New Regulation Requires Medical Device Complaint Resolutions in 90 Days

In a landmark decision aiming to overhaul the marketing practices within the medical devices industry, the Indian government has introduced a comprehensive set of rules known as the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024. This move is tailored to curb unethical marketing tactics that have marred the industry for years, ensuring a transparent and honest interaction between medical device companies, healthcare professionals, and ultimately, the beneficiaries—patients.

The newly notified UCMPMD mandates the formation of Ethics Committees by medical devices associations. These committees, consisting of three to five members including the chief executive officer (CEO) as the chairperson, are tasked with the responsibility of adjudicating complaints concerning violations of the code. Significantly, the committees are expected to deliver their verdicts within 90 days of receiving a complaint, highlighting the emphasis on efficiency and swift justice.

The directives, explicitly detailed in the notification dated September 6, 2024, by the Department of Pharmaceuticals (DoP), stem from a need to protect healthcare personnel from undue influence. Consequently, the code strictly prohibits medical representatives and medical device companies from employing any form of inducement or deceit to sway healthcare professionals. This includes a ban on offering gifts, monetary rewards, and lavish hospitality, like foreign trips to both healthcare personnel and their relatives.

The essence of the UCMPMD lies in its commitment to eradicating conflicts of interest, ensuring that choices concerning medical devices are made purely on merit, and not swayed by any underhand inducements. This principled stand is expected to foster an environment where the best interests of patients are always the top priority.

Adding to its holistic approach, the UCMPMD also mandates a full disclosure of information regarding the distribution of evaluation samples—devices provided to healthcare professionals to gain hands-on experience. Moreover, details of expenses incurred on continuing medical education (CME), along with participation in conferences, workshops, and seminars, must be disclosed. This disclosure process is not a one-off but requires ongoing updates, culminating in a mandatory submission within two months of the financial year’s close on the UCPMP portal, as detailed within the DoP notification.

The repercussions for breaching the UCMPMD are severe, underscoring the code’s commitment to integrity. Entities found in violation may face suspension or expulsion from their medical device association, alongside public reprimands. Additionally, there’s the mandate for violators to recover and return any money or gifts given in breach of the code, ensuring accountability.

Industry experts have heralded the new norms as a significant step toward imposing stringent guidelines on promotional activities within the medical devices sector. The rules aim to ensure transparency, shield healthcare personnel from deceptive practices, and, most importantly, safeguard patients from being unduly influenced by unethical marketing practices.