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As Products Pose as ‘Immunity Boosters’, the Government Looks On

As Products Pose as ‘Immunity Boosters’, the Government Looks On

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The better your body’s immune system is, the better are your chances of successfully fighting off an infection of the novel coronavirus – or any infection for that matter. Some people have stretched this factoid to infer that an infection can be kept away entirely if a person’s immune system is ‘boosted’. And this in turn has precipitated an array of products and suggestions to ‘boost immunity’.

The government itself has fuelled this mistaken belief. The Ministry of AYUSH [footnote]Ayurveda, yoga and Naturopathy, Unani, Siddha and homoeopathy[/footnote] has issued more than one advisory on herbal and non-herbal concoctions that purportedly boost immunity. The ministry has also fast-tracked statutory clearance for Ayurvedic, Siddha and Unani (ASU) drugs in an effort to promote ‘immunity-boosting’ products for healthy people.

Note that immunity is the product of a system, not one or two organs executing a fixed set of actions. As such, researchers are yet to identify the exact changes that might strengthen or weaken a body’s immune response to COVID-19. And in the absence of a vaccine or an efficacious antiviral drug, doctors and medical researchers have only advised prevention – by washing your hands, using alcohol-based sanitisers, wearing a mask when stepping outside, etc.

However, many other products already in the market, such as medicinal drinks and some food products, often accompanied with vague reassurances that they contain vitamins or probiotics, make bold claims about ‘boosting’ immunity without ever having specifically tested them.

Even apropos one’s general immune health and the use of supplements, Michael Starnbach, a professor of microbiology at Harvard Medical School, told a university publication, “Unfortunately, the reality is that those kinds of products aren’t really offering you any benefit. There’s no evidence that they help in fighting disease.”

So every product that claims to ‘boost’ the immunity of an otherwise healthy individual warrants closer examination – especially vis-à-vis the novel coronavirus, the immune response to which is still under study.

Many of these problem products in India are also touted as alternative forms of treatment. The efficacy of their active pharmaceutical ingredients isn’t backed by clinical trials of sufficient quality. But despite the lack of evidence, they’re a common sight in pharmacies and supermarkets around the country. Even the Government of Tamil Nadu encouraged its police personnel to consume a concoction called ‘kabasura kudineer‘ when patrolling the roads during the lockdown, claiming it enhanced immunity.

But for all the dangers these products pose – from encouraging a false sense of safety to undermining trust in proven therapies and medicines – the laws that govern them remain stunted.

The Food Safety and Standards Authority of India (FSSAI) regulates dietary supplements and other food products but its various regulations don’t touch on claims about enhancing immunity. Instead, the authority simply allows manufacturers to make claims about effects on the immune system, and manufacturers are not required to report what they say unless the FSSAI specifically asks for them. Finally, the FSSAI imposes no preconditions to making such claims either.

A section of the Food Safety and Standards Regulations 2016 deals with claims about specific ingredients and about reducing disease risk. The FSSAI scrutinises these products more. But claims about ‘boosting immunity’ are not necessarily product-led, so they are able to escape scrutiny.

The Drugs and Cosmetics Act 1940 encompasses the regulation of ASU drugs. But while its Rules prescribe different processes and approval mechanisms, they don’t require manufacturers to ascertain the products’ safety and efficacy before they are sold to consumers. It is common knowledge that ASU drugs are not subjected to the same regulatory standards as allopathic drugs are, so ASU products can make claims about boosting immunity sans empirical evidence.

All that remains is for these products to become profitable – as they would be in the middle of a pandemic, with vaccines at least a year away.

This state of affairs is considerably aggravated when the AYUSH ministry claims ASU remedies can help “prevent” a COVID-19 infection. However, in an April 1 notification, the ministry responded to orders of the home ministry and decided “to stop and prevent publicity and advertisement of AYUSH-related claims for COVID-19 treatment.” But in a notification dated the next day, the AYUSH ministry asked authorities involved in drug regulation to expedite the approval of ASU products. The latter notification specifically refers to ASU-based “immunity boosting products for healthy people”.

So with minimal regulatory oversight, ASU-based “immunity boosters” are likely to inundate in the market again.

This is an unacceptable state of affairs. Only the Advertising Standards Council of India (ASCI) seems to be doing anything. It sends notices to brands that make unproven or unverified immunity-related claims, among others. And after giving them a chance to be heard, it requires the product to be advertised without making any untenable claims. However, its initiative has largely been muted because ASCI is a self-regulatory body and does not have any enforcement powers.

Note that although the AYUSH ministry has indicated that ASU remedies should be backed by evidence, and has advised researchers to abide by guidelines issued by the Indian Council of Medical Research, the words appear to be advisory.

On the other hand, the US Food and Drug Administration has issued multiple advisories and warning letters against advertising claims about boosting immunity vis-à-vis COVID-19.

The AYUSH ministry and other concerned authorities in India should at least consider tempering or muting their immunity-related claims. Such claims may improve the commercial viability of a product but only at the cost of spreading misinformation about how the immune system works. The government must clamp down on all of them – in addition to overhauling the regulatory framework.

Even in the short-term, for as long as the pandemic lasts, the government must pay close attention to health-related claims on foods and drugs, and take all steps to quell the smallest bit of misinformation.

Sheetal Srikanth is an advocate practising in the Karnataka high court. Arun C. Mohan is an advocate practising in the Madras high court.

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