IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-07-08

DGFT Committee Minutes

Document text

UDIN00200864AM23

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/Jun/202223/5 DATED: 08/07/2022

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/Jun/202223/5 dated 08/07/2022 of Norms Committee - III for the year 2022-23 was held on 08/07/2022 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:-

	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
4	Rajiv Soni ,Joint DGFT	Directorate General of Foreign Trade, Delhi

Case Details and Decision(s):

Case No.	1 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected

Signature Not Verified Signature Not Verified Digitally Signed. Digitally signe Name: Ajay Kumar( Deputy Director ) Name: Ajay Kumar( uty Director ) Date: 07-Sep-2022 17:36:48Reason: AJAY.DHIMAN88@GOV.IN Date:Reason:07-86AJAY.20 IAN88@GOV.IN36:48 Location: DGFT(HQ) Location: DGFTIHG)

This document has been digitally signed by AJAY KUMAR, Deputy Director,DGFT(HQ) on 07-Sep-2022.

UDIN00200864AM23

Party Name	HESTER BIOSCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205000216AM14
RA File Number	082404000081 AM14
Licence No and<br>Date	0810121432/27/05/2013
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	2 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	ALCHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00162223AM22
RA File Number	052304000365 AM14
Licence No and<br>Date	0510373480/13/12/2013
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and as per the details furnished by the firm<br>alongwith Production / Consumption data certified for the period 2013-14, 2014-15 and 2015-16, it was<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>VINPOCETINE<br>EP/BP/USP<br>1 kg<br>1<br>VOACANGA SEEDS/ APOCYNACEAE SP<br>146.78 kg<br>Note: The above norms are for regularization and closure purpose only. No repeat licence will be issued on<br>the basis of above decision.<br>RA concerned may take further necessary action as per above decision of NC.

Case No. 3 / NC/3/MEET/Jun/202223/5

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00166247AM22
RA File Number	082404000415 AM14
Licence No and<br>Date	0810127686/03/01/2014
Norms Committee Decision:
The Committee considered the request of firm for revision of norms and it was decided to call the firm for attending
Personal Hearing<br>	before Norms Committee alongwith following documents / information:
Why Acetone cannot be recovered in the process on the basis of parameters of Reaction, that is, temp etc.<br>i.
Copy of Shipping Bill indicating purity and impurity level of export.<br>ii.
iii End use of	Export Product.

The Committee considered the request of firm for revision of norms and it was decided to call the firm for attending Personal Hearing before Norms Committee alongwith following documents / information:

Case Status	Case Status	Case Deferred	Case Deferred	Case Deferred	Case Deferred	Case Deferred
Party Name		ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00166247AM22
RA File Number		082404000415 AM14

Licence No and<br>		0810127686/03/01/2014
Date

Norms Committee		Decision:
The Committee co		nsidered the request of firm for revision of norms and it was decided to call the firm for attending
Personal Hearing<br>		before Norms Committee alongwith following documents / information:

Why Aceto<br>i.		ne cannot be recovered in the process on the basis of parameters of Reaction, that is, temp etc.
Copy of Sh<br>ii.<br>		ipping Bill indicating purity and impurity level of export.<br>
iii End use of Export Product.

Case No.		4 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		ALCHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number		NC/ 3/ MEET/ J/ 202223/ 5 d 08/07/2022
and Date		un an
HQ File Number		HQRNORM REVIW00162147AM22
RA File Number		052304000413 AM14
Licence No and		0510376990/24/01/2014
Date
Norms Committee<br>		Decision:<br>
The Committee considered the request of firm for fixation of adhoc norms and as per the details furnished by the firm<br>alongwith Production / Consumption data certified for the period 2013-14, 2014-15 and 2015-16, it was<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.
	Export product		Qty.	Sl. No.	Import items	Qty.

	VINPOCETINE		1 k	1	VOACANGA SEEDS/ APOCYNACEAE SP	14678 k
	<br>EP/BP/USP		g			. g

	Note: The abo<br>	ve norms are for regularization and closure purpose only. No repeat licence will be issued on<br>
	the basis of abov	e decision.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

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

Case No.<br>5 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Approved
Party Name<br>V & V PHARMA INDUSTRIES
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00000474AM23
RA File Number<br>039504001061 AM14
Licence No and<br>Date<br>0310776760/02/04/2014
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify				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.	Import items	Qty.
		No.
ETHYL Na- LAUROYL - L- ARGINATE	<br>1 kg	1	L-ARGININE FREE BASE	0.68 kg
HYDROCHLORIDE (LAE)
<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	6 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	V & V PHARMA INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000473AM23
RA File Number	039504000190 AM15
Licence No and<br>Date	0310785305/13/06/2014
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under
Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Export product	Qty.	Sl.	Import items	Qty.
		No.
ETHYL Na- LAUROYL - L- ARGINATE	<br>1 kg	1	L-ARGININE FREE BASE	0.68 kg
HYDROCHLORIDE (LAE)

Case No.<br>7 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Approved
Party Name<br>ALCHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00165491AM22
RA File Number<br>052304000053 AM15
Licence No and<br>Date<br>0510388783/18/06/2014
Norms Committee Decision:
:The Committee considered the request of firm for review of adhoc norms and as per the COA furnished by the firm
for various consignments of Imported Leaves, the content of Digoxin varies from 0.4% to 0.5%.	Accordingly, it was
decided to revise adhoc norms as under:
Export product<br>Qty.<br>Sl. No. Import items	Qty.
Digoxin<br>1 kg<br>1<br>Digitalis Lanata Leaves	343.16 kg
Note: The above revised norms are for regularization and closure purpose only.
RA concerned may take further necessary action as per above decision of NC.

Case No.	8 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	ALCHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00165566AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

RA File Number<br>052304000235 AM15	RA File Number<br>052304000235 AM15
Licence No and<br>Date<br>0510391191/18/09/2014
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as per the COA furnished by the firm for
various consignments of Imported	Leaves,	the content of Digoxin varies from 0.4% to 0.5%. Accordingly, it was
decided to revise adhoc norms as under:
Export product<br>Qty.	Sl. No.	Import items	Qty.
Digoxin<br>1 kg	1	Digitalis Lanata Leaves	343.16 kg
Note: The above norms are for regularization and closure purpose only.
RA concerned may take further necessary action as per above decision of NC

Case No.	Case No.	9 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		ALCHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00162043AM22
RA File Number		052304000278 AM15
Licence No and<br>Date		0510391347/25/09/2014
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and as per the details furnished by the firm
alongwith Production / Consumption data certified for the period 2013-14, 2014-15 and			2015-16, it was
decided to ratify 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.<br>Sl. No. Import items	Qty.
	VINPOCETINE	<br>1 kg<br>1<br>VOACANGA SEEDS/ APOCYNACEAE SP	146.78 kg
	EP/BP/USP
	Note: The above norms are for regularization and closure purpose only. No repeat licence will be issued on

Case No.	Case No.	9 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		ALCHEM INTERNATIONAL PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00162043AM22
RA File Number		052304000278 AM15
Licence No and<br>Date		0510391347/25/09/2014
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms and as per the details furnished by the firm
alongwith Production / Consumption data certified for the period 2013-14, 2014-15 and			2015-16, it was
decided to ratify 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.<br>Sl. No. Import items	Qty.
	VINPOCETINE	<br>1 kg<br>1<br>VOACANGA SEEDS/ APOCYNACEAE SP	146.78 kg
	EP/BP/USP
	Note: The above norms are for regularization and closure purpose only. No repeat licence will be issued on

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

the basis of above decision.

Case No.	10 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000284AM23
RA File Number	092404000563 AM15
Licence No and<br>Date	0910061513/08/01/2015
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	Case No.	11 / NC/3/MEET/Jun/202223/5	11 / NC/3/MEET/Jun/202223/5	11 / NC/3/MEET/Jun/202223/5	11 / NC/3/MEET/Jun/202223/5	11 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		ALKALOIDS CORPORATION
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00000457AM23
RA File Number		022404000203 AM15
Licence No and<br>Date		0210205448/14/01/2015
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same<br>export product / import item in Meeting No.NC/3/MEET/May/202223/3 dated 27.05.2022 against advance<br>authorization No.0210206661 dt. 04.05.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less for the present Advance Authorization:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Digoxin<br>1 kg<br>1<br>Digitalis Lanata Leaves (Dried)<br>(Digoxin content NMT 0.3%)<br>436.525 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Digoxin		1 kg	1	Digitalis Lanata Leaves (Dried)<br>(Digoxin content NMT 0.3%)	436.525 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	12 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00166244AM22
RA File Number	082404000397 AM15
Licence No and<br>Date	0810134800/13/03/2015
Norms Committee Decision:<br>The Committee considered the request of firm for revision of norms and it was decided to call the firm for attending<br>Personal Hearing<br> before Norms Committee alongwith following documents / information:<br>Why Acetone cannot be recovered in the process on the basis of parameters of Reaction, that is, temp etc.<br>i.<br>Copy of Shipping Bill indicating purity and impurity level of export.<br>ii.<br>iii End use of Export Product.

Case No.	Case No.	13 / NC/3/MEET/Jun/202223/5	13 / NC/3/MEET/Jun/202223/5	13 / NC/3/MEET/Jun/202223/5	13 / NC/3/MEET/Jun/202223/5	13 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		ALKALOIDS CORPORATION
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00000460AM23
RA File Number		022404000181 AM16
Licence No and<br>Date		0210206452/19/01/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same<br>export product / import item in Meeting No.NC/3/MEET/May/202223/3 dated 27.05.2022 against advance<br>authorization No.0210206661 dt. 04.05.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less for the present Advance Authorization:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Digitalis Lanata Leaves (Dried)<br>Digoxin<br>1 kg<br>1<br>436.525 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Digoxin		1 kg	1	Digitalis Lanata Leaves (Dried)	436.525 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

(Digoxin content NMT 0.3%) RA concerned may take further necessary action as per above decision of NC.

Case No.	14 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00160014AM22
RA File Number	039404000859 AM16
Licence No and<br>Date	0310802380/09/02/2016
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	15 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00166233AM22
RA File Number	082404000104 AM17
Licence No and<br>Date	0810138218/28/06/2016
Norms Committee Decision:<br>The Committee considered the request of firm for revision of norms and it was decided to call the firm for attending<br>Personal Hearing<br> before Norms Committee alongwith following documents / information:<br>Why Acetone cannot be recovered in the process on the basis of parameters of Reaction, that is, temp etc.<br>i.<br>Copy of Shipping Bill indicating purity and impurity level of export.<br>ii.<br>iii End use of Export Product.

Case No.	16 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ALKALOIDS CORPORATION
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000462AM23

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

RA File Number	022404000145 AM17
Licence No and<br>Date	0210207123/07/11/2016
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information / documents from the firm:<br>Production / Consumption data for last three years duly certified by GST Authorities.

Case No.	17 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	ALKALOIDS CORPORATION
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000456AM23
RA File Number	022404000216 AM17
Licence No and<br>Date	0210207287/27/01/2017
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and taking cue from earlier decision for same<br>export product / import item in Meeting No.NC/3/MEET/May/202223/3 dated 27.05.2022 against advance<br>authorization No.0210206661 dt. 04.05.2016, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per<br>details given below or as applied by the firm, whichever is less for the present Advance Authorization:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>Digoxin<br>1 kg<br>1<br>Digitalis Lanata Leaves (Dried)<br>(Digoxin content NMT 0.3%)<br>436.525 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	18 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	KAIRAV CHEMOFARBE INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00160008AM22
RA File Number	039404000838 AM18

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Licence No and 0310818810/31/01/2018 Date Norms Committee Decision:

Deferred for comments of TE.

Licence No and	Licence No and	0310818810/31/01/2018	0310818810/31/01/2018	0310818810/31/01/2018	0310818810/31/01/2018	0310818810/31/01/2018
Date
Norms Committee		Decision:
Deferred for comments of TE.

Case No.		19 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		YASH RASAYAN & CHEMICALS
Meeting Number
and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00000642AM23
RA File Number		342404000401 AM18
Licence No and		3410044109/27/04/2018
Date
Norms Committee		Decision:

The Committee co<br>same exort rodu		nsidered the request of firm for fixation of adhoc norms and taking cue from earlier decision for<br>t in Meetin NoNC/3/MEET/Ar/202223/1 dated 29042022aainst advance authorization No
p p<br>3411001494 dt. 06<br>or as applied by th		g .p ..g .<br>-12-2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>firm whichever is less:
	,
	Export product		Qty.	Sl.<br>No.	Import items	Qty.

	2-METHOXY BENZOIC ACID		1 kg	1	METHYL SALICYLATE	1.052 kg


				2	DIMETHYL SULPHATE	08717 k
						. g

RA d		k fh i		b dii f NC
concerne may		tae urter necessary acton as		per aove ecson o .

Case No.		20 / NC/3/MEET/Jun/202223/5

Case Status		Case Rejected
Party Name		AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		018205000537AM19
RA File Number		522404000016 AM19
Licence No and
Date		5210042638/10/05/2018
Norms Committee		Decision:

Case No.	20 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205000537AM19
RA File Number	522404000016 AM19
Licence No and<br>Date	5210042638/10/05/2018
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT Portal. Hence, the Committee decided to reject the case.

Case No.	21 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000283AM23
RA File Number	092404000491 AM19
Licence No and<br>Date	0910067225/27/02/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	Case No.	22 / NC/3/MEET/Jun/202223/5	22 / NC/3/MEET/Jun/202223/5	22 / NC/3/MEET/Jun/202223/5	22 / NC/3/MEET/Jun/202223/5	22 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00001423AM23
RA File Number		092404000600 AM19
Licence No and Date		0910067264/12/03/2019
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and it was decided to revise the adhoc<br>norms as under for the present case only:<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>PROPIONALDEHYDE<br>1.66 kg<br>2<br>SODIUM CYANIDE<br>1.40 kg<br>3<br>L(+) TARTARIC ACID<br>1.45 kg<br>S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE<br>1 kg
	Export Product		Qty.	Sl. No.	Import items	Qty.
	S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE		1 kg	1	PROPIONALDEHYDE	1.66 kg
				2	SODIUM CYANIDE	1.40 kg
				3	L(+) TARTARIC ACID	1.45 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

	4	METHYLENE DI	CHLORIDE	1.12 kg
	5	ACETONE		1.795 kg
	6	METHANOL		1.39 kg

Case No.	23 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205002595AM19
RA File Number	522404000085 AM19
Licence No and<br>Date	5210043000/19/03/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	24 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205000113AM20
RA File Number	092404000011 AM20
Licence No and<br>Date	0910067466/09/05/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.<br>25 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>GLAND PHARMA LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00000141AM23
RA File Number<br>092404000043 AM20
Licence No and<br>Date<br>0910067519/14/05/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	26 / NC/3/MEET/Jun/202223/5	26 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/	5 and 08/07/2022
HQ File Number	018205000182AM20
RA File Number	039504000143 AM20
Licence No and<br>Date	0310829108/17/05/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br>		before Norms Committee to explain its case.

Case No.	27 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000444AM23
RA File Number	022404000044 AM20
Licence No and<br>Date	0210209260/17/06/2019
Norms Committee Decision:
T
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information / documents from the firm:
Production / Consumption data for last three years duly certified by GST Authorities for Noscapine and
Noscapine HCL separately.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	28 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001314AM23
RA File Number	039504000232 AM20
Licence No and<br>Date	0310829915/25/06/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information / documents from the firm:
Percentage purity of Export Product.<br>i.
Justification of low yield of 47.36% against DMB.<br>ii.
Production / Consumption data for the year 2019-20 duly certified by GST.<br>iii.

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

Case No.	29 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SYNNAT PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000446AM23
RA File Number	022404000056 AM20
Licence No and<br>Date	0210209307/12/07/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information / documents from the firm:
Production / Consumption data for last three years duly certified by GST Authorities for Noscapine and
Noscapine HCL separately.

Case No.	30 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001427AM23
RA File Number	092404000229 AM20
Licence No and Date	0910067855/01/08/2019

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Norms Committee Decision:

The Committee considered the request of firm for revision of adhoc norms and it was decided to revise the adhoc norms as under for the present case only:

Export Product	Qty.	Sl. No.	Import items	Qty.
S(+)-2-AMINOBUTYRAMIDE	1 kg	1	PROPIONALDEHYDE	1.66 kg
HYDROCHLORIDE
		2	SODIUM CYANIDE	1.40 kg
		3	L(+) TARTARIC ACID	1.45 kg
		4	METHYLENE DI CHLORIDE	1.12 kg
		5	ACETONE	1.795 kg
		6	METHANOL	1.39 kg

Case No.	31 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001316AM23
RA File Number	039504000497 AM20
Licence No and<br>Date	0310831036/16/08/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information / documents from the firm:
Percentage purity of Export Product.<br>i.
Justification of low yield of 47.36% against DMB.<br>ii.
Production / Consumption data for the year 2019-20 duly certified by GST.<br>iii.

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

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	32 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001317AM23
RA File Number	039504000551 AM20
Licence No and<br>Date	0310831364/04/09/2019
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and it was decided to call for following<br>information / documents from the firm:<br>Percentage purity of Export Product.<br>i.<br>Justification of low yield of 47.36% against DMB.<br>ii.<br>Production / Consumption data for the year 2019-20 duly certified by GST.<br>iii.

