Patanjali's Coronil did not emerge out of a proper clinical trial and should not have ever been launched in the market as a cure for COVID-19, said legal and pharma industry experts to BOOM. They also said that Patanjali's claims were result of a marketing ploy and should attract legal action by the authorities.
"Patanjali's Coronil did not have a proper clinical trial," said Murali Neelakantan, Lawyer & former global general counsel at Cipla and Glenmark. Explaining the process that ayurvedic drugs have to undergo during a trial, Neelakantan said, "The process of approving the marketing of an ayurvedic drug was in divergence with approving an allopathic drug a few years ago. But now there is a convergence between the strict rules that apply for both ayurvedic and allopathic drugs."
Patanjali launched its Coronil kit, which claims to help cure COVID-19, on June 23, and also claimed the drug had undergone a clinical trial. But following a public outrage within a day, the Ministry of Ayush asked Patanjali to put a pause on the advertisements of Coronil until it investigates the ingredients used in Coronil that claim to effectively cure COVID-19.
This advertisement comes under the purview of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules and directives issued by the Union Government in the wake of COVID outbreak which prevents medicines from being branded as wonder drugs to help cure the pandemic.
These new rules mean that the drug has to undergo the same amount of scrutiny and get clinical trial results from regulators, just as allopathic drugs do.
While Coronil was clinically tried on 280 COVID-19 patients and 69% of them were cured within three days according to Patanjali's Baba Ramdev, Neelakantan is apprehensive about the efficacy of the trial.
"According to the Clinical Trial Registry of India (CTRI), the Coronil trial happened at National Institute of Medical Sciences (NIMS) of Jaipur, which is inexperienced in trials, and the trial started in on May 29. It's highly unlikely that within a day of announcing recruitment perfect candidates for that trial will be available," he added.
Neelakantan points out it is dubious to have a trial, test a drug, and have positive results in less than 4 weeks like it was for Coronil. "In the allopathic world, it takes 6 to 8 weeks to recruit appropriate candidates," he added.
BOOM also spoke to Dr Narendra Bhatt, Ayurveda Consultant & Researcher, who explained that Ayurveda drugs are divided into two categories, classical products, made of formulations based on 54 ancient texts, and proprietary medicine where the manufacturer needs to justify the composition based on ayurvedic logic of those ingredients and the claims that they have made.
Coronil falls in the proprietary medicine category where the composition of the medicine based on ayurvedic rationale, logic of those ingredients, claims made thereof need to be justified. Nobody can claim a cure that hasn't been approved. The Ministry of Ayush provides these guidelines but the implementation is done by the state FDA.
Talking about Coronil's claim to be a medicine to cure COVID-19, Dr Bhatt echoes Neelakantan's sentiments. "There is no way I could have claimed to cure corona unless I had the proof of it. 'Cure' is a very loaded word and that is why the Ministry of Ayush has tried to look at the periphery of immunity and not cure when they have undertaken research studies."
Dr Bhatt points out the problem is in India's medical pluralism and the way it classifies drugs, which also translates in pluralism in regulation.
"Before putting out a claim for curing COVID-19, we need to put in a process to evaluate the drug, which doesn't need to be as rigorous as allopathic drugs, but it needs to be there in place for the consumer's sake. There's an ambiguity in the process which allows situations this to prosper," he said.
The Ministry of Ayush has issued a notification on April 21 stating all the requirements and the manner the research studies on COVID-19 with Ayush interventions/medicines should be undertaken.
But the government is trying to stop misbranding products. "In 2018 all advertisements need to be approved by the ministry before they're put out. When COVID-19 struck, the Ayush ministry put out a notification saying if there is anyone doing any research, talk to us first to prevent misbranding of products." said Neelakantan.
With Coronil, the misbranding seems to have been done on purpose because no one would buy the drugs if it was advertised according to what it did.
Neelakantan pointed out, "If each product in the Coronil kit said that if one is for cough, one is for chest congestion, no one would have bought it. The clear objective was that it was a marketing ploy to say it says it cures COVID-19. But it is done in the face of regulation, so there's no way to go and hide from legal action."
Highlights
-There's an ambiguity in the process of evaluating ayurvedic drugs that allows loopholes to be there.
-Coronil might not have undergone a proper clinical trial.
-The misbranding of the Coronil Kit saying it can cure corona can invite legal action.
Catch the full interview on YouTube or click on the link here.