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The Supreme Court on Tuesday dismissed a petition for prohibiting Ranbaxy from producing and marketing its alleged adulterated medicines in the Indian market in the wake of reports of the pharma major having sold misbranded drugs in the US. A bench of Justice A.K.Patnaik and Justice Ranjan Gogoi dismissed the Public Interest Litigation (PIL) by advocate M.L. Sharma, asking him to produce the material to show that drugs being marketed by the pharma major were substandard.
Holding that the courts could not be used for publicity, the court said: You can't rely on newspaper reports. What is a relevant material in USA can't be relied upon in India. You show us some material to show that the drugs produced by Ranbaxy are misbranded, spurious or adulterated and they are harmful to people in India, the court said. Justice Patnaik said: Unless you show these materials, we can't interfere on PIL based on newspaper reports for the sake of publicity.
Dismissing the PIL, the court, however, granted liberty to Sharma to move a fresh petition if he gets new material to support his contention. When the court took up the matter for hearing June 10, it had sought proof that the alleged adulterated drugs that were sold in US were being marketed in India too and were part of same consignment.
In the wake of Ranbaxy's $555 million out-of-court settlement with the US Food and Drug Administration (FDA) for falsifying data and selling substandard drugs, Sharma moved the apex court seeking direction to the central government to prohibit the production and marketing of substandard drugs by Ranbaxy in India.
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.
Recently, Jaslok Hospital became the first one to ban Ranbaxy drugs and Apollo Pharmacy the country s biggest drug retail network alsos uspended the sales and procurement of Ranbaxy drugs until further investigations. Meanwhile the Indian Medical Association asked the Drugs Controller General of India (DCGI) to investigate the quality of drugs sold by Ranbaxy Laboratories in India.
The Ranbaxy issue evoked a strong response from the government which said that the country has proven international quality standard capabilities . India enjoys a unique position of low-cost manufacturing and the highest quality medicine, the best of both the worlds , the statement added. It invited global importers to visit factories to satisfy themselves of the quality of production of drugs . There s a school of thought which believes that all the complaints about generic medicines originate from Big Pharma with big brands unhappy with the growing use of cheap generics, as developed nations fight to lower healthcare costs. Also read: India vs Big Pharma.
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