Written By: Nirmalya Dutta | Updated : May 29, 2013 8:04 AM IST
The Indian Medical Association (IMA) has asked the Drugs Controller General of India (DCGI) to investigate the quality of drugs 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, added Saini.
The ramifications of Ranbaxy s admission of seven federal charges including selling adulterated drugs with intent to defraud and the subsequent fine of $500 million to resolve false claim allegations are starting to be felt yesterday after Jaslok Hospital put up a notice advising docs to avoid prescribing Ranbaxy drugs. According to insiders, the notice hasn t given any reason for these actions. All it says is that Ranbaxy medicines won t be available and doctors should avoid prescribing them . Hospital officials weren t available for comment. KEM Hospital and Apollo told the ET that that no decision on Ranbaxy yet. There is no directive or review at Apollo with respect to Ranbaxy, said a spokesperson from Apollo Hospitals. The IMA says that it is unfair to penalise a company without a thorough investigation, and it hopes that the drug controller will make sure that drug companies will not violate the rule of the Drugs and Cosmetics Act.
Ranbaxy is one of the big Indian drug companies well known for selling generic medicines both in India as well as the US and other nations. 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.
The Ranbaxy story till now
The Ranbaxy episode started in September 2008 when the USFDA issued two Warning Letters to Ranbaxy Laboratories and import alert for generic drugs produced at two different plants. However, in June 2008, Daiichi Sankyo, a major Japanese company had procured a majority in Ranbaxy in a deal believed to be worth $4.6 billion dollar. A fortnight ago, Ranbaxy offered to pay a $500 million fine for selling adulterated drugs and pleaded guilty to seven criminal counts including fudging of data, intention to defraud and failing to report that its drug didn t meet specifications. Since then a lot of dirty linen has been washed in public with the Japanese company accusing the Singh brothers the former owners of Ranbaxy of concealing and misrepresenting critical information regarding the USFDA investigations. Malvinder Singh, the former Chairman however eschewed all guilt and claimed the Japanese company had mismanaged the company.
He said, There was no misleading Daiichi approached us when they came, US FDA investigations were on. They knew about it and it was public information. So there was nothing that was hidden. Whatever they wanted and asked for was shown to them. They did a due diligence. Who would risk $5 billion without a due diligence?
Meanwhile the Drug Controller General of India (DCGI) Dr GN Singh said that all the approvals given to Indian drugs manufactured by Ranbaxy Laboratories were in order. As per the laws, there was no indication of any company violating the Indian laws, including Ranbaxy. However, Dr Singh admitted that all matters including approvals in the past would be examined again. Dr Singh added that appropriate action would be taken and a special team would be set up to examine the case. They would send officials to the US if the situation demands it. My most important concern is to assure the safety and efficacy of the drugs in India and action will be taken as per the Drugs and Cosmetics (D&C) Act, not just against Ranbaxy but other companies also if found guilty, Dr Singh told Pharmabiz. Yesterday, Jaslok Hospital became the first one to ban Ranbaxy drugs.
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