IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-05-27

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/May/202223/3 Meeting Date - 27/05/2022

Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/May/202223/3 dated 27/05/2022, actually held on 22.06.2022 held 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/Apr/202223/1 dated 29/04/2022, was actually held on 10.05.2022.

Ajay AJAY . Ajay Kumar 2022.06.28 Ajay2022.06.28 Kumar Kumar Kumar 10:54:57 10:54:57 , +05'30' jeso

MANUAL CASES

Case No.	A-01
MeetingNo.	NC/3/MEET/May/202223/3
Date	27/05/2022
Firm’s Name	M/s Clean Science and Technology Private Limited, Pune
HQF. No.	01/82/050/00149/AM18/DES-III
RLA F. No.	31/83/040/00012/AM18
Advance Authorization No. and Date	3110066716 dated 02.05.2017
Subject	Request of M/s CLEAN SCIENCE AND TECHNOLOGY PVT.<br>LTD., Pune for enhancement in the quantity of import items of<br>norms in respect of adhoc norms fixed against Advance<br>Authorization No. 3110066716 dated 02.05.2017
Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call<br>for following information / documents from the firm:<br>(i)<br>Copy of provisional Patent submitted in support of 79.18% yield.

Case No.	A-02
MeetingNo.	NC/3/MEET/May/202223/3
Date	27/05/2022
Firm’s Name	M/s Clean Sciences and Technology Pvt. Ltd., Pune
HQF. No.	01/82/050/01261/AM19/DES-III
RLA F. No.	31/83/040/00133/AM19
Advance Authorization No. and Date	3110067248 dated 10.12.2018
Subject	Request of M/s Clean Sciences and Technology Pvt Ltd Pune for<br>enhancement in the quantity of import item in respect of adhoc<br>norms fixed against Advance Authorization No. 3110067248<br>dated 10.12.2018
Decision:<br>The Committee considered the request of firm for enhancement of norms and it was decided to call<br>for following information / documents from the firm:<br>(i)<br>Stoichiometric balance on molar basis and percentage of yield to arrive at the<br>quantity of raw material for which enhancement is required.

Ajay Kumar Ajay 2022.06.28 Kumar 10:55:28 +05'30'

Case No.	A-03
MeetingNo.	NC/3/MEET/May/202223/3
Date	27/05/2022
Firm’s Name	M/s Clean Science and Technology Private Limited, Pune
HQF. No.	01/82/050/00916/AM19/DES-III
RLA F. No.	31/83/040/00034/AM19
Advance Authorization No. and Date	3110067081 dated 15.06.2018
Subject	Request of M/s CLEAN SCIENCE AND TECHNOLOGY PVT.
	LTD., Pune for enhancement in the quantity of import items of
	norms in respect of adhoc norms fixed against Advance
	Authorization No. 3110067081 dated 15.06.2018

Decision: The Committee considered the request of firm and taking into consideration 93% purity of Anisole and 80% reaction yield and also GST data given by the firm, it was decided to revise adhoc norms as under:

<br>under:
Export product	Qty.	Sl.<br>No.	Import items	Qty.
4-Methoxy Acetophenone ( 4 MAP) /<br>Acetyl Anisole	1 kg	1	Anisole93% Max	0.967 kg
		2	Acetic Anhydride 99%	0.755 kg

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

Ajay Kumar Ajay 2022.06.28 Kumar 10:55:44 +05'30'


	Case No.					A-04
	MeetingNo.					NC/3/M	EET/May/202223/3
	Date					27/05/2	022
	Firm’s Name					M/s J.B	Chemicals & Pharmaceuticals Ltd, Mumbai
	HQF. No.					01/82/0	50/00058/AM16/DES-III
	RLA F. No.					03/94/0	40/00932/AM15
	Advance Authorization No. and Date					031079	2548 dated 01.01.2015
	Subject					Reques<br>for rev	t of M/s J.B Chemicals & Pharmaceuticals L<br>iew of adhoc norms fixed against Advance A				td, Mumbai<br>uthorization
						<br>No. 031	<br>0792548 dated 01.01.2015
	Decision:<br>The Committee cons<br>Sheet furnished by the firm, it was			idered th<br>decided		e reques<br>to revise	t of firm for revision of norms and as per Licence<br>adhoc norms as under:				Amendment

