The Drug Controller General of India has placed anti-diabetic drug, rosiglitazone, under the scanner of national pharmacovigilance programme in the wake of adverse reports about the drug. Recent research studies had indicated that continued intake of the drug could cause serious cardiovascular disorders to some patients.

``In view of the global developments, rosiglitazone is being brought under focused monitoring of adverse drug reactions in the National Pharmacovigilance Programme,'' sources in the DCGI office said.

A research was carried out by Dr Steven Nissen of the Cleveland Clinic in the US by conducting meta analysis of 42 trial results of only one anti-diabetic drug rosiglitazone. In the recent article published in New England Journal of Medicine (NEJM), the results of meta analysis claimed that rosiglitazone is associated with increased risk of cardiovascular disorders.

``However, in the opinion of another scientific journal Lancet, it was reported that to avoid unnecessary panic, a calmer and more considered approach to the safety of rosiglitazone is needed. The Scientific Advisory Committee of US FDA has examined the issue and clear decision has come out of the committee. Out of 23 members of the committee, 22 recommended for the continued use of the drug.

The US FDA takes decisions based on the recommendations of Scientific Advisory Committee,'' sources explained referring to the controversy about the Glaxo SmithKline's rosiglitazone brand, Avandia.

DCGI with its plan to strengthen the pharmacovigilance programme, is also in the process of collecting more information from the developed countries on the drug. The team will be commencing a review of the GSK brand, Windia, for its safety aspects in India. Rosiglitazone is also marketed here by at least seven local drug makers under different brand names.

Recently, the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted that the data suggests some ischemic risk with Avandia, a treatment for type 2 diabetes. The committee declined to comment on comparative risk of Avandia to other oral anti-diabetic medicines. The committee also voted to keep the medicine available to patients in the US. The FDA will review the panel's recommendation before making a decision.

According to GSK India officials, the company will provide information for all required reviews and the drug will be available for the patients in the market.