IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2022-11-24

DGFT Committee Minutes

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

Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Nov/202223/13 dated 24/11/2022 under the Chairmanship of Shri Rajiv Kumar Soni, Jt. 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
3 Shri Nand Lal, Technical–3 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.

  2. The committee went through the Minutes of earlier Meeting No. NC/3/MEET/Nov/202223/12 dated 18/11/2022 (actually held on 21/11/2022).

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MANUAL CASES

Case No. Case No. A-01 A-01 A-01 A-01
MeetingNo. NC/3/MEET/Nov/202223/13
Date 24/11/2022
Firm’s Name M/s Aarti Drugs Ltd.
Subject Request of M/s Arti Drugs review of adhoc norms fixed against 77<br>Advance Authorizations
Sl.<br>No Hqrs. F. No. RLA F. No. Advance<br>Authorization<br>No. Advance<br>Authorization Date
1 HQRNORMAPPLY00100557AM22 03AA04029700AM21 0311002516 27-05-2021
2 HQRNORMAPPLY00099246AM22 03AA04000112AM22 0311004037 25-05-2021
3 HQRNORMAPPLY00099853AM22 03AA04006277AM22 0311004052 25-05-2021
4 HQRNORMAPPLY00100048AM22 03AA04010840AM22 0311004059 25-05-2021
5 HQRNORMAPPLY00100049AM22 03AA04014004AM22 0311004060 25-05-2021
6 HQRNORMAPPLY00106682AM22 03AA04021320AM22 0311004283 03-06-2021
7 HQRNORMAPPLY00106683AM22 03AA04021287AM22 0311004284 03-06-2021
8 HQRNORMAPPLY00107444AM22 03AA04021339AM22 0311004322 04-06-2021
9 HQRNORMAPPLY00112663AM22 03AA04022427AM22 0311004537 11-06-2021
10 HQRNORMAPPLY00120846AM22 03AA04028717AM22 0311004808 22-06-2021
11 HQRNORMAPPLY00130745AM22 03AA04042926AM22 0311005095 05-07-2021
12 HQRNORMAPPLY00148514AM22 03AA04052584AM22 0311005674 27-07-2021
13 HQRNORMAPPLY00154546AM22 03AA04058773AM22 0311005930 05-08-2021
14 HQRNORMAPPLY00157208AM22 03AA04061662AM22 0311006047 09-08-2021
15 HQRNORMAPPLY00158859AM22 03AA04062552AM22 0311006072 10-08-2021
16 HQRNORMAPPLY00168069AM22 03AA04065122AM22 0311006313 21-08-2021
17 HQRNORMAPPLY00168174AM22 03AA04065311AM22 0311006321 22-08-2021
18 HQRNORMAPPLY00169932AM22 03AA04069290AM22 0311006414 24-08-2021
19 HQRNORMAPPLY00173288AM22 03AA04074480AM22 0311006526 29-08-2021
20 HQRNORMAPPLY00204926AM22 03AA040107079AM22 0311007539 06-10-2021
21 HQRNORMAPPLY00231062AM22 03AA040112473AM22 0311008038 29-10-2021
22 HQRNORMAPPLY00252656AM22 03AA040113394AM22 0311008534 15-11-2021
23 HQRNORMAPPLY00263425AM22 03AA040109731AM22 0311008810 24-11-2021
24 018205001745AM21 039404000392AM21 0310838931 16-10-2020
25 018205001746AM21 039404000516AM21 0310838932 16-10-2020
26 018205001749AM21 039404001019AM20 0310838949 16-10-2020
27 018205001750AM21 039404000978AM20 0310838950 16-10-2020
28 018205001751AM21 039404000297AM21 0310838951 16-10-2020
29 018205001753AM21 039404000524AM21 0310838953 16-10-2020
30 018205001755AM21 039404000184AM21 0310838958 16-10-2020
31 018205001758AM21 039404000525AM21 0310838974 19-10-2020
32 018205001759AM21 039404000528AM21 0310838975 19-10-2020
33 018205001766AM21 039404000548AM21 0310839000 20-10-2020
34 018205001767AM21 039404000526AM21 0310839001 20-10-2020
35 018205001769AM21 039404000527AM21 0310839017 20-10-2020
36 018205001778AM21 039404000412AM21 0310839084 23-10-2020
37 018205001779AM21 039404000411AM21 0310839085 23-10-2020

