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MARKETING CODE FOR MEDICAL DEVICES

Ramesh Shankar
Wednesday, September 25, 2024, 08:00 Hrs  [IST]

The Department of Pharmaceuticals has recently released the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024, prohibiting medical devices companies from offering gifts, travel benefits, hospitality and monetary grants to the doctors, while allowing brand reminders, evaluation samples, continuing medical education and support for research. The code is in line with the uniform code released for pharmaceuticals some time back. As per the new code, no gift should be offered or provided for the professional benefit of any healthcare professionals or family members (both immediate and extended) by any medical devices company or its agents. No pecuniary advantage or benefit in kind may be offered, supplied or promised to any person qualified to prescribe or use medical devices. Companies or their representatives should not pay cash or monetary grants to any healthcare professionals or their family members under any pretext. The code restricts medical devices firms from using the words safe or safety must not be used without qualification and it must not be stated categorically that a device has no adverse consequences. Comparison of medical devices must be factual, fair and capable of substantiation by way of available data, and brand names of products of other companies must not be used in comparison unless the prior consent of the companies concerned has been obtained. However, companies are permitted to give brand reminders for professional use in healthcare settings, provided their value does not exceed Rs. 1000 per item and the items do not have an independent commercial value for the healthcare professionals. Evaluation samples can be provided for the purpose of acquiring hands on experience in using the product. Free evaluation samples must not be provided to any person other than the qualified healthcare professionals.

It is a fact that even though the medical devices industry has been growing by leaps and bounds in the country for the last some years, so far there has been no separate marketing code for the medical devices industry in the country. The Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) has also been applicable to the medical devices industry also. By bringing out a separate marketing code, the government wanted to remove or eliminate the mechanisms that distort the medical devices market in the country. The marketing code has been issued to ensure high ethical standards for the medical device industry much in the similar manner as has been done in the case of pharmaceutical industry by introducing the UCPMP in 2011. As the medical devices industry is growing exponentially in the country, it has become a big challenge for the regulators to ensure the ethical marketing of these devices. It is an undeniable fact that the medical devices marketing companies put artificially inflated high MRP with high trade margins to induce hospitals and retailers to push their products. Ideally, the MRP of these products should not be over four to five times of import landed price or ex-factory price (on which GST is charged initially). But the fact remains that instead of four or five times, the prevailing MRP goes even up to a whopping 20 times.  In fact, the medical devices industry in the country has been demanding to the government for a separate marketing practices code different from pharma industry. Of course, the characteristics of the medical device industry are different from the pharmaceutical industry. So, the government has done well to release a separate marketing practices code for the medical devices industry.

 
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