Critically discuss the factors that make India one of the most sought-after destinations of clinical trials in the world. Also throw light upon the legal framework around clinical trials in the country.

Published: February 4, 2016

India is a favoured destination for clinical trials because of few reasons such as, low cost, large numbers of people with a range of illnesses; availability of trained human power and infrastructure; good patient compliance. However, there are three main reasons as follows:

  • Population of India comprises several gene types such as Caucasoid, Mongoloid and Australoid. This makes India different from other countries which have homogenous populations.
  • People in India are “treatment naive”. This implies that the people here are less exposed to medicines.
  • Third major reason is widely prevalent poverty and illiteracy. Poverty is a major factor because people in rural India are unable to afford treatment but likely to accept test of new drugs.

Further, increasingly accommodating regulatory environment has made India the most sought after destination for clinical trials.
Legal Framework
Clinical trials in India are subject to several laws and orders. The major act is Drugs and Cosmetics Act (1940). Other legislations include

  • Medical Council of India Act (1956)
  • Central Council for Indian Medicine Act (1970)
  • Guidelines for Exchange of Biological Material Order (1997)
  • Right to Information Act (2005).

Further, in 2013, a bill to amend Drugs and Cosmetics Act (1940) was introduced to make clinical trials more streamlined in the country. The Drugs and Cosmetics Act mandates drug companies wanting to recruit volunteers or patients to participate in clinical trials to get their “informed consent”. Besides, all clinical trials in India need to follow the ICMR guidelines. Also there is an online Clinical Trial Registry of India (CTRI) under the ICMR, which is creating a database of prospective clinical trials. The data and reports of these clinical trials and their status will be made available to public.

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