India emerged as a favoured destination for clinical research and trials recently for many multinational companies due to the easy availability of volunteers at low cost as well as lax regulatory authorities governing the clinical trials in India. This is in total contrast to increasingly difficult conditions and sparse availability of volunteers for clinical trials in many European nations and USA.

The recent report of 49 child deaths over two years allegedly related to the clinical trials in paediatric patients in the premier medical institute in India, AIIMS does raise lots of new questions.

The internal enquiry conducted at AIIMS, into deaths of these children reported no direct link between deaths and the clinical trials. It is expected that there will be further enquiries investigating this matter in near future.

India for sure needs to maintain its momentum in the field of clinical research. Along with optimism of growth in this industry there is a real concern that vulnerable population may be exploited.

While Good Clinical practice has been clearly spelt out and ethical guidelines have been articulated, our experience with implementation is relatively short. The regulatory authority is already stretched in terms of its ability to monitor proper implementation.

The expected fast growth is going to further stretch the capabilities of the system and highlight complexities and unintended consequences.

Wide cross-section of stake holders in the clinical research trials include the industry, government, patient advocacy, medical practice, ethics review board, clinical research organizations, media and independent investigators.

Various stakeholders in the clinical research industry should be clearly made aware of the ethical regulations governing the conducting of clinical trials in India.

ICMR needs to introduce more stringent regulations to avoid such exploitation of vulnerable volunteers and unethical practices in India.

There is a need at present for strong centralised regulatory regime which can guide high quality development of ethical capacity with extra vigilance but an informed understanding of acceptable risk. Such a system while confirming to international standards needs to be uniquely Indian.

It needs to include indigenous medicine, devices, drugs and therapies while incorporating the advent of biotechnology in general and genomics and proteomics in particular.

CTRI (clinical trials registry India) has been set up by the ICMR in order to ensure that all the clinical trials being conducted in India are closely monitored.

India is projected to have accelerated growth in this sector with already many big global and local players in the field and a more research focused pharmaceutical industry. India is poised to face formidable challenges at the same time.

The regulatory regime in India has to identify ways of creating balance between benefits and costs/risks.