IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2021-08-13

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi -0

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Para 4.07 Decision

Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Aug/202122/7 dated 13.08.2021, actually held on 26.08.2021 under the Chairmanship of Shri Vijay Kumar, Addl. DGFT and on 10.09.2021 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 AjayKumar,DeputyDirector 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/Jul/202122/4 dated 15.07.2021 (actually held on 19.07.2021 and 26.07.2021).

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MANUAL CASES

Case No. A-01
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Gopinath Chem-Tech Ltd., Ahmedabad
HQF. No. 01/82/050/00674/AM17/DES-III
RLA F. No. 08/24/040/00215/AM17
Advance Authorization No. and Date 0810138683 dated 16.09.2016
Subject Request of M/s Gopinath Chem-Tech Ltd., Ahmedabad for
enhancement in the quantity of import items in respect of adhoc
norms fixed against Advance Authorization No. 0810138683 dated
16.09.2016
Decision: The Committee considered the request of the firm and it was decided to call for following information
from the firm:
(i) Justification for low yield of 48.65% in third stage of reaction.
(ii) GST / Central Excise certified data for the year 2016-17.
Case No. Case No. A-02
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Gopinath Chem-Tech Ltd., Ahmedabad
HQF. No. 01/82/050/00051/AM18/DES-III
RLA F. No. 08/24/040/00474/AM17
Advance Authorization No. and Date 0810139903 dated 15.03.2017
Subject Request of M/s Gopinath Chem-Tech Ltd., Ahmedabad for
enhancement in the quantity of import items in respect of adhoc
norms fixed against Advance Authorization No. 0810139903 dated
15.03.2017
**Decision:**The Committee considered the request of the firm and as per the details furnished by the firm, it was
observed that the firm has to take 1.2 Mole of first import item instead of 1 Mole, so that reaction takes place
completely.
In view of above, the Committee decided to revise the norms as under:
Export product Qty. Sl.<br>Import items Qty.
No.
ACETYL MPDSA 1 kg 1<br>META PHENYLENE DIAMINE(MPD) 0.704 kg
2<br>SODA ASH 1.80 kg
3<br>CAUSTIC SODA FLAKES / CAUSTIC 0.70 kg
SODA LYE(ON 100%REAL BASIS)
RA concerned maytake further necessaryaction asper above decision of NC.

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Case No. A-03 A-03 A-03 A-03 A-03
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Gopinath Chem-Tech Ltd., Ahmedabad
HQF. No. 01/82/050/00040/AM18/DES-III
RLA F. No. 08/24/040/00513/AM17
Advance Authorization No. and Date 0810139940 dated 24.03.2017
Subject Request of M/s Gopinath Chem-Tech Ltd., Ahmedabad for<br>enhancement in the quantity of import item No. 4 – Soda Ash in<br>respect of adhoc norms fixed against Advance Authorization No.<br>0810139940 dated 24.03.2017
**Decision:**The Committee considered the request of the firm for enhancement in the quantity of import items and<br>based on the Production / Consumption data furnished by the firm for the period 2018-19 duly certified by GST<br>and after taking average value, the Committee decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DASA (4,4 DIAMINO SULFANILIDE)<br>1 kg<br>1<br>PARA NITROANILINE<br> 0.728kg<br>2<br>ANILINEOIL<br> 0.468kg<br>3<br>ACETIC ACID<br>0.317 kg<br>4<br>SODA ASH<br>1.50 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Export product Qty. Sl.<br>No. Import items Qty.
DASA (4,4 DIAMINO SULFANILIDE) 1 kg 1 PARA NITROANILINE 0.728kg
2 ANILINEOIL 0.468kg
3 ACETIC ACID 0.317 kg
4 SODA ASH 1.50 kg
RA concerned maytake further necessaryaction asper above decision of NC.
Case No. A-04
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’s Name M/s Keva Frangrances Private Limited, Mumbai<br>(Formerly known as M/s K.V. Arochem Private Limited, Mumbai)
HQF. No. 01/82/050/01075/AM16/DES-III
RLA F. No. 03/94/040/00345/AM16
Advance Authorization No. and Date 0310797937 dated 04.08.2015
Subject Request of M/s Keva Fragrances Private Limited, Mumbai<br>(Formerly known as M/s K.V. Arochem Private Limited, Mumbai)<br>for enhancement in the quantity of import items in respect of adhoc<br>norms fixed against Advance Authorization No. 0310797937 dated<br>04.08.2015
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>Detailed chemistry, chemical reaction involved and percentage yield.<br>(ii)<br>Hard copy of 4.07 application.<br>(iii)<br>Production / Consumption data for last two years duly certified by GST.

