IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-02-21

DGFT Committee Minutes

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Government of India Ministry of Commerce and Industry Department of Commerce DIRECTORATE GENERAL OF FOREIGN TRADE

Meeting No - NC/3/MEET/Feb/202122/14

Meeting Date - 21/02/2022

Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Feb/202122/14 dated 21.02.2022, was actually held on 25.02.2022 under the Chairmanship of Dr. Amiya Chandra, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

Following members were present in the Meeting:

Sl.<br>No.	Name & Designation	Department
1	Shri Shaish Kumar, Technical–1	Consultant
2	Shri D.N. Mathur, Technical–2	Consultant
In attendance
1	Shri Ajay Kumar, Deputy Director	DGFT

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.

The committee went through the minutes of earlier Meeting No. NC/3/MEET/Jan/202122/13 dated 21.01.2022, was actually held on 04.02.2022

MANUAL CASES

Case No.	Case No.			A-01
MeetingNo.				NC/3/MEET/Feb/202122/14
Date				21/02/2022
Firm’s Name				M/s Sandhya Organic Chemicals Pvt. Ltd., Mumbai
HQF. No.				01/82/050/00168/AM20/DES-III
RLA F. No.				03/95/040/01387/AM19
Advance Authorization No. and Date				0310828997 dated 14.05.2019
Subject				Request of M/s Sandhya Organic Chemicals Pvt. Ltd., Mumbai
				for review of adhoc norms fixed against Advance Authorization
				No. 0310828997 dated 14.05.2019
Decision:		The Committee considered		the request of the firm and it was decided to revise adhoc norms as
under:
	Export product		Qty.	Sl.<br>Import items	Qty.
				No.
	2 ETHYLHEXYL DIPHENYL		1 kg	1<br>PHENOL	0.604 kg
	PHOSPHITE (2 EHDP)			2<br>2 ETHYLHEXANOL	0.386 kg
				3<br>YELLOW PHOSPHORUS	0.093 kg
RA concerned maytake further necessary				action asper above decision of NC.

Case No.			A-02
MeetingNo.			NC/3/MEET/Feb/202122/14
Date			21/02/2022
Firm’s Name			M/s Sandhya Organic Chemicals Pvt. Ltd., Mumbai
HQF. No.			01/82/050/00167/AM20/DES-III
RLA F. No.			03/95/040/01388/AM19
Advance Authorization No. and Date			0310828995 dated 14.05.2019
Subject			Request of M/s Sandhya Organic Chemicals Pvt. Ltd., Mumbai
			for enhancement in the quantity of import item No. 2 – Isodecyl
			Alcohol in respect of adhoc norms fixed against Advance
			Authorization No. 0310828995 dated 14.05.2019
Decision:	The	Committee considered the request of the firm and it was decided to call for following
information from the firm:
	(i)	Stoichiometric balance on molecular weight basis to justify the enhancement in
		consumption of Isodecyl Alcohol.


	Case No.			A	-03
	MeetingNo.			N	C/3/ME	ET/Feb/202122/14
	Date			21	/02/202	2
	Firm’s Name			M	/s J.B. C	hemicals & Pharmaceuticals Ltd., Mumb				ai
	HQF. No.			01	/82/050	/01590/AM16/DES-III
	RLA F. No.			03	/94/040	/00552/AM16
	Advance Authorization No. and Date			0310799930 dated 02.11.2015
	Subject			Request of M/s J.B. Chemicals & Pharmaceuticals Ltd<br>Mumbai for revision/correction in adhoc norms fixed against<br>Advance Authorization No. 0310799930 dated 02.11.2015
	Decision:<br>The Committee considered the case as per agenda and it was decided to revise adhoc norms as
	under:
			Pdt<br>t<br>It It<br>t
	Sl	Et	Pdt				t	It It	t
	.<br>No.	xpor	rouc				Qy.	mpor em	Qy.<br>(in gm for 100
									lozenges)

