Uniform Code for Medical Device Marketing Practices

