IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-10-20

DGFT Committee Minutes

Document text

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Government of India Ministry of Commerce and Industry Department of Commerce

DIRECTORATE GENERAL OF FOREIGN TRADE (DES - III SECTION)

MINUTES OF THE NORMS COMMITTEE- III

MEETING No. NC/3/MEET/Oct/202223/10 DATED: 20/10/2022

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/Oct/202223/10 dated 20/10/2022 of Norms Committee - III for the year 2022-23 was held on 20/10/2022 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

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	BIO-GEN EXTRACTS PRIVATE LIMITED

This document has been digitally signed by AJAY KUMAR, Deputy Director on 21-10-2022 18:22:26.

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Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number<br>HQRNORM APPLY 00003010AM23
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following
information / documents from the firm:
What is the difference between import and export items.<br>i.
COA of import and export item.<br>ii.
Whether export item is pharma product. If yes, please give DML.<br>iii.
Stepwise process with wastage.

Case No.<br>2 / NC/3/MEET/Oct/202223/10
Case Status<br>Case Deferred
Party Name<br>BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number<br>HQRNORM APPLY 00003011AM23
RA File Number<br>NA
Licence No and<br>Date<br>NA
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following
information / documents from the firm:
What is the difference between import and export items.<br>i.
COA of import and export item.<br>ii.
Whether export item is pharma product. If yes, please give DML.<br>iii.
Stepwise process with wastage.

Case No.	3 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	BIO-GEN EXTRACTS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	HQRNORM APPLY 00003012AM23
RA File Number	NA
Licence No and	NA

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Date

Norms Committee Decision:

The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following information / documents from the firm:

i. What is the difference between import and export items.
ii. COA of import and export item.
iii. Whether export item is pharma product. If yes, please give DML.

Stepwise process with wastage.

Date	Date	Date	Date
Norms Committee<br>				Decision:<br>
The Committee considered the request of firm for fixation of adhoc norms and it was decided to call for following<br>information / documents from the firm:
Wht i th diff bt it d t it<br>i
a s<br>.<br>COA of i<br>ii.				e erence eween mpor an expor ems.<br>mport and export item.
<br> <br>Whether<br>iii.				<br>export item is pharma product. If yes, please give DML.
<br>				<br>
Stepwise process				with wastage.


C N				4 / NC/3/MEET/O/202223/10
ase o.				ct
C S				C Rd
ase tatus				ase ejecte
Party Name				MYLAN LABORATORIES LIMITED

Meeting Number<br>and Date				NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number				HQRNORM REVIW00002843AM23
RA File Number				092404000489 AM12
Licence No and<br>Date				0910050751/12/01/2012
N<br>S<br>ex<br> <br>th<br> <br>1<br> <br>fo<br>in<br> <br>0<br>le	orms Committee Decision:
	hri Ravik<br>plained t		umar Yanamandra, Associate Vice President<br>heir case for review of Advance Authorization					and Shri Chavha<br>No. 091005075	n Bhaus<br>1 dated	abeb, GM; attended the Personal<br>12/01/2012.		Hearing and
	<br>e request<br> <br>2/01/2012		The Committee heard the explanation of the<br>of firm.<br>Hence, it was decided torejectthe case maint<br>.					Representative<br>aining the status	of firm a<br>quo for	nd it was observed that there wa<br>Advance Authorization No. 0910		s no merit in<br>050751 dated
	<br>r which,<br>respect o<br>Th<br>91003407<br>		During discussion in PH, the firm also informe<br>norms have not been fixed yet. Accordingly,<br>f their Advance Authorization No. 091003407<br>e Committee considered the request of firm a<br>5 dated 25.05.2008 under Para 4.07 of HBP<br>					d about their Ad<br>the firm submitt<br>5 dated 25.05.20<br>nd it was decide<br>Vol. I as per det	vance Au<br>ed its do<br>08.<br>d to ratif<br>ails give	thorization No. 0910034075 date<br>cuments and requested to fix the<br>y adhoc norms of Advance Auth<br>n below or as applied by the firm,		d 25.05.2008<br>adhoc norms<br>orization No.<br>whichever is
	ss	:
		Export product			Qty	Sl	Import items				Qty
					.	.					.