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Case No. A-05
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’s Name M/s Keva Frangrances Private Limited, Mumbai<br>(Formerly known as M/s K.V. Arochem Private Limited,<br>Mumbai)
HQF. No. 01/82/050/01076/AM16/DES-III
RLA F. No. 03/94/040/00335/AM16
Advance Authorization No. and Date 0310797897 dated 03.08.2015
Subject Request of M/s Keva Fragrances Private Limited, Mumbai<br>(Formerly known as M/s K.V. Arochem Private Limited,<br>Mumbai) for enhancement in the quantity of import items in<br>respect of adhoc norms fixed against Advance Authorization No.<br>0310797897 dated 03.08.2015
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>Complete technical details as per Annexure to Appendix 4E.<br>(ii)<br>Complete chemistry, molecular weight and percentage yield.<br>(iii)<br>Production / Consumption data for last two years duly certified by GST.
Case No. A-06
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Emmennar Pharma (P) Ltd., Hyderabad
HQF. No. 01/82/050/01516/AM19/DES-III
RLA F. No. 09/24/040/040/00164/AM19
Advance Authorization No. and Date 0910066401 dated 28.06.2018
Subject Request of M/s EMMENNAR PHARMA PRIVATE LIMITED,<br>Hyderabad for enhancement in the quantity of import items in<br>respect of adhoc norms fixed against Advance Authorization<br>No. 0910066401 dated 28.06.2018
<br> <br> <br> **Decision:**The Committee considered the request of the firm and as per the Production / Consumption<br>Certificate given by the firm for the period 2018-19 duly certified by GST and taking average value, the<br>Committee decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>S(+)-2-AMINO BUTYRAMIDE HCL<br>1 kg<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>6<br>METHANOL<br>1.39 kg<br>Note: Above revised norms are for regularization and closure purpose only. No repeat licence will<br>be issued on the basis of above decision.<br>RA concerned maytake further necessaryaction asper above decision of NC.

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Case No. A-07
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Ami Lifesciences Pvt. Ltd., Vadodara
HQ F. No. 01/82/050/01297/AM19/DES-III<br>01/82/050/02597/AM19/DES-III<br>01/82/050/02598/AM19/DES-III<br>01/82/050/00104/AM20/DES-III<br>01/82/050/00105/AM20/DES-III
RLA F. No. 34/24/040/00019/AM19<br>34/24/040/00372/AM19<br>34/24/040/00374/AM19<br>34/24/040/00043/AM20<br>34/24/040/00044/AM20
Advance Authorization No. and Date 3410044121 dated 01.05.2018<br>3410044955 dated 07.03.2019<br>3410044956 dated 07.03.2019<br>3410045104 dated 01.05.2019<br>3410045105 dated 01.05.2019
Subject Request of M/s Ami Life sciences Pvt Ltd, Vododara for<br>enhancement in the quantity of import items in respect of<br>adhoc norms fixed against Advance Authorization Nos.<br>3410044121 dated 01.05.2018, 3410044955 dated 07.03.2019,<br>3410044956 dated 07.03.2019, 3410045104 dated 01.05.2019 and<br>3410045105 dated 01.05.2019
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.

