Indian cos among firms yet to pay annual facility fees to FDA

US health watchdog FDA has named at least five Indian companies, including Marck Biosciences and RPG Life Sciences, among 43 drugmakers that have failed to meet their annual facility fee payment obligations.
The other Indian firms that have not satisfied their annual fee requirements under the Generic Drug User Fee Amendments (GDUFA) include Virupaksha Organics Pvt Ltd, Vista Pharmaceuticals Limited and Vital Laboratories Private Ltd.
The non-Indian companies on the GDUFA Facility Arrear List, as on September 4, 2013, include Akzo Nobel, Allergan, Colgate Oral Pharmaceuticals and Daichi Sankyo Bethlehem.
India is the second largest drug exporter to the US.

Indian drugmakers mostly specialise in manufacturing of generic versions of innovative drugs at a fraction of cost after their patent expiry and are estimated to command 10 per cent share in the USD 30-billion US generic drug market. About 40 per cent of the over the counter (OTC) prescription drugs sold in the US market comes from India.
The US regulations require the companies to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.

"Failure to timely submit the annual facility payment means that the Food and Drug Administration (FDA) will not be able to receive new ANDAs (Abbreviated New Drug Applications) or PASs (Prior Approval Supplements) referencing these facilities until the outstanding fee is paid," FDA said.

The FDA will also not be able to process applications submitted by the owners, or affiliates of the owners, of these facilities, the notification added.
FDA said these facilities have not satisfied their annual facility fee as required under GDUFA. These facility fee was due no later than March 4, 2013.
Companies from other nations like 5N Plus Lubeck GmbH, BSP Pharmaceuticals Srl, Fujimoto Chemicals Co Ltd, Hainan Hailing Chemipharma Corporation Ltd, Korea United Pharm Inc and Purdue GMP Center LLC also figure in the FDA list of entities with fee arrears.
FDA also said that it encourages the companies to seek verification from business partners that all applicable fee(s) have been received in full by the Agency in order to minimise the risk that a receipt of an application will be jeopardised.

Many Indian drugmakers will soon have to bear higher costs for sale of products in American markets, as the US health regulator FDA is hiking the fees for generic drugmakers by up to 48 per cent from October.
FDA says that these fees help it reduce the backlog of pending applications, cut the average time required to review generic drug applications for safety, and improve the risk-based inspections.