Experts in the field of clinical research have hailed the Union health ministry's recent decision providing exemption from the mandatory prior permission from Drug Controller General of India (DCGI) for clinical trials, approved by the ethics committees, which are undertaken in the medical institutions or hospitals for academic research.

This according to experts is poised to boost institutional research conducted in India as it will give the institutional ethics committee power to govern the number of studies an investigator can undertake based on requirement of a particular study.

Notification also bears relevance because in each therapeutic area the study requirement varies immensely. This is also in line with the Prof. Ranjit Roy Chaudhury Committee recommendations to ensure better clinical outcomes.

This further also comes at a time when the clinical research being done in India is insufficient to address the country’s growing disease burden. India has 16 per cent of the world’s population, 20 per cent of the global disease burden and yet less than 1.4 per cent of global research is being done in India.

Says Dr. Shashwati Pramanik, chair, Regulatory Council, ISCR, “The notification will significantly reduce start-up time-lines due to exemption from DCGI approval while maintaining vigilance through ethics committees. Thus, this will give a big fillip to these institutions, encouraging more medical practitioners to get involved in clinical research.”

Experts also have pinpointed that in order to ensure that better clinical research prevails in the country as per the ethical guidelines as laid down in good clinical practices (GCP), investigators who are well versed in clinical practice should also acquire skills of documentation, presentation, management and forecasting of the study to usher in clinical research to address unmet medical needs of the Indian population.

Clinical research is essential not just for developing medicines for emerging health concerns like antibiotic resistant pathogens, H1N1 and dengue but also to find safer medicines for endemic diseases such as malaria, tuberculosis and lifestyle diseases such as diabetes and cardiac disorders.

“Our academic and teaching institutions are engaged in path-breaking research that addresses the unique health challenges of our country. The work they are doing is helping create not just new and better treatment for diseases endemic to our region, but is also making them more affordable and accessible to patients,” adds Dr. Pramanik saying that focus on patient safety and good clinical practices must continue to be the guiding principles of such research.

Concludes Dr CS Pramesh, chief, thoracic surgery, department of surgical oncology, Tata Memorial Hospital, Mumbai “If we have to tackle India’s unmet medical needs, we need to make clinical research work for our country. Academic and investigator-initiated research is an imperative not merely an option in India. Academic research is done to the same stringent local and international guidelines as research done by any sponsor in the country and with equal commitment to patient safety, ethics and quality. Tremendous benefits have been derived by cancer patients at Tata Memorial Hospital from local academic research, both in terms of cost and efficacy and will continue to invest in bringing better and more cost effective treatments to patients.”

A greater focus on clinical research is needed in many disease areas where there are unmet medical needs. Regulatory amendments that encourage research and innovation such as this notification has brought about can pave the way for more breakthrough research.