	Sl. No.	Export product			Q	ty.		Sl.<br>No.	Import items	Qty.
	1	Boots Sore Throat<br><br>Lozenges Black Currant<br>Free.<br>Each<br>Lozenges<br>con<br>Isomalt<br>ST-M<br>2141.6<br>Amylmetacrysol 0.6mg		Relief<br>Sugar<br>tains<br>4mg,	1	00 lozen	ges	1.	Amylmetacresol	0.061	2 gram
								2.	Isomalt ST-M	214.1	64 gram

	2	Duro-Tuss Chesty Sugar<br>Lozenges Lemon/Eucal<br>&<br>Me<br>Each<br>Lozenges<br>co		Free<br>yptus<br>nthol.<br>ntain	1	00 lozen	ges	1.	Cetylpyridinium Chloride	0.135	6 gram

								2.	Isomalt ST-M	214.1	64 gram
		Isomalt<br>ST-M<br>2141.64mg,<br>Cetylpyridinium<br>Chloride<br>1.33mg
	3	Septolete Lozenges / Septolete<br>Extra Lozenges / Septolete			100 lozenges			1.	Cetylpyridinium Chloride	0.102 gram
		<br>Ultra Lozenges / Septolete
								2	Ilt STM	258055
		Omni<br>	Lozenges / Septolete<br>					.	soma -	. gram
		Total<br>Duo	Lozenges / Septolete<br>ozenges / Septabene
		<br>Lozeng	<br>es.
		Each<br>Cetypy<br>	Lozenges<br>contains<br>ridinium Chloride EP<br> <br> <br>
		1.00<br>25805	MG<br>Isomalt<br>ST-M<br>5 mg
		.

RA concerned	RA concerned		maytake further necessaryaction asper above decision of NC.

Ajay Kumar Ajay 2022.06.28 Kumar 10:56:04 +05'30'

	Case No.	A-05
	MeetingNo.	NC/3/MEET/May/202223/3
	Date	27/05/2022
	Firm’s Name	M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
	HQF. No.	01/82/050/00619/AM18/DES-III
	RLA F. No.	03/94/040/00260/AM18
	Advance Authorization No. and Date	0310814635 dated 14.07.2017
	Subject	Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai<br>for revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0310814635 dated 14.07.2017
	Decision:<br>The Committee considered the request of firm for revision of norms and as per Licence Amendment<br>Sheet furnished by the firm, it was decided to revise adhoc norms as under:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No<br>Import items<br>Qty.<br>1<br>Benzydamine<br>Hydrochloride<br>&<br>Cetylpyridinium<br>Chloride<br>Anti<br>Inflammatory and<br>Antiseptic Sugar<br>Free<br>Lozenges<br>with all Flavours.<br>Each Lozenges contains Benzydamine<br>Hydrochloride<br>3.00<br>mg,<br>Cetylpyridinium Chloride 1.33 mg,<br>Isomalt ST-M 2591.86 mg. Net Content<br>Benzydamine<br>Hydrochloride<br>87.60<br>Kgs, Cetylpyridinium Chloride 38.84<br>Kgs,Isomalt ST-M 75682.31 Kgs.<br>1000<br>Number<br>1.<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>2<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>3<br>Isomalt ST-M<br>2591.86 gram<br>2<br>Benzydamine<br>Hydrochloride<br>Anti<br>Inflammatory Sugar Free Lozenges<br>with all Flavours.<br>Each Lozenge contains Benzydamine<br>Hydrochloride 3.00 mg, Isomalt ST-M<br>2591.86 mg. Net Content Benzydamine<br>Hydrochloride<br>58.39Kgs, Isomalt ST-<br>M 50449.83 Kgs<br>1000<br>Number<br>4<br>Benzydamine<br>Hydrochloride<br>3.06 gram<br>5<br>Isomalt ST-M<br>2591.86 grram<br>3<br>Cetylpyridinium<br>Chloride<br>1mg<br>Antiseptic Sugar Free Lozenges with<br>Mint<br>Flavours.<br>Each<br>Lozenge<br>contains<br>Cetylpyridinium Chloride 1mg, Isomalt<br>ST-M<br>2591.86<br>mg.<br>Net<br>Content<br>Cetylpyridinium Chloride 18.25 Kgs,<br>Isomalt ST-M 47301.45Kgs.<br>1000<br>Number<br>6<br>Cetylpyridinium<br>Chloride<br>1.02 gram<br>7<br>Isomalt ST-M<br>2591.86 gram<br>4<br>Zecuf Herbal Cough Lozenges Sugar<br>Free.<br>Each Lozenge contains Isomalt ST-M<br>2591.86 mg. Net Content Isomalt ST-M<br>15243.91 Kgs<br>1000<br>Number<br>8<br>Isomalt ST-M<br>2591.86 gram<br>5<br>Cetylpyridinium<br>Chloride<br>and<br>Bromhexine Hydrochloride Antiseptic<br>Lozenges Sugar Free with all Flavours<br>1000<br>Number<br>9<br>Cetylpyridinium<br>Chloride<br>1.356 gram<br>10<br>Isomalt ST-M<br>2591.86 gram<br>RA concerned may take further necessary action as per above decision of NC.