3
3 8 018 205001789AM21 0394040 00346A M21 0310839184 28- 10-2020
3 9 018 205001826AM21 0394040 00596A M21 0310839361 05- 11-2020
4 0
018 205001827AM21 0394040 0597 M21 0310839362 05- 11-2020
4 1 018 205001844AM21 0394040 00423A M21 0310839485 11- 11-2020
4 2 HQ RNORMAPPLY00063660AM21 03AA04 018890 AM21 0311001030 16- 01-2021
4 3 HQ RNORMAPPLY00067209AM21 03AA04 019643 AM21 0311001122 21- 01-2021
4 4 HQ RNORMAPPLY00067214AM21 03AA04 019645 AM21 0311001129 21- 01-2021
4 5 HQ RNORMAPPLY00067215AM21 03AA04 019655 AM21 0311001134 21- 01-2021
4 6 HQ RNORMAPPLY00067217AM21 03AA04 019654 AM21 0311001138 21- 01-2021
4 7 HQ RNORMAPPLY00068617AM21 03AA04 020063 AM21 0311001190 22- 01-2021
4 8 HQ RNORMAPPLY00068219AM21 03AA04 020020 AM21 0311001191 22- 01-2021
4 9 H RNORMAPPLY00069628AM21 03AA04 20216 M21 0311001225 25 012021
Q - -
5 0 HQ RNORMAPPLY00075441AM21 03AA04 021687 AM21 0311001421 02- 02-2021
5 1 HQ RNORMAPPLY00097305AM21 0394040 00673A M21 0311001441 04- 03-2021
5 2 HQ RNORMAPPLY00098942AM21 03AA04 022238 AM21 0311001500 08- 03-2021
5 3 HQ RNORMAPPLY00093160AM21 03AA04 024760 AM21 0311001926 26- 02-2021
5 4 HQ RNORMAPPLY00094934AM21 03AA04 026242 AM21 0311002125 02- 03-2021
5 5 HQ RNORMAPPLY00096069AM21 03AA04 027466 AM21 0311002195 03- 03-2021
5 6 HQ RNORMAPPLY00108415AM21 03AA04 028192 AM21 0311002303 22- 03-2021
5 7 HQ RNORMAPPLY00100470AM21 03AA04 028406 AM21 0311002391 10- 03-2021
5 8 HQ RNORMAPPLY00100472AM21 03AA04 028410 AM21 0311002393 10- 03-2021
5 9 HQ RNORMAPPLY00108766AM21 0394040 00652A M21 0311002733 22- 03-2021
6 0 A1A22 44 22 21
HQ NORMPPLY0000303M 03900 09 M 0311002737 05- 04-2021
6 1 HQ RNORMAPPLY00003027AM22 03AA04 031763 AM21 0311002768 05- 04-2021
6 2 HQ RNORMAPPLY00047353AM22 03AA04 031724 AM21 0311002771 21- 05-2021
6 3 HQ RNORMAPPLY00184798AM22 03AA04 091486 AM22 0311007000 15- 09-2021
6 4 HQ RNORMAPPLY00287541AM22 03AA04 013141 5AM22 0311009528 16- 12-2021
6 5 HQ RNORMAPPLY00292375AM22 03AA04 013152 8AM22 0311009652 21- 12-2021
6 6 HQRNORMAPPLY00300612AM22 03AX04000458AM22 0311009880 29-12-2021
6 7 HQRNORMAPPLY00300738AM22 03AX04000454AM22 0311009888 29-12-2021
6 8 HQRNORMAPPLY00301808AM22 03AX04000439AM22 0311009908 30-12-2021
6 9 HQRNORMAPPLY00305699AM22 03AA040128756AM22 0311009997 03-01-2022
70 0 HRNORMAPPLY00320474AM22 03AA040113369AM22 0311010560 1012022
Q 7--
71 HQRNORMAPPLY00320476AM22 03AX04000684AM22 0311010562 17-01-2022
7 2 HQRNORM APPLY00331312AM22 03AX04000872AM22 0311010876 25-01-2022
7 3 HQRNORM APPLY00356040AM22 03AX04001181AM22 0311011428 15-02-2022
7 4 HQRNORM APPLY00363471AM22 03AX04000968AM22 0311011657 22-02-2022
7
5 HQRNORM APPLY00365148AM22 03AX04001134AM22 0311011711 23-02-2022
7 6 HQRNORM APPLY00365877AM22 03AX04001350AM22 0311011719 24-02-2022
7
7 HQRNOR APPLY00367127AM22 03AX04001176AM22 0311011786 25-02-2022
ecision:<br>Shri <br> Prasannan Namboodivi, Advocate, Shri Dhanaji L. Kakade, Vice President (Technical) and<br>
hri Rajesh Gore,<br>M/s Aarti Drugs is<br>xort to various c Manager Liaison had attended the Personal Hearing and explained firm’s case stating that<br>the largest manufacturer of Ciprofloxacin Hydrochloride BP/EP/USP(Ciprofloxacin) with 90%<br>untries includin hihl reulated International Markets Tomeet the strinent reuirements of
p g gy g . g q<br>egulated international markets, purity as well as impurity profile wastage is high in terms of conversion losses in the<br>rocess. The firm has taken 77 Advance Authorizations so far in last 3-4 years and export is still going on. The firm<br>as further stated that approx 50% of its export is to regulated markets like US, European Countries and Japan. The<br>irm was not ready with the list of Advance Authorizations where the export has been to regulated markets exclusively.

