Recently on 26 July, the Supreme Court Judges were appreciative of the fact that the Ministry of Health was taking steps to strengthen the regulatory framework for the conduct and monitoring of clinical trials in India. The Supreme court also granted time to the petitioners to respond with suggestions that will further strengthen the regulatory environment for clinical research in the country.
Indian Society for Clinical Research (ISCR) is fully supportive of the initiatives undertaken to create a more robust and regulated environment in India for the conduct of clinical research. As per the spokesperson of ISCR, "Towards this end, we work very closely with different stakeholders on regulatory developments. Any steps to ensure the practice of the highest standards of ethics and quality and the protection of patient rights and safety is welcomed by us".The Government of India sponsored Working Group on Disease Burden for the 12th Five Year Plan refers to the "triple burden of disease" that developing countries like ours are facing arising from Communicable Diseases, Emerging Non-Communicable Diseases related to lifestyles and emerging infectious diseases.
In the larger context of India's unique healthcare demands and the growing incidence of endemic diseases and emerging lifestyle diseases, the need of clinical research is prominent . It will help to develop new and effective medicines and vaccines to tackle mammoth disease burden and unmet medical need. India has 16 percent of the world's population and 20 percent of the global disease burden and yet, less than 2 percent of global trials take place in India. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country.