Pharmacopeia Nomenclature Treated as Interchangeable for Export Product for Fulfillment of Export Obligation

[DGFT Policy Circular No. 35 dated 3rd June 2010]

Subject:-Inter-changeability of pharmacopeia suffix USP/EP/BP/JP/IP with the export product for fulfillment of Export Obligation.

PHARMEXCIL has represented that if an exporter has been issued an Advance Authorization for an export product suffixing one pharmacopoeia say USP and at the time of redemption of Advance Authorization, the exporter submits the export documents containing the export product suffixing another pharmacopoeia, say BP, the Zonal/Regional offices sometimes do not accept such exports towards fulfillment of export obligation. It has been suggested that the pharmacopoeia standard other than mentioned in the licenses should be considered towards fulfillment of export obligation, i.e., pharmacopoeia, viz., USP/EP/BP/JP may be treated as interchangeable.

2. The matter has been considered by the concerned Norms Committee. It was noted that General Note No.4 for ‘Chemical and Allied Products’ already existing in Hand Book of Procedure Vol. II reads as under:-

“In respect of drug items, export products have been described with/without suffix such as IP, BP, USP. While issuing licenses, suffix as such IP, BP, USP, depending upon the suffix used in the export order, may be added along with the description of the export product.”

3. From the above, it is seen that even if a firm does not use any suffix, they are allowed to export the product with suffix BP or JP or USP as the case may be. It is thus clarified here that if an advance authorization is issued for the export product suffixing pharmacopeia say USP, the export documents containing the export product suffixing any other pharmacopoeia, viz., BP or EP or JP or IP may also be accepted towards fulfillment of export obligation against relevant Advance Authorization. Thus pharmacopeia IP, BP, EP, JP, or USP may be treated as interchangeable for the purpose of fulfillment of export obligation.

4. This issues with the approval of Director General of Foreign Trade.