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

Case No.<br>	33 / NC/3/MEET/Jun/202223/5
Case Status<br>	Case Deferred
Party Name<br>	OC SPECIALITIES PRIVATE LIMITED
Meeting Number<br>and Date<br>	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>	018205000672AM20
RA File Number<br>	039504000625 AM20
Licence No and<br>Date<br>	0310831873/27/09/2019
Norms Committee Decision:<br>The Committee considered the case as per agenda andit was decided to call the firm for attendingPersonal Hearing<br>before Norms Committee alongwith following documents / information:<br>What is Palladium content in import item No. 4.<br>i.<br>COA of import item No. 3 and 4.<br>ii.<br>Please clarify the meaning of export on free of cost mentioned in the description of Export Product No. 2 -<br>PALLADIUM METAL SPONGE.<br>iii.<br>iv Production / Consumption data duly certified by GST for both export product separately for the licensing<br>year 2019-2020.		Personal Hearing

Case No.	34 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

H	Q File N	umber	umber	umber	HQRNORM REVIW00001428AM23	HQRNORM REVIW00001428AM23	HQRNORM REVIW00001428AM23	HQRNORM REVIW00001428AM23	HQRNORM REVIW00001428AM23	HQRNORM REVIW00001428AM23	HQRNORM REVIW00001428AM23	HQRNORM REVIW00001428AM23
R	A File Nu	mber			092404000376 AM20
L	icence No	and Date			0910068138/28/10/2019
N<br>T<br>n<br>R	orms Co<br>he Com<br>	mmittee Decision:<br>mittee considered the request of firm for revision of adhoc norms and it was decided to r<br>											evise the adhoc
	orms as u	nder for the present case only:
	Export P	roduct				Qty.	Sl. No.		Import items			Q	ty.

	S(+)-2-<br>HYDRO	AMINOBUTYRAMIDE<br>CHLORIDE				1 kg	1		PROPIONALDEHYDE			1	.66 kg
							2		SODIUM CYANIDE			1	.40 kg

							3		L(+) TARTARIC ACID			1	.45 kg
							4		METHYLENE DI CHLORIDE			1	.12 kg
							5		ACETONE			1	.795 kg

							6		METHANOL			1.39 kg
	A concerned may take further necessary action as						per above decision of NC.

C	ase No.			35 / NC/3/MEET/Jun/202223/5
C
	ase Status			Case Rejected
P	arty Name			MAPAEX CONSUMER HEALTHC				ARE PRIVATE LIM		ITED
M<br>a	eeting Num		ber
	<br>nd Date			NC/ 3/ MEET/ Jun/ 202223/ 5 and 0				8/07/2022
H	Q File Num		ber	HQRNORM REVIW00000442AM2				3
R	A File Num		ber	562404000018 AM20
L<br>D	icence No a<br>ate		nd	5610005722/07/11/2019

N<br>T<br>g<br>	orms Comm<br>		ittee Decision:<br>
	he Commit<br>iven any tec		ee considered the request of firm for rev<br>hnical details.					iew of adhoc norms		and it was observed t	at the firm has not
			In view of above, the Committee decided					torejectthe case.

Case No.	35 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	MAPAEX CONSUMER HEALTHCARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000442AM23
RA File Number	562404000018 AM20
Licence No and<br>Date	5610005722/07/11/2019
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was observed that the firm has not
given any technical details.
In view of above, the Committee decided torejectthe case.

The Committee considered the request of firm for review of adhoc norms and it was observed that the firm has not given any technical details.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.<br>36 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>YASHO INDUSTRIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00000521AM23
RA File Number<br>039504000760 AM20
Licence No and<br>Date<br>0310832692/11/11/2019
Norms Committee Decision:
T
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information / documents from the firm:
Production / Consumption data duly certified by GST.<br>i.
ii Stoichiometric balance with yield to arrive at the quantity of raw material asked for.

Case No.	37 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000615AM23
RA File Number	039504000702 AM20
Licence No and<br>Date	0310832785/14/11/2019
Norms Committee	Decision:
T
The Committee considered the request of firm for fixation of adhoc norms and taking cue from earlier decision for
same export product / import item in Meeting No.NC/3/MEET/Apr/202223/1 dated 29.04.2022against advance
authorization No.	0311005307 dt. 12-07-2021, it was decided to ratify 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.<br>Sl. No.	Import items	Qty.
1<br>SODIUM ACETATE (TRIHYDRATE)<br>1 kg		ACETIC ACID	0.463 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

2 CAUSTIC ACID 0.568 kg

Case No.	38 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	LINK PHARMACHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205000855AM20
RA File Number	342404000256 AM20
Licence No and<br>Date	3410045634/21/11/2019
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	39 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001320AM23
RA File Number	039504000849 AM20
Licence No and<br>Date	0310833213/04/12/2019
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:
Percentage purity of Export Product.<br>i.
Justification of low yield of 47.36% against DMB.<br>ii.
Production / Consumption data for the year 2019-20 duly certified by GST.<br>iii.

Case No.	40 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	SREEPATHI PHARMACEUTICALS LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001594AM21
RA File Number	092404000502 AM20
Licence No and<br>Date	0910068349/09/01/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	41 / NC/3/MEET/Jun/202223/5	41 / NC/3/MEET/Jun/202223/5	41 / NC/3/MEET/Jun/202223/5	41 / NC/3/MEET/Jun/202223/5	41 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00001429AM23
RA File Number		092404000485 AM20
Licence No and Date		0910068366/13/01/2020
Norms Committee Decision:<br>T<br>The Committee considered the request of firm for revision of adhoc norms and it was decided to revise the adhoc<br>norms as under for the present case only:<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>PROPIONALDEHYDE<br>1.66 kg<br>2<br>SODIUM CYANIDE<br>1.40 kg<br>3<br>L(+) TARTARIC ACID<br>1.45 kg<br>4<br>METHYLENE DI CHLORIDE<br>1.12 kg<br>5<br>ACETONE<br>1.795 kg<br>S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE<br>1 kg<br>6<br>METHANOL<br>1.39 kg
	Export Product		Qty.	Sl. No.	Import items	Qty.
	S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE		1 kg	1	PROPIONALDEHYDE	1.66 kg
				2	SODIUM CYANIDE	1.40 kg
				3	L(+) TARTARIC ACID	1.45 kg
				4	METHYLENE DI CHLORIDE	1.12 kg
				5	ACETONE	1.795 kg
				6	METHANOL	1.39 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.<br>42 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00001325AM23
RA File Number<br>039504001121 AM20
Licence No and<br>Date<br>0310835077/26/02/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.<br>43 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00001324AM23
RA File Number<br>039504001215 AM20
Licence No and<br>Date<br>0310835591/11/04/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	44 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001253AM21
RA File Number	052404000022 AM21
Licence No and<br>Date	0510414098/04/05/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	45 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	RECKITT BENCKISER HEALTHCARE INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001265AM21
RA File Number	052404000026 AM21
Licence No and<br>Date	0510414109/06/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the norms for subject Advance<br>Authorization have already been ratified by NC-3 in its Meeting No.NC/3/MEET/Jan/202021/4dated12.02.2021.<br>In view of above, the Committee decided towithdrawthe case.

The Committee considered the case as per agenda and it was observed that the norms for subject Advance Authorization have already been ratified by NC-3 in its Meeting No. NC/3/MEET/Jan/202021/4 dated 12.02.2021 .

Case No.	46 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001271AM21
RA File Number	072404000032 AM21
Licence No and<br>Date	0710116423/06/05/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>proper. Hence, it was decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Case No.	47 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	S KANT HEALTHCARE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001272AM21
RA File Number	039504000715 AM20

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Licence No and 0310836133/07/05/2020 Date Norms Committee Decision: The Committee considered the case as per agenda and it was observed that the firm has not given any technical details in the Appendix 4E furnished by it. Hence, it was decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the firm has not given any technical details in the Appendix 4E furnished by it. Hence, it was decided to reject the case.

Case No.		48 / NC/3/MEET/Jun/202223/5
Case Status		Case Deferred
Party Name		CLARIANT INDIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		018205001343AM21
RA File Number		039404000110 AM21
Licence No and<br>Date		0310836469/01/06/2020
Norms Committee Decision:
The Committee considered the case as per agenda and reply received from the firm and it was observed that reply
furnished by the	firm is incomplete. Hence, it was decided to call for following information / documents from the
firm:
Production Consumption data duly certified by GST

Case No.<br>49 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00001326AM23
RA File Number<br>039504000075 AM21
Licence No and<br>Date<br>0310836467/01/06/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.


C	50 / C/3/MEET//202223/5
ase No.	NJun
C S	C Rd
ase tatus	ase ejecte
P	GLOBAL CALCIM PRIATE LIMITED
arty Name	U V
Meeting Number	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

and Date
HQ File Number	018205001431AM21
RA File Number	072404000092 AM21
Licence No and<br>Date	0710116675/29/06/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>proper. Hence, it was decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Case No.	51 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001466AM21
RA File Number	072404000105 AM21
Licence No and<br>Date	0710116735/13/07/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>proper. Hence, it was decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Case No.	52 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001501AM21
RA File Number	072404000118 AM21
Licence No and<br>Date	0710116798/27/07/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>proper. Hence, it was decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.<br>53 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>PIRAMAL ENTERPRISES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00001327AM23
RA File Number<br>039504000288 AM21
Licence No and<br>Date<br>0310837797/20/08/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	54 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	BIOLOGICAL E. LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001365AM23
RA File Number	092404000253 AM21
Licence No and<br>Date	0910069107/27/08/2020
Norms Committee Decision:
The Committee considered the request of firm for revision of norms and it was decided to revise the norms as under:
“For export product DIPTHERIA AND TETANUS (DT) / TETANUS AND DIPTHERIA (TD) VACCINE
ADSORBED 10ML 20 DOSES – 500000 vials, allowing wastage as applied by the firm for import item No. 1 to 9,
and 13 to 15, however for import item No. 10 to 12, only 2% wastage is allowed.”


C N	55 / NC/3/MEET/J/202223/5
ase o.	un
C S	C Rd
ase tatus	ase ejecte
P N	GLOBAL CALCIUM PRIVATE LIMITED
arty ame
Meeting Number<br>d D	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
an ate
H Fil Nb	018205001588AM21
Q e umer
RA Fil Nb	072404000146 AM21
e umer
Licence No and<br>D	0710116939/28/08/2020
ate
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>
proper. Hence, it was decided torejectthe case.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	56 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001589AM21
RA File Number	072404000145 AM21
Licence No and<br>Date	0710116940/28/08/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not
proper. Hence, it was decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Case No.	57 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	VN CREATIVE CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001315AM23
RA File Number	039504000298 AM21
Licence No and<br>Date	0310838023/01/09/2020
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and it was decided to call for following
information / documents from the firm:
Percentage purity of Export Product.<br>i.
Justification of low yield of 47.36% against DMB.<br>ii.
Production / Consumption data for the year 2019-20 duly certified by GST.<br>iii.

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

Case No.	58 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	NASENSE LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

HQ File Number	018205001676AM21
RA File Number	092404000306 AM21
Licence No and<br>Date	0910069226/21/09/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>proper. Hence, it was decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Case No.	Case No.	59 / NC/3/MEET/Jun/202223/5	59 / NC/3/MEET/Jun/202223/5	59 / NC/3/MEET/Jun/202223/5	59 / NC/3/MEET/Jun/202223/5	59 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00001449AM23
RA File Number		092404000071 AM21
Licence No and Date		0910069270/29/09/2020
Norms Committee Decision:<br>The Committee considered the request of firm for revision of adhoc norms and it was decided to revise the adhoc<br>norms as under for the present case only:<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>PROPIONALDEHYDE<br>1.66 kg<br>2<br>SODIUM CYANIDE<br>1.40 kg<br>3<br>L(+) TARTARIC ACID<br>1.45 kg<br>4<br>METHYLENE DI CHLORIDE<br>1.12 kg<br>5<br>ACETONE<br>1.795 kg<br>S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE<br>1 kg<br>6<br>METHANOL<br>1.39 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import items	Qty.
	S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE		1 kg	1	PROPIONALDEHYDE	1.66 kg
				2	SODIUM CYANIDE	1.40 kg
				3	L(+) TARTARIC ACID	1.45 kg
				4	METHYLENE DI CHLORIDE	1.12 kg
				5	ACETONE	1.795 kg
				6	METHANOL	1.39 kg
				per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23


Case No.			60 / NC/3/MEET/Jun/202223/5
Case Status			Case Approved
Party Name			EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and
Date			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number			HQRNORM REVIW00001426AM23
RA File Number			092404000171 AM21
Licence No and Da		te	0910069271/29/09/2020
Norms Committee		Decision:

The Committee co<br>d f		nsidered the request of firm for revision of adhoc norms and it was decided to revise the adhoc<br>th t l
n	orms as uner or	e presen case ony:
	Export Product<br>Qty.<br>S(+)-2-AMINOBUTYRAMIDE<br>HYDROCHLORIDE<br>1 kg
					Qty.	Sl. No.	Import items	Qty.
					1 kg	1	PROPIONALDEHYDE	1.66 kg
						2	SODIUM CYANIDE	1.	40 kg
						3	L(+) TARTARIC ACID	1.	45 kg
						4	METHYLENE DI CHLORIDE	1.	12 kg
						5	ACETONE	1.	795 kg
						6	METHANOL	1.	39 kg

	A concerned may take further neces			sary action as		per above decision of NC

Case No.			61 / NC/3/MEET/Jun/202223/5
Case Status			Case Approved

P N			EMMENNAR PHARMA PRIVATE LIMITED
arty ame
Mti Nb		d
eeng umer a<br>Date			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022

HQ File Number			HQRNORM REVIW00001425AM23

RA File Number			092404000642 AM20
Li N d D			0910069286/30/09/2020
cence o an a		e
N Citt		Dii
orms ommee		ecson:

Case No.	61 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	EMMENNAR PHARMA PRIVATE LIMITED
Meeting Number and<br>Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001425AM23
RA File Number	092404000642 AM20
Licence No and Date	0910069286/30/09/2020
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

The Committee considered the request of firm for revision of adhoc norms and it was decided to revise the adhoc norms as under for the present case only:

Qty.	Sl. No.	Import items<br>	Qty.
1 kg	1	PROPIONALDEHYDE<br>	1.66 kg
	2	SODIUM CYANIDE<br>	1.40 kg
	3	L(+) TARTARIC ACID<br>	1.45 kg
	4	METHYLENE DI CHLORIDE<br>	1.12 kg
	5	ACETONE<br>	1.795 kg
	6	METHANOL<br>	1.39 kg

Case No.	Case No.	Case No.	62 / NC/3/MEET/Jun/202223/5	62 / NC/3/MEET/Jun/202223/5	62 / NC/3/MEET/Jun/202223/5	62 / NC/3/MEET/Jun/202223/5	62 / NC/3/MEET/Jun/202223/5
Case Status			Case Approved
Party Name			MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number			018205001782AM21
RA File Number			082404000249 AM21
Licence No and<br>Date			0810148893/26/10/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>AENOXA<br>PRE<br>FILLED<br>ENOXAPARIN SODIUM USP (Low<br>1<br>1 Number<br>1<br>44.00 mg
	Sl. No.	Export product		Qty.	Sl. No.	Import items	Qty.
	1	AENOXA<br>PRE<br>FILLED		<br>1 Number	1	ENOXAPARIN SODIUM USP (Low	<br>44.00 mg

Signature Not Verified

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

	SYRINGE<br>(Enoxaparin	SYRINGE<br>(Enoxaparin			molecular<br>weight<br>Heparin<br>)THIS
	Sodium<br>Injection)	<br>40MG			AUTHORISATION ISSUED AS PER
	(0.40ML)(NET CONTENTS				POLICY CIRCULAR No.9
	OF BULK
	DRUG : 1.80KGS.)
2	AENOXA<br>PRE	FILLED	<br>1 Number	2	ENOXAPARIN SODIUM USP (Low	<br>66.00 mg
	SYRINGE<br>(Enoxaparin				molecular weight Heparin ) THIS
	Sodium<br>Injection)	<br>60MG			AUTHORISATION ISSUED AS PER
	(0.6ML)(NET CONTENTS				POLICY CIRCULAR No.9
	OF BULK
	DRUG: 6.60KGS.)

