The office of the DCGI last month said that the pharmacovigilance programme, launched in 2004, will be revived by the end of December after organizing a workshop for leading doctors in the country. The programme remains neglected for the last five years after 21 centres were opened to record adverse drug reactions. The plan now is to involve 40 of the 294 medical colleges in the country to revive the programme. The key agenda of the workshop was to decide which all drugs to be included for the pharmacovigilance. Drugs Technical Advisory Board had examined a few drugs which are already banned in certain developed countries for their serious side effects but are widely marketed and promoted in India. Some of these like letrozole, Nimesulide, phenylpropanolamine and gatifloxacine already recommended for pharmacovigilance. These and other drugs have been in market for several years in the country but there is no record for knowing how many people died or got injured due to the intake of them. Physicians on their own do not maintain any record of adverse reactions of the drugs they are prescribing. It is unfortunate that neither Indian Medical Association nor Medical Council of India advocate the need for maintaining a record of ADRs amongst practicing doctors although that is considered to be a professional obligation to their patients.


Pharmacovigilance needs to be an integral part of any modern drug administration and it has been in existence in developed countries for more than two decades. The 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 out in the market. In the absence of regular post marketing surveillance by pharma companies, serious adverse drug reactions of the drug after it is launched in the market remain undetected and can pose serious threat to health of the patients. Withdrawal of some of the blockbuster drugs in the US and Europe in recent years after being allowed to be marketed in these countries is a clear warning to the regulatory authorities that ADR need to be strictly recorded. Recall of drugs from the market also points to the fact that some pharmaceutical corporations manage to get their new molecules with doubtful safety and efficacy approved for marketing even from the most reputed drug control authorities. Growing clamor by the patient organizations and consumer action groups to strictly monitor the efficacy and adverse drug reactions of a new drug after it is allowed for marketing is, thus,understandable. DCGI's awakening now to give a push to the pharmacovigilance programme by involving medical colleges is encouraging. But,that alone will not make the programme effective. Pharmaceutical companies should be mandated to submit post marketing surveillance reports of their new drugs regularly to the authorities as in the case of most developed countries. A strategy needs to be worked out to get a large number independent medical practitioners motivated to maintain ADR records as an integral part of their practice.