US bans Avandia drug for ‘causing cardiac problems’
New Delhi: Even as the US restricted the use of diabetes medication Avandia following reports of it causing cardiac problems, the drug remains freely available in India with the government taking no decision on its usage in the country yet.
The Union Health Ministry had formed a special committee to look into whether there is a need to ban the drug, also known as Rosiglitazone, which is said to have the potency of raising the risk of heart attack and death.
The committee had been formed by the Drug Technical Advisory Committee of India on November nine last year and had members representing the Indian Council of Medical Research, National Institute of Pharmaceutical Education and Research (NIPER) as well as Director of Indian Veterinary Research Institute and officials of the Indian Medical Association.
"I have no idea about the drug or the committee," Health Secretary Sujatha Rao told a news agency when asked about the status of the panel.
In a similar response, Director General of ICMR and Secretary Health Research V M Katoch said he does not have any clue of any such report or any such discussion on this drug.
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.
Both drugs have Rosiglitazone as one of their active ingredients, according to GSK India website.
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 sensitiser, by binding a component in fat cells and making the cells more responsive to insulin.
The diabetes drug market in India amounts to over 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.
India accounts for the largest number of people -- 50.8 million -- suffering from diabetes in the world, followed by China (43.2 million) and the United States (26.8 million), reveal new figures released by the organisation.
The US Food and Drug Administration (FDA) had on Friday restricted the use of the diabetes drug Avandia (rosiglitazone) after studies suggested its use could increase the risk of cardiovascular problems.
Avandia can remain in the market, but with tough new restrictions on its use, said the FDA.
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.