New code for medical devices mandates complaint decisions within 90 days

This report has been updated

Ethics Committees to be formed by medical devices associations under the new Uniform Code for Marketing Practices in Medical Devices (UCMPMD), 2024 would have to decide on any complaints regarding breach of code within 90 days of its receipt by the committee.   

This comes as the central government on Friday notified the UCMPMD 2024 in a move to regulate unethical marketing practices in the medical devices industry. The code bars medical representatives and medical device companies from using any inducements or subterfuge to access healthcare professionals.    

In a notification dated September 6, 2024, the Department of Pharmaceuticals (DoP) asked medical device associations to constitute a three to five-member Ethics Committee for Marketing Practices in Medical Devices (ECMPMD), chaired by its chief executive officer (CEO) and set up a dedicated portal on their websites.

The ethics committee formed by each association will be used by member companies to lodge complaints against any violation of the UCMPMD. 

The code also has norms for claims and comparisons and the nature of the relationship between healthcare professionals and medical representatives for companies. This includes prohibition on offering gifts, monetary grants and hospitality such as foreign trips by medical device companies to healthcare personnel and their family members.  

“The code is aimed at eliminating any conflicts of interest, ensuring that all decisions taken related to medical devices are based on merits, rather than inducements,” an industry expert said.    

The code also entails complete disclosure of particulars related to distribution of evaluation samples (provided to give hands-on experience on the device) and expenses incurred on continuing medical education (CME) and training in conferences, workshops and seminars.  

“The particulars are to be filled on an ongoing basis and mandatorily within two months of the end of every financial year on the UCPMP portal of the department within the time limit fixed for submitting self- declaration by the executive head of the company,” the DoP notification stated.

According to the new UCMPMD, any breach of this code made by an entity can lead to suspension or expulsion of that entity from the medical device association. Penalties for breaches also include public reprimands to the concerned entity and asking it to recover money or items given in violation of the code from the concerned persons.    

“These norms aim to impose stringent guidelines on promotional activities, ensuring transparency, protecting healthcare personnel from subterfuge and saving patients,” an industry expert said.

Calling the implementation of UCMDMP a step in the right direction, Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) said the by curbing unethical practices and widening the circle of probity, the code should strengthen the culture of compliance in India, which is heartening for all ethical and compliant companies.

A separate marketing code for medical devices was an industry demand, as medical device companies would earlier have to comply with the marketing practices code for pharmaceuticals.
 

“This action corroborates the fact that the government understands that medical devices (electro-mechanical entities) need to be regulated by code quite distinct from the one used to regulate pharmaceuticals (chemical entities)”, Choudary added.