Daijiworld Media Network - New Delhi

New Delhi, Sep 3: The Department of Pharmaceuticals (DoP) has amended its Uniform Code for Marketing Practices in Medical Devices (UCMPMD), 2024, a move welcomed by the Association of Indian Medical Device Industry (AiMeD) as a significant step toward greater transparency and accountability.

The changes will allow medical device manufacturers to provide free evaluation samples to doctors, with a cap of 2% of domestic sales. This measure aims to give healthcare professionals valuable hands-on experience with new products. The valuation of these samples must be recorded at either the stockist price (for in-house manufacturing) or the purchase price (for external sourcing).

The updated code also introduces stricter disclosure requirements. Companies must now detail their spending on samples, Continuing Medical Education (CME) programs, event sponsorships, and pre-approved international travel and lodging for specialist doctors. This information must be submitted annually in a new annexure format.

A key provision of the revised framework is the strict prohibition of gifts, cash grants, and personal benefits to healthcare professionals and their families. To enforce these rules, industry associations are required to securely retain disclosure data for five years and cooperate with official inquiries.

"At AiMeD, we welcome the Universal Code of Ethical Marketing of Medical Devices and the simplified annual reporting format," said Rajiv Nath, Forum Coordinator for AiMeD. He added that the code will ensure "ethical and transparent marketing, fostering fair competition and stronger reputations for both domestic and overseas manufacturers."

Under the new regulations, chief executives or managing directors of medical device companies must file an annual declaration of marketing expenditure within two months of the financial year's end. For the fiscal year 2025, the deadline has been extended to September 30.