Summary: Part 1 of this Article examines the CDSCO’s March 2026 Advisory directed at manufacturers, importers and marketing authorisation holders of GLP-1 receptor agonists, reinforcing that regulatory scrutiny of prescription-only medicine promotion will focus on substance over form. It prohibits all advertising — whether direct, surrogate, or influencer-led — that create brand recall among public.
Introduction
On March 10, 2026, the Central Drugs Standard Control Organisation (“CDSCO”) issued a formal advisory to manufacturers, importers and marketing authorisation holders of GLP-1 receptor agonists and similar prescription drugs for obesity and metabolic disorders (“Advisory”)[1], defining the contours of permissible disease awareness and impermissible promotion of prescription-only medicines under the law. The Advisory is grounded in the Drugs and Cosmetics Act, 1940 (“D&C Act”), and the Drugs and Cosmetics Rules, 1945 (“Rules”). The Advisory prohibits surrogate and indirect advertising, including influencer-led campaigns, and emphasises that the key concern is whether the campaign generates brand recall for a prescription drug among the public, regardless of its format. These developments underscore that regulatory scrutiny in this space will prioritise substance over form.
The Advisory lays down a consolidated compliance framework for manufacturers, importers and marketing authorisation holders, reinforcing both regulatory discipline and patient protection. The directive reiterates the obligation to strictly adhere to the D&C Act and Rules, while also enhancing transparency in prescribing and patient-facing materials by requiring clear disclosure of authorised personnel, office codes and the implementation of an organised consumer grievance redressal mechanism. It adopts a zero‑tolerance stance on advertising of prescription products, extending the prohibition to surrogate and indirect promotion across all media, including disease awareness initiatives or influencer‑led campaigns that generate brand recall. The Advisory further underscores the need for ethical marketing conduct, particularly to prevent the exploitation of vulnerable populations, and requires firms to proactively address safety concerns by submitting a comprehensive Risk Management Plan to ensure ongoing pharmacovigilance and effective risk‑minimisation measures.
These directives are being issued as GLP-1 receptor agonists have become highly sought-after therapeutic agents globally. This article sets out the statutory foundations of the Advisory, identifies who it binds, what it prohibits, how it interacts with the concept of surrogate advertising and what the law provides by way of consequence for non-compliance.
The Legal Architecture Behind the Advisory
The prohibition on promotion of prescription-only medicines is firmly established and constitutes a key condition within the licensing requirements for manufacturing and sale. It stipulates that advertisement of Schedule H, Schedule H1 or Schedule X drugs is prohibited, unless prior approval of the Central Government is obtained[2]. Schedules H and H1 together constitute a comprehensive list of prescription-only medicines, and these drugs may not be sold over the counter, without the prescription of a Registered Medical Practitioner. This prescription-only character is further underscored by mandatory labelling requirements, which require Schedule H and Schedule H1 formulations to carry the conspicuous warning “Not to be sold by retail without the prescription of a Registered Medical Practitioner.[3]”
Furthermore, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“DMR Act”) bans advertisements for certain drugs used to treat specific diseases and disorders. Among other things, it states that publishing any advertisement about a drug that implies or encourages its use for diagnosing, curing, mitigating, treating, or preventing any disease, disorder, or condition specified in the Schedule — or any additional disease, disorder or condition (by whatever name called) specified by rules under this Act — is prohibited.[4] Obesity is listed at item number 39 of the Schedule. Likewise, the Rules forbid any drug from claiming or suggesting that it can prevent or cure diseases/ ailments[5], including obesity, or conveying such an impression to potential users.
The DMR Act, which relates to prohibition of misleading advertisements relating to drugs, prohibits taking any part in the publication of any advertisement relating to a drug that contains matters which (a) directly or indirectly gives a false impression regarding the true character of the drug; or (b) makes a false claim for the drug; or (c) is otherwise false or misleading in any material particular.[6] The definition of “advertisement” under the DMR Act is broad, covering any notice, circular, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke.
While the Advisory does not expressly set out the legal provisions on which it is founded, the above legal provisions may appear to be the basis and context for it.
Five Categories of Prohibited Conduct
The Advisory proceeds on the footing that certain pharmaceutical companies are engaging in direct or indirect, including surrogate, promotional activities of GLP‑1 receptor agonists and other prescription‑only medicines indicated for obesity and metabolic disorders. It treats such conduct as misleading and impermissible, encompassing, inter alia, the promotion of prescription medicines to the general public, the exaggeration or misrepresentation of therapeutic efficacy, communications implying assured or guaranteed weight-loss outcomes, the dilution of the clinically established role of lifestyle interventions such as diet and exercise, and practices intended to induce or artificially stimulate demand for pharmacological therapy.
Surrogate Advertisement
The Advisory makes it clear that it does not matter what a campaign is called, what matters is whether it creates brand recall or product visibility for a prescription drug in the minds of the general public.
The Central Consumer Protection Authority’s Guidelines for Prevention of Misleading Advertisements and Endorsements, 2022 (“CCPA Guidelines”), issued under the Consumer Protection Act, 2019, lends some guidance on the meaning of surrogate advertisement. The CCPA Guidelines define “surrogate advertisement” as an advertisement for goods, products or services whose advertising is otherwise prohibited or restricted by law, by circumventing such prohibition or restriction and portraying it to be an advertisement for other goods, products or services, the advertising of which is not prohibited or restricted by law.[7]
Critically, the CCPA Guidelines also delineate specific circumstances under which an advertisement shall be treated as surrogate. An advertisement is considered surrogate or indirect if it indicates or suggests, directly or indirectly, that it is an advertisement for goods or services whose advertising is prohibited or restricted, or if it uses any brand name, logo, colour, layout or presentation associated with such goods or services. Applied to GLP-1 receptor agonists, any campaign however styled, that deploys the branding, imagery, or associations of a prescription drug to create public awareness of or demand for that product may be caught by this definition. The CCPA Guidelines further prohibit any surrogate or indirect advertisement of goods or services whose advertising is otherwise prohibited or restricted by law. It applies to all advertisements regardless of form, format or medium and extends to manufacturers, service providers, traders, advertising agencies and endorsers alike.
The second part of this article will examine the specific prohibitions under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, the emerging jurisprudence in this area, and the consequences of non-compliance with the Advisory.
[2] Rules 74, 74A(i) and 74B(7) (which govern different categories of retail/wholesale licences) and Rule 78(q) (which governs manufacturing licences) of the Rules.
[3] Rule 97
[4] Section 3(d) of the DMR Act.
[5] Specified in Schedule J and Rule 106 of the Rules.
[6] Section 4 of the DMR Act.
[7] Section 2(h) of the CCPA Guidelines.