Need to review functioning of food & drug regulatory agencies

Dinesh C. Sharma

Science commentator

THE ongoing legal battle in the Supreme Court over misleading claims made in advertisements by Patanjali Ayurved has evoked great interest for several reasons. The SC’s insistence on personal and repeated apologies by the Patanjali promoters, Ramdev and Balkrishna, for contempt of court is unprecedented. We are yet to hear the last word in this case, but the proceedings thus far have several important lessons for all concerned — drug manufacturers, regulators, the government and, above all, consumers.

At the heart of the case are the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, the Drugs and Cosmetics Act, 1940, and the rules made thereunder in 1945. The 1954 law prohibits the advertisement of drugs for some conditions and regulates how certain drugs can be advertised. The diseases for which remedies can’t be advertised include cancer, diabetes, infertility, AIDS, obesity, premature ageing, blindness, etc. The law specifically deals with misleading advertisements that claim miracle cures for diseases or make false or exaggerated claims about the effectiveness of certain drugs. Under this law, the Central Government is empowered to take action against those who violate its provisions. The 1940 Act and the rules made thereunder are the primary legislation governing the manufacture, distribution and sale of drugs, cosmetics, medical devices and other related products in India.

Patanjali has been advertising several herbal products that claim to ‘cure’ a range of diseases and conditions, including diabetes, thyroid-related problems and even cancer. During the Covid-19 pandemic, it launched Coronil, which it claimed could cure the disease. The product was endorsed by Dr Harsh Vardhan, then India’s Health Minister. When objections were raised, the marketing claim was changed from ‘treatment’ to ‘management.’ While claiming cures for several diseases, Patanjali advertisements also targeted the modern system of medicine, saying that it had no cure for them. This irked not only health activists but also the Indian Medical Association (IMA). The company was dragged to court for the violation of the two drug laws and reprimanded. Yet, it continued with misleading advertisements, in contempt of a court order.

Misleading advertising related to drugs, remedies and health is a major problem, going beyond Patanjali. Newspapers and television channels (during certain time slots) across India are filled with advertisements and sponsored content containing tall claims about cures and treatment for everything, from constipation to heart disease. Online platforms like YouTube, Instagram and Facebook are inundated with such claims from doctors and companies, in complete violation of the law. So-called ‘social media influencers’ have joined the bandwagon of promoting potentially harmful health products. Though large pharmaceutical companies mostly refrain from direct advertising, they indulge in unethical marketing practices like paid news, sponsorship of medical conferences and gifts for the doctors who prescribe medicines. A few years ago, even the IMA was accused of endorsing certain products without sufficient evidence about their efficacy or addressing the ethical questions involved in doing so.

We are in this mess not because our laws are inadequate or toothless, but because their enforcement by the government is lax, and the regulatory bodies have decided to look the other way. The laws are old and have been amended from time to time, and several committees have looked into their relevance and the need to make the rules more stringent. While the process of change will take its course, there is no reason why the existing provisions cannot be put to the best use. This columnist flagged the claims made by Ramdev about a cure for HIV/AIDS in 2008. Anbumani Ramadoss — a trained medical doctor who was then the health minister — got the ministry to serve a notice on Ramdev. But very soon, he did a U-turn and attended a yoga session of Ramdev in Gurugram, where the latter repeated his claim about the HIV/AIDS cure. Brinda Karat, a CPM MP at that time, too, raised the matter of misleading claims with the Uttarakhand Government, but no action was taken.

In the present case, the Central and state regulatory agencies delayed action and then acted in cohesion to give Patanjali free rein with its misleading claims. Dr Babu KV, a Kerala-based health and RTI activist who filed a series of complaints against Patanjali, first wrote to the state licensing authority in Uttarakhand, urging action for violation of the 1954 Act. The authority wrote to the company to withdraw the advertisements in question but took no action when Patanjali refused to act, though it had the power to do so. Not only this, the authority gave an escape route to Patanjali. The company was served the notices not under the 1954 Act but under a specific rule of the Drugs and Cosmetics Act, which was sub judice in the Bombay High Court. Patanjali cited the legal case and did not budge. The rule in question was added through an amendment in 2018, and it mandated the pre-approval of advertisements with health claims.

Celebrity endorsements and health claims over food products are also a major challenge. In this case, too, the food safety regulator has been sluggish. The advertising of nutraceuticals and food supplements is a problem area that needs urgent attention.

Given the changing contours of the media landscape and forms of direct and indirect advertising, we need a comprehensive review of all laws and rules relating to the marketing and advertising of medicines, food products and supplements, including those of the Indian systems of medicine. The law against misleading advertising, claims and celebrity endorsements of harmful products (including surrogate advertising) needs to be very stringent. We should review the functioning of Central and state food and drug regulatory agencies and provide them with adequate resources, authority and independence to effectively monitor and enforce compliance. The Patanjali case is a wake-up call for all the parties concerned. After all, it is directly related to the health and wellbeing of people.

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