The ‘Coronil’ controversy last month highlighted the problems with regulating Ayurveda in India. Patanjali claimed to have developed an Ayurvedic medicine that would protect people from Covid-19 and also cure the disease. Later revelations raised doubts about these claims and the process of testing these medicines.
The episode highlighted how modern thinking is creeping into alternative medicine. This is good, and India stands to gain enormously as a producer and exporter of traditional herbal medicines.
The world’s growing fascination with natural remedies, traditional and alternative medicines and herbs augurs well for India. These can provide a substantial source of income for farmers and companies across the country.
Traditional medicines have been used in India, even though there is little quality control or trials. A very small quantity of herbal medicines produced in India is exported, as they do not meet the regulatory standards required by importing countries. While they can be a great source of income and exports for India, we will need a modern regulatory system to succeed.
Even at its current levels, with little exports, estimates are that Ayurveda is a Rs 30,000 crore industry in India.
Promoting alternative medicines
Successive governments have taken steps to promote alternative medicines. In 2003, the government published the first official list of Ayurvedic medicines, called a pharmacopoeia. The publication of a pharmacopoeia is the first step towards formalising any medical system.
In 2014, the Narendra Modi government merged the regulation of Ayurveda, Yoga, Unani, Siddha, and Homoeopathy (collectively called AYUSH) into a separate eponymous ministry.
Recently, the government decided to sell Ayurvedic medicines in Jan Aushadhi stores.
In 2017, the All India Ayurveda Institute was set up in Delhi, on the lines of the famous All India Institute of Medical Sciences. The government is encouraging farmers to grow Ayurvedic plants in various states to diversify agriculture and boost farm income. The budgetary allocation for alternative medicines has doubled since the present government has come to power.
Why Ayurveda needs regulation
The ‘Coronil’ controversy emphasises the role the government has to play beyond encouraging the use of Ayurveda. At the core of promoting alternative medicines are two government regulatory functions: One, ensuring safety, and two, checking the truth of claims about efficacy. In addition to all the other schemes, the government has to emphasise on these two functions.
Contrary to popular belief, Ayurvedic medicines can be dangerous to health. The dangers arise primarily for three reasons: (i) All plants are not safe for consumption, (ii) Use of ashes and non-plant materials, (iii) Illegal addition of allopathic medicines.
Ayurveda uses many plants which are toxic to humans, like datura and nux vomica, in large doses. It is essential that their dosage is limited or the plants are treated before they are included in the medicine.
Similarly, ashes may concentrate dangerous metals in the formulation. As recently as 2017, the Food and Drug Administration of the US warned against the use of certain Ayurvedic medicines. The FDA found the medication to contain dangerous levels of lead. This is not the first time this has happened.
Some unscrupulous medicine manufacturers go a step further. They mix allopathic medicines in Ayurvedic drugs, usually steroids. Some steroids (mostly corticosteroids) give a false sense of well-being by improving circulation and alertness. For the wrong ailments, like infections, they may accelerate the underlying disease, but since the patient gets a steroid high, he or she feels better and ascribes it to the medicine. A study by the King Edward Memorial Hospital in Mumbai found around 40% of Ayurvedic drugs tested contained steroids.
Uncontrolled use of poisonous plants, presence of heavy metals, and outright fraud (adding steroids) damages the reputation of Indian medicine. The unscrupulous and negligent manufacturers make profits by cheating, but harm the status of the entire industry.
The problem is worse in international markets. While we in India may be able to distinguish between established brands and suspicious ones, this is difficult sitting in the US. A patient with a negative experience will probably avoid all Ayurvedic medicines.
Two necessary steps
The first step of regulation of medicines is to ensure safety. Irrespective of whether they have any therapeutic effect, an AYUSH medicine should not harm patients. While the government published guidelines for the development and manufacture of Ayurvedic drugs, the enforcement of these provisions is inadequate. Lax enforcement of detailed regulations undermines the efforts made to develop the rules in the first place and encourage a culture of ignoring the law. Even companies which start by complying with the legislation may slowly slip up if they observe systemic non-compliance.
The second step after enforcing safety provisions is checking therapeutic claims. Therapeutic claims are very difficult to establish in allopathic medicines. In alternate medicine, this may be even tougher. Unlike allopathic medicine, the active ingredient is usually not extracted in Ayurveda. This makes Ayurvedic medicines less potent and may take longer timelines to show effectiveness. However, Ayurvedic medicine manufacturers mustn’t make claims about curing conditions or diseases which are demonstrably false. Such false claims have a similar effect to dangerous medicines. Perceptions will develop that false claims dominate the whole field. Even where Ayurvedic medicines have positive outcomes, customers will be sceptical.
Regulation of any medical system has concentrated on safety and efficacy to protect patients. However, another role that governance plays is in developing trust in the system. When confidence in a system erodes, the effectiveness of subsidies, promotional campaigns and other schemes will be limited. Along with the promotion of AYUSH and farming of herbs, if we set up proper regulation of Ayurvedic medicines, we will not merely protect patients, but also promote Ayurveda as a safe and effective system of medicine, a system in which India can be a world leader.