Indian doctors’ body asks DCGI to probe Ranbaxy drug quality

The Indian Medical Association (IMA), which represents medical practitioners, has asked the Drug Controller General of India (DCGI), to investigate the quality of drugs manufactured and sold by Ranbaxy Laboratories in India.

"We will soon be writing to the DCGI asking them to check and investigate if Ranbaxy drugs are of poor quality," said Narendra Saini, secretary general, IMA. "However, we will continue to prescribe the drugs to our patients, until the investigation proves that the drugs are of poor quality."

Two weeks ago, Ranbaxy agreed to pay a $500-million penalty to US authorities for "selling adulterated drugs" in the American market (See: Ranbaxy fined $500 mn by US regulator over drug safety lapses). It had pleaded guilty to criminal charges for manufacturing and distributing certain adulterated drugs manufactured at its two Indian facilities at Poanta Sahib and Dewas.

It also pleaded guilty to charges of consistently falsifying data, including annual reports that were submitted to the US Food and Drug Administration (FDA), which were a violation of good manufacturing practices prescribed by the US regulator.

Former Ranbaxy employee Dinesh Thakur blew the whistle on Ranbaxy and alleged that company executives knowingly fabricated test data on generics destined not only for the US but several other markets.

Following these revelations, Mumbai's Jaslok Hospital, one of the city's leading hospitals, has put up a notice since last week advising its doctors to avoid prescribing drugs manufactured by Ranbaxy.

Consultants at Jaslok Hospital said an advisory was put up at the receptionist's circular desk four days ago.

"The notice doesn't give any reason, but merely states that Ranbaxy medicines won't be available at the hospital and doctors should, as far as possible, not prescribe these drugs," one of them told The Times of India.

No other hospital has so far followed suit; and most of them say they have no plans to bar Ranbaxy drugs. However, Business Standard quoted a senior official at Apollo Hospitals as saying it was reviewing the situation and would take action if necessary.

Ranbaxy is one of the biggest drug manufacturers in the country, having made a name for itself by producing generics. However, in 2008-09, the US Food and Drug Administration found the company had not followed adequate rules in manufacturing drugs meant for the American market. This resulted in a ban of around 30 Ranbaxy drugs.

Its problems with the FDA and American authorities have continued to erupt sporadically since then.

Ranbaxy had earlier won considerable sympathy, as it was felt the FDA was seeking to unfairly protect the big pharmaceutical companies. However, the latest incident inclines one to believe that there is no smoke without a fire.