The revised Schedule Y that is to be notified soon would have an all-comprising definition for "Clinical trial" to cover all aspects of clinical research programmes under the ambit of the rule. The changes in the Rule 122 DA, that is to appear in the revised Schedule as 122DAA will define "clinical trial" in very broad based manner that will leave no room for any misinterpretation, Ashwini Kumar, Drugs Controller General of India (DCGI) said.

According to him, all clinical trial activities to be taken place in the country in future would be covered under the new definition. "All the regulatory activities in the clinical research segment would be guided by the definition and it is going to be the centre of several litigations in future," he noted.

Speaking at the inaugural function of the first "National Conference on Clinical Research: Challenges and Opportunities in India," organised by the Institute of Clinical Research (India), here on November 26, the DCGI said that the new Schedule Y would empower the regulatory authorities to take penal action against the defaulters in the clinical trial area.

"We are soon to have all regulations in place to monitor the clinical trial activities. We will have the power to prosecute the defaulters and can withdraw the approval given for a trial. But we are yet to have the experts who can really do the monitoring of clinical trials. The monitoring of manufacturing activity is much easier than the monitoring of clinical trials as the former involves inspection of products. There is no product in the second case. The experts will have to inspect the documentation procedure and ensure its reliability," he explained.

Kumar wanted such expertise to be built up either in-house or out-sourced to ensure that Indian documents are accepted / recognized world over. Terming the recent instances involving bioequivalence centres which had compelled Ranbaxy and Hetero to withdraw the WHO pre qualification as unfortunate, DCGI said India needs to gain more experience and learn from its mistakes.

He also pointed out that there were atleast 8 Indian companies who have really invested in setting up R & D facilities but are finding it difficult to identify proper human talent.

Dr Anbumoni Ramdoss inaugurated the seminar. Dr S P Agarwal, DGHS, Ministry of Health, Dr Neelima Khirsagar, Dean, G & K Hospital, Mumbai also presented on the occasion.