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

Central Government enforces uniform code to regulate marketing practices in medical device industry, curbing unethical behavior.

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.

Also read: Explained | What is the National Medical Devices Policy, 2023?

It added that companies or their representatives, or any person acting on their behalf, should not extend hospitality like hotel stay, expensive cuisine, resort accommodation etc., to healthcare professionals or their family members (both immediate and extended) unless the person is a speaker for a continued medical education programme etc. Additionally, no monetary grants should be given under any pretext. 

It prohibits organising workshops abroad for healthcare professionals and said that “all associations should constitute an ethics committee for marketing practices in medical devices (ECMPMD), upload it on their websites along with a detailed procedure of complaints, which will be linked to the UCPMP portal of Department of Pharmaceuticals.” 

The DoP has also sought disclosures form medical devices firms for particulars related to distribution of evaluation samples and expenses incurred on conferences , workshops, seminars etc. As part of the code, a medical device must not be promoted prior to receipt of product approval by the regulatory authority, the notification said. 

It also noted that the words “safe” or “safety” must not be used without qualification, and it must not be stated categorically that a medical device has no adverse consequences.