The Central Drugs Standard Control Organization will start the proposed Special Central Bureau to monitor adverse drug reaction (ADR) by May next year. The Bureau, which would be a separate cell within the central drug control department, will have semi-autonomous power as far as the operations and networking services are concerned. The Drug Control General of India (DCGI) will also be a member in the special cell.

While talking to Pharmabiz.com in Pune, Ashwini Kumar, DCGI, said that the special ADR cell will have a nationwide data collection network mainly connected with major hospitals and medical colleges besides the existing six peripheral monitoring centers across the country.

As part of the national data network, the special cell will have a website through which the doctors and medical professionals can submit their reports online. The website will have a detailed information filling form prepared in such way that information submitted by the doctors are authentic and also in a systematic way. Besides the online format, there will be a toll-free number attached to the Bureau with which the public can report any drug adverse reaction what they come across.

The DCGI said that the Union Ministry of Health has already 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. However, by putting in place this model of regulatory framework, the surveillance of the performance of new drugs after grant of marketing approvals could be propped up, the DCGI 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.