India’s drug regulator agency Central Drugs Standard Control Organization (CDSCO) is drawing up plans to allow international companies to conduct initial-stage drug trials in the country.
At present, global drug firms are allowed to conduct only mid-stage and last stage or phase III trials in India. However, Indian companies are allowed to conduct all stages of trials. The move by the CDSCO is expected to increase contract research outsourcing business to India. According to global auditing company KPMG, Indian clinical research market is estimated at $200 million in 2007 and is expected to touch $500-$600 million by 2010.
Policy initiatives like revisions in the Patents Act, stringent measures to prevent making spurious drugs and creation of pharma R&D (research and development) fund with corpus of $33.3 million are some of the steps taken by the regulator.
Drug Controller General India Surinder Singh said that two series of meetings with stakeholders has been done and there are certain areas that need to be addressed. We can notify phase zero and phase I. (Phase zero and phase I are the initial stage tests, where drug is first tested on a few human beings.)