Clinical Trials Boost to Indian Research Sector

Government moves to relax rules on clinical trials are set to boost foreign investment in India's pharmaceuticals industry. Previously, authorities only permitted Phase III and bioequivalence studies to be conducted in India. A comprehensive ban was imposed on Phase I trials, at least with drugs under development by a foreign company, unless the studies had already been concluded outside the country and the data submitted to the drug regulator. The strictness of the rules was attributed to popular fears that Indians could be exploited as "guinea pigs" by foreign-based drug companies.

However, an independent panel convened on the issue recommended that the government should allow Phase I trials 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. In January 2005, the Union Health Ministry duly issued a series of provisions relating to the so-called Schedule Y of the Drugs and Cosmetics Act, which governs clinical trials in the country.

The revised regulations, largely welcomed by the multinational sector, will redefine clinical trials and allow early-stage discovery work. Notably, 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.

Both locally-based firms and the Indian units of multinational drug companies are now set to drive development through the new rules, which have been accompanied by substantial improvements to patent protections. The country's large pool of genetically diverse potential trial volunteers, low costs and plentiful English-speaking doctors and nurses are also major factors in the positive outlook for the sector.