The much awaited national pharmacovigilance programme, expected to begin in select 40 medical colleges across the country from April this year, has been delayed at least for one month, thanks to the red-tapism in the Union Health Ministry. The files regarding the programme are still pending with the secretary in the union health ministry. Once they get the secretary's nod, the first phase of the programme will be launched in 40 of the around 300 medical colleges in the country.

According to sources, the programme will be now launched in the middle of May instead of April. The concerned authorities have submitted a Rs 48-crore detailed project to the Health Ministry for approval which is under the active consideration of the ministry. The project is for the next five years and all the around 300 medical colleges in the country will be brought under the programme in phases.

The pharmacovigliance programme for India has been designed by the central drugs standard control organisation (CDSCO), in collaboration with the Department of Pharmacology, AIIMS, for comprehensive drug safety monitoring with nationwide coverage. Inputs from scientific organizations like WHO and ICMR have been incorporated into this programme.

Dr YK.Gupta, professor and head, Department of Pharmacology, AIIMS, who heads the national pharmacovigilance programme, said that almost all the 40 colleges have been identified for the first phase of the programme which will take off soon once the ministry approves the project.

In the first phase, 40 medical colleges that have been identified as adverse drug reports (ADR) monitoring centres, will send ADR reports to the national coordinating centre at Department of Pharmacology, AIIMS, which will be involved in quality assurance, causality assessment and training. The programme also envisages to include all the medical colleges and corporate hospitals by 2012.

In addition to routine spontaneous reporting, these ADR monitoring centres will also carry out focussed ADR monitoring on selected drugs of national importance, Dr Gupta said.

A number of drugs including two H1N1 drugs – oseltamivir and zanamavir, the controversial sub-fertility drug letrozole, popular non-steroidal anti-inflammatory drug Nimesulide, decongestant drug phenylpropanolamine (PPA), antibiotic drug gatifloxacine, chronic constipation drug Tegaserod, type-2 diabetes drugs, Pioglitazone and Rosiglitazone have been selected for the first phase of the programme.

Dr Gupta 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 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 under the NPV.