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		No.
Atovaquone	1 kg	1.	4-(4-Chlorophenyl) Cylohexyl Carboxylic Acid	2.00 kg
		2.	2-Chloro-1,4-Naphthoquinone	1.62 kg
		3.	Sulpholane	1.00 kg
		4.	Toluene	2.40 kg
		5.	Acetonitrile	6.85 kg
		6.	Dichloromethane	1.60 kg
		7.	Methanol	1.68 kg

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

Case No.	5 / NC/3/MEET/Oct/202223/10
Case Status	Case Rejected
Party Name	MYLAN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	HQRNORM REVIW00002957AM23
RA File Number	092404000274 AM13
Licence No and<br>Date	0910053628/29/08/2012
Norms Committee Decision:<br>Shri Ravikumar Yanamandra, Associate Vice President and Shri Chavhan Bhausabeb, GM; attended the Personal<br>Hearing and explained their case.<br>The Committee after hearing the explanation of the Representative of firm observed that the<br>justification given by the firm was not found convincing.<br>Hence, it was decided torejectthe case maintaining the status quo.<br>RA concerned may take further necessary action as per above decision of NC.

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Case No.	6 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	MYLAN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	HQRNORM REVIW00003162AM23
RA File Number	092404000288 AM13
Licence No and<br>Date	0910053905/26/09/2012
Norms Committee Decision:<br>Shri Ravikumar Yanamandra, Associate Vice President and Shri Chavhan Bhausabeb, GM; attended the Personal<br>Hearing and explained their case and submitted its documents.<br>The Committee heard the explanation given by Representatives of firm given and examined the<br>documents. It was observed that the firm still has not furnished the complete information. Hence, it was decided to<br>call for following information / documents from the firm:<br>Molecular weight each export product and each import item in all steps.<br>i.<br>Requirement and recovery of solvent at each step.<br>ii.

Case No.<br>	7 / NC/3/MEET/Oct/202223/10
Case Status<br>	Case Approved
Party Name<br>	MYLAN LABORATORIES LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number<br>	HQRNORM REVIW00002848AM23
RA File Number<br>	092404000484 AM14
Licence No and<br>Date<br>	0910058825/06/01/2014
Norms Committee Decision:<br>Shri Ravikumar Yanamandra, Associate Vice President and Shri Chavhan Bhausabeb, GM; attended the Personal<br>Hearing and explained their case.<br>The Committee after deliberation decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:

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Export product	Qty.	Sl.<br>No.	Import items	Qty.
Atovaquone	1 kg	1.	4-(4-CHLOROPHENYL)<br>CYLOHEXYLCARBOXYLIC<br>ACID OR 4-(4-CHLOROPHENYL) CYCLOHEXANE-1-<br>CARBOXYLIC ACID	<br>2.00 kg
		2.	2-Chloro-1,4-Naphthoquinone	1.62 kg
		3.	Sulpholane	1.00 kg
		4.	Toluene	2.40 kg
		5.	Acetonitrile	6.85 kg
		6.	Dichloromethane	1.60 kg
		7.	Methanol	1.68 kg

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

Case No.	8 / NC/3/MEET/Oct/202223/10
Case Status	Case Approved
Party Name	MYLAN LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	HQRNORM REVIW00002855AM23
RA File Number	092404000555 AM15
Licence No and<br>Date	0910061520/09/01/2015
Norms Committee Decision:<br>Shri Ravikumar Yanamandra, Associate Vice President and Shri Chavhan Bhausabeb, GM; attended the Personal<br>Hearing and explained their case.<br>The Committee after deliberation decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less:

