
With international scientific journals recently raising doubts on credibility of certain drug research work in India, the Health Ministry is taking steps to regulate clinical research. The Ministry has set up a Central Drug Standard Control Organisation under Drug Controller General of India for the purpose, sources said. So far, the Ministry was confined to giving approvals for the projects.
A stringent mechanism to evaluate the research work was being evolved. The evaluation and regulation will be done through experts. Besides research sites, the ethics committee, and fund-sponsors for the project would be subjected to random inspections, sources said. Compliance with clinical practice regulations would be stressed.
‘‘The international scientific community sees huge potential in clinical research in India. We should build up the confidence in Indian science,’’ said Dr Ashwani Kumar, DCGI, who added, ‘‘The only way to do it is by regulation. This will give credibility as the government will be in partnership with the researchers.’’
‘‘We were so far just involved in approving research projects. The rest of the job was done by researchers. Now, regular inspections will be made in course of the research,’’ he said.
The Ministry has contacted a panel of ‘‘regulators’’ mostly eminent doctors and researchers to inspect research sites in their ‘‘zones’’.
A two-day workshop on good clinical practice for the regulators would be held at AIIMS on October 7-8. It will be an orientation programme for them on standards and operating procedure.
‘‘It will give them a uniform understanding of the underlying issues,’’ said Dr Kumar.