Case No.	63 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000514AM23
RA File Number	318304000085 AM21
Licence No and<br>Date	3110067911/29/10/2020
Norms Committee Decision:
The Committee considered the request of firm for fixation of adhoc norms 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:
Sl. No. Export product		Qty.
1<br>TYLODOX GOLD POWDER 1Kg Jar TYLODOX GOLD POWDER		2000 Number
2<br>TYLODOX GOLD POWDER 100 GMS Sachet TYLODOX GOLD POWDER		10000 Number
3<br>NEODOX GOLD POWDER 1KG Jar NEODOX GOLD POWDER		1500 Number
4<br>NEODOX GOLD POWDER 100GMS Sachet NEODOX GOLD POWDER		4000 Number

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Sl. No.	Import items	Qty.
1	DOXYCYCLINE HYCLATE DOXYCYCLINE HYCLATE GRADE BP	797.90 kg
2	TYLOSIN TARTRATE TYLOSIN TARTRATE VET IP/EP/BP	303.00 kg

Case No.	64 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	ALPHAMED FORMULATIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001816AM21
RA File Number	092404000410 AM21
Licence No and<br>Date	0910069429/03/11/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>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>Tincture Matricaria Duplex<br>4.136 mg<br>Ashton<br>&<br>Parson<br>Infant<br>Powders((Each<br>Sachet<br>Contains<br>-<br>4.055 Mg of Tincture Matricaria<br>Duplex ) ( the Net content of import<br>item no.181.10kgs and import item<br>no.2) 5192.40 kgs should be accounted<br>for on the s.bills & invoices ))<br>1 Number<br>Sachet<br>2<br>Lactose<br>Monohydrate<br>modified<br>(Fast flow 316)<br>259.62 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	65 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Party Name	BHARAT SERUMS AND VACCINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001824AM21
RA File Number	039404000594 AM21
Licence No and<br>Date	0310839355/05/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and on the basis of written comments furnished by Department of
Technology vide e-mail dated 21.01.2022 (F. No. PID-13011(15)/1/2021-PPB-DBT dated 21.06.2022, it was decided
to ratify adhoc norms for import of 56.51 kg Human Normal Immunoglobin Bulk for manufacturing 10,000 vials of
GAMMA IV 5 GM.

The Committee considered the case as per agenda and on the basis of written comments furnished by Department of Technology vide e-mail dated 21.01.2022 (F. No. PID-13011(15)/1/2021-PPB-DBT dated 21.06.2022, it was decided to ratify adhoc norms for import of 56.51 kg Human Normal Immunoglobin Bulk for manufacturing 10,000 vials of GAMMA IV 5 GM.

Case No.	66 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	EAST AFRICAN INDIA OVERSEAS
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001829AM21
RA File Number	052304000263 AM21
Licence No and<br>Date	0510415769/06/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm has not furnished		DML and also
import unit is confusing. No norms can be proposed in its present form.
In view of above discrepancy, it was decided to call firm for attendingPersonal Hearing		<br> before Norms
Committee alongwith relevant documents to explain its case.

The Committee considered the case as per agenda and it was observed that the firm has not furnished DML and also import unit is confusing. No norms can be proposed in its present form.

In view of above discrepancy, it was decided to call firm for attending Personal Hearing before Norms Committee alongwith relevant documents to explain its case.

Case No.	67 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	018205001832AM21
RA File Number	052404000405 AM21
Licence No and<br>Date	0510415761/06/11/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call the firm for attendingPersonal Hearing
before Norms Committee alongwith following documents / information:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

i. Complete and balanced chemical reactions showing molecular weight and percentage yield on molar basis.
ii. Production / Consumption data duly certified by GST.

Case No.	68 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	RISHABH METALS & CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00038772AM21
RA File Number	039504000554 AM21
Licence No and<br>Date	0311000111/15/12/2020
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>69 / NC/3/MEET/Jun/202223/5	Case No.<br>69 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Approved
Party Name<br>ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00041626AM21
RA File Number<br>08AA04004845 AM21
Licence No and<br>Date<br>0811000109/18/12/2020
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Apr/202223/2 dated 21.04.2022 against advance authorization No.
0810143988 dt. 29.11.2018, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below
or as applied by the firm, whichever is less:
	Sl. No. Export product<br>Qty.	Sl. No.	Import items	Qty.
	ISOTRETINOIN CAPSULES USP 10<br>1<br>1 Number	1	ISOTRETINOIN USP	10.2 mg / 10 mg capsule

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

	MG<br>(ACTIVE<br>INGREDIENT:<br>ISOTRETINOIN USP - NET WT.<br>11.249 KGS.))	<br>	2	GELATIN NF	Not allowed
			3	GLYCERIN USP	Not allowed
			4	ISOPROPYL ALCOHOL USP	200 mg / 10 mg capsule
2	ISOTRETINOIN CAPSULES USP 20<br>MG<br>(ACTIVE<br>INGREDIENT:<br>ISOTRETINOIN USP - NET WT.<br>107.998 KGS.))	<br> <br> <br>1 Number	1	ISOTRETINOIN USP	20.4 mg / 20 mg capsule
			2	GELATIN NF	Not allowed
			3	GLYCERIN USP	Not allowed
			4	ISOPROPYL ALCOHOL USP	250 mg / 20 mg capsule
3	ISOTRETINOIN CAPSULES USP 30<br>MG<br>(ACTIVE<br>INGREDIENT:<br>ISOTRETINOIN USP - NET WT.<br>161.995 KGS.))	<br> <br> <br>1 Number	1	ISOTRETINOIN USP	30.6 mg / 30 mg capsule
			2	GELATIN NF	Not allowed
			3	GLYCERIN USP	Not allowed
			4	ISOPROPYL ALCOHOL USP	300 mg / 30 mg capsule
4	ISOTRETINOIN CAPSULES USP 40<br>MG<br>(ACTIVE<br>INGREDIENT:<br>ISOTRETINOIN USP - NET WT.<br>359.993 KGS.))	<br> <br> <br>1 Number	1	ISOTRETINOIN USP	40.8 mg / 40 mg capsule
			2	GELATIN NF	Not allowed
			3	GLYCERIN USP	Not allowed
			4	ISOPROPYL ALCOHOL USP	300 mg / 40 mg capsule

Case No.	70 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	CIPLA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00044044AM21
RA File Number	03AA04011698 AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Licence No and 0311000235/21/12/2020 Date Norms Committee Decision: The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on DGFT Portal. Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.	71 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00049028AM21
RA File Number	07AA04006399 AM21
Licence No and<br>Date	0711000171/28/12/2020
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	72 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	DELTA FINOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00051264AM21
RA File Number	03AA04014749 AM21
Licence No and<br>Date	0311000410/31/12/2020
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	73 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00053377AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

RA File Number	09AA04003174 AM21
Licence No and<br>Date	0911000111/04/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	74 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	INDO AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00054949AM21
RA File Number	039404000664 AM21
Licence No and<br>Date	0311000458/05/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>75 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>YASH RASAYAN & CHEMICALS
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00056208AM21
RA File Number<br>34AA04001756 AM21
Licence No and<br>Date<br>3411000089/06/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Percentage yield of reaction for second import item - DIMETHYL SULPHATE.<br>i.
ii Stoichiometric balance to arrive at the quantity of raw material asked on the basis of yield for second
import item - DIMETHYL SULPHATE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	76 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	SHREYANS CHEMICALS
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00056440AM21
RA File Number	03AA04016449 AM21
Licence No and<br>Date	0311000702/06/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I 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>Ethyl Chloroacetate((CAS- 105-39-5)) (Purity Min.<br>99.70%)<br>1 kg<br>1<br>Mono Chloroacetic Acid<br>1.22 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	77 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00057063AM21
RA File Number	03AA04015653 AM21
Licence No and<br>Date	0311000731/07/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Yield on 45.6% on molar basis is very low. Please furnish copy of technical literature in support of yield.

Case No.	78 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00058376AM21
RA File Number	09AA04003607 AM21
Licence No and<br>Date	0911000131/08/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Yields shown in all the steps are very low. Please furnish copy of technical literature in support of yields.<br>i.
ii GST for Production / Consumption data for the current production.

Case No.	79 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00060368AM21
RA File Number	31AA04005070 AM21
Licence No and<br>Date	3111000082/12/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on
DGFT Portal. Hence, the Committee decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC.

Case No.	80 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00060369AM21
RA File Number	31AA04005050 AM21
Licence No and<br>Date	3111000081/12/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

DGFT Portal. Hence, the Committee decided to reject the case.

Case No.	81 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00066631AM21
RA File Number	03AA04019289 AM21
Licence No and<br>Date	0311001091/20/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Five import items are shown in the licence, whereas only 2 inputs have been shown imported under<br>Appendix 4E. Please clarify it.<br>i.<br>Consumption-coefficient of each imported input for API.<br>ii.<br>Wastage claimed on API to manufacture tablets.<br>iii.

i. Five import items are shown in the licence, whereas only 2 inputs have been shown imported under Appendix 4E. Please clarify it.

Case No.	Case No.	82 / NC/3/MEET/Jun/202223/5	82 / NC/3/MEET/Jun/202223/5	82 / NC/3/MEET/Jun/202223/5	82 / NC/3/MEET/Jun/202223/5	82 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		SHIVA PHARMACHEM LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00066410AM21
RA File Number		34AA04002140 AM21
Licence No and<br>Date		3411000125/20/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1,6 DICHLORO HEXANE<br>500000 kg<br>1<br>1, 6 HEXANE DIOL<br>423000 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	1,6 DICHLORO HEXANE		500000 kg	1	1, 6 HEXANE DIOL	423000 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.<br>83 / NC/3/MEET/Jun/202223/5	Case No.<br>83 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Approved
Party Name<br>SMILAX LABORATORIES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00067337AM21
RA File Number<br>09AA04003910 AM21
Licence No and<br>Date<br>0911000229/21/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Aug/202122/7 dated 13.08.2021 against advance authorization No.
0910066915 dt. 28.11.2018, it was decided to ratify 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. No.	Import items	Qty.
1-Bromo-3,5-Dimethyl	1 kg	1	1, 3 Dimethyl adamantane	0.769 kg
Adamantane(POWDER)
RA concerned may take further necessary action	as per above decision of NC.

Case No.	84 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00067524AM21
RA File Number	07AA04007364 AM21
Licence No and<br>Date	0711000345/21/01/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No. 85 / NC/3/MEET/Jun/202223/5

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case Status<br>Case Approved
Party Name<br>AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00070344AM21
RA File Number<br>34AA04002285 AM21
Licence No and<br>Date<br>3411000156/25/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.6/82/ALC/4/2018 dated 26.07.2018		against advance authorization No.3410043546 dt.
16.10.2017, it was decided to ratify 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<br>Qty.	Sl. No.	Import items	Qty.
SEVELAMER CARBONATE<br>1 kg	1	ALLYLAMINE	1.00 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.<br>86 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Approved
Party Name<br>AMI LIFESCIENCES PVT LTD
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00070372AM21
RA File Number<br>34AA04002286 AM21
Licence No and<br>Date<br>3411000157/25/01/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.6/82/ALC/4/2018 dated 26.07.2018		against advance authorization No.3410043546 dt.
16.10.2017, it was decided to ratify 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<br>Qty.	Sl. No.	Import items	Qty.
SEVELAMER HYDROCHLORIDE<br>1 kg	1	ALLYLAMINE	1.00 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	87 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00070745AM21
RA File Number	03AA04020126 AM21
Licence No and<br>Date	0311001263/27/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Five import items are shown in the licence, whereas only 2 inputs have been shown imported under<br>Appendix 4E. Please clarify it.<br>i.<br>Consumption-coefficient of each imported input for API.<br>ii.<br>Wastage claimed on API to manufacture tablets.<br>iii.

i. Five import items are shown in the licence, whereas only 2 inputs have been shown imported under Appendix 4E. Please clarify it.

Case No.	88 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	R.L.FINE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00071643AM21
RA File Number	07AA04007643 AM21
Licence No and<br>Date	0711000370/28/01/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete chemistry, molecular weight and percentage yield on molar basis for each step.<br>i.<br>Requirement and recovery of solvent.<br>ii.<br>iii Material balance for each step of manufacturing process.

Case No.	89 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Party Name	Party Name	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED	PUNJAB CHEMICALS AND CROP PROTECTION LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00072096AM21
RA File Number		30AA04003277 AM21
Licence No and<br>Date		0311001236/28/01/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per 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>1<br>DIMETHYL SULFOXIDE<br>0.932 kg<br>TRIMETHYL<br>SULFOXONIUM<br>BROMIDE<br>1 kg<br>2<br>TRIMETHYL ORTHO FORMATE<br>0.018 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	TRIMETHYL<br>SULFOXONIUM<br>BROMIDE		<br>1 kg	1	DIMETHYL SULFOXIDE	0.932 kg
				2	TRIMETHYL ORTHO FORMATE	0.018 kg
				above decision of NC.

Case No.	Case No.	90 / NC/3/MEET/Jun/202223/5	90 / NC/3/MEET/Jun/202223/5	90 / NC/3/MEET/Jun/202223/5	90 / NC/3/MEET/Jun/202223/5	90 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		ANUH PHARMA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00074189AM21
RA File Number		03AA04020171 AM21
Licence No and<br>Date		0311001314/01/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I 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>Sulfadoxine<br>BP/USP/EP/IP<br>(WHITE 1 kg<br>1<br>4, 6 Dichloro 5 –Methoxy Pyrimidine<br>0.780 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	Sulfadoxine<br>BP/USP/EP/IP<br>(WHITE		1 kg	1	4, 6 Dichloro 5 –Methoxy Pyrimidine	0.780 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

POWDER)

Case No.<br>91 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Approved
Party Name<br>FARBE FIRMA PRIVATE LIMITED
Meeting Number and Date NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00074339AM21
RA File Number<br>34AA04002219 AM21
Licence No and Date<br>3411000188/01/02/2021
Norms Committee 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<br>Qty.<br>Sl. No.	Import items	Qty.
QUININE<br>DIHYDROCHLORIDE<br>1 Number<br>1	QUININE DIHYDROCHLORIDE	<br>673.56 mg
BP INJECTION, 500 mg / 2 ml -	BP
Ampoules<br>(Each<br>2ml<br>contains
Quinine Dihydrochloride equivalent
to Quinine 500 mg)
RA concerned may take further necessary action as per above decision of NC.

Case No.	92 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	CHIRAG ENTERPRISE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00076610AM21
RA File Number	24AA04002562 AM21
Licence No and<br>Date	2411000202/04/02/2021
Norms Committee Decision:
Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	93 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	SUN PHARMACEUTICAL INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00077017AM21
RA File Number	05AA04028600 AM21
Licence No and<br>Date	0511001102/04/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I 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>Ciprofloxacin Hcl (Non-Sterile)<br>26.22 mg<br>Ciprofloxacin and Dexamethasone<br>Sterile Otic Suspension 7.5ml((Each<br>ml contains Ciprofloxacin 3mg. &<br>Dexamethasone 1mg (Equivalent to<br>43.875 Kg. Ciprofloxacin and 14.625<br>Kg. Dexamethasone Bulk Drug))<br>1 Number Bottle<br>2<br>Dexamethasone<br>7.87 mg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	94 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00079899AM21
RA File Number	31AA04006080 AM21
Licence No and<br>Date	3111000151/09/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Export Product			Qty.	Sl. No.	Import items	Qty.
1,3-Dicyclo	Hexyl	Carbodimide	<br>100 MT	1	Cyclohexylamine (CHA)	141 MT
(DCC)(-)
				2	Iodine	1.3 MT
				3	Methanol	13 MT
				4	Phosphorus Qxy Chloride	162 MT
				5	Ammonia	94 MT

Case No.	95 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	MAHIMA LIFESCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00080306AM21
RA File Number	05AA04029372 AM21
Licence No and<br>Date	0511001191/09/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the Assay of import and export item is not
matching and particle size of import item is not given. Hence, it was decided to call the firm for attendingPersonal
Hearing<br> before Norms Committee to explain it case.

Case No.	96 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	MAKCUR LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00081247AM21
RA File Number	08AA04008852 AM21
Licence No and<br>Date	0811000632/10/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP

The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Vol. I as per details given below or as applied by the firm, whichever is less:

Sl. No.	Export product	Qty.	Sl. No.	Import items	Qty.
1	APRINOL 25000 IU (Heparin Injection	<br>153000 Vials	1	HEPARIN SODIUM	18.98 kg
	25000<br>IU)<br>(1<br>Vial
	=117.52mg)(APRINOL<br>25000<br>IU
	(Heparin Injection 25000 IU) (1 Vial
	=117.52mg))
2	APRINOL 5000 IU (Heparin Injection	<br>102000 Vials	2	HEPARIN SODIUM	2.53 kg
	5000 IU) (1 Vial =23.504mg)(APRINOL
	5000 IU (Heparin Injection 5000 IU) (1
	Vial =23.504mg))

Case No.	Case No.	97 / NC/3/MEET/Jun/202223/5	97 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00081537AM21
RA File Number		31AA04006044 AM21
Licence No and<br>Date		3111000156/11/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify 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.<br>Sl.	Import items	Qty.
		No.
	Anisole	1<br>1 kg	Phenol	0.92 kg
		2	Methanol	0.36 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	98 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AUROBINDO PHARMA LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00082860AM21
RA File Number	092404000486 AM21
Licence No and<br>Date	0911000238/12/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as<br>per Annexure to Appendix 4E.<br>i.

i. Copy of 4.07 application having copy of Advance Authorization alongwith complete technical details as per Annexure to Appendix 4E.