UDIN00239179AM23

Export product	Qty.	Sl.	Import items		Qty.
		No.
Atovaquone	1 kg	1.	4-(4-CHLOROPHENYL)	CYLOHEXYLCARBOXYLIC	<br>2.00 kg
			ACID OR 4-(4-CHLOROPHENYL) CYCLOHEXANE-1-
			CARBOXYLIC ACID
		2.	2-Chloro-1,4-Naphthoquinone		1.62 kg
		3.	Sulpholane		1.00 kg
		4.	Toluene		2.40 kg
		5.	Acetonitrile		6.85 kg
		6.	Dichloromethane		1.60 kg
		7.	Methanol		1.68 kg

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

Case No.	9 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	RELIANCE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	018205000111AM18
RA File Number	039504001013 AM17
Licence No and<br>Date	0310812389/10/04/2017
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to transfer the case to Norms Committee–		7 as
the cases norms for same export product / import items have been finalised by NC-7 in the past.

Case No.	10 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	RELIANCE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022

UDIN00239179AM23

HQ File Number	018205000113AM18
RA File Number	039504001012 AM17
Licence No and<br>Date	0310812393/10/04/2017
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to transfer the case to Norms Committee–<br>7 as<br>the cases norms for same export product / import items have been finalised by NC-7 in the past.

Case No.	11 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	RELIANCE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	018205000746AM19
RA File Number	039504001122 AM18
Licence No and<br>Date	0310820561/20/04/2018
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to transfer the case to Norms Committee–		7 as
the cases norms for same export product / import items have been finalised by NC-7 in the past.

Case No.	12 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	RELIANCE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	018205000166AM20
RA File Number	039504001362 AM19
Licence No and<br>Date	0310829020/14/05/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to transfer the case to Norms Committee–		7 as
the cases norms for same export product / import items have been finalised by NC-7 in the past.

Case No.	13 / NC/3/MEET/Oct/202223/10
Case Status	Case Approved
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	HQRNORM REVIW00404233AM22
RA File Number	039404000908 AM20
Licence No and<br>Date	0310834502/28/01/2020

UDIN00239179AM23

Norms Committee Decision:

The firm vide e-mail dated 17.10.2022 has requested to withdraw its request for amendment in the description of Export Product.

In view of above, the Committee decided to withdraw the case.

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

Case No.	14 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	018205001829AM21
RA File Number	052304000263 AM21
Licence No and<br>Date	0510415769/06/11/2020
Norms Committee Decision:<br>Shri Gopal Kumar, Manager and Shri Deepesh Kumar Mishra, Sr. Executive attended the Personal Hearing and<br>explained their case.<br>It was observed by the Committee that the persons who attended the Meeting do not have any<br>technical knowledge.<br>Hence, it was decided to give anotherPersonal Hearing<br>to firm before Norms Committee with the<br>instructions to come with a Technical person who have in depth knowledge of the case.

Case No.	15 / NC/3/MEET/Oct/202223/10
Case Status	Case Approved
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	HQRNORM APPLY 00114386AM21
RA File Number	03AA04027304 AM21
Licence No and<br>Date	0311002339/26/03/2021
Norms Committee Decision:<br>Shri Anurag Khera, Head Corporate Affairs, Shri Kishan Kaira, DGM, Shri Prabhat Sagre, DGM, Shri Hitendra, DGM and<br>Shri Mahendra, AM; attended the Personal Hearing and explained their case. The Representatives of firm also informed<br>that one of their Advance Authorization No. 0310839645 dated 20.11.2020 did not appear in any of the previous Meetings<br>of Norms Committee-3 and requested to fix adhoc norms for this Advance Authorization too. The Committee after

