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How Untested AYUSH Medicines Threaten India’s COVID-19 Response

How Untested AYUSH Medicines Threaten India’s COVID-19 Response

Representative image: dertrick/pixabay.

Recently, the Ministry of AYUSH directed the Ayush Society of Uttar Pradesh to use a kit of four supposedly Ayurvedic medicines to treat COVID-19 infection and distribute it to all districts in the state, which is India’s most populous. Patients with COVID-19-like symptoms are supposed to follow the regimen prescribed for the kit’s use for seven days, with the implied promise that they will get better in this time.

To test the kit’s efficacy, the AYUSH ministry started a clinical trial in May 2020. However, the details of this study remain obscure – apart from the fact that an exceptionally large sample size of 50 lakh patients was selected. Moreover, one of the drugs in this kit, AYUSH-64, was based on the premise of a 2018 study that demonstrated its effectiveness against influenza-like illnesses. However, this study had some major design flaws that explicitly invalidated its results. One group of scientists from Rajasthan and Uttar Pradesh, including Subhash C. Lakhotia, known for his studies with chromosomes in fruit flies, wrote on August 8 this year:

We note that there is a clear departure from the approved intervention. The study was registered prospectively at the Clinical Trials Registry of India. The intervention that was approved and uploaded in the CTRI did not include any modern medicine, as is evident from the entry under the “Intervention/Comparator”. The name of the drug entered in the CTRI database is only AYUSH-64. … Furthermore, the comparator agent is noted as nil. However, when the trial was conducted, modern medicines viz., “acetaminophen, antihistaminic and cough syrup as per the standard guidelines” were co-prescribed. This co-intervention of modern medicine constitutes a critical departure from the recorded intervention at CTRI database. By not adhering to AYUSH-64 alone as originally decided, the entire objective of scientific exercise becomes flawed, and inferences therefrom equivocal. Because allopathic drugs were co-administered without an appropriate modification in the methodology capable of discerning the comparative effect, there is no way one can find out the proportionate effect of AYUSH-64 in the intervened condition.

State-funded distribution of an unproven remedy at such a large scale is pretentious and potentially harmful. Initial clinical trials for efficacy testing are usually conducted on a small population with up to 100 patients. The bizarre cohort of 50 lakh patients – too big for any institution in the country – however implies an unproven drug was relentlessly distributed for public consumption. This also excludes the possibility of having a control group, which receives standard of care and to which the group receiving the drug being tested can be compared – the norm for valid clinical trials. Since most patients with COVID-19 recover on their own, there is bound to be positive data from this trial but which won’t say anything about the kit’s efficacy.

However, one could argue that even if these remedies are unproven, there is no harm in consuming them. Apparently, they don’t have major side-effects and are supposed to be innocuous ‘immunity boosters’.

Risk compensation theory in the field of safety studies disagrees. According to this theory, people are likely to take more risks when they feel safer. Consuming supposedly curative medicines can exaggerate risky behaviour that can then increase opportunities for infection to spread. The people consuming these medicines will feel protected and may become negligent with practices like covering their faces, maintaining physical distance and washing their hands regularly. That is, people tend to nullify an increase in safety by increasing risky behaviour. But in this case, an increase in safety is dubious – it is only perceived – since the medications are unproven, but the increase in risk-taking is real, and could allow the novel coronavirus to spread faster.

In the 1960s, cigarettes with filters were introduced and were marketed as “safe”. However, the rate of lung cancer has shot up since. One reason is because the filters prevented large particles from entering the body while the smaller, more harmful particles could still do so. But since many people believed that filtered cigarettes were ‘safe’, they started smoking more, which led to the increasing incidence of lung cancer.

The problem is not limited to the COVID-19 kit. In another incident, the health department of Gujarat distributed a homeopathic remedy to half of the state claiming that it was a “prophylaxis” – following a March 6 advisory by the Ministry of AYUSH recommending it. Telangana also followed suit. Again, this drug is not backed by any scientific evidence of effectiveness, even as the number of COVID-19 infections continues to rise in the state.

Meanwhile, Patanjali Ayurved, the private FMCG company run by yoga guru Baba Ramdev, introduced a prophylactic regimen consisting of three drugs. After journalists raised a clamour, the ministry pulled up the company for selling them as a “cure” for COVID-19, before allowing them to be marketed as “immunity boosters”. However, none of this has been proved with well-designed clinical trials.

On September 18, PTI reported Union health minister Harsh Vardhan saying the AYUSH ministry had knowledge of at least 154 misleading advertisements about alternative treatments of COVID-19 until last month. India provides a unique habitat in which exponents and practitioners of alternative medicinal traditions can survive and thrive – both in urban and rural pockets. And a general lack of awareness, together with desperation brought on by the pandemic, prompt people to believe in these practitioners’ exaggerated claims and fall prey to false remedies.

While the Centre created the Ministry of AYUSH (out of a department) in 2014 to regulate and bring traditional cures for various illnesses into the mainstream, its efforts continue to be hamstrung by a deep lack of evidence and a mindlessness of best practice and ethics. This can only have deleterious consequences.

Amulya Gupta is pursuing an MBBS at the All India Institute of Medical Sciences, New Delhi. He is part of the India COVID Apex Research Team (I-CART), and recently started a patient education website, He tweets at @dramulyagupta.

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