	1	Sugar<br>throat<br>Black C	ased Medicated Lozenges: Medi-Keel A<br>Lozenges/ Medi-Keel A Thraot Lozenges<br>urrant /Honey & Lemon. Each Lozenges				100 Lozenges	Benzocaine	1.224 gm
		contains	Benzocaine 12 mg
			<br> <br>
	2	Codral<br>Antibac	Sore<br>Throat<br>Lozenges,<br>teral+Anaesthetic Lime & Lemon Flavour,				100 Lozenges	Benzocaine	1.020 gm
		<br>Each Lo	<br>zengesContains Benzocaine 10Mg_,_
	3	Cepacol<br>	Plus Black<br>Currant Lozenges,<br>Each<br> i i 1				100 Lozenges	Benzocaine	1.020 gm
LozengesContans Benzocane0Mg<br>4<br>Cepacol Sore Throat & Cough Relief Disc, Each<br>Lozenges ContainsBenzocaine1.25Mg<br>100 Lozenges<br>Benzocaine<br>0.1275 gm<br>5<br>Cepacol plus Original Lozenges, Each Lozenges<br>ContainsBenzocaine10MG<br>100 Lozenges<br>Benzocaine<br>1.020 gm<br>RA concerned maytake further necessaryaction asper above decision of NC.		LozengesContans Benzocane0Mg
	4	Cepacol Sore Throat & Cough Relief Disc, Each<br>Lozenges ContainsBenzocaine1.25Mg					100 Lozenges	Benzocaine	0.1275 gm
	5	Cepacol plus Original Lozenges, Each Lozenges<br>ContainsBenzocaine10MG					100 Lozenges	Benzocaine	1.020 gm

Case No.	Case No.	Case No.	A-04	A-04	A-04	A-04	A-04
MeetingNo.			NC/3/MEET/Feb/202122/14
Date			21/02/2022
Firm’s Name			M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
HQF. No.			F. No. 01/82/050/00535/AM18/DES-III
RLA F. No.			03/95/040/00244/AM18

Advance Autho		rization No. and Date	0310814244 dated 23.06.2017
Subject			Rt f M/ JB Chil & Phtil Ltd
			eques o s .. emcas armaceucas .,<br>Mumbai for revision / correction in respect of adhoc norms
			<br>fixed against Advance Authorization No. 0310814244 dated<br>23.06.2017

Decision:<br>T<br>d		he Committee considered the case as per agenda and it was decided to revise adhoc norms as
uner:
					Sl.<br><br>Import items<br>Qty.<br>
Sl.<br>	Export	product		Qty.	Sl.<br>	Import items	Qty.<br>
No.					No.		(in Gms)
1	Benzocaine<br>and<br>Cetylpridinium<br>Chloride Anaesthetic Throat Lozenges<br>Flavours<br>Black<br>Currant,<br>Honey<br>Lemon & other Flavours<br>(Each			100 Lozenges	1	Benzocaine	12.240 gm
	Lozenges contains Benzocaine 12 mg)
2	Benzoca<br>Chlorid	ine<br>and<br>Cetylpridinium<br>Anaesthetic Throat Lozenes		100 Lozenges	2	Benzocaine	10.20 gm
	<br>Flavours	g<br>Lime and Lemon & other
	flavours<br>	(Each Lozenges<br>contains<br>i
	Benzoca	ne 10mg)
3	Benzoca<br>Chloride	ine<br>and<br>Cetylpridinium<br> <br>and<br>Dextromethorphan		100 Lozenges	3	Benzocaine	1.275 gm
	Hydrobr<br>L	omide<br>Anaesthetic<br>Throat<br>Eh Lti
	ozenge<br>Benzoca	s (ac ozenges conans<br>ine1.25mg)
4	Life Br<br>Congest<br>Ch	and Sore Throat & Nasal<br>ion Relief Extra Strength<br>l S F L		100 Lozenges	4	Benzocaine	15.300 gm

