Perception of various stakeholders regarding clinical drug trial industry in India

Perspect Clin Res. 2011 Jul;2(3):86-9. doi: 10.4103/2229-3485.83225.

Abstract

Context: Though India has been thought to be an ideal destination for conduct of clinical drug trials, other smaller countries seem to be doing better. The pace of growth observed during 2005-2009 seems to be plateaued in 2010.

Aims: There is an urgent need for introspection and corrective actions.

Materials and methods: An online survey was conducted among various stakeholders from clinical drug trial industry in India regarding their perception about clinical drug trial industry in India. Respondents were requested to rate training of investigator sites, industry, performance of regulatory, etc.

Results: Majority of respondent felt that the clinical drug trial industry in India is growing, though India is not utilizing its full potential. Lack of trained investigators and delay in regulatory approvals came out as biggest hurdles.

Conclusions: Urgent steps need to be taken in terms of proper training of all stakeholders. Regulatory bodies ought to bring about some radical changes in the system so as to match the other competing nations.

Keywords: Clinical drug trials in India; ethical issues; hurdles in clinical drug trials; investigator training; regulatory delay.