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September 8, 2025

Streamlining Medical Device Marketing Compliances: Summary of the DoP’s September 2025 UCMPMD Circular

The Department of Pharmaceuticals (Medical Device Division) has standardized the valuation method of free evaluation samples distributed to healthcare practitioners.

Additional disclosure requirement of location of conduct of Education Programs introduced.

Companies to now submit marketing expenditure disclosures to their respective industry associations.

Industry associations required to implement robust data retention policies.

 

I.              Introduction

The Department of Pharmaceuticals (“DoP”) – Medical Device Division, through a circular dated September 1, 2025 (“UCMPMD Circular”)1, has introduced revised and simplified disclosure requirements in addition to providing clarification on the manner of submission of disclosures by medical device companies and has introduced compliances for the industry associations under the Uniform Code for Marketing Practices in Medical Devices, 2024 (“UCMPMD”).

These revisions come in response to representations made by industry stakeholders, which raised concerns over the administrative and operational challenges faced by medical device companies in complying with certain aspects of the UCMPMD – particularly the requirements relating to the reporting of marketing expenditure and the valuation of free evaluation samples provided to healthcare professionals (“HCPs”).

The UCMPMD Circular aims to ease the compliance burden while maintaining transparency and accountability in medical device marketing practices.

II.             Key Takeaways

We have provided our brief analysis of some of the key takeaways in this update.

Free Evaluation Samples

The UCMPMD Circular provides specific guidance on the method for valuing free evaluation samples distributed to HCPs. To standardise the method of calculating the value of free evaluation samples, the UCMPMD Circular has provided the following key clarifications:

  • Where the company is the manufacturer of the evaluation samples, the value should be determined on a per-unit basis (such as per device, vial, millilitre etc) of the price charged to the stockist or immediate customer for the same make, brand, product variant and value of the medical device.
  • Where the company has procured the evaluation samples from another supplier, the purchase price of such samples should be used to determine their monetary value under the UCMPMD.

In both cases, the price of free evaluation samples should be recorded as either the average price charged to the stockist or immediate customer, or the average purchase price paid for the purchase of the medical device, for the same make, brand, product variant and value, on an annual basis.

By aligning the valuation method to either the selling price (in the case of in-house manufacturing) or the purchase price (in the case of procurement), and by introducing an annual average basis for recording these values, the UCMPMD Circular removes ambiguity and minimises variation in interpretation across the medical device industry.

Marketing Expenditure Disclosures

Under the previous draft of UCMPMD, medical device companies were required to submit detailed disclosures of their monthly marketing expenditure directly to the DoP. However, the DoP through the amended UCMPMD now requires companies to submit these disclosures to the association of which the company is a member.

The DoP has further clarified that where the company is a member of multiple associations, it may submit the disclosure form to any one association with due intimation to the other industry associations about such submission. The company is required to continue submitting the marketing expenditure disclosures to the same association in subsequent years, unless it ceases to be a member of that association and decides to start disclosing to another association, it would be required to formally notify both the DoP and the concerned associations of such change. For companies not affiliated with any association, disclosure must be made directly on the DoP’s UCMPMD portal.

The revised Annexure, which replaces the earlier Annexures to the UCMPMD, continues to retain the requirement for disclosure of expenses incurred for distribution of free evaluation samples, undertaking continuous medical education or continuing professional development programs (“Education Programs”) on an annual basis. Companies are also required to disclose the methodology adopted for calculating the expenditure incurred for such activities in addition to the disclosure on the locations where the events were organised and the number of times such events were organised at each location. This comes as a fresh disclosure requirement indicating the intent of the DoP to monitor the restriction placed on companies in hosting events in foreign locations without prior approval of the DoP.

Publication of Complaint Details

Previously, the UCMPMD required that details of complaints received by medical device association, details of company, action taken against the company and the decision of the Ethics Committee for Marketing Practices in Medical Devices (“ECMPMD”) to be uploaded both on the association’s website and the UCMPMD portal maintained by the DoP.

As a relief to the industry, the recent UCMPMD Circular removes the requirement to publish these details on the UCMPMD portal of the DoP. While associations may continue to maintain internal records, public disclosure via the DoP's platform is no longer necessary.

Data Security and Retention by Industry Associations

The UCMPMD Circular introduces an additional requirement for industry associations to implement systems that securely store and protect data submitted by their member companies. This data must be retained for a minimum period of five (5) years, or longer if necessary to support investigations or decisions related to complaints or proceedings before the ECMPMD, the Apex Committee, judicial courts, or other relevant authorities. Associations are also required to share this data upon request from these bodies.

While this measure ensures continuity in enforcement by maintaining access to relevant records over time, industry associations will need to implement robust data protection and access control measures to mitigate the risk of unauthorised disclosure or misuse of the data.

III.            Conclusion

In conclusion, the UCMPMD Circular strikes a balanced approach by streamlining compliance requirements and provides much needed clarity on the manner of valuation of free evaluation samples distributed by medical device companies. Decentralisation of compliance functions to industry associations, along with the shift from monthly to annual reporting, is likely to significantly reduce the administrative and compliance burden on medical device companies, while still preserving regulatory oversight and aligning with the broader intent of the UCMPMD. While further clarity on the disclosure of company revenue for group companies comprising of various divisions remains to be provided by the DoP. However, by easing the administrative burden, these changes will promote more effective adherence to the UCMPMD by medical device companies.

 

1Accessible at: https://pharma-dept.gov.in/sites/default/files/ucmpmd%20circular%20with%20amended%20code_1.pdf (last accessed September 3, 2025)