Opinion | India’s Ayush industry needs an entirely new regulatory model5 min read . Updated: 08 Jul 2020, 08:29 PM IST
This industry has gotten away with light rules for too long and we must insist on tighter standards of therapeutic evidence
The controversy that has erupted over Patanjali’s claim to have developed a cure for covid—called Coronil—has once again cast a spotlight on India’s Ayush industry. In the past, this industry, often supported by government laboratories, has peddled remedies for diabetes, malaria, dengue and rheumatoid arthritis without demonstrating any clinical proof of efficacy that would withstand rigorous scientific scrutiny.
A string of controversies over some ayurvedic diabetic medication had caused the government to relook advertising laws for Ayush drugs. Pertinently, in 2018, the Ayush Ministry amended India’s Drugs & Cosmetics Rules, 1945, to prohibit manufacturers of Ayush drugs from advertising their products “for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition". In other words, these products could no longer make therapeutic claims. This amendment was made in response to heavy criticism piled on to the Ayush ministry by the Parliamentary Standing Committee on Health since 2013. The Ayush industry, which does business worth thousands of crore every year, managed to procure a de facto stay from the Delhi High Court on these new rules in January, 2019. The matter has since languished before the courts. This is unfortunate.
The government’s strategy of banning the Ayush industry from making therapeutic claims is proof that even the Ayush ministry, which was set up with the sole purpose of promoting ayurvedic products, has little faith in the many dubious claims that are constantly made by the industry. The advertising ban on therapeutic claims was a rare moment of bureaucratic courage, for it is not easy to rebuff a powerful industry. The ban, however, is limited to “publication"; it does not address direct marketing of these products to Ayush practitioners, who may prescribe these to their patients. So, why then is the government allowing the Ayush industry to manufacture and sell products that make dubious therapeutic claims when it does not trust these claims enough to allow them to be advertised?
Since the Ayush industry was brought within the ambit of the Drugs & Cosmetics Act in 1964, it has been subject to very light regulation. Under the 1964 provisions of law, the industry can manufacture any product based on substances mentioned in traditional books listed under the legislation’s First Schedule. The government could then test the products to ensure the contents matched the label. This is similar to how the food industry is regulated. There was absolutely no requirement in the law for any of these Ayush manufacturers to establish the therapeutic efficacy of their products through a documented process that would substantiate their claims, as is the case for drugs that are marketed by the pharmaceutical industry.
It is important in this context to explain how ayurvedic products differ from those that are marketed by pharmaceutical companies. A typical medicine approved on the basis of clinical evidence is often a singular entity, whether chemical or biological. Most ayurvedic drugs are concoctions of two or more ingredients. This is because unlike the pharmaceutical industry, which also derives some of its active ingredients from plants, the Ayush industry does not isolate its active ingredients from its plant based sources; rather, it uses the entire leaf or herb or root in its concoction. Drugs like morphine, asprin, quinine and even anti-cancer drugs paclitaxel and camptothecin were isolated and purified from naturally-occurring plant species. Isolating and stabilizing active ingredients from plants is one of the key challenges of chemistry. The holy grail of any therapeutic product is to determine the right dosage that elicits a dose response when administered therapeutically, while controlling any adverse physiological effects that its administration could generate. Without a pure form of a drug’s active substance, it is not possible to understand the dose at which it will deliver its intended therapeutic benefits to a patient. Evidence-based medicine has established procedures that allow for the determination of such a dose range, which can then be tested on human subjects.
The other issue that is often cited as a problem with Ayush concoctions is the presence of heavy metals. While a majority of Ayush products are safe from a toxicity viewpoint at the doses they are consumed (even if they are therapeutically ineffective), documentation exists to suggest that most of these concoctions contain detectable levels of lead, mercury and arsenic, which are known to produce harmful toxicological effects in humans. There is plenty of anecdotal evidence from Indian doctors on patients suffering severe liver damage after self-medicating themselves with Ayush based tonics. The reason this happens is that many Ayush manufacturers simply do not test their concoctions for toxic side-effects.
Perceptions exist among people that ayurvedic drugs are “safe". Without an understanding of the therapeutic dosage and data supporting longitudinal usage, it is hard to substantiate such a claim. The balance between safety and therapeutic efficacy is an important aspect of drug development, and this appears largely absent in the Ayush industry.
Why is there such a reluctance to adopt the tools of modern science to validate the claims made by traditional texts? Is the cost of possible evidence that supports such claims acting as a deterrent? Or are we worried that the claims of ancient Indian science were greatly exaggerated?
Either way, as demonstrated by the Coronil fiasco, products of the Ayush industry could pose a threat to public health. The government must take some difficult decisions on the future of this industry. It should insist that it plays by the rules of evidence-based medicine. If not, the advertising and marketing rules for its products should be significantly tightened to prohibit both the industry and ayurveda practitioners from making therapeutic claims in relation to their products.
We should also remind ourselves that changing the letter of the law does not automatically change the manner in which society behaves. There has to be a wider movement in Indian society, led by doctors and scientists, in favour of science and reason. There are far too many educated Indians who view Ayush products as an effective alternative to modern medicine without having adequately interrogated the science behind their claims. Thankfully, eminent doctors have spoken out against Coronil, but India needs far greater awareness.
Dinesh Thakur and Prashant Reddy T. are a public health activist and a lawyer working on drug regulatory issues, respectively