The Pharmaceutical Export Promotion Council of India (Pharmexcil) has called on the Indian government to provide more help to domestic drugmakers seeking to export to the US, following Congressional approval for new US Food and Drug Administration (FDA) user fees.
The FDA Safety and Innovation Act (FDASIA), which was approved by both the US House and Senate at the end of June, includes the Generic Drug User Fee Act (GDUFA), which requires the generic drug industry to pay $299 million in annual user fees for the next five years, starting this October 1.
Pharmexcil has told India’s Union Ministry of Commerce and Industry that, as a result of GDUFA, the reimbursement fees provided by the Ministry to all Indian companies seeking to register their products in the USA under the Market Access Initiative (MAI) scheme need to be increased by 50%, from 5 million rupees a year to 10 million rupees.
According to Pharmaxecil, FDASIA empowers the US government to set an “exorbitant” fee on the import of each generic product category coming from any overseas source, and that this could range from $35,000 for active pharmaceutical ingredient (API) manufacturers to $150,000 for finished drug units. The imposition of such fees on imports could either force Indian drugmakers to cut their profits drastically or make their prices uncompetitive, the Council tells the Ministry.
Pharmexcil has also recently completed a study comparing the fee structures of various countries for product registration, and this reveals that the proposed new US fees are “much higher and unreasonable” in comparison to other countries, according to Pharmexcil director general Dr PV Appai.
“After analysing the study, we have come to the conclusion that some concrete steps have to be taken to support the industry to afford the huge fees structure included in the Act,” he said. “Indian companies will need support from the government to export to the US. It is a serious issue that needs to be deliberated and discussed so that companies are not discouraged from exporting to the US, which will be bad for both countries,” added Dr Appai, who also noted that Pharmexcil is planning to take up the matter with the US government shortly, to try to urge a reconsideration of the proposed fee structure.
Meantime, India’s Department of Pharmaceuticals is set to meet with drugmakers and doctors’ representatives on July 18 to discuss whether the pharmaceutical marketing code should be made mandatory.
The Department put the code forward a year ago as a voluntary measure to end the practice of firms giving doctors gifts and incentives to prescribe their products, but drugmakers have not been adhering to it, according to Congress MP Jyoti Mirdha, a member of the parliamentary standing committee on health. The Department, which is part of the Ministry of Chemicals and Fertilisers, has said that it would make the code mandatory if companies were found not to be adhering to it on a voluntary basis.
Local observers comment that, as the Department does not have the power to regulate the pharmaceutical industry, responsibility for drugmakers’ marketing practices should be passed to the Drugs Controller General of India (DCGI).
