Clinical trial : An evolving regulatory science in India- Challenges and way forward

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The most efficient and reliable method of generating credible data for evidence based medicine is clinical research, including clinical trial. Few years ago, India has been one of the idle destinations for clinical research activities,due to relatively low cost of conducting clinical trials when compared with developed world and trained human resource. But in recent times there have been few incidents of unethically and incorrectly conducted trials. This has spread certain degree of negativity associated with the clinical research in the country. This resulted in sharp decline of clinical trials (from 529 in 2010 to nearly 250 in 2012 to just over 100 n 2013).The clinical trial issues generated public debate in the country .Main
issues raised were regarding:



1) Process of informed consent in clinical trials
2) Justifiable compensation of trial participants for injury or death and
3) Exploitation of Indian subjects in the clinical trials

Government of India has taken several initiatives to address the loopholes in the existing regulations related to clinical trials in India through enforcement of ethical guidelines.

Though mostly all regulatory reforms are well taken by Indian and
International stakeholders, few generated strong debate amongst scientists, academicians and pharmaceutical industry. One of the key issues amongst it is compensation for clinical trial related injury due to ineffectiveness of placebo, investigators negligence, ineffectiveness of drug under trial etc.
The government regulations have been made after detailed
deliberations, consultation and analysis of the situation. These steps were essential to safeguard the interest of clinical trial participants. It is needed that these regulations are clearly understood and followed correctly by all stakeholders.



The regulatory guidelines are a part of a dynamic process and
will continue evolving as per the changing demands of the system. Therefore it is needed that these regulations must be carried forward by proactively responding to such challenges with suitable clarifications or amendments without compromising the well being of trial participants.