Pharmaceutical Export Promotion Council of India (Pharmexcil) has demanded the Union Ministry of Commerce and Industry to increase the reimbursement fees provided to the Indian companies for product registration in the US by 50 per cent. Through this proposal, the Council aims to safeguard the interest of the Indian companies against the burden of huge user fee that the US FDA is planning to levy from all the companies exporting to the US through its proposed Generic Drug User Fee Act (GDUFA).

In its representation, the council has demanded the government to increase the reimbursement fees from the current Rs.50 lakh per annum to Rs.1 crore per annum for all the companies interested in registering their products in the US under MAI scheme. This move comes in the wake of the proposed GDUFA which is aimed at curbing the import of generic drugs into that country.

The proposed Act empowers the US government to fix an exorbitant fee on the import of each generic product category coming from any overseas sources. The proposed fees could range from $35,000 for API manufacturers to $150,000 for finished drug units, imposition of such a fee on imports could either force the Indian companies to cut their profits drastically or make the prices uncompetitive.

Dr P V Appaji, director general (DG), Pharmexcil stressed, “By increasing reimbursement, we hope to provide some kind of relief to all the exporters in the backdrop of this proposed Act. We have initiated to take-up this export friendly decision to ensure that no matter what the circumstances the exports are not affected drastically due to this issue.”

He said that to get a better understanding on this issue, Pharmexcil just recently completed a study on the fee structure adopted by various countries for product registration. In this independent study conducted by Pharmexcil, they found that compared to other countries the fees that is proposed by the US is much higher and unreasonable. And to ensure that the implementation of this Act does not hamper the exports to the US, Pharmexcil has already began the process to push the Indian government to take some action in the interest of the Industry so that the exports are not affected.

He informed, “After analysing the study we have come to the conclusion that some concrete steps have to be taken to support the industry to afford such huge fees structure that the US FDA has come up with. If this Act gets passed, Indian companies will need the support from the government to export to the US. It is a serious issue that needs to be deliberated and discussed so that the companies are not discouraged from exporting to the US which will be bad for both the countries.”

He further informed that Pharmexcil is soon planning to take-up this issue with the US government as well so that they can urge them to re-consider their proposal on the fee structure.