Covid-19: AYUSH ministry issues guidelines for research projects

The AYUSH ministry has notified guidelines for researchers of traditional medicines in submitting Covid-19 cure proposals even as it received over 5000 suggestions on possible treatment of the virus infection in the last two weeks.

Currently, there is no specific regulatory provision in the Drugs & Cosmetics Rules 1945 for the clinical trials of Ayurveda, Siddha, Unani and Homeopathy drugs.

As per the notification, it’s mandatory for organisations, institutions and individuals to comply with at least nine conditions while undertaking research in “prophylaxis and clinical management” of Covid-19.

The proposals should be approved by scientific advisory bodies and institutional ethics committees. The clinical research should be conducted as per AYUSH guidelines or the Indian Council of Medical Research (ICMR) guidelines. Further the clinical trial projects should be registered with the ICMR’s Clinical Trials Registry-India (CTRI). The proposals should be backed by statistical evidence. Further an AYUSH registered practitioner/ expert should be part of the study team.

“It would be mandatory to the institution/organization to appraise the Ministry of AYUSH, Govt of India about the research developments as per the research timeline and the outcome,” the notification further added.

Earlier on March 31, the ministry issued a notification inviting AYUSH practitioners, institutions and organisations to submit their inputs. It has also set up a task force consisting of representatives from the department of biotechnology, Council of Scientific and Industrial Research and AYUSH practitioners to review the proposals.

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