In a significant development, the Department of Pharmaceuticals (‘DoP’), under the aegis of the Ministry of Chemicals and Fertilizers, published the Uniform Code for Marketing Practices in Medical Devices on September 6, 2024 (‘UCMPMD’). In March 2024, the DoP had published the Uniform Code of Pharmaceutical Marketing Practices (‘UCPMP’) which was primarily applicable to members of pharmaceutical associations, however, was made applicable on medical device companies as well. Going forward, the UCMPMD will be applicable to medical device companies.

The DoP mandates medical device associations to circulate the UCMPMD to all its members for strict compliance. The DoP further mandates the medical device associations to constitute an ethics committee for marketing in medical devices (‘Ethics Committee’) and upload the UCMPMD on their website along with detailed procedures for lodging complaints. The key provisions and compliance requirements under the UCMPMD have been highlighted below:

1. Disclosures by Medical Device Companies: The DoP mandates medical device companies to submit certain disclosures relating to distribution of evaluation samples, expenses incurred in continuing medical education (‘CME’), continuing professional development (‘CPD’), conferences, workshops, trainings, seminars, etc., on the portal set up by the DoP (‘Portal’). Such disclosures need to be made on an ongoing basis and mandatorily within two months of the end of every financial year;
2. Medical Device Promotion: The UCMPMD mandates that a medical device should be promoted only after receipt of product approval, as well as the sale and distribution authorizations as per the Medical Devices Rules, 2017. Such promotion should also be consistent with the terms of documents submitted by the companies along with product information, which should be up-to-date and accurate. Such product information should not be misleading, capable of substantiation and reflecting the current knowledge or responsible opinion of persons. Any claims on usefulness of the medical device must be based on evaluation of published evidence, while any comparisons made should be factual, fair and capable of substantiation. The UCMPMD also prohibits the use of the names and photographs of healthcare professionals (‘HCPs’) in promotional material, be it textual or audio-visual;
3. Brand Reminders, Evaluation Samples and Demonstration Products: The DoP stipulates, inter alia, the following conditions for distribution of such items:

• brand reminders, such as books, calendars, diaries, journals and dummy device models, intended for professional use are permitted provided the value does not exceed INR 1000 (approx. US$ 12) per item;
• evaluation samples, provided for the purpose of acquiring hands-on experience using the medical device must be handed over to HCPs only, or a person authorized to receive the same. The medical device company is required to keep proper records of the samples as well as supply of the same. The monetary value of samples distributed should not exceed two percent of annual domestic sale of the medical device company. Further, each evaluation sample should be marked “Evaluation Sample – Not for Sale”; and
• demonstration products should be taken back by the medical device company and relevant product identification and traceability of information must be maintained for a period of five years.

4. CPD, CME, Other Trainings: Conduct of CPD, CME and other trainings is prohibited in foreign locations, unless it is for advanced clinical training sessions in exceptional circumstances. Any training which is to be conducted outside India requires detailed justifications along with the relevant particulars as identified under the UCMPMD. Further, medical devices companies are required inter alia: (a) to upload details of events conducted by them (including expenditures incurred) on the website, which may be subject to independent, random or risk-based audits; (b) to provide the procedure for selection of participants and speakers and display a statement on funding sources on the website; and (c) to comply with relevant provisions of the Income Tax Act, 1961 etc.;
5. Relationship with HCPs: The UCMPMD prohibits the offering of gifts, pecuniary advantages, monetary grants or benefits of any kind to the HCPs or their family members either by the medical device companies or their agents. The UCMPMD also prohibits medical device companies from extending travel facilities and hospitality (within or outside India) to HCPs (or their family members) unless the person is acting as a speaker for CME/CPD program or a participant in a training program where specific approval for such a program has been obtained from the DoP;

6. Non-compliance with UCMPMD: Non-compliance with the UCMPMD may result in complaints being lodged against the concerned medical devices company with the Ethics Committee of the concerned medical devices association that such company is a member of. If breach of UCMPMD is established, the Ethics Committee may: (a) suspend or expel the company from the association; (b) reprimand the company and publish details of the reprimand; (c) require the entity to issue a corrective statement; (d) ask the entity to recover money or items given in violation of the UCMPMD and submit details of actions taken to the Ethics Committee; or (e) send recommendations to governmental agencies or authorities in case disciplinary, penal, or remedial actions lie within the domain of such authorities; and

7. Adherence to Code: The UCMPMD requires the Chief Executive Officer of the medical device company to be responsible for such company’s compliance with the UCMPMD and is required to file a self-declaration within two months of the end of every financial year directly on the Portal or to the concerned medical devices association which the company is a member of.

The release of the UCMPMD is a step in the right direction as it demonstrates the intent of the Central Government to curb unethical practices and build trust and transparency between medical device companies, HCPs and patients. Interestingly, similar to the approach followed for UCPMP, the Central Government has opted to enforce the UCMPMD through the relevant medical device association instead of enforcing it directly.