Pharmacovigilance is considered to be an integral part of any effective drug administration and it has been in existence in developed countries for more than two decades. 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 whereas several lakhs of people take the drug once it is in the market. Recent withdrawal of some of the blockbuster drugs in the US after being allowed to be marketed is a testimony to the successful functioning of ADR reporting system in developed countries. Such recall of drugs from the market also points to the fact that certain powerful pharmaceutical companies are capable of managing to get their new molecules of doubtful safety and efficacy approved for marketing even from the most respected drug control authorities. There is, therefore, a growing demand from the patient organizations and concerned consumer action groups to closely monitor the efficacy and adverse drug reactions of a new drug once it is allowed for marketing. The governments of several countries are now seriously considering to make pharmacovigilance an integral part of their drug control system. In some of the developed countries, pharmaceutical companies are also mandatorily required to submit post marketing surveillance reports of their new drug regularly to the drug authorities.
In India, the National Pharmacovigilance Advisory Committee was set up in 2004 under the chairmanship of the Director General of Health Services with the objective of building a comprehensive ADR data bank in the country. The programme was promised financial support from the World Bank. In the first phase of the programme, started in 2004 itself, NPAC had set up two zonal centres and 6 regional centres in Mumbai, New Delhi, Kolkata, Lucknow, Chandigarh and Pondicherry to coordinate collection of ADR data. NPAC subsequently set up 12 more regional centres in different parts of the country. Each of this regional centre was to cover a population of 50 million with a medical officer, a pharmacist and a nurse. Although NPAC and some of these centres are in place for more than four years, its overall functioning is far from satisfactory. It is yet to generate credible data of ADR of several new drugs approved for marketing by the office of the DCGI since 2004. Surprisingly, that there has been no effective monitoring of the functioning of the reporting centres by the office of CDSCO. No serious efforts were made to involve medical practitioners and patients for generating and compiling the ADR data so far. Unless there is a drive to educate the medical community the need for reporting ADR on a regular basis, no credible data could be collected. The Union health ministry is now thinking of adding some specific provisions to the draft clinical research rules to make pharmacovigilance more effective. While it is important to add new provisions to a set of rules, what is most urgent is enforcement of pharmacovigilance programme without any further delay.