Despite high-profile Ranbaxy alerts, US FDA finds India okay

Jan 09 2014, 08:32 IST
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It is not obvious, therefore, that Indian companies should be subjected to such stiff and fractious scrutiny. It is not obvious, therefore, that Indian companies should be subjected to such stiff and fractious scrutiny.
SummaryIndia has 526 US FDA units but China attracts only 10% of FDA inspections outside the US.

manufacturing facilities. We believe that we have no outstanding issues with the FDA at this point in time,” Glenmark said.

Mumbai-based Lupin received three Form 483s, of which one was issued against Lupin Bioresearch Center in Pune. The other two facilities were its Madideep unit located in Madhya Pradesh and its unit in Indore. The company has not responded to queries regarding whether the facilities are now cleared by the FDA. Three of Dr Reddy’s Laboratories’ manufacturing facilities were inspected in 2012 – while one was checked in 2011. The Hyderabad-based company said that all 483s were resolved to the satisfaction of the regulator. The company’s Mexico facility received a warning letter in June 2011 which was cleared in July 2012.

“Regulatory headwinds remain one of the key risks to the Indian pharmaceutical sector especially in light of the increasing scrutiny by the USFDA to ensure quality and compliance. While the volume of warning letters issued by USFDA has increased over the last four years, there has been a higher impact on Indian companies recently from the increasing activities of the US regulator (import alerts, warning letters, Form 483s),” a JPMorgan report dated Sept 2013 said.

Eight Indian companies received US-FDA warning letters in FY2013, all of which are still being resolved.

Ranbaxy Laboratories Ltd,

Wockhardt Ltd and Aurobindo are some of the Indian companies that have faced the short end of the regulatory straw in the last two years. While Aurobindo has resolved the import alert issued against its unit-VI cephalosporin facility in Hyderabad facility in March 2013, Wockhardt and Ranbaxy are still struggling to get USFDA nod for its units.

Wockhardt, whose Waluj and Chikalthana units are already facing an import ban for deviations from current good manufacturing practices, received six visits from the USFDA during 2013, of which five resulted in Form 483s. The latest of the five was for the Mumbai-based company’s Baddi unit located in Himachal Pradesh – which was inspected in September, 2013. Gurgaon-based Ranbaxy has three of its units under an import ban, located in Mohali, Dewas and Paonta Sahib. The company’s units were investigated eight times in 2011 and 2012, with no inspection conducted in 2013.

Yusuf Hamied-led Cipla has received eight Form 483s after inspections were conducted in 2011, 2012 and 2013. Its units located in Dhar in Madhya Pradesh and Goa were checked in March and May, 2013.

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