2025 Amendments to Medical and Pharmaceutical Marketing Practices: Valuation of Free Samples & Annual Disclosures

On 1-9-2025, the Ministry of Chemicals and Fertilizers issued Amendments to:

• Uniform Code for Pharmaceuticals Marketing Practices (‘UCPMC’) 2024.

• Uniform Code for Marketing Practices in Medical Devices (‘UCMPMD’) 2024.

These Amendments simplify disclosure of marketing expenditure and sample valuation by shifting reporting from government portals to industry associations, aimed at enhancing transparency, accountability, and ethical conduct in the pharmaceutical sector.

Background:

UCPMP 2024

Originally introduced in 2014 as a voluntary framework, the Uniform Code for Pharmaceuticals Marketing Practices was revised in 2024 to include semi-mandatory provisions, annual disclosure requirements, and a formal complaint redressal system to curb unethical promotional practices in the pharmaceutical sector.¹

UCMPMD 2024

Launched in September 2024, the Uniform Code for Marketing Practices in Medical Devices is India’s first dedicated code for regulating device marketing. It establishes standards for sample valuation, expenditure disclosure, and industry-led compliance, aiming to enhance transparency and ethical conduct across the medical device ecosystem.²

Key Amendments to UCMPMD 2024:

The 2025 amendment to the UCMPMD aims to make things easier for medical device companies while ensuring they follow ethical marketing practices in pharmaceutical marketing.

1. A new Clause 5.2.2(vi) is inserted which establishes a standardized methodology for valuing free evaluation samples distributed to healthcare professionals, ensuring consistency and fairness in reporting marketing expenditure. It states:

   • For manufacturers: Samples will be valued on a per-unit basis (e.g., per device, vial, or milliliter), using the price charged to the stockist or immediate customer for the same make, brand, product variant, and value of the medical device.

   • For purchased samples: The purchase price will be used for valuation.

   • Annual Averaging: In both cases, the value must be recorded as the average price charged or paid over the financial year.

2. Clause 9.1 has been updated to replace the reference to “UCPMP” with “UCMPMD”, to align terminology with the medical device sector.

3. To reduce administrative burden and promotes ease of doing business, Clause 14.3 is modified to simplifies the disclosure process for marketing expenditure:

   • Companies will be required to submit their annual declaration within two months of the financial year’s end.

   • Disclosures can be made either:

     • On the website of the industry association to which the company belongs, or

     • On the UCMPMD portal if the company is unaffiliated.

   • Companies with multiple memberships can choose one association for disclosure and must notify the others. Future disclosures will continue with the selected association unless formally changed and communicated to both the Department and the original association.

4. To ensure the integrity and accessibility of disclosed data, Clause 14.4 mandates that:

   • Associations must implement secure systems to store and protect member data.

   • Data must be retained for a minimum of five years, extendable if required for investigations or legal proceedings.

   • Associations must be prepared to share data with relevant authorities (Ethics Committee, Apex Committee, courts) upon request, without compromising its integrity.

5. To further streamline compliance, following provisions are removed:

   • Clause 9.5: Requirement to upload details on the UCPMP portal.

   • Clause 11.10: References to the UCPMP portal, eliminating duplication in reporting.

6. A new Annexure is introduced which ensures disclosure of marketing expenditure, uniformity and facilitates easier audits and reviews. Key fields include:

   • Company identification (CIN, PAN, address)

   • Financial year and domestic sales

   • Value and quantity of free evaluation samples

   • Details of educational events (direct and third-party)

   • Methodology for valuation

   • Digital signature of the executive head.

Key Amendments to UCPMP 2024:

The 2025 amendment to the UCPMP introduces a series of targeted reforms aimed at simplifying compliance, enhancing transparency, and reinforcing ethical standards in pharmaceutical marketing.

1. The newly inserted Clause 5.1(g), mandates that pharmaceutical companies to calculate and disclose the monetary value of free samples distributed to healthcare practitioners using a standardized valuation method. It states:

   • If the company manufactures the samples: The valuation will be done per unit (e.g., per tablet, capsule, vial, gram, or milliliter). The value will be based on the price charged to the stockist or immediate customer for the same dosage form and strength.

   • If the company purchases the samples from another supplier: The valuation will be based on the purchase price of the medicine for the same dosage form and strength.

   • Annual Averaging: The price of free samples will be recorded as the average price charged or paid over the financial year.

2. Earlier companies were required to upload monthly marketing expenditure reports to the Department of Pharmaceuticals (‘DoP’) portal. To reduce the administrative burden and duplication, modification to Clause 14.4, to states:

   • Companies will be required to submit a declaration within two months of the financial year’s end.

   • Submission Options:

     • To the industry association of which the company is a member.

     • If unaffiliated, disclosure will be made on the UCPMP portal.

   • Companies belonging to multiple associations can choose one for disclosure and notify others. Future disclosures must continue with the chosen association unless formally changed.

3. To ensure that disclosures are not only made but are also safeguarded and accessible for accountability and recognise the sensitivity of disclosed data, the amendment to Clause 14.5 mandates:

   • Associations will implement robust systems to protect member data.

   • Minimum of five years, expandable if required for investigations or legal proceedings.

   • Associations will share data with relevant authorities (Ethics Committee, Apex Committee, courts) when requested, without compromising data integrity.

4. To further streamline compliance, following provisions are removed:

   • Clause 9.5: Requirement to upload details on the UCPMP portal.

   • Clause 11.10: Reference to the DoP, eliminating duplication in reporting.

5. The Amendment introduces a new standardized Annexure that replaces the earlier forms. The new format ensures uniformity and facilitates easier audits and reviews, key fields including:

   • Company identification (CIN, PAN, address)

   • Financial year and domestic sales

   • Value and quantity of free samples

   • Details of educational events (direct and third-party)

   • Methodology for valuation

   • Digital signature of the executive head.