Earlier this month Balkrishna had claimed that a company-developed Ayurvedic medicine was possible to treat Covid-19 patients within 3-14 days.
On Tuesday, Patanjali unveiled ‘Coronil and Swasari’ at Patanjali Yogpeeth in Haridwar, which it says is the Ayurvedic cure for COVID-19, that has been shown to provide 100 per cent positive outcomes during clinical trials on affected patients. Acharya Balkrishna, MD of Patanjali Ayurved believed a company-developed Ayurvedic medication could cure COVID-19 cases within 3-14 days.
Govt says Patanjali’s claims to have Covid-19 medicine can’t be justified
New Delhi: AYUSH Ministry decided to order Patanjali Ayurved on Tuesday to start boycotting its assertions to have a Covid-19 therapeutic drug until it is fully investigated. The Ministry doesn’t really understand the truths of an assertion and information of the research journal mentioned, and full information of the alleged medicines was sought, AYUSH said in a declaration.
Yoga guru Ramdev’s herbal medicine company claimed to have discovered coronavirus cure on Tuesday, but no medical authority could immediately claim ‘Coronil and Swasari’ medicine to cure the highly contagious disease in seven days.
AYUSH Ministry said Patanjali’s alleged drug-related an advertising campaign is controlled underneath the Drugs as well as Magic Remedies Act, 1954.
‘The Ayurvedic drug manufacturing plant worried has also been notified that such drug commercials, such as Ayurvedic drugs, are controlled in accordance with the terms of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and its Rules and the guidelines issued by the Central Government due to the outbreak of COVID.
The Ministry as well posted a notification to the Gazette No. L.11011/8/2020 / AS of 21 April 2020 setting out the specifications as well as ways in which Ayush interventions/medicines research studies on COVID-19 must be conducted, “the Ministry said.
AYUSH Ministry has requested Patanjali not to advertise/publicize such statements until we’ve been thoroughly investigated. Patanjali has been requested for large sample data, locations, hospitals where work has also been performed, and ethical committee clearances.
‘Patanjali Ayurved Ltd has also been requested to do it as soon as possible specifics of a title and structure of the medications assumed for COVID diagnosis; site(s)/hospital(s) where even the COVID-19 study survey was undertaken; method, sample size, clearance of the Institute Ethics Committee, CTRI registration and study(s) results, and also to hold back marketing/publication of such assertions until the date of publication.
The Ministry as well demanded that Uttrakhand Government’s State Licensing Authority focuses on providing duplicates of the permit and brand authorization specifics of the Ayurvedic medicines that are assumed for Covid-19 therapy.
In May the Ministry of AYUSH had permitted clinical studies of four ayurvedic ‘rasayanas’ for coronavirus therapy.
The company attempted to claim that throughout drug testing on COVID-19 hospitalized individuals apart from it on a life-supporting system, the two Ayurved-based medicines showed 100 per cent positive results.
Patanjali Research Center, Haridwar and private-owned National Institute of Medical Science, Jaipur developed the medicines following all protocols with medically regulated trial-based evidence, Ramdev told PTI in phone communication with PTI.
“Patanjali performed a therapeutic case report for the first time and scientific safety studies for both product development procedures,” he added.
Evading queries on the medication getting authorized by government entities such as ICMR, Ramdev said that controlled clinical study of such medications had been required to conduct in many cities such as Delhi, Ahmedabad and Meerut and the placebo-controlled RCT (Randomized Clinical Trial) was performed at the National Institute of Medical Sciences & Research in Jaipur.
“These were achieved after receiving Clinical Trial Registry of India (CTRI) approval and all other formalities needed,” he added.
“We also adopted all the guidelines for these clinical studies laid down by modern science.”
Both the Ayush ministry and the Indian Medical Research Council (ICMR) have allegedly declined to comment mostly on assertion citing lack of knowledge of the topic.
A government notice bars firms from marketing a cure without government approval.
Ramdev tried to claim that during the clinical trial, his ayurvedic drugs showed 100 per cent favourable results.
We said that at a takeoff media briefing in Haridwar, “The entire country and world were going to wait for the coronavirus medication or flu shot.
