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----- Start of picture text -----<br> Government of India<br>Ministry of Commerce and Industry<br>Department of Commerce<br>----- End of picture text -----<br>

Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Sep/202122/8 dated 24.09.2021, actually held on 01.10.2021 under the Chairmanship of Dr. Amiya Chandra, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30.

Following members were present in the Meeting:

Sl.<br>No. Name & Designation Department
1 Shri Shaish Kumar, Technical – 1 Consultant
2 Shri D.N. Mathur, Technical – 2 Consultant
In attendance
1 Shri Ajay Kumar, Deputy Director DGFT
  1. The Norms Committee has taken decision only with respect to technical aspect/ wastage norms. While redeeming the application, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in policy circulars issued from time to time or any other provisions under FTP/HBP for issuance of Advance Authorization and regularization of the case.

The committee went through the minutes of earlier meeting No. NC/3/MEET/Aug/202122/7 dated 13.08.2021, actually held on 26.08.2021 and 10.09.2021.

MANUAL CASES

Case No. A-01
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Deepak Novochem Technologies Ltd, Pune
HQ F. No. 01/82/050/00522/AM17/DES-III<br>01/82/050/00109/AM18/DES-III
RLA F. No. 31/83/040/00178/AM16<br>31/83/040/00187/AM17
Advance Authorization No. and Date 3110066046 dated 14.03.2016<br>3110066649dated31.03.2017
Subject Request of M/s Deepak Novochem Technologies Ltd, Pune for<br>enhancement in the quantity of import item No. 1 - Meta Cresol<br>(MC99) in respect of adhoc norms fixed against Advance<br>Authorization No. 3110066046 dated 14.03.2016 and 3110066649<br>dated 31.03.2017
Decision:The Committee considered the request of the firm and it was decided to call for following information<br>from the firm:<br>(i)<br>Production / Consumption data for the period 2016-17 duly certified by the Central<br>Excise.
C ase No. ase No. A-02 A-02 A-02 A-02 A-02 A-02
M eetingNo. NC/3/MEET/Sep/202122/8
D ate 24/09/2021
F irm’sName M/s OC Specialities Pvt. Ltd., Mumbai
H QF. No. 01/82/050/01370/AM21/DES-III
R LA F. No. 03/95/040/00138/AM21
A dvance Authorization No. and Date
vance Autorzaton No. and Date 03 0836618 dated 10. 6.2020
S u bject Re<br>enh<br> quest of<br>anceme<br>fi M/s<br>nt in the<br>i **OC Specialities Pvt.

|||||||| |||vance Autorzaton No. and Date|03|0836618|dated 10.|6.2020||| |S|u|bject|Re<br>enh<br>|quest of<br>anceme<br>fi|M/s<br>nt in the<br>i|OC Specialities Pvt. Ltd.,<br>quantity of import item in re<br>d Ahii N 03|Mumbai for<br>spect of adhoc<br>0836618 dd|| ||||no<br>10.|ms xe<br>06.2020|aganst|vance utorzaton o.|ate|| |D<br>f|ecision:The Committee considered the request of the firm and it was decided to call for following information<br>rom the firm:<br>(i)<br>Complete set of 4.07 application.|cision:The Committee considered the req<br>m the firm:<br>(i)<br>Complete set of 4.07 ap||uest of th<br>plication|e firm and|it was decided to call for follow|ing information|| ||||||.||||

Case No. A-03
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Deccan Nurtaceuticals Pvt. Ltd., Kolkata
HQF. No. 01/82/050/00854/AM18/DES-III
RLA F. No. 02/24/040/00100/AM18
Advance Authorization No. and Date 0210207932 dated02.11.2017
Subject Request of M/s Deccan Nurtaceuticals Pvt. Ltd., Kolkata for
enhancement in the quantity of import item in respect of adhoc
**norms fixed against Advance Authorization No.

Subject|||Request of M/s Deccan Nurtaceuticals Pvt. Ltd., Kolkata for| ||||enhancement in the quantity of import item in respect of adhoc| ||||norms fixed against Advance Authorization No. 0210207932 dated| ||||02.11.2017| |Decision:|The|Committee considered the request of the firm and it was decided to call for following information|| |from the firm:|||| ||(i)|Complete 4.07 application alongwith Appendix 4E submitted earlier for this Advance|| |||Authorization.|| ||(ii)|COA of import item from the foreign supplier for the import against present Advance|| |||Authorization.||

Case No. A-04
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Piramal Enterprises Ltd, Mumbai
HQF. No. 01/82/050/01200/AM21/DES-III
RLA F. No. 03/95/040/01217/AM20
Advance Authorization No. and Date 0310835767 dated 21.04.2020
Subject Request of M/s Piramal Enterprises Ltd, Mumbai for enhancement<br>in the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310835767 dated 21.04.2020
**Decision:**The Committee considered the request of firm and it was observed that earlier the norms were fixed<br>taking cue from SION A-3663, however, the firm has requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.

requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.||

Case No. A-05
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Piramal Enterprises Ltd., Mumbai
HQF. No. 01/82/050/01017/AM20/DES-III
RLA F. No. 03/95/040/01020/AM20
Advance Authorization No. and Date 0310834270dated 17.01.2020
Subject Request of M/s Piramal Enterprises Ltd., Mumbai for enhancement<br>in the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310834270 dated 17.01.2020
**Decision:**The Committee considered the request of firm and it was observed that earlier the norms were fixed<br>taking cue from SION A-3663, however, the firm has requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.

requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.||

Case No. A-06
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Stellence Pharmscience Pvt Ltd, Bangalore
HQF. No. 01/82/050/01683/AM19/DES-III
RLA F. No. 07/24/040/00040/AM17
Advance Authorization No. and Date 0710109873dated 26.05.2016
Subject Request of M/s Stellence Pharmscience Pvt Ltd, Bangalore for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed against Advance Authorization No. 0710109873 dated 26.05.2016
Decision:The Committee considered the request of the firm and it was decided to call for following information<br>from the firm:<br>(i)<br>Production / Consumption data for the licensing year duly certified by the Central<br>Excise / GST.

m and it was decided to call for following information<br>from the firm:<br>(i)<br>Production / Consumption data for the licensing year duly certified by the Central<br>Excise / GST.||

Case No. Case No. Case No. A-07 A-07
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
F irm’sName M/s Stellence Pharmscience Pvt Ltd, Bangalore
H F N 01/82/050/00442/AM13/DESIII
Q. o. -
R LA F. No. 07/24/040/00062/AM13
A dvance Authorizati on No. and Date 0710088213dated 16.05.2012
S ubject Request of M/s Stellence Pharmscience Pvt Ltd, Bangalore for<br>enhancement in the quantity of import item in respect of adhoc norms<br>
fixed against Advance Authorization No. 0710088213 dated<br>16052012
..
D<br>f **ecision:**The Co mmittee considered the request of the firm and it was decided to call for following information
<br>rom the firm:<br> <br>
(i)<br>Production / Consumption data for the licensing year duly certified by the Central<br>Excise / GST.