Case No.	Case No.	99 / NC/3/MEET/Jun/202223/5	99 / NC/3/MEET/Jun/202223/5	99 / NC/3/MEET/Jun/202223/5	99 / NC/3/MEET/Jun/202223/5	99 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		PANACEA BIOTEC LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM REVIW00000335AM23
RA File Number		05AA04030159 AM21
Licence No and<br>Date		0511001262/12/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br> <br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Purified<br>Diptheria<br>Toxoid<br>Concentrate Antigen Bulk @2050<br>Lf/ml<br>13.33 Litre<br>Purified<br>Tetanus<br>Toxoid<br>Easy Five TT Vaccine DTwP-Hep B-<br>Hib-Pentavalent Vaccine (Each vial of<br>0.5 ml contains 1 dose)<br>1<br>Million<br>Vials<br>2<br>5.23 Litre
	Export product		Qty.	Sl. No.	Import items	Qty.
	Easy Five TT Vaccine DTwP-Hep B-<br>Hib-Pentavalent Vaccine (Each vial of<br>0.5 ml contains 1 dose)		<br>1<br>Million<br>Vials	1<br>	Purified<br>Diptheria<br>Toxoid<br>Concentrate Antigen Bulk @2050<br>Lf/ml	<br> <br>13.33 Litre
				2	Purified<br>Tetanus<br>Toxoid	<br>5.23 Litre

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

	Concentrate Antigen @1900 Lf/ml
3	Inactivated Whole Cell Pertussis<br>Bulk @192 OU/ml	<br>86.46 ml
4	Rubber Stopper	1010000<br>Numbers
5	AGS HB Purification MABS<br>Column	<br>5.4 Litre
6	Tetanus toxoid for conjugation	6.15 Litre

Case No.	Case No.	100 / NC/3/MEET/Jun/202223/5	100 / NC/3/MEET/Jun/202223/5	100 / NC/3/MEET/Jun/202223/5	100 / NC/3/MEET/Jun/202223/5	100 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00085588AM21
RA File Number		03AA04023854 AM21
Licence No and<br>Date		0311001784/17/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Clobetasol<br>Propionate<br>Micronized USP<br>7.65 mg<br>2<br>Sorbitan<br>Sesquioleate<br>NF<br>(SPAN 83 LO-SG)<br>75.00 mg<br>White<br>Petrolatum<br>USP<br>1<br>Medicinal Cream/ Ointments -<br>Clobetasol Propionate Ointment<br>0.05 percentage 15Gm(Clobetasol<br>Propionate<br>Ointment<br>0.05<br>percentage<br>15Gm<br>Net<br>WT:<br>1999.98 Kg<br>1 Number<br>3<br>14170.00 mg
	Export Product		Qty.	Sl. No.	Import items	Qty.
	Medicinal Cream/ Ointments -<br>Clobetasol Propionate Ointment<br>0.05 percentage 15Gm(Clobetasol<br>Propionate<br>Ointment<br>0.05<br>percentage<br>15Gm<br>Net<br>WT:<br>1999.98 Kg		1 Number	1	Clobetasol<br>Propionate<br>Micronized USP	<br>7.65 mg
				2	Sorbitan<br>Sesquioleate<br>NF<br>(SPAN 83 LO-SG)	<br>75.00 mg
				3	White<br>Petrolatum<br>USP	<br>14170.00 mg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

				(Ultima)
			4	Empty<br>Aluminium<br>Printed<br>Tube	<br>Relevant as per<br>packing policy
2	Medicinal<br>Cream/<br>Ointments-<br>Clobetasol Propionate Ointment<br>0.05 percentage 30Gm(Clobetasol<br>Propionate<br>Ointment<br>0.05<br>percentage<br>30Gm<br>Net<br>WT:<br>1499.97 Kg	1 Number	1	Clobetasol<br>Propionate<br>Micronized USP	<br>15.30 mg
			2	Sorbitan<br>Sesquioleate<br>NF<br>(SPAN 83 LO-SG)	<br>150.00 mg
			3	White<br>Petrolatum<br>USP<br>(Ultima)	<br>28340.00 mg
			4	Empty<br>Aluminium<br>Printed<br>Tube	<br>Relevant as per<br>packing policy
3	Medicinal Cream/ Ointments -<br>Clobetasol Propionate Ointment<br>0.05 percentage 45 Gm(Clobetasol<br>Propionate<br>Ointment<br>0.05<br>percentage 45Gm Net WT: 999.99<br>Kg	1 Number	1	Clobetasol<br>Propionate<br>Micronized USP	<br>22.95 mg
			2	Sorbitan<br>Sesquioleate<br>NF<br>(SPAN 83 LO-SG)	<br>225.00 mg
			3	White<br>Petrolatum<br>USP<br>(Ultima)	<br>42500.00 mg
			4	Empty<br>Aluminium<br>Printed<br>Tube	<br>Relevant as per<br>packing policy
4	Medicinal Cream/ Ointments -<br>Clobetasol Propionate Ointment<br>0.05 percentage 60 Gm Clobetasol<br>Propionate<br>Ointment<br>0.05<br>percentage 60Gm Net WT: 8808.98<br>Kg	<br> <br> <br> <br> <br>1 Number	1	Clobetasol<br>Propionate<br>Micronized USP	<br>30.60 mg
			2	Sorbitan<br>Sesquioleate<br>NF<br>(SPAN 83 LO-SG)	<br>300.00 mg
			3	White<br>Petrolatum<br>USP<br>(Ultima)	<br>56570.00 mg
			4	Empty<br>Aluminium<br>Printed<br>Tube	<br>Relevant as per<br>packing policy

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	101 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	DEEPAK NITRITE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00085836AM21
RA File Number	34AA04001557 AM21
Licence No and<br>Date	3411000043/17/02/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	102 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ATUL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00087487AM21
RA File Number	08AA04009727 AM21
Licence No and<br>Date	0811000726/19/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Molecular weight, yield and stoichiometric balance.

Case No.	103 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00088461AM21
RA File Number	03AA04022816 AM21
Licence No and<br>Date	0311001602/22/02/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

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. No.	Import items	Qty.
3 Amino Benzotrifluoride (LIQUID)	85 MT	1	BENZOTRIFLUORIDE	90.78 MT

Case No.	104 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SPEED INTERNATIONAL (INDIA) PRIAVTE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00089812AM21
RA File Number	03AA04022711 AM21
Licence No and<br>Date	0311001589/23/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Chemistry, molecular weight and stoichiometric balance of reaction.

Case No.	105 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SHREE MAHADEV INTERMEDIATE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00090280AM21
RA File Number	34AA04002739 AM21
Licence No and<br>Date	3411000251/23/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

i. Percentage Acetic content in export alongwith COA.

ii Chemistry, molecular weight, yield and Stoichiometric balance.

Percentage Acetic content in export alongwith COA.<br>i.<br>ii Chemistry, molecular weight, yield and Stoichiometric balance.	Percentage Acetic content in export alongwith COA.<br>i.<br>ii Chemistry, molecular weight, yield and Stoichiometric balance.	Percentage Acetic content in export alongwith COA.<br>i.<br>ii Chemistry, molecular weight, yield and Stoichiometric balance.	Percentage Acetic content in export alongwith COA.<br>i.<br>ii Chemistry, molecular weight, yield and Stoichiometric balance.	Percentage Acetic content in export alongwith COA.<br>i.<br>ii Chemistry, molecular weight, yield and Stoichiometric balance.	Percentage Acetic content in export alongwith COA.<br>i.<br>ii Chemistry, molecular weight, yield and Stoichiometric balance.	Percentage Acetic content in export alongwith COA.<br>i.<br>ii Chemistry, molecular weight, yield and Stoichiometric balance.

Case No		106 / NC/3/MEET/Jun/202223/5
.
C S		C Ad
ase tatus		ase pprove
Pt N		SUN PHARMACEUTICAL INDUSTRIES LIMITED
ary ame
Mti Nb
eeng umer<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022

HQ File Number		HQRNORM APPLY 00090323AM21
RA Fil Nb		05AA04035066 AM21
e umer
Li N d
cence o an<br>Date		0511001405/23/02/2021

Norms Committee		Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>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>Brinzolamide<br>Ophthalmic<br>Suspension,<br>1 Number<br>1<br>Relevant Bulk Drug<br>51.00 mg
	Export Product		Qty.	Sl. No.	Import items	Qty.
	Brinzolamide<br>Ophthalmic<br>Suspension,		<br>1 Number	1	Relevant Bulk Drug	51.00 mg
	<br> <br>1percent w/v 5ml ( Sterile Eye Drops)		<br>
	<br>(BRINOLAR	<br>/<br>BRAZTEC)<br>(Each<br>ml	<br>
	contains(Brinzo	lamide<br>equivalent<br>to
	Brinzolamide<br>	Micronized Sterile 10 mg<br>
	(Equivalent to 6	50.000 Gm of Bulk Drug),)



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


Case No.		107 / NC/3/MEET/Jun/202223/5
Case Status		Case Rejected
Party Name		SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00091235AM21
RA File Number		30AA04004572 AM21

Licence No and
<br>Date		3011000300/24/02/2021

Norms Committee		Decision:

The Committee con		sidered the case as per agenda and it was observed that the firm still has not furnished its reply on

Case No.	107 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00091235AM21
RA File Number	30AA04004572 AM21
Licence No and<br>Date	3011000300/24/02/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

DGFT Portal. Hence, the Committee decided to reject the case.

Case No.	108 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	LAXMI ORGANIC INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00092003AM21
RA File Number	038504000144 AM21
Licence No and<br>Date	0311000450/25/02/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>One of the import items mentioned is Acetic Acid, while in manufacturing process item is Menthol as Acetic Acid.<br>Please clarify it.

Case No.	109 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ALEMBIC PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00094103AM21
RA File Number	34AA04002716 AM21
Licence No and<br>Date	3411000254/01/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the norms applied by the firm in its<br>Advance Authorization does not confirm to the composition shown in DML. Hence, the norms cannot be worked out<br>in its present form.<br>In view of above, it was decided to call the firm for attendingPersonal Hearing<br> before Norms<br>Committee alongwith relevant documents to explain its case.

The Committee considered the case as per agenda and it was observed that the norms applied by the firm in its Advance Authorization does not confirm to the composition shown in DML. Hence, the norms cannot be worked out in its present form.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	110 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00097569AM21
RA File Number	03AA04027566 AM21
Licence No and<br>Date	0311002238/05/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>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)-2-amino<br>butyramide<br>hydrochloride<br>(SABA)<br>0.95 kg<br>Levetiracetam USP / BP / EP<br>1 kg<br>2<br>Methylene Chloride<br>2.26 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.<br>	Case No.<br>	111 / NC/3/MEET/Jun/202223/5	111 / NC/3/MEET/Jun/202223/5	111 / NC/3/MEET/Jun/202223/5	111 / NC/3/MEET/Jun/202223/5	111 / NC/3/MEET/Jun/202223/5
Case Status<br>		Case Approved
Party Name<br>		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date<br>		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>		HQRNORM APPLY 00098898AM21
RA File Number<br>		31AA04006436 AM21
Licence No and<br>Date<br>		3111000180/08/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>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.
	Export Product		Qty.	Sl. No.	Import items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

PIPERAZINE<br>ANHYDROUS	<br>1 kg	1	MONOETHANOL AMINE	1.46 kg
(ORGANIC CHEMICAL)

Case No.<br>112 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>BALAJI AMINES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00098900AM21
RA File Number<br>31AA04006116 AM21
Licence No and<br>Date<br>3111000158/08/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Percentage yield of reaction.<br>i.
Justification for quantity of Hydrogen used.<br>ii.
Name of Morpholine Catalyst with catalogue.<br>iii.
iv Production / Consumption data duly certified by GST.

Case No.	113 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00098795AM21
RA File Number	03AA04028082 AM21
Licence No and<br>Date	0311002315/08/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Complete and Balanced chemical reactions, molecular weight and percentage yield on molar basis.<br>i.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	114 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00098842AM21
RA File Number	03AA04028081 AM21
Licence No and<br>Date	0311002319/08/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Complete and Balanced chemical reactions, molecular weight and percentage yield on molar basis.<br>i.

Case No.	115 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00098861AM21
RA File Number	31AA04006764 AM21
Licence No and<br>Date	3111000201/08/03/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	116 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	BAYER VAPI PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00098875AM21
RA File Number	03AA04027340 AM21
Licence No and<br>Date	0311002180/08/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23


Export Product	Qty.	Sl. No.	Import items		Qty.
FLUMETHRIN 90 PERCENT	1 kg	1	BAYTICOL P ACID		0.564 kg
		2	4-FLUORO-3	PHENOXY	<br>0.416 kg
			BENZALDEHYDE ( 4 - FPBA )
		3	STEEL DRUMS OF 25Kgs capacity for		<br>Relevant as per
			packing		packing policy
A concerned may take further necessary action as per above decision of NC.

	Export Product<br>FLUMETHRIN 90 PERCENT	Export Product<br>FLUMETHRIN 90 PERCENT	Qty.	Sl. No.	Import items	Import items	Import items	Qty.
			1 kg	1	BAYTICOL P ACID			0.564 kg
				2	4-FLUORO-3<br>PHENOXY			<br>0.416 kg
					BENZALDEHYDE ( 4 - FPBA )

					i f			<br>l
				3	STEEL DRUMS OF 25Kgs capacty or<br>ackin			<br>Reevant as per<br>ackin olic
					pg			pg py


R	A d	tk fth ti b dii f NC
	concerne may	ae urer necessary acon as per aove ecson o .


Case No.		117 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00100512AM21
RA File Number		09AA04005394 AM21
Licence No and
Date		0911000470/10/03/2021
Norms Committee		Decision:

The Committee co<br>		nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>
import item in M<br>11.05.2020, it was<br>th fi hih		eting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.0910068738 dt.<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>i l
	e rm, wceve	s ess:



	Export product<br>			Qty.	Sl. No.	Import items	Qty.
	2-Phenyl-3,3-bis(4-hydroxy<br>phenyl)phthalimide (PPP-BP)<br>			1 kg	1	PHTHALIC ANHYDRIDE	0.927 kg
					2	PHENOL	1.145 kg
					3	ZINC CHLORIDE	0.104 kg


					4	ANILINE	0.596 kg

	Export Product<br>FLUMETHRIN 90 PERCENT	Export Product<br>FLUMETHRIN 90 PERCENT	Qty.	Sl. No.	Import items	Import items	Import items	Qty.
			1 kg	1	BAYTICOL P ACID			0.564 kg
				2	4-FLUORO-3<br>PHENOXY			<br>0.416 kg
					BENZALDEHYDE ( 4 - FPBA )

					i f			<br>l
				3	STEEL DRUMS OF 25Kgs capacty or<br>ackin			<br>Reevant as per<br>ackin olic
					pg			pg py


R	A d	tk fth ti b dii f NC
	concerne may	ae urer necessary acon as per aove ecson o .


Case No.		117 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		PORUS LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00100512AM21
RA File Number		09AA04005394 AM21
Licence No and
Date		0911000470/10/03/2021
Norms Committee		Decision:

The Committee co<br>		nsidered the case as per agenda and taking cue from earlier decision for same export product /<br>
import item in M<br>11.05.2020, it was<br>th fi hih		eting No.5/82-ALC4/2020 dated 09.10.2020 against advance authorization No.0910068738 dt.<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by<br>i l
	e rm, wceve	s ess:



	Export product<br>			Qty.	Sl. No.	Import items	Qty.
	2-Phenyl-3,3-bis(4-hydroxy<br>phenyl)phthalimide (PPP-BP)<br>			1 kg	1	PHTHALIC ANHYDRIDE	0.927 kg
					2	PHENOL	1.145 kg
					3	ZINC CHLORIDE	0.104 kg


					4	ANILINE	0.596 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

	5	METHANOL	0.715	kg
	6	ACTIVATED CARBON	0.100	kg

Case No.	118 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	DISCOVERY LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00100529AM21
RA File Number	092404000465 AM21
Licence No and<br>Date	0911000490/10/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Complete technical details as per Annexure to Appendix 4E.

