / documents from<br>the firm:

This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-12-2022 17:49:44.

6

UDIN00274142AM23

To get the licence amended for complete description of import item as per their DML and COA for actual import.

This document has been digitally signed by AJAY KUMAR, Deputy Director on 07-12-2022 17:49:44.

7

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

Analysis

No analysis has been generated for this document yet.

Citation copied