On 6 September 2024, the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers (“DoP”) introduced the Uniform Code for Marketing Practices in Medical Devices, 2024 (“UCMPMD”). This code aims to establish a set of guidelines to reduce unethical practices and promote transparency, integrity, and accountability in the marketing of medical devices throughout India. The UCMPMD is self-regulatory in nature and will be implemented via industry associations. The UCMPMD complements the existing Uniform Code for Pharmaceuticals Marketing Practice, 2024.
The DoP requires medical device associations to distribute the UCMPMD to all their members for strict adherence. Additionally, UCMPMD requires all medical device associations to constitute an Ethics Committee for Marketing Practices in Medical Devices (“Ethics
Committee”), chaired by its CEO and 3-5 members for handling complaints and to publish the UCMPMD on their websites, along with detailed procedures for filing complaints. The key provisions and compliance requirements outlined in the UCMPMD are summarised below:
- Promotion of medical devices can only take place once the necessary approvals have been obtained from the relevant regulatory authority, where applicable. Such promotion must align with the terms outlined in the documents submitted for product registration or licensing. The product information shared should be current, accurate, and balanced, ensuring it does not mislead, either directly or indirectly. Additionally, this information must be substantiated within a reasonable time-frame if requested by Healthcare Professionals (“HCPs”).
- Medical device companies are required by the DoP to provide specific disclosures regarding the distribution of evaluation samples, as well as the costs associated with continuing medical education (CME), continuing professional development (CPD), conferences, workshops, training sessions, seminars, and similar activities. These disclosures must be submitted regularly through the portal established by the DoP and are required to be completed within two months following the conclusion of each financial year.
- Medical device companies are allowed to provide free samples to HCPs for evaluation, accompanied by a user manual, and must label them as “evaluation sample-not for sale”. These companies must maintain traceability records, including the HCP’s name, sample quantity, and value, for at least five years. The total monetary value of these samples should not exceed 2% of the company’s annual domestic sales. Similarly, demonstration products, which are used to showcase the features of the medical device to HCPs, must be retrieved by the company after the demonstration period, with traceability information kept for a minimum of five years.
- Failure to comply with the UCMPMD may lead to complaints being filed against the medical device company with the Ethics Committee of the relevant association to which the company belongs. Appeals against the decision of the Ethics Committee can be filed with the Apex Committee for Marketing Practices in Medical Devices (“Apex Committee”) within 15 days, with a possible extension of up to 30 days. If a violation of the UCMPMD is confirmed, the Ethics Committee/Apex Committee may take several actions, including: (a) suspending or expelling the company from the association; (b) issuing a reprimand and publicly disclosing the details; (c) requiring the company to issue a corrective statement; (d) demanding the recovery of money or items provided in violation of the UCMPMD, along with details of the corrective actions taken; or (e) forwarding recommendations to government agencies or authorities if disciplinary, penal, or remedial actions fall under their jurisdiction.
- Under the UCMPMD, the Chief Executive Officer (CEO) of a medical device company is held accountable for ensuring the company’s compliance with the code. The CEO must submit a self-declaration of compliance within two months after the end of each financial year, either directly on the portal or to the relevant medical device association to which the company belongs.