Exemption from registraion procedure for import of all types of approved and unapproved drugs under the Advance Licencing Scheme - DGFT - 05/2003

Exemption from registraion procedure for import of all types of approved and unapproved drugs under the Advance Licencing Scheme TRADE NOTICE NO. 05/2003 Dated 08/10/2003 The attention of Trade is invited to Policy Circular No.9(RE-2003)/2002-07 dated 30.6.2003 and Policy circular No.15(RE-2003)/2002-2007 on exemption from registration procedure for import of all types of approved and unapproved drugs under the Advance Licensing Scheme. 2.With a view to smoothly implement the provisions of the above mentioned Policy Circulars the members of trade and Industry are hereby informed of the procedure to be followed while making applications for grant of a fresh Advance Licence involving import of all drugs or while applying for grant of revalidation/extension in Export Obligation period/seeking enhancement in quantities in respect of an already issued Advance Licence as follows: 3. Applications for grant of fresh Advance Licences (A) Where an applicant wants to get a licence as per para 3(a) of Policy Circular No. 15 and wishes to avail the benefit of exemption from registration procedure under the Drugs Cosmetics Act. Such applicant will submit declaration as per "Annexure-A" to this Trade Notice. Upon this, licences falling in this category will be issued with the following endorsement: "This licence is issued in terms of Policy Circular No. 9(RE-2003)/2002-2007 dated 30.06.2003. Licensee will comply with all conditions of the said circular read with conditions mentioned in Policy Circular No. 15 (RE-2003)/2002-2007 dated 17.09.2003". 3.(B) As provided under Para 3(b) of Policy Circular No. 15 dated 17.09.2003 the applicants who will import drugs from the registered source and do not wish to seek exemption from registration procedures, they will be issued licences as per existing EXIM Policy provisions and Procedures and the licensee will have to comply with registration procedure under the Drugs Cosmetics Acts for import of any drug against the subject licence.. Such applicants will submit declaration as per "Annexure - B" enclosed to this Trade Notice alongwith their application. Licences falling in this category will be issued with following endorsement: "This licence is issued with condition that import of any drug against this licence will be allowed only through registered sources as per provisions laid down in Drugs Cosmetics Act." 4.Grant of Revalidation/Extension in Export Obligation/enhancement in quantities of import Export against already existing licences: Members of Trade may note that it has already been clarified in Para 6 of Policy Circular No. 15 dated 17.09.2003 that consignments of import of drugs against licences already issued in the past will be cleared subject to the following of registration procedure or subject to obtaining fresh licence in terms of Policy Circular No. 9 dated 30.6.03 if the consignments are from the unregistered sources. It may therefore be noted that in cases of all the past licences the request of the exporters for revalidation/revalidation as well as extension in E.O./enhancement in quantity of imports will have to be necessarily made from registered sources. Therefore, all applications for revalidation/revalidation alongwith extension in E.O./enhancement in quantity of imports and exports should be accompanied by Annexure 'C' to this Trade Notice. Licences falling under this category will be issued with following endorsements: "Revalidation upto ________/Revalidation upto_______ alongwith extension in E.O. upto _______/enhancement in quantities of imports against this licence is allowed subject to the condition that import of drugs against this licences will be allowed only subject to following of registration Procedure by the licencee in accordance with provisions of Drugs Cosmetics Act." However in cases where licence has already been fully utilised and request is for extension in export obligation period only, no additional endorsement regarding compliance with registration procedure will be required since no further imports are to be effected against the subject licence. The Trade may note the above for necessary compliance. Sd/- ( S.S. SANDHU ) ZONAL JT. DIRECTOR GENERAL OF FOREIGN TRADE ANNEXURE 'A' TO TRADE NOTICE NO.5 dated 8.10.2003 I/We M/s. ………… do hereby declare that following items sought to be imported against this application are drugs and we request for grant of Advance License as per conditions of Policy Circular No.9(RE-2003)/2002-07 dated 30.6.2003 Sr.No. Item of Import ITC(HS)CODE Sr No in the list of inputs I/We further undertake to abide by all conditions of Policy Circular No. 9(RE-2003)2002-07 and conditions prescribed by Drug Controller General of India. Signature of Applicant Name in Block Letters OFFICIAL ADDRESS Telephone No: Residential Address E-Mail Address PLACE: Date : ANNEXURE 'B' TO TRADE NOTICE NO. 5 dated 8.10.2003 I/We M/s. ………… do hereby declare that following items sought to be imported against this application are drugs and I/we request for grant of Advance License as per normal conditions of EXIM Policy and Procedures since we shall be following registration procedure under the Drugs Cosmetics Act while importing the under mentioned drugs. Sr.No. Item of Import ITC(HS)CODE Sr No in the list of inputs I/We further undertake to abide by all conditions prescribed by Drug Controller General of India. Signature of Applicant Name in Block Letters OFFICIAL ADDRESS Telephone No: Residential Address E-Mail Address PLACE: Date : ANNEXURE 'C' TO THE TRADE NOTICE NO.5 dated 8.10.2003 I/We M/s. ………… do hereby declare that *(a)I/We request for revalidation upto _____ in respect of advance licence No._______ dt_________ issued from file No. _________. *(b)I/We request for grant of extension in Export Obligation upto ______aong with request for grant of extension in Export Obligation upto _______in respect of advance licence No.________dt.________issued from file No._______________. *(c)I/We request for enhancement in quantities of inputs against advance licence no.__________dt.__________issued from file No._________ *(d) I/We request only for grant of extension in export obligation period upto _______and no further imports are pending against Advance Licence No. ____________dated_________. Therefore please allow extension without any additional conditions. *(Strike out whichever is not applicable) # The following items yet to be imported against this application are drugs and we request for allowing revalidation/revalidation as well as extension in Export Obligation/enhancement in quantities as requested above. We undertake to follow registration procedure under the Drugs Cosmetics Act while importing under mentioned drugs against the advance licence # (Not applicable for applicants making application under category "d" above) Sr.No. Item of Import ITC(HS)CODE Sr No in the list of inputs We further undertake to abide by all conditions prescribed by Drug Controller General of India. Signature of Applicant Name in Block Letters OFFICIAL ADDRESS Telephone No: Residential Address E-Mail Address PLACE: Date