Hours after a splashy launch of its claimed ayurvedic treatment for the novel coronavirus, Patanjali Ayurved Ltd. was told by the government to stop advertising or publicising any such claim due to the lack of requisite approval. The legal provisions cited in the ministry statement also indicate that Patanjali cannot sell the product as of now.
The facts and claims made by Patanjali of the efficacy of its virus medicine, branded ‘Coronil', were not known to the Ministry of AYUSH, according to a statement by the ministry that governs ayurvedic medicines. It asked Patanjali to stop advertising and publicising claims till the issue is examined.
“In order to make this Ministry aware of the facts of the aforesaid news and verify the claims, Patanjali Ayurved Ltd. has been asked to provide at the earliest details of the name and composition of the medicines being claimed for Covid treatment; site(s)/hospital(s), where the research study was conducted for Covid-19; protocol, sample size, Institutional Ethics Committee clearance, CTRI registration and results data of the study (ies) and stop advertising/publicising such claims till the issue is duly examined. Ministry has also requested concerned State Licensing Authority of Uttarakhand Government to provide copies of license and product approval details of the Ayurvedic medicines being claimed for the treatment of COVID -19.”
Launch of first and foremost evidence-based ayurvedic medicine for Covid-19@yogrishiramdev @Ach_Balkrishna #Patanjali #आयुर्वेदविजय_कोरोनिल_श्वासारि pic.twitter.com/3hiyUSnZJX
June 23, 2020Earlier today, Patanjali Founder Swami Ramdev and Managing Director Acharya Balkrishna hosted a press conference claiming the consumer goods company had developed a medicine to treat Covid-19. The company claimed it had conducted trials that showed that 69 percent of Covid-19 positive cases turned negative in three days and all patients were cured in seven days. Except for these claims by the company, it is not clear which authorities had approved the medicine, if at all, and what was the clinical evidence provided for such approvals.
Patanjali has now been cautioned by the ministry that advertising such a drug, including an Ayurvedic medicine, is regulated by the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules and directives issued by the central government pursuant to the virus outbreak.
The ministry statement also cites an April notification that lays downs guidelines for development of drugs based on any of the AYUSH systems -- Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy -- recognised under the Drugs and Cosmetics Act, 1940.
As per those guidelines, recognised scientists, researchers and clinicians can undertake research on such drugs provided
- the proposals are approved by their scientific advisory bodies and Institutional ethics Committees
- clinical trials, if any, are registered with CTRI
- sample size should be based on statistical justification
- research should be conducted as per AYUSH guidelines
- compliance with relevant ICMR guideline among other requirements
The ministry's April notification also makes clear that it must be appraised by the institution or organisation conducting such research about the developments timeline and outcome.Since, the ministry said it had no information on the Patanjali medicine, does that suggest that the company does not even have clearance to sell the product?
Murali Neelakantan, a lawyer who has worked in the pharmaceutical industry, said based on the statement issued by AYUSH ministry it is fair to deduce that the product has not been licensed under Chapter IVA of the Drugs & Cosmetics Act and Rule 158(B) of the Drugs & Cosmetics Rules.
As a consequence, the manufacture or sale of this product is punishable under section 33I of the Drugs Act,” Neelakantan said in an email comment.
Even if each of the ingredients in the product is licensed for manufacture and sale, advertisement of the claim that it cures Covid is a clear violation of section 3 (d) of the Magic Remedies Act, 1954, he added. “I am surprised that the press is carrying the story and effectively “advertising” the product, a violation of section 4 of the same legislation.”
Patanjali's Acharya tweeted late evening that his company has met all parameters of randomised placebo controlled clinical trials and has provided information to the ministry.
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