Govt issues uniform code for marketing practices for the medical device industry

New Delhi: The Central Government has notified a uniform code for marketing practices for the medical device industry aimed at curbing unethical practices, which includes misleading advertisement of the product, extending extensive hospitality, monetary benefits to medical staff, and not following prescribed complaint redressal mechanisms.

In a notification, Department of Pharmaceuticals (DoP) has asked the medical devices associations to ensure that medical devices are not promoted prior to receipt of the product approval (wherever applicable) by the Regulatory Authority, authorizing its sale or distribution as per the provisions of the Medical Device Rules, 2017.

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.

The code bars medical representatives and medical device companies from using any inducements or subterfuge to access healthcare professionals. 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.

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.

MTaI welcomes the move

Welcoming the move, Pavan Choudary, Chairman, Medical Technology Association of India (MTaI) said, “We compliment the government for bringing a separate code for Medical Devices. This code aims to ensure that quality products reach patients through irreproachably trained healthcare professionals. It will curb unethical practices and widen the circle of probity thereby strengthening the culture of compliance in India.”

“The move supports 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). Though we are still studying the fine print of the code just released we do hope it would fare well on all these expectations and will not encumber the companies which will most meticulously follow it,” added Choudary.