Case No.	119 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00100855AM21
RA File Number	072404000200 AM21
Licence No and<br>Date	0711000645/10/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not
proper. Hence, it was decided torejectthe case.
RA concerned may take further necessary action as per above decision of NC

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Case No.	120 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Party Name	Party Name	Party Name	ENCUBE ETHICALS PRIVATE LIMITED	ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number<br>d D			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
an ate

HQ File Number			HQRNORM APPLY 00103187AM21

RA File Number			03AA04026743 AM21

Licence No and<br>Dt			0311002213/15/03/2021
ae
Ci			ii
Norms ommttee			ecson:
The Committee co			nsidered the case as per agenda and taking cue from earlier decision for same export product /
import item in Me			eting No.3/82/ALC4/2013 dated 02.05.2013against advance authorization No.0310664617 dt.
14.11.2021, it was			decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by
the firm, whicheve			r is less:


	S. No.	Export Product		Qty.
	1.	Medicinal Cream/ Ointments(Clotrimazole 1Percentage Cream 10 Gm tube<br>Labelled content Clotrimazole 1 Percentage W/W Brand Canesten or any other.<br>		1 Number
		Net WT: 4750Kg Net Contents: Clotrimazole USP 47.50Kg, Octyldo 641.25Kg,<br>
		Cetyl P	alm 142.50Kg, Ceto Alco 475Kg, Emp Tube 475000Nos)




	2.	Medicin	al Cream/ Ointments(Clotrimazole1 Percentage Vaginal cream 35 Gm	1 Number

		Tube w	ith 6 Applicator Labelled content Clotrimazole 1 Percentage W/W Brand
		Caneste<br>	n or any other Net WT: 1999.90Kg Net Con: ClotriUSP 20Kg, Oct<br>
		269.99K	g, Cetyl 60Kg, Ceto Alco 199.99Kg, EmpTube 57140Nos,)




	3.	Medicin	al Cream/ Ointments(Clotrimazole 1 Percentage Cream 100 Gm Tube	1 Number
		<br>Labelle	<br>d content Clotrimazole 1Percentage W/W Brand Canesten or any Net WT:
		1000 K	g Net Con: Clotri USP 10Kg, Octyl 135Kg, Cetyl 30Kg, Ceto 100Kg, Emp
		<br>10000Nos)
	4.	Medicinal Cream/ Ointments(Clotrimazole 1 Percentage Cream 20Gm.Tube<br>Labelled content Clotrimazole1 PercentageW/W Brand Canesten or any other Net<br>WT: 1000 Kg Net Con: Clotri USP 10Kg, Octyl 135Kg, Cetyl 30Kg, Ceto 100Kg,<br>Emp 10000Nos)		1 Number



	5.	Medicin	al Cream/ Ointments(Clotrimazole 1 PercentageCream 50 Gm.Tube	1 Number

		Labelle	d content Clotrimazole1 PercentageW/W Brand Canesten or any other. Net
		WT 87	60 K N C Cli 8760K Ol 118260K Cl 26280K C
		:<br>	g et on: otr .g, cty .g, ety .g, eto<br>
		876Kg,	Emp Tube 175200Nos)



	6.	Medicin	al Cream/ Ointments(Clotrimazole 2 Percentage Vaginal Cream 20	1 Number

		Gm.Tub	e with 3 ApplicatorLabelled content Clotrimazole 2 PercentageW/W
		Brand	Canesten Net WT: 2000 Kg Net Cont: Clotri 40Kg, Octyl 270Kg, Cetyl

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

	60Kg, Ceto 200 Kg, Emp Tube 100000Nos, Plas App 300000Nos)	60Kg, Ceto 200 Kg, Emp Tube 100000Nos, Plas App 300000Nos)	60Kg, Ceto 200 Kg, Emp Tube 100000Nos, Plas App 300000Nos)	60Kg, Ceto 200 Kg, Emp Tube 100000Nos, Plas App 300000Nos)	60Kg, Ceto 200 Kg, Emp Tube 100000Nos, Plas App 300000Nos)
7.	Medicinal Cream/ Ointments(Clotrimazole10 PercentageVaginal cream 5 Gm<br>Tube with 1 Applicator. Labelled content Clotrimazole 10 Percentage W/W;Brand<br>Canesten or any other Net WT: 100Kg Net Con: Clotri 10Kg, Cetyl 3Kg, Ceto<br>3.5Kg, Emp Tube 20000Nos, Plast Appl 20000Nos)					1 Number


8.	Medicin		al Cream/ Ointments(Clotrimazole 1 Percentage Cream 5 Gm.Tube			1 Number
	Labelle		d content Clotrimazole 1 Percentage W/W Brand Canesten or any other.

	Net WT		: 750Kg Net Cont: Clotri 7.50Kg, Octyl 101.25Kg, Cetyl 22.50Kg, Ceto

	75Kg, E		mp Tube 150000Nos)


9.	Medicin		al Cream/ Ointments(Clotrimazole 1 Percentage Cream 3 Gm. Tube			1 Number
	<br>Labelle		<br>d content Clotrimazole 1 Percentage W/W Brand Canesten or any other
	Net WT		: 900 Kg Net Cont: Clotri 9Kg, Octyl 121.50Kg, Cetyl 27Kg, Ceto 90Kg,
	<br>Emp Tu		<br>be 300000Nos)



For Export Product No. 2, 6 and 7


S. No.		Impo	rt Item	For Export of 1 No. Clotrimazole Vaginal Cream


				1% 35 m tube	2% 20 m tube		10% 5 m tube
				, g	, g		, g


1.		Clotri	mazole	0.357 gm	0.408 gm		0.510 gm




2.		Octyl	dodecanol	4.725 gm	2.70 gm		--

3		Ctl	Pltd	105	060		0150
.		ey	amae	. gm	. gm		. gm

4.		Cetos	tearyl Alcohol	3.50 gm	2.00 gm		0.173 gm

5.		Empty Aluminium Collapsible Tube		Relevant, as per packing policy

6.		Plasti	c Applicator

For Export Product No. 2, 6 and 7

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

For Export Product No. 1, 3, 4, 5, 8 and 9

S.<br>No	Import Item	For Export of 1 No. Clotrimazole 1% cream, 100 gm pack
1.	Clotrimazole	1.02 gm
2.	Octyldodecanol	13.50 gm
3.	Cetyl Palmated	3.00 gm
4.	Cetostearyl Alcohol	10.00 gm
5.	Empty Aluminium Collapsible Tube	Relevant, as per packing policy

For different pack sizes, RA may work out norms on pro-rata basis.

Case No.	Case No.	121 / NC/3/MEET/Jun/202223/5	121 / NC/3/MEET/Jun/202223/5	121 / NC/3/MEET/Jun/202223/5	121 / NC/3/MEET/Jun/202223/5	121 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00103227AM21
RA File Number		31AA04006434 AM21
Licence No and<br>Date		3111000178/15/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>AMINO ETHYL ETHANOL AMINE<br>(ORGANIC CHEMICAL)<br>1 kg<br>1<br>MONO ETHANOL AMINE<br>1.173 kg
	Export product		Qty.	Sl. No.	Import items	Qty.
	AMINO ETHYL ETHANOL AMINE<br>(ORGANIC CHEMICAL)		1 kg	1	MONO ETHANOL AMINE	1.173 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	122 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	LUPIN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00103407AM21
RA File Number	03AA04019762 AM21
Licence No and<br>Date	0311002479/15/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>(i) Copy of DML with Approved Composition of each export item.<br>(ii) Justification / Working of norms applied.<br>i.

Case No.	123 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	ORIENTAL AROMATICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00104014AM21
RA File Number	03AA04029725 AM21
Licence No and<br>Date	0311002554/16/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	124 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AETHER INDUSTRIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00104575AM21

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

RA File Number	52AA04007931 AM21
Licence No and<br>Date	5211000485/16/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not
proper. Hence, it was decided to again call for following documents / information from the firm:
Justification for requirement of 1.0 kg / kg of Magnesium in terms of Stoichiometric Balance and percentage
yield of reaction.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to again call for following documents / information from the firm:

Case No.	125 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	THERAPIVA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00104605AM21
RA File Number	09AA04005655 AM21
Licence No and<br>Date	0911000535/16/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
(i) The export item is shown as API, whereas in the Drug License Declaration, it is shown as Drug –
Intermediate. The discrepancy may be clarified alongwith Pharmacopial name of the Drug.
(ii) Complete and balanced chemical reactions, molecular weight, etc.
(iii) Percentage yield on molar basis for each step, alongwith technical literature in support of yield.

(i) The export item is shown as API, whereas in the Drug License Declaration, it is shown as Drug – Intermediate. The discrepancy may be clarified alongwith Pharmacopial name of the Drug.

Case No.	126 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	GOPINATH CHEM-TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00105836AM21
RA File Number	08AA04012038 AM21
Licence No and<br>Date	0811001061/18/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Export product	Qty.	Sl.<br>No.	Import items	Qty.
4,4 Diamino Diphenyl Amine -2-<br>Sulphonic Acid (F.C.Acid)	<br>1 kg	1	Para Phenylene Diamine (PPD)	0.610 kg
		2	Soda Ash	1.155 kg

Case No.	127 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	INCHEM LABORATORIES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00106311AM21
RA File Number	09AA04004395 AM21
Licence No and<br>Date	0911000512/18/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Complete chemistry, molecular weight and percentage yield on molar basis for each step of process.

Case No.	128 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	VALENS MOLECULES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00107380AM21
RA File Number	26AA04001057 AM21
Licence No and<br>Date	2611000112/19/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Sl. No.	Export Product	Qty.	Sl. No.	Import items	Qty.
1	SULFADIMETHOXINE<br>USP<br>/<br>EP(USP/EP)	<br>1 kg	1	PYRIDINE	0.33 kg
			2	Methyl Cyano Acetate	0.85 kg
			3	Triethyl Amine	1.45 kg
			4	Urea	0.52 kg
			5	Sodium Methoxide Powder	0.90 kg
			6	Methanol	1.13 kg
2	SULFADIMETHOXINE<br>SODIUM<br>USP / Ph.Eur(USP/Ph.Eur)	<br>1 kg	7	PYRIDINE	0.33 kg
			8	METHYL CYANO ACETATE	0.85 kg
			9	TRIETHYL AMINE	1.45 kg
			10	UREA	0.52 kg
			11	SODIUM METHOXIDE POWDER	0.90 kg
			12	METHANOL	1.13 kg

Case No.	129 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	WEST BENGAL CHEMICAL INDUSTRIES LTD.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00107455AM21
RA File Number	02AA04010857 AM21
Licence No and	0211000433/19/03/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:

i. Complete chemistry, molecular weight and yield.

ii Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.

Case No.	130 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00107042AM21
RA File Number	03AA04029353 AM21
Licence No and<br>Date	0311002597/19/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Requirement and recovery of import item No. 2 – Methanol at each stage of manufacturing process.<br>i.

Case No.	131 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	REYAANSH HEALTHCARE
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00107278AM21
RA File Number	03AA04022151 AM21
Licence No and<br>Date	0311002655/19/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Copy of DML with Approved Composition for each export item.

Case No. 132 / NC/3/MEET/Jun/202223/5

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case Status	Case Deferred
Party Name	NAVIN FLUORINE INTERNATIONAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00109027AM21
RA File Number	03AA04031482 AM21
Licence No and<br>Date	0311002729/22/03/2021
Norms Committee Decision:
T
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Percentage yield at every stage of reaction.<br>i.
ii Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.

Case No.<br>133 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Approved
Party Name<br>AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00112890AM21
RA File Number<br>09AA04006435 AM21
Licence No and<br>Date<br>0911000600/24/03/2021
Norms Committee 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:<br>
Export product<br>Qty.	Sl. No.	Import items	Qty.
Oxcarbazepine (Pharmaceutical product)<br>1 kg	1	10 Methoxyiminostilbene	1.10 kg
RA concerned may take further necessary action as per above decision of NC.

Case No.	134 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AMOLI ORGANICS PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00114387AM21
RA File Number	03AA04029354 AM21
Licence No and<br>Date	0311002596/26/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Requirement and recovery of import item No. 2 – Methanol at each stage of manufacturing process.<br>i.

Case No.	135 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00114423AM21
RA File Number	09AA04006434 AM21
Licence No and<br>Date	0911000598/26/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Requirement and recovery of import item No. 3 – Isopropyl alcohol at each stage of manufacturing<br>i.
process.

i. Requirement and recovery of import item No. 3 – Isopropyl alcohol at each stage of manufacturing process.

Case No.	136 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GRANULES INDIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00114107AM21
RA File Number	09AA04005572 AM21
Licence No and<br>Date	0911000481/26/03/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Copy of Master Batch Formula showing net content of all the inputs in the export product.

Case No.	137 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00114386AM21
RA File Number	03AA04027304 AM21
Licence No and<br>Date	0311002339/26/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda andand it was decided to call the firm for attending<br>before Norms Committee alongwith following documents / information:<br>Applied Intermediate and its raw materials.		Personal Hearing<br>

Case No.	138 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00115936AM21
RA File Number	09AA04006613 AM21
Licence No and<br>Date	0911000627/29/03/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	139 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	RENOWN PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00116892AM21
RA File Number	34AA04003261 AM21
Licence No and<br>Date	3411000335/30/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Export product	Qty.	Sl.<br>No.	Import items	Qty.
Soft Gelatin Capsule Shells (330 mg to<br>370<br>mg)<br>(ITC(HS)<br>Code<br>30045090/30045039)(Net<br>Content:<br>Gelatin 175 Bloom 5-15 Mesh:25480.00<br>KGS)	<br> <br> <br> <br>65839793<br>Number	1	Gelatin 175 Bloom 5-15 Mesh	26754.00 kg

Case No.	Case No.	Case No.	140 / NC/3/MEET/Jun/202223/5	140 / NC/3/MEET/Jun/202223/5	140 / NC/3/MEET/Jun/202223/5	140 / NC/3/MEET/Jun/202223/5	140 / NC/3/MEET/Jun/202223/5
Case Status			Case Approved
Party Name			VEKO CARE PRIVATE LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number			HQRNORM APPLY 00116666AM21
RA File Number			31AA04007577 AM21
Licence No and<br>Date			3111000245/30/03/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import Items<br>Qty.<br>1<br>Tylosin Tartrate<br>1224.625 kg<br>1<br>TYLODOX GOLD Powder(1 kg<br>Jar Tylosin Tartrate Doxycycline<br>Hyclate)<br>12125 Number<br>2<br>Doxycycline Hyclate<br>2449.25 kg<br>3<br>Tylosin Tartrate<br>1224.625 kg<br>2<br>TYLODOX GOLD Powder(100<br>gm<br>Sachet<br>Tylosin<br>Tartrate<br>Doxycycline Hyclate)<br>121250<br>Number<br>4<br>Doxycycline Hyclate<br>2449.25 kg
	Sl.<br>No.	Export Product		Qty.	Sl.<br>No.	Import Items	Qty.
	1	TYLODOX GOLD Powder(1 kg<br>Jar Tylosin Tartrate Doxycycline<br>Hyclate)		<br> <br>12125 Number	1	Tylosin Tartrate	1224.625 kg
					2	Doxycycline Hyclate	2449.25 kg
	2	TYLODOX GOLD Powder(100<br>gm<br>Sachet<br>Tylosin<br>Tartrate<br>Doxycycline Hyclate)		<br> <br>121250<br>Number	3	Tylosin Tartrate	1224.625 kg
					4	Doxycycline Hyclate	2449.25 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

3<br>AmpKO-50 Powder(100 gm Sachet<br>Amprolium HCl USP)<br>14500 Number 5<br>Amprolium HCl USP<br>732.25 kg<br>4<br>AmpKO-50<br>Powder(1<br>kg<br>Jar<br>Amprolium HCl USP)<br>1450 Number<br>6<br>Amprolium HCl USP<br>732.25 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	3	AmpKO-50 Powder(100 gm Sachet<br>Amprolium HCl USP)	<br>14500 Number	5	Amprolium HCl USP	732.25 kg
	4	AmpKO-50<br>Powder(1<br>kg<br>Jar<br>Amprolium HCl USP)	<br>1450 Number	6	Amprolium HCl USP	732.25 kg

Case No.	141 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00116713AM21
RA File Number	31AA04007907 AM21
Licence No and<br>Date	3111000255/30/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Percentage yield of reaction.<br>i.<br>Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.<br>ii.<br>iii COA of export item indicating percentage purity.

Case No.	142 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00116715AM21
RA File Number	31AA04007850 AM21
Licence No and<br>Date	3111000256/30/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	Case No.	143 / NC/3/MEET/Jun/202223/5	143 / NC/3/MEET/Jun/202223/5	143 / NC/3/MEET/Jun/202223/5	143 / NC/3/MEET/Jun/202223/5	143 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00116717AM21
RA File Number		31AA04007858 AM21
Licence No and<br>Date		3111000257/30/03/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Export Product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Cyclohexylamine (CHA)<br>14100 kg<br>2<br>Iodine<br>130 kg<br>3<br>Methanol<br>1300 kg<br>4<br>Phosphorus Qxy Chloride<br>16200 kg<br>1,3-Dicyclo<br>Hexyl<br>Carbodimide<br>(DCC)(-)<br>10000 kg<br>5<br>Ammonia<br>9400 kg<br>RA concerned may take further necessary action as per above decision of NC.
	Export Product		Qty.	Sl. No.	Import items	Qty.
	1,3-Dicyclo<br>Hexyl<br>Carbodimide<br>(DCC)(-)		<br>10000 kg	1	Cyclohexylamine (CHA)	14100 kg
				2	Iodine	130 kg
				3	Methanol	1300 kg
				4	Phosphorus Qxy Chloride	16200 kg
				5	Ammonia	9400 kg
				above decision of NC.

Case No.	144 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	VERTELLUS SPECIALTY MATERIALS (INDIA) PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00117102AM21
RA File Number	03AA04032376 AM21
Licence No and<br>Date	0311002851/31/03/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:

i. Complete chemistry with molecular weight and percentage yield.

ii Stoichiometric balance on molar basis to arrive at the quantity of raw material asked for.

