Coronil for 'management' of COVID-19, not treatment, Ayush ministry tells Patanjali

After over a week of controversy around Patanjali’s claims of “curing” COVID-19 patients with the Ayurvedic cocktail ‘Coronil’, Baba Ramdev on Wednesday claimed that the AYUSH ministry had stated that the Patanjali Research Foundation has “appropriately worked” on COVID-19 management. The ministry has approved the word “management” as opposed to treatment, Ramdev said at a live press conference, insisting that the two were no different, and merely an example of wordplay.

His statement came a day after the AYUSH ministry sent a letter to the drug licensing authority in Uttarakhand. It said that the proposed drug—'Divya Coronil tablet'—had been registered by the state licensing authority as an “immunity booster”, especially against respiratory tract involvement and all types of fever. This is against the claims of it being a cure that were made by Patanjali on June 23. “It is observed that M/s Divya Patanjali research Foundation has initiated necessary activities for the management of COVID-19 appropriately which is duly noted,” the letter stated.

“Divya Coronil Tablet, Divya Shwasahari Vati 540 mg, and Divya Shwasahari Vati 350mg should be marketed in accordance with the scope of license issued by the State Licensing Authority, Ayurvedic and Unani services Uttarkahand, Dehradun,” it reads.

The ministry also cautioned that the packaging or labelling of the product should not display any claims of a “cure”. It also advised appropriate advertising and asked Patajanli to follow the relevant provisions of the Drugs and Magic Remedies (Objectionable advertisements), Act, 1954 and Drugs and Cosmetics Act, 1940. The letter also stated that the company is allowed to go-ahead with its clinical trials, as per the rules of the AYUSH ministry.

At his press conference, Ramdev claimed that he had shared all clinical trial documents with the ministry. He, however, did not elaborate on details of the randomised placebo double-blind controlled trial conducted with Coronil. “Now there is no difference of opinion between Ayush Ministry and Patanjali,” he said.

The drug had helped control the “cytokine storm” in COVID-19 patients, he claimed. A cytokine storm refers to a situation when the immune system goes into an overdrive, and the patient's condition turns serious.

On the controversy over Coronil licensing and clinical trials Ramdev maintained that these were two different things—Ayurvedic drug licences, and controlled clinical trials that belonged to modern medicine. All manufacturing and distribution licences for Ayurvedic medicines are granted on the basis of their reported traditional usages. Clinical studies are then conducted on those medicines, in some cases.

“Patanjali’s Divya pharmacy had taken the licence approval for Divya Coronil Tablet and Divya Swasarivati on their traditional reported usages, and have now connected those with the modern research based clinical findings,” he said.

While discussing sketchy details about the clinical trial, a visibly perturbed Ramdev lashed out at his critics, stating that they had been making personal attacks on him. He said that the Patanjali Research Institute, Haridwar and NIMS University, Jaipur had jointly conducted a randomised, placebo-controlled double-blinded clinical trials on COVID-19 positive patients. This trial had been approved by Institutional Ethics Committee (IEC) and duly registered at Clinical Trial Registry – India. “In this trial, 95 patients between 15-65 years, (male and female, asymptomatic, mild to moderate) participated by giving their written consent. 45 patients were treated with Patanjali medicines and rest 50 patients were given placebo formulations. The COVID-19 patient group that received Patanjali medicines showed 67 per cent recovery in three days, and 100 per cent recovery in seven days of treatments, that is, all 45 patients became COVID-19 negative. In addition, blood serum levels of C-reactive proteins (CRP), Interleukin-6 (IL-6) and TNF- alpha cytokines were also detected to be significantly lower in Patanjali medicine treated COVID-19 recovered patients, than the placebo group. This was the first and foremost clinically controlled trial of Ayurvedic medicines on COVID-19 positive patients,” he said.

However, until the results were published in a peer-reviewed journal, experts say it would be hard to evaluate the results.

Ramdev, however, went on to claim that they were now heading to hold multi-centric clinical trials for the same aetiology. Ramdev also claimed that Patanjali had completed in-vivo, pre-clinical research on hypertension, cardiac diseases, diabetes, arthritis, liver and skin ailments, dengue and chikungunya along with learning and memory enhancement, in various animal models.

“We have embarked upon the detailed clinical trial based investigations of these diseases, as well,” he said.