Did Ranbaxy's case really sound alarm bells for generic drug industry?

The industry experts seem to be divided on whether Ranbaxy is being maligned or it has really erred big time on meeting quality standards. At the same time, Ranbaxy has its own version of the story. BioSpectrum delves into the issue to know more


Quality Generic Drugs: Experts say that the internal controls must be uncompromising and of the highest standards!

It all started five years back when the so called whistle-blower, Mr Dhiren Shah, an ex employee of Ranbaxy alleged that the adulterated drugs were being sold by the company in US market. Though the company battled it out in the US court but it eventually agreed to pay $500 million to the United States Food and Drug Administration (USFDA). The development not only led to a fear among the general public in India but also raised serious questions on whether the generic drugs are low on quality.

However, Ranbaxy denies any that it lost the case and points out that what has been said is not fully truthful. According to its spokesperson, "On May 13, 2013, Ranbaxy announced conclusion of a previously disclosed investigation by the U.S. Department of Justice (DOJ) of data integrity and manufacturing processes at certain Ranbaxy facilities in India. In anticipation of this settlement with the DOJ, Ranbaxy had earlier in 2011 made a financial provision of $500 million. Therefore the recent settlement with DOJ does not materially impact Ranbaxy's current financial situation or performance.

There have been few related incidents in the past too. In 2007, US-based Merck & Co had agreed to pay $4.85 billion to settle most claims its painkiller Vioxx had led to thousands of users reporting heart attacks and strokes. This was one of the costliest settlements in the pharmaceuticals sector. In February this year, Jubilant Life Sciences had received a US FDA letter that cited major violations of manufacturing standards at its facility in Canada. The US FDA might delay drug approvals until Jubilant HollisterStier General Partnership took necessary corrective steps, Jubilant had said in a statement. Not just Indian pharmaceutical companies, many others, too, had been issued cautionary letters by US FDA, either for violation of norms or for selling substandard drugs, Shah said. In March, Johnson & Johnson had recalled about two million glucose meters, following the death of a patient in Europe after an inaccurate blood-sugar reading.

Mr D G Shah, secretary general, Indian Pharmaceutical Alliance, believes competitors in the US generics market would use the recent episodes as tools to reduce demand for Indian generic versions in that market. "There would be a collateral damage. Other large generic makers could create propaganda against Indian copycat drugs, through their connections with practitioners and other related parties," Shah had said in a statement.

Can't demonize the generics industry!


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