DGFT clears doubts over registration need for drug imports under AL Scheme
The Directorate General of Foreign Trade (DGFT) has clarified that the recently announced exemption from registration procedure for import of all types of approved and unapproved drugs under Advance Licensing (AL) Scheme does not cover AL under deemed exports, AL for annual requirements, DFRC & DEPB.
In a clarification to the Policy Circular No 9 of DGFT, the authority has said that all importers making imports against AL, 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.
As per the clarification, 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, it said.
For ratification of AL 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 Head Quarters. For items where SION is fixed, the existing prescribed procedure will be followed and a copy of the AL 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, it explained.
The circular wanted the applicants wishing to avail of the benefit of exemption from registration procedure under the Drugs & Cosmetics Act to apply for an AL 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. 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, it said.