UDIN00239179AM23

deliberation decided to ratify adhoc norms against Advance Authorization No. 0311002339 dated 26/03/2021 and 0310839645 dated 20.11.2020 under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Export product	Qty.	Sl. No.	Import items	Qty.
PERINDOPRIL ERBUMINE	1 kg	1	S-(-)-INDOLINE-2-CARBOXYLIC<br>ACID	Not<br>required<br>in<br>the<br>process
		2	L-NORVALINE	Not<br>required<br>in<br>the<br>process
		3	ACETONITRILE	3.90 kg
		4	N,N-CARBONYLDIIMIDAZOLE	0.64 kg
		5	(S)-2-CARBOXY<br>OCTAHYDROINDOLE	0.60 kg
		6	N-[(S)-ETHOXYCARBONYL -1-<br>BUTYL)-(S)-ALANINE	0.85 kg
		7	METHYLENE CHLORIDE (MDC)	6.15 kg
		8	SODIUM PYRUVATE	Not<br>required<br>in<br>the<br>process
		9	METHANOL	Not<br>required<br>in<br>the<br>process

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

Case No.	16 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number	HQRNORM APPLY 00039055AM22
RA File Number	05AA04009662 AM22

UDIN00239179AM23

Licence No and 0511002560/12/05/2021 Date Norms Committee Decision:

Shri Gopal Kumar, Manager and Shri Deepesh Kumar Mishra, Sr. Executive attended the Personal Hearing and explained their case.

It was observed by the Committee that the persons who attended the Meeting do not have any technical knowledge.

Hence, it was decided to give another Personal Hearing to firm before Norms Committee with the instructions to come with a Technical person who have in depth knowledge of the case.

Case No.	Case No.	17 / NC/3/MEET/Oct/202223/10	17 / NC/3/MEET/Oct/202223/10	17 / NC/3/MEET/Oct/202223/10	17 / NC/3/MEET/Oct/202223/10	17 / NC/3/MEET/Oct/202223/10
Case Status		Case Approved
Party Name		GLENMARK LIFE SCIENCES LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
HQ File Number		HQRNORM APPLY 00191008AM22
RA File Number		03AA040103051 AM22
Licence No and Date		0311007157/23/09/2021
Norms Committee Decision:<br>Shri Anurag Khera, Head Corporate Affairs, Shri Kishan Kaira, DGM, Shri Prabhat Sagre, DGM, Shri Hitendra,<br>DGM and Shri Mahendra, AM; attended the Personal Hearing and explained their case. The Committee after<br>deliberation decided to ratify adhoc norms as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>S-(-)-INDOLINE-2-CARBOXYLIC<br>ACID<br>Not<br>required<br>in<br>the<br>process<br>2<br>L-NORVALINE<br>Not<br>required<br>in<br>the<br>process<br>3<br>ACETONITRILE<br>3.90 kg<br>4<br>N,N-CARBONYLDIIMIDAZOLE<br>0.64 kg<br>PERINDOPRIL<br>ERBUMINE<br>1 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	PERINDOPRIL<br>ERBUMINE		1 kg	1	S-(-)-INDOLINE-2-CARBOXYLIC<br>ACID	Not<br>required<br>in<br>the<br>process
				2	L-NORVALINE	Not<br>required<br>in<br>the<br>process
				3	ACETONITRILE	3.90 kg
				4	N,N-CARBONYLDIIMIDAZOLE	0.64 kg

UDIN00239179AM23

5	(S)-2-CARBOXY<br>OCTAHYDROINDOLE	0.60 kg
6	N-[(S)-ETHOXYCARBONYL -1-<br>BUTYL)-(S)-ALANINE	0.85 kg
7	METHYLENE CHLORIDE (MDC)	6.15 kg
8	SODIUM PYRUVATE	Not<br>required<br>in<br>the<br>process
9	METHANOL	Not<br>required<br>in<br>the<br>process

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

Case No.	18 / NC/3/MEET/Oct/202223/10
Case Status	Case Deferred
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Oct/ 202223/ 10 and 20/10/2022
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 Gopal Kumar, Manager and Shri Deepesh Kumar Mishra, Sr. Executive attended the Personal Hearing and<br>explained their case.<br>It was observed by the Committee that the persons who attended the Meeting do not have any<br>technical knowledge.<br>Hence, it was decided to give anotherPersonal Hearing<br>to firm before Norms Committee with the<br>instructions to come with a Technical person who have in depth knowledge of the case.

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