Decision: Shri Prasannan Namboodivi, Advocate, Shri Dhanaji L. Kakade, Vice President (Technical) and Shri Rajesh Gore, Manager Liaison had attended the Personal Hearing and explained firm’s case stating that M/s Aarti Drugs is the largest manufacturer of Ciprofloxacin Hydrochloride BP/EP/USP(Ciprofloxacin) with 90% export to various countries including highly regulated International Markets. To meet the stringent requirements of regulated international markets, purity as well as impurity profile wastage is high in terms of conversion losses in the process. The firm has taken 77 Advance Authorizations so far in last 3-4 years and export is still going on. The firm has further stated that approx 50% of its export is to regulated markets like US, European Countries and Japan. The firm was not ready with the list of Advance Authorizations where the export has been to regulated markets exclusively.

The Committee observed that the firm has large number of Advance Authorizations pertaining to Ciprofloxacin Hydrochloride BP/EP/USP(Ciprofloxacin) and there is also variation in the consumption norms from other small exporters. Hence, the Committee decided that the Plant / Factory may be visited by DGFT Officials to ascertain the actual wastage in above Advance Authorizations to arrive at a conclusion.

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C
ase No. A-02
iN NC/3/MEET/N/202223/13
eetngo. ov
D ate 24/11/2022
F irm’s Name M/s Ascent Finechem Private Limited
HQ F. No. Q F. No. HQRNORMREVIW00166247AM22
(Earlier F. No. 01/82/050/01116/AM14/DES-III)<br>HQRNORMREVIW00166244AM22<br>(Earlier F. No. 01/82/050/00174/AM16/DES-III)<br>HQRNORMREVIW00166233AM22<br>
(Earlier F. No. 01/82/050/00539/AM17/DES-III)<br>
01/82/050/00699/AM13/DES-III
R LA F No 08/24/040/00415/AM14
. . 08/24/040/00397/AM15
08/24/040/00104/AM17<br>
08/24/040/00160/AM13
A dvance Authorizati on No. and Date 0810127686 dated 03.01.2014<br>0810134800 dated 13032015
..<br>0810138218 dated 28.06.2016
0810114398 dated 21.08.2012
S ubject Request of M/s Ascent Finechem Private Limi<br>adhoc norms against Advance Authorization Nos<br>03012014 0810134800 dtd 13032015 ted for revision of<br>. 0810127686 dated<br>0810138218 dtd
.., ae ..,<br>28.06.2016 and0810114398 dated 21.08.2012 ae
