Delhi

Noting that currently, the regulations do not allow for clinical trials of Ayurveda, Siddha, Unani, and Homeopathy drugs whose efficacy need to be determined in the wake of rising cases of coronavirus, the Ministry of AYUSH has given its nod to conduction of research in this domain.

The confirmation to the same was given by the Ministry of AYUSH through a recently issued gazette notification.

In the notification, the ministry stated that in the wake of COVID-19 caused by SARS CoV 2, there has been a surge in proposals received by the Ministry of AYUSH for claiming possible treatment of COVID-19. At present, there is no approved treatment for COVID-19 infection.

"Indian Traditional Medicines have the wide potential for usage in such conditions owing to their longstanding use in the community, huge number of ancient references and large number of publications in scientific journals on their phyto-chemical constituents, mode of action, clinical efficacy etc. At the same time, it is also essential to have scientific evidence on use of any Ayurveda, Unani, Siddha or Homeopathy formulation on prevention/management of COVID-19. Therefore, it is felt necessary to make serious efforts for the development of drugs based on any of the AYUSH systems recognized under the Drugs and Cosmetics Act, 1940," the notification said.

The ministry noted currently there are no specific regulatory provisions in the Drugs & Cosmetics Rules 1945, for the conduct of clinical trials of Ayurveda, Siddha, Unani, and Homeopathy drugs. At the same time, it is also necessary that the clinical data generated is scientifically valid and credible. In this context, the Ministry has undertaken consultation with DCGI, CDSCO as well as other research experts.

"In the above background and based on the consultation of CDSCO, the Ministry of AYUSH with the approval of Minister of State Independent Charge for AYUSH notifies that scientists, researchers, clinicians of any of recognized systems of medicine under IMCC Act, 1970, HCC Act 1973 and NMC Act 2019 (formerly IMC Act 1956) can undertake research on COVID-19 through Ayurveda, Siddha, Unani and Homeopathy systems including prophylactic measures, intervention during the quarantine, asymptomatic and symptomatic cases of COVID-19, public health research, survey, lab-based research etc. to generate evidence," the gazette stated.

Research Compliance Conditions

While undertaking research, it is mandatory for organizations to comply with the following conditions:

• The proposals should be approved by their scientific advisory bodies and Institutional Ethics Committees.
• If it is a clinical trial, the project should be registered with CTRI.
• The sample size should be based on statistical justification.
• Clinical research should be conducted as per AYUSH guidelines for Clinical Research or ICMR guidelines.
• Compliance with relevant regulations for Bio-medical and Health Research.
• Compliance with Good Clinical Practice Guidelines.
• Compliance to National Ethical Guidelines for Bio-medical and Health Research on Human Participation published by ICMR.
• Compliance with any other relevant regulations in force.
• AYUSH registered practitioner/expert should be part of the study team at each site.

"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," it further added.

For more details, refer to the official gazette notification.