Patanjali Ayurveda Limited’s announcement on June 23 that it had found an Ayurvedic cure for COVID-19 in the form of the medicines "Coronil" and "Swashri Vati" has been called out by the Ministry of AYUSH, the nodal Ministry that sanctions clinical trials for treatments under the AYUSH stream. The Ministry, in a press release, said neither the claim nor the scientific study was known to it. It directed the company, founded by the yoga guru Baba Ramdev, to "stop advertising/publicising such claims till the issue was duly examined". The Minisry also requested the State licensing authority to provide "copies of the licence" and "product approval details" of the medicines.
The Uttarakhand government clarified separately to the news agency ANI that it had only issued Patanjali a licence for immunity boosters. The licence officer of the State Ayurveda department told ANI that a notice would be issued to Patanjali asking it how it got permission to make the medicines for COVID-19.
Ramdev, while launching the medicines in a Corona kit, claimed that a controlled clinical study was done, and hundred people were tested and within three days 65 per cent of the people who were found positive turned negative. "Coronil" had hundred per cent recovery rate, he claimed. The media was informed that the drug would be available in all Patanjali stores within a week. In addition, an "order me" application would also be launched for home delivery of the drug.
As the breakthrough made news, there was some disquiet as no authoritative source from the government had authenticated it. Finally, at around 5.30 p.m. the same day, mediapersons received a press release from the Ministry of AYUSH wherein it was stated that the facts and claims pertaining to a certain scientific study by the Haridwar based Patanjali Ayurveda Limited were not known to the Ministry.
In the press release the Ministry cautioned the company that such advertisements of drugs, including Ayurvedic medicines, was regulated under the provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and Rules as well as by the Central government’s directives in the context of the COVID-19 outbreak. The Ministry also referred to an April 21 gazette notification regarding the requirements and the manner in which research studies with Ayurvedic interventions/medicines needed to be undertaken. Patanjali was asked to furnish the details of the name and composition of the medicines, the sites or hospitals where the research study was conducted, protocols, sample size, institutional ethics committee clearance, Clinical Trial Registry of India (CTRI) registration and results of the data collected and studies conducted.
Two other government orders were also released to the media in the context of the Patanjali claims, perhaps as reminders of previous orders of the AYUSH Ministry. One order, dated April 1, was issued by the Adviser and Head of the ASU&H Drugs Policy Section of the Ministry under the Drugs and Cosmetics Act 1940. It was sent to all regulatory authorities dealing with ASU&H government officials in the States. These authorities were directed to "stop and prevent publicity and advertisement of all AYUSH related claims for COVID-19 treatment in print, TV and electronic media". The regulatory authorities were told to take "necessary action against the persons/agencies involved in contravening the relevant legal provisions and the aforesaid guidelines of the National Disaster Management Authority".
On April 21, a notification from the AYUSH Ministry stated that there had a been a "surge in proposals" claiming possible treatment of COVID-19. The notification clarified that "at present there is no approved treatment for COVID-19 infection" and that while scientists, researchers, clinicians could undertake research through any of the AYUSH systems to generate evidence, they would have to follow certain conditions, including established guidelines for clinical research and trials. It would also be mandatory for the institution to appraise the Ministry of AYUSH about the research developments as per research timeline and outcome.
On June 2, the Principal Secretary, AYUSH, wrote to his counterparts in the States about the "menace of misleading communications about AYUSH remedies" in the media. There were false claims publicising approval of research study or product on COVID-19 control by the Ministry and also naming of the Ministry in AYUSH products that claimed a cure for COVID-19. State licensing authorities and drug controllers were directed to take "necessary action" against all such instances of misleading information, fake claims and mis-branding.
Patanjali responds
On June 23 evening, Patanjali Research Foundation Trust wrote to the Drug Policy Section of the AYUSH Ministry regarding news items about Coronil and Swashri Vati. It gave details of the composition of the medicines and stated that the research study was conducted at the Department of Medicine, National Institute of Medical Sciences and Research (NIMS, Jaipur). NIMS, Jaipur, is a private university. It also attached the clearance from the Institutional Ethics Committee and the CTRI details. The results of the research had not been uploaded on the CTRI website.
The scientific title of the study was "impact of Indian traditional Ayurvedic treatment regime for nCoV-2 or COVID-19. The study claimed to have "discovered" that "natural phytochemicals in Ashwagandha, Giloy and Tulsi indeed have potential to combat COVID-19 and its pathogenicity". The principal investigator at NIMS, Dr Ganpat Devpura, had apparently written to the Director General, Central Council for Research in Ayurvedic Sciences, in the AYUSH Ministry and the Additional Chief Secretary of Rajasthan on June 2 giving details of the clinical trial registered in the CTRI.
Clearly, Patanjali had not shared the results of its trials with the parent Ministry before the launch of its drugs. The claim was a highly irresponsible one to make, and it had embarrassed the government as well.
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