Written by : Aishwarya Sarthe
September 9, 2024
The new UCMPMD 2024 seeks to enforce greater transparency and limit undue influence on healthcare professionals.
The Indian government has implemented a uniform marketing code for the medical devices industry to address unethical practices in the sector.
The Department of Pharmaceuticals (DoP) issued the notification on Friday, which outlines strict measures to regulate how medical devices are marketed and promoted.
The new Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024 seeks to enforce greater transparency and limit undue influence on healthcare professionals.
The new code requires all medical device associations to establish an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD). Each association is expected to upload the details of its ethics committee and complaint procedures on its official website.
Furthermore, these details will be linked to the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) portal of the Department of Pharmaceuticals, allowing easy access and accountability.
This measure aims to establish a formal system for filing, reviewing, and addressing complaints about unethical marketing practices.
The DoP has also made it mandatory for medical device companies to upload the UCMPMD 2024 on their websites. Alongside this, they are required to provide a clear procedure for lodging complaints, which should include a link to the UCMPMD portal.
One of the key elements of the new code is the prohibition of gifts, hospitality services, and monetary grants to healthcare professionals by medical device companies.
According to the notification, companies are not allowed to offer any personal benefits to healthcare professionals or their families, either through cash payments or through the provision of travel, hotel stays, or expensive meals.
“Companies or their representatives or any person acting on their behalf should not extend travel facilities inside or outside the country to healthcare professionals or their family members for attending conferences, seminars, workshops, etc.,” the notification stated.
This restriction applies to both national and international events, ensuring that there is no undue influence on healthcare professionals through luxurious perks.
Additionally, medical device firms must refrain from providing gifts or benefits that might influence the decisions of healthcare professionals.
The notification makes it clear that no company or its agents should offer gifts that serve a personal purpose for healthcare professionals or their families.
To further ensure ethical practices, the code specifies that a medical device must not be promoted before receiving product approval from the relevant regulatory authorities. This clause prevents companies from marketing products that have not yet been tested or verified for safety.
The notification also emphasized that certain terms such as “safe” or “safety” must not be used without proper qualification.
It stated, “The word safe or safety must not be used without qualification, and it must not be stated categorically that a medical device has no adverse consequences.”
This ensures that medical devices are marketed with clear, accurate, and transparent claims, preventing the use of misleading language that could endanger patient safety.
In addition, the DoP has instructed medical device companies to disclose all details related to the distribution of evaluation samples and the expenses incurred for conferences, workshops, and seminars.
This is intended to create transparency and accountability in companies engaging with healthcare professionals.
The introduction of the UCMPMD 2024 follows similar regulatory measures in the pharmaceutical sector.
Earlier this year, the DoP notified UCPMP 2024, which also seeks to curb unethical practices in the marketing of pharmaceutical products.