India Medical Device Advertising Rules: Compliance with Approved Intended Use and UCMPMD

India Medical Device Advertising Requirements

Medical device advertising in India is an area with evolving regulations, primarily governed by adherence to the device's approved registration and pending new codes. Manufacturers are expected to self-regulate their promotional activities to ensure claims align with regulatory approvals.

📜 Legal Framework and Core Principle

The advertising of medical devices is currently primarily regulated by an overarching principle within the Medical Device Rules, 2017:

• Approved Intended Use: All promotional material must strictly adhere to the intended use for which the device was approved by the Central Drugs Standard Control Organization (CDSCO) on the Import License (Form MD-15).
• Drugs and Magic Remedies Act: Import Licenses explicitly state that literature and packaging must not contravene the provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act. This Act broadly prohibits misleading or objectionable claims related to treatment or magical properties.

Definition of Intended Use

Under the Medical Device Rules, 2017, "intended use" is defined as the use for which the device is intended according to the data supplied by the manufacturer on the labeling, instructions for use, or promotional material, which is as per approval obtained from the Central Licensing Authority.

🔍 Expanding Scope of Advertising

Recent draft guidance indicates a significant expansion of what constitutes an "advertisement":

• Draft Drugs and Magic Remedies Amendment (2020): This draft seeks to amend the definition of "advertisement" to include electronic media, the internet, and websites, alongside traditional formats like print, banners, and labels (if they contain claims beyond the rules). This change explicitly extends regulatory oversight to digital and social media promotion.

💼 Mandatory Marketing Ethics Code

The Uniform Code for Marketing Practices in Medical Devices (UCMPMD), released by the Department of Pharmaceuticals (DoP), establishes a mandatory self-regulatory ethical framework:

• Self-Declaration: Every medical device company is responsible for adhering to this code. Companies are required to upload a self-declaration of compliance on the association website and the DoP's Uniform Code for Pharmaceutical Marketing Practices (UCPMP) portal.
• Compliance: This code ensures ethical practices, mandating that all marketing materials are accurate, balanced, and reflect the scientific evidence and the CDSCO's approval. The DoP views compliance with this code as mandatory.