India's national pharmacovigilance program to begin in April will open with several important drugs to come under review

Among the drugs selected to kick of India's national pharmacovigilance program, which starts in April, are two H1N1 influenza drugs - oseltamivir and zanamivir, the controversial sub-fertility agent letrozole, the non-steroidal anti-inflammatory nimesulide, the decongestant phenylpropanolamine (PPA), the antibiotic gatifloxacine, the chronic constipation drug tegaserod and type-2 diabetes drugs pioglitazone and rosiglitazone. The program will begin in 40 medical colleges across the country.

The much awaited pharmacovigilance program for India has been designed by the Central Drugs Standard Control Organization (CDSCO), in collaboration with the Department of Pharmacology, All Indian Institute of Medical Sciences (AIIMS), for comprehensive drug safety monitoring with nationwide coverage, reports the local news service PharmaBiz. Inputs from scientific organizations such as the World Health Organization (WHO) and the Indian Council of Medical Research (ICMR) have been incorporated into this program.

Leading the national program is Dr Y K Gupta, professor and head, Department of Pharmacology, AIIMS, who, said that several criteria have been used for putting a drug on the watch list like restriction/withdrawal by any other regulatory agency in the world; reports in the media; adverse reports published in WHO Newsletters; diseases of public health importance in relation to Indian population; drugs, vaccines for epidemics/pandemics; and signals generated from the spontaneous reports received.