Ministry of AYUSH on Tuesday ordered Patanjali Ayurved to stop advertising its claims of having a Covid-19 treatment drug until it is fully examined. Facts of the claim and details of the stated scientific study are not known to the Ministry and complete details of the supposed medicines have been sought, AYUSH said in a statement.
Yoga guru Ramdev's herbal medicine company on Tuesday claimed to have discovered cure for coronavirus but no medical authority could immediately vouch for the claim of 'Coronil and Swasari' medicine curing the highly contagious disease within seven days.
AYUSH Ministry said advertisement of Patanjali's alleged drugs are regulated under Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
"The concerned Ayurvedic drug manufacturing company has been informed 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 and the directives issued by the Central Government in the wake of COVID outbreak. Ministry had also issued a Gazette Notification No. L.11011/8/2020/AS dated 21st April, 2020 stating the requirements and the manner the research studies on COVID-19 with Ayush interventions/medicines should be undertaken," the ministry said.
Patanjali has been asked by AYUSH Ministry to not advertise/publicise these claims until they have been fully examined. Patanjali has also been asked for details of sample size, sites, hospitals where research study was conducted, and ethics panel clearance.
"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/publicizing such claims till the issue is duly examined," the ministry further said.
The ministry has also requested concerned State Licensing Authority of Uttrakhand Government to provide copies of license and product approval details of the Ayurvedic medicines being claimed for the treatment of Covid-19.
In May, the AYUSH ministry had allowed clinical trials of four ayurvedic 'rasayanas' for the treatment of coronavirus.
The firm claimed that the two Ayurved-based medicines have shown 100 per cent favourable results during clinical trials on COVID-19 infected patients except those on a life support system.
The medicines have been developed by Patanjali Research Center, Haridwar and privately-owned National Institute of Medical Science, Jaipur following all protocols with clinically controlled trial-based evidence, Ramdev told PTI in a telephonic interaction with PTI.
"Patanjali first conducted clinical case study and conducted clinical control trials following all protocols of drug discovery," he said.
Sidestepping questions on the drug being approved by government agencies such as ICMR, Ramdev said clinical 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."
Both the Ministry of Ayush and the Indian Council of Medical Research (ICMR) have reportedly refused to comment on the claim citing lack of knowledge of the issue.
A government notification bars companies from advertising a cure without government approval.
Ramdev claimed that his ayurvedic drugs have shown 100 per cent favourable results during the clinical trial.
At a launch press conference in Haridwar, he 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 clinical controlled trial, and found 69 per cent patients recovered in 3 days and 100 patients recovered in 7 days," he added.
According to him, this medicine is useful for prevention from COVID-19 and also for treatment.
He claimed that no infected patient lost his life during the trial.
Ramdev also claimed that during the trial other complications of patients were also cured and their critical parameters were normalised.
"Even parameters as hsCRP and IL-6 levels were also controlled during the trials," he added.
The test has been done on all kinds of patients except those who are highly infected and are on life support systems as ventilators.
"Trials on the infected people who are on a Ventilation support system are still due," he said adding that the trial has been conducted only on a normal infected person and persons with medium infections.
Ramdev further claimed "severely infected patients, which are on a life support system, can also be cured by this medicine but trials for such cases are due in the second stage."
Patanjali had started to work on corona medicines in December 2019.
The Corona kit, priced at ₹545, would be available pan India within a week. The kit will have medicines for 30 days.
This is not an immunity booster but a coronavirus cure, Ramdev said.