New Delhi: The AYUSH ministry has announced that it will distribute two ‘Ayurvedic’ medicines – AYUSH 64 and Kabasura Kudineer – to out-of-hospital COVID-19 patients. The distribution will be carried out through Seva Bharathi, an umbrella of community service organisations allied to the Rashtriya Swayamsevak Sangh (RSS), The News Minute has reported.

Experts, including in The Wire Science, have pointed out that there is no reliable scientific evidence to suggest AYUSH 64 and Kabasura Kudineer could be beneficial to patients.

As Dr Jammi Nagaraj Rao wrote:

There is no reliable scientific evidence that any of these drugs have any benefits, let alone benefits that outweigh risks (including out-of-pocket expenses). The clinical trials that the government notes have said ‘prove’ these drugs’ potential are all small and use soft endpoints like time to recovery – instead of hard endpoints like death at 28 days. They also measure improvement of symptoms that are easily fudged.

Nonetheless, a statement from the ministry said, “In a concerted response to the second surge of COVID-19 infection in the country, Ministry of AYUSH is launching a massive nationwide campaign today to distribute its proven poly herbal Ayurvedic drugs AYUSH 64 and Siddha drug Kabasura Kudineer for the benefit of the vast majority of out of hospital COVID-19 patients. The efficacy of these drugs has been proved through robust multi-centre clinical trials.”

While no particular date has been mentioned regarding the launch, the ministry statement said it will be launched by Union minister of state for AYUSH Kiren Rijiju.

“A comprehensive strategy of distribution has been chalked out and the rollout will unfold in a phased manner, utilising the wide network of various institutions working under the aegis of the ministry and this will be supported by the countrywide network of Seva Bharathi,” the statement added.

Indeed, Seva Bharati has already begun distributing the substances. Quoting IANS, The News Minute said the organisation had given out AYUSH-64 tablets in villages of the Awadh region of Lucknow on May 23.

According to Devendra Asthana, sewa pramukh of Awadh region, 1.5 lakh tablets have already been distributed, and more will be given away depending upon the requirement. The medicine is being distributed at four centres in Lucknow.

First developed to manage malaria, AYUSH 64 was later apparently repurposed for COVID-19, as ingredients used in the drug have reportedly shown “notable antiviral, immune-modulator and antipyretic properties”, according to the ministry. However, this hasn’t been backed by evidence.

The ministry only offered that an in silico study – i.e. a computer simulation – showed that 35 of its 36 plant-based constituents “have high binding affinity against COVID-19 virus”. In silico studies are a far cry from the clinical trials required to establish the utility and usability of drugs for infectious diseases like COVID-19.

The AYUSH ministry has further said that clinical trials conducted on AYUSH 64 came out with positive results, but it hasn’t shared a peer-reviewed or preprint paper describing the trial’s methods. The trials are also not registered on the national Clinical Trial Registry – a requirement for all clinical trials in India.

Kabasura Kudineer is a Siddha formulation and can be prescribed to people with mild to moderate COVID-19, according to a set of Siddha guidelines that the AYUSH ministry issued.

The ministry has claimed that Kabasura Kudineer was also subjected to clinical trials for studying the efficacy in COVID-19 patients by Central Council Research in Siddha under the ministry of AYUSH, and found it useful for cases of mild infection.