The Government has banned the production and import of diabetes drug Rosiglitazone or Avandia close on the heels of the US and European Union restricting its use following reports of the drug causing cardiac problems.
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 sensitiser, 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.