Regulation of Drug Trials: A National Consultation

As the medical research world becomes increasingly globalised, there is a need to make research methodologically valid, and to observe the highest standard of ethics. An increasing number of pharmaceutical companies have started outsourcing drug trials to Contract Research Organizations (CROs) in developing countries; these now make up a specialized global industry focusing on research on human participants. Shifts in the very science of drug development have influenced the decision to increase participant recruitment, with India becoming an attractive destination for international, outsourced clinical trials.

Revealingly, in India, debates over the conduct of drug trials by CROs, research institutions, pharmaceutical industries, international health NGOs, and the State are emerging. Indian sites for the research are without any independent institutions for monitoring and auditing of drug trials. In the absence of such a mechanism, it is difficult to ensure that scientific standards are upheld, and that good research practices and mandated trial protocols are fulfilled. Eventually, the quality, practice, ethics and effectiveness of science itself may be compromised.

Currently, the infrastructure for regulation, ethics review and monitoring is insufficient to regulate clinical trials in the country. In this situation, the government’s push to encourage clinical trials in India must be viewed with concern. There are many examples of drug trials that have taken place without proper protocols of consent. Without adequate and necessary regulatory jurisdiction or systematic review, the reliability and validity of such research is jeopardized. Considerations of transparency along with protection of participant rights have to be made priority for policy that truly engages and respects the public. This is particularly critical in the context of medicine and vaccine trials, placebo-based trials and genetic studies that are often in violation of both, the Declaration of Helsinki as well as the guidelines for biomedical research as laid out by the Indian Council of Medical Research (ICMR). India requires more substantial regulation, and effective implementation, that can institutionalise the highest standards of independent inquiry, good clinical practice, protocols, monitoring, and follow up, so that a strong and pro-people policy framework can be put in place.

It is in this context that the National-level Consultation on the Regulation of Drug Trials in India in September 2011 seeks to promote dialogue and deliberation between a range of stakeholders, particularly health networks and activists, the medical and scientific community, legal experts, research organisations, and policy makers, towards evolving concrete recommendations for policy and regulation on these issues.

The specific objectives of the workshop are to;

  • open channels for dialogue between science and policy, so that regulation that brings the interests of both these communities together can be evolved.
  • develop an understanding of the multi-faceted nature of drug trials in India, and explore its linkages with different forms of marginalisation, business and commerce, and ethics and human rights in various contexts, as well as its relationship with a growing biotechnology/ pharmaceutical industry.
  • create space for dialogue and discussion on policy-level advocacy, for the regulation of biomedical and health research in India, including ethical obligations and management of conflict of interest.
  • identify the gaps and strengthen the existing regulatory mechanisms such as Schedule Y of Drugs and Cosmetics Act, and Ethical Guidelines for Biomedical Research on Human Participants by ICMR.


Sarojini N and Anjali, Sama- Resource Group for Women and Health, Delhi
S. Srinivasan, Low Cost Standard Therapeutics (LOCOST), Baroda
Dr. Amar Jesani, Independent consultant for Research and Training in Bioethics and Public Health
Neha Madhiwala, Centre for Studies in Ethics and Rights (CSER), Mumbai
Dr. Gopal Dabade, Drug Action Forum, Karnataka (DAF-K)
Dr. Amit Sen Gupta, All India People’s Science Network (AIPSN)

Date: Monday, September 26, 2011 (All day) to Tuesday, September 27, 2011 (All day)
Venue: India International Centre Annexe, New Delhi

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