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Case No. Case No. Case No. Case No. Case No. A-08 A-08 A-08 A-08 A-08 A-08
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Aurobindo Pharma Limited, Hyderabad
HQF. No. 01/82/050/02091/AM19/DES-III
RLA F. No. 09/24/040/00376/AM19
. .
Advan ce Authorization No. and Date 091 0066832 dated 13.11.2018
Subject Request of M/s Aurobindo Pharma Ltd, Hyderabad for<br>enhancement in the quantity of import items in respect of adhoc
norms fixed against Advance Authorization No. 0910066832<br>
dated 13.11.2018
**Decision:**The Committee considered the request of the firm and it was decide to revise the n<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>PIPERACILLIN SODIUM<br>AND<br>TAZOBACTAM<br>SODIUM<br>8:1<br>FOR<br>INJECTION<br>1 kg<br>1.<br>4-Ethyl-2, 3 Dioxo Piperazine (EDP)<br>2.<br>6-Amino Penicillanic Acid (6-APA)<br>3.<br>Activated Carbon (Carbon Enoanticromos)<br>4.<br>Isopropyl Alcohol (IPA)<br>5.<br>Methanol(Methyl Alcohol)<br>6.<br>Methylene Chloride (MDC)<br>7.<br>D(-) Alpha Phenyl Glycine Base (P G Base)<br>8.<br>Penicillin G Amidase (Particle size 250 -<br>500 micron, Creamish to Brown regularly<br>shaped beads) or (Immobilized Acylase<br>Enzyme)Xinase<br>9.<br>Tazobactam Acid<br>10.<br>Toluene<br>11.<br>Triethylamine<br>12.<br>Trimethyl chlorosilane<br>13.<br>Triphosgene<br>14.<br>Aluminium Canisters / Bottles with Chloro<br>Butyl Plug / Inner & Outer Lid and Gasket /<br>Alu Caps[21 Ltrs(10KgCap)]<br>RA concerned maytake further necessaryaction asper above decision of NC. **n:**The Committ ee considered the request of the firm and it was decide to revise the n orms as under::
Qty.<br>03323 k
Exp ort product Qty. Sl.<br>No. Import items Qty.
PIP<br>AN<br>SO<br>INJ RACILLI SODI M 1 k 1 4Ehl2 3 Di Pii EDP 03323 k
N<br>D<br>TAZOBACT <br>AM g . -ty-, oxo perazne () . g
DIUM<br>8:1<br>F<br> OR 2. 6-Amino Penicillanic Acid (6-APA) 0.436 kg
ECTION 3. Activated Carbon (Carbon Enoanticromos) 0.050 kg
4. Isopropyl Alcohol (IPA) 0.105 kg
5 Methanol(Methl Alcohol) 0335k
. y . g
6. Methylene Chloride (MDC) 2.27 kg
7. D(-) Alpha Phenyl Glycine Base (P G Base) 0.335 kg
8. Penicillin G Amidase (Particle size 250 -<br>500 micron Creamish to Brown regularly 0.0015 kg
,<br>shaped beads) or (Immobilized Acylase<br>Enzyme)Xinase
9. Tazobactam Acid 0.1078 kg
10. Toluene 0.3062 kg
11. Triethylamine 0.466 kg
12. Trimethyl chlorosilane 0.3069kg
13. Triphosgene 0.2761 kg
14. Aluminium Canisters / Bottles with Chloro<br>Butyl Plug / Inner & Outer Lid and Gasket /<br>Alu Caps[21 Ltrs(10KgCap)] Relevant as<br>per packing<br>policy
necessaryaction asper above decision of NC.

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Case No. A-09
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s KLJ Plasticizers Ltd, New Delhi
HQF. No. 01/82/050/02579/AM19/DES-III
RLA F. No. 05/23/040/00562/AM19
Advance Authorization No. and Date 0510409975 dated 19.03.2019
Subject Request of M/s KLJ Plasticizers Ltd, New Delhi for enhancement in<br>the quantity of import item No. 2 –N-BUTANOL in respect of adhoc<br>norms fixed against Advance Authorization No. 0510409975 dated<br>19.03.2019
**Decision:The Committee considered the request of the firm and it was observed that the norms have been<br>worked out on the basis of 90% yield as against 88.53% yield. Since, the firm has not furnished any technical<br>justification for enhancement in thequantityof import item No. 2,theCommittee decided toreject **the case.
Case No. A-10
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Piramal Enterprises Ltd, Mumbai
HQ F. No. 01/82/050/01293/AM21/DES-III<br>01/82/050/01361/AM21/DES-III
RLA F. No. 03/95/040/00074/AM21<br>03/95/040/00132/AM21
Advance Authorization No. and Date 0310836193 dated 14.05.2020<br>0310836576 dated 08.06.2020
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 Nos. 0310836193 dated 14.05.2020 and<br>0310836576 dated 08.06.2020
**Decision:**The Committee considered the request of the firm and after deliberation,it was decided to grant<br>Personal Hearing to firm to explain their case.
Case No. A-11
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Arjun chemicals Pvt Ltd., Chennai
HQF. No. 01/82/050/01235/AM17/DES-III
RLA F. No. 04/24/040/00140/AM17
Advance Authorization No. and Date 0410162476 dated 08.11.2016
Subject Request of M/s Arjun chemicals Pvt Ltd., Chennai for enhancement in<br>the<br>quantity<br>of<br>import<br>item<br>No.<br>2-<br>Solbond<br>SBC<br>40S<br>Cationic Potato Starch in respect of adhoc norms fixed against<br>Advance Authorization No. 0410162476 dated 08.11.2016
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>Catalogue of import item No. 2 from foreign supplier indicating quantity to be used for<br>emulsification.<br>(ii)<br>Production / Consumption data duly certified by GST.

