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IN FORCE Advance Authorisation

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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/Jul/202324/09 dated 28/07/2023 (Manual Case) 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:

S.N.<br>Name & Designation<br>Department S.N.<br>Name & Designation<br>Department S.N.<br>Name & Designation<br>Department
1<br>Shri D.N. Mathur, Technical<br>Consultant
In attendance
1<br>Shri T. Songzalian, Deputy DGFT<br>DGFT
2 Shri Uttam Dey Sarkar, ASO 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.

Manual Cases for Personal Hearing held on 28/07/2023.

Manual Cases for Personal Hearing held on 28/07/2023.
Case No. A-01
MeetingNo. NC/3/MEET/Jul/202324/9
Date 28/07/2023
Firm’s Name M/s Arch Pharmalabs Limited
HQ F. No. 01/82/050/01249/AM19/DES-III<br>01/82/050/01251/AM19/DES-III<br>01/82/050/01260/AM19/DES-III<br>01/82/050/01263/AM19/DES-III<br>01/82/050/01264/AM19/DES-III
RLA F. No. 03/94/040/00126/AM19<br>03/94/040/00141/AM19<br>03/94/040/00158/AM19<br>03/94/040/00160/AM19<br>03/94/040/00162/AM19
Advance<br>Authorization<br>No. and Date 0310822659 dated 27.07.2018<br>0310822660 dated 27.07.2018<br>0310822729 dated 31.07.2018<br>0310822732 dated 31.07.2018<br>0310822734 dated 31.07.2018
Subject Request of M/s Arch Pharma Labs Limited for fixation of adhoc norms<br>with the description of Export Product “3a-Hydroxy-7-keto-5b-cholan-<br>24-oic acid (IP-5)”
Decision : Shri Ashish Ujagare, Technical Director, Shri Sanjay Dhyalter and Shri<br>Parth V.

oc norms<br>with the description of Export Product “3a-Hydroxy-7-keto-5b-cholan-<br>24-oic acid (IP-5)”| |Decision :|Shri Ashish Ujagare, Technical Director, Shri Sanjay Dhyalter and Shri<br>Parth V. had attended the Personal Hearing and explained firm’s case.<br>The Committee heard the explanation of Representatives of the firm and<br>after personal hearing the committee decided to change the description<br>of Export Product from**‘URSODEOXYCHOLIOC ACID (UDCA)’to“3a-<br>Hydroxy-7-keto-5b-cholan-24-oic acid (IP-5)”with the following<br>conditions:<br>(i)<br>Against<br>100<br>kg<br>of<br>export<br>obligation<br>of<br>‘URSODEOXYCHOLIOC ACID (UDCA’ , the export of 85**<br>kg of “3a-Hydroxy-7-keto-5b-cholan-24-oic acid (IP-5)”<br>may be endorsed based on the main raw material<br>Cholic Acid.<br>(ii)<br>Import of input item No. 4 and 6 are not allowed for<br>export of “3a-Hydroxy-7-keto-5b-cholan-24-oic acid (IP-<br>5)”. Custom duty plus interest etc. will be paid for such<br>import, as per policy.<br>(iii)<br>For any excess of other inputs imported in each<br>license, the firm will pay custom duty + interest as<br>applicable under the Policy.|

*<br>import, as per policy.<br>(iii)<br>For any excess of other inputs imported in each<br>license, the firm will pay custom duty + interest as<br>applicable under the Policy.|

Following adhoc norms for**“3a-Hydroxy-7-keto-5b-cholan-24-oic**<br>**acid (IP-5)”**are approved after Personal Hearing as under:- Following adhoc norms for**“3a-Hydroxy-7-keto-5b-cholan-24-oic**<br>**acid (IP-5)”**are approved after Personal Hearing as under:-
Export Product<br>Qty Sl.<br>No.<br>Import Items<br>Qty
3a-Hydroxy-7-<br>keto-5b-cholan-<br>24-oic acid<br>(IP-5)<br>[7-Ketolithocholic<br>acid(3α-Hydroxy-<br>7-oxo-5β-cholanic<br>acid),<br>Minimum<br>99.75%. No single<br>related<br>or<br>unrelated impurity<br>should be more<br>than 0.05%]<br>1 kg 1<br>CHOLIC ACID<br>1. 65kg
2<br>HYDRAZINE<br>HYDRATE<br>(80% SOLUTION)<br>1.65 kg
3<br>IEP OX 239 SPRAY<br>DRIED<br>ENZYME<br>POWDER<br>0.033 kg
4<br>IEP OX 235 SPRAY<br>DRIED<br>ENZYME<br>POWDER<br>Not required
5<br>IEP OX 152 SPRAY<br>DRIED<br>ENZYME<br>POWDER<br>0.050 kg
6<br>IEP SP 41 SPRAY<br>DRIED<br>ENZYME<br>POWDER<br>Not required
7<br>IEP OX 243 SPRAY<br>DRIED<br>ENZYME<br>POWDER<br>0.040 kg
8<br>(B-NAD)B-<br>NICOTINAMIDE-<br>ADENINE<br>DINUCLEOTIDE<br>( COENZYME-1)<br>0.008 kg
**Note:**Above norms are for regularization and closure purpose only.<br>No fresh licence will be issued on above said ad-hoc norms.
RA concerned may take further necessary action as per above decision<br>of NC.

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