Indian Government Eases Obstacles for Clinical Research Organisations

The Indian government has made strenuous efforts to attract good levels of foreign direct investment within the local pharmaceuticals sector. This is certainly the case with Phase I trials, which previously the government had not allowed to be conducted in India with drugs under development by a foreign company, unless initial trials had already been concluded elsewhere and the data was submitted to the drug regulator.

However, on the grounds that the participation in global trials of new drugs would give India greater and speedier access to the latest drugs and therapies, the Union Health Ministry issued a series of provisions relating to the so-called Schedule Y of the Drugs and Cosmetics Act in January 2005. These new provisions represent a step forward for the clinical research industry in India. The revisions also allow for the export of human tissue samples, potentially a major boost to biotechnology companies seeking to outsource some of their clinical trials in the country. A number of provisions were also included which allow regulators to penalise contract research organisations (CROs) found to be in violation of any of Schedule Y's terms. These items were included as a safeguard against popular fears that foreign pharmaceutical manufacturers would seek to use Indians as 'guinea pigs'.