Dept of Health Research India fast-tracking cabinet nod for bill to regulate clinical research

After keeping it dormant for many years, the Department of Health Research India is fast-tracking for the final approval from the Cabinet a comprehensive bill to regulate and monitor the entire research on the human subjects in the country.

Sources said the modified Biomedical Research on Human Subjects Bill is in the final stages. “The Cabinet note is being prepared for submission and approval. The plans are afoot to place it before the Parliament this year itself and put into effect,” sources said.

The Bill assumes significance in the wake of the recent findings by the Parliamentary panel on the state of affairs in the clinical trials segment and the widespread concerns about the alleged approval of drugs without trials in the country.

The Bill which has been debated for over five years now aims to protect the safety and rights of humans used in scientific research. It has been modified by the DHR keeping in view of the international guidelines and to include provisions of punishment at par with international laws, sources said. The bill was drafted based on the existing guidelines in the sector.