MANUFACTURING AND ADVERTISING OF AYURVEDIC MEDICINES AS CURE FOR COVID-19 – Eshwars
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MANUFACTURING AND ADVERTISING OF AYURVEDIC MEDICINES AS CURE FOR COVID-19

Authored by Ammu Brigit

Patanjali Ayurveda Limited (Patanjali) along with Divya Pharmacy Limited in its recent press conference launched ayurvedic medicines claiming to be the first ayurvedic cure medicines with 100% recovery within seven days for Covid-19. Taking notice of this announcement, Ministry of Ayurveda, Yoga, Neuropathy, Unani, Siddha and Homeopathy (Ministry of AYUSH) instructed Patanjali to stop advertisements, and sought from it the name and composition of the medicines, site/hospital where the research study was conducted, protocol, sample size, Institutional Ethics Committee (IEC) clearance, Clinical Trial Registry-India (CTRI) registration, result data of the study. In the context, in this article we look into the legal position with regard to the research, manufacturing and advertising of Ayurvedic medicines in India.

Manufacturing of Ayurvedic Medicines

Under section 33EEC of Drugs and Cosmetics Act,1940 (DCA) read together with Part XVI of Drugs and Cosmetics Rules 1945 (DCR), a person intending to manufacture any ayurvedic medicine should obtain appropriate license after fulfilling the conditions of license under DCA and DCR.

The AYUSH ministry taking note of the gap in DCR as it does not contain specific regulatory provision requiring conduct of clinical trials for Ayurveda, Siddha, Unani and Homeopathic drugs (AYUSH Drugs), and recognising the need for scientifically generated clinical data for validation and credibility of drugs for Covid-19, came up with a notification dated 21st April 2020.

Under this notification, the AYUSH Ministry required scientists, researchers, clinicians of any recognised systems of medicine under Indian Medicine Central Council Act 1970 (IMCC Act), National Medical Commission Act, 2019 (NMC Act), and Homeopathy Central Council Act 1973 (HCC Act) undertaking research on cure or prevention of Covid-19 through Ayurveda, Siddha, Unani and Homeopathy systems (“AYUSH System”) for Covid-19 to generate evidence of their claim. The notification without being exhaustive of the areas of research, included the following too within the ambit of generation of evidence: (i) intervention during quarantine, (ii) research on asymptomatic and symptomatic cases of Covid-19, (iii) public health research, (iv) survey, (v) lab based research etc.

According to this notification, it is necessary to obtain IEC approval; register with CTRI for conducting clinical trial and have statistical justification for sample size; conduct clinical research complying with AYUSH and ICMR guidelines for clinical research and Good Clinical Practices; comply with National Ethics Guidelines for Bio-Medical and Health Research on Human Participation; have an  AYUSH registered practitioner or expert as a part of the study team, at each site. The notification has also required those conducting research and clinical trials to keep the Ministry of AYUSH informed about the research development and outcomes.

The Ministry of AYUSH by an order dated 28th July 2020, has centralised the power to verify results of clinical trial and research study before issue by the state regulators of approval and license to manufacture after clearance by the central government. The regulators in each state are required to the applications along with the results of the trials to the AYUSH Ministry for verification and clearance.

Advertisements of AYUSH Medicines

Section 4 of the Drugs and Magical Remedies (Objectionable Advertisements Act), 1954 (DMROA)  prohibits a person to participate in the publication of any advertisement (which means any notice, circular, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light, sound, or smoke) relating to a drug if the advertisement contains any matter which directly or indirectly give a false impression regarding the true character of the drug; or makes a false claim for the drug or is otherwise false or misleading in any material particular.

The Drugs and Cosmetics Rules, 1945 (“DCR”) was specifically amended in 2018 with respect to the advertisement of AYUSH medicines, and it now prohibits the participation of the manufacturer of AYUSH medicines or his agent in the publication of any advertisement relating to any drugs for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition. For any AYUSH medicine other than for the above purpose, advertisement is permitted after obtaining an unique identification number for such advertisement by making an application with the State Licensing Authority or the Drug Controller, in Form 26 E-4. This amendment to DCR implies that no manufacturer can claim therapeutic claims on AYUSH products.

Owing to the outbreak of Covid-19, the Ministry of AYUSH vide an Order dated 21st April 2020 instructed all state AYUSH regulatory authorities to stop and prevent publicity and advertisement of AYUSH related claims for Covid-19 treatment in print, TV and electronic media and take necessary actions against the agencies/persons involved in contravening the relevant provisions and the guidelines given by National Disaster Management Authority (NDMA) under the order of Ministry of Home Affairs dated 24th March 2020.

Conclusion

 At a time when researchers from every field of medicine are engaged in the  development of the cure for Covid-19, it is imperative to ensure that the research for such cure is carried on based on the guidelines of the government authorities and advisory bodies. It is a welcome move by the government to centralise the power to verify and clear AYUSH drugs for Covid-19, and also on its advertising to avoid dubious therapeutic claims of Ayurvedic medicines and thereby protect public health. These, together with civil penalties having been brought under the Consumer Protection Act 2019 with regard to the misleading advertisements has also become an additional legislative support to ensure that AYUSH drugs are not marketed or sold with misleading claims.

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