Amendment to Uniform Code for Marketing Practices in Medical Devices, 2024

On 1^st September 2025, the Department of Pharmaceuticals (“DoP”) notified the amendment to the Uniform Code for Marketing Practices in Medical Devices, 2024 (“UCMPMD”) to simplify the disclosure requirements in relation to the marketing expenditure for the companies (hereinafter referred to as the “Company”) engaged in manufacture, import, distribute or sell medical devices in India.

UCMPMD was issued by DoP in 2024 to regulate how medical devices are marketed in India. Its goal is to ensure ethical, transparent, and patient-centric interactions between the Companies and healthcare professionals (HCPs), while preventing undue influence through gifts, freebies, or misleading promotions.

Key Highlights of UCMPMD (prior to amendment)

1. General Principles:
   1. The Company shall not promote any medical device before obtaining regulatory approval under Medical Device Rules, 2017 authorizing its sale or distribution.
   2. Information in relation to the medical devices must be accurate, verifiable, balanced, and consistent with approved documents including instructions for use (IFU) or directions for use (DFU).
   3. All aforementioned information must be capable of substantiation, which must be provided within a reasonable time frame.
2. Claims and Comparisons: Use of claims in marketing medical devices must be based on published evidence and the product’s IFU/ DFU. The Companies shall ensure that the claims such as “safe” must be qualified, and no device should be stated as entirely free of adverse effects. Any comparisons with other medical devices must be factual, fair, and substantiated, and competitors’ brand names should not be used without prior consent. The Company must not disparage other companies, their products, or HCPs, whether directly or indirectly.
3. Textual and Audio-Visual Promotion: Any promotional material issued by the Company must comply with the UCMPMD and provide clear, legible, and sufficient information for HCPs to make informed decisions. This includes the generic or brand name, manufacturer/ importer details, warnings, contraindications etc. They must not use HCP’s names or photos, and not imitate other companies’ designs or slogans in a misleading way.
4. Medical Representatives: All medical representatives i.e., sales representatives, clinical specialists etc. must maintain high ethical conduct and they shall not employ any inducements or payments for access to HCPs in relation to the medical devices. The Companies are responsible for the medical representatives and an appropriate clause in the employment contract in this regard to be includes accordingly.
5. Brand Reminders, Evaluation Samples: Brand reminders by way of books, calendars, diaries, journals for HCPs allowed only if their value is less than ₹1,000 per item and not of independent commercial value to the HCPs. The Companies are also allowed to provide evaluation samples to HCPs for the purpose of acquiring hands on experience in using the medical device, however subject to following conditions:
   1. Evaluation samples shall be strictly supplied to qualified HCPs.
   2. The name and address of the HCP along with product name date of supply of evaluation samples, quantity and value of evaluation samples must be noted for records minimum period of five years.
   3. Each sample should be supplied with latest version of the Product IFU/ DFU/ e-IFU or User Manual.
   4. The number of evaluation samples provided at no charge shall not exceed the quantity that is reasonably necessary for evaluation of that product.
   5. There should be a mandatory marking as “Evaluation Sample – Not for Sale.”
   6. The monetary value of such samples shall be capped at 2% of annual domestic sales of the Company.
6. Continuing Education and Research Support: Engagement with HCPs for Continuing Medical Education (CME), Continuing Professional Development (CPD), Training Research studies solely in India are permitted subject to a well-defined, transparent and verifiable set of procedures. Payments to HCPs to provide rational support and encouragement to research and innovation is allowed as consultancy/ honorarium in compliance with tax and ethics rules. However, requisite approval from the competent authority (such as ICMR, DCG1, Ethics Committee, Institutional Authority etc.)
7. Relationship with HCPs: The Companies are strictly prohibited from giving gifts, cash, grants, hospitality, or travel for personal benefit of HCPs or their families. Travel/ hospitality only permissible when HCP is a speaker or participant in an approved training.
8. Governance & Enforcement: Each medical device association shall have a system in place to ensure that data disclosed by its members is stored securely and is adequately protected for a period of 5 years. Each medical device association must also set up an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD). The complaint must be made within six months of the alleged breach of the Code, with a maximum of another six months for reasonable delay. Penalties include suspension, reprimand, corrective statements, recovery of items, and referral to government agencies. All appeals shall go to an Apex Committee for Marketing Practices in Medical Devices (ACMPMD) headed by the Secretary, DoP and final decision binding on both parties.

Latest Amendment:

The latest amendment, dated 1st September 2025, introduces the following key requirements:

1. The DoP has introduced a new UCMPMD portal for the compliance under this Code.
2. For the purpose of disclosure of marketing expenditure as required under the Code, the following method shall be used to arrive at the value of free evaluation samples distributed to healthcare professionals:
   1.  If manufactured by the Company, use the per-unit price charged to stockists or immediate customers for the same product.
   2. If purchased by the Company, use the purchase price. In both cases, the price should reflect the annual average for the same make, brand, variant, and value.
3. The CEO has been made responsible for ensuring compliance with this Code. Specifically the CEO shall ensure that the Company discloses its marketing expenditure annually, either by submitting it to one industry association or uploading it online, and inform any other associations of the submission.

Author: Jay Datta Legal Associate, NovoJuris Legal.