Govt says no need for clinical trial approval for academics
ICSR
feels it will help promote domestic research
New Delhi, April
20:
The
government has done away with the need for permission to conduct clinical
trials if the same was being conducted by an academic institution provided the
trial gets a seal of approval from an ethics committee.
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
clinica
l research is being conducted in India and red tapes are noted as a
prominent cause for the slack.
Exemption welcome
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.”
Source
| Business Line |21 April 2016
Regards
Pralhad
Jadhav
Senior
Manager @ Library
Khaitan
& Co
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