Ajay Kumar Ajay 2022.06.28 Kumar 10:56:28 +05'30'

Case No.	A-06
MeetingNo.	NC/3/MEET/May/202223/3
Date	27/05/2022
Firm’s Name	M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
HQ F. No.	01/82/050/01625/AM16/DES-III<br>01/82/050/01612/AM16/DES-III<br>01/82/050/01615/AM16/DES-III<br>01/82/050/01613/AM16/DES-III
RLA F. No.	03/94/040/00816/AM16<br>03/94/040/00814/AM16<br>03/94/040/00815/AM16<br>03/94/040/00817/AM16
Advance Authorization No. and Date	0310801629 dated 07.01.2016,<br>0310801603 dated 06.01.2016,<br>0310801571 dated 05.01.2016<br>0310801604 dated 06.01.2016
Subject	Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumbai<br>for enhancement in the quantity of import item in respect of<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0310801629 dated 07.01.2016, 0310801603 dated 06.01.2016,<br>0310801571 dated 05.01.2016 and 0310801604 dated 06.01.2016
Decision:<br>The Committee considered the request of firm for revision of norms and as per Licence Amendment<br>Sheet furnished by the firm, it was decided to revise adhoc norms as under:<br>For Advance Authorization No. 0310801629 dated 07.01.2016<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(in gm for<br>100lozenges)<br>1<br>Difflam Sugar Free Lozenges<br>Flavours Raspberry / Eucalyptus<br>& Menthol / Honey & Lemon /<br>Orange / Double Mint / Other<br>Flavours / Andolex–C Lozenges<br>Sugar Free Flavour Raspberry /<br>Eucalyptus & Menthol / Honey &<br>Lemon / Orange / Other Flavours.<br>Each<br>lozenges<br>contains<br>Benzydamine Hydrochloride 3.00<br>mg,<br>Cetylpyridinium<br>Chloride<br>1.33 mg, Isomalt ST-M 2591.86<br>mg.<br>100<br>lozenges<br>1<br>Benzydamine Hydrochloride<br>0.306 gm<br>2<br>Cetylpyridinium Chloride<br>0.1356 gm<br>3<br>Isomalt ST-M<br>259.186 gm<br>2<br>Difflam<br>AAA<br>Sugar<br>Free<br>Lozenges Flavours / Eucalyptus &<br>Menthol / Honey & Lemon /<br>Black Currant / Berry.<br>Each<br>lozenges<br>contains<br>Benzydamine Hydrochloride 3.00<br>mg,Isomalt ST-M 2591.86 mg.<br>100<br>lozenges<br>4<br>Benzydamine Hydrochloride<br>0.306 gm<br>5<br>Isomalt ST-M<br>259.186 gm<br>3<br>Cetylpridinium<br>Chloride<br>and<br>Benzydamine<br>Hydrochloride<br>Antiseptic Lozenges sugar free.<br>Each<br>lozenges<br>contains<br>Cetylpyridinium Chloride EP 1.00<br>MT,Isomalt ST-M 2591.86 mg.<br>100<br>lozenges<br>6<br>Cetylpyridinium Chloride<br>0.102 gm<br>7<br>Isomalt ST-M<br>259.186 gm

