Commerce ministry may step up MAI sops to exporters to cope with burden of GDUFA.

In a move that could bring huge relief to the Indian exporters to the US, the commerce ministry may soon provide some incentives to support the exporters to cope up with the increasing burden of huge user fee that the US FDA has been levying from them under its Generic Drug User Fee Act (GDUFA).

The ministry is said to be seriously considering the possibility of increasing the reimbursement fees from the current Rs.50 lakh per annum for all the companies interested in registering their products in the US under the MAI scheme. This development comes in the wake of growing unrest in the industry over the huge and growing financial burden that the exporters have been facing since implementation of GDUFA in the US.

With a view to safeguard the interest of the exporters, even Pharmaceuticals Export Promotion Council of India (Pharmexcil) has been pushing the ministry to take some pro active steps in this regard.

“We completely understand the issues faced by the industry and recognise the fact that it is becoming increasing difficult for them, especially, the small scale manufactures to export to the US under the present circumstances. Industry is feeling the brunt of the of the high cost of registration fee and considering the overall situation the government should come up with a suitable relief measure for them to deal with this pressure.”

In fact the Council has already sent representation to the ministry demanding the ministry to increase the reimbursement fees to Rs.1 crore per annum for product registration in the US, an increase by 50 per cent. As per the latest reports, the fees that the Indian exporters have to pay range from Rs.28 lakh for API manufacturers to Rs.50 lakh for finished drug units.

A highly placed source from the industry claims that the imposition of GDUFA has come as a huge shock to the industry and they have already started feeling the heat of the same. Under this pressing circumstances the government should provide immediate support to the industry to ensure that the exports and the future of the industry is not threatened.


Source : pharmabiz.com