New Marketing Code Enhances Transparency in India’s MedTech Sector

The Department of Pharmaceuticals (DoP) has recently amended several clauses of the marketing code for medical devices, a move aimed at enhancing transparency within the MedTech sector in India. This update to the Uniform Code for Marketing Practices in Medical Devices (UCMPMD), 2024, will allow manufacturers to provide free evaluation samples to healthcare professionals, facilitating hands-on experience with their products.

The amendment specifies that the provision of free evaluation samples is capped at 2 percent of domestic sales. The valuation of these samples must be recorded at the stockist price if manufactured in-house or at the purchase price if sourced externally. This structured approach aims to create a more transparent environment for medical device marketing.

In addition to the sample provisions, the revised code mandates that companies disclose their spending on samples, continuing medical education (CME) programs, event sponsorships, and pre-approvals for international travel, lodging, and hospitality for specialist doctors. This information will be documented in a newly prescribed annexure format, which further enhances accountability.

Under the new regulations, companies are prohibited from offering gifts, cash grants, or personal travel and hospitality benefits to healthcare professionals and their families. Industry associations are required to retain disclosure data for a minimum of five years, with stricter penalties imposed for any violations of the code.

The Association of Indian Medical Device Industry (AiMeD) has welcomed these amendments, emphasizing their potential to improve transparency and fairness within the sector. Rajiv Nath, Forum Coordinator of AiMeD, expressed that the Universal Code of Ethical Marketing of Medical Devices fosters ethical marketing practices, ensuring fair competition. He stated, “Patients benefit through safer devices, trustworthy information, and freedom from exploitative promotions.”

As part of the new requirements, chief executives or managing directors of medical device companies must file annual declarations of their marketing expenditures within two months of the financial year’s close. For the financial year 2025 (FY25), this deadline has been extended to September 30, 2025.

The DoP has emphasized the importance of secure data management by industry associations. These associations must implement systems to ensure that disclosed data is stored securely and adequately protected. This data will be retained for a minimum of five years or longer if needed for inquiries or complaints before relevant committees or authorities.

In conclusion, the amendments to the marketing code represent a significant step towards a more ethically responsible MedTech environment in India. By prioritizing transparency and accountability, the DoP aims to enhance the industry’s reputation and ultimately benefit patients through improved medical device safety and reliability.