Health ministry seeks Rs.250-cr financial outlay for national pharmacovigilance programme

The union health ministry has sought a financial outlay of Rs.250 crore for the national pharmacovigilance programme (PvP) for setting up more adverse drug reaction (ADR) centres and increasing the manpower during the 12th five year plan.
The ministry has sought Rs.50 crore per year during the plan period towards strengthening the programme, including setting up more ADR centres and increasing the manpower. Thus Rs.250 crore has been sought for the next five year plan period, sources said.
The programme was launched in July 2010 to capture ADR data in Indian population in a systematic way. The main objective of the programme is to monitor ADR in Indian population. The data would be captured through the medical colleges in the country which would be provided necessary administrative and logistic support.
The programme, that ultimately aims at helping the drug regulators to limit the use or even phasing out approved drugs with high toxicities, will also help generate independent, evidence based ADR data which would help in taking regulatory decisions on safety aspects of drugs marketed in India, sources said.
While endorsing the demand for Rs.250 crore for the programme, an expert panel under the Planning Commission has recently recommended to make the process of reporting adverse reactions simple and accessible. “Steps should be taken to encourage patients and consumer protection groups - to report drug reactions as it has been observed that consumers do a better job in reporting drug reaction than doctors,” the panel said.
“Develop and maintain a national (computerised) pharmacovigilance database consisting of all suspected adverse drug reactions to medicines observed in India. Mandate that the report of any suspected adverse drug reaction should be filed with the national pharmacovigilance database and not with the manufacturer. Sensitise the overworked physicians to the why and how of pharmacovigilance,” the recommendations of the panel said.
In the first phase of the programme, the target was to set up 40 ADR centres, but 20 were set up. The target is to cover the entire country through the network or ADR centres by 2017.
Source:Pharmabiz