Case No.	145 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	GLOBAL CALCIUM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00027741AM22
RA File Number	07AA04002414 AM22
Licence No and<br>Date	0711000982/27/04/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>proper. Hence, it was decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Case No.	146 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00031414AM22
RA File Number	03AA04000436 AM22
Licence No and<br>Date	0311003517/03/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	147 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00031409AM22
RA File Number	03AA04000162 AM22
Licence No and<br>Date	0311003516/03/05/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the firm still has not furnished its reply on<br>DGFT Portal. Hence, the Committee decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

Case No.	Case No.	148 / NC/3/MEET/Jun/202223/5	148 / NC/3/MEET/Jun/202223/5	148 / NC/3/MEET/Jun/202223/5	148 / NC/3/MEET/Jun/202223/5	148 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		CLEAN SCIENCE AND TECHNOLOGY LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00033227AM22
RA File Number		31AA04000906 AM22
Licence No and<br>Date		3111000308/05/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for fixation of adhoc norms and it was decided to ratify norms under<br>Para 4.07 of HBP Vol. I as per 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>1<br>Cyclohexylamine (CHA)<br>28200 kg<br>2<br>Iodine<br>200 kg<br>3<br>Methanol<br>1600 kg<br>4<br>Phosphorus Qxy Chloride<br>29800 kg<br>1,3-Dicyclo Hexyl Carbodimide (DCC)(-)<br>20000 kg<br>5<br>Ammonia<br>14400 kg
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	1,3-Dicyclo Hexyl Carbodimide (DCC)(-)		20000 kg	1	Cyclohexylamine (CHA)	28200 kg
				2	Iodine	200 kg
				3	Methanol	1600 kg
				4	Phosphorus Qxy Chloride	29800 kg
				5	Ammonia	14400 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	149 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000277AM23
RA File Number	09AA04000173 AM22
Licence No and<br>Date	0911000784/07/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case.

Case No.	150 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000276AM23
RA File Number	09AA04006940 AM21
Licence No and<br>Date	0911000856/18/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	151 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000270AM23
RA File Number	09AA04007005 AM21
Licence No and<br>Date	0911000882/20/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	152 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000275AM23
RA File Number	09AA04006941 AM21
Licence No and<br>Date	0911000880/20/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	153 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000217AM23
RA File Number	09AA04006942 AM21
Licence No and<br>Date	0911000887/21/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	154 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000272AM23
RA File Number	09AA04007003 AM21
Licence No and<br>Date	0911000900/24/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	155 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLAND PHARMA LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00000143AM23
RA File Number	09AA04005477 AM21
Licence No and<br>Date	0911000482/24/05/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	156 / NC/3/MEET/Jun/202223/5
Case Status	Case Rejected
Party Name	U. K. AROMATICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00106679AM22
RA File Number	03AA04019445 AM22
Licence No and<br>Date	0311004281/03/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not<br>proper. Hence, it was decided torejectthe case.<br> RA concerned may take further necessary action as per above decision of NC.

The Committee considered the case as per agenda and it was observed that the reply furnished by the firm is not proper. Hence, it was decided to reject the case.

Case No.	Case No.	Case No.	157 / NC/3/MEET/Jun/202223/5	157 / NC/3/MEET/Jun/202223/5	157 / NC/3/MEET/Jun/202223/5	157 / NC/3/MEET/Jun/202223/5	157 / NC/3/MEET/Jun/202223/5
Case Status			Case Approved
Party Name			GLAND PHARMA LIMITED
Meeting Number<br>and Date			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number			HQRNORM APPLY 00114248AM22
RA File Number			09AA04003134 AM22
Licence No and<br>Date			0911000921/14/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:<br>Sl.<br>Sl.<br>Export Product<br>Qty.<br>Import Items<br>Qty.
	Sl.	Export Product		Qty.	Sl.	Import Items	Qty.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

No.<br>No.<br>1<br>Heparin Sodium Injection USP, 1000IU<br>30ml Vial(Each ml contains Heparin<br>Sodium USP 1000 USP Heparin Units<br>(From Porcine intestines), Benzyl alcohol<br>NF 0.01 mL, Water for lnjection USP q.s.<br>Condition: The firm should account for<br>225.00 Kgs Heparin Sodium of the import<br>list in the resultant product)<br>1500000<br>Number<br>1<br>Heparin Sodium<br>236.25 kg<br>2<br>Heparin Sodium Injection USP, 5000IU 1ml<br>Vial(Each ml contains Heparin Sodium USP<br>5000 USP Heparin Units (From Porcine<br>intestines), Benzyl alcohol NF 0.01 mL,<br>Water for lnjection USP q.s. Condition: The<br>firm should account for 37.50 Kgs Heparin<br>Sodium of the import list in the resultant<br>product)<br>1500000<br>Number<br>2<br>Heparin Sodium<br>41.25 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.	No.			No.
	1	Heparin Sodium Injection USP, 1000IU<br>30ml Vial(Each ml contains Heparin<br>Sodium USP 1000 USP Heparin Units<br>(From Porcine intestines), Benzyl alcohol<br>NF 0.01 mL, Water for lnjection USP q.s.<br>Condition: The firm should account for<br>225.00 Kgs Heparin Sodium of the import<br>list in the resultant product)	1500000<br>Number	1	Heparin Sodium	236.25 kg
	2	Heparin Sodium Injection USP, 5000IU 1ml<br>Vial(Each ml contains Heparin Sodium USP<br>5000 USP Heparin Units (From Porcine<br>intestines), Benzyl alcohol NF 0.01 mL,<br>Water for lnjection USP q.s. Condition: The<br>firm should account for 37.50 Kgs Heparin<br>Sodium of the import list in the resultant<br>product)	<br> <br> <br> <br> <br> <br> <br>1500000<br>Number	2	Heparin Sodium	41.25 kg

Case No.	Case No.	158 / NC/3/MEET/Jun/202223/5	158 / NC/3/MEET/Jun/202223/5	158 / NC/3/MEET/Jun/202223/5	158 / NC/3/MEET/Jun/202223/5	158 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		AMANTA HEALTHCARE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00114285AM22
RA File Number		08AA04007100 AM22
Licence No and<br>Date		0811001728/14/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Mar/202122/16/ dated 08.04.2022 against advance authorization No.<br>0811002839 dt. 08.10.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less: :<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>SODIUM<br>HYALURONATE<br>EYE<br>SODIUM<br>HYALURONATE<br>1 Number<br>1<br>20 mg / Vial
	Export product		Qty.	Sl. No.	Import items	Qty.
	SODIUM<br>HYALURONATE<br>EYE		<br>1 Number	1	SODIUM<br>HYALURONATE	<br>20 mg / Vial

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

DROPS 0.2 W/V (XAILIN HA / XILIN (HA-EP1) HA / AQAEYE HA)((EACH 10ML EYE DROPS CONTAINING SODIUM HYALURONATE 20MG + WASTAGE 29.81 PERCENTAGE = 25.961 MG))

Case No.	159 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	INDORAMA VENTURES OXIDES ANKLESHWAR PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00116364AM22
RA File Number	03AA04018728 AM22
Licence No and<br>Date	0311004668/16/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Complete chemical reactions with molecular and structural formula and molecular weights alongwith<br>i.
stage wise percentage yields on molar basis.
Complete technical details as per Annexure to Appendix 4E for chemical products.<br>ii.
Stoichiometric balance between import and export on molar basis.<br>iii.
iv Details of indigenous input with quantity.

Case No.	160 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00118710AM22
RA File Number	03AA04019330 AM22
Licence No and<br>Date	0311004745/19/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.NC/3/MEET/Mar/202122/16 dated 08.04.2022 against advance authorization No.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

0311008613 dt. 16.11.2021 , it was decided to ratify 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. No.	Import items			Qty.
MEROPENEM	FOR	INJECTION	<br>1 kg	1	MEROPENEM	NON	STERILE	<br>0.655 kg
(MEROPENEM	BUFFERED	STERILE)			MEROPENEM	TRIHYDRATE
					NON STERILE
				2	PACKING MATERIAL			Relevant as per
								packing policy

Case No.<br>161 / NC/3/MEET/Jun/202223/5	Case No.<br>161 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Approved
Party Name<br>GLENMARK LIFE SCIENCES LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00119041AM22
RA File Number<br>03AA04029178 AM22
Licence No and<br>Date<br>0311004771/20/06/2021
Norms Committee 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<br>Qty.<br>Sl. No.<br>Import items	Qty.
	1<br>6-ETHYL-5-FLURO-4-HYDROXYPYRIMIDINE<br>VORICONAZOLE<br>1 kg	3.30 kg
	2<br>1R-10-CAMPHOR SULPHONIC ACID	1.01 kg
	3<br>METHYLENE CHLORIDE (MDC)	6.87 kg
	4<br>TETRA HYDRO FURAN (THF)	23.30 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

5 METHANOL 1.50 kg

Case No.	162 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	KOPRAN RESEARCH LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00122106AM22
RA File Number	03AA04032146 AM22
Licence No and<br>Date	0311004837/23/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents
from the firm:
Yield on 45.6% on	molar basis is very low. Please furnish copy of technical literature in support of yield.

Case No.	163 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SUDEEP PHARMA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00122419AM22
RA File Number	34AA04003768 AM22
Licence No and<br>Date	3411000762/23/06/2021
Norms Committee Decision:
Deferred for comments of TE

Case No.	164 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	APOTHECARY PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00122476AM22
RA File Number	31AA04008718 AM22
Licence No and<br>Date	3111000421/23/06/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to ratify 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.	Import items	Qty.
		No.
Levostin ( Levofloxacin 10 percent w/v and	<br>10000	1	COLISTIN SULFATE	150 kg
colistin sulphate 1.5 percent w/v oral liquid	<br>Litres
)(Levostin ( Levofloxacin 10 Percent w/v and
colistin sulphate 1.5 percent w/v oral liquid ))

Case No.	Case No.	165 / NC/3/MEET/Jun/202223/5	165 / NC/3/MEET/Jun/202223/5	165 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		CIPLA LIMITED
Meeting Number<br>and Date		<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00122489AM22
RA File Number		03AA04032754 AM22
Licence No and<br>Date		0311004856/23/06/2021
Norms Committee Decision:
The Committee		considered the case as per agenda and taking cue from earlier decision for same export product /
import item in Meeting No.13/82-ALC4/2018 dated					14.01.2019 against advance authorization No.0310823508 dt.
04.09.2018, it was decided to ratify 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.	Import items	Qty.
				No.
	Potassium	Chloride	<br>1 Number of	1	POTASSIUM CHLORIDE USP	612.0 mg
	Extended<br>Capsules	Release<br>600mg<br>/	<br> <br>capsule	2	CITRIC ACID (MONOHYDRATE USP)	8.0 mg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

3	DIBUTYL SEBACATE NF	9.6 mg
4	ETHANOL USP 99.9 Percent	2.62 ml
5	100CC WHITE HDPE BOTTLE WITH<br>38MM NECK DB-02 TRIVENI PLASTIC	Relevant, as<br>per packing<br>policy
6	38/400 FG, CRC HAVING UNIPAC SG-<br>75M LINER PTD. WITH SFYP IN BLACK<br>(REXAM CLOSURES)

Case No.	166 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GOPINATH CHEM-TECH LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00123213AM22
RA File Number	08AA04009668 AM22
Licence No and<br>Date	0811001833/24/06/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	167 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	AURORE LIFE SCIENCES PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00123227AM22
RA File Number	09AA04005065 AM22
Licence No and<br>Date	0911001102/24/06/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No. 168 / NC/3/MEET/Jun/202223/5

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

C	ase Status	Case Approve	d
P	arty Name	SMILAX LA	BORATO	RIES LI	MITED
Meeting Number<br>and Date
		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00123634AM22
RA File Number		09AA04003388 AM22

Licence No and<br>Dt		0911001113/24/06/2021
ae
N Citt		ii
orms ommee		ecson:
The Committee co		nsidered the case as per agenda and taking cue from earlier decision for same export product /
import item in Me<br>10.12.2019, it was		eting No.13/82/ALC/4/2019 dated 31.01.2019 against advance authorization No.0910068276 dt.<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by
the firm, whicheve		r is less:



	Export product					Qty.	Sl. No.	Import items	Qty.
	CLOPIDOGREL CAMPHORSULFONATE					1 kg	1	Thiophene-2-Ethylamine	0.53 kg
							2	L-Camphor Sulfonic Acid	0.455 kg
							3	Isopropyl Acetate	1.82 kg




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



Case No.		169 / NC/3/MEET/Jun/202223/5

Case Status		Case Approved

Party Name		ZIM LABORATORIES LIMITED.
Meeting Number<br>		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
and Date
HQ File Number		HQRNORM APPLY 00123784AM22
RA File Number		50AA04001407 AM22
Licence No and<br>Date		5011000169/24/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:

Case No.	169 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	ZIM LABORATORIES LIMITED.
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00123784AM22
RA File Number	50AA04001407 AM22
Licence No and<br>Date	5011000169/24/06/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as
per details given below or as applied by the firm, whichever is less:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Export product		Qty.	Sl.	Import items	Qty.
			No.
Doxyzim<br>100	(Doxycycline	<br>1 Number	1	Doxycycline Hyclate EP 10.0	117.73 mg
Capsules BP 100	mg)(Finished
Formulation)


	Export product					Qty.				Sl.	Import items				Qty.
										No.


	Doxyzim<br>100<br>			(Doxycycline<br>		<br> <br>1 Number				1	Doxycycline Hyclate EP 10.0				117.73 mg
	Capsules BP 10<br>Fli			0 mg)(Finished
ormuaton)	ormuaton)

<br>RA concerned may take further necess							ary action as per above decision of NC.

Cas		e No.		170 / NC/3/MEET/J			un/202223/5
Cas
		e Status		Case App	roved
Par		ty Name		SWISS P	ARENTE		RALS LIM		ITED
Me<br>and		eting Number
		<br>Date		NC/ 3/ M	EET/ Jun/		202223/ 5		and 08/07/2022
HQ		File Number		HQRNO	RM APPL		Y 0012451		6AM22
RA		File Number		08AA040	07142 AM
							22
Lic<br>Dat		ence No and<br>e		08110018	42/25/06/		2021

Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per details given below or as applied by the firm, whichever is less:



	Sl. No.		Export p	roduct				Qty.				Sl.	Import items	Qty.
												No.

	1		CEFTA<br>	ZIDIME FOR INJECTION<br>				<br> <br>1 Number				1	CEFTAZIDIME<br>FOR<br>	<br>550.00 mg
			USP/ B<br>500mg (<br>	P/ EP/ CEP/ EP/ IP/ ChP<br>Net Content of Export Item<br>				<br>					INJECTION
			is 105 K.G.))
	2		CEFTAZIDIME FOR INJECTION<br>USP/ BP/ EP/ CEP/ EP/ IP/ ChP<br>1GM (Net Content of Export Item is<br>150 K.G.))					<br> <br> <br>1 Number				2	CEFTAZIDIME<br>FOR<br>INJECTION	<br>1100.00 mg

	3		CEFTAZIDIME FOR INJECTION					<br>1 Number				3	CEFTAZIDIME<br>FOR	<br>2200.00 mg
			USP/ B<br>	P/ EP/ CEP/ EP/ IP /ChP<br>				<br>					INJECTION
			2GM (N	et Content of Export Item is

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

300 K.G.))

Case No.	171 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	MACLEODS PHARMACEUTICALS LTD
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00124524AM22
RA File Number	03AA04027724 AM22
Licence No and Date	0311004915/25/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per 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>FAMCICLOVIR 250MG TABLETS (Net<br>content: 580.750 kgs Famciclovir))<br>1 Number<br>1<br>9-(4-ACETOXY-3-<br>ACETOXYMETHYLBUT-<br>1YL)-2-AMINO-6-<br>CHLOROPURINE<br>318.747 mg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No.	172 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ZEE LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00124557AM22
RA File Number	05AA04028399 AM22
Licence No and<br>Date	0511003336/25/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

from the firm:

i. Export quantity in Number of Tablets.
ii. Drug Manufacturing Licence.

iii Master Batch Formula with wastage applied on API.

Case No.	173 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ASCENT FINECHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00124729AM22
RA File Number	08AA04009431 AM22
Licence No and<br>Date	0811001850/25/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Justification for low yield of 70.8% in second stage of reaction.<br>i.<br>ii Production / Consumption data duly certified by GST.

Case No.	174 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	HIKAL LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00125843AM22
RA File Number	34AA04002140 AM22
Licence No and<br>Date	3411000771/28/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Complete chemistry, molecular weight and percentage yield on molar basis for each step.<br>i.<br>Material balance for entire process.<br>ii.<br>iii CA certified Past Production / Consumption data.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	175 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	TIDE INDUSTRIES
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00126124AM22
RA File Number	34AA04004372 AM22
Licence No and<br>Date	3411000778/28/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>COA of import and export item indicating percentage purity level and impurity profile.<br>i.<br>In the distillation process which are impurities, which are being removed and their commercial value.<br>ii.<br>Production / Consumption data for last two years duly certified by GST.<br>iii.

