Back On Track?

- Usha Sharma

Recent years have seen a slowdown of clinical trials in India in the wake of stringent directives from the Supreme Court asking the government and regulatory agencies to take measures to ensure safety of patients participating in clinical trials of new medicines.

Over the last year and a half, the Ministry of Health and Family Welfare has taken various steps to address the challenges posed by regulatory uncertainty. Regulations were amended and further guidance was given on existing ones.

India accounts 17 per cent of the global population and 20 per cent of the global disease burden but still accounts for a significantly low number of clinical-trials.

Suneela Thatte, President, Indian Society for Clinical Research (ISCR) informs, “For a country that has the second highest population in the world and the highest burden of disease, around 1.4 per cent of global clinical trials takes place in India (https://clinicaltrials. gov/ct2/search/map?map=SS). That in itself is indicative of how under represented India is in terms of clinical research. Besides a high patient population and a significant representation of diseases characteristics of both developing and developed economies, India also has well qualified English speaking investigators and good infrastructure. So, we have all the requisite requirements needed for clinical research.”

However, market reports explain that the situation was not so unfavourable for the Indian clinical research industry till 2010 from between 2004-10, many multinational and domestic pharmaceutical companies choose India as the preferred destination for conducting clinical trials. Then why did the situation turned so bad?