The Indian government has issued a clarification under the Uniform Code for Pharmaceutical Marketing Practices, mandating that drug and medical device manufacturers must value free promotional samples using the same price charged to the stockist or immediate customer. This pricing must be applied on a per-unit basis, ensuring that samples provided to healthcare professionals are assigned a monetary value equal to standard market entry price.

In cases where samples were sourced externally, companies are permitted to use the annual average purchase price of that identical product to determine its equivalent value. Manufacturers are required to disclose these valuations as part of their marketing expenditure, with the information submitted within two months of the end of each financial year. A company’s Chief Executive Officer will be held accountable for compliance with these rules.

Interestingly, these disclosures need not necessarily be made on the Department of Pharmaceuticals (DoP) portal. If the company belongs to a trade association, it may upload the information to the association’s own website. Entities not affiliated with any association must report directly through the DoP’s UCPMP or UCMPMD portal.

This clarification reinforces the government’s earlier move to make the once voluntary marketing code mandatory in 2024, which now demands greater transparency in promotional practices, including free sample distribution.