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MAI promise for reimbursement of drug registration fees remains a dream
Joe C Mathew, New Delhi | Tuesday, January 6, 2004, 08:00 Hrs  [IST]

The central assurance for reimbursement of the amount spent towards product registration charges in select foreign markets for pharmaceuticals and biotechnology products under the Market Access Initiative (MAI) continues to remain in paper as the ministry has failed to announce any corresponding scheme or procedure for availing this facility.

It should be noted that the rationale behind the announcement (Chapter 3 - Para 3.2 (viii) of Exim Policy, 2003-04) was to share the burden of the medicine exporting community by reimbursing the registration fees charged by overseas authorities. The registration involves substantial cost and is also of a recurring nature, applicable to every product cleared for export. The implementation of the policy provision would have helped to make the pharma exports cost effective. The countries that are being covered under the MAI include the Latin American region, Sub-Saharan region and some of the constituents of the erstwhile Soviet Union.

According to the Basic Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council (Chemexcil), MAI exists only in theory as far as re-imbursement of registration fees is concerned. "Under the MAI provided for in Exim Policy, there is a provision for re-imbursement of registration charges paid to authorities in registering country's in respect of pharmaceutical and biotechnology products. However, there is no corresponding scheme or procedure laid down for the exporting community to avail of this provision of policy. In the absence of concrete scheme or protocol, it has not been possible for the exporting community to make practical use of the MAI." The council has noted.

"Proper implementation of this provision would attract many more manufacturers into the export fold and maximise exports. Products can be offered at lesser price and our products will be more competitive." It has felt. The council is to take up the matter with the parent ministry for necessary follow up action.

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