MNCs will have to wait longer for clinical trials

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DCGI is also working towards starting auditing and inspection of clinical trials in near future. Such team could consist of a drug inspector, toxicologist or pharmacologist and a field expert (paedetrician, cardiologist or a specialist). Once these protocols are in place, DCGI will open the phase-I sector to MNCs, and allow phase-0 trials, an official said. The country’s 2007 clinical research market is estimated at $200 million and is expected to touch $500 million to $600 million by 2010, said KPMG in a report citing Cygnus Industry Insight January 2008. Other estimates project the market to touch $2 billion by 2012-13.

Currently, Indian laws permit MNCs to conduct phase-II and phase-III trials here. But if the company has conducted phase-0 and phase-I trials in at least two other countries, they can be allowed to do the same here. Domestic companies, however, are allowed to conduct drug trials at all stages in the country. According to DCGI, the time taken to give clearances for phase-I trial is 90 days, for phase-II trial is 45 days and for phase-III is 60 days.

•The DCGI has conducted a series of meetings with all stakeholders, representatives of contract research organiastions, pharmacologists, toxicologists and public health groups

• Main concerns include reliability, validity and the resulting credibility of the data generated. DCGI is also concerned that it hardly has a domestic manufacturer of accelerator mass spectrometry