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Case No. A-12
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Arjun chemicals Pvt Ltd., Chennai
HQF. No. 01/82/050/00295/AM18/DES-III
RLA F. No. 04/24/040/00029/AM18
Advance Authorization No. and Date 0410163109 dated 16.05.2017
Subject Request of M/s Arjun chemicals Pvt Ltd, Chennai for enhancement in
the quantity of Import Item No. 2 - Solbond SBC 40S Cationic Potato
Starch in respect of adhoc norms fixed against Advance
Authorization No. 0410163109 dated 16.05.2017
Decision: The Committee considered the request of firm and it was decided to call for following information
from the firm:
(i) Catalogue of import item No. 2 from foreign supplier indicating quantity to be used for
emulsification.
(ii) Production / Consumption data duly certified by GST.
Case No. Case No. A-13
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Corporate Channels India Pvt. Ltd.
HQF. No. 01/82/050/00501/AM14/DES-III
RLA F. No. 13/24/040/00019/AM14
Advance Authorization No. and Date<br>1310044179 dated 29.08.2013
Subject Request of M/s Corporate Channels India Pvt. Ltd. for
enhancement in the quantity of import item No. 4, 5 and 6 in adhoc
norms fixed against Advance Authorization No. 1310044179 dated
29.08.2013
Decision: The Committee considered the request of the firm and taking cue from SION K-41, it was decided to
enhance the quantity of import item No. 4, 5 and 6 as per SION K – 41. Quantity of Copper Tube may be allowed
as per import item Copper Sleeve, since Copper Tube is a raw material for Copper Sleeve.
In view of above, the Committee decided to revise the norms as under:
Export product Qty.<br>Sl.<br>Import items Qty.
No.
COPPER BEARING 1 kg<br>1<br>COPPER WIRE(99.99%PURITY) 0.0180kg
CONTRACEPTIVE DEVICE 2<br>HDPEGRANULES 0.00353kg
(COPPER T 380A) 3<br>PE-PE FILM PROCESS Net + 10 %
4<br>COPPER TUBE (PURITY 99.99% 0.00029 kg
MINIMUM)
5<br>POLYPROPYLENE<br>(GRANULES)- 0.165 kg
GAMMA RADIATION STABLIZED
6<br>COMPOUND OF LDPE RESIN AND 0.049 kg
BARIUM SULPHATE
7<br>PVC GRANULES 0.00088 kg
RA concerned maytake further necessaryaction asper above decision of NC.

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Case No. A-14
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00953/AM/15/DES-III
RLA F. No. 09/24/040/00060/AM15
Advance Authorization No. and Date 0910060145Dated. 19.05.2014
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation<br>of adhoc norms against Advance Authorization No. 0910060145<br>dated 19.05.2014
Decision: Deferred for comments of TE.
Case No. A-15
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/01328/AM/15/DES-III
RLA F. No. 09/24/040/00235/AM15
Advance Authorization No. and Date 0910061256 dated 17.11.2014
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation<br>of adhoc norms against Advance Authorization No. 0910061256<br>dated 17.11.2014
**Decision:**The Committee considered the request of the firm and it was decided to ratify the ad-hoc input<br>output norms under para 4.07 of HBP Vol. I as 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>DIPYRIDAMOLE<br>1 kg<br>1<br>2,6-Dichloro-4,8-di(piperidin-1-<br>yl)pyrimido[5,4-d]pyrimidine<br>0.935 kg<br>2<br>Diethanolamine<br>2.543kg<br>3<br>Toluene<br>2.244 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Case No. A-16
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd., Hyderabad
HQF. No. 01/82/050/00135/AM/15/DES-III
RLA F. No. 09/24/040/00576/AM14
Advance Authorization No. and Date 0910059289dated 14.02.2014
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad (earlier<br>known as M/s Astrix Laboratories Ltd.) for fixation of adhoc<br>norms against Advance Authorization No. 0910059289 dated<br>14.02.2014
Decision:The Committee considered the request of firm and it was observed that earlier this case was<br>rejected on the ground that both the import item and export items are chemically same and no such<br>manufacturing activity was involved, which might account for 34.3% wastage. Further, it was observed that the<br>firm has not furnished any technical justification in support of its request. Hence, it was decided torejectthe<br>case maintainingstatusquo.

