SLAs to issue manufacture/sale licenses for AYUSH formulations only after approval from AYUSH Ministry

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 Authorities (Ayush), who have been issuing licences arbitrarily without following the statutory provisions provided under rules 158-B and 169 of the Drugs and Cosmetics Rules,1945.”

Explaining the need for such steps, he informed, “The market is flooded with misbranded and spurious AYUSH products on which Central Government has shown the serious concern. Earlier also, the Central Government had issued letters to States to check spurious products and misleading advertisements of AYUSH products claiming COVID-19 treatment. Now SLAs (Ayush) has been directed not to issue licences for such products without prior approval of the Central Government. It would certainly check the mushrooming of spurious and misleading products.”

Dr G Selvaraj, Former Director, Drugs Control, Tamil Nadu said that in this pandemic situation, many manufacturers of Ayurvedic, Unani, Siddha and Homeopathic medicines came forward with many formulations claiming that they are curing COVID-19, which appears to be misquoting or misleading advertisements; for e.g. Patanjali. Since the COVID-19 is a new virus there is no data or basis or earlier studies for these indications.

He explained, “Realising the critical situation many manufacturing companies applied for product permission for COVID-19 drugs under AYUSH category in various States. Therefore, now the AYUSH department wants all the state licensing authorities (SLAs) to forward the details of product, formula, clinical trial study, etc., of those applications to the Government of India. And based on approval from Central Government the SLA can grant the licence.”

Selvaraj added, “It is similar to “new drug” approval of CDSCO in allopathy under Rule 122. It helps in controlling mushroom growth and unnecessary flow of AYUSH drugs in the market and exploiting the consumers in the name of COVID-19.”