ed to call for following information||| ||<br>rom the firm:<br>|<br>||| ||(i)<br>Production / Consumption data for the licensing year duly certified by the Central<br>Excise / GST.||||

Case No. A-08
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Stellence Pharmscience Pvt Ltd, Bangalore
HQF. No. 01/82/050/00657/AM13/DES-III
RLA F. No. 07/24/040/00183/AM13
Advance Authorization No. and Date 0710089972 dated31.07.2012
Subject Request of M/s Stellence Pharmscience Pvt Ltd, Bangalore for
enhancement in the quantity of import item in respect of adhoc norms
fixed against Advance Authorization No. 0710089972 dated
31.07.2012
Decision: The Committee considered the request of the firm and it was decided to call for following information
from the firm:
(i) Production / Consumption data for the licensing year duly certified by the Central
Excise / GST.

and it was decided to call for following information|| |from the firm:|||| ||(i)|Production / Consumption data for the licensing year duly certified by the Central|| |||Excise / GST.||

Case No. A-09
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Stellence Pharmscience Pvt Ltd, Bangalore
HQ F. No. 01/82/050/01934/AM19/DES-III
01/82/050/02463/AM19/DES-III
RLA F. No. 07/24/040/00143/AM17
07/24/040/00420/AM16
Advance Authorization No. and Date 0710110111 dated 15.07.2016
0710109590dated 29.03.2016
Subject Request of M/s Stellence Pharmscience Pvt Ltd, Bangalore for
enhancement in the quantity of import item in respect of adhoc norms
fixed against Advance Authorization No. 0710110111 dated 15.07.2016
and 0710109590 dated 29.03.2016
Decision: The Committee considered the request of the firm and it was decided to call for following information
from the firm:
(i) Production / Consumption data for the licensing year duly certified by the Central Excise
/ GST.

and it was decided to call for following information|| |from the firm:|||| ||(i)|Production / Consumption data for the licensing year duly certified by the Central Excise|| |||/ GST.||

Case No. A-10
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Inchem Laboratories pvt Ltd Hyderabad
HQF. No. 01/82/050/01497/AM19/DES-III
RLA F. No. 09/24/040/00230/AM19
Advance Authorization No. and Date 0910066657 dated 11.09.2018
Subject Request of M/s Inchem Laboratories pvt Ltd, Hyderabad for
enhancement in the quantity of import item in respect of adhoc norms
fixed against Advance Authorization No. 0910066657 dated 11.09.2018
Decision: The Committee considered the request of the firm and it was observed that overall yield of 17% is
very low, hence it was decided to call for following information from the firm:
(i) Technical literature in support of yields shown at various steps.
(ii) Production / Consumption data for the licensing year onward duly certified by GST.

the firm:|||| ||(i)|Technical literature in support of yields shown at various steps.|| ||(ii)|Production / Consumption data for the licensing year onward duly certified by GST.||

C ase No. A-11
M eetingNo . NC/3/MEET /Sep/202122/ 8
D ate 24/09/2021
Fi rm’sNam e M/s Inchem Laboratories pvt Ltd Hyderabad
H QF. No. 01/82/050/01 498/AM19/D S-III
R LA F. No. 09/24/040/00 261/AM19
A dvance A uthorization No. and Date 0910066658 dated 11.09.20 18
S ubject Reuest of M/s Inchem Labo atories vt Ltd Hde abad for
q<br>enhancemen<br>fixed against <br>t in t<br>Adv <br>he quant<br>ance Au <br>ity of i<br>thorizat p , y<br>mport item in respect of<br>ion No. 0910066658 date <br>a<br>d <br>dhoc norms<br>11.09.2018
D<br>v ecision:<br>ery low, h The Committee considere d the request of th e firm a nd it wa s observed that overall yi el d of 17% is
<br>ence it was decided to call fo<br>(i)<br>Technical literat <br>r following in<br>ure in suppo <br>form<br>rt of <br>ation fro<br>ields sh <br>m the fir<br>own at <br>m:<br>various steps.
<br>(ii)<br>Production / Consumption da <br>ta for the lice <br>nsing ye <br>ar onward duly certified by GST.

at**|<br>m:<br>various steps.|||| |||<br>(ii)<br>Production / Consumption da||||<br>ta for the lice||<br>nsing ye|<br>ar onward duly certified||by GST.|| ||||||||||||||

Case No. A-12 Meeting No. NC/3/MEET/Sep/202122/8 Date 24/09/2021 Firm’s Name M/s Saga Lifesciences Ltd, Ahemdanad HQ F. No. 01/82/050/01280/AM21/DES-III RLA F. No. 08/24/040/00018/AM21 Advance Authorization No. and Date 0810147725 dated 11.05.2020 Subject Request of M/s Saga Lifesciences Ltd, Ahemdanad for enhancement in the quantity of import item in respect of adhoc norms fixed against Advance Authorization No. 0810147725 dated 11.05.2020 Decision: The Committee considered the request of firm and it was decided to revise the norms as under:

Decision: The Committee considered the request of firm considered the request of firm and it was decided to revise the norms as under: and it was decided to revise the norms as under:
Export product Qty. Import item Qty.
DIFLAH 500 (Diosmin <br>and 1 Number Tablet DIOSMIN + HESPERIDIN 9:1 564.29 mg
Hesperidin Tablets 500mg) (Assay NMT 93% and Water
content NLT 2.9%)
RA concerned maytake further necessaryaction asper above decision of NC.

HESPERIDIN 9:1|564.29 mg|| ||Hesperidin|Tablets 500mg)||||(Assay NMT 93% and Water||| |||||||content NLT 2.9%)||| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||

Case No. A-13
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Piramal Enterprises Ltd., Mumbai
HQF. No. 01/82/050/01530/AM21/DES-III
RLA F. No. 03/95/040/00268/AM21
Advance Authorization No. and Date 0310837588dated 10.08.2020
Subject Request of M/s Piramal Enterprises Ltd., Mumbai for enhancement in<br>the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310837588 dated 10.08.2020
**Decision:**The Committee considered the request of firm and it was observed that earlier the norms were fixed<br>taking cue from SION A-412, however, the firm has requested for more quantity than allowed in SION A-412.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.

s requested for more quantity than allowed in SION A-412.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.||

Case No. A-14
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Piramal Enterprises Ltd., Mumbai
HQF. No. 01/82/050/01547/AM21/DES-III
RLA F. No. 03/95/040/00283/AM21
Advance Authorization No. and Date 0310837743dated 18.08.2020
Subject Request of M/s Piramal Enterprises Ltd., Mumbai for enhancement in<br>the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310837743 dated 18.08.2020
**Decision:**The Committee considered the request of firm and it was observed that earlier the norms were fixed<br>taking cue from SION A-3663, however, the firm has requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.

requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.||

A-15 A-15 A-15 A-15 A-15 A-15 A-15 A-15 A-15 A-15 A-15 A-15 A-15 A-15
C ase No A-15
.
MeetingNo. NC/3/MEET/Sep/202122/8
D ate 24/09/2021
F irm’sName M/s Ciron Drugs & Pharmaceuticals P. Ltd., Mumbai
H QF. No. F. No.01/82/050/00425/AM20/DES-III
R A 44425A2
L F. No. 03/9/00/00/M0
A dvance Authorization No. and Date 0310830435dated 19.07.2019
S ubject Request of M/s Ciron Drugs & Pharmaceuticals P Ltd Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>**fixed against Advance Authorization No.

