What governs advertising medicines to the public in India

Two bars that run in parallel

It is commonly said that a prescription medicine cannot be advertised to patients because it is Schedule H. That is half the picture. Until the Cosmetics Rules 2020, the Drugs and Cosmetics Rules 1945 were called the Drugs and Cosmetics Rules 1945. These Rules attach a condition to the manufacturing licence. It reads: 'No advertisement of the drugs specified in Schedule H, Schedule H1 and Schedule X shall be made except with the previous sanction of the Central Government'. It appears as Rule 74(p), and in substantially the same words in Rules 74A(i), 74B(7), 78(q) and 78A(8).

Separately, the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 restricts advertising of every drug, scheduled or not. The distinction matters in practice, because reasoning from the schedule alone leads teams to assume a non-scheduled product is unrestricted. It is not.

What the Drugs and Magic Remedies Act covers

Section 3 bars any advertisement referring to a drug in terms which suggest its use for any of four purposes. The first is 'the procurement of miscarriage in women or prevention of conception in women'. The second is 'the maintenance or improvement of the capacity of human beings for sexual pleasure'. The third is 'the correction of menstrual disorder in women'. The fourth is 'the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule'. Section 4 separately bars any drug advertisement that 'directly or indirectly gives a false impression regarding the true character of the drug'. It equally bars one that 'makes a false claim for the drug' or 'is otherwise false or misleading in any material particular'. Section 5 covers any person 'carrying on or purporting to carry on the profession of administering magic remedies'. Such a person may not take part in publishing an advertisement for a magic remedy that claims efficacy for any section 3 purpose. Whether a medicine needs a prescription does not change sections 3 and 4.

The Schedule includes conditions such as diabetes and high or low blood pressure. The Act is not confined to material for patients. Under section 2(a), 'advertisement' includes 'any notice, circular, label, wrapper or other document'. Section 14 has more than one saving. The one that matters for drug promotion to doctors is section 14(c). It covers only 'any advertisement relating to any drug sent confidentially in the manner prescribed under section 16 only to a registered medical practitioner'.

Rule 106 and Schedule J

Rule 106(1) of the Drugs and Cosmetics Rules 1945 adds a claim restriction that applies to every drug. It reads: 'No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure'. That applies to 'one or more of the diseases or ailments specified in Schedule J'. The rule sits in Part IX of the Rules, the Part on labelling and packing. It does not use the word advertisement. Its words 'convey to the intending user thereof any idea' are commonly read to reach promotional claims.

There is no over-the-counter category in Indian law

The Drugs and Cosmetics Act defines no over-the-counter class. The prescription schedules are not the only legal markers either. A medicine for internal use containing a Schedule G substance carries a prescribed caution on its label. That caution comes from a label rule under the Drugs and Cosmetics Rules 1945. Rule 106 with Schedule J also applies to every drug. Schedule K, read with Rule 123, exempts some classes, such as listed household remedies, from parts of the Rules. That exemption does not lift the Drugs and Magic Remedies Act. Every medicine, scheduled or not, remains subject to the Drugs and Magic Remedies Act. Treating 'over-the-counter' as a category that permits patient advertising is a common and expensive assumption.

Where UCPMP 2024 fits

UCPMP 2024 Clause 3.2 applies where the purpose of the material is to inform a prescribing decision. The Code's definition of promotion in Clause 1.1 is wider. It reads: 'all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medical drugs'.

What CDSCO has said about promotion to the public

CDSCO has written to the State regulators about promotion to the public. On 27 March 2026 the Drugs Controller General (India) wrote to all State and Union Territory Drug Controllers. The subject was 'Strengthening Enforcement against Unauthorized Promotion and Distribution of GLP-1 Based Drugs'. The letter asks them to monitor print, electronic, digital, social media and outdoor platforms. They are to look for 'non-compliant advertisements or surrogate promotional activities relating to these drugs'.

The letter says 'appropriate action should be initiated' under the Drugs and Magic Remedies Act 1954 and the Drugs and Cosmetics Act 1940 and its Rules. It also refers to an 'advisory issued by this office'. The letter does not identify that advisory by title, date or number. The letter records monitoring requests, and it records no outcome of action on advertising. The practical point is simple. Surrogate promotion of these drugs to the public is treated as a matter for action under these laws.

The consumer framework alongside them

The Consumer Protection Act 2019 applies to advertising addressed to the public. So do the Central Consumer Protection Authority (CCPA) Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022. The self-regulatory ASCI Code applies as well. The CCPA Guidelines set standards for disclaimers. A disclaimer must be in the same language as the claim, and in the same font. It must not hide material information. ASCI publishes its own guidelines on disclaimers, with further standards for video and digital advertising.