Phase I Clinical Trials for New Drugs in India: Proposed Amendment

A panel headed by Dr. R.A. Mashelkar, Director General of the Council for Scientific and Industrial Research (CSIR), recommended in its report that Phase I clinical trials be allowed in India concurrently as they are being conducted abroad. Phase I clinical trials involve testing new drugs on human volunteers after the completion of animal trials.

Currently, Schedule Y under the Drugs and Cosmetics Act of 1940 allows Phase I clinical trials to be conducted in India only on new drugs discovered in other countries when foreign clinical trial data is available. The Mashkelar panel has recommended amending Schedule Y to allow Phase I clinical trials to be conducted in India at the same time that they are conducted abroad.

According to the panel’s report, allowing concurrent Phase I clinical trials in India and aboard will allow new drugs discovered overseas to become more accessible to the Indian people. Conducting these trials will also help to determine the drugs’ effects on Indians and their genetic profiles. As more clinical trials are conducted in India, drug manufacturers abroad will also realize the lowered costs of conducting trials in India, thus, providing incentives to perform clinical trials in India.

However, the proposed amendment to Schedule Y has also raised concerns regarding ethics. Many are concerned that the poor in India may be willing to offer themselves up as “guinea pigs” in order to earn money from participating in clinical trials. In the past, India has been known for poor people who were willing to sell their organs in order to earn money. Thus, additional measures must be taken by the Indian government to prevent the exploitation of the poor should the proposed amendment be implemented.