S|ubject||||Request of M/s Ciron Drugs & Pharmaceuticals P Ltd Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed against Advance Authorization No. 0310830435 dated 19.07.2019|||||||||||| |||De|**cision:**The Committee considered the request of firm and it was decided to revise the norms as under:<br>t dt<br>Qt<br>It it<br>Qt||||||||||||||| |||E|t dt||Qt|||||It it||||Qt|||| ||||xpor prouc||y.|||||m|por ems|||y.|||| |||E<br>F<br>6<br>R<br>E<br>U<br>(1<br>1<br>E<br>K|RYTHROMYCIN ESTOLATE<br>||2028.000 kg<br>|||||ER<br>|YTHROM<br>||YCIN|2730 mg/60 m|l bottle||| ||||OR ORAL SUSPENSION USP<br>0 ML (EACH 5 ML AFTER<br>ECONSTITUTION CONTAIN<br>RYTHROMYCIN ESTOLATE<br>SP-EQ TO ERYTHROMYCIN<br>25 MG) NET CONTENT :||(7,80,000 No.|||Bottles)||ES|TOLATE||||||| ||||<br>)ERYTHROMYCIN<br>STOLATE:2,028.000<br>ILOGRAM||||||||||||||| ||ERYTHROMYCIN ESTOLATE<br>FOR ORAL SUSPENSION USP<br>60 ML (EACH 5 ML AFTER<br>RECONSTITUTION CONTAIN<br>ERYTHROMYCIN ESTOLATE<br>USP-EQ TO ERYTHROMYCIN<br>(250 MG) NET CONTENT :<br>1)ERYTHROMYCIN<br>ESTOLATE:6,240.000<br>KILOGRAM|ERYTHROMYCIN ESTOLATE<br>FOR ORAL SUSPENSION USP|||6240.000 kg<br>(1200000 No Bottles)|||||ERYTHROMYCIN<br>ESTOLATE||||5460 mg/ 60 ml bottle|||| ||||||,, .||||||||||||| |||<br>1)ERYTHROMYC||<br>IN|||||||||||||| |||ESTOLATE:6,240.<br>||000|||||||||||||| |||KILOGRAM|||||||||||||||| ||R||||||||||||||||| |||A concerned mayt||ake further necessaryaction asper above decision of NC.|||||||||||||| |||||||||||||||||||

|ESTOLATE:6,240.<br>||000|||||||||||||| |||KILOGRAM|||||||||||||||| ||R||||||||||||||||| |||A concerned mayt||ake further necessaryaction asper above decision of NC.|||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |||||||||||||||||||

Case No. A-16
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Shilpa Medicare Ltd, Banglore
HQF. No. 01/82/050/01731/AM19/DES-III
RLA F. No. 07/24/040/00034/AM17
Advance Authorization No. and Date 0710109729dated 27.04.2016
Subject Request of M/s Shilpa Medicare Ltd, Banglore for enhancement in<br>the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0710109729 dated 27.04.2016
Decision:The Committee considered the request of the firm and it was observed that earlier the norms were<br>given on the basis of comparative data from the industry and also the firm has not furnished any technical<br>justification in support of its request for enhancement in norms. Hence, it was decided torejectthe case<br>maintaining the status quo.<br>RA concerned maytake further necessaryaction asper above decision of NC.

of its request for enhancement in norms. Hence, it was decided torejectthe case<br>maintaining the status quo.<br>RA concerned maytake further necessaryaction asper above decision of NC.||

Case No. A-17 A-17 A-17 A-17 A-17
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Shilpa Medicare Ltd, Banglore
HQ F. No. 01/82/050/00950/AM16/DES-III<br>01/82/050/00617/AM16/DES-III
RLA F. No. 07/24/040/00078/AM16<br>07/24/040/00002/AM16
Advance Authorization No. and Date 0710108349 dated 10.06.2015<br>0710108028 dated 15.04.2015
Subject Request of M/s Shilpa Medicare Ltd, Banglore for enhancement in<br>the quantity of import item Nos. 1 and 3 and to allow import item<br>Nos. 8, 9 and 10 in respect of adhoc norms fixed against Advance<br>Authorization Nos. 0710108349 dated 10.06.2015 and 0710108028<br>dated 15.04.2015
**Decision:**The Committee considered the request
Export product Qty. Sl.<br>No. Import items Qty.
3a 7b Dioxy Cholanic Acid 1 kg 1 Cholic Acid 1.88 kg
2 Di Methyl Amino 0.032 kg
3 2-Methoxy Ethanol 3.15 kg
4 Hydrazine Hydrate 80% 1.705 kg
5 Sodium Bromate 0.79 kg
6 Sodium Metal 0.829 kg
7 Potassium Hydroxide 2.51 kg
8 Potassium carbonate 1.57 kg
9 Phosphoric Acid 1.28 kg
10 Methylene Chloride 1.50 kg

|Sodium Metal|0.829 kg| |||||7|Potassium Hydroxide|2.51 kg| |||||8|Potassium carbonate|1.57 kg| |||||9|Phosphoric Acid|1.28 kg| |||||10|Methylene Chloride|1.50 kg| ||Note: The above norms are only for closure purpose of these two Advance Authorizations only.<br>Hence, no repeat norms will be allowed on the basis of the above decision.||||||

Case No. A-18 A-18 A-18 A-18 A-18
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Rusan Pharma Ltd., Mumbai
HQF. No. 01/82/050/00739/AM19/DES-III
RLA F. No. 03/95/040/00148/AM19
Advance Authorization No. and Date 0310821117 dated 21.05.2018
Subject Request of M/s Rusan Pharma Ltd., Mumbai for enhancement in the<br>quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310821117 dated 21.05.2018
**Decision:**The Committee considered the request of firm and it was decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>NALBUPHINE HYDROCHLORIDE<br>1 kg<br>1<br>THEBAINE<br>2.58 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Export product Qty. Sl.<br>No. Import items Qty.
NALBUPHINE HYDROCHLORIDE 1 kg 1 THEBAINE 2.58 kg
RA concerned maytake further necessary action as per above decision of NC.