Ajay Kumar Ajay 2022.06.28 Kumar 10:56:46 +05'30'

For Advance Authorization No. 0310801603 dated 06.01.2016


For Advance Authorization No. 0310801603 dated 06.01.2016<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(in gm for 100
	Sl.<br>No.	Export product			Qty.	Sl.<br>No.	Import items	Qty.<br>(in gm for 100
								lozenges)
		<br> <br> <br>
	1	Difflam<br>Flavour	<br>Sugar<br>Free<br>Lozenges<br>s Raspberry / Eucalyptus &		100<br>lozenes	1	Benzydamine Hydrochloride	0.306 gm
		<br>Mentho<br>	<br>l / Honey & Lemon / Orange /<br>		g
						2	Cetylpyridinium Chloride	01356 gm
		Double<br>Other F	Mint Flavours Strawberry &<br>lavour.					.
		Each<br>Benzyd<br>	lozenges<br>contains<br>amine Hydrochloride<br>3.00<br>			3	Isomalt ST-M	259.186 gm
		mg, Ce<br>mg,Iso	tylpyridinium Chloride 1.33<br>maltST-M 2591.86mg.
	2	Difflam	AAA Sugar Free Lozenges		100	4	Benzydamine Hydrochloride	0.306 gm
		Flavour<br>Honey<br>Berry.	s / Eucalyptus & Menthol /<br>& Lemon / Black Currant /		lozenges
						5	Isomalt ST-M	259186 gm
		Each lozenges contains Benzydamine<br>Hydrochloride 3.00 mg, Isomalt ST-<br>M 2591.86mg.						.
				For Advance Authorization No. 0310801571 dated 05.01.2016

	Sl.<br>No.	Export product			Qty.	Sl.<br>No.	Import items	Qty.<br>(in gm for<br>100l
								ozenges)
	1	Difflam Suar		Free Lozenes	100	1	Benzdamine Hdrochloride	0306 m
		<br>Flavour	g g<br>s Raspberry / Eucalyptus		lozenges		y y	. g
		& Men<br>	thol / Honey & Lemon /<br>			2	Cetylpyridinium Chloride	0.1356 gm
		Orange<br>	/ Double Mint / Other<br>
		Flavour<br>Each<br>Benzyd	s.<br>lozenges<br>contains<br>amine Hydrochloride 3.00			3	Isomalt ST-M	259.186 gm
		mg,<br>C<br>	etylpyridinium<br>Chloride<br>
		1.33 m<br>m	g, Isomalt ST-M 2591.86
		g.
	2	Difflam<br>Lozeng	<br>AAA<br>Sugar<br>Free<br>es Flavours / Eucalyptus &		100<br>lozenges	4	Benzydamine Hydrochloride	0.306 gm
		<br>Menthol / Honey & Lemon /<br>Black Currant / Berry.<br>Each<br>lozenges<br>contains<br>Benzydamine Hydrochloride 3.00<br>mg,Isomalt ST-M 2591.86 mg.
						5	Isomalt ST-M	259.186 gm
	3	Cetylpridinium<br>Chloride<br>and<br>Benzydamine<br>Hydrochloride<br>Antiseptic Lozenges sugar free.<br>Each<br>lozenges<br>contains			100<br>lozenges	6	Cetylpyridinium Chloride	0.102 gm
						7	Isomalt ST-M	259.186 gm
		Cetylpyridinium Chloride EP 1.00
MT,Iso		MT,Iso	malt ST-M 2591.86 mg.

