In a major blow to the Indian pharmaceutical company, US Food and Drug Administrator (FDA) told Ranbaxy earlier this month that it had made an error in granting the company tentative approvals to launch generic version of the drugs Nexium and Valcyte and revoked these approvals citing non-compliance with FDA’s manufacturing quality standards in Ranbaxy’s India plants.
The agency also stripped Ranbaxy of six month market exclusivity on the launch of generic Valcyte and has already given a go ahead to India based Dr. Reddy’s Laboratories Ltd and US based Endo International to launch generics of Valcyte. Stung by the revocation, Ranbaxy sued the US FDA before the District Court of Columbia for revoking these approvals contending that the FDA had no power to correct a mistake it made six years ago and the order was unconstitutional, arbitrary and capricious.
It also sought an injunction against the competitors from launching copies of these drugs as the tentative approval gave an exclusive right to the company. It also stressed on the fact that the FDA issued its revocation decision with no prior notice. Earlier in 2008, Ranbaxy was the first company to receive tentative approvals by US FDA to launch generic versions of the two drugs making it eligible to exclusively market the medicines for six months.
However the US Court has denied any relief to Ranbaxy and declined to stop competitors from launching generic versions of Astrazeneca’s Nexium and Roche’s antiviral Valcyte. The patent term of the drugs has already ended. Since last year, several manufacturing plants of leading domestic companies including Ranbaxy, Sun Pharma and Wockhardt have come under the FDA’s scrutiny on compliance with quality standards. Even, recently FDA conducted a surprise inspection of Dr Reddy’s Laboratories’ Visakhapatnam plant.
The surprise check by the regulator was at the chemical technical operation (CTO) unit VI, which manufactures both active pharmaceutical ingredients(APIs) and bulk drugs. It also warned Cadila Pharmaceuticals Ltd regarding quality and manufacturing standards at the plants, which caused impurities in drug ingredients made there. Apart from the compliance issues, price rise for generic drugs by Indian generic makers have also come under scrutiny by the US. It is being contented that generic drugs were meant to help make medication affordable for the millions of Americans who rely on prescriptions to manage their health needs and some of them are becoming unaffordable because of the highly priced generics.