The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) has asked licensing authorities of States and Union Territories to forward the license applications for research studies/clinical trials of AYUSH interventions on COVID-19 to it for prior approval and study verification.
A notification issued by the AYUSH Ministry informed that this move was initiated after realising that approvals are being given for medicinal products selected/ registered for clinical trials/research studies and spurious claims and misleading advertisement made in the media about the treatment of COVID-19 patients.
Now, only with prior approval from the Central Government can the state licensing authorities issue an approval for research studies and clinical trials for AYUSH intervention on COVID-19. It aims to generate proof of effectiveness for new indications and curb down the false claims associated with AYUSH-related research treatment mechanism.
Earlier, on April 21, 2020, the AYUSH Ministry has issued a gazette notification No. L.11011/8/2020/AS stating, “In the wake of COVID-19 caused by SARS CoV 2, there has been a surge in proposals received by Ministry of AYUSH claiming possible treatment of COVID-19. At present, there is no approved treatment for COVID-19 infection. The Indian traditional medicines have wide potential for usage in such conditions owing to their longstanding use in the community, a huge number of ancient references and a large number of publications in scientific journals on their phytochemical constituents, mode of action, clinical efficacy etc. At the same time, it is also essential to have scientific evidence on the 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 recognised under the Drugs and Cosmetics Act, 1940.
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. However, it is necessary that the clinical data generated is scientifically valid and credible. In this context, the Ministry, after consulting with the DCGI, CDSCO as well as other research experts and based on that, notified that scientists, researchers, clinicians of any of recognised 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
However, the same notification also indicated that while undertaking research, it is mandatory for the organisations to comply with the following conditions:
(i) The proposals should be approved by their scientific advisory bodies and Institutional Ethics Committees
(ii) If it is a clinical trial, the project should be registered with CTRI
(iii) The sample size should be based on statistical justification
(iv) The clinical research should be conducted as per AYUSH guidelines for clinical research or ICMR guidelines
(v) Compliance with relevant regulations for biomedical and health research
(vi) Compliance to good clinical practice guidelines
(vii) Compliance to national ethical guidelines for biomedical and health research on human participation published by ICMR.
(viii) Compliance with any other relevant regulations in force
(ix) AYUSH registered practitioner/expert should be part of the study team at each site
It was also mentioned in the notification that it would be mandatory for the institution/organisation to apprise the Ministry of AYUSH, Government of India about the research developments along with research timelines and the outcomes.
Commenting on the recent notification issued by the AYUSH Ministry, Manmohan Taneja, Assistant State Drugs Controller, FDA, Head Quarter, Haryana, Panchkula said, “These directions have been issued by Central Government to tighten the screw on the State Licensing Authoritie...
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