Ajay Kumar Ajay 2022.06.28 Kumar 10:57:03 +05'30'

For Advance Authorization No. 0310801604 dated 06.01.2016

Sl.	Export product	Qty.	Sl.	Import items	Qty.
No.			No.		(in gm for
					100 lozenges)
1	Difflam Sugar Free Lozenges	100	1	Benzydamine Hydrochloride	0.306 gm
	Flavours Raspberry / Eucalyptus	lozenges
	& Menthol / Honey & Lemon /<br>Orange / Double Mint / Mint /		2	Cetylpyridinium Chloride	0.1356 gm
	Other Flavours.<br>Each<br>lozenges<br>contains		3	Isomalt ST-M	259.186 gm
	Benzydamine Hydrochloride 3.00
	mg,<br>Cetylpyridinium<br>Chloride
	1.33 mg, Isomalt ST-M 2591.86
	mg.
2	Difflam<br>AAA<br>Sugar<br>Free	100	4	Benzydamine Hydrochloride	0.306 gm
	Lozenges Flavours / Eucalyptus &	lozenges
	Menthol / Honey & Lemon /<br>Black Currant / Berry.		5	Isomalt ST-M	259.186 gm
	Each<br>lozenges<br>contains
	Benzydamine Hydrochloride 3.00
	mg,Isomalt ST-M 2591.86 mg.
3	Cetylpridinium<br>Chloride<br>and	100	6	Cetylpyridinium Chloride	0.102 gm
	Benzydamine<br>Hydrochloride<br>Antiseptic Lozenges sugar free.	lozenges	7	Isomalt ST-M	259.186 gm
	Each<br>lozenges<br>contains
	Cetylpyridinium Chloride EP 1.00
	MT,Isomalt ST-M 2591.86 mg.

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

Ajay Kumar Ajay 2022.06.28 Kumar 10:57:17 +05'30'

Case No.	A-07
Meeting No.	NC/3/MEET/May/202223/3
Date	27/05/2022
Firm’s Name	M/s Fermenta Biotech Limited<br>(Formerlyknown as M/s DIL Limited)
HQ F. No.	01/82/050/00746/AM20/DES-III
RLA F. No.	03/94/040/00553/AM20
Advance Authorization No. and Date	0310832316 dated 18.10.2019
Subject	Request of M/s Fermenta Biotech Limited for fixation of adhoc<br>norms against Advance Authorization No. 0310832316 dated<br>18.10.2019
Decision:<br>Shri Arun Khedwal - GM Supply Chain Management, Shri Amol Lone Business Finance<br>Controller and Shri Srinath Trivikram - Senior Group leader; attended the Personal Hearing and explained their<br>case. 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:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CHOLESTEROL<br>(Assay by GC not less than<br>91.0%)<br>1 kg<br>1<br>DETOX FOC-27<br>(FISH BODY OIL CRUDE)<br>(Non–edible grade, FFA content not<br>less than 20%)<br>4.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Case No.	A-08
Meeting No.	NC/3/MEET/May/202223/3
Date	27/05/2022
Firm’s Name	D.K Bio Pharma Pvt. Ltd.
HQ F. No.	01/82/050/02253/AM19/DES-III<br>01/82/050/01006/AM19/DES-III
RLA F. No.	03/94/040/00842/AM19<br>03/94/040/00603/AM18
Advance Authorization No. and Date	0310826158 dated 04.01.2019<br>0310816992dated13.11.2017
Subject	Request of M/s D.K Bio Pharma Pvt. Ltd. for fixation of adhoc<br>norms against Advance Authorization No. 0310826158 dated<br>04.01.2019and 0310816992 dated 13.11.2017
Decision:<br>Shri Sushant Shinde - Senior Manager Accounts; attended the Personal Hearing and explained its<br>case. 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:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>CHOLESTEROL<br>(Assay by GC not less than<br>91.0%)<br>1 kg<br>1<br>DETOX FOC-27<br>(FISH BODY OIL CRUDE)<br>(Non–edible grade, FFA content not<br>less than 20%)<br>4.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Meeting ended with thanks to Chair and participants

Ajay Kumar Ajay 2022.06.28 Kumar 10:57:40 +05'30'

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