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Case No. A-17
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. F. No. 01/82/050/00162/AM/14/DES-III
RLA F. No. 09/24/040/00537/AM13
Advance Authorization No. and Date 0910055106dated 19.02.2013
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation<br>of adhoc norms fixed against Advance Authorization No.<br>0910055106 dated 19.02.2013
**Decision:**The Committee considered the request of the firm and it was decided to ratify the ad-hoc input<br>output norms under para 4.07 of HBP Vol. I as 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>DARUNAVIR (DAR)<br>1 kg<br>1<br>(2S,3S)-1,2-epoxy-3-<br>(butoxycarbonyl)amino-4-phenyl<br>butane<br>[(S,S)-BOCEpoxide]<br>0.854 kg<br>2<br>Isobutyl amine<br>0.854 kg<br>3<br>Triethylamine<br>5.40kg<br>4<br>P-Nitrobenzene sulfonyl chloride<br>0.73kg<br>5<br>Methylene Dichloride(MDC)<br>17.18kg<br>6<br>Isopropyl alcohol<br>1.89kg<br>7<br>2,3dihydrofuran<br>1.45kg<br>8<br>Toluene<br>1.20kg<br>9<br>N-Bromo succinimide(NBS)<br>3.75kg<br>10<br>Sodium borohydride<br>1.00kg<br>11<br>4-Dimethyl aminopyridine(DMAP)<br>0.024 kg<br>12<br>CAL B<br>1.00kg<br>13<br>Potassium carbonate<br>0.011 kg<br>14<br>Methanol<br>1.65kg<br>15<br>Bis(4- nitrophenyl)carbonate<br>1.17 kg<br>16<br>Triethanolamine<br>0.03kg<br>17<br>N-Methyl Pyrrolidone(NMPO)<br>3.59kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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Case No. A-18
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/01149/AM/11/DES-III
RLA F. No. 09/24/040/00054/AM11
Advance Authorization No. and Date 0910042623dated06.07.2010
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation<br>of adhoc norms against Advance Authorization No. 0910042623<br>dated. 06.07.2010
**Decision:**The Committee considered the request of the firm and it was decided to ratify the ad-hoc input<br>output norms under para 4.07 of HBP Vol. I as 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>DIPYRIDAMOLE<br>1 kg<br>1<br>2,6-Dichloro-4,8-di(piperidin-1-<br>yl)pyrimido[5,4-d]pyrimidine<br>0.935 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Case No. A-19
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00533/AM/16/DES-III
RLA F. No. 09/24/040/00387/AM15
Advance Authorization No. and Date 0910061210dated 11.11.2014
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation<br>of adhoc norms fixed against Advance Authorization No.<br>0910061210 dated 11.11.2014
**Decision:**The Committee considered the request of the firm and it was decided to ratify the ad-hoc input<br>output norms under para 4.07 of HBP Vol. I as 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>TOLMETIN<br>SODIUM<br>DIHYDRATE<br>2000 kg<br>1<br>P-ToluoylChloride<br>3160kg<br>2<br>Toluene<br>10240kg<br>3<br>N-Hexane<br>6400kg<br>4<br>Methanol<br>8000kg<br>5<br>Dichloromethane<br>14400kg<br>6<br>Methyl-1-methyl pyrrole 2 Acetate (or) 1-<br>Methylpyrrole-2-acetic Acid methylester<br>2660 kg<br>7<br>Morpholine<br>1960kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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Case No. A-20
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00997/AM13/DES-III
RLA F. No. 09/24/040/00354/AM13
Advance Authorization No. and Date 0910054116dated 16.10.2012
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms against Advance Authorization No. 0910054116
dated 16.10.2012
**Decision:**Deferred for comments of TE.
Case No. A-21
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00044/AM12/DES-III
RLA F. No. 09/24/040/00422/AM11
Advance Authorization No. and Date 0910045287 dated 28.01.2011
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms fixed against Advance Authorization No.
0910045287 dated 28.01.2011
**Decision:**Deferred for comments of TE.
Case No. Case No. A-22 A-22
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00306/AM/13/DES-III
RLA F. No. 09/24/040/00600/AM12
Advance Authorization No. and Date 0910051800dated 27.06.2013
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms fixed against Advance Authorization No.
0910051800 dated 27.06.2013
**Decision:**The Committee considered the request of the firm 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. Import items Qty.
No.
BOSENTAN 500 kg 1 Toluene 713.50kg
2 Ethyleneglycol mono tertiarybutyl ether 89.00kg
3 4.6-Dichloro-5-(2-Methoxyphenoxy)-2,2 892.00 kg
bipyrimidinyl
4 Cyclohexane 1252.00kg
5 Dimethyl sulfoxide 2195.00kg
6 Potassium carbonate 956.50kg
7 Dichloromethane 6370.00kg
8 Methanol 1220.00 kg
RA concerned maytake further necessaryaction asper above decision of NC.

13

Case No. Case No. A-23 A-23
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00900/AM14/DES-III
RLA F. No. 09/24/040/00322/AM14
Advance Authorization No. and Date 0910057914 dated 14.10.2013
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms against Advance Authorization No. 0910057914
dated 14.10.2013
**Decision:**The Committee considered the request of the firm 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. Import items Qty.
No.
DULOXETINE 1000 kg 1 (S)-3-methyl amino-1-(thiophene-2-yl)propan- 676.00 kg
HYDROCHLORIDE 1-ol
2 1-Fluoronaphthalene 710.00kg
3 Tertiarybutyl methyl ether 5430.00kg
4 Dimethyl sulfoxide 610.00kg
5 Isopropyl alcohol 2770.00kg
RA concerned maytake further necessaryaction asper above decision of NC.
Case No. Case No. A-24
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00241/AM14/DES-III
RLA F. No. 09/24/040/00583/AM13
Advance Authorization No. and Date 0910055475dated 21.03.2013
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms fixed against Advance Authorization No.
0910055475 dated 21.03.2013
**Decision:**The Committee considered the request of the firm 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. Import items Qty.
No.
TOLMETIN SODIUM 2000 kg 1 P-ToluoylChloride 3160kg
DIHYDRATE (TLS) 2 Toluene 10240kg
3 N-Hexane 6400kg
4 Methanol 8000kg
5 Dichloromethane 14400kg
6 Methyl-1-Methyl Pyrrole 2 Acetate 2660kg
7 Morpholine 1960kg
RA concerned maytake further necessaryaction asper above decision of NC.

