Summary: This article examines the reach of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, through the lens of key judicial pronouncements – from the Supreme Court’s ruling in Hamdard Dawakhana upholding the constitutionality of advertising restrictions to the Bombay High Court’s broad reading of Section 4 as a catch-all prohibition against misleading drug advertisements and the Supreme Court’s recent observations in the Patanjali matter. These rulings map the boundaries of what constitutes a prohibited advertisement and identify the penal consequences under the Drugs and Cosmetics Act, 1940 Act and the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, for non-compliance with the Advisory.
Part 1 of this article examined the CDSCO’s March 2026 Advisory and its prohibition on direct, surrogate, and influencer-led advertising of GLP-1 receptor agonists.
The Original Prohibition: Understanding the Reach of DMR Act
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (“DMR Act”) prohibits advertisements that claim efficacy for purposes specified[1] and create a false impression about a drug. Mass media advertising of drugs is impermissible, in that drugs may only be advertised confidentially to registered medical practitioners through catalogues or circulars. The Central Government is empowered to exempt specified advertisements from the Act’s operation in the public interest by notification in the Official Gazette. The DMR Act also carves out limited exceptions for medical practitioners’ signboards, bona fide scientific treatises, confidential communications to practitioners, and government-published advertisements.
The Karnataka High Court,[2] in a criminal appeal arising from a prosecution under the DMR Act,[3] examined the scope of liability and identified the three essential ingredients for attracting liability[4]: (a) the accused must have taken part in the publication of an advertisement; (b) that advertisement must relate to or have reference to a drug; and (c) that the drug must be suggested as a cure for the specific ailments enumerated under the provision or the treatment of the disease listed in the Schedule of the DMR Act. The Court held that an advertisement, promoting a product as a “special invigorative nervine tonic” useful for restoring “vim, vigour, and vitality” does not constitute an offence if it does not even obliquely suggest that it is a cure for impotence or that it aids the maintenance or improvement of the capacity of human beings for sexual pleasure. Further, the Court clarified that the mere seizure of drugs and literature from the accused person’s private hotel room, absent any evidence of public display or distribution, would not amount to the publication of an advertisement under the DMR Act.[5] It reiterated that the DMR Act aims to protect ignorant persons from being duped by eloquent advertising into purchasing medicines, but this protective purpose does remove the requirement that each element of the offence be strictly established before criminal liability can be fastened.
The Supreme Court settled the constitutional validity of the DMR Act’s advertising restrictions,[6] holding that a commercial advertisement that has an element of trade or commerce, no longer falls within the concept of freedom of speech and does not attract the protection of Article 19(1)(a) of the Constitution, as its object is not propagation of social, political, or economic ideas or the furtherance of literature or human thought but rather the commendation of the efficacy, value, and importance in the treatment of particular diseases by certain drugs and medicines. The Court also affirmed that the definition of “advertisement” extends beyond newspapers to cartons, labels, and wrappers, holding that if it was not so broad and inclusive, it would defeat the very purpose for introducing the DMR Act. It held that the true object of the DMR Act is to prevent self-medication or treatment by prohibiting instruments that may advocate for and spread such practices.
Delegated legislation as contained in the DMR Act[7] prohibits the publication of any advertisement, suggesting that a drug could be used for the diagnosis, cure, mitigation, treatment, or prevention of any venereal disease or any other disease or condition specified in the Drugs and Magic Remedies (Objectionable Advertisements) Rule, 1955. On this issue, the Court drew a distinction between conditional legislation (where the delegate merely determines when a legislatively complete rule of conduct shall become operative) and delegated legislation (where the legislature lays down the broad policy and leaves the details to be filled in by the administrative authority within the prescribed limit). It was held that the words “or any other disease or condition which may be specified in the Rules made under this Act” as contained in the DMR Act[8] conferred uncanalised and uncontrolled power upon the executive, as Parliament had prescribed no criteria, standards, or principles on which a particular disease or condition were to be added to the Schedule. Therefore, the delegation was held to be unconstitutional and the Schedule in the said Rules was struck down. However, this did not affect the remaining provisions of the Act, as they were severable.
A pending writ petition before the Supreme Court[9] challenges this provision of the DMR Act,[10] contending that it[11] imposes a blanket prohibition on medical advertisements, without distinguishing between misleading claims by quacks and bona fide information from duly qualified and statutorily recognised practitioners. It further contends that the DMR Act’s definition of “registered medical practitioner” unjustifiably excludes AYUSH practitioners, despite their recognition under central legislation. It also contended that the Schedule listing diseases for which advertisements are prohibited has not been updated since 1963, despite significant developments in medicine and diagnostics. The petition seeks a reading down of the impugned provisions and the constitution of an expert committee to periodically review and update the Schedule. The Supreme Court has issued notice to the Union of India and other Respondents, including the Ministries of AYUSH, Health and Family Welfare, and Women and Child Development. The outcome of this petition could significantly impact how the interpretation and enforcement of the DMR Act, redefining the scope of permission for qualified medical practitioners across all recognised systems of medicine to advertise and share medical information with the public.
