The Central Drugs Standard Control Organization had all the good intentions when it announced the decision to set up a centralized bureau to monitor ADR in the country as early as 2002. As per this plan CDSCO had envisaged establishing a national network of 40 pharmacovigilance centres both in the government and private sectors by August 2003. The project had the support of the World Bank. Currently, All India Institute of Medical Sciences at Delhi is functioning as the apex ADR monitoring centre with no proper system of nationwide collection of data. The main objective of the CDSCO plan was to decentralize ADR monitoring activities and to coordinate the entire data recording programme in the country with six regional centres, two zonal centres and an apex control body at CDSCO headquarters in Delhi. The CDSCO also expected that these centres would play a supportive role to the emerging clinical research activities in the country in the coming years. There cannot be a better blueprint than this to streamline a vital area like drug management system in the country. But, like all well-meaning projects, this plan is yet to take off.

Pharmacovigilance as a drug monitoring system is in its infancy in India although the country has made commendable progress in various aspects of drug administration. In the US and Europe, the system has been in existence for more than two decades. Withdrawal of several drugs from these countries after being allowed to be marketed for some years testifies the successful functioning of ADR reporting system in these countries. The routine three phase clinical trials do not always guarantee the safety of a drug as the trials usually cover a few thousands of volunteers whereas when the drug is launched in the market, lakhs of people take it. ADR reporting is, thus, considered to be the most effective way of monitoring the safety of a drug throughout its life in the market. And the spontaneous ADR reporting by the health practitioners forms the cornerstone of post marketing drug safety surveillance. But, such a practice does not exist in India and is not encouraged by the health authorities. The relevance of this vigilance is becoming extremely important for India with continued marketing of quite a few unsafe drugs and several fixed dose combinations which are not in use in most developed countries. It is the absence of a reliable ADR reporting machinery in the country that makes difficult for the regulatory authorities to ban or restrict the use of a potentially harmful drug. The sad part is that the pharmaceutical companies in India fully know about the weakness of the system and take advantage of it by continuing to market such doubtful products.