14

ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021 ase No.<br>A-25<br>eeting No.<br>NC/3/MEET/Aug/202122/7<br>ate<br>13/08/2021
C ase No. A-25
M eeting No. NC/3/MEET/Aug/202122/7
Date ate 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQ F. No. 01/82/050/00899/AM/14/DES-III<br>01/82/050/00958/AM/15/DES-III
RLA F. No. 09/24/040/00316/AM14<br>09/24/040/00053/AM15
A dvance Authorizati on No. and Date 0910057908 dated 11.10.20 13
0910060088 dated 13.05.20 14
S
ubject Request of M/s Mylan Lab<br>of adhoc norms against Ad oratories Ltd, Hyderabad for fixation<br>vance Authorization Nos 0910057908
<br>dated 11.10.2013 and 0910 .<br>060088 dated 13.05.2014
D<br>o<br>R **ecision:**The C ommittee considered the request of the firm and it was decided to ratify the ad-hoc input
utput norms under p ara 4.07 of HBP Vol. I as per details below or as a pplied by firm whichever is less:
Qty.
Export Product Qty. Sl. Import items Qty.
<br>No.
DIPYRIDAMOL E 1 kg 1 2,6-Dichloro-4,8-di(pip 0.935 kg
yl)pyrimido[5,4-d]pyrimidine
2 Diethanolamine 2.543kg
3 Toluene 2.244 kg
A concerned maytake further necessaryaction asper above decision of NC.
Case No. A-26
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00104/AM16/DES-III
RLA F. No. 09/24/040/00662/AM15
Advance Authorization No. and Date 0910061843dated31.03.2015
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms against Advance Authorization No. 0910061843
dated 31.03.2015
Decision: Deferred for comments of TE.
Case No. A-27
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00847/AM/13/DES-III
RLA F. No. 09/24/040/288/AM13
Advance Authorization No. and Date 0910053905dated 26.09.2012
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms fixed against Advance Authorization No.
0910053905 dated 26.09.2012
**Decision:**Deferred for comments of TE.

15

Case No. A-28
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. F. No. 01/82/050/00528/AM/16/DES-III
RLA F. No. 09/24/040/00396/AM15
Advance Authorization No. and Date 0910061183 dated 05.11.2014
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms fixed against Advance Authorization No.
0910061183 dated 05.11.2014
**Decision:**Deferred for comments of TE.
Case No. A-29
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00832/AM/13/DES-III
RLA F. No. 09/24/040/00274/AM13
Advance Authorization No. and Date 0910053628dated 29.08.2012
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms against Advance Authorization No. 0910053628
dated 29.08.2012
**Decision:**The Committee considered the request of firm and it was observed that the firm still has not replied
to the points due to which their case was earlier rejected. The firm has shown export item as Fluticasone
Propionate (Crystalline) whereas as per COA furnished by the firm, export description is Fine White Powder.
Physical properties of imported Fluticasone Propionate are not mentioned.
Inviewof above,theCommittee decided to**reject **the case maintainingstatusquo.
Case No. A-30
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00092/AM/15/DES-III
RLA F. No. 09/24/040/00451/AM13
Advance Authorization No. and Date 0910058792 dated31.12.2013
Subject Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation
of adhoc norms against Advance Authorization No. 0910058792
dated 31.12.2013
**Decision:**Deferred for comments of TE.

16

Case No. A-31
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Mylan Laboratories Ltd, Hyderabad
HQ F. No. 01/82/050/00043/AM/12/DES-III<br>01/82/050/01506/AM/15/DES-III<br>01/82/050/01056/AM/15/DES-III
RLA F. No. 09/24/040/00452/AM11<br>09/24/040/00085/AM13<br>09/24/040/00240/AM15
Advance Authorization No. and Date 0910045290 dated 28.01.2011<br>0910052887 dated 05.06.2012<br>0910060930 dated 10.09.2014
Subject Request of M/s Mylan Laboratories Ltd., Hyderabad (formerly<br>known as M/s Matrix Laboratories Ltd.) for fixation of adhoc<br>norms against Advance Authorization Nos. 0910045290 dated<br>28.01.2011, 0910052887 dated 05.06.2012 and 0910060930 dated<br>10.09.2014
**Decision:**Deferred for comments of TE.
Case No. A-32
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’s Name M/s Keva Frangrances Private Limited, Mumbai (Formerly K.V.<br>Arochem Private Limited)
HQF. No. 01/82/050/00986/AM16/DES-III
RLA F. No. 03/94/040/00284/AM16
Advance Authorization No. and Date 0310797268dated 15.07.2015
Subject Request of M/s KevaFrangrances Private Limited, Mumbai<br>(Formerly K.V. Arochem Private Limited) for fixation of adhoc<br>norms against Advance Authorization No. 0310797268 dated<br>15.07.2015
**Decision:**The Committee considered the request of firm and on the basis of chemistry and other details like<br>production / consumption data, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as 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>ISOJASMONE<br>58000.000 kg<br>1<br>CYCLOPENTANONE<br>42816.000kg<br>2<br>HEXANAL<br>41184.000kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

