India enforces new Uniform Code for Marketing Practices in Medical Devices

In a move to regulate the marketing practices in the medical devices industry, the Government on Friday, September 6, notified the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024. The Department of Pharmaceuticals has mandated the adoption of the UCMPMD 2024, urging all medical devices associations to circulate and implement the code among their members.

This new code is set to overhaul industry practices by imposing stringent guidelines on promotional activities, ensuring transparency, and protecting healthcare professionals and patients.

The new regulations require the establishment of an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD) and the disclosure of detailed information regarding evaluation samples and expenses related to Continuing Medical Education (CME) and other professional activities.

Key Highlights of the UCMPMD 2024

1. Prohibition of Gifts, Hospitality, and Monetary Grants:

• The UCMPMD 2024 strictly prohibits the offering of gifts, hospitality, and monetary grants by medical device companies to healthcare professionals or their family members. This includes travel facilities, hotel stays, and expensive meals. These measures are aimed at eliminating potential conflicts of interest and ensuring that decisions related to medical devices are made based on merit rather than inducements.

2. Prescribed Marketing Claims and Counter Claims:

• The code mandates that all marketing claims related to medical devices must be accurate and substantiated by evidence. Companies are prohibited from making misleading statements about the efficacy or safety of their products. Additionally, any comparative claims between products must be fair and based on objective data.

3. Permitted Training, Research, and Continuing Medical Education (CME):

• While the code prohibits personal benefits to healthcare professionals, it allows for the conduct of training, research, and CME under stringent conditions. CME events must be conducted by accredited institutions, and any foreign training programs require prior approval from the Department of Pharmaceuticals. Research engagements must adhere to ethical guidelines and obtain necessary approvals from competent authorities.

4. Compliance and Oversight:

• Compliance with the UCMPMD 2024 is to be overseen by medical device associations, which will be responsible for enforcing the code within their jurisdictions. Each association will establish an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD) to handle complaints and ensure adherence to the code.
• An Apex Committee for Marketing Practices in Medical Devices (ACMPMD), chaired by the Secretary of the Department of Pharmaceuticals, will provide additional oversight. This committee will review appeals and address cases of non-compliance, ensuring that the code is implemented effectively across the industry.

5. Penalties and Enforcement:

• The code outlines several penalties for non-compliance, including suspension or expulsion from associations, corrective statements, and recommendations for actions to government authorities. A structured appeals process is also in place, allowing dissatisfied parties to seek redressal through the ACMPMD.