AYUSH Ministry forbids Patanjali to advertise its COVID-19 drugs as a “cure”

Published : July 02, 2020 19:18 IST

Yoga guru Ramdev addresses the media during the launch of ‘Coronil’ and ‘Shwashari’ on June 23. Photo: PTI

In a major snub to the Haridwar-based Patanjali Research Foundation Trust, which claimed that it had discovered a wonder combination of drugs to cure COVID-19, the AYUSH Ministry has directed the Uttarakhand State licensing authority (Ayurveda and Unani Services) to ensure that “all the three drugs be marketed in accordance with the scope of license issued by the State Licensing Authority” and that “on the package and label displayed on the medicines, no claim for the cure of COVID-19 be mentioned”. The three drugs, part of a “Corona kit”, were called Divya Coronil Tablet, Divya Shwashari Vati and Divya Anu Taila. They were “launched” on June 23 by the yoga guru Ramdev, founder of the Patanjali group.

The letter from the Drug Policy Division of the Ministry to the Uttarakhand Licensing Authority, a copy of which is with Frontline, stated that no advertisements making such claims of a cure should be made, that “the advertisement and the publicity of the drugs should be ensured in accordance with the relevant provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954”, and that the “relevant provisions of the Drugs and Cosmetics Act, 1940 should also be duly followed”. The letter also said that Patanjali could continue its clinical trials under the AYUSH Ministry’s gazette notification of April 20, 2020.

As news of the wonder drugs became viral, the Ministry had no option but to demand an explanation from Patanjali. It was, in a sense, compelled to take cognisance. It demanded that Patanjali furnish all the relevant information pertaining to the clinical trial process. The organisation complied, and gave information regarding its registration with the Clinical Trials Registry, details of the collaborating institute where the clinical trial was conducted and the written clearance of the collaborative institute’s ethics committee.

It may be recalled that the licensing authority in the Uttarakhand government had denied that it issued a license to Patanjali for manufacturing a cure for COVID-19. The “Divya Coronil Tablet” was registered with the State licensing authority only as an immunity booster against “respiratory tract involvement” and “all types of fever”. The other drug, Divya Shwashari Vati (540 and 350 MG) was registered for “Kasa” and “Svasa”.

U-turn from Patanjali

Caught in an awkward position for making patently false claims, the yoga guru held a press conference on July 1 to clear the air. Taking a complete u-turn from his previous position, he claimed that the AYUSH Ministry had allowed him to market the medicines not as a “cure” for but for the “management” of COVID-19. He tried to make light of the difference between the two terms and insisted that there was a conspiracy, national and international, to defame Ayurveda.

A separate statement from Patanjali stated that the “Ministry had agreed that Patanjali Research Foundation” had “worked appropriately on COVID-19 management” and that there was no difference of opinion between the Ministry and the foundation. Divya Pharmacy had taken approval for the drugs on their “traditional reported usages” and had now “connected with the (sic) modern research based clinical findings.” The institute claimed that it had shared with the media the positive outcome of the clinical trial, jointly done with the National Institute of Medical Sciences (NIMS), Jaipur. Interestingly, no representative from NIMS was present at the July 1 press conference which was a Patanjali event entirely, in stark contrast to the June 23 press meet when Coronil was launched with NIMS officials in tow.

Curiously, the word “cure” was not mentioned even once in the press statement. Neither was it issued jointly by Patanjali and the collaborating institute. The statement reiterated what had been mentioned before. The trial was conducted on asymptomatic COVID-19 patients with mild and moderate symptoms. As many as 45 of the total 95 enrolled patients were treated with Patanjali medicines and had recovered. The group that received the Patanjali drugs showed a 67 per cent recovery in three days and a 100 per cent recovery in seven days. The foundation planned to go in for multi-centric clinical trials. It also claimed that more than 500 scientists were engaged in research and development on yoga and Ayurveda and that Patanjali was never a part of “false claims and propaganda”. The “medicine mafia”, opponents of “indigenous” (sic) and nationalism, were trying to malign them, the statement said.

At the press conference, Ramdev, who did most of the talking, said all the three medicines would be available in the market and would continue to boost immunity, which most Ayurvedic medicines were already doing. He thanked the Prime Minister and the AYUSH Ministry for “finding a solution” to the problem. He claimed that all the protocols based on “modern scientific methods” had been followed, that trial registration had been done following due process, and that he would be doing more clinical trials. He said that phase 1 of the clinical controlled trial had been done. He alleged that there were some formulations claiming to cure COVID that were selling at exorbitant prices. He claimed that those drug had not gone through any clinical trials. “The Ministry has said that the term ‘cure’ should not be used,” he said.

At the press conference, Ramdev and his team sought to give impression that they had been victimised. The CEO of Patanjali, Acharya Balakrishna, alleged that there was a conspiracy. “All these controversies over ‘pathies’ have been generated from outside the country,” he said.

Clearly, had the yoga guru found a cure, it would have made international headlines. But, obviously, he was unable to convince the Indian medical and scientific establishment of his methods or the curative aspects of the wonder drug Coronil. As for the government, it saved itself from a major international embarrassment.