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.


