In early September, India’s Department of Pharmaceuticals has requested that there is a new code set up for marketing and advertising medical devices in-country. The new regulation is titled – Uniform Code for Marketing Practices in Medical Devices (UCMPMD). Prior to this new announcement, under the previous regulations including the Drugs and Cosmetics Act of 1940, the Drugs and Cosmetics Rules of 1945 and the 2017 Medical Device Rules, there were no documents that were related to the Advertising and Promotion of devices in India.
One of the main provisions of this new Uniform Code is that medical devices cannot be promoted before product approval. This may seem straightforward and obvious, but examples of fraudulent marketing have been found. It also states that device companies and their employees may not extend “benefits” to healthcare providers or their families like hotel stays at conferences longer than required, paid vacations, etc. Under no situations should money be paid to healthcare providers when marketing devices. In addition, all device associations in India should set up an ethics committee for marketing devices which will be associated with the Department of Pharmaceutical’s UCPMP portal. Other parts of the Uniform Code put restrictions on the use of samples, exaggeration of expenses at conferences, etc. Finally, the Department of Pharmaceuticals has asked all medical device companies to put the UCMPMD on their website with the ability to allow anyone to be able to send in real healthcare complaints. To learn more, please click here.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.