The decision, which came into force in March, has been lauded by the Indian Society for Clinical Research (ISCR) which said it would give a fillip to institutional research in the country.The notification by the Ministry of Health and Family Welfare said, “No permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where the trial is approved by the Ethics Committee; and subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority.”
Shashwati Pramanik, Chair, Regulatory Council, ISCR, said “The recent amendment will significantly reduce start-up timelines due to exemption from the Drug Controller General of India approval, while maintaining vigilance through Ethics Committees. This will encourage more medical practitioners to get involved in clinical research.” While India is the largest producer and exporter of generic medicines in the world, domestic research in new medicines is low. According to estimates, less than 1.5 per cent of the global clinical research is being conducted in India and red tapes are noted as a prominent cause for the slack.
Domestic research, especially on endemic diseases, is key to more affordable access for patients, Pramanik said. “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. We are pleased that the government has provided certain exemptions to academic research which will further encourage academic research in our country,” said CS Pramesh, Professor and Chief of Thoracic Surgery, Department of Surgical Oncology at Tata Memorial Hospital.
He further added, “We have seen the tremendous benefits that cancer patients at the 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.”
Pharm.D @ SRIPMS-CBE-TN