||||| ||Export product||Qty.|Sl.<br>No.|Import items|Qty.| ||NALBUPHINE HYDROCHLORIDE||1 kg|1|THEBAINE|2.58 kg| ||RA concerned maytake further necessary||action as|per above decision of NC.|||

Case No. A-19
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Nisarg Biosciences Pvt Ltd, Hyderabad
HQF. No. 01/82/050/00455/AM20/DES-III
RLA F. No. 09/24/040/00221/AM20
Advance Authorization No. and Date 0910067836dated 25.07.2019
Subject Request of M/s Nisarg Biosciences Pvt. Ltd., Hyderabad for fixation of<br>adhoc norms against Advance Authorization No. 0910067836 dated<br>25.07.2019
Decision:The Committee considered the request of the firm and it was observed that the reply furnished by the<br>firm vide letter dated 16.10.2020 is deficient. Hence, the Committee decided to call for following information<br>from the firm:<br>(i)<br>Molecular weight of import and export item.<br>(ii)<br>Catalogue of export item and its end use.

e Committee decided to call for following information<br>from the firm:<br>(i)<br>Molecular weight of import and export item.<br>(ii)<br>Catalogue of export item and its end use.||

Case No. A-20
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune
HQ F. No. 01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III
RLA F. No. 31/83/040/00081/AM19<br>31/83/040/00157/AM19
Advance Authorization No. and Date 3110067162 dated 24.08.2018<br>3110067278dated09.01.2019
Subject Request of M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD,<br>Pune for fixation of adhoc norms against Advance Authorization Nos.<br>3110067162 dated 24.08.2018 and 3110067278 dated 09.01.2019
Decision:The Committee considered the request of the firm and it was decided to call for following information<br>from the firm:<br>(i)<br>As per details furnished, import item OCP-50, itself contain about 58% of O-Cresol,<br>which is an export product. Detailed justification, why 58% of Ortho-Cresol content<br>in import item cannot be used directly for export.<br>(ii)<br>Justification of 233% wastage in Menthol.<br>(iii)<br>Production / Consumption data for the year 2018-19 duly certified by GST..

cannot be used directly for export.<br>(ii)<br>Justification of 233% wastage in Menthol.<br>(iii)**<br>Production / Consumption data for the year 2018-19 duly certified by GST..||

Case No. A-21
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Virchow Biotech Pvt. Ltd., Hyderabad
HQF. No. 01/82/050/00861/AM16/DES-III
RLA F. No. 09/24/040/00052/AM16
Advance Authorization No. and Date 0910061973dated06.05.2015
Subject Request of M/s Virchow Biotech Pvt. Ltd., Hyderabad for fixation of<br>adhoc norms against Advance Authorization No. 0910061973 dated<br>06.05.2015
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per<br>details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TODAY CONTRACEPTIVE<br>SPONGE<br>1 Number<br>1<br>NONOXYNOL9<br>0.9983 gram<br>2<br>Sorbic Acid<br>0.0061gram<br>3<br>Prepol HDW-2002<br>2.4030 gram<br>4<br>Tape Removal<br>0.2457 Yard<br>5<br>Anchoring Scrim<br>0.0864 Yard<br>6<br>MouldCups - Bottom<br>0.0039Number<br>7<br>MouldCups- Top<br>0.0039Number<br>8<br>Pouch-TopWeb<br>0.0233Yard<br>9<br>Pouch-Bottom Web<br>0.0233Yard<br>10<br>TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric

TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric acid USP<br>0.0141gram<br>RA concerned maytake further necessaryaction asper above decision of NC.||

Case No. A-22
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Virchow Biotech Pvt. Ltd., Hyderabad
HQF. No. 01/82/050/01296/AM15/DES-III
RLA F. No. 09/24/040/00327/AM15
Advance Authorization No. and Date 0910061001 dated 19.09.2014
Subject Request of M/s Virchow Biotech Pvt. Ltd., Hyderabad for fixation of<br>adhoc norms against Advance Authorization No. 0910061001 dated<br>19.09.2014
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

mmittee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per<br>details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TODAY CONTRACEPTIVE<br>SPONGE<br>1 Number<br>1<br>NONOXYNOL9<br>0.9983 gram<br>2<br>Sorbic Acid<br>0.0061gram<br>3<br>Prepol HDW-2002<br>2.4030 gram<br>4<br>Tape Removal<br>0.2457 Yard<br>5<br>Anchoring Scrim<br>0.0864 Yard<br>6<br>MouldCups - Bottom<br>0.0039Number<br>7<br>MouldCups- Top<br>0.0039Number<br>8<br>Pouch-TopWeb<br>0.0233Yard<br>9<br>Pouch-Bottom Web<br>0.0233Yard<br>10<br>TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric acid USP<br>0.0141gram<br>RA concerned maytake further necessaryaction asper above decision of NC.||

12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric acid USP<br>0.0141gram<br>RA concerned maytake further necessaryaction asper above decision of NC.||

Case No. A-23
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Virchow Biotech Pvt. Ltd., Hyderabad
HQF. No. 01/82/050/01239/AM16/DES-III
RLA F. No. 09/24/040/00362/AM16
Advance Authorization No. and Date 0910062635dated 22.09.2015
Subject Request of M/s Virchow Biotech Pvt. Ltd., Hyderabad for fixation of<br>adhoc norms against Advance Authorization No. 0910062635 dated<br>22.09.2015
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per<br>details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TODAY CONTRACEPTIVE<br>SPONGE<br>1 Number<br>1<br>NONOXYNOL9<br>0.9983 gram<br>2<br>Sorbic Acid<br>0.0061gram<br>3<br>Prepol HDW-2002<br>2.4030 gram<br>4<br>Tape Removal<br>0.2457 Yard<br>5<br>Anchoring Scrim<br>0.0864 Yard<br>6<br>MouldCups - Bottom<br>0.0039Number<br>7<br>MouldCups- Top<br>0.0039Number<br>8<br>Pouch-TopWeb<br>0.0233Yard<br>9<br>Pouch-Bottom Web<br>0.0233Yard<br>10<br>TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citri

TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric acid USP<br>0.0141gram<br>RA concerned maytake further necessaryaction asper above decision of NC.||

