CIR. NO. 15/2003, DT. 17/09/2003

Exemption from registration procedure for import of all types of approved and unapproved drugs under the Advance Licensing Scheme

A number of representations have been received from members of the exporting community and Trade Bodies/Associations, after the issuance of Policy Circular No.9 dated 30.6.2003. The following clarifications are made in this regard:

2. The exemption from registration procedure of the Drugs & Cosmetics Act will not only cover those drugs listed in Notification No.2 dated 31.3.2003 but all drugs.

3. (a) Applicants wishing to avail of the benefit of exemption from registration procedure under the Drugs & Cosmetics Act will apply for an Advance Licence in accordance with the instructions contained in Policy Circular No.9 dated 30.6.2003. The Licensing Authority will make an endorsement on the licence that the exemption has been granted in terms of Policy Circular No.9 dated 30.6.2003.

(b) Other applicants who comply with the registration procedure under the Drugs & Cosmetics Act may apply for a Advance licence as per the existing EXIM Policy provisions & procedures.

4. For ratification of advance licences issued under Para 4.7 of the Handbook of Procedure (Vol. I), the representative of the Drugs Controller General of India (DCGI) will be a member of the ALC at DGFT Hqrs. For items where SION is fixed, the existing prescribed procedure will be followed and a copy of the Advance Licence will be endorsed to DCGI & State Drugs Controller Office. Copies of advance licences issued under Para 4.7 and amendments recommended by ALC will also be endorsed to the State Drugs Controller’s office.

5. The exemption from Registration formalities does not cover Advance Licence under deemed exports, Advance Licence for annual requirements, DFRC & DEPB.

6. All importers making imports against advance licences, which have not been issued in terms of Policy Circular No.9, will either follow the registration procedure and utilise the licence OR get a fresh licence issued in terms of Policy Circular No.9 to clear their consignments.

7. The export obligation period for the advance licences issued as per Policy Circular No.9 dated 30.6.03 will be fulfilled within a period of six months from the date of import of the first consignment (and not from date of issuance of licence as laid down in Policy Circular No.9 dated 30.6.03). Para 4.22.1 of Handbook of Procedures (Vol I) shall however be applicable for advance licences issued under Policy Circular 9 dated 30.09.2003 for the purpose of extension in export obligation period.

This issues with the approval of the DGFT.

(DR. PRATIMA DIKSHIT)
JT. DIRECTOR GENERAL OF FOREIGN TRADE

(Please refer CIR. NO. 41/2003, DT. 22/07/2004 - Import of approved and unapproved drugs under the Advance Licensing Scheme-Exemption from Registration Procedure)

(Please refer CIR. NO. 33/2003, DT. 30/04/2004 - Import of approved and unapproved drugs under the Advance Licensing Scheme-Exemption from Registration procedure.)

(Please refer Trade Notice No. 05/2003, Dt. 08/10/2003 - Exemption from registraion procedure for import of all types of approved and unapproved drugs under the Advance Licencing Scheme)

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