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Rule change provides fresh impetus to clinical study: Experts- 12-Jan-2016
Mumbai: Medical experts today welcomed the recent draft amendments to Drugs and Cosmetic Rules, 1945, saying the move would encourage academic research, as they called for undertaking more clinical study in India.
"Clinical research in India provides better, safer and more accessible treatment for patients. There was unanimous agreement that the changing regulations in 2015 had provided a fresh impetus to doing clinical research in India and we welcome the more recent draft amendments to the Drugs and Cosmetic Rules, 1945 to encourage academic research," they said at the 9th annual conference of the Indian Society for Clinical Research (ISCR) here.
"We have a gazette notification of January 6, 2016, which introduces draft amendments in the Drugs & Cosmetics Rules, 1945, that will definitely go a long way in encouraging investigator-initiated research. This is a welcome move," Tata Memorial Hospital Chief, Thoracic Surgery, Department of Surgical Oncology, C S Pramesh said at the conference.
"We have underestimated and undervalued the impact of investigator-initiated research in India and are nowhere close in recognising its worth. We have had regulatory challenges in the past which have been addressed," he said.
Pramesh pointed out that investigator-initiated research in India led to significant outcomes for patients while addressing specific and real needs - accessibility and affordability - of cancer treatment.
"If we have to tackle India's unmet cancer burden, we need to make clinical research work for our country."
The conference discussed a slew of topics such as clinical operations quality, investigator-initiated and collaborative research and understanding career opportunities in clinical research for students and young professionals.
Suneela Thatte, President of ISCR, said, "ISCR has functioned as both a catalyst and an enabler for clinical research industry in India. We are fully conscious of the role this industry plays in meeting the unmet medical needs of Indian patients in several disease areas. Our resolve now is to continue with even greater commitment and rigour in this direction."
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