On Tuesday 23 June 2020, the Ministry of AYUSH asked the FMGC retail giant Patanjali to furnish details of the medicine ‘Coronil’, which the company claimed to be the cure for the novel coronavirus. The notice came hours after Patanjali launched its medicine through a press conference.
Earlier on Tuesday, Patanjali Founder Baba Ramdev and Managing Director Acharya Balakrishna, in a press conference, claimed that Patanjali Research Institute had developed a medicine that can cure COVID-19. The press conference was held at Patanjali headquarter in Haridwar, Uttarakhand. The research was conducted in collaboration with the National Institute of Medical Science, Jaipur.
“We conducted a clinical case study and clinically controlled trial and found that 69 percent of patients recovered in three days and 100 percent patients recovered in seven days,” Baba Ramdev said. “Coronil has been tested in a randomized placebo-controlled clinical trial on COVID-19 patients, he added. The Yoga guru also claimed that Coronil was the first Ayurvedic, clinically controlled, research, evidenced, and trial based medicine for Covid-19.
However, the Indian Council of Medical Research (ICMR) and AYUSH Ministry have distanced themselves from the alleged cure ‘Coronil’. Commenting on the cure, ICMR, which is the nodal agency for COVID-19 treatment and apex medical body in India, said they do not deal with ayurvedic medicines, AYUSH Ministry does. On the other hand, AYUSH Ministry said that the Uttarakhand government is responsible for granting a license to a pharmaceutical firm, including the Ayurvedic drug manufacturer.
In the notification issued by AYUSH, the Ministry has asked Patanjali Ayurved Ltd. to submit details of the medicine such as name and composition, site(s)/hospital(s), where the research study was conducted, protocol, sample size, Institutional Ethics Committee clearance, CTRI registration and results data of the study(ies). The ministry also asked Patanjali to refrain from advertising its medicine kit for the COVID-19 cure until the claims are duly examined.
“Ministry of AYUSH has taken cognizance of the news being recently flashed in the media about Ayurvedic medicines developed for the treatment of COVID-19 by Patanjali Ayurved Ltd. Facts of the claim and details of the stated scientific study are not known to the Ministry,” the statement added. The 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.
The ministry also cited an April notification that laid down guidelines for the development of drugs based on AYUSH systems that are recognized under the Drugs and Cosmetics Act, 1940. The notification contained guidelines, as per which recognized scientists, researchers and clinicians can undertake research on such drugs provided that ‘the proposals are approved by their scientific advisory bodies and Institutional Ethics Committees’ etc.
Advocate Murali Neelakantan, a practitioner in the pharmaceuticals industry, said, “From the statement issued by the AYUSH ministry, it is fair to deduce that the product has not been licensed under Chapter IV-A of the Drugs & Cosmetics Act and Rule 158(B) of the Drugs & Cosmetics Rules. As a consequence, the manufacturer or sale of this product is punishable under Section 131 of the Drugs Act.”
Patanjali is yet to comment on the Ministry’s statement and its implications on the sale of Coronil.