Sep 07, 2024
A simple regulatory remedy would be for the apex court to mandate state drug controllers to disclose all file- notings that form the basis of approval of “patent and proprietary” Ayush drugs
For over two years now, the Supreme Court has been hearing a public interest litigation (PIL) filed by the Indian Medical Association (IMA), on misleading advertisements made by Patanjali regarding its Ayurvedic products. The Ayurvedic industry poses a multi-dimensional challenge to public health in India today. It is important for both the Supreme Court and the lawyers advising it to be aware of the historical challenges in regulating the health care industry, lest they spend time reinventing the wheel.
Traditionally, there are five levers to regulate the pharmaceutical industry: Advertising, safety, efficacy, standardisation, and good manufacturing practices. The Ayush (Ayurvedic, Yoga, Unani, Siddha, and Homoeopathy) industry today is subject to only the first lever — that is, its advertising is regulated. The common explanation offered by the Ayush industry to evade providing data on the safety and efficacy of their products is that these have been used for centuries by many satisfied consumers. Except, this argument is not true on three counts.
First, it is well known that one particular branch of Ayurveda encourages the use of heavy metals, which is harmful to humans. There are well-researched and peer-reviewed studies published in the Journal oftheAmerican Medical Association (JAMA) as far back as 2004 that document a heavy-metal problem with Ayurvedic drugs. Other studies have focussed specifically on lead poisoning in Indian-origin patients known to consume Ayurvedic products.
Second, most Ayush products sold in India are classified as “patent and proprietary” — a category introduced via an amendment to the Drugs and Cosmetics Act (D&C Act) in 1982. These products, created with new ingredients that can’t be traced to the old texts from where the industry generally draws its legitimacy, are practically “new drugs.” When this category was created, there was no requirement that these products be tested to establish their safety and efficacy. In 2010, the Drugs and Cosmetics Rules were amended to introduce Rule 158B, which required the industry to provide evidence of safety and efficacy. However, there was a catch. It did not require the industry to collect such evidence through standards that are applicable to modern medicine, for example, double-blinded, randomised clinical trials. Instead, it prescribed “pilot studies” as the preferred methodology, and nobody really knows what that meant. The Ayush ministry first said that it meant “clinical trial” before changing its mind in 2018 and clarifying that no “clinical trials” were required for Ayush products.
Third, India does not have a robust pharmacovigilance system to monitor adverse events as a result of Ayush products. In short, nobody has been keeping an eye on the adverse events faced by patients consuming Ayush products. Individual doctors often publish case studies, but this a poor proxy for a systematic pharmacovigilance programme that tracks adverse events resulting from use of these products.
Since the Ayush industry has a licence to sell products without demonstrating any evidence of safety or efficacy, it is critical to exercise the only lever that can restrain the excesses of the industry, namely advertising regulations. However, the Ayush ministry deleted Rule 170 of the D&C Rules during the pendency of the IMA PIL in July 2024.
The history of Rule 170 of the D&C Act is crucial in understanding the modus operandiof the Ayush industry. Its origin can be traced back to continuous pressure piled on the Ayush ministry by the parliamentary standing committee (PSC) on health over the brazen claims being made by the Ayush industry. In four different reports tabled in 2013, 2015, 2016, and 2018, the PSC repeatedly flagged this issue, pointing out that the existing law — Drugs and Magic Remedies (Objectionable Advertisements) Act — regarding advertising of drugs was not effective in checking the claims of the Ayush industry, through advertisements that boasted of drugs that could cure cancer, AIDS, and diabetes.
After repeated pressure from the PSC, the Ayush ministry first floated the idea of Rule 170 on April 4, 2016, when it published a draft of the rule in the Gazette of India, inviting public feedback. This proposed draft created an ex-ante mechanism — the industry needed to seek permission for its advertisements from regulators before using them in their marketing campaigns. The regulator was to verify whether the advertisement made misleading claims about the effectiveness of the drug. For 37 medical conditions, it prohibited any advertisement by the industry.
The draft Rule 170 faced immense pushback from the industry. It did not get notified for years; the PSC continued to pile pressure on the Ayush ministry, questioning its “laidback” approach in a report tabled in 2018. Finally, on December 21, 2018, the ministry notified it into law. In early 2019, the Ayush industry challenged the constitutionality of the rule before three different high courts, claiming it infringed on their freedom of speech.
This is, at best, a questionable claim given India has a censorship regime for cinema and the fact that, in 1954, in a landmark case lost by the Ayush industry, the Supreme Court ruled that the fundamental right to speech did not include commercial speech such as advertisements. In any event, the legality of Rule 170 should have been swiftly decided by the high courts. Instead, the high courts stayed the rule without deciding on the matter. As a result, it was never enforced against the industry.
Fast forward to the IMA’s PIL, where the issue of Rule 170 and the lack of its enforcement came up before the court. The Ayush ministry issued a notification on July 2, 2024, while the case was sub judice, omitting Rule 170 from the law. A rule that was created to hold the industry accountable was removed from the law without ever being enforced. The Supreme Court has stayed the deletion of the rule, but this stay is an untenable remedy in the long term.
Going ahead, it is difficult to predict the direction of this Pl L. The Supreme Court’s track record in tackling regulatory issues via the PIL route is unfortunately not impressive.
A simple remedy with potentially long-term consequences is for the apex court to mandate all state drug controllers to disclose all file-notings that form the basis of approval of “patent and proprietary” Ayush drugs. Sunlight, it is said, is the best disinfectant. By providing consumers and doctors with more information about the approval process by which these products are marketed, the apex court will empower patients to make better decisions. That would be a victory for public health in India.
Source: Hindustan Times