Patanjali Ayurved & COVID-19 medicine

Hours after yoga guru Baba Ramdev unveiled an Ayurvedic medicine — ‘Coronil and Swasari’ — on Tuesday, claiming that clinical trials on COVID-19 affected patients had shown favourable results, the Central government asked Patanjali Ayurved Limited to stop advertising the drug and sought details on its claimed “successful trial and cure”.

In a statement issued by the Ministry of Ayush on the claims made by Haridwar (Uttrakhand)-based Patanjali Ayurved in treating COVID-19, the Ministry noted that it had taken cognisance of the news being recently flashed on its drug by the company. Facts of the claim related to the drug and details of the stated scientific study are not known to the Ministry, the statement said.

Patanjali Ayurved has been asked to provide, at the earliest, details of the name and composition of the medicines being claimed as successful in COVID-19 treatment; site(s)/ hospital(s) where the research study was conducted; the protocol, sample size, Institutional Ethics Committee clearance, Clinical Trials Registry-India (CTRI) registration, and results in data of the study, and to stop advertising/publicising such claims till the issue had been duly examined. The Ministry has also requested the concerned State Licensing Authority of the Uttarakhand government to provide copies of the license and product approval details of Ayurvedic medicines being claimed as useful in the treatment of COVID -19.

“Also, the concerned Ayurvedic drug manufacturing company has been informed that such advertisements of drugs including Ayurvedic medicines are regulated under the provisions of the 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. The Ministry had also issued a Gazette Notification on April 21, 2020, stating the requirements and the manner in which research studies on COVID-19 with Ayush interventions/medicines should be undertaken,’’ the Ministry said.‘100 patients’.

Meanwhile, scientists associated with the trial said they had not yet published the results. Dr Abhishekh Sharma, Assistant Professor of Medicine, National Institute of Medical Sciences, and among those who supervised the trial, said that 100 patients, who had tested positive for the virus, were recruited for the trial. Of them, 50 were given the medicine and five dropped out midway. The remaining 50 were administered a place “69% of the 45, when tested on the third day, were found clear of the virus and half of those on the placebo recovered,” said Dr Sharma. That works out to 31 of those on the treatment tested negative, and 25 of those on placebo tested negative.

No other details on the profiles of the COVID-19 positive persons — the degree of sickness in those who enrolled for the trial, their age, whether they were on other medication prior to enrolment — were immediately available. A check on the clinical trial registry, where all trials must be registered, showed that a wide spectrum of patients was solicited. They were “asymptomatic, mildly symptomatic, moderately symptomatic and those aged 15-80”. The original aim of the study was to check the status of patients on day 3, day 7 and day 14, and whether they had improved immunological parameters due to the medicine. The medicine regime involved is the Tablet Swasari Ras (500 mg), Tablet Pure Ashwagandha Extract (500 mg), Tablet Pure Giloy Extract (500 mg), Tablet Pure Tulsi Extract (500 mg) and Anu Taila (nasal drop), according to information on the clinical trial website.

Have given info of Covid-19 medicine to AYUSH Ministry: Patanjali CEO

Patanjali Ayurved CEO on Tuesday said the firm gave all the information about its newly launched Covid-19 medicine to Ministry of AYUSH. On Twitter, Acharya Balkrishna said, "communication gap has been done away with". "This govt provides encouragement and pride to Ayurveda. Communication gap has been done away with and we have 100% fulfilled all standard parameters for Randomised Placebo-Controlled Clinical Trials. We've given info for the same to Ministry of AYUSH," Balkrishna said on Twitter. The AYUSH ministry on Tuesday asked yoga guru Ramdev's Patanjali Ayurved to provide “at the earliest" the composition and other details of the medicine it claimed is for the treatment of COVID-19, and ordered the firm to stop advertising the product until the "issue" is examined.

Patanjali Ayurved has launched the ‘Coronil and Swasari’ medicine with the claim that it has discovered a cure for COVID-19. However, the ministry said the facts of the claim and details of the stated scientific study are not known to it. Patanjali has also been asked for details of the sample size, sites and hospitals where the research study was conducted and the Institutional Ethics Committee clearance, the ministry said.

Yoga guru Ramdev's herbal medicine company Patanjali Ayurved on Tuesday claimed to have discovered a 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. 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 a 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 the place were conducted at Jaipur-based National Institute of Medical Sciences & Research.

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. Manufactured by Haridwar-based Divya Pharmacy and Patanjali Ayurved Ltd, the medicine is the result of a research partnership between Patanjali Research Institute and the Jaipur based National Institute of Medical Sciences. Ramdev said the medicines can be ordered online through a mobile app from next Monday. The COVID-19 therapy suggested by Patanjali is applicable for adults ranging between 15-80 years of age whereas children are advised to take half the dosage prescribed for adults. Patanjali's anti-COVID tablet, Divya Coronil Tablet consists of Giloy, Tulsi and Ashwagandha and is prescribed to be taken thrice a day with hot water 30 minutes after breakfast, lunch and dinner.