	erry avours ugar ree ozenges.<br>Each Lozenges Contains Benzocaine<br>15Mg &Isomalt ST-M 2591.86Mg.				5	Isomalt ST-M	259.186 gm
5	Life Brand Sore Throat & Nasal<br>Congestion Relief Extra Strength<br>Honey & Lemon Flavours Sugar Free<br>Lozenges. Each Lozenges Contains<br>Benzocaine 15 mg & Isomalt ST-M<br>2591.86Mg.			100 Lozenges	6	Benzocaine	15.300 gm
					7	Isomalt ST-M	259.186 gm
concerne maytae urter necessaryacton asper aove ecson o .

Case No.	A-05
Meeting No.	NC/3/MEET/Feb/202122/14
Date	21/02/2022
Firm’s Name	M/s Inchem Laboratories pvt Ltd Hyderabad
HQF. No.	01/82/050/01497/AM19/DES-III
RLA F. No.	09/24/040/00230/AM19
AdvanceAuthorizationNo. andDate	0910066657dated11.09.2018
Subject	Request of M/s Inchem Laboratories pvt Ltd, Hyderabad for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 0910066657<br>dated 11.09.2018
Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information<br>from the firm:<br>(i)<br>Copy of technical literature in support of yields claimed at various steps.

Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm: (i) Copy of technical literature in support of yields claimed at various steps.

Case No.	A-06
MeetingNo.	NC/3/MEET/Feb/202122/14
Date	21/02/2022
Firm’s Name	M/s Inchem Laboratories pvt Ltd Hyderabad
HQF. No.	01/82/050/01498/AM19/DES-III
RLA F. No.	09/24/040/00261/AM19
Advance Authorization No. and Date	0910066658 dated 11.09.2018
Subject	Request of M/s Inchem Laboratories pvt Ltd, Hyderabad for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 0910066658<br>dated 11.09.2018
Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information<br>from the firm:<br>(i)<br>Copy of technical literature in support of yields claimed at various steps.

Case No.	Case No.			A-07
Meeting No.				NC/3/MEET/Feb/202122/14
Date				21/02/2022
Firm’s Name				M/s Concord Biotech Ltd, Ahmadabad
HQF. No.				01/82/050/00103/AM19/DES-III
RLA F. No.				08/24/040/00328/AM18
AdvanceAuthorizationNo. andDate				0810142000 dated14.02.2018
Subject				Request of M/s Concord Biotech Ltd, Ahmadabad			for fixation
				of<br>adhoc<br>norms<br>against	Advance	Authorization		<br>No.
				0810142000 dated 14.02.2018
Decision:		The Committee considered the		case as per agenda and it was decided to ratify adhoc			norms	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.<br>Import items			Qty.
				No.
	MYCOPHENOLATE		1 kg	1<br>MYCOPHENOLIC ACID			0.90	kg
	SODIUM	POWDER FOAM		(NOT FOR DIRECT	MEDICAL USE)
				POWDER FOAM
RA concerned maytake further necessaryaction asper above decision of NC.

Case No.		A-08
MeetingNo.		NC/3/MEET/Feb/202122/14
Date		21/02/2022
Firm’s Name		M/s Songwon Speciality Chemicals India Pvt. Ltd., Vadodara
HQF. No.		01/82/050/01146/AM19/DES-III
RLA F. No.		34/24/040/00232/AM19
AdvanceAuthorizationNo. andDate<br>3410044578 dated11.10.2018
Subject		Request of M/s Songwon Speciality Chemicals India Pvt. Ltd.,
		Vadodara for revision of adhoc norms against Advance
		Authorization No. 3410044578 dated 11.10.2018
Decision:	The Committee considered the request of firm and the reply furnished by the firm and it was
observed that	the reply furnished by the firm was not clear. Hence, it was decided to call for following
information from the		firm:
	(i)	Whether process of manufacturing changed to reduce the quantity of import item
		No. 2 – Sodium Methoxide Powder.
	(ii)	As per letter dated 11.02.2020, import item No. 2 – Sodium Methoxide Powder is
		alongwith Methanol and if so, quantity of Sodium Methoxide in it.
	(iii)	To justify the quantity of import item No. 7 – Sodium Sulphide with the help of
		molecular weight and percentage yield in the reaction.

