Clinical trials needed to develop new medicines: Industry body

 New Delhi: Clinical research would enable India to find newer and better medicines to treat its population and reduce mortality rates for various diseases, according to an apex association of clinical research professionals.

 "We strongly believe in the need to create a sound clinical research ecosystem that encourages local research and innovation," Indian Society for Clinical Research (ISCR) President Suneela Thatte told PTI.

There is a need to encourage such innovation and not deter the scientific and medical community from continuing in the quest to find safer and more effective treatment for the country's disease burden, she added.

 Earlier, a Supreme Court bench headed by Justice R M Lodha had said that a system  must be put in place to protect the lives of people and asked the Centre not to allow clinical trials for untested medicines.

 Emphasising that clinical trials need to be encouraged in India, she said: "At present less then 2 per cent of global clinical trials are happening in India which has around 16 per cent of the world's population and has 20 per cent of the disease burden."

 On being asked about the need for robust regulation of clinical trials in India Thatte said: "ISCR is fully supportive of the need for a more robust and regulated environment for the conduct of clinical trials in India which ensures the practise of the highest standards of ethics and quality and where patient rights and safety are protected."

 However, it is also important to ensure the continuity of clinical trials for thousands of patients for whom clinical trials are the last option, she added.

 In September this year, the Centre had informed the Supreme Court that an apex committee, headed by the Health and Family Welfare Secretary, has been formed to supervise the regulation of clinical trials based on the recommendation of the Technical Committee constituted under the chairmanship of the Director General Health Services.

 It had also said that a new Bill containing penal provisions for violation on conduct of trials for untested medicines has already been introduced in Parliament.


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