Even as the US Food and Drug Administration (US FDA) is all set to introduce the proposed Generic Drug User Fee Act (GDUFA) incurring a huge financial burden ranging from $35,000 to $150,000 on the exporters, Indian exporters have demanded to enhance the financial benefits provided under the export promotion schemes like Market Access Initiatives (MAI) scheme and marketing development assistance (MDA) scheme.

As per the proposed GDUFA, which the US FDA has recently recommended to the US Congress, US FDA is going to levy from October 2012 a user fee of $35,000 for API and $100,000 on each generic drug approval. The US FDA is also proposed to impose a fee for re-inspection of FDA-approved facilities abroad and on Drug Master Files (DMFs) filed by the companies.

In order to partially offset the financial burden due to the introduction of the proposed GDUFA, the exporters have asked the union commerce ministry to enhance the financial benefits under the MAI scheme to Rs.1 crore per annum from the existing Rs.50 lakh. Besides, bio-equivalence and country registration charges have also to be reimbursed under the MAI scheme.

Likewise, the MDA scheme also needs to be revised in case of air tickets and delegations abroad. It is still the same for the last many years. In reality it is not really appealing to the first time entrepreneurs. Export ceiling to be increased from Rs.15 crore to Rs.50 crore for availing this scheme, exporters demanded to the government.

Unlike the brand manufacturers who pay fees under Prescription Drug User Fee Act (PDUFA), the generic industry does not pay a user fee to support US FDA activities related to its applications. The GDUFA is expected to help fund a portion of US FDA’s drug review activities while FDA agrees to overall performance goals, such as reviewing a certain percentage of applications within a particular timeframe.

Meanwhile, exporters in the country, who suspect the hand of US generic industry leaders behind the proposed GDUFA to stop competition from the Indian generic manufacturers, said that they are not against GDUFA which is designed to address the regulatory challenges in an affordable manner. However they pointed out that what they are concerned about is the unreasonable fees that is proposed to be levied from the exporters.