Government enforces uniform code for ethical marketing of medical devices
DoP curbs unethical practices with new guidelines for medical device promotions, mandating transparency and strict adherence to regulatory approval.
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In a significant move aimed at curbing unethical practices in the medical device industry, the Central Government has introduced a uniform code for marketing practices. The new guidelines, issued by the Department of Pharmaceuticals (DoP), are designed to prevent misleading advertisements, curb extensive hospitality and monetary inducements to healthcare professionals, and enforce stringent compliance with complaint redressal mechanisms.
The DoP has instructed medical device associations to ensure that no medical devices are promoted prior to receiving the necessary regulatory approval under the Medical Devices Rules, 2017. It underscores that product promotion should only take place after authorization from the relevant regulatory authority.
In addition to advertising restrictions, the code prohibits companies and their representatives from offering extravagant hospitality to healthcare professionals, such as hotel stays, expensive meals, or resort accommodations, unless the individual is serving as a speaker for a continued medical education programme. The guidelines also ban the provision of monetary grants under any guise.
The DoP further stressed that workshops for healthcare professionals must not be held abroad, reinforcing the need for local and transparent practices. Each medical device association is now required to establish an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD).
A key element of the new code is a requirement for medical device companies to disclose information about the distribution of evaluation samples, as well as detailed expenses incurred in hosting conferences, workshops, and seminars.
The DoP also reiterated that medical devices must not be marketed with the unqualified use of terms such as "safe" or "safety" and cautioned against making categorical claims that a device has no adverse consequences.
The notification serves as a comprehensive guide for the industry to follow ethical marketing practices. It requires companies to prominently 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 notification of the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024, further demonstrating the government's commitment to promoting ethical standards across the healthcare sector.
