How Will the Amendment of the Marketing Code for Medical Devices Enhance Transparency in the MedTech Sector?

New Delhi, Sep 3 (NationPress) The Department of Pharmaceuticals (DoP) has recently revised certain aspects of the marketing code for medical devices, aiming to enhance transparency within the MedTech sector, as stated by the Association of Indian Medical Device Industry (AiMeD) on Wednesday.

The changes to the Uniform Code for Marketing Practices in Medical Devices (UCMPMD), 2024, will allow medical device manufacturers to provide complimentary evaluation samples to physicians.

This initiative is designed to give healthcare professionals practical experience with the products.

However, the Code limits the free evaluation samples to 2% of domestic sales, with valuation based on stockist price for in-house manufactured products or purchase price for externally sourced items.

According to the amendment, companies are required to disclose expenditures on samples, Continuing Medical Education (CME) programs, event sponsorships, and pre-approvals for specialist doctors' international travel, accommodation, and hospitality in a newly defined annexure format.

Importantly, the updated framework prohibits gifts, cash donations, and personal travel or hospitality perks to healthcare professionals and their families. Industry associations must retain disclosure records for five years, with stricter penalties for non-compliance.

In welcoming this amendment, AiMeD expressed that this development would introduce essential transparency, equity, and responsibility to India’s burgeoning MedTech sector.

“At AiMeD, we applaud the Universal Code of Ethical Marketing of Medical Devices and the streamlined annual reporting format. This Code promotes ethical and transparent marketing, encouraging fair competition and enhancing the reputation of both domestic and international manufacturers. Patients stand to gain through safer devices, reliable information, and protection from exploitative promotions,” stated Rajiv Nath, Forum Coordinator of AiMeD.

With the amendment, the chief executives or managing directors of medical device companies are now mandated to submit annual declarations of marketing expenses within two months following the end of the financial year. For FY25, the deadline has been extended to September 30.

“Associations must implement systems to ensure that data disclosed by their members is securely stored and adequately protected. Such data shall be kept for a minimum of five years, or longer if necessary for inquiries or proceedings before the Ethics Committee for Marketing Practices in Medical Devices, the Apex Committee for Marketing Practices in Medical Devices, or any court or authority that may direct otherwise,” the DoP remarked.

“Associations must also establish a system to share this data or information, ensuring its integrity is maintained, as required by such committees, courts, or authorities for inquiry or decision-making purposes,” it added.