At last, the Union health ministry has started acting on establishing a nationwide network for building up a comprehensive pharmacovigilance data in the country. Last month end, the ministry announced formation of a National Pharmacovigilance Advisory Committee (NPAC) under the chairmanship of Director General of Health Services. The Drug Controller General of India will function as the member secretary of the Committee. The initiative is a welcome move although the ministry had taken two years to act upon on this plan. NPAC has been given the sole responsibility of putting in place machinery for monitoring of the pharmacovigilance programme throughout the country. As per the plan, 24 peripheral centres, six regional centres and two zonal centres will form the national network for recording adverse events and scrutinising the data. The zonal centres will be providing training and coordinate the functioning of regional centres. Even after the formation of the national network, role of NPAC as a supporting body to the programme will continue in areas like evaluation of protocol compliance, publication of ADR data, seeking experts from various fields for the centres, etc.
The need for ADR monitoring in India is particularly urgent considering the current non availability of reliable and adequate ADR data and the huge number of drugs and fixed dose combinations floating in the market. One of the significant features of any chemical based drug is its inherent toxicity and consequent adverse reactions. Regulatory authorities are, therefore, expected to assess these negative aspects of any drug before and after marketing approvals are given. Extensive and genuine clinical trials are, possibly, the only way of ensuring the safety and efficacy of a drug. But, even after the scrutiny of toxicity studies and clinical trial reports, regulatory authorities could clear a potentially harmful drug for marketing. There are quite a few such instances. Seven new drugs approved by US FDA since 1993 had to be withdrawn from the market after reports of deaths and severe side effects. This has been possible for US FDA because of a highly effective ADR monitoring system and the regular post marketing surveillance carried out by the pharmaceutical companies in that country. In India both these practices are non-existent. Post marketing surveillance has been made mandatory on drug companies in India just an year ago but very few companies submit such data with DCGI. Therefore, it is extremely difficult to get a harmful drug or combination withdrawn from the Indian market once the marketing permission is granted. The cases of cisapride and phenylpropanolamine are just that. They are still sold in the Indian market although many countries have withdrawn both on the basis of ADR. Now with ADR monitoring system in place and enforcement of Phase IV trials on companies, Indian regulatory authorities should be able to bring a better degree of drug safety in future.