Introduction to Uniform Code for Marketing Practices in Medical Devices, 2024 (UCMPMD 2024)

On September 6, 2024, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers (DoP) unveiled the Uniform Code for Marketing Practices in Medical Devices, 2024 (UCMPMD 2024) with a view towards providing a set of guidelines that would mitigate unethical practices, and ensure transparency, integrity, and accountability in the marketing of medical devices across India. In this regard, UCMPMD 2024 is an addition to the Uniform Code for Pharmaceuticals Marketing Practice, 2024 (UCPMP 2024). While the foundation of UCMPMD 2024 and UCPMP 2024 have similarities, this new code for medical devices stands out with some subtle distinctions.

The CEO of the company is responsible for the adherence of the code. In such pursuit, he/she is obligated to submit the self-declaration form (Annexure to UCMPMD 2024) regarding the compliance of the code within two months after the end of every financial year (FY) to the association, or directly on the UCPMP portal of the DoP. The UCMPMD 2024 mandates the continuous disclosure of expenses related to Evaluation samples, CME/CPD/ training or any other events. These disclosures must be uploaded within two months after the end of each FY on the UCMPMD portal of FICCI. The disclosure format of these submissions is placed at the end of the code and on FICCI UCMPMD Website as well.

Applicability of Uniform Code for Marketing Practices in Medical Devices, 2024 (UCMPMD 2024)

UCMPMD 2024 is applicable to promotion and marketing activities undertaken by medical device companies. Implementation is overseen by Medical Devices associations that have industry players as members. The DoP plays a guiding role in enforcement of the code.

The code governs product promotion, the conduct of agents and medical representatives, and interactions with HCPs and their families. While multinational and some domestic organisations may already have strict ethical policies, it is crucial to realign these policies as needed and implement proper controls to ensure compliance with the UCMPMD.

Procedure of Handling Complaints under Uniform Code for Marketing Practices in Medical Devices, 2024 (UCMPMD 2024)

The complaints regarding the breach of UCMPMD 2024 will be investigated by the Ethics Committee for Marketing Practices in Medical Devices (ECMPMD) and decided basis a majority vote. The MD or CEO of the company against whom a complaint is made must respond to all aspects of the complaint that the ECMPMD has received. The Respondent company would have 30 (thirty) days to respond and the ECMPMD has 90 (ninety) days to render its decisions. Detailed requirements regarding handling of complaints are defined under Provision 11 (Handling of Complaints) of the UCMPMD 2024
Incase the complainant is not satisfied with the decision of the ECMPMD, he can appeal against the ECMPMD decisions to the Apex Committee for Marketing Practices in Medical Devices (ACMPMD), chaired by the Secretary, DoP, with other members including a Joint Secretary and a Finance Adviser. The ACMPMD holds authority to impose penalties or refer matters to relevant governmental bodies, per the “Penalties and Reference” provision. The time limit for appeal or review is 15 (fifteen) days, extendable by another 15 (fifteen) days. The ACMPMD is obliged to reach a decision within 6 (six) months, which is binding and final on all parties. Detailed requirements for entertaining and filing appeals are defined under Provision 13 (Appeal). The Appeal provision adds a nuanced layer absent in UCPMP 2024, where if a case is referred by DoP to an association and there is delay or inaction, the ACMPMD may proceed as per the provisions of the code.

You may click on the below tabs to access the code, Self declaration form and FICCI’s Policy for Handling of Complaints under UCMPMD 2024.