Decision:<br>Shri Anil Jain, CEO, Shri D.K. Singh and Shri R.K. Singh had attended the Personal Hearing and<br>explainedfirm’scase.<br>The Representatives of the firm furnished the copy of various patents and technical documents in<br>support of their request for excess quantity of Acetone.<br>The Committee after hearing the explanation of Representatives of firm decided to re-fix adhoc<br>norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>RASPBERRY KETONE/ 4-(4-<br>HYDROXYPHYENYL)<br>BUTANE - 2 - ONE WHITE<br>CRYSTALLINE POWDER<br>(Assay NLT 99%)<br>1 kg<br>1<br>p-HYDROXY BENZALDEHYDE (LIGHT<br>YELLOW CRYSTALLINE POWDER),<br>PARA HYDROXY BENZALDEHYDE, 4-<br>HYDROXY BENZALDEHYDE<br>1.69 kg<br>2<br>ACETONE (COLORLESS LIQUID)<br>1.810 kg<br>3<br>G2PAC ASSEMBLY 700 LITER / 250<br>KGS (35 inch x 35 inch x 35 inch<br>polypropylene woven fabric bags)<br>Relevant as<br>per packing<br>policy<br>Note:<br>The above norms are valid only with the fulfillment of following conditions:<br>1.<br>Export to US only.<br>2.<br>Content of 1, 5-Bis(4-Hydroxyphenyl)-Pentan-3-one is NMT 1.2%.<br>3.<br>Assay of export item is NLT 99% by HPLC.<br>RA concerned may take further necessary action as per above decision of NC. ecision:<br>Shri Anil Jain, CEO, Shri D.K. Singh and Shri R.K. Singh had attended the Pe<br>xplainedfirm’scase.<br>The Representatives of the firm furnished the copy of various patents and tech rsonal Hearing and<br>nical documents in
The C<br>orms as under: ommittee after hearing the explanation of Representatives of firm decided to re-fix adhoc
Export product Sl.<br><br>Import items<br>Qty.
Qty. Sl.<br> Import items Qty.
RASPBERRY No.
ETONE/ 44 1 k 1 HYDROXY BENZALDEHYDE LIGHT 169 k
<br>HYDROXYPHY -(-<br>ENYL) g p- (<br>YELLOW CRYSTALLINE POWDER), . g
BUTANE - 2 - <br>CRYSTALLINE ONE WHITE<br>POWDER <br>PARA HYDROXY BENZALDEHYDE, 4-<br>HYDROXY BENZALDEHYDE
(Assay NLT 99%)<br>2<br>ACETONE (COLORLESS LIQUID)<br>1.810 kg<br>3<br>G2PAC ASSEMBLY 700 LITER / 250<br>KGS (35 inch x 35 inch x 35 inch<br>polypropylene woven fabric bags)<br>Relevant as<br>per packing<br>policy<br>Note:<br>The above norms are valid only with the fulfillment of following conditions:<br>1.<br>Export to US only.<br>2.<br>Content of 1, 5-Bis(4-Hydroxyphenyl)-Pentan-3-one is NMT 1.2%.<br>3.<br>Assay of export item is NLT 99% by HPLC.<br>A concerned may take further necessary action as per above decision of NC. 2<br>3 ACETONE (COLORLESS LIQUID) 1.810 kg
G2PAC ASSEMBLY 700 LITER / 250<br>KGS (35 inch x 35 inch x 35 inch<br>polypropylene woven fabric bags) Relevant as<br>per packing<br>policy
concerned may take furth er necessar y action as per above decision of NC.
Meeting en ded with thanks to Chair and part<br>***** icipants

Meeting ended with thanks to Chair and participants

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