The Kerala High Court[12] identified a limiting principle, holding that the provisions of the DMR Act[13] apply only where an advertisement refers to a specific “drug” as defined under the DMR Act. A mere offer of treatment, without naming or implying any drug, falls outside the prohibition. Applying this principle, the Court, in a complaint filed against the publishers, printer, and editor of the magazine Vanitha in which a practitioner had advertised treatment for impotency and breast beautification, held that provision of the DMR Act[14] was not attracted and that the Magistrate had taken cognizance of an offence under the DMR Act[15] without any legal basis, as the advertisement contained no reference to any drug whatsoever. The complaint and all proceedings before the Magistrate were accordingly quashed.
The Supreme Court[16] later clarified the scope of the DMR Act while deciding whether distribution of physician’s samples by a pharmaceutical company amounted to “advertisement, publicity and sales promotion” under the Income Tax Act, 1961. It noted that the DMR Act[17] prohibits the publication of any advertisement referring to any drug that suggests or could lead to the use of that drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, or condition specified in the Schedule. The assessee had argued that a finding that physician’s samples constituted advertisement expenditure would imply that it had advertised prescription drugs, violating the DMR Act. The Supreme Court rejected this argument, holding that the prohibition under the DMR Act is not applicable to physician’s samples and only bars publication, which is clear from the definition of “advertisement” under the Act. Distinguishing between the physical distribution of drug samples (outside the prohibition) and the publication of an advertisement referring to a drug (what the DMR Act[18] targets), the Court reinforced that the prohibitory provisions of the DMR Act must be read in consonance with the definition of “advertisement” under the DMR Act. It also reinforced that acts not involving publication do not attract the prohibition, regardless of their characterisation for other statutory purposes.
The Bombay High Court,[19] in a public interest litigation challenging drug advertisements on television for encouraging self-medication and making false or misleading claims, held that the DMR Act covers the specific diseases listed under its provisions[20] as well as objectionable or unethical advertisements promoting self-medication. It drew a distinction between Sections 3 and 4, holding that Section 4 operates as a wider, catch-all prohibition against any advertisement that creates a false or misleading impression of a drug’s true character, regardless of whether the drug or disease falls within Section 3.
In a writ petition seeking strict action against Patanjali Ayurveda Ltd.[21] for repeatedly publishing advertisements making prohibited claims, the Supreme Court reaffirmed the reach of the prohibitions under the DMR Act and DMR Rules in the context of misleading health claims. Complaints alleged that Patanjali was advertising its products as permanent cures for ailments specifically listed in the Schedules to the DMR Act and the DMR Rules including diabetes, high blood pressure, heart disease, obesity, and asthma. The provisions of the DMR Act[22] and the DMR Rules[23] both prohibit the publication of any advertisement referring to a drug in terms suggesting its use for the diagnosis, cure, mitigation, treatment, or prevention of any disease or condition listed in the respective Schedules. Patanjali had published advertisements claiming to have “completely cured” lakhs of people of diseases such as diabetes, high blood pressure, thyroid, arthritis, and asthma, and had labelled its products, including “BP GRIT” and “Madhu GRIT”, as offering a “permanent solution” for such conditions. The Court held that these claims, which directly referred to ailments listed in the Schedules, amounted to a clear violation of the DMR Act and DMR Rules.
Likely Consequences for Non-Adherence to the Advisory
Actions leading to penalties under the Drugs & Cosmetics Act, 1940 (“D&C Act”) postulates imprisonment for a minimum term of one year extendable to two years along with fine of not less than INR 20,000 may be initiated.[24] Actions leading to confiscation of stock of drugs, along with machinery, implements, packaging, and vehicles used in their manufacture or distribution could also potentially follow.[25]
Actions leading to penalties under the DMR Act, which postulates punishment with imprisonment of up to six months and/or fine may be initiated.[26]
[1] Section 3 of the DMR Act
[2] State of Karnataka v. Dr. R.M.K. Sivasubramanya Om, 1978 SCC OnLine Kar 350
[3] Sections 3(b) and 3(d) of the DMR Act
[4] Section 3 of the DMR Act
[5] Section 3 of the DMR Act
[6] Hamdard Dawakhana v. Union of India (1959) SCC OnLine SC 38
[7] Section 3(d) of the DMR Act
[8] Clause (d) of Section 3 of the DMR Act
[9] Nitin Upadhyay v. Union of India, W.P.(C) No. 001278/2025 (Supreme Court)
[10] Section 3 of the DMR Act
[11] Section 3(d) of the DMR Act
[12] Vanitha Malayalam Fortnightly v. State of Kerala, Crl. MC. No. 5867 of 2017 (Kerala High Court)
[13] Section 3 of the DMR Act
[14] Section 3 of the DMR Act
[15] Section 7 of the DMR Act
[16] Eskayef v. Commissioner of Income Tax (2000) 6 SCC 451
[17] Section 3 of the DMR Act
[18] Section 3 of the DMR Act
[19] Mahesh Ramnath Sonawane v. Union of India (2014) SCC OnLine Bom 4008
[20] Section 3 of the DMR Act
[21] Indian Medical Association v. Union of India (W.P.(C) No. 645/2022) (Supreme Court)
[22] Section 3 of the DMR Act
[23] Rule 6 of the DMR Rules
[24] Section 27 of the D&C Act.
[25] Section 31 of the D&C Act.
[26] Section 7 of the DMR Act.