Trust needed to bring back clinical trials to India, says ISCR president

By Melissa Fassbender

- Last updated on GMT

Image: iStock
Image: iStock

Related tags Clinical research Clinical trial

India has 16% of the world’s population, 20% of the disease burden, and has contributed to less than 1.4% of global clinical trials, but the country is looking to fix this imbalance.

As previously reported​ by, India has a “natural potential to grow,” according to Syngene CEO Peter Bains. However, this growth will not be without its challenges.  

Hasty regulatory reforms, judicial and social activism and some sensational/misleading media reporting – have posed a challenge to conducting clinical [research] in the country​,” Suneela Thatte, President of the Indian society for Clinical Research (ISCR) tells us.

At the end of 2014 through 2015, Indian regulators took steps to mitigate these challenges and to address stakeholder concerns by amending regulations, creating new orders, and offering further guidance on existing ones.

While more still needs to be done and it will take time before parity is restored, the step forward is a positive one​,” says Thatte.

The setbacks

India didn’t enter the global clinical trial market until the 1990s, and it wasn’t until the early 21st​ century that the market was established and recognized as a science on its own – making the market relatively younger than more developed ones, such as in the US and Europe.

Yet, data from indicates that the growth in the number of clinical trials registered in India was in line with worldwide growth, and in proportion with growth in developed markets, such as the US, Japan, and Korea – up until about 2010.

Thereafter, a combination of several factors in the external environment resulted in a major setback for clinical research in India​,” explains Thatte.

At this point, several sponsors, including Indian and multinational biopharma companies, academic institutions, and non-profits, decided to move studies to other countries because of “the unpredictable and uncertain regulatory environment​,” she explains.

As a result, the proportion of clinical trials has fallen at a time when our burden of disease is only increasing​.”


In order to move forward, Thatte explains the importance of continuing on the current trajectory of change and evolution.

What has been extremely encouraging is the inclusive approach adopted by the regulators whereby stakeholder feedback has been actively sought and acted upon in many cases, and we hope this will continue​,” she adds.

However, regulators still need to invest in building the infrastructure to ensure better governance and clinical research management for the future.

ISCR is fully supportive of these initiatives to create a more robust and regulated environment which ensures the practice of the highest standards of ethics and quality and where patient rights and safety are protected​,” explains Thatte.

Yet, one of the greatest challenges the country faces is building trust among global stakeholders in India’s new regulatory environment, which is “now a more conducive environment for clinical research in the country​.”

While this not an easy task and will take time​,” says Thatte, “it is the collective responsibility of all stakeholders across the clinical research to restore confidence in a clinical research process that stands not only for quality and innovation, but also safety and ethics, while also highlighting the need for clinical research in the country​.”

Thatte hopes that India will eventually reach a point where it is recognized for the high quality of clinical research done in the country and that its patients will be acknowledged for their “selfless contribution to bringing new drugs and new treatment to market.​” Part of this is creating “more acceptance and realization across the public at large about the role and relevance of clinical research in India and that it contributes to the greater good of everyon​e,” she adds.

Ultimately, Thatte says that India needs to take a more proactive role in conducting clinical research for India.

We have a great responsibility on our shoulders given where clinical research stands today in India​.”

Related news

Related products

show more

The Right CDMO Can Unlock Faster Drug Development

The Right CDMO Can Unlock Faster Drug Development

Content provided by Lonza Small Molecules | 15-May-2023 | Interview

Drug development presents biotech companies with ever-changing challenges. Enabling a faster end-to-end process requires seamless flexibility and extensive...

SDTM supplemental qualifiers explained

SDTM supplemental qualifiers explained

Content provided by Formedix | 12-May-2023 | White Paper

What are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard....

Plan for success with process liquid and buffer preparation

Plan for success with process liquid and buffer preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 25-Apr-2023 | White Paper

Setting the groundwork for successful scale-up is essential for getting a therapeutic to market quickly and efficiently, but navigating the unknowns associated...

Related suppliers

Follow us


View more