Drug and Device Makers Must Comply with Market Entry Pricing for Promotional Samples: Government Clarification, ETPharma

New Delhi: Under the mandatory marketing discourses, drug and medical device makers in India are required to follow market entry pricing for free samples distributed by them among healthcare professionals as part of promotional efforts.

In a clarification note over the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) rules, the Department of Pharmaceuticals specified that, “under the disclosure of marketing expenditure, the value of free evaluation samples distributed to healthcare professionals, should be valued on the same price charged to the stockist or immediate customer on per unit basis.”

“In case the company has purchased such samples from another supplier, such samples monetary value can also be valued with the annual average price paid to purchase the same dosage medicines/identical device variant,” it added.

The mandatory disclosure is required to be submitted within two months of the end of every financial year and the CEO will be held for adherence to this Code.

Additionally in its circular, the nodal body also outlined that, “companies can make their disclosures on the website of a Association of which the entity is a member and is no longer required to share the details on the UCPMP portal of the Department of Pharmaceuticals.”

However, in case the company is not a member of any such body, the disclosure shall be made on the UCPMP/ UCMPMD portal of the department.

Replacing the earlier voluntary guidelines in 2024, the Ministry of Chemicals and Fertilizers notified a detailed set of rules outlining the rules, and norms to be followed by the pharma and medical device industry for undertaking various marketing activities.

The latest rules prohibit any kind of gist to healthcare professionals and mandates companies to make annual disclosure of their marketing expenses.

Notably the latest guidelines places greater responsibility on industry associations and mandates them to collect and store the data disclosed by its members for a minimum period of five years without affecting the integrity and may be asked to share it incase of a direction by court or other authority,

Commenting on the development, Pavan Choudary, Chairman, MTaI stated, “while we are going through the fine print of the amendments made to the UCMPMD code, the revised framework provides greater clarity for the MedTech industry and also places weighted responsibility on industry associations to ensure compliance and safeguard members’ data.”

“We have already constituted an Ethics Committee and updated our web portal in line with UCMPMD requirements, and are now gearing up to shoulder the additional responsibilities,” he added.

• Published On Sep 3, 2025 at 07:25 PM IST

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