Hours after Baba Ramdev’s Patanjali Ayurved claimed to have formulated medicines to combat the novel coronavirus with products named 'Coronil and Swasari', the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) has taken cognizance of the same. The Ministry said that the facts and details of the study on the basis of which Patanajali is making such claims are not known to it, and directed the company to stop advertising the 'medicines' till the issue is examined.
Patanjali claimed on Tuesday that its medicines 'Coronil and Swasari' can help patients recover from COVID-19 within seven days and that they have shown 100% favourable results during clinical trials on COVID-19 affected persons except those on life support.
Ramdev told PTI that the medicines have been developed by Patanjali Research Centre, Haridwar, and privately-owned National Institute of Medical Science, Jaipur, following all protocols with clinically controlled trial-based evidence.
However, the ministry of AYUSH has said in a statement that it informed Patanjali that such advertisements of drugs including Ayurvedic medicines are regulated under the provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder, as well as directives issued by the central government in the wake of COVID-19 outbreak.
The government notification bars companies from advertising a ‘cure’ without government approval. The ministry had also issued a notification on April 21 stipulating the requirements and the way the research studies on COVID-19 with AYUSH interventions/medicines should be undertaken.
At a launch press conference in Haridwar, Ramdev said, "The whole country and the world was waiting for the medicine or vaccine for coronavirus. We are proud to announce that the first ayurvedic, clinically controlled trial-based evidence and research-based medicine has been prepared by the combined efforts of Patanjali Research Centre and National Institute of Medical Sciences (NIMS)".
"We conducted a clinical case study and clinically controlled trial and found 69% patients recovered in three days and 100% patients recovered in seven days," he added.
Patanjali Ayurved has been asked by the AYUSH Ministry to provide details of the name and composition of the medicines in question, the site(s)/hospital(s) where the research study was conducted, the protocol followed, sample size, Institutional Ethics Committee clearance, CTRI registration and results data of the studies at the earliest.
Ramdev told PTI that a clinically controlled study of these medicines was done in several cities including Delhi, Ahmedabad and Meerut and the RCT (Randomized Clinical Trial) controlled with placebo was conducted at Jaipur-based National Institute of Medical Sciences & Research.
"This was done after getting approval from Clinical Trial Registry of India (CTRI) and all other required formalities," he said. "We have followed all the parameters set up by modern science for such clinical trials."
The ministry of AYUSH has also asked Patanjali to stop advertising and publicizing such claims till the issue is duly examined.
“Ministry has also requested the 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 further added.