The Government of India has banned the production and import of diabetes drug Avandia (rosiglitazone) close on the heels of the US and European Union restricting its use following reports of the drug causing cardiac problems, reports the Press Trust of India, a government supported news agency.
The decision was taken on Thursday at a meeting of a special committee formed to look into whether there is a need to ban the drug or not. The committee had been formed by the Drug Technical Advisory Committee of India on November 9 last year and had members representing the Indian Council of Medical Research, National Institute of Pharmaceutical Education and Research (NIPER) as well as the Director of Indian Veterinary Research Institute and officials of the Indian Medical Association.
“The production and import of the drug has been banned,” Dr Anoop Mishra, diabetes expert and member of the committee said. Only the existing stock which is in the shelves will be sold, he added.
India has over 50 million diabetics. The drug which is sold overseas as Avandia is used by an estimated 7—10 million people in India where it is sold as Windamet and Windia by GlaxoSmithKline. The generic versions of rosiglitazone are made by Sun Pharmaceuticals Ltd, Dr Reddy’s Laboratories Ltd and Torrent Pharmaceuticals Ltd, among 30 other firms.
Rosiglitazone is an anti-diabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding a component in fat cells and making the cells more responsive to insulin.
The diabetes drug market in India was estimated to be worth Rs 1,350 crore (in 2008) and is steadily growing at close to 20 per cent, which is almost three times more than the global growth rate, according to International Diabetes Federation.
The US Food and Drug Administration (FDA) has already restricted the use of Avandia (rosiglitazone) after studies suggested its use could increase the risk of cardiovascular problems.
The FDA said drug companies have to develop a “restricted access programme” that would limit the use of the drug only to new Type 2 diabetes patients.
Meanwhile, doctors in the western Indian city of Pune have asked diabetes patients to stop using medicine that contains rosiglitazone, reports the Indian Express. The government has now officially banned this anti-diabetic drug, though the controversy about its side effects had erupted two years ago.
“The anti-diabetic drug was banned by the European Medicines Agency last month for its adverse reactions,” said Dr C S Yajnik, head of diabetes centre at KEM Hospital. The US FDA had restricted its use. The Drug Controller General of India has now banned the use of the drug.
According to Dr Uday Phadke, diabetologist at Ruby Hall Clinic, the drug that is sold as ‘Rosicon, Reglit, Windia, Windamet, Enselin, Rezult and even combination form of Rosicon G’ in India was sparingly used. The use of anti-diabetic drugs containing rosiglitazone formulation had dwindled since the last two years due to reports of its cardio-vascular-related side effects. “We have had no problems among our group of patients who have been taking the drugs, but now we will have to discontinue it,” said Phadke.
Yajnik has put up a circular at his clinic informing patients to stop using these drugs. According to several doctors, the ban on the drug was long overdue. Several private hospitals had adopted a cautious approach and stopped prescribing the controversial drug. Rosiglitazone is sold by GSK, which sells the drug as Avandia overseas and Windia in India.
Cardiologist Dr A Chandorkar said patients who are on anti-diabetes drug containing rosiglitazone should stop the medication immediately. While the drug does bring about a marginal improvement in controlling the sugar levels, it can lead to other cardio-vascular side effects. Cardiologist Dr Jagdish Hiremath too said it was up to the doctors not to prescribe the drugs as the patients were not really aware of the ban.
“Type II diabetes, characterised by high blood sugar, is the most common form of diabetes and is increasingly believed to be a lifestyle disorder,” Yajnik said, adding that according to rough estimates, at least two hundred thousand people would be diabetic in Pune.
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