The Central government has been contemplating to have a national pharmacovigilence programme for the last six years with the objective of building a comprehensive ADR data bank for drugs marketed in the country. A National Pharmacovigilance Advisory Committee was thus formed in 2004 under the chairmanship of the Director General of Health Services. NPAC had then set up two zonal centres and 6 regional centres in Mumbai, New Delhi, Kolkata, Lucknow, Chandigarh and Pondicherry to coordinate collection of ADR data. Twelve more regional centres were set up in different parts of the country subsequently. Although NPAC and some of these centres are in place for more than four years, the overall functioning of the programme has not been satisfactory. However, the Union health ministry has woken up now and has decided to activate the project. A deadline of July 1 is set to commence the pharmacovigliance programme by shortlisting a total of 300 medical colleges across the country. The first phase of the programme is expected to start in 10 of these medical colleges from next month and will be extended to 40 medical colleges by next year and to 60 the year after. By 2014, all the 300 medical colleges will be participating in this national initiative. The pharmacovigliance programme has been designed by the central drugs standard control organisation (CDSCO), in collaboration with the Department of Pharmacology, AIIMS. The short listed medical colleges, designated as adverse drug reports (ADR) monitoring centres, should be sending ADR reports to the Department of Pharmacology of AIIMS which is the national coordinating centre. Apart from routine spontaneous reporting, the ADR monitoring centres will also carry out focused ADR monitoring on selected drugs.
The need for pharmacovigilance is well understood by the government and the scientific community in the country in the context of increasing number of recalls of drugs from the market due to their serious side effects. The routine three phase clinical trials do not always guarantee safety of a new drug as the human trials usually cover only a few thousands of volunteers but several lakhs of people take the drug after it is allowed to be marketed. Recent withdrawal of certain blockbuster drugs in the US and Europe is a testimony to the successful functioning of ADR reporting system in developed countries. Frequent recall of drugs from the market also points to the fact that the pharmaceutical companies do manage to get their new molecules of doubtful safety and efficacy approved for marketing from the drug control authorities of even the developed nations. In the current situation where even leading pharma companies are increasingly finding it tough to get new drugs from their research labs, such tendency amongst pharma companies are likely to continue. The need to closely monitor the adverse reactions of a new drug is, therefore, extremely significant. That is why governments of many countries are seriously considering to make pharmacovigilance an integral part of the drug control system. Now having initiated the project, health ministry has to enforce the data collection of ADR with regular monitoring of these centres. There are already quite a few drugs in the market which are of doubtful safety and efficacy. DCGI is not able to take a decision on these drugs probably because of insufficient ADR data.