Case No.	Case No.	176 / NC/3/MEET/Jun/202223/5	176 / NC/3/MEET/Jun/202223/5	176 / NC/3/MEET/Jun/202223/5	176 / NC/3/MEET/Jun/202223/5	176 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		ENCUBE ETHICALS PRIVATE LIMITED
Meeting Number and<br>Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00126335AM22
RA File Number		03AA04024851 AM22
Licence No and Date		0311004989/29/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>1<br>Relevant Bulk Drug(s) in the<br>export product<br>0.030 grams<br>2<br>Excipient<br>17.094 grams<br>3<br>Excipient<br>3.960 grams<br>4<br>Packaging Material<br>Medical<br>Creams/<br>Ointments(FLUOCINONIDE<br>TOPICAL<br>SOLUTION<br>0.05<br>Percentage<br>60<br>ML<br>Total<br>Wt.<br>1799.82<br>Kgs<br>(Net<br>Content<br>Fluocinonide<br>Micronized<br>USP<br>(Farmabios) 0.94 Kgs, Ethyl Alco<br>512.77 Kgs, DI- Isopropyl 126.35<br>Kgs, 2 OZ. Bottle 29997 Nos,<br>Dropper Tip 29997 Nos, Needle<br>Relevant as per<br>1 Number
	Export product		Qty.	Sl. No.	Import items	Qty.
	Medical<br>Creams/<br>Ointments(FLUOCINONIDE<br>TOPICAL<br>SOLUTION<br>0.05<br>Percentage<br>60<br>ML<br>Total<br>Wt.<br>1799.82<br>Kgs<br>(Net<br>Content<br>Fluocinonide<br>Micronized<br>USP<br>(Farmabios) 0.94 Kgs, Ethyl Alco<br>512.77 Kgs, DI- Isopropyl 126.35<br>Kgs, 2 OZ. Bottle 29997 Nos,<br>Dropper Tip 29997 Nos, Needle		1 Number	1	Relevant Bulk Drug(s) in the<br>export product	<br>0.030 grams
				2	Excipient	17.094 grams
				3	Excipient	3.960 grams
				4	Packaging Material	Relevant as per

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

29997	Nos)		5	Packaging Material	packing policy
			6	Packaging Material

Case No.	Case No.	177 / NC/3/MEET/Jun/202223/5	177 / NC/3/MEET/Jun/202223/5	177 / NC/3/MEET/Jun/202223/5	177 / NC/3/MEET/Jun/202223/5	177 / NC/3/MEET/Jun/202223/5
Case Status		Case Approved
Party Name		SATYADIVIS PHARMACEUTICALS PRIVATE LIMITED
Meeting Number<br>and Date		NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number		HQRNORM APPLY 00126598AM22
RA File Number		09AA04004597 AM22
Licence No and<br>Date		0911001127/29/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per 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>1<br>BENZALDEHYDE<br>0.83 kg<br>2<br>PALLADIUM<br>0.0005 kg<br>3<br>ACETOPHENONE<br>0.847 kg<br>4<br>DIMETHYL SULPHOXIDE<br>2.29 kg<br>5<br>PARAFORMALDEHYDE<br>0.253 kg<br>FLUOXETINE HCL<br>1 kg<br>6<br>PARA CHLORO BENZO TRIFLOURIDE<br>1.054 kg<br>
	Export product		Qty.	Sl.<br>No.	Import items	Qty.
	FLUOXETINE HCL		1 kg	1	BENZALDEHYDE	0.83 kg
				2	PALLADIUM	0.0005 kg
				3	ACETOPHENONE	0.847 kg
				4	DIMETHYL SULPHOXIDE	2.29 kg
				5	PARAFORMALDEHYDE	0.253 kg
				6	PARA CHLORO BENZO TRIFLOURIDE	1.054 kg

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Case No.	178 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	BALAJI AMINES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00126661AM22
RA File Number	31AA04017918 AM22
Licence No and<br>Date	3111000428/29/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and taking cue from earlier decision for same export product /<br>import item in Meeting No.NC/3/MEET/Feb/202122/14 dated 21.02.2022 against advance authorization No.<br>3111000345 dt. 21.05.2021, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below<br>or as applied by the firm, whichever is less: :<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>METHANOL<br>0.370 kg<br>2<br>AMMONIA ANHYDROUS<br>0.160 kg<br>N-METHYL-2-<br>PYRROLIDONE(ORGANIC CHEMICAL)<br>1 kg<br>3<br>1,4 BUTANEDIOL<br>1.044 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	179 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ETERNIS FINE CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00126786AM22
RA File Number	03AA04025749 AM22
Licence No and<br>Date	0311005018/29/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

firm:

i. Justification for the quantity required of Sodium Methoxide.

ii Production / Consumption data duly certified by GST.

Case No.	180 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00127112AM22
RA File Number	31AA04015472 AM22
Licence No and<br>Date	3111000431/30/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>AMINO ETHYL ETHANOL AMINE<br>(ORGANIC CHEMICAL)<br>1 kg<br>1<br>MONO ETHANOL AMINE<br>1.173 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	181 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SCOTT EDIL PHARMACIA LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00127163AM22
RA File Number	30AA04008308 AM22
Licence No and<br>Date	3011000821/30/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to refer the case to Department of Biotechnology

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

for obtaining their comments.

Case No.	182 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	SPANSULES FORMULATIONS
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00127175AM22
RA File Number	09AA04003012 AM22
Licence No and<br>Date	0911001131/30/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Doxycycline EC Pellets 33 Percent<br>1 kg<br>1<br>Doxycycline Hyclate IP / BP<br>0.3850 kg<br>2<br>Doxycycline EC Pellets 35.715 Percent<br>1 kg<br>2<br>Doxycycline Hyclate IP / BP<br>0.4163 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	183 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	LUPIN LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00126829AM22
RA File Number	03AA04024028 AM22
Licence No and<br>Date	0311005020/30/06/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:

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:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Export product	Qty.	Sl. No.	Import items	Qty.
QUININE SULFATE CAPSULES USP	<br>1 Number	1	QUININE SULFATE USP	330.48 mg /
324MG(QUININE<br>SULFATE				Capsule
CAPSULES USP 324MG (NET WT.
50.54 KGS, WT OF DRUGS : 56.61
KGS))


	Export product			Qty.	Sl. No.	Import items			Qty.


	QUININE SUL<br>324MG(QUININ		FATE CAPSULES USP<br>E<br>SULFATE	<br> <br>1 Number	1	QUININE SULFATE USP			330.48 mg /<br>Capsule
	CAPSULES U		SP 324MG (NET WT.
	50.54 KGS, W<br>		T OF DRUGS : 56.61
KGS))	KGS))

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




Case No.			184 / NC/3/MEET/Jun/202223/5

Case Status			Case Approved

Party Name			LYRUS LIFE SCIENCES PRIVATE LIMITED

Meeting Number			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
and Date
HQ File Number			HQRNORM APPLY 00127105AM22
RA File Number			07AA04005173 AM22
Licence No and<br>			0711001394/30/06/2021
Date

Norms Committee			Decision:
The Committee co			nsidered the case as er aenda and it was decided to ratif adhoc norms under Para 407 of HBP
<br>Vol. I as per detai			p g y .<br>ls given below or as applied by the firm, whichever is less:






	Sl. No.	Export p	roduct		Qty.		Sl. No.	Import items		Qty.


	1	LISINO	PRIL DIHYDRATE 2.5MG TABLETS		7200000<br>Number		1	LISINOSPRIL<br>DIHYDRATE		18.00 kg


	2	LISINO	PRIL DIHYDRATE 5.0 MG TABLETS		3600000<br>Number		2	LISINOSPRIL<br>DIHYDRATE		18.00 kg


			<br> <br> <br>		<br>
	3	LISINO<br>	PRIL<br>DIHYDRATE<br>10.0<br>MG<br>		<br>1800000<br>		3	LISINOSPRIL<br>		18.00 kg
		TABLE	S		Number			DIHYDRATE

	4	LISINO	PRIL<br>DIHYDRATE<br>20.0<br>MG		<br>1800000		4	LISINOSPRIL		36.00 kg
		TABLE	TS		Number			DIHYDRATE

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

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

Case No.			185 / NC/3/MEET/Jun/202223/5
Case Status			Case Approved
Party Name			GLENMARK PHARMACEUTICALS LIMITED
Meeting Number
<br>and Date			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number			HQRNORM APPLY 00128671AM22
RA File Number			03AA04033555 AM22
Licence No and
Date			0311005056/02/07/2021
Norms Committee			Decision:
The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.
	Sl. No.	Export product		Qty.

	1	Clobeta<br>	sol Propionate Foam 0.05percent 50gm(( Net. wt. of Net. wt. of Clobetasol<br>	<br>1 Number
		Propion	ate USP (Micronized) is 5.00 Kgs.))


	2	Clobeta<br>(Micron	sol Propionate Foam 0.05percent 100gm((Net. wt. of Clobetasol Propionate USP<br>ized) is 10.00 Kgs.))	<br>1 Number


	3	Clobeta	ol Proionate Cream USP 005ercent (Pack Size 15m)((Net Weiht of	<br>1 Number
		<br>Clobeta	p .p g g<br>sol Propionate USP (Micronized) 0.15 Kgs))	<br>
	4	Clobetasol Propionate Cream USP 0.05percent (Pack size 30gm)((Net Weight of<br>Clobetasol Propionate USP (Micronized) 0.300 Kgs))		<br>1 Number
	5	Clobetasol Propionate Cream USP 0.05percent (Pack size 45 gm)((Net Weight of<br>Clobetasol Propionate USP (Micronized) 1.125 Kgs))		<br>1 Number

	6	Clobetasol Propionate Cream USP 0.05percent (Pack size 60gm)((Net Weight of<br>Clobetasol Propionate USP (Micronized) 1.500 Kgs))		<br>1 N	umber

	7	Clobetasol Propionate Ointment USP 0.05percent (Pack size 15gm)((Net Weight of<br>		<br>1 N	umber
		Clobetasol Propionate USP (Micronized) 0.375 Kgs))
	8			<br>
		Clobetasol Propionate Ointment USP 0.05percent (Pack size 30gm)((Net Weight of<br>Clobetasol Propionate USP (Micronized) 0.750 Kgs))		<br>1 N	umber

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

9	9	Clobetasol Propionate Ointment USP 0.05percent (Pack size 45gm)((Net Weight of<br>Clobetasol Propionate USP (Micronized) 0.900 Kgs))	Clobetasol Propionate Ointment USP 0.05percent (Pack size 45gm)((Net Weight of<br>Clobetasol Propionate USP (Micronized) 0.900 Kgs))	<br>1 Number
10		Clobetasol Propionate Ointment USP 0.05percent (Pack size 60gm)((Net Weight of<br>Clobetasol Propionate USP (Micronized) 0.600 Kgs))		<br>1 Number
11		Clobetasol Propionate Spray 0.05percent (Pack size 59ml)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 1.180 Kgs))		<br>1 Number
12		Clobetasol Propionate Spray 0.05percent (Pack size 125ml)((Net Weight of Clobetasol<br>Propionate USP (Micronized) 2.500 Kgs))		<br>1 Number
13		Clobetasol Prop. Top Sol USP, 0.05percent 25ml((Net Weight of Clobetasol Propionate<br>USP (Micronized) 0.625 Kgs))		<br>1 Number
14		Clobetasol Prop. Top Sol USP, 0.05percent 50ml((Net Weight of Clobetasol Propionate<br>USP (Micronized) 1.000 Kgs))		<br>1 Number
15		Clobetasol Pro Shampoo, 0.05 percent 118ml((Net Weight of Clobetasol Propionate USP<br>(Micronized) 2.360 Kgs))		<br>1 Number
16		Clobetasol Propionate Foam 0.05percent 100gm (Emulsion Formulation)(( Net. wt. of<br>Clobetasol Propionate USP (Micronized) is 0.500 Kgs.))		<br>1 Number
17		Clobetasol Propionate Foam 0.05percent 50gm (Emulsion Formulation)(( Net. wt. of<br>Clobetasol Propionate USP (Micronized) is 0.250 Kgs.))		<br>1 Number
	Import Item		Qty.
	CLOBETASOL PROPIONATE USP (MICRONIZED)		0.051 gram/ 100 gram pack
	(For other pack size from Sl. No. 1 to 10 and 16 and 17 of Export Products, the quantity of import item<br>CLOBETASOL PROPIONATE USP (MICRONIZED) will be worked out on pro rata basis.

Import Item

Import Item	Qty.
CLOBETASOL PROPIONATE USP (MICRONIZED)	0.051 gram/ 100 gram pack
(For other pack size from Sl. No. 1 to 10 and 16 and 17 of Export Products, the quantity of import item
CLOBETASOL PROPIONATE USP (MICRONIZED) will be worked out on pro rata basis.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

Import Item	Qty.
CLOBETASOL PROPIONATE USP (MICRONIZED)	0.051 gram/ 100 ml
(For other pack size from Sl. No. 11 to 15 of Export Products, the quantity of import item CLOBETASOL
PROPIONATE USP (MICRONIZED) will be worked out on pro rata basis.

Case No.	186 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	GLENMARK PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00129541AM22
RA File Number	03AA04033537 AM22
Licence No and<br>Date	0311005080/02/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	187 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ORGANIC INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00129686AM22
RA File Number	06AA04003603 AM22
Licence No and<br>Date	0611000533/02/07/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	188 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	INDOCO REMEDIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

HQ File Number	HQRNORM APPLY 00130667AM22
RA File Number	03AA04041463 AM22
Licence No and<br>Date	0311005091/04/07/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	189 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	DORF-KETAL CHEMICALS INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00130670AM22
RA File Number	03AA04035632 AM22
Licence No and<br>Date	0311005092/04/07/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following documents / information<br>from the firm :<br>Production / Consumption data for use of Heptone duly certified by GST.<br>i.<br>ii Recovery of Heptone in the process of working.

Case No.	190 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	HARMAN FINOCHEM LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00164102AM22
RA File Number	03AA04065031 AM22
Licence No and<br>Date	0311006216/17/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	191 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00164145AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

UDIN00200864AM23

RA File Number<br>34AA04006527 AM22	RA File Number<br>34AA04006527 AM22
Licence No and<br>Date<br>3411000984/17/08/2021
Norms	Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
i.	End use of export product.<br>
ii.	Complete chemistry, molecular weight, percentage yield.<br>
iii.	Stoichiometric balance on molar basis to arrive the quantity of raw material asked for.<br>
iv.	Production / Consumption data for last two years duly certified by GST.<br>

Case No.<br>192 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>BEST VALUE CHEM PRIVATE LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM APPLY 00164975AM22
RA File Number<br>34AA04006491 AM22
Licence No and<br>Date<br>3411000985/18/08/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
End use of export product.<br>i.
Complete chemistry, molecular weight, percentage yield.<br>ii.
Stoichiometric balance on molar basis to arrive the quantity of raw material asked for.<br>iii.
Production / Consumption data for last two years duly certified by GST.<br>iv.


Case No	193 / NC/3/MEET/Jun/202223/5
.
Case Status	Case Deferred

Party Name	ANTILA LIFESCIENCES PRIVATE LIMITED

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022

HQ File Number	HQRNORM APPLY 00165364AM22

RA File Number	08AA04018980 AM22

Licence No and<br>Date	0811002348/18/08/2021

Norms Committee Decision:<br>Deferred for comments of TE.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

100

UDIN00200864AM23

Case No.	194 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	FRESENIUS KABI ONCOLOGY LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00165403AM22
RA File Number	05AA04062260 AM22
Licence No and<br>Date	0511004178/18/08/2021
Norms Committee Decision:
Deferred for comments of TE

Case No.	195 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	RAJASTHAN ANTIBIOTICS LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00165816AM22
RA File Number	05AA04070414 AM22
Licence No and<br>Date	0511004197/18/08/2021
Norms Committee Decision:
Deferred for comments of TE

Case No.	196 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	MANGALAM ORGANICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00169050AM22
RA File Number	03AA04027384 AM22
Licence No and<br>Date	0311006375/23/08/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	197 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	LITMUS ORGANICS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00169051AM22
RA File Number	03AA04044240 AM22

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

101

UDIN00200864AM23

Licence No and 0311006376/23/08/2021 Date Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:

i. Complete chemical reactions with molecular and structural formula and molecular weights alongwith stage wise percentage yields on molar basis.
ii. Complete technical details as per Annexure to Appendix 4E for chemical products.
iii. Stoichiometric balance between import and export on molar basis.
iv. Details of indigenous input with quantity.

v Production / Consumption data duly certified by GST for the year 2018-19, 2019-20 and 2020-21.

Case No.	198 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	HONOUR LAB LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00168774AM22
RA File Number	09AA04010336 AM22
Licence No and<br>Date	0911001387/23/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify norms under Para 4.07 of HBP Vol. I as<br>per 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>1<br>(3R,4S,5S,6R)-3,4,5-Trihydroxy-6-(Hydroxymethyl)<br>tetrahydro-2H-pyran-2-one<br>0.42 kg<br>EMPAGLIFLOZIN<br>1 kg<br>2<br>S)-3-(4-(5-bromo-2-chlorobenzyl)phenoxy)<br>tetrahydrofuran<br>1.33 kg<br> <br>RA concerned may take further necessary action as per above decision of NC.

