Some of the state drug procurement agencies have stopped purchasing rosiglitazone formulations, the anti diabetic drug banned by the European Medicines Agency (EMA) last month for its serious adverse drug reactions. Drug Controller General of India is yet to take a decision about its continued sale in the domestic market.
Apart from the government agencies, several private hospitals and nursing homes in the country have also adopted a cautious approach and stopped prescribing the controversial drug, it is learnt.
According to sources, as the rosiglitazone became controversial due to its adverse reactions on the diabetes patients, the drug procurement agencies in states like Gujarat and Karnataka have stopped the drug from the list of purchases. Private hospitals in Bangalore, including Fortis, BTS Global, MS Ramaiah Hospital, Manipal Hospital, etc, have also stopped prescribing the drug. Moreover, the Private Hospital and Nursing Home Association in Bangalore has taken a decision not to prescribe the drug due to its adverse effect on the patients.
Interestingly, while the European Medicines Agency banned the drug in Europe and the US FDA significantly restricted the use of the drug in USA, the drug is widely available in the country.
Rosiglitazone is sold by GSK and its generic versions are manufactured in the country by Sun Pharmaceuticals Ltd, Dr Reddy’s Laboratories Ltd and Torrent Pharmaceuticals Ltd, among 30 other manufacturers. GSK sells the drug as Avandia overseas and Windia in India.
Though the DCGI could not be contacted, it is learnt that the matter has been left to the DTAB which had set up a six-member expert panel to review whether this diabetic drug needs to be banned from being sold in the country. An action will be taken only on report of the panel and the decision of the DTAB, it is learnt. The committee consists of a few officials from the Indian Medical Association (IMA), Indian Council of Medical Research (ICMR) and the Indian Veterinary Research Institute.