We are pleased to announce that the very first proof and research-based medicine based on ayurvedic, clinically randomized studies were equipped through the combined efforts of the Patanjali Research Center and the National Institute of Medical Sciences (NIMS) »
“We performed a clinical study and regulated new treatment and found 69 per cent recovered patients in 3 days and 100 recovered patients in 7 days,” he added.
This medication, he believes, is useful for COVID-19 preventive measures as well as for therapy.
During the trial, he tried to claim no infectious disease lost his life.
Ramdev as well attempted to claim that perhaps the trial also cured other patient complications and normalized we’re important components.
“The tests also monitored parameters such as hsCRP and IL-6 levels,” he added.
The test was performed on all sorts of patients except those who are highly infected and areas ventilators on life support systems.
“Trials are still expected on the infected people on a Ventilation Support Device,” he said adding that the trial was performed only on a regular infected individual and medium-infected persons.
Ramdev further believed “This medication can also cure seriously infected patients who are on a life-supporting device. However, studies for such situations are expected in the second phase.”
In December 2019 Patanjali had begun working on corona medicines.
Within a week, the Corona kit, priced at about 545, would’ve been accessible to pan India. The kit will also have 30 days of medication.
This is not an enhancer for an immune response but rather a cure for coronavirus, Ramdev said.
Baba Ramdev also says that the corona drugs he releases are without side effects.
A total of 100 positive patients with coronavirus have been tried to recruit for the clinical trial, claims Patanjali. Of which 95 were researched, one patient was lost on the specifics of follow-up, and four patients decided to withdraw permission among study, Patanjali claims.
Criteria for isolation of clinical study plan for Patanjali (did claim)
1) Patients with serious symptoms (SaO2 < 90 per cent)
2) The syndrome of acute breathing difficulties
3) Under other co-morbid conditions, lifespan is less than one year
Patanjali Clinical Study Plan Inclusion Criteria (Claimed)
1) The documented cases RT-PCR
2) 15-60 years old
Two random groups for the clinical study program were created, 1) placebo arm, and 2) treatment arm.
1) 100% recovery from coronavirus infection during seven days of treatment with Ayurvedic Patanjali medicines.
2) The levels of hsCRP and IL-6 in the intervention group were reduced as compared to a sugar pill.
3) Ayurvedic therapy showed a weaker IL-6 reply that indicated less risk of the cytokine storm.
· We’ll also launch an e-commerce app to deliver the medicines within 2 hours of placing the order, says Acharya Balkrishna.
· We used herbal minerals to start making this the medicinal product even more effective, says Acharya Balkrishna.
· Patanjali asserts its corona medication kit could also be used as coronavirus prevention.
· At just $5545, says Acharya Balkrishna, the Corona kit will be made available. The corona package will have 30 days of drugs.
· We check the medicines on mice and rabbits, Patanjali says.
· This medicine kit is not available today somewhere, would be made accessible in a week’s time at Patanjali shops, says Baba Ramdev.
· As from December 2019, we started to work on Corona medications, say Patanjali.
· For COVID19, humans’ve prepared the first clinically controlled Ayurvedic, study, evidence, and trial-based medicine. We conducted a clinical case study&clinical controlled trial, and found 69 per cent recovered patients in 3 days & 100 per cent recovered patients in 7 days, Baba Ramdev says.
· We also will carry out ventilator test results on humans, says Baba Ramdev.
· This is not an immune boost; however, a treatment for coronavirus, Baba Ramdev says.
· The Corona kit will be delivered with an app, says Baba Ramdev
· The death rate of 0 per cent and the recovery rate of 100 per cent have been noted, Baba Ramdev says.
· In 3 days, 69 per cent of people recovered, Baba Ramdev says.
· We’ve done every study and are going to ask the questions, Baba Ramdev says.
· Patanjali said the regulated clinical studies were conducted jointly by Patanjali Research Institute, Haridwar, and National Medical Science Institute, Jaipur.
After the COVID-19 outbreak, we named a team of scientists. Firstly, the simulation was done, and substances have been identified that can fight the virus and stop spreading it in the body. Then, on hundreds of positive patients, we conducted a clinical case study, and we have 100 per cent positive results, Balkrishna” says.