The Central Drugs Standard Control Organisation (CDSCO) has recently issued an Advisory that has the effect of re-shaping the legal landscape around disease awareness campaigns, surrogate promotion, and other communications for an entire class of medicines popularly known as GLP-1 receptor agonists or GLP-1 drugs (such as Semaglutide, Liraglutide, and Tirzepatide).
Informing patients about a medical condition and spreading awareness in terms of prevention or cure has never been the same as advertising a drug. For decades, disease awareness campaigns that made no product claim, named no drug, and directed patients to registered medical practitioners were understood to fall within that permitted space. That is the status quo that the Advisory has now broken, not just for GLP-1 drugs but for all kinds of prescription drugs.
I. What the existing law already says (What cannot be done)
The Indian law currently prohibits (i) any person making or participating in the publication of communication which claims to cure diabetes or obesity; (ii) any manufacturer or importer of drugs from advertising any prescription drug; and (iii) making a claim on the label to the effect that a drug can cure diabetes and obesity. Violation of any of the aforementioned can result in criminal prosecution and cancellation of the manufacturing and import license.
Importers and manufacturers build their market strategy around educating about the disease, which are popularly known as disease awareness campaigns. For instance, in the context of GLP-1 drugs, companies have started conducting educational campaigns to highlight obesity as a medical condition and urge people to consult a doctor, without directly naming a drug or making any efficacy claim, in compliance with applicable drug law frameworks.
II. What does the advisory change
The Advisory has, for the first time, brought disease awareness campaigns under the purview of advertisement. However, if the disease awareness campaign seeks to indirectly (i) promote prescription-only medicines to the general public, or (ii) exaggerate therapeutic efficacy, or (iii) suggest assured or guaranteed weight loss outcomes, or (iv) downplay lifestyle modification measures (diet, exercise, behavioural interventions), or (v) induce demand for pharmacological therapy, then it would amount to ‘surrogate advertisement’, then the regulator may take action against erring manufacturers, importers and marketers. In the paragraph below, we have given examples for each of these situations:
(i) Promotion of Prescription Drugs: A paid Instagram reel by a manufacturer depicting that consumption of a GLP-1 drug has led to weight loss would amount to promotion of a prescription-only drug to the general public.
(ii) Exaggeration of Therapeutic Effect: Statements such as “Works even without diet or exercise”, where the drug’s own prescribing information mandates lifestyle modification, would constitute an exaggeration of therapeutic effect.
(iii) Assured Outcome Claims: Claims such as “Guaranteed 10 kg loss in 8 weeks or your money back” would amount to a claim of assured outcome.
(iv) Downplaying Diet, Exercise, and Lifestyle Modification: Any communication where diet, exercise, is shown as ineffective, or unnecessary, may be construed as downplaying lifestyle modification.
(v) Inducement of Pharmacological Therapy: An educational or awareness campaign in which individuals are shown, encouraging or directing an overweight person to consult a doctor in a manner that suggests that medical or pharmacological intervention is the only and necessary solution.
The Advisory does not define what constitutes “inducement”, nor does it prescribe any objective threshold. This creates a zone of significant interpretational uncertainty. A script that never mentions a drug may still be found to create an impression of pharmacological inducement if the overall communication suggests that medical intervention is the primary or natural solution to the condition. In such cases, even in the absence of any product reference, the communication may be treated as a surrogate advertisement based on the impression it creates rather than the words it uses.
For example, if an influencer publicly discusses her medically supervised GLP-1 treatment journey without promoting any specific product, but emphasises the need to consult a doctor, could this be said to induce demand for pharmacological therapy? The Advisory leaves this question open, even when it extends its ambit to influencer engagements and collaborations.
It is important to note that while the drug regulatory framework under Drugs and Cosmetics Act, 1940 and the rules thereunder, primarily governs manufacturers, importers and marketers, advertisements by celebrities and influencers are independently regulated under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“DMRA”). The DMRA prohibits any person, including manufacturers, importers, marketers, influencers and even doctors, from publishing or participating in advertisements that directly or indirectly claim that a drug can be used for the treatment, cure, prevention, or mitigation of obesity and diabetes.
Therefore, in a scenario where a manufacturer engages or pays an influencer to create content documenting or promoting a GLP-1 treatment journey, the manufacturer may be exposed to liability under the Drugs and Cosmetics Act, 1940 and the rules governing prescription drug advertising, as well as under the DMRA. The influencer, on the other hand, while not directly regulated under the drug approval and marketing framework, would nevertheless fall within the scope of the DMRA, which applies to “any person” participating in such advertisements.
III. Surrogate Advertisement Problem
Further, this Advisory also sweeps all educational activity as a surrogate advertisement if it is “under the pretext of disease awareness” that creates “brand recall or product visibility”. The Advisory’s twin tests (the inducement standard and brand recall test) are both impression- and output-based, not content- or intention-based.
In simple terms, brand recall would include any element that reminds the viewer of a particular drug or brand, such as brand colours, taglines, packaging style, or any visual identity associated with a product. Product visibility or product placement would include showing a product, its packaging, or any identifiable brand element, even if it appears only in the background.
This gives rise to two important questions in light of the Advisory. (i) Is corporate branding allowed in disease awareness campaigns? Can disclaimers include product references or directions to product information?
In our view, corporate branding is permitted so long as it does not create an association with a specific prescription drug or product brand. Similarly, if a disclaimer mentions a product name, directs viewers to a product website, or provides product-related information, or if any scientific reference contains a product name or information, such communication may no longer remain a disease awareness campaign and may instead be treated as product promotion or surrogate advertisement. Furthermore, if a brand makes a tagline that strikingly resembles the product brand name, it would again be termed a violation.
IV. Way forward after the Advisory
Going forward, all drug and medical manufacturers and importers who invest in disease awareness campaigns would now need to ensure that such campaigns meet the requirements of the Advisory. From a visual standpoint, the standard imposed by the Advisory would effectively require zero product appearance. Beyond the visuals, the scripts will need to be vetted at every stage, not only for what they explicitly state, but also for what they may imply. How a disease awareness campaign is structured, including positioning of the elements such as doctor’s consultation, pharmacological treatment, efficacy claims, etc., in compliance with the Advisory, will be of critical importance to keep companies outside the risk of violation.
For obesity disease awareness campaigns specifically, it will be important to have a balanced and holistic approach in the advertisement, providing equal emphasis on lifestyle and diet, without medical consultation being shown as the only option. Further, medical consultation, if shown at all, would have to be framed generally as one of the options.
On a separate note, all drug and medical manufacturers and importers may proactively undertake a comprehensive review of their websites, creating disease awareness, containing educational materials, as well as their social media content and strategy, to not be caught off guard in light of the sweeping nature of the Advisory.
