The Central Drugs Standard Control Organization (CDSCO) would set up a special bureau to monitor adverse drug reaction (ADR) with a pubic information website. The central bureau, which will be located at New Delhi, would be linked to another six peripheral monitoring centers across the country.

According to CDSCO sources , the Union Ministry of Health has already been given nod to go ahead with the project with Rs five crore outlay by the Finance Ministry. Last year, the Department of Health had approached the finance ministry for funds to create the necessary infrastructure for the project.

The decision to set up this exclusive ADR monitoring cell follows the conclusions of a high-level committee that looked into the presence of internationally banned drugs in the domestic market. The committee has recommended that a regulatory framework for post-marketing surveillance of drugs be established in the country soon. The report of the committee would now be put before the Drug Technical Advisory Board (DTAB).

At present, ADR monitoring in India is not effective, with a DTAB sub committee doing the job with no facility proportionate to its task. With a constant increase in number of new drug introductions, the limitation of the present system has become obvious. By putting in place a unique model of regulatory framework, the surveillance of the performance of new drugs after grant of marketing approvals could be propped up, sources said. The central bureau in New Delhi will be attached to the Central Drug Standard Control Organization. The bureau would be linked to half-a-dozen peripheral monitoring centers across the country, the sources said.

The proposed mechanism would follow up any adverse reaction that might occur due to consumption of a new drug, that is, the drugs introduced for the first time in Indian market in the preceding three-to four years. Sources added that the ADR monitoring mechanism would function effectively only with the support and involvement of the drug industry, trade and consumers. Leading drug companies who have the necessary facilities need to inform the government of the findings of post-marketing clinical trials of new drugs.

The government has also decided to re-activate the non-functional ADR (adverse drug reaction) monitoring centers in the country. Out of the six ADR monitoring centers in the country, only two -- AIMS, New Delhi and KEM Hospital, Mumbai -- are operational now, while the remaining are not being utilized for years. Surveillance of ADR of new drugs has assumed increased significance in India with the introduction of top-of-the-line products in the domestic market by multinational companies. The gap between India and developed countries in new drug introduction schedules has narrowed down. In this context, Phase 4 clinical trials (ADR) have become essential. The issue of drugs banned abroad has been brought to light recently with the debate over the safety of drugs/ingredients namely cisapride, chloroquinols and phenylpropanolamine and of late, nimesulide, a NSAID prescribed for the indication of fever and cold.