Indian firms seek reg changes for clin trials

Indian pharmaceutical manufacturers are calling for the DrugsController General to amend the country's regulations governing clinical trials, in order to boost India's research capability, reports The Times of India.

Currently, Schedule Y of India's Drugs and Cosmetics Rules 1945 says clinical trials must be conducted in India one phase below those done in developed countries. However, the proposal, which is put forward by the R&D subcommittee of the Confederation of Indian Industries' national committee on drugs and pharmaceuticals, says this should be changed to allow simultaneous trials to be conducted in India with other countries. To ensure that the most advanced treatments are available to Indian patients, researchers in the country should be encouraged to participate in international work with other countries, says the committee.

The panel also seeks changes to the requirement that clinical trials for all new recombinant DNA products be approved by the DCG and the Genetic Engineering Approval Committee, saying this leads to unnecessary delays and problems for developers and importers of these products. The World Health Organization has said that rDNA products should be regarded as the same as any other biological product in terms of licensing or approval for manufacture, so they should come under the Drugs and Cosmetic Acts and Rules, which means the DCG would not have to refer them to the GEAC.