India’s most famous yoga guru launched an alternative medicine drug for coronavirus, claiming huge success during “clinical trials.” What could go wrong?
A lot, it appears.
Coronil, a coronavirus treatment kit launched by Ramdev, yoga guru and founder of ayurveda giant Patanjali, has found itself receiving notice after notice from government departments, a criminal complaint, and flak from the medical community in India.
Coronil was launched on June 23 with much aplomb. Ramdev added jargon such as “clinically controlled” to his announcement to lend scientific gravitas to the medicine. He also claimed that there was a 100% improvement in the 280 patients of coronavirus who were a part of Coronil’s clinical trial.
Patanjali’s kit will hit shelves in the backdrop of large Indian pharmaceutical companies investing in experimental drugs such as remdisvir and favipiravir, both of which have shown to help patients with acute symptoms of Covid-19, but neither claims to cure it. These are besides the various vaccines that are being developed to prevent coronavirus.
Ayurveda has for long held the belief that it is one of the greatest ancient schools of medicine, claiming secrets that would make modern medicine look insignificant. Ramdev, too, has been a proponent of this belief, often blaming the West for capitalising on India’s age-old wisdom. He has also previously claimed that he can cure homosexuality with yoga, and offer a drug to women so that they can conceive a male child.
But Patanjali, which had an estimated turnover of Rs25,000 crore ($3.25 billion) in 2019-2020, has found itself in a tangle soon after the launch of Coronil, one that only kept getting worse.
India has a long tradition of alternative medicine, which are all governed by the ministry of ayurveda, yoga & naturopathy, unani, siddha, and homoeopathy (Ayush). Any new announcement for traditional medicine must go through approvals from this ministry.
Soon after the fanfare that was the Patanjali press conference, the Ayush ministry asked the company for detailed reports of its clinical trials and the composition of its medicine. Patanjali claimed it was a mere miscommunication, and sent details of its study to the ministry immediately on June 23.
Through those filings, other inconsistencies emerged. For instance, instead of 280, there were only 100 participants in the trial. Half of those were given placebo drugs, and five dropped out of the study. In essence, a total of 45 coronavirus-positive patients received Patanjali’s drug. These studies were also not peer-reviewed.
Besides the questionable number of participants, Coronil was tested only on patients with mild to moderate symptoms, and those with any comorbidities were excluded. Its miraculous claims also diminished when the filings revealed that while 69% of Covid-19 patients tested negative on the third day of the treatment, 50% of those on placebo drugs tested negative around the same time.
The soup thickens
The second embarrassment for Patanjali came in the form of a notice that the Ayush department of the state of Uttarakhand sent to the company. The department said Patanjali had only filed applications for immunity boosting medication and had no mention of Covid-19.
This entire mess unravels the uncharted territory of clinical trials for traditional medicine. Doctors and health activists have been questioning how a drug like Coronil could be launched without any gatekeeping. For instance, Dinesh Thakur, public health activist and whistleblower, said that mere registration on Clinical Trials Registry-India (CTRI) is not enough. Drugs in India are controlled by the Central Drugs Standard Control Organisation, which also finds no mention in Patanjali’s findings.
There are discrepancies in the Coronil application with CTRI, too. For instance, the proper protocol for a randomised-controlled trial is completely missing.
Now, a criminal complaint against Patanjali has been filed in a court in the state of Bihar against Ramdev and Patanjali’s managing director Balkrishna. The petitioner has alleged that Ramdev and his company have misled people and endangered their lives.