Govt Introduces New Guidelines To Ensure Transparency In Medical Device Marketing

The Central Government has introduced a new uniform code for marketing practices to combat unethical practices within the medical device industry. Issued by the Department of Pharmaceuticals (DoP), the guidelines aim to eliminate misleading advertisements, restrict excessive hospitality and monetary inducements to healthcare professionals and enforce rigorous compliance with complaint redressal mechanisms.

The DoP mandates that medical devices cannot be promoted before receiving the necessary regulatory approval under the Medical Devices Rules, 2017. Promotion is only permitted after authorisation from the relevant regulatory authority.
The new code also prohibits companies and their representatives from offering lavish hospitality, such as luxury hotel stays, expensive meals or resort accommodations unless the individual is participating as a speaker in a continuing medical education program. Additionally, it bans any form of monetary grants.

Workshops for healthcare professionals must be conducted locally as the code forbids hosting such events abroad. Each medical device association is required to form an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD).
Another critical aspect of the code is the requirement for companies to disclose information regarding the distribution of evaluation samples and detailed expenses related to hosting conferences, workshops, and seminars.

The DoP also emphasises that medical devices should not be marketed using unqualified terms like 'safe' or 'safety' and cautions against making definitive claims about a device having no adverse effects.
The new notification serves as a detailed guide for ethical marketing practices, requiring companies to display the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024 on their websites along with complaint procedures and a link to the official UCMPMD portal of the Department of Pharmaceuticals.

The development follows the earlier introduction of the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024, underscoring the government's commitment to upholding ethical standards across the healthcare sector.