The Department of Pharmaceutical (DoP) had recently published the draft Uniform Code for Medical Device Marketing Practices (UCMDMP). It is aimed at bringing in a voluntary code to regulate fair marketing practices by the medical device industry.
What are ‘medical devices’?
- The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of medical conditions, diseases, illnesses, and disabilities.
- The medical device is a multi-product sector, with the following broad classifications –
- Electronics Equipment
- Consumables and Disposables
- IVD reagents
- Surgical Instruments
- The current market size of the medical devices sector in India is estimated to be $11 billion and its share in the global medical device market is estimated to be 1.5%.
Need for a uniform code –
- In India, Rules on National Medical Devices are formulated by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers.
- At present, medical devices companies may voluntarily adopt and follow the Uniform Code for Pharmaceutical Marketing Practices (“UCPMP”), which is primarily applicable to the pharmaceutical industry.
- The Department of Pharmaceuticals, acknowledging that the medical devices industry is a separate constituent of the healthcare system, sought to frame a Uniform Code for Medical Device Marketing Practices (UCMDMP).
Features of the draft UCMDMP –
- Health Care Professional (HCP) – Any person or entity that is authorised to provide healthcare services or items to patients, or is involved in the decision to purchase, prescribe, order, use or recommend a medical device in India.
- Comparative Advertisements – Prior consent from a competitor need not be obtained for using their brand name as long as the feature of the competitor’s product that is the subject of comparison is clearly specified within the advertisement.
Role of Medical Device Representatives – The UCMDMP envisages a more involved role for medical device representatives in a clinical setting than medical representatives under the UCPMP. The representatives are expected to provide technical support to HCPs on the safe and effective use of the devices.
- Training of HCPs by Medical Devices Companies – Companies are expected to develop training sessions on the effective use of devices and their use in procedures, which will be a requirement for an HCP to get access to the product.
- No Gifts – No gifts, pecuniary advantages or benefits in kind shall be supplied, offered or promised to persons qualified to use, prescribe or supply Medical Devices, by a Medical Device Company or any of its agents i.e., distributors, wholesalers, retailers etc.
- The UCMDMP has done away with the restriction on the use of the word “new” for products that have been in the market for over a year, which is present under the UCPMP.
- Medical devices must not be promoted prior to obtaining the requisite registrations and licenses for sale under the Medical Device Rules, 2017.