Amendment of marketing code for medical devices to boost transparency in MedTech sector — AiMeD

NEW DELHI — The Department of Pharmaceuticals’ (DoP) recent amendment to certain clauses of the marketing code for medical devices is set to boost transparency in MedTech sector, said the Association of Indian Medical Device Industry (AiMeD) on Wednesday.

The amendment to the Uniform Code for Marketing Practices in Medical Devices (UCMPMD), 2024, will enable manufacturers of medical devices to provide free evaluation samples to doctors.

This will help the healthcare professionals acquire hands-on experience in using the product.

However, the Code capped the free evaluation samples at 2 per cent of domestic sales, with valuation to be recorded at stockist price if manufactured in-house, or at purchase price if sourced externally.

As per the amendment, companies must disclose spending on samples, CME programmes, event sponsorships, and pre-approvals needed for specialist doctors' international travels, lodging, and hospitality in a newly prescribed annexure format.

Notably, the revised framework also prohibits gifts, cash grants, and personal travel or hospitality benefits to healthcare professionals and their families. Industry associations will be required to retain disclosure data for five years, with stricter penalties for violations.

Welcoming the amendment, AiMeD said that the move would bring much-needed transparency, fairness, and accountability to India’s growing MedTech sector.

“At AiMeD, we welcome the Universal Code of Ethical Marketing of Medical Devices and the simplified annual reporting format. The Code ensures ethical and transparent marketing, fostering fair competition and stronger reputations for both domestic and overseas manufacturers. Patients benefit through safer devices, trustworthy information, and freedom from exploitative promotions,” said Rajiv Nath, Forum Coordinator, AiMeD.

With the amendment, the chief executives or managing directors of medical device companies will now have to file annual declarations of marketing expenditure within two months of the financial year’s close. For FY25, the deadline has been extended till September 30.

"The Associations shall have a system in place to ensure that data disclosed by its members is stored securely and is adequately protected. Such data shall be retained for a minimum period of five years, or for such longer period as may be necessary for the purpose of facilitating inquiry into or decision on any complaint made or proceeding instituted before the Ethics Committee for Marketing Practices in Medical Devices, the Apex Committee for Marketing Practices in Medical Devices or any court or other authority or as such committee, court or authority may direct for such purpose," the DoP said.

"The Associations shall also have a system in place to share such data or information, without affecting the integrity of the same in any manner, on being required to do so by such committee, court or authority for the purpose of such inquiry or decision," it added.