The Indian government has taken a big step to make the medical device industry more transparent and trustworthy. The Department of Pharmaceuticals recently updated the rules for marketing medical devices, and industry experts believe this move will benefit both healthcare professionals and patients.
One of the key changes is that medical device companies can now give doctors free evaluation samples. This allows doctors to try out the equipment before recommending it to patients. However, there’s a limit—companies can provide up to 2% of their domestic sales as free samples, and the value of these samples must be recorded carefully.
The revised rules also require companies to be transparent about their spending. They must now disclose how much money they spend on samples, continuing medical education (CME) programs, sponsoring events, and covering costs for specialist doctors traveling abroad for approved courses. This information will be maintained in a new, easy-to-understand format.
Importantly, the updated code bans giving gifts, cash, or personal perks to doctors and their families. Industry groups will keep records of all disclosures for five years and face stricter penalties if they don’t follow the rules.
The Association of Indian Medical Device Industry (AiMeD) welcomed these changes. They believe the new rules will bring more fairness, honesty, and accountability to India’s growing MedTech sector. AiMeD’s spokesperson, Rajiv Nath, said, “These rules promote ethical marketing. Patients will receive safer devices, honest information, and will no longer be duped by unfair promotions.”
Additionally, company CEOs or managing directors now need to submit yearly reports on their marketing expenses. For the financial year 2025, the deadline has been extended to September 30 to give companies more time to comply.
The Department of Pharmaceuticals also emphasized that all data must be securely stored and kept for at least five years. Authorities can access this information when investigating complaints or ensuring companies follow the rules.
Overall, these updates aim to create a more ethical, transparent, and responsible medical device industry in India—benefiting healthcare professionals, patients, and manufacturers alike.
