The Supreme Court late last month rightly expanded the scope of the misleading ads case against Patanjali Ayurved to include the promotion of fast moving consumer goods as well. The judges observed that “FMCG/pharma companies who have been issuing misleading advertisements.. adversely affecting the health and well-being of babies, young children, women (including lactating and pregnant women), senior citizens and the sick and infirm” must be ‘closely examined’.
On the issue of AYUSH (ayurveda, unani, siddha and homoeopathy) medicines, there are two regulatory lacuna — one that pertains to mis-selling, which the Supreme Court called out in its April 23 hearing with respect to Patanjali, and the second that deals with the approval of proprietary AYUSH medicines. On the first, the court has taken a serious view of the Centre’s move last August to ‘omit’ Rule 170 of the Drugs and Cosmetics Rules, 1945, which empowers the State licensing authorities to take pre-emptive steps against misleading ads of AYUSH products. Curiously enough, Rule 170 was introduced by the Centre in December 2018. Over time, going by the Centre’s August 29, 2023 letter, the Ayurvedic Siddha and Unani Drugs Technical Advisory Board pushed for the omission of Rule 170. It is strange, as the judges have noted, that the Rule has not actually been dropped through a formal order; yet, its implementation has been stalled.
According to the Drugs and Magic Remedies (Objectionable Advertisments Act) 1954, promoting any medicine (AYUSH or allopathy) that claims to cure cancer, heart disease, hypertension, among 50 other ailments, is not allowed. Rule 170 would have supplemented this law. However, it seems that this law is observed more in the breach. This is also because it is somewhat sweeping in scope, thereby encouraging violative behaviour. It could be clubbed into the Drugs and Cosmetics Act, with a more granular set of rules on permissible promotional activity. A ‘positive list’ could usher in more responsible business behaviour.
It is also not clear whether AYUSH producers who put out proprietary medicine comply with Chapter IV A of the Drugs and Cosmetics Act (DCA). Under this Chapter, classical ayurveda, siddha and unani medicines made in accordance with the ancient texts listed under the DCA do not have to go through clinical trials. But proprietary AYUSH medicines, where the producers make their own combinations, cannot avoid such trials. These ‘medicines’ often come with outlandish claims, including Patanjali’s Coronil. The Health Ministry should shed more light on the ecosystem here. The Food Safety and Standards Authority of India is tasked with monitoring misselling of food products. While the FSSAI is reputed to conduct rigorous tests and often tones down the ‘ad line’, there are products that slip through the cracks. These foods and nutraceuticals would escape the ‘Magic Remedies’ Act. Such issues will hopefully be addressed in days to come.