The Indian Society for Clinical Research (ISCR) today said the March 16 gazette notification by the Health Ministry exempting clinical trials undertaken in medical institutions or hospitals for academic research from seeking permission would give a much needed boost to institutional research being conducted in India.
The Health Ministry recently amended the Drugs and Cosmetics Rules, 1945 whereby no permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation will be required for any new indication or new route of administration or new dose or new dosage form where the trial has been approved by the Ethics Committee.
"Our academic and teaching institutions are engaged in research, helping create not just new and better treatment for diseases endemic to our region, but are also making them more affordable and accessible to patients.
"The recent amendment will significantly reduce start-up timelines 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," said Shashwati Pramanik, Chair, Regulatory Council, ISCR.
In order to tackle India's unmet medical needs, there is need for greater focus on clinical research for our country, said C S Pramesh, Professor and Chief, Thoracic Surgery, Department of Surgical Oncology at Tata Memorial Hospital.
"Academic and investigator-initiated research is an imperative not merely an option in India. We are pleased that the government has provided certain exemptions to academic research which will further encourage academic research in our country," said Dr Pramesh said.
"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.
"We have seen the tremendous benefits that cancer patients at Tata Memorial Hospital have derived 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," he added.
Currently, the 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, Pramanik said.
"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 amendment can pave the way for more breakthrough research," he added.
