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Ranbaxy drugs cleared FDA test before import alert

Regulator says it did not find any failures in the tests

Sushmi Dey  |  New Delhi 

The US Food and Drugs Administration (FDA) says before it imposed an on the Laboratories three key Indian facilities in 2008, it had “sampled and tested” their products in the

“FDA did not find any failure for the tests performed,” Christopher C Kelly from the US FDA’s Office of Media Affairs told Business Standard.

FDA, after its inspection in early 2008, imposed import alerts on Ranbaxy’s Paonta Sahib, Batamandi (both in Himachal Pradesh), and Dewas (Madhya Pradesh) facilities in September that year, barring the importation of active pharmaceutical ingredients and finished drug products from these facilities. “The covered more than 100 different drug products,” Kelly said.

FDA had also issued warning letters to Ranbaxy’s Paonta Sahib and Dewas facilities as it found extensive problems and deviations from manufacturing norms. Despite such stringent actions, the regulator did not order recall of any of the products that were present in the at that point in time.

Asked why the regulator did not recall stocks available in the market, FDA responded: “Based on the evidence we had at the time, FDA acted appropriately within the scope of its authority to protect the public from drugs that failed to comply with federal quality standards.”

FDA’s statement assumes significance in the backdrop that Ranbaxy’s previous promoter Malvinder Mohan Singh, who was the chairman of the company in 2008 when it received US FDA’s import alert, recently denied that he was aware of any wrongdoing or fraud in the company. Instead, he said pleading guilty in the US was the current management’s decision and could be their business model.

“What they (Daiichi Sankyo) have gone and done, how can I comment on that? No wrongdoings were ever reported to us… It is for them to talk about. How can I talk about what they discussed, why they agreed,” Singh said during a recent interaction with Business Standard.

“We had the best people in the industry, the best global managers in the company. Do you want to imply that they were all doing wrong things? Building a business of global stature on wrongdoing? We are talking about India’s most reputed company, which had taken Brand India global. I sold this business (to Daiichi Sankyo), and they wanted to do it their way; so I moved out.”

Daiichi Sankyo acquired a majority stake in in 2008. The company had signed the initial deal agreement with Singh and his family in June 2008, while the transaction was finally closed in November that year.

Meanwhile, FDA imposed on Ranbaxy’s key Indian facilities in September 2008.

This year, on May 13, Laboratories, under its current Japanese owner, pleaded guilty to US authorities for making fraudulent statements to FDA in the past related to drug testing and data for gaining approvals for its products. The company, still undergoing a consent decree with FDA, also agreed to pay a hefty penalty of $500 million to the US Department of Justice.

The development also spurred action in India with various hospitals and pharmacies reviewing prescribing medicines manufactured by the company. The Drugs Controller General of India is also conducting an inspection of the two Ranbaxy facilities in Paonta Sahib and Dewas, which attracted the US penalty.

First Published: Tue, June 11 2013. 00:49 IST