With its vast pool of patients, India is attracting the attention of clinical research organisations.
Higher costs and inefficient recruitment in the US and Europe are prompting CROs to look to Asia, Latin America and East Europe for good clinical practices, the phrase used in medical parlance.
Backed by well-developed IT infrastructure, CROs are betting it big on India. Against this background, the question raised by Dhananjay Bhakle, senior director (medical and regulatory affairs), Sanofi-Aventis India, at a two-day workshop on 'Building and Managing Clinical Trial Capacity in India: Challenges in Ethics, Equity and Efficiency' was: Is India ready for clinical research revolution?
The workshop was held recently at the Administrative Staff College of India, in association with the Indian Council for Medical Research and Fordham University, US.
Giving a perspective of the emerging regulatory scenario on clinical trials in India, Ashwini Kumar, drug controller-general of India, said, "We have come out with a policy statement on training of subject experts for clinical trial inspections and have initiated Central Drugs Standard Control Organisation trials for GCP inspections in October 2005."
He was explaining some of the regulatory initiatives taken for providing credible clinical research by ensuring credibility of data submitted to support new drug applications and safety of human trials.
To a question on the availability of clinical protocol and database for every drug trial in the public domain, Kumar said that India was a relatively new player in clinical trials and the need was of recent origin.
Lalit Dandona, chairperson, Health Studies Area, ASCI, said that drugs and vaccines that undergo clinical trials should be relevant to the distribution of disease burden in India.
India is projected to have accelerated growth in this sector with the entry of a number of major global and domestic players and the expected transformation in the pharmaceutical industry giving drug discovery research a higher priority.
About 65 representatives from industry, government, law, public advocacy, clinical research organisations and institutions, institutional review boards and healthcare providers, participated in the workshop to deliberate on transparency, accountability, legislation and regulation issues of clinical trials in India that might not be met with just adopting international guidelines on clinical research.