Case No. A-24
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s D.K. Bio Pharma Pvt. Ltd., Mumbai
HQ F. No. 01/82/050/02253/AM19/DES-III<br>01/82/050/01006/AM19/DES-III
RLA F. No. 03/94/040/00842/AM19<br>03/94/040/00603/AM18
Advance Authorization No. and Date 0310826158 dated 04.01.2019<br>0310816992 dated 13.11.2017
Subject Request of M/s D.K. Bio Pharma Pvt. Ltd., Mumbai for fixation of<br>adhoc norms against Advance Authorization Nos. 0310826158 dated<br>04.01.2019 and 0310816992 dated 13.11.2017
Decision:The Committee considered the request of firm and it was observed that the import item –DETOX<br>FOC-27 Fish Body Oil having ITC HS – 15042010 comes under Chapter 15 and as per para 4.11 (A) (i) of the<br>FTP 2015-20, all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self-<br>declaration basis under para 4.07 of the FTP.<br>Norms Committee is not authorize to allowDETOX FOC-27 FISH BODY OIL CRUDEunder para 4.07 of HBP<br>Vol. I. Hence, the Committee decided torejectthe case.<br>For other issues,firm mayapproach concerned RA.

not authorize to allowDETOX FOC-27 FISH BODY OIL CRUDEunder para 4.07 of HBP<br>Vol. I. Hence, the Committee decided torejectthe case.<br>For other issues,firm mayapproach concerned RA.||

Case No. A-25
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Chemical Brothers Enterprises Pvt. Ltd., Mumbai
HQF. No. 01/82/050/00784/AM19/DES-III
RLA F. No. 03/94/040/01014/AM18
Advance Authorization No. and Date 0310820204 dated02.04.2018
Subject Request of M/s Chemical Brothers Enterprises Pvt. Ltd., Mumbai for<br>fixation of adhoc norms against Advance Authorization No.<br>0310820204 dated 02.04.2018
Decision:The Committee considered the request of the firm and it was observed that the reply furnished by the<br>firm vide letter dated 13.04.2021 is deficient. Hence, the Committee decided to call for following information<br>from the firm:<br>(i)<br>Chemical name of export product and its catalogue.<br>(ii)<br>Percentage composition of export product.<br>(iii)<br>Net content of import item No. 3 and 4 in export product.

Chemical name of export product and its catalogue.<br>(ii)<br>Percentage composition of export product.<br>(iii)<br>Net content of import item No. 3 and 4 in export product.||

Case No. A-26 A-26
Meeting No. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Yasho Industries Limited, Mumbai
HQF. No. 01/82/050/01615/AM21/DES-III
RLA F. No. 03/95/040/00343/AM21
Advance Authorization No. and Date 0310838067 dated03.09.2020
Subject Request of M/s Yasho Industries Limited, Mumbai for revision of<br>norms against Advance Authorization No. 0310838067 dated<br>03.09.2020
**Decision:**The Committee considered the request of firm and it was decided to revise the norms a<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>YALUB<br>PA<br>135(3,5-DI-TERTIARY-<br>BUTYL-4-HYDROXYHYDROCINNAMIC<br>ACID)<br>1 kg<br>1<br>2,6-DI-TERTIARY-BUTYL PHENOL<br>2<br>METHYL ACRYLATE<br>3<br>EXXAL 8(ISO OCTANOL)<br>RA concerned may take further necessary action as per above decision of NC. s under:<br>Qty.<br>0.825kg<br>0.349kg<br>0.366 kg

br>2<br>METHYL ACRYLATE<br>3<br>EXXAL 8(ISO OCTANOL)<br>RA concerned may take further necessary action as per above decision of NC.||s under:<br>Qty.<br>0.825kg<br>0.349kg<br>0.366 kg|

Case No. A-27 A-27 A-27 A-27 A-27
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Navin Fluorine International Limited, Mumbai
HQF. No. 01/82/050/00765/AM17/DES-III
RLA F. No. 03/95/040/00437/AM17
Advance Authorization No. and Date 0310807709dated08.09.2016
Subject Request of M/s Navin Fluorine International Limited, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0310807709<br>dated<br>08.09.2016.
**Decision:**The Committee considered the request of firm and as per the GST data provided by the firm, the<br>consumption norms are 2.12 kg / kg.

0310807709*<br>dated<br>08.09.2016.||||| ||**Decision:**The Committee considered the request of firm and as per the GST data provided by the firm, the<br>consumption norms are 2.12 kg / kg. However, it seems that at the time of application, the norms applied for is<br>1.65 kg/kg and NC-3 has recommended 1.40 kg/kg on the basis of 95% yield, since there export product is new<br>and no other data is available.<br>NC-3 cannot recommend the quantity of 2.12 kg, which is more than the quantity applied for by the<br>firm, that is 1.65 kg.<br>In view of above, the Committee decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>HFO1234yf(2,3,3,3Tetra Fluoro Prop-l-ene)<br>1 kg<br>1<br>Hexa Fluoro Propylene<br>1.60 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.|||||| ||Export product||Qty.|Sl.<br>No.|Import items|Qty.| ||HFO1234yf(2,3,3,3Tetra Fluoro Prop-l-ene)||1 kg|1|Hexa Fluoro Propylene|1.60 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||

l.<br>No.|Import items|Qty.| ||HFO1234yf(2,3,3,3Tetra Fluoro Prop-l-ene)||1 kg|1|Hexa Fluoro Propylene|1.60 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||

Case No. A-28
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
HQ F. No. 01/82/050/01625/AM16/DES-III<br>01/82/050/01612/AM16/DES-III<br>01/82/050/01615/AM16/DES-III<br>01/82/050/01613/AM16/DES-III
RLA F. No. 03/94/040/00816/AM16<br>03/94/040/00814/AM16<br>03/94/040/00815/AM16<br>03/94/040/00817/AM16
Advance Authorization No. and Date 0310801629 dated 07.01.2016<br>0310801603 dated 06.01.2016<br>0310801571 dated 05.01.2016<br>0310801604 dated06.01.2016
Subject Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0310801629<br>dated<br>07.01.2016,<br>0310801603<br>dated<br>06.01.2016,<br>0310801571<br>dated<br>05.01.2016 and 0310801604 dated 06.01.2016
**Decision:**Deferred for comments of TE.

<br>07.01.2016,<br>0310801603<br>dated<br>06.01.2016,<br>0310801571<br>dated<br>05.01.2016 and 0310801604 dated 06.01.2016| |**Decision:**Deferred for comments of TE.||

Case No. A-29
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
HQF. No. 01/82/050/01590/AM16/DES-III
RLA F. No. 03/94/040/00552/AM16
Advance Authorization No. and Date 0310799930dated02.11.2015
Subject Request of M/s J.B. Chemicals & Pharmaceuticals Ltd Mumbai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310799930 dated 02.11.2015
**Decision:**Deferred for comments of TE.

