FDA issues warning letters to India's largest drugmaker

The US Food and Drug Administration (FDA) has banned the import of more than 30 drugs made by Ranbaxy, India’s largest drugmaker. The ban - which includes generic copies of simvastatin (Zocor) and the antiviral drug acyclovir - covers the drugs made at two Ranbaxy plants which the FDA says failed to meet current Good Manufacturing Practice (cGMP) standards. 

The FDA investigated the two plants, in Dewas and Paonta Sahib, India, early in 2008. Investigators found ’significant cGMP deviations’, which include inadequate cross-contamination control, inadequate sterile processing operations, and a lack of record keeping. No safety issues have been found with the drugs themselves - and the regulator recommends patients continue to take any Ranbaxy medications they have been prescribed. 

Ranbaxy says it is disappointed by the ban, claiming that it had responded to each concern raised by the FDA and that progress was being made. The company adds that it will continue to work with the FDA to resolve the outstanding issues, and has hired former New York City mayor Rudolph Giuliani as an advisor and to review the compliance issues.

The FDA had come under increasing pressure to act over ongoing investigations of the Indian firm. On 22 July, Democratic Congressmen John Dingell and Bart Stupak, key members of the US House of Representatives’ Energy and Commerce Committee, requested an array of documentation from the FDA to assess allegations the regulator had concerns about Ranbaxy drugs but had failed to pull them from the market.

A spokesperson for the European Medicines Agency (EMEA) told Chemistry World that none of the drugs implicated in the FDA’s action have central, EU-wide approval, so no action has been taken by the EMEA. However, several of the drugs have country-specific approval within the EU, so the relevant national authorities will need to investigate the impact of the FDA’s findings - work understood to be underway, the spokesperson added.

James Mitchell Crow

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