	Case No.	A-09
	MeetingNo.	NC/3/MEET/Feb/202122/14
	Date	21/02/2022
	Firm’s Name	M/s Sanofi Healthcare India Private Limited<br>[Formerly known as M/s Sanofi-Synthelabo (India) Pvt. Ltd.]
	HQF. No.	01/82/162/00003 /AM22/DES-III
	RLA F. No.	03/88/040/00023/AM18<br>03/88/040/00321/AM18<br>03/88/040/00076/AM20<br>03/88/040/00264/AM20
	Advance Authorization No. and Date	0310813345 dated 17.05.2017<br>0310819721 dated 12.03.2018<br>0310830014 dated 01.07.2019<br>0310835089 dated 26.02.2020
	Subject	Request of M/s Sanofi Healthcare India Private Limited<br>[Formerly known as M/s Sanofi-Synthelabo (India) Pvt. Ltd.] is<br>to allow the norms as per SION A-3663 instead of SION A-412 in<br>respect of Advance Authorization No. 0310813345 dated<br>17.05.2017, 0310819721 dated 12.03.2018, 0310830014 dated<br>01.07.2019 and 0310835089 dated 26.02.2020
	Decision:<br>Shri Anil Sukhatme, Manager Exports and Shri Avinash Pujary, Assistant Manager Exports<br>attended the Personal Hearing on 25.02.2022 through Video Conferencing and explained their case in line with<br>the composition approved in the DML.<br>The Committee considered the request of firm and in accordance with the Approved<br>Composition from Durg Authority and in line with SION available for the export product, it was decided to<br>allow following norms:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Clopidogrel 75 mgTablets 100s<br>(Clopidogrel Zentiva 75 mg<br>Filmtabletten / Plavix 75mg<br>Filmtabletten) (Each film coated<br>Tablet<br>contains:<br>Clopidogrel<br>Hydrogn sulphate equivalent to<br>Clopidogrel 75 mg)<br>1 Number<br>1<br>Clopidogrel<br>OR<br>Clopidogrel Bisulfate Form II<br>(Clopidogrel<br>Hydrogen<br>Sulfate Form II)<br>76.5 mg / Tablet<br>99.61 mg/ Tablet<br>RA concerned may take further necessary action as per above decision of NC.

	Case No.	A-10
	MeetingNo.	NC/3/MEET/Feb/202122/14
	Date	21/02/2022
	Firm’s Name	M/s Chemplast Sanmar Limited (Formerly known as<br>M/s Sanmar Speciality Chemicals Limited)
	HQF. No.	01/82/050/00852/AM14/DES-III
	RLA F. No.	04/24/040/00146/AM14
	Advance Authorization No. and Date	0410150519dated 03.10.2013
	Subject	Request of M/s Chemplast Sanmar Limited (Formerly known<br>as M/s Sanmar Speciality Chemicals Limited) for enhancement<br>in the quantity of import item in respect of adhoc norms fixed<br>against<br>Advance<br>Authorization<br>No.<br>0410150519<br>dated<br>03.10.2013
	Decision:<br>The Committee considered the case as per agenda and it was decided to revise adhoc norms as<br>under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4 CHLOROBUTYLVERATRATE<br>60% SOLUTION IN METHYL-<br>ETHYL-KETONE<br>1 kg<br>1<br>3, 4 DIMETHOXYBENZOIC ACID<br>0.992 kg<br>Note: Above revised norms are for regularization and closure purpose only. No repeat licence<br>will be issued on the basis of above decision.<br>RA concerned maytake further necessaryaction asper above decision of NC.

Meeting ended with thanks to Chair and participants

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