Case No. A-30 Meeting No. NC/3/MEET/Sep/202122/8 Date 24/09/2021 Firm’s Name M/s J.B. Chemicals & Pharmaceuticals Limited, Mumbai HQ F. No. 01/82/050/00536/AM18/DES-III RLA F. No. 03/94/040/00246/AM18 Advance Authorization No. and Date 0310814210 dated 22.06.2017 Subject Request of M/s J.B. Chemicals & Pharmaceuticals Limited, Mumbai for fixation of adhoc norms against Advance Authorization No. 0310814210 dated 22.06.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

genda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:

Export product Qty. Sl.<br>No. Import items Qty.
Bupivacaine with adrenaline injection<br>10x20ml ampoules, each ml contains<br>Bupivacaine Hydrochloride 5.3175 mg.<br>Adrebakube Bitartarate 0.010465mg. Net<br>content<br>Bupivacaine<br>Hydrochloride<br>44.241kgs,<br>Adrebakube<br>Bitartarate<br>0.0871kgs 1 Number 1 Bupivacaine Hydrochloride 105.00 mg /<br>vial
2 Adrenaline Bitartarate 0.1911 mg /<br>vial

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

Case No. Case No. A-31 A-31 A-31 A-31 A-31
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
HQF. No. F. No.01/82/050/00731/AM17/DES-III
RLA F. No. 03/94/040/00516/AM17
Advance Authorization No. and Date 0310807914 dated 20.09.2016
Subject Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>**Authorization No.

||Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310807914 dated 20.09.2016||||| ||Decision:The Committee considered the request of firm and it w||||as decided to revise the norms||as under:<br>Quantity<br>(in Gms)<br>0.612 gm<br>25.7 gm<br>0.612 gm<br>0.612 gm<br>0.612 gm<br>0.612 gm| ||Sl.<br>No.|Description||Quantity|Sl.<br>No.|Description|| ||1|Amylmetacresol Antiseptic Throat Lozenges<br>Suger Free Blackcurrant and other Flavor.<br>Each Lozenges contains Amylmetacresol 0.6<br>MG,IsomaltST-M-2533.567 MG.||1000<br>Lozenges|1|Amylmetacresol|| ||||||2|Isomalt ST-M|| ||2|Amylmetacresol Antiseptic Throat Lozenges<br>Lemon and Other Flavor. Each Lozenges<br>contains Amylmetacresol0.6MG,||1000<br>Lozenges|1|Amylmetacresol|| ||3|Hexoral Lorsept with Orange, Lemon,<br>Honey Lemon, Blackcurrant and Other<br>Flavor.Each<br>Lozenges<br>contains<br>Amylmetacresol0.6MG||1000<br>Lozenges|1|Amylmetacresol|| ||4|Hexoral Tabs Classic Orange, Lemon,<br>Honey Lemon, Blackcurrant and Other<br>Flavor.Each<br>Lozenges<br>contains<br>Amylmetacresol0.6MG||1000<br>Lozenges|1|Amylmetacresol|| ||5|Cufo Lozenges Lemon, Orange, and Other<br>Flavor.Each<br>Lozenges<br>contains<br>Amylmetacresol0.6MG,||1000<br>Lozenges|1|Amylmetacresol||

lmetacresol0.6MG||1000<br>Lozenges|1|Amylmetacresol|| ||5|Cufo Lozenges Lemon, Orange, and Other<br>Flavor.Each<br>Lozenges<br>contains<br>Amylmetacresol0.6MG,||1000<br>Lozenges|1|Amylmetacresol||

6 TIN<br>TIN<br>LIDO<br>Orange and <br>Other 1000 1 Amylmetacresol 0.612 gm
Flavor.Each<br>Lozenges contains Lozenges
Amylmetacresol0.6MG
7 Vicks Honey Lemon Suger Free Lozenges. 1000 1 Isomalt ST-M No<br>details
Each Lozenges contains Isomalt ST-M- Lozenges found in the
2533.567 MG application
8 Vicks orange suger Free Lozenges. contains 1000 1 Isomalt ST-M No<br>details
Isomalt ST-M-2533.567 MG Lozenges found in the
application
9 Zecug Herbal Cough Lozenges Suger Free. 1000 1 Isomalt ST-M 2507 gm
Each Lozenge content Isomalt ST-M- Lozenges
2533.567 MG.

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

Case No. A-32
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
HQF. No. F. No.01/82/050/00535/AM18/DES-III
RLA F. No. 03/95/040/00244/AM18
Advance Authorization No. and Date 0310814244 dated 23.06.2017
Subject Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai for
revision / correction in respect of adhoc norms fixed against Advance
Authorization No. 0310814244 dated 23.06.2017
**Decision:**Deferred for comments of TE.

d., Mumbai** for| ||revision / correction in respect of adhoc norms fixed against Advance| ||Authorization No. 0310814244 dated 23.06.2017| |**Decision:**Deferred for comments of TE.||

C ase No. A-33
M eetingNo. NC/3/MEET/Sep/202122/ 8
D
ate 24/09/2021
Fi rm’sName M/s J.B. Chemicals & Pha rmaceuticals Ltd., Mumbai
H QF. No. <br>F. No.01/82/050/00047/A <br>M19/DES-III
R LA F. No. 03/94/040/00787/AM18
A dvance Authorizati on No. and Date 0310818076dated 28.12.20 17
S
ubject Request of M/s J.B. Che<br> <br>
D **ecision:**The Committee considered the request of firm and it was decided to revise the nor ms as under:<br>Qty.<br>(for 1 Number<br>Lozenges)<br>12.24 mg<br>10.20 mg<br>1.275 mg<br>15.30 mg<br>2571.29 mg
S<br>N l.<br>o. Export product Qty. Sl.<br>No. Import items Qty.<br>(for 1 Number<br>Lozenges)
1 Benzocaine<br>and<br>Cetylpyridinium<br>Chloride<br>Anaesthetic Throat Lozenges Flavours Black<br>Current, Honey Lemon & other Flavours. Each<br>Lozenges Contains Benzocaine 12mg.

