The union commerce ministry is soon expected to come up with some relief measures to support the Indian pharma exporters to cope up with the additional expenses they will have to bear with the implementation of the proposed Generic Drug User Fee Act (GDUFA) in the US. With a view to address the woes of the Indian exporters, the ministry is seriously considering to increase the level of financial assistance allotted to the Indian companies for exporting to the US.

Industry experts informed that the commerce ministry is showing positive inclination towards taking up the long standing demand of the Indian exporters for enhanced financial benefits under the export promotion schemes like Market Access Initiatives (MAI) scheme and marketing development assistance (MDA) scheme. It is learnt that discussions are under way for analysing the present conditions so as to raise the government incentives allotted for product registration in the US from Rs.50 lakh to Rs.1 crore per annum.

The proposed Generic Drug User Fee Act empowers the US government to fix an exorbitant fee on 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 feels that though this move which is expected to help fund a portion of FDA’s drug review activities is a natural process, the huge fees that they are planning to levy seems to be utterly unreasonable. “Though it is natural on their part as a development process to implement user fees it will be an additional burden on the Indian pharma exporters especially the small scale manufacturers to shell out such a huge amount for each product registration. Under the circumstances it is essential to provide some kind of relief to all the exporters to ensure that the export to the US, which is one of the biggest markets, does not get affected in the backdrop of this proposed Act,” he added.

Industry insiders pointed out that discussion on possibility of increasing the reimbursement is a good start towards identifying the issues of the industry which reassures the government's efforts to boost exports.