India to Ramp Up Drug Pharmacovigilance Program

The Drug Controller General of India (DCGI) plans to revive the pharmacovigilance program initially launched in 2004, after holding a workshop on December 29 and 30, 2009. About 20 centers were open to record adverse drug reactions but the program has been neglected for the past five years.

Now, the national pharmacovigilance program will be headquartered at the All India Institute for Medical Sciences (AIIMS) in Delhi. The DCGI office (Central Drugs Standard Control Organization, CDSCO) will provide administrative and financial support to AIIMS. The four CDSCO zonal offices located in Chennai, Ghaziabad, Kolkata, and Mumbai will act as branch offices of the program.

40 of 294 medical colleges in the country will be involved in the first phase of this program. Eventually, the hope is to have all 294 medical colleges participate in pharmacovigilance. In addition, there are plans to have pharmacovigilance centers in hospitals to keep track of adverse drug reactions. The AIIMS center would then collect all the data from the medical colleges, hospitals, and the public to make sure appropriate, corrective action is taken.

The pharmacovigilance program would work to ensure that fake drugs were not circulated in the market, and outdated and banned drugs are not sold. In addition, certain controversial drugs would also be under close watch. India’s Drugs Technical Advisory Board recommended such drugs as nasal decongestant phenlypropanolamine, fertility drug letrozole, non-steroidal anti-inflammatory nimesulide, and antibiotic gatifloxacine to be on this list. Some of these drugs have been sold in the India market for years but there is no record of adverse drug reactions.