After the Uniform Code for Pharmaceutical Marketing Practices, 2024[1], the Department of Pharmaceuticals introduced a Code for marketing practices governing medical devices for the first time in India. The core of the Code for Medical Devices seems to be aligned with that of Pharmaceuticals, which was introduced in March 2024, but tailored for the medical device industry, including provisions for evaluation samples, demo products, and device-specific promotional practices. The Code targets medical devices, including diagnostic equipment and surgical tools, which require specific regulatory considerations and aims at addressing concerns about unethical marketing practices that can influence healthcare professionals’ decisions, potentially impacting patient care.
In this article, we have focussed our attention on key compliance requirements for medical device manufacturers, importers, exporters and dealers.
Prohibition on gifts and benefits
The Code has placed a blanket prohibition on medical device companies from offering gifts, cash, or monetary benefits to healthcare professionals (HCPs) or their families, including extended family members. Companies can also not sponsor entertainment, recreation, or similar events for HCPs unless expenses are clearly documented, filled in on an ongoing basis and mandatorily declared along with a self-declaration by the Executive Head of the Company on the UCPMP portal as well as the Company website by 31st May every year. Specific responsibility for adherence to this Code has been placed on the Chief Executive Officer of the company.
Promotional material
All promotional activities for medical devices must begin only after securing necessary product approvals from the relevant competent authority[2]. Companies are required to establish rigorous systems to verify product status before marketing efforts commence. This includes aligning promotional materials with documentation submitted for product registration, specifically Instructions for Use (IFU) and Directions for Use (DFU)[3].
Promotional materials must correspond with the registration documents submitted for the product, guaranteeing that the information is factual, fair, and substantiated, avoiding misleading distortions or omissions[4]. Claims about the efficacy of medical devices should be backed by based on thorough evaluations of the most recent evidence available[5]. If marketing materials inaccurately suggest that a device treats conditions outside the approved documentation, the company risks regulatory violations and potential harm to patient care.
To mitigate these risks, companies must establish rigorous review processes to ensure that all promotional content is up-to-date and accurately reflects current medical knowledge and responsible opinions[6].
Companies must exercise caution in their choice of terminology, particularly regarding claims about safety. The use of absolute terms, such as “safe,” without appropriate qualifications can lead to misleading interpretations[7]. Instead, marketing language including the date of printing or review in promotional materials, should accurately reflect the product’s risk-benefit profile, acknowledging any potential adverse effects[8].
All promotional materials must clearly indicate their nature, allowing recipients to distinguish between promotional content and editorial matter[9].
Comparative Advertising
Companies engaging in comparative advertising must obtain consent[10] from the brands being referenced, ensuring that comparisons are factual, fair, and relevant[11]. Misleading practices, such as distorting facts or placing undue emphasis on certain product features at the expense of competitors as well as imitating competitors’ medical devices or copy slogans/general layout are strictly prohibited
Brand Reminders and Continuing Medical Education
Brand reminders including non-commercial items like calendars or journals, are permitted to be provided to HCPs as long as their value does not exceed Rs. 1000 and does not carry any commercial intent[12].
With respect to evaluation samples, the Code mandated that their value must be capped at 2% of the company’s annual domestic sales, should be strictly limited in quantity and handed directly to the healthcare professional or their authorized representative, and are clearly labelled “Evaluation Sample – Not for Sale”[13]. Companies are now required to document the healthcare professional’s information and distribution details for a minimum of five years[14].
Demonstration products are specifically designed for educational purposes by medical representatives and are distinct from evaluation samples as they cannot be utilized on patients[15]. These items, often single-use or mock-ups, must be returned post-demonstration[16]. Companies must keep detailed records of distribution and returns for at least five years, reinforcing accountability[17].
Continuing Medical Education (CME) and Continuing Professional Development (CPD) events must adhere to stringent guidelines such as the events not being held abroad unless there are no available local trainers or equipment[18]. Transparency is paramount; companies must disclose event details, including expenses, on their websites, subject to audits. The Code places a responsibility on the shoulders of organizers of events as well, who are also mandated to provide clear information on participant and speaker selection processes and funding sources, enhancing ethical compliance and accountability.
Similar to the Uniform Code for Pharmaceutical Marketing Practices, the Code for Medical Devices aims to influence industry behaviour by requiring companies to implement stringent checks and processes. The objective is to enhance patient safety, uphold professional integrity, and strengthen industry credibility. A key focus is on holding executive officers in the medical device sector more accountable for their companies’ practices and procedures, with an overarching emphasis on fostering a corruption-free India.
[1] https://pharmaceuticals.gov.in/sites/default/files/UCMPMD_0.pdf
[2] Paragraph 1.1
[3] Paragraph 1.2 and 2.3
[4] Paragraph 2.3 and 2.4
[5] Paragraph 2.1
[6] Paragraph 1.3
[7] Paragraph 2.2
[8] Paragraph 2.2
[9] Paragraph 3.2
[10] Paragraph 2.5
[11] Paragraph 2.4
[12] Paragraph 5.1
[13] Paragraph 5.2
[14] Paragraph 5.2
[15] Paragraph 5.3
[16] Paragraph 5.3
[17] Paragraph 5.3
[18] Paragraph 6
Written by: Vidya Mukherjee
Co-authored by: Ananya Shukla
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