Clinical research is one of the mainstay parts of the drug discovery process that is carried out to ensure the efficacy and safety of the drug. Though it has a robust set of standards and guidelines, there have been some reports of unethically conducted trials giving rise to humanitarian concerns. This resulted in a decline in the number of clinical trials conducted in recent times. In this context, Indian government took initiatives to standardize the regulatory guidelines and enforced rules to maintain a balance between ethical issues and business. There are several regulatory bodies involved in pharmaceutical regulation in India such as Drug Control General India (DCGI), Indian Council of Medical Research (ICMR), Genetic Engineering Approval Committee (GEAC), Department of Biotechnology (DBT), Central Drugs Laboratory (CDL), Central License Approving Authority (CLAA), Drugs Technical Advisory Board (DTAB) etc to name a few.

Availability of study subjects, highly skilled healthcare professionals, cost effectiveness and timeliness are prerequisites of a successful clinical trial. Large patient pool is one of the reasons that put India up as one of the most favorable destinations for clinical trials. India constitutes about 18% of total world population with one fifth of the global burden of disease. It records highest toll on maternal, neonatal and child deaths in the world. Also, there is an increasing prevalence of communicable (e.g., TB, malaria, HIV etc) and non-communicable diseases (e.g., cancer, cardiovascular diseases, diabetes etc) levying heavy cost burden on healthcare expenditure. India consists of diverse talent pool with a large number of healthcare professionals such as doctors, nurses, laboratory technicians, researchers and clinical practitioners. Further, a large number of skilled professionals in the field of information technology and other sciences related to clinical trials made India an obvious place of choice for clinical trials.

Another important factor that draws the attention of clinical trials industry towards India is cost competitiveness. The cost for conducting clinical trials in India is one tenth of the cost in the USA. With many pharmaceutical companies relocating or outsourcing the clinical trial processes to India, the research and development expenditure in pharmaceutical industry has witnessed an exponential increase. The timelines set by the regulatory bodies in India ensure the trial applications to be approved in a relatively shorter span of time. For instance, DCGI gives its first response or approval for conducting clinical trials within 45 days whereas for conducting a bioequivalence study it takes 28 working days. Approval of investigational new drug (IND) by any referral bodies or expert would take additional 12 to 14 weeks. Any discrepancies in the applications will be sent back for review and hence delays the process by another 45 days.

Exploitation of the poor population of India by pharmaceutical companies to conduct clinical trials is a debatable issue. However, most of the trials in India involve testing of already tested drugs (clinical trial phase III) thus minimizing the risk as well as providing access to new therapies. In addition, there is an increased emphasis on following proper regulatory norms in order to stop the unethical practice of recruiting patients to carry out the clinical trials and protect the vulnerable population against any kind of exploitation.

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To learn more about the clinical research landscape in India, you may consider enrolling in a clinical research course conducted by the James Lind Institute.