Home / Compliance Cues / Trade & Regulatory Compliance Updates / The Department of Pharmaceuticals Notifies Uniform Code for Marketing Practices in Medical Devices, 2024.
Introduction
On 6th September 2024, the Department of Pharmaceuticals (“DoP”) issued the Uniform Code for Marketing Practices in Medical Devices, 2024 (“Code”). This Code mandates all Medical Device Associations (“MDAs”) to disseminate its provisions to their respective members, ensuring strict adherence.
Furthermore, the DoP directed MDAs to establish Ethics Committees for Marketing Practices in Medical Devices. These committees are tasked with uploading the Code onto the association’s websites, along with detailed procedures for filing complaints. These complaint mechanisms will be linked to the DoP’s Uniform Code for Pharmaceutical Marketing Practices (“UCPMP”) Portal. The Code is self-regulatory in nature and will be implemented via industry associations.
Key Features
- Promotion of medical devices: A medical device can only be promoted after acquiring necessary approvals (wherever applicable) by the regulatory authority and such promotion should be consistent with the terms of documents submitted for obtaining product registration/ license. Product information must be up-to-date, accurate, balanced, and must not mislead either directly/impliedly, and must be capable of substantiation within a reasonable time when sought by Healthcare Professionals (“HCPs”).
- Claims and Comparisons: All marketing claims related to the usefulness of medical devices should be accurate and substantiated by evidence. There is a prohibition on the unqualified use of words like ‘safe’ or ‘safety’ or a claim of no adverse consequences. Comparison of the Medical Devices must be factual, fair, and capable of substantiation by way of available data and the brand names of products of other companies can only be used with prior consent. There’s also a prohibition on disparaging other companies, their products, services, or promotions and clinical or scientific opinions of HCPs.
- Textual and Audio-Visual Promotion: In case the medical device company provides promotional materials to HCPs who may prescribe the use of their medical devices, it also has to mandatorily supply information such as the generic name/brand name, warnings and precautions, etc. All paid publishing of promotional material in journals will have to comply with the Code, irrespective of editorial control of the material published. The Code strictly prohibits the use of names/photographs of HCPs. Wherever applicable, the Code requires the date of printing or of the last review of promotional material to be stated and any audio-visual material must be supported by all relevant printed material to comply with this Code.
- Obligations regarding personnel engaged by Medical Device companies: Any personnel (such as marketing/sales executives) employed by the medical device companies in connection with promoting the sale of medical devices are required to maintain a high standard of ethical conduct and must not pay, under any guise, for access to an HCP. The medical device companies will be responsible for any third parties working for or on their behalf.
- Regulation of brand reminders, evaluation samples, and demonstration products: Free samples of medical devices can be provided to HCPs for evaluation along with a user manual and are to be marked as ‘Evaluation Sample-Not For Sale’. Medical device companies have to maintain traceability information (such as HCP’s name, quantity and value of evaluation samples, etc.) of these samples for at least 5 years. The monetary value of such samples should not exceed 2% of the domestic sales of the company per year. Similarly, demonstration products (i.e. products to explain the functioning/features of the medical device to HCPs) should be taken back by the company after the demonstration period is over and traceability information (such as HCP’s name, date of supply to HCPs, etc.) should be maintained for a minimum period of 5 years. Further, any receipt of evaluation samples, demonstration products and, brand reminders (such as books, calendars, diaries, journals, etc. for professional use in healthcare settings which are below Rs 1000 per item) by the HCPs would not amount to an endorsement as long as the HCPs do not actively recommend or issue statements promoting the use of the brand.
- Conferences, seminars, and workshops: Any engagement by the medical device companies with HCPs for continuing medical education/professional development, training or otherwise for conferences, seminars or workshops can be done only through a well-defined, transparent and, verifiable set of procedures. The Code prohibits the conduct of such events in foreign locations except with the specific approval of the DoP. Further, all medical device companies are mandated to share details of such events including the expenses undertaken on their website which may be subject to independent, random or, risk-based audit for this purpose. Organisers of such events are also required to spell out the procedure followed in the selection of participants and speakers and display a statement of their funding sources and expenditures on their website, which may be subject to a special audit.
- Industry-Academia Collaboration: The code requires approval for any medical device industry-funded research/study from the authorities such as ICMR, Ethics Committee, etc. and at a recognised site/location, where applicable. Engagement of HCPs in a consultant-advisory capacity for bonafide research services is allowed subject to the same being conducted under an agreement stipulating the fee/honorarium. Such engagement shall ensure that patient interest is not compromised, and integrity of HCP is maintained in line with National Medical Commission regulations.