Lozenges)**||| ||1||Benzocaine<br>and<br>Cetylpyridinium<br>Chloride<br>Anaesthetic Throat Lozenges Flavours Black<br>Current, Honey Lemon & other Flavours. Each<br>Lozenges Contains Benzocaine 12mg. Net Content<br>Benzocaine 171.23 Kgs|||1 Number<br>Lozenges||1|Benzocaine|12.24 mg||| ||2||Benzocaine<br>and<br>Cetylpyridinium<br>Chloride<br>Anaesthetic<br>Throat<br>Lozenges.<br>Flavours Black Current and Lime & Lemon and<br>other<br>flavours.<br>Each<br>Lozenges<br>Contains<br>Benzocaine 10mg, Net Content Benzocaine 99.01<br>Kgs.|||1 Number<br>Lozenges||1|Benzocaine|10.20 mg||| ||3||Benzocaine,<br>Cetylpyridinium<br>Chloride<br>and<br>Dextromethorphan<br>Hydrobromide<br>Anaesthetic<br>Throat<br>Lozenges.<br>Each<br>Lozenges<br>Contains<br>Benzocaine 1.25 mg, Net Content Benzocaine<br>23.81 Kgs|||1 Number<br>Lozenges||1|Benzocaine|1.275 mg||| ||4||Life Brand Sore Throat & nasal Congestion Relief<br>Extra<br>Strength(Flavours<br>Cherry/Honey<br>&<br>Lemon/other Flavours) Sugar Free Lozenges. Each<br>Lozenge Contains Benzocaine 15 Mg & Isomalt<br>STM 257129 M Nt Ctt Bi|||1 Number<br>Lozenges||1|Benzocaine|15.30 mg||| |||||||||2|Isomalt ST-M|2571.29 mg||| ||||- . g. e onen enzocane<br>38.760 Kgs. And Isomalt ST-M 6644.234 Kgs.|||||||||| ||5||Personnelle Oral Anesthetic Sore Throat Lozenges<br>Extra Strength Sugar Free (Flavours Cherry/Honey<br>Lemon/other Flavours) Each Lozenges Contains<br>Benzocaine 15mg & Isomalt ST-M 2571.29 Mg.|||1 Number<br>Lozenges||1|Benzocaine|15.30 mg||| |||||||||2|Isomalt ST-M|2571.29 mg||| |||||||||||||| ||||Net Content B<br>|enzocaine 38.760 Kgs.

ontains<br>Benzocaine 15mg & Isomalt ST-M 2571.29 Mg.|||1 Number<br>Lozenges||1|Benzocaine|15.30 mg||| |||||||||2|Isomalt ST-M|2571.29 mg||| |||||||||||||| ||||Net Content B<br>|enzocaine 38.760 Kgs. And Isomalt<br>||||||||| ||||ST-M 6644.23|Kgs.||||||||| ||6||Option+Oral|Lozenges Sore Throat & nasal||1 Number||1|Benzocaine|15.30 mg||| ||||<br>Congestion<br> <br>|<br>Relief<br>Extra<br>Strength(Flavours<br>||Lozenges||||||| ||||Cherry/Honey<br>Free<br>Lozeng<br>Benzocaine 15|& Lemon/other Flavours) Sugar<br>es.<br>Each<br>Lozenge<br>Contains<br>Mg & Isomalt ST-M 2571.29 Mg.||||2|Isomalt ST-M|2571.29 mg||| ||||<br>Net Content B<br>|<br>enzocaine 38.760 Kgs. And Isomalt<br>||||||||| ||||ST-M 6644.23|4 Kgs||||||||| ||R|||||||||||| |||A concerned mayt||ake further necessaryaction asper above decis|||ion of NC.|||||| |||||||||||||| ||||||||||||||

Case No. Case No. A-34 A-34 A-34 A-34 A-34
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
HQF. No. F. No.01/82/050/00582/AM17/DES-III
RLA F. No. 03/94/040/00255/AM17
Advance Authorization No. and Date 0310805960dated05.07.2016
Subject Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>**Authorization No.

ect||Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310805960 dated 05.07.2016||||| ||**Decision:**The Committee considered the request of firm and it was decided to revise the norms as under:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Amylmetacresol Antiseptic Throat Lozenges Sugar<br>Free Blackcurrant and Other Flavor.Each Lozenges<br>contains Amylmetacresol 0.6 MG, Isomalt ST-M<br>2533.567 MG. Net Content Amylmetacresol 0.99<br>Kgs,IsomaltST-M 4195.75Kgs.<br>1000<br>Number<br>1.<br>Amylmetacresol<br>0.612 gm<br>2.<br>Isomalt St-M<br>2507 gm<br>2<br>Amylmetacresol<br>Antiseptic<br>Throat<br>Lozenges<br>Lemon / Cherry and Other Flavor. Each<br>Lozenges<br>contains<br>Amylmetacresol<br>0.6<br>MG.<br>Net<br>Content<br>Amylmetacresol 0.28 Kgs<br>1000<br>Number<br>1.<br>Amylmetacresol<br>0.612 gm<br>RA concerned maytake further necessaryaction asper above decision of NC.||||||| ||Sl.<br>No.|Export product||Qty.|Sl.<br>No.|Import items|Qty.| ||1|Amylmetacresol Antiseptic Throat Lozenges Sugar<br>Free Blackcurrant and Other Flavor.Each Lozenges<br>contains Amylmetacresol 0.6 MG, Isomalt ST-M<br>2533.567 MG.

o.**|Import items|Qty.| ||1|Amylmetacresol Antiseptic Throat Lozenges Sugar<br>Free Blackcurrant and Other Flavor.Each Lozenges<br>contains Amylmetacresol 0.6 MG, Isomalt ST-M<br>2533.567 MG. Net Content Amylmetacresol 0.99<br>Kgs,IsomaltST-M 4195.75Kgs.||1000<br>Number|1.|Amylmetacresol|0.612 gm| ||||||2.|Isomalt St-M|2507 gm| ||2|Amylmetacresol<br>Antiseptic<br>Throat<br>Lozenges<br>Lemon / Cherry and Other Flavor. Each<br>Lozenges<br>contains<br>Amylmetacresol<br>0.6<br>MG.<br>Net<br>Content<br>Amylmetacresol 0.28 Kgs||1000<br>Number|1.|Amylmetacresol|0.612 gm| ||RA concerned maytake further necessaryaction asper above decision of||||NC.|||

Case No. A-35
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai
HQF. No. F. No.01/82/050/00619/AM18/DES-III
RLA F. No. 03/94/040/00260/AM18
Advance Authorization No. and Date 0310814635dated 14.07.2017
Subject Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310814635 dated 14.07.2017
**Decision:**Deferred for comments of TE.

ision/correction**<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310814635 dated 14.07.2017| |**Decision:**Deferred for comments of TE.||

Case No. A-36
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s J.B Chemicals & Pharmaceuticals Ltd, Mumbai
HQF. No. 01/82/050/00058/AM16/DES-III
RLA F. No. 03/94/040/00932/AM15
Advance Authorization No. and Date 0310792548dated01.01.2015
Subject Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumbai for<br>review of adhoc norms fixed against Advance Authorization No.<br>0310792548 dated 01.01.2015
**Decision:**Deferred for comment of TE.
Case No. A-37
Meeting No. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Arch pharmalabs Ltd, Mumbai
HQ F. No. 01/82/050/01328/AM/19/DES-III<br>01/82/050/01369/AM/19/DES-III<br>01/82/050/01331/AM/19/DES-III<br>01/82/050/01250/AM/19/DES-III
RLA F. No. 03/94/040/00585/AM19<br>03/94/040/00583/AM19<br>03/94/040/00576/AM19<br>03/94/040/00192/AM19
Advance Authorization No. and Date 0310824086 dated 01.10.2018<br>0310824121 dated 01.10.2018<br>0310824101 dated 01.10.2018<br>0310822731 dated 31.07.2018
Subject Request of M/s Arch pharmalabs Ltd, Mumbai for fixation of<br>**adhoc norms against Advance Authorization No.