17

Case No. A-33
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’s Name M/s Keva Frangrances Private Limited, Mumbai (Formerly K.V.
Arochem Private Limited)
HQF. No. 01/82/050/00728/AM17/DES-III
RLA F. No. 03/94/040/00525/AM17
Advance Authorization No. and Date 0310807975dated 22.09.2016
Subject Request of M/s Keva Frangrances Private Limited, Mumbai
(Formerly K.V. Arochem Private Limited) for fixation of adhoc
norms against Advance Authorization No. 0310807975 dated
22.09.2016
Decision: The Committee considered the request of the firm and it was decided to call for following information
from the firm:
(i) Complete technical details as per Annexure to Appendix 4E.
(ii) Chemistry, molecular weight & yield.
(iii) Production / Consumption data for last two years duly certified by GST.
C ase No ase No A-34 A-34 A-34 A-34 A-34
<br>M .<br>eetingNo. NC/3/MEET/Aug/20212 2/7
D ate 13/08/2021
F irm’s Name M/s KevaFrangrances<br>Ah Pit Liit Private Limited, Mumbai (Formerly K.V.<br>d
rocem rvae m )
H QF. No. 01/82/050/00124/AM19/ DES-III
R LA F. No. 03/94/040/00762/AM18
A<br> dvance Authorizati<br> on No. and Date 0310818348dated09.01.<br> 2018<br>
S ubject Request of M/s Keva<br>(Formerly KV Aroche Frangrances Private Limited, Mumbai<br>m Private Limited) for fixation of adhoc
..<br>norms against Advanc<br> <br>e Authorization No. 0310818348 dated
09.01.2018
D<br>fr **ecision:**The Co mmittee considered the request of the firm and it w
<br>om the firm:
<br>(i)<br>Chemical name of export and import.<br>(ii)<br>If item is crude or Mixture.<br>(iii)<br>Certificate of Analysis (COA).
<br>(iv)<br>Production / Consumption data for 2017-18, 2018-19 duly certified by GST.

18

Case No. Case No. A-35
Meeting No. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Himalayan Products & Industries Corpn; Pvt Ltd, Deharadun
HQF. No. 01/82/050/02010/AM19/DES-III
RLA F. No. 61/24/040/00005/AM18
Advance Authorization No. and Date 6110001494 dated 27.02.2018
Subject Request of M/s Himalayan Products & Industries Corpn; Pvt Ltd,
Deharadun for fixation of adhoc norms against Advance
Authorization No. 6110001494 dated 27.02.2018
**Decision:**The Committee considered the request of firm and on the basis of chemistry and other details like
production / consumption data, 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.<br>Sl. Import items Qty.
No.
BERBERINECHLORIDEJP 1 kg<br>1 BERBERISARISTATA EXTRACT 1.00kg
RA concerned maytake further necessaryaction asper above decision of NC.
C
ase No. A-36
M eeting No. NC/3/MEET/Aug/202 122/7
<br>D <br>ate <br>13/08/2021
Fi rm’sName M/s Himalayan Produ cts & Industries Corpn; Pvt Ltd, Deharadun
H QF. No. 01/82/050/00920/AM1 9/DES-III
R
LA F. No. 61/24/040/00006/AM1
A dvance Authorizati on No. and Date 6110001534 dated08.0 8.2018
S ubject Request of M/s Himal ayan Products & Industries Corpn; Pvt Ltd,
Deharadun for fi<br>Authorization No. 611 xation of adhoc norms against Advance<br>0001534 dated 08.08.2018
**Decision:**The Committee considered the request of firm and on the basis of chemistry and other details like<br>production / consumption data, it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as 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>BERBERINECHLORIDEJP<br>1 kg<br>1<br>BERBERISARISTATA EXTRACT<br>1.00kg<br>RA concerned maytake further necessaryaction asper above decision of NC. ii
**ecson:**The Committee considered the request of firm and<br>
<br>Qty.<br>1.00kg
Export Product Qty. Sl.<br>No. Import items Qty.
BERBERINECHLORIDEJP 1 kg 1 BERBERISARISTATA EXTRACT 1.00kg
sper above decision of NC.

