Human drug trials to come under strict regulatory vigil

P Vinod Kumar - Chennai

The Central Drug Standard Control Organisation (CDSCO) has initiated steps to strictly monitor trials of new drugs on humans by multinational and domestic pharma companies. The CDSCO has also sought the help of healthcare professionals to keep a close tab on the adverse events (AE) of various drugs marketed in the country.

The move assumes significance as India is fast emerging as a major destination for clinical trials of drugs developed by multinational pharmaceutical companies ever since the new product patent law came into vogue in January. A Confederation of Indian Industry study has estimated that clinical trials would bring in receivables to the tune of $200 million by 2007 and between $500 million and $1 billion by 2010.

This is because the cost of such trials in India is 50 per cent to 60 per cent less than in the US or Europe. The human trials for a standard drug in the US is estimated to cost about $150 million. CDSCO, in a notification, has sought the cooperation of all healthcare professionals in collecting data of adverse events related to drugs marketed in India.

The Committee will collate the submitted data which would be evaluated by the National Pharmacovigilance Centre (NPC) at the All India Institute of Medical Sciences, New Delhi. According to sources, with a number of new drugs being regularly approved for marketing, it became imperative to set up a monitoring system to track the side effects of these drugs. Besides, after the new product patent regime came into effect, India with its multi ethic demographic profile and low cost, has emerged as a favourite destination for new drug trials.

‘‘Therefore, it is imperative to set up the Adverse Drug Reaction (ADR) data capturing system,” sources said. The new system would help the CDSCO to assess the benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective, including cost effective, use,’’ they added.

As per the programme CDSCO is in the process of setting up 24 peripheral centres for recording AEs of new drugs.

Six regional centres would be set up to collate and scrutinise the data received from the peripheral centres. Two zonal centres would be set up for casuality analysis of the reported AEs.

The operation of these centres would be controlled by the National Pharmacovigilance Advisory Committee (NPAC). The Committee would also initiate regulatory steps based on the data compiled by various centres.

— Financial Express