India Proposes Creation of New Agency to Monitor Clinical Trials

The Indian government has proposed the creation of a new agency to monitor and raise standards for clinical trials conducted in India. India’s Science and Technology Minister Kapil Sibal met with the U.S. FDA in August 2005 to request its assistance in establishing systems and protocols of the highest quality so that clinical trials conducted in India would be of a standard comparable to those in the U.S. and other developed countries. The creation of a new agency is a pro-active measure to increase transparency amongst national drug regulators and to conform to internationally accepted clinical trial procedures and standards. India hopes such efforts will help to continue to attract more investment by foreign pharmaceutical companies.

In 2005, the India government issued new regulations on clinical trials that now allow early-stage discovery work, in addition to the Phase II and bioequivalence studies that were already permitted. Also, in an effort to attract more foreign drug companies, the Indian government has begun training officials to supervise the clinical trials procedures and to ensure compliance with regulations. In October 2005, the government announced that by February 2006 the Central Drugs Standard Control Organization plans to begin auditing ongoing clinical trial programs. Groups of inspectors from the Health Ministry will make either planned or impromptu visits to clinical trial sites to ensure the trials are conducted in compliance with Good Clinical Research Practice and other guidelines established for clinical trials.

The Indian government has taken another step towards international standards compliance by committing to the intellectual property rights standards as outlined in the WTO’s TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement. In March 2005, it passed a new, more stringent product patent law that prohibits domestic firms from manufacturing low-cost generic versions of patented drugs. Stronger protection of intellectual property rights will hopefully attract more clinical research to India. Because local laws have not adequately protected patents and copyrights in the past, U.S. pharmaceutical companies have been hesitant to conduct trials in India.