Govt says it can't vouch for Patanjali's claims of having Covid-19 medicine

Ramdev's Patanjali launches Coronil kit for ₹545

Patanjali on Tuesday launched 'Coronil and Swasari', what it claims is the Ayurvedic cure for treating COVID-19, which they said has been shown 100 per cent favourable results during clinical trials on affected patients, at Patanjali Yogpeeth in Haridwar. Acharya Balkrishna, MD of Patanjali Ayurved, claimed that an Ayurvedic medicine developed by the company has been able to cure COVID-19 patients within 3-14 days.

Baba Ramdev also claims that there are no side-effects of the corona medicines he is launching.

  • A total of 100 coronavirus positive patients were recruited for the controlled clinical trial, Patanjali claims. Of which 95 were studied, 1 patient was lost on the follow up details and 4 patients withdrew consent between the study, claims Patanjali.

Exclusion criteria for Patanjali clinical study plan (Claimed)

1) Severely symptomatic patients (SaO2 <90%)

2) Acute respiratory distress syndrome

3) Life expectancy less than 1 year due to other co-morbid conditions

Inclusion criteria for Patanjali clinical study plan (Claimed)

1) RT-PCR confirmed cases

2) Age 15-60 years of age

3)Two random groups were formed, 1) Placebo arm and, 2) treatment arm for the clinical study plan.

Patanjali claims,

  • 100% recovery from coronavirus infection within 7 days treatment with Patanjali Ayurvedic medicines.

  • hsCRP and IL-6 levels were reduced in treatment group as compared to placebo group.

  • Ayurvedic treatment showed weaker IL-6 response implicating lesser chance of cytokine storm.

  • We will also launch an e-commerce app for the delivery of the medicines within 2 hours for the order placement, says Acharya Balkrishna.

  • We have used minerals with herbs to make this medicine even more effective, says Acharya Balkrishna.

  • Patanjali claims that its corona medicine kit can also be taken as prevention for coronavirus.

  • The Corona kit will be made available at just ₹545, says Acharya Balkrishna. The corona kit will have medicines for 30 days.

  • We are testing the medications on mice and rats, says Patanjali.

  • This medicine kit is not available anywhere for now, will be made available at Patanjali stores in a week, says Baba Ramdev.

  • We started working on Corona medicines from December 2019, says Patanjali.

  • We've prepared the first Ayurvedic-clinically controlled, research, evidence and trial based medicine for COVID19. We conducted a clinical case study&clinical controlled trial, and found 69% patients recovered in 3 days & 100% patients recovered in 7 days, says Baba Ramdev.

  • We will even conduct tests on people on ventilators.

  • This is not an immunity booster but a coronavirus cure.

  • An app will be launched for the delivery of the Corona kit.

  • 0% death rate and 100% recovery rate has been observed.

  • 69% of the people recovered within 3 days.

  • We have done every research and will answer all questions, says Baba Ramdev.

  • Patanjali has claimed that the controlled clinical trials was jointly conducted by Patanjali Research Institute, Haridwar and National Institute of Medical Sciences, Jaipur.

We appointed a team of scientists after COVID-19 outbreak. Firstly, the simulation was done and compounds were identified which can fight the virus and stop its spread in the body. Then, we conducted a clinical case study on hundreds of positive patients and we have got 100 per cent favourable results, Balkrishna said.

"After taking our medicine, COVID patients recovered in 3-14 days and then tested negative. So, we can say the cure for COVID is possible through Ayurveda. We are performing controlled clinical trials only. In the next 4-5 days, evidence and data will be released by us," Balkrishna had earlier this month claimed.

Govt says it can't vouch for Patanjali's claims of having Covid-19 medicine

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.

"Patanjali first conducted clinical case study and conducted clinical control trials following all protocols of drug discovery," Ramdev 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.

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.

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.

Source - LIVE MINT