Case No. 199 / NC/3/MEET/Jun/202223/5

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

102

UDIN00200864AM23

Case Status	Case Deferred
Party Name	SV PLASTOCHEM PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00168909AM22
RA File Number	31AA04024928 AM22
Licence No and<br>Date	3111000540/23/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	200 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00169946AM22
RA File Number	03AA04066953 AM22
Licence No and<br>Date	0311006419/25/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Yield is low, that is, 81%. Please furnish Production / Consumption data for last two years duly certified<br>by GST.<br>i.

Case No.	201 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SI GROUP - INDIA PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00170117AM22
RA File Number	03AA04063156 AM22
Licence No and<br>Date	0311006435/25/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	202 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

103

UDIN00200864AM23

Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00170350AM22
RA File Number	03AA04069090 AM22
Licence No and<br>Date	0311006443/25/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	203 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	ATHENA DRUG DELIVERY SOLUTIONS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00170357AM22
RA File Number	03AA04069088 AM22
Licence No and<br>Date	0311006444/25/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	204 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00170502AM22
RA File Number	08AA04022482 AM22
Licence No and<br>Date	0811002393/25/08/2021
Norms Committee Decision:<br>The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided<br>to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	205 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	ZYDUS LIFESCIENCES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00171310AM22
RA File Number	08AA04022255 AM22
Licence No and<br>Date	0811002414/26/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

104

UDIN00200864AM23

Norms Committee 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:

N	orms Co	mmittee	Decision:	Decision:	Decision:	Decision:
T<br>	he Com<br>l	mittee co<br>d	nsidered the case as per ag<br>l i bl li				enda and it was<br>b h fi		decide<br>ih	d to ratify adhoc nor<br>i l		ms under Para 4.07 of HBP
	o. I as	per etas gven eow or as appe					y te rm, w		ceve	r s ess:


	Sl. No.	Export product						Qty.	Sl. No.		Import items			Qty.
	1	CLINDAMYCIN PHOSPHATE AND<br>BENZOYL<br>PEROXIDE<br>GEL<br>1.2						159974<br>Number	1		CLINDAMYCIN PHOSPHATE<br>USP			<br>88.114 kg

		PERCENT<br>/<br>5<br>PER			CENT,
		45GM((E<br>	ACH<br>GRAM<br>CON<br>		TAIN<br>
		CLINDA	MYCIN PHOSPHATE		USP
		EQUIVA	LENT CLINDAMYCI		N 10
		<br>MG)	<br>(ACTIVE<br>INGRED		<br>IENT:
		CLINDA<br>EQUIVA<br>	MYCIN PHOSPHATE<br>LENT TO CLINDAMY<br>		USP<br>CIN -
		NET WT	. 71.988 KGS.))


	2	CLINDA<br>TOPICA<br>	MYCIN<br>PHOSPHATE<br>L<br>SOLUTION<br>USP<br>1<br> <br> <br>					124988<br>Number	2		CLINDAMYCIN PHOSPHATE<br>USP			<br>45.896 kg
		PERCENT,<br>30ML((EACH<br>ML<br> <br>

		CONTAIN<br>CLINDAMYCIN<br>PHOSPHATE<br>USP<br>EQUIVALENT							3		BOTTLE 1OZ ROUND WHITE			<br>Relevant as
		<br>CLINDA	<br> <br> <br>MYCIN 10 MG) (ACTIVE								<br>OPAQU HDPE JERHEL PT			<br> <br>per packing
		<br>INGRED	<br>IENT:<br>CLINDAMYCIN											policy
		PHOSPH<br>	ATE USP EQUIVALENT TO<br>

		CLINDA<br>KGS))	MYCIN - NET WT. 37.496						4		CLOSURE 24MM WHITE PP			<br>Relevant as
		.									SG75 MOLDRITE			per packing
														policy


									5		CLOSURE 24MM WHITE<br>UP & APP DAB O MATIC		STEP	<br>Relevant as<br>per packing
														policy
	3	CLINDAMYCIN<br>PHOSPHATE<br>TOPICAL<br>SOLUTION<br>USP<br>1						49998 Number	6<br>		CLINDAMYCIN PHOSPHATE<br>USP			<br>36.719 kg
		PERCENT,<br>60ML((EACH<br>ML
		CONTAI<br>PHOSPH	N<br>CLINDAMYCIN<br>ATE<br>USP<br>EQUIVALENT						7		BOTTLE 2OZ ROUN WHITE			<br>Relevant as
		<br>CLINDA	<br> <br> <br>MYCIN 10 MG) (ACTIVE								<br>OPAQUE HDPE JERHEL PT			<br> <br>per packing
		<br>INGRED	<br>IENT:<br>CLINDAMYCIN											policy
			<br>
		PHOSPH<br>CLINDA<br>	ATE USP EQ<br>MYCIN - N	UIVALEN<br>ET WT. 2		T TO<br>9.999			8
											CLOSURE 24MM WHITE PP			<br>Relevant as
		K.												<br>
											SG75 MOLDRITE			per packing
														policy

									9		CLOSURE 24MM WHITE STEP			Relevant as<br>
											UP & APP DAB O MATIC			per packing

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

105

UDIN00200864AM23

policy

Case No.	206 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	BENZO CHEM INDUSTRIES PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00171413AM22
RA File Number	50AA04002705 AM22
Licence No and<br>Date	0311006477/26/08/2021
Norms Committee Decision:
The Committee considered the case as per agenda and it was decided to call for following information / documents from the
firm:
Yield is low, that is, 81%. Please furnish Production / Consumption data for last two years duly certified<br>i.
by GST.

Case No.	207 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	HARMONY ORGANICS PVT LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00171602AM22
RA File Number	31AA04024595 AM22
Licence No and<br>Date	3111000549/26/08/2021
Norms Committee Decision:
Deferred for comments of TE.

Case No.	208 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00171241AM22
RA File Number	31AA04025740 AM22
Licence No and	3111000548/26/08/2021

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

106

UDIN00200864AM23

Date

Norms Committee Decision:

The Committee considered the case as per agenda and it was decided to call for following information / documents from the firm:

i. COA of Export Item with percentage purity.

Case No.	209 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	SUPREET CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00172393AM22
RA File Number	52AA04014297 AM22
Licence No and<br>Date	5211001238/27/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I 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>5-NITRO-2-AMINO<br>PHENOL<br>or<br>2APN BASE (Purity NLT 99%)<br>1 kg<br>1<br>5 NITRO 2 AMINO PHENOL or<br>2 AMINO 5 NITRO PHENOL<br>(Purity NMT 90%)<br>1.10 kg<br>RA concerned may take further necessary action as per above decision of NC.

Case No.	210 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	OSMED FORMULATIONS PVT. LTD.,
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00172452AM22
RA File Number	56AA04003575 AM22
Licence No and<br>Date	5611000465/27/08/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

107

UDIN00200864AM23

Deferred for comments of TE.

Case No.	211 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	IPCA LABORATORIES LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00172940AM22
RA File Number	03AA04051423 AM22
Licence No and<br>Date	0311006518/28/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents<br>from the firm:<br>Technical Literature in support of low yields in all steps.<br>i.<br>Molar requirement of Furfurylamine in the reaction with justification.<br>ii.<br>iii Material balance for entire process.

Case No.	212 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	SRIAM LABS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00173574AM22
RA File Number	09AA04010955 AM22
Licence No and<br>Date	0911001455/30/08/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	213 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	BALAJI SPECIALITY CHEMICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00173361AM22
RA File Number	31AA04025739 AM22
Licence No and<br>Date	3111000553/30/08/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

108

UDIN00200864AM23

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. No.	Import items	Qty.
AMINO ETHYL ETHANOL AMINE<br>(ORGANIC CHEMICAL)	1 kg	1	MONO ETHANOL AMINE	1.173 kg

Case No.	214 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	DR.REDDY'S LABORATORIES LTD
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00173524AM22
RA File Number	09AA04010645 AM22
Licence No and<br>Date	0911001444/30/08/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>Ibuprofen 400mg and Paracetamol<br>325mg Powder for Oral Solution<br>(Ibuclin Express) Pack Size :6's<br>1 Number<br>1<br>Ibuprofen Sodium Dihydrate<br>517.12 mg<br>2<br>Ibuprofen 400mg and Paracetamol<br>325mg Powder for Oral Solution<br>(Ibuclin Express) Pack Size :9's<br>1 Number<br>2<br>Ibuprofen Sodium Dihydrate<br>517.12 mg<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

109

UDIN00200864AM23

Case No.	215 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	BHARAT PARENTERALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00175489AM22
RA File Number	34AA04006862 AM22
Licence No and<br>Date	3411001052/02/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.<br>	Case No.<br>	Case No.<br>	216 / NC/3/MEET/Jun/202223/5	216 / NC/3/MEET/Jun/202223/5
Case Status<br>			Case Approved
Party Name<br>			ALEOR DERMACEUTICALS LIMITED
Meeting Number<br>and Date<br>			NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>			HQRNORM APPLY 00175833AM22
RA File Number<br>			34AA04005756 AM22
Licence No and<br>Date<br>			3411001056/02/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to ratify adhoc norms under Para 4.07 of HBP<br>Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl. No. Export product<br>Qty.<br>1<br>Clobetasol Propionate Cream(Clobetasol Propionate Cream USP 0.05 percentage 15 gm<br>net content of active ingredients 375.00gm.)<br>1 Number<br>2<br>Clobetasol Propionate Cream(Clobetasol Propionate Cream USP 0.05 percentage 30 gm<br>net content of active ingredients 1200.00 gm.)<br>1 Number<br>3<br>Clobetasol Propionate Cream(Clobetasol Propionate Cream USP 0.05 percentage 45 gm<br>net content of active ingredients 1800.00 gm.)<br>1 Number<br>4<br>Clobetasol Propionate Cream(Clobetasol Propionate Cream USP 0.05 percentage 60 gm<br>net content of active ingredients 2850.00 gm.)<br>1 Number<br>5<br>Clobetasol Propionate Topical Solution(Clobetasol Propionate Topical Solution USP 0.05<br>percentage 25ml net content of active ingredients 362.50 gm.)<br>1 Number
	Sl. No.	Export product		Qty.
	1	Clobetasol Propionate Cream(Clobetasol Propionate Cream USP 0.05 percentage 15 gm<br>net content of active ingredients 375.00gm.)		<br>1 Number
	2	Clobetasol Propionate Cream(Clobetasol Propionate Cream USP 0.05 percentage 30 gm<br>net content of active ingredients 1200.00 gm.)		<br>1 Number
	3	Clobetasol Propionate Cream(Clobetasol Propionate Cream USP 0.05 percentage 45 gm<br>net content of active ingredients 1800.00 gm.)		<br>1 Number
	4	Clobetasol Propionate Cream(Clobetasol Propionate Cream USP 0.05 percentage 60 gm<br>net content of active ingredients 2850.00 gm.)		<br>1 Number
	5	Clobetasol Propionate Topical Solution(Clobetasol Propionate Topical Solution USP 0.05<br>percentage 25ml net content of active ingredients 362.50 gm.)		<br>1 Number

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

110

UDIN00200864AM23

6		Clobetasol Propionate Topical Solution(Clobetasol Propionate Topical Solution USP 0.05<br>percentage 50 ml net content of active ingredients 1250.00 gm.)	Clobetasol Propionate Topical Solution(Clobetasol Propionate Topical Solution USP 0.05<br>percentage 50 ml net content of active ingredients 1250.00 gm.)	<br>1 Number
7		Clobetasol Propionate Topical Shampoo(Clobetasol Propionate Shampoo, 0.05 percentage<br>118 ml net content of active ingredients 5310.00 gm.)		<br>1 Number
8		Clobetasol Propionate Spray(Clobetasol Propionate Spray, 0.05 percentage 59 ml net<br>content of active ingredients 383.50 gm.)		<br>1 Number
9		Clobetasol Propionate Spray(Clobetasol Propionate Spray, 0.05 percentage 125 ml net<br>content of active ingredients 747.50 gm.)		<br>1 Number
	ort Item
	Import Item		Qty.
	CLOBETASOL PROPIONATE USP (MICRONIZED)		0.051 gram/ 100 gram pack
	(For other pack size from Sl. No. 1 to 4 of Export Products, the quantity of import item CLOBETASOL<br>PROPIONATE USP (MICRONIZED) will be worked out on pro rata basis.

	Import Item		Qty.
	CLOBETASOL PROPIONATE USP (MICRONIZED)		0.051 gram/ 100 ml
	(For other pack size from Sl. No. 5 to 9 of Export Products, the quantity of import item CLOBETASOL<br>PROPIONATE USP (MICRONIZED) will be worked out on pro rata basis.

6	Clobetasol Propionate Topical Solution(Clobetasol Propionate Topical Solution USP 0.05	<br>1 Number
	percentage 50 ml net content of active ingredients 1250.00 gm.)
7	Clobetasol Propionate Topical Shampoo(Clobetasol Propionate Shampoo, 0.05 percentage	<br>1 Number
	118 ml net content of active ingredients 5310.00 gm.)
8	Clobetasol Propionate Spray(Clobetasol Propionate Spray, 0.05 percentage 59 ml net	<br>1 Number
	content of active ingredients 383.50 gm.)
9	Clobetasol Propionate Spray(Clobetasol Propionate Spray, 0.05 percentage 125 ml net	<br>1 Number
	content of active ingredients 747.50 gm.)

Import Item

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

111

UDIN00200864AM23

Case No.	217 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	DEEPAK PHENOLICS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00175852AM22
RA File Number	34AA04006370 AM22
Licence No and<br>Date	3411000952/02/09/2021
Norms Committee Decision:<br>The Committee considered the case as per agenda and it was decided to call for following information / documents from the<br>firm:<br>Commercial value of Co-Product Acetone in September to December 2021 with documentary

Case No.	218 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	UNIMAX CHEMICALS PRIVATE LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM APPLY 00176177AM22
RA File Number	03AA04077623 AM22
Licence No and<br>Date	0311006660/03/09/2021
Norms Committee Decision:<br>Deferred for comments of TE.

Case No.	219 / NC/3/MEET/Jun/202223/5
Case Status	Case Deferred
Party Name	INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number	HQRNORM REVIW00001475AM23
RA File Number	08AA04022429 AM22
Licence No and<br>Date	0811002501/06/09/2021
Norms Committee Decision:

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

112

UDIN00200864AM23

The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided to call the firm for attending Personal Hearing before Norms Committee to explain its case

Case No.<br>220 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00001473AM23
RA File Number<br>08AA04029213 AM22
Licence No and<br>Date<br>0811002696/27/09/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.<br>221 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00001209AM23
RA File Number<br>08AA04033169 AM22
Licence No and<br>Date<br>0811002929/20/10/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.<br>222 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00001474AM23
RA File Number<br>08AA04033170 AM22
Licence No and<br>Date<br>0811002920/20/10/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

113

UDIN00200864AM23

Case No.<br>223 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00000529AM23
RA File Number<br>08AA04033768 AM22
Licence No and<br>Date<br>0811002982/26/10/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.<br>224 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00000528AM23
RA File Number<br>08AA04034748 AM22
Licence No and<br>Date<br>0811003137/15/11/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.<br>225 / NC/3/MEET/Jun/202223/5
Case Status<br>Case Deferred
Party Name<br>INTAS PHARMACEUTICALS LIMITED
Meeting Number<br>and Date<br>NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022
HQ File Number<br>HQRNORM REVIW00000530AM23
RA File Number<br>08AA04034735 AM22
Licence No and<br>Date<br>0811003139/15/11/2021
Norms Committee Decision:
The Committee considered the request of firm for review of adhoc norms and as requested by the firm, it was decided
to call the firm for attending Personal Hearing<br> before Norms Committee to explain its case

Case No.	226 / NC/3/MEET/Jun/202223/5
Case Status	Case Approved
Party Name	GODAVARI DRUGS LIMITED
Meeting Number and Date	NC/ 3/ MEET/ Jun/ 202223/ 5 and 08/07/2022

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

114

UDIN00200864AM23

HQ File Number	HQRNORM APPLY 00325261AM22
RA File Number	09AX04000086 AM22
Licence No and Date	0911002342/20/01/2022
Norms Committee Decision:<br>Shri Mohit Jaju, Director attended the Personal Hearing and explained its case. The Committee after deliberation<br>decided to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the firm, whichever<br>is less:<br>Export product<br>Qty.<br>Sl. No. Import items<br>Qty.<br>1<br>ETHYL<br>3-CYCLOPROPYLAMINO-2-(2,4-<br>DICHLORO-5-FLUOROBENZOYL) ACRYLATE<br>1.24 kg<br>2<br>CAUSTIC SODA FLAKES<br>0.35 kg<br>3<br>TOLUENE<br>0.123 kg<br>4<br>ANHYDROUS PIPERAZINE<br>0.39 kg<br>CIPROFLOXACIN HCL /<br>BASE(CIPROFLOXACIN<br>HCL / BASE)<br>1 kg<br>5<br>METHANOL<br>1.00 kg<br>Note: Regarding removal of condition of Appendix 4J, the firm may approach RA.<br>RA concerned may take further necessary action as per above decision of NC.

Digitally Signed. Name: Ajay Kumar( Deputy Director ) Date: 07-Sep-2022 17:36:48 Reason: AJAY.DHIMAN88@GOV.IN Location: DGFT(HQ)

115

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.