What a pharma visual aid must carry in India
A visual aid that informs a prescribing decision must carry the five items in UCPMP 2024 Clause 3.2. The drug, with the authorisation holder's name and address. The generic name and active ingredients, immediately adjacent to the most prominent drug name. Dosage, method of use and, where not obvious, method of administration. Adverse reactions, warnings, precautions and relevant contraindications. Last, a statement that more information is available on request, with the date the particulars were generated or last updated.
In short
- One clause sets the minimum information: UCPMP 2024 Clause 3.2. It applies by purpose, whatever the piece is called.
- The generic name goes immediately adjacent to the most prominent display of the drug name. The Code says nothing about matching the brand name in size.
- Company name and address are required here as well as on a leave-behind.
- Clause 3.2(v) is easy to forget: a statement that further information is available on request, plus the date the particulars were generated or last updated.
- The Code says 'legibly'. It sets no point size.
The rule is one clause, and it is about purpose
Clause 3.2 opens with a condition, and the condition is about purpose rather than format. "Where the purpose of the promotional material is to provide persons qualified to prescribe with sufficient information upon which to reach a decision for prescription or for use". If that describes the piece, all five items below apply to it, whatever the piece is called internally.
| Feature | Clause | Basis | What the Code says |
|---|---|---|---|
| Company identification | UCPMP 2024, Clause 3.2(i) | Code (UCPMP 2024) | The relevant drug, the name and address of the holder of authorization for the drug (or the business name and address of the part of the business responsible for placing the drug on the market). Required whether or not the piece is left behind. The manufacturing licence number is a label requirement under the labelling rules of the Drugs and Cosmetics Rules 1945. Clause 3.2 does not require it on promotional material. |
| Generic name | UCPMP 2024, Clause 3.2(ii) | Code (UCPMP 2024) | The name of the drug, along with a list of active ingredients, using the generic name, placed immediately adjacent to the most prominent display of the name of the drug. Adjacency is the requirement. Size is not. The Code sets no relationship between the generic name and the brand name in point size. |
| Dosage and administration | UCPMP 2024, Clause 3.2(iii) | Code (UCPMP 2024) | Recommended dosage, method of use, and where not obvious, its method of administration. |
| Safety information | UCPMP 2024, Clause 3.2(iv) | Code (UCPMP 2024) | Adverse reactions, warnings, precautions for use and relevant contraindications for the use of the product. Read with Clause 1.3, which requires information to be balanced and not misleading. That is where fair balance actually comes from. |
| Availability statement and date | UCPMP 2024, Clause 3.2(v) | Code (UCPMP 2024) | A statement that additional information is available on request, and the date on which the above particulars were generated or last updated. Easy to add and easy to forget. A piece reprinted for years with no date on the particulars does not meet this. |
The Code requires the information to be given 'legibly' and to be 'an integral part of the promotional material'. It sets no point size. Any minimum your team works to, such as 8pt, is an internal MLR standard. It is not a legal threshold. Be clear about that in review, so nobody defends a house rule as though it were law.
Clause 3.2 sets the minimum information. Other clauses of the Code apply too. Clause 3.8 asks for the date of printing or of the last review 'wherever appropriate', for example on technical and other informative material. That date is different from the Clause 3.2(v) date. Clause 3.6 bars the names or photographs of health professionals in promotional material. The general points and the clauses on claims and comparisons, in Sections 1 and 2, also apply.
What this format gets wrong in practice
A visual aid is presented rather than read, so the pressure is always to move information off the page and into the conversation. Clause 3.2 does not allow that. The minimum information has to be an integral part of the material itself. What the representative says does not count towards it. Where an e-detailing deck includes audio-visual material, such as video or a voice-over, a further rule applies. Clause 3.10 requires audio-visual material to 'be supported by all relevant printed material' so that every relevant requirement of the Code is met.
The second pattern is the date. A visual aid tends to be reprinted across cycles. Clause 3.2(v) asks for the date the particulars were 'generated or last updated'. An old date is accurate only if the particulars really have not changed. If the dosing or safety information has moved on, the piece falls short of Clause 1.3. That clause requires information about drugs to be 'balanced, up-to-date'. Clause 3.8 also asks, wherever appropriate, for the date of printing or of the last review. A normal reprint process catches neither.
What the Code does not require here
The Rx symbol appears nowhere in UCPMP 2024. Marking prescription status on a detailing deck is widespread convention, and worth doing. It is not a requirement of the Code, though, and should not be recorded as one.
The Drugs and Cosmetics Rules 1945, prescribe label wording for medicines for internal use with Schedule H, H1 or X substances. For Schedule H, for example, that is the Rx symbol and a statement that the medicine is to be sold by retail on prescription only. These are requirements for the medicine's container label. Only the Schedule H1 wording is set in a box with a red border. None of them is listed in UCPMP 2024 Clause 3.2.
The Drugs and Cosmetics Rules 1945 also matter beyond the label. Their manufacturing licence conditions say no advertisement of Schedule H, H1 or X drugs may be made without previous Central Government sanction (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.
Frequently asked questions
Is there a size rule for the generic name relative to the brand name?
No. UCPMP 2024 Clause 3.2(ii) requires the generic name 'placed immediately adjacent to the most prominent display of the name of the drug'. Adjacency is the requirement. The Code sets no size relationship for promotional material. Indian law does have a prominence rule for the medicine's label. The Drugs and Cosmetics Rules 1945 require the proper name to appear 'in a more conspicuous manner than the trade name'. That rule governs the label. It does not govern a visual aid.
Is the Rx symbol legally required on a visual aid?
No. UCPMP 2024 does not mention the Rx symbol at all. Under the Drugs and Cosmetics Rules 1945, the Rx symbol is a container-label requirement for Schedule H and H1 medicines for internal use. Schedule X medicines carry XRx instead. Schedule H medicines that come under the Narcotic Drugs and Psychotropic Substances Act 1985 carry NRx. Marking prescription status on promotional material is industry convention rather than a requirement of the Code.
Does a visual aid need the company name if it is never left behind?
Yes. Clause 3.2(i) applies to promotional material whose purpose is to inform a prescribing decision. It requires the name and address of the authorisation holder, or of the business responsible for placing the drug on the market. Whether the piece is left behind does not change that.
What is the minimum font size for the Clause 3.2 information?
The Code does not set one. Clause 3.2 requires the information to be given "legibly" and to be "an integral part" of the material. Any point-size minimum your team applies is an internal MLR standard.
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