- Relationship with HCPs: It prohibits medical device companies from offering any gift, pecuniary benefit in kind, travel facilities inside or outside the country, hospitality like hotel stay, etc., cash or monetary grant for personal benefit of any HCPs or family members (both immediate and extended). However, medical device companies can provide hospitality and travel expenses for HCPs participating in DoP-approved conferences, seminars or workshops. For all other matters, the Indian Medical Council (Professional Conduct, Etiquettes and Ethics) Regulations, 2002 (as amended) will prevail.
- Constitution of an Ethics Committee: The Code 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. The composition of the Ethics Committee will have to be approved by the Board of the medical device association and the same should be prominently placed on its website along with the detailed procedures for lodging complaints.
- Grievance Redressal: All MDAs must upload the Code on their websites along with the detailed procedure for lodging complaints which will be linked to the UCMP Portal of the DoP. Disposed-off complaints should be shared by MDAs on their website with the details concerning the complaint (such as the company against whom the complaint was lodged, action taken on the complaint, etc.) for 5 years. Such details shall also be uploaded on the UCPMP portal.
- Lodging of Complaints: All complaints relating to the breach of the Code need to be made to the Ethics Committee within 6 months (extendable up to 12 months) of the alleged breach. If it appears from media reports that a company may have breached the code, the Ethics Committee can treat such reports as a complaint and the source/correspondent as the complainant. The DoP retains the right to deal with the complaint directly.
- Details of the Complaint: The Complaint should be in writing, identifying the complainant, the company allegedly in breach, and details of the activity amounting to the breach. Complaints cannot be filed pseudonymously or anonymously.
- Handling of Complaints: The respondent company has to respond within 30 days to the notice received from the Ethics committee. The Ethics committee must render a decision (via a majority vote) within 90 days from the date of receipt of the complaint. Members of the Ethics Committee will have to recuse themselves in case of a conflict of interest.
- Adjudication of Complaints: Where the Ethics Committee decides there is no breach, then the Complainant will be advised in writing of the same including about the appropriate forum to approach in such cases. In cases where the Ethics Committee decides that there is a breach, then it will advise the complainant and the respondent company in writing about the remedial steps that need to be taken.
- Appellate Proceedings: An appeal against the decision of the Ethics Committee can be instituted before the Apex Committee for Marketing Practices in Medical Devices (“Apex Committee”) within 15 days (extendable up to 30 days).
- Apex Committee: The Apex Committee consists of the Secretary, DoP (Chairman) with two members – a Joint Secretary and a Financial Adviser. The Apex Committee has to give a final decision within 6 months. The Apex Committee has the power to proceed by itself in case of an inordinate delay on the part of the Ethics Committee.
- Penalties and Reference: Once a breach of the Code has been established, the Ethics Committee/Apex Committee can propose to suspend/expel the concerned company from MDA, reprimand the company, require the company to issue a corrective statement in the media as approved by the Ethics Committee, ask the company to recover money or items given in violation of the Code. It may give recommendations to such agency or authority through DoP where action can only be taken through them.
- Responsibility of the CEO: The CEO of the company is required to give a self-declaration of compliance with the Code on the MDA’s website and the UCPMP portal within 2 months of the end of every financial year.
Our Take
By formulating and notifying the UCMP-MD, the DoP has recognised the need for regulating medical devices as a sui generis category that is distinct from pharmaceutical products.
From a consumer protection perspective, the Code is laudable since it inter alia mandates that medical devices can only be promoted after acquiring necessary approvals (wherever applicable) by the regulatory authority and imposes a duty on medical device companies to ensure that their marketing claims regarding the medical device are truthful and accurate. To promote consumer awareness, the Code requires MDAs to publish the Code, complaint details, and action taken on such complaints on their respective websites.
The Code seeks to promote transparency in the industry-HCP interactions by allowing MDAs to fund hospitality-related expenses for HCPs if they are going as a speaker for continued medical education, continued professional training, etc. Further, all MDAs are required to share details of such events including the expenses undertaken on their website which may be subject to an audit.
Institutionalization of the grievance redressal mechanism through the Ethics Committee and the Apex Committee is also noteworthy. However, the limited punitive powers of the Ethics Committee to enforce the Code is a drawback and would likely not discourage MDAs from violating the Code. It remains to be seen whether the Code is successful in inculcating a culture of compliance in the medical device industry.
Links
Uniform Code for Marketing Practices in Medical Devices, 2024: https://pharmaceuticals.gov.in/policy/uniform-code-marketing-practices-medical-devices-ucmpmd-2024