What a leave-behind must carry in India
A leave-behind carries the same five items of UCPMP 2024 Clause 3.2 as any other piece intended to inform a prescribing decision. Company name and address are required, but they are not what distinguishes a leave-behind: Clause 3.2(i) requires them on presented material too.
In short
- Same five items as a visual aid. The Code does not treat leave-behinds separately.
- Company identification is NOT the distinguishing feature. Clause 3.2(i) applies to presented material as well.
- The manufacturing licence number is not a Clause 3.2 item. It is a requirement for the medicine label.
- Because the piece is read later and alone, Clause 3.2(v) matters more here in practice.
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.
Correcting a common misconception
It is often said that manufacturer information is what separates a leave-behind from a presented visual aid. That is not what the Code says. Clause 3.2(i) requires the name and address of the authorisation holder on promotional material whose purpose is to inform a prescribing decision. It draws no distinction based on whether the piece stays with the reader.
The point is worth stating plainly because the opposite view is common, and reading Clause 3.2 is what settles it.
What is NOT required
The manufacturing licence number belongs on the medicine's label under the Drugs and Cosmetics Rules 1945. UCPMP 2024 asks for a name and an address. The licence number is not one of the Clause 3.2 items.
Why the date matters most on this format
A leave-behind is read after the conversation, sometimes months later. Clause 3.2(v) requires a statement that additional information is available on request. It also requires the date the particulars were generated or last updated. That is exactly the information a reader coming to it cold needs.
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
What distinguishes a leave-behind from a visual aid under UCPMP?
Under the Code, nothing about the required content. Clause 3.2 applies to both by purpose. The difference is practical: a leave-behind is read later and without the representative present, which makes the availability statement and date in Clause 3.2(v) more useful.
Does a leave-behind need the manufacturing licence number?
No. That is a labelling requirement under the Drugs and Cosmetics Rules 1945. UCPMP 2024 Clause 3.2(i) requires the name and address of the authorisation holder, or of the business responsible for placing the drug on the market.
Do visual aids really need company identification too?
Yes. Clause 3.2(i) makes no exception for material that is only presented.
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