*<br>0310824101 dated 01.10.2018<br>0310822731 dated 31.07.2018| |Subject|Request of M/s Arch pharmalabs Ltd, Mumbai for fixation of<br>adhoc norms against Advance Authorization No. 0310824086 dated<br>01.10.2018, 0310824121 dated 01.10.2018, 0310824101 dated<br>01.10.2018 & 0310822731 dated 31.07.2018| |**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as<br>per details below or as applied by firm whichever is less:<br>For Advance Authorization Nos.0310824086 dated 01.10.2018, 0310824121 dated 01.10.2018 and<br>0310824101 dated 01.10.2018<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(4-R-CIS)-1,1-DIMETHYL-<br>6-CYANOMETHYL-2,2-<br>DIMETHYL-<br>1,3-DIOXANE-4-ACETATE<br>(ATS-8)<br>1 kg<br>1<br>ETHYL-4-CHLOROACETOACETATE<br>1.060kg<br>2<br>LITHIUM METAL<br>0.100kg<br>3<br>TERT BUTYL ACETATE<br>2.110kg<br>4<br>LYOPHILISED<br>ENZYME<br>POWDER<br>CDX-403<br>0.0102 kg<br>5<br>IEP OX 58 SPRAY DRIED ENZYME<br>POWDER<br>0.0160 kg<br>6<br>IEP OX 56 SPRAY DRIED ENZYME<br>POWDER<br>0.117 kg<br>7<br>(B-NAD) B-NICOTINAMIDE-ADENINE<br>DINUCLEOTIDE<br>( COENZYME-1)<br>0.00132 kg<br>8<br>2,2-DIMETHOXY PROPANE<br>0.950kg<br>9<br>ETHYL ACETATE<br>3.60kg||

For Advance Authorization No. 0310822731 dated 31.07.2018

DE-ADENINE<br>DINUCLEOTIDE<br>( COENZYME-1)<br>0.00132 kg<br>8<br>2,2-DIMETHOXY PROPANE<br>0.950kg<br>9<br>ETHYL ACETATE<br>3.60kg||

For Advance Authorization No. 0310822731 dated 31.07.2018

Export product Qty. Sl.<br>No. Import items Qty.
(4-R-CIS)-1,1-DIMETHYL-<br>6-CYANOMETHYL-2,2-<br>DIMETHYL-1,3-DIOXANE-<br>4-ACETATE (ATS-8) 1 kg 1 ETHYL-4-CHLOROACETOACETATE 1.06kg
2 LITHIUM METAL 0.100kg
3 TERT BUTYL ACETATE 2.11 kg
4 OPTIMIZED<br>ENZYME<br>CDX-041,<br>LYOPHIZED POWDER 0.019 kg
5 LYOPHILISED<br>ENZYME<br>POWDER<br>CDX-901 0.00555 kg
6 LYOPHILISED<br>ENZYME<br>POWDER<br>CDX-403 0.0031 kg
7 NADP-SP-B-NICOTINAMIDE-ADENINE<br>DINUCLEOTIDE<br>PHOSPHATE<br>OXIDIZED<br>FORM,<br>MONOSODIUM<br>SALT (B-NADP+,B-TPN+,COENZYME-<br>II) 0.0005 kg
8 2,2-DIMETHOXY PROPANE 0.95kg
9 ETHYL ACETATE 3.60kg

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

Case No. A-38
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’s Name M/s Cadila Healthcare Limited, Ahmedabad
HQF. No. 01/82/050/01612/AM21/DES-III
RLA F. No. 08/24/040/00158/AM21
Advance Authorization No. and Date 0810148474 dated 03.09.2020
Subject Request of M/s Cadila Healthcare Limited, Ahmedabad for<br>**enhancement in the quantity of import items No.

58/AM21| |Advance Authorization No. and Date|0810148474 dated 03.09.2020| |Subject|Request of M/s Cadila Healthcare Limited, Ahmedabad for<br>enhancement in the quantity of import items No. 1 in respect of<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0810148474 dated 03.09.2020| |Decision:The Committee considered the request of the firm and it was observed that the firm has not<br>furnished any technical justification for enhancement in norms. Hence, it was decided torejectthe case<br>maintainingstatusquo.||

Case No. A-39
Meeting No. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Arch pharmalabs Ltd, Mumbai
HQF. No. 01/82/050/01392/AM/19/DES-III
RLA F. No. 03/94/040/00565/AM19
Advance Authorization No. and Date 0310824069 dated 28.09.2018
Subject Request of M/s Arch pharmalabs Ltd, Mumbai for fixation of<br>adhoc norms against Advance Authorization No. 0310824069<br>dated 28.09.2018
**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.

mmittee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as<br>per details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4-Fluoro-alpha-[2-methyl-1-oxopropyl]-<br>gama-oxo-N-beta-diphenylbenzene<br>butaneamide (DKT-III)<br>1 kg<br>1<br>Fluoro Benzene<br>0.520kg<br>2<br>Methyl Aceto Acetate<br>Not<br>required<br>in theprocess<br>3<br>Methylene DiChloride<br>1.011 kg<br>RA concerned may take further necessary action as per above decision of NC.||

Case No. A-40
MeetingNo. NC/3/MEET/Sep/202122/8
Date 24/09/2021
Firm’sName M/s Raj Dhanvantry Pharmacy, Rajkot
HQF. No. 01/82/050/01529/AM16/DES-III
RLA F. No. 24/24/040/00007/AM16
Advance Authorization No. and Date 2410041748dated 15.06.2015
Subject Request of M/s Raj Dhanvantry Pharmacy, Rajkot for fixation of<br>adhoc norms against Advance Authorization No. 2410041748<br>dated 15.06.2015
Decision:The Committee considered the request of the firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Composition given in CA Certificate and quantity asked are as under:<br>**Sl.

nsidered the request of the firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Composition given in CA Certificate and quantity asked are as under:<br>Sl. No.<br>Import Items<br>Quantity as per application<br>Quantity as per CA<br>1<br>SodiumSaccharin<br>0.247 kg<br>0.1205kg<br>2<br>Aspartame<br>0.348kg<br>0.1602 kg<br>3<br>SodiumCyclamate<br>0.418kg<br>0.2002 kg<br>Please explain the difference.<br>(ii)<br>Indigenous items used and their quantity.||

Meeting ended with thanks to Chair and participants


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