How UCPMP 2024 governs claims and comparisons

Clause 2.1, and where substantiation sits

'Claims for the usefulness of a drug must be based on up-to-date evaluation of all available evidence.'

Clause 2.1 requires claims to rest on an up-to-date evaluation of all available evidence. The general duty to substantiate sits in Clause 1.3. It requires information about drugs to be 'balanced, up-to-date, verifiable'. That information must also be 'capable of substantiation, which must be provided without delay, at request of the members of the medical and pharmacy professions'. Clause 1.2 requires promotion to be 'consistent with the terms of its marketing approval'. Clause 2.4 adds that comparisons must be 'capable of substantiation'. Clauses 1.2, 1.3 and Section 2 together govern claims made to prescribers. The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 can apply to that material too, unless its section 14(c) saving covers it. The Advertising Standards Council of India (ASCI) Code self-regulates paid advertising addressed to the public or a section of it. It is applied mainly to consumer advertising, and it is not the reference code for a detail aid. The Drugs and Cosmetics Rules 1945, set a licence condition for Schedule H, H1 and X drugs. No advertisement of those drugs may be made without the previous sanction of the Central Government (for example Rules 74(p) and 78(q)). Their text sets no audience limit. How they apply to material addressed only to prescribers is a question for your regulatory team.

Clause 2.2, and the word 'safe'

Clause 2.2 says: 'The word "safe" must not be used without qualification'. It adds that 'it must not be stated categorically that a medicine has no side effects, toxic hazards, or risk of addiction'.

Two distinct things sit in that clause. 'Safe' is restricted rather than banned: it may not be used WITHOUT QUALIFICATION. A categorical claim of no side effects, no toxic hazards or no risk of addiction is prohibited outright.

Clause 2.3, and what 'new' costs you after a year

Clause 2.3 says: 'The word "new" must not be used to describe any drug which has been generally available or any therapeutic intervention'. The clause continues: 'which has been generally promoted in India for more than a year'.

This is a clock rather than a judgment. The claim is true at launch and becomes false on a date nobody diarises. That makes it a predictable failure in promotional copy and an easy one to miss on reprinted artwork.

Clauses 2.4 to 2.6, comparisons and competitors

'Comparisons of drugs must be factual, fair, and capable of substantiation. In presenting a comparison, care must be taken to ensure that it does not mislead by distortion, by undue emphasis, by omission, or in any other similar way.'

Clause 2.5 says: 'Brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained'. Clause 2.6 says: 'Other companies, their products, services, or promotions must not be disparaged either directly or by implication'.

Clause 2.7, the opinions of healthcare professionals

Clause 2.7 protects the 'clinical or scientific opinions' of doctors and other professionals in healthcare. They 'must not be disparaged either directly or by implication'. The clause protects their opinions in the same way that Clause 2.6 protects other companies.