Decision: The Committee considered the request of firm and on the basis of chemistry and other details like production / consumption data, 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:

19

Case No. Case No. A-37
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Nisarg Biosciences Pvt Ltd, Hyderabad
HQF. No. 01/82/050/00484/AM20/DES-III
RLA F. No. 09/24/040/00236/AM20
Advance Authorization No. and Date<br>0910067858dated01.08.2019
Subject Request of M/s Nisarg Biosciences Pvt. Ltd., Hyderabad for
fixation of adhoc norms against Advance Authorization No.
0910067858 dated 01.08.2019
**Decision:**The Committee considered the request of firm and on the basis of Production / Consumption data
certified by CGST, 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.<br>Sl.<br>Import items Qty.
No.
2-Methyl 5-Amino phenol 7000.000 kg<br>1<br>2M5NA (2-Methyl-5-Nitro aniline) 20293.000 kg
orJarocol 2M5AP
RA concerned maytake further necessaryaction asper above decision of NC.
Case No. A-38
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Shree Ganesh Remedies Pvt. Ltd., Vadodara
HQF. No. 01/82/050/00696/AM16/DES-III
RLA F. No. 34/24/040/00295/AM15
Advance Authorization No. and Date 3410040965dated 16.02.2015
Subject Request of M/s Shree Ganesh Remedies Ltd., Vadodara for
review of norms fixed against Advance Authorization No.
3410040965 dated 16.02.2015
(Grievance Registration No. DOCOM/E/2020/00340 dated
30.03.2020)
Decision: The Committee considered the case as per agenda and it was observed that the reply furnished
by the firm is incomplete. Hence, it was decided to call for following information from the firm:
(i) Percentage yield at every stage of reaction.
(ii) Production / Consumption data for 2015-16 duly certified by Central Excise /
GST.

20

Case No. A-39
MeetingNo. NC/3/MEET/Aug/202122/7
Date 13/08/2021
Firm’sName M/s Aurobindo Pharma Limited, Hyderabad
HQF. No. 01/82/050/01515/AM19/DES-III
RLA F. No. 09/24/040/00168/AM19
Advance Authorization No. and Date 0910066418dated04.07.2018
Subject Request of M/s Aurobindo Pharma Limited, Hyderabad for review<br>of adhoc norms fixed against Advance Authorization No.<br>0910066418 dated 04.10.2018
Decision:The Committee considered the request of the firm and it was decide to revise the norms as under::<br>Sl.<br>No.<br>Export product<br>Qty.<br>(for total export)<br>1<br>Cefepime<br>for<br>Injection<br>1000<br>mg<br>(20ml<br>Vial)<br>(The relevant Bulk Drug content in the Export Product is Cefepime HCl 850<br>Kgs)<br>892.50 kg<br>2<br>Cefepime<br>for<br>Injection<br>2000mg<br>(50ml<br>Vial)<br>(The relevant Bulk Drug content in the Export Product is Cefepime Hcl 500<br>Kgs)<br>525.00 kg<br>Sl.<br>No.<br>Import Items<br>Qty.<br>(for 1 kg Cefepime for injection)<br>1<br>Cefepime Hydrochloride<br>0.655kg<br>2<br>L – Arginine<br>0.37 kg<br> 3<br>Acetone<br>1.00kg<br>4<br>Isopropyl Alcohol<br>0.50kg<br> 5<br>Methanol<br>1.50kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

21

Case No. A-40 Meeting No. NC/3/MEET/Aug/202122/7 Date 13/08/2021 Firm’s Name M/s Supreet Chemicals Pvt Ltd., Surat HQ F. No. 01/82/050/01751/AM19/DES-III RLA F. No. 52/24/040/00006/AM18 Advance Authorization No. and Date 5210042249 dated 05.05.2017 Subject Request of M/s Supreet Chemicals Pvt. Ltd., Surat for enhancement in the quantity of import item in respect of adhoc norms fixed against Advance Authorization No. 5210042249 dated 05.05.2017

Decision: The Committee considered the request of the firm for enhancement in the quantity of import item ortho amino phenol and it was observed that earlier the norms were fixed on the basis of 90% yield in both stages. However, the firm has not claimed 64% yield on both stages. No justification was provided for lower yield, however applicant has now stated the norms for the same export product / import item have already been fixed at SION A-478.

Accordingly, the Committee decided to revise the norms as under:

Export product Qty. Sl. Import items Qty.
No.
5nitro 2 aminophenol 1 kg 1 Ortho amino phenol 1.32 kg

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

Meeting ended with thanks to Chair and participants


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