The pharmacovigilance programme was launched in India by the Union health ministry in July 2010 to capture adverse drug reactions of drugs already in the market from the Indian population in a systematic manner. Regular monitoring of clinical data of patients taking both old and newly approved drugs is considered necessary to determine their safety and efficacy as the 3 phase clinical trials usually cover only a few thousands of subjects. Adverse drug reaction of some of the drugs may be only known when the drug is launched in the market and lakhs of people start using them. Therefore, post marketing surveillance and regular monitoring ADRs of drugs is extremely necessary for the health authorities to decide their safety. In India, pharmacovigilance or ADR monitoring was not in existence until 2010 and decision to withdraw any harmful drug from the market used to be taken on the basis of data available from the US and Europe. This is despite the fact that India is recognized for its high quality and timely delivery of pharmaceutical products with drug data for the US and European companies and hospitals. The health ministry’s decision to develop India’s own clinical data before recalling a drug from the market was taken in the context of variations in ADRs among different patient populations.
The country has over one lakh formulations in the domestic market and many of them could be irrational and harmful combinations calling for stringent scrutiny and follow up action. The health ministry does not have any ADR data of most of these combination drugs ever since they were launched. This calls for developing a national pharmacovigilance database consisting of all suspected adverse drug reactions to medicines observed in India. Even after launching the pharmacovigilance programme two years ago, the progress of setting up adequate number of centres to collect clinical data is far from satisfactory. In the first phase of the programme, the target was to set up 40 ADR centres, but just 22 were set up. Although 60 more centres were planned last year at an investment of Rs.60 crore, only 40 more added subsequently. There is no doubt that the country requires a massive capacity building for this programme and the number of centres should have been expanded to at least 100 by now. The union health ministry has sought a financial allocation of Rs.250 crore for the national pharmacovigilance programme mainly to set up more ADR centres and increasing the manpower during plan period. Funding may not be a constraint for the government considering the seriousness of the project but the question is how seriously the programme will be implemented in the coming years.