India to Amend Clinical Trial Regulations

Many companies look to India for clinical trials, as the country offers a large, diverse population and varied gene pool. Therefore, patient recruitment is often an easier and faster process in India than in the West and companies can save as much as 50% in clinical trial costs. In October 2004, India’s Ministry of Health (MOH) announced plans to amend the Drugs and Cosmetics Act, permitting foreign and domestic companies to conduct clinical trials for pharmaceuticals in India and other countries simultaneously. Currently, a pharmaceutical had to undergo a clinical trial one phase higher in another country first, before the previous trial phase can be conducted in India.

Once the new amendment to the Drugs and Cosmetics Act goes into effect, phase II and III clinical trials may occur in India and outside of India simultaneously. However, since the purpose of a phase I trial is to test the safety of the drug, the MOH does not intend to include phase I trials in the new amendment. Pharmaceutical companies will still be required to conduct phase I trials outside of India first, before they may test the drug in India. This guideline will help protect Indian citizens from being subject to untested and unproven drugs.

The MOH will also set up a special group to monitor clinical trials. This group will ensure that companies comply with Good Clinical Practices (GCP) and end any trials that violate GCP regulations. Additionally, clearances to conduct trials will be granted on a case-by-case basis and foreign companies will not be permitted to conduct clinical trials solely in India.