Drug-maker had paid $500 million in fine over drug safety.
By R. Chandrasekaran
CHENNAI: The Supreme Court of India has admitted a public interest litigation against Ranbaxy Laboratories, one of India’s biggest pharmaceutical companies, seeking cancellation of its manufacturing license besides initiating actions against its directors.
The PIL admission comes on the heels of the company striking a $500 million settlement with the U.S. Food and Drug Administration on May 13 for allegedly falsifying data and selling inferior drugs. Japan-based Daiichi Sankyo Co Ltd. is the owner of Ranbaxy now. The FDA has banned close to 30 drugs blaming the company for having failed to follow adequate rules while making drugs for the U.S. market.
Following the settlement, Indian hospitals have started shunning drugs from Ranbaxy though there is no specific order either from the government or from the Indian drug regulator. Jaslok Hospital in Mumbai was the first to advise its doctors not to prescribe medicines of Ranbaxy since the settlement with the FDA suggested a subtle acceptance of making and supplying adulterated drugs.
Other hospitals such as Medanta of Gurgaon and Apollo Hospitals have also started reviewing their policies toward the company’s drugs. Apollo Pharmacy, a division of Apollo Hospitals, has taken a precautionary step to stop selling Ranbaxy drugs as an interim measure after its medical oversight committee raised concerns.
Apollo Hospitals, headed by Dr. Pratap C. Reddy, which has about 50 hospitals in the country, said recently that it was working closely with Ranbaxy to verify all necessary certifications of its drugs. The matter is expected to be resolved as the drugmaker continues to make available the necessary approvals.
Meanwhile, Director General of Health Services Jagdish Prasad has reportedly told the press that the matter has been needlessly highlighted and that the company’s drugs were not inferior.
Ranbaxy is not the only company from India to face the heat on generic drugs being marketed in the U.S. Another company, Wockhardt Ltd., also disclosed in May that it had been served with an import alert by the FDA about its plant in Maharashtra.
However, the Indian government came to the defense of the companies. The commerce ministry recently issued a press statement stating that “there are reasons to believe that vested interests are raking up isolated issues reported regarding technical deficiencies on manufacturing practices.” The government also accused other countries of defaming Indian companies.
The Indian government’s concern is quite understandable. The Indian generic industry is projected to be worth Rs.1 trillion and India is one of the top exporters of generic drugs to the United States. There are about 323 FDA approved manufacturing plants in India offering an employment to 2.5 million people.
Ranbaxy is also getting full support from Bangalore-based Narayana Hrudayalaya Hospital chairman Devi Shetty, who said he will prescribe Ranbaxy medicine and even take it himself if the situation required. He has reportedly advised people to take the medicine from Ranbaxy. His contention seemed to be that the drug company’s agreement with the FDA for what had happened years ago. Shetty said that he fully trusts the integrity of its management and the quality of its drugs is not inferior.
Despite support from the government and some select group of professionals, the fact remains that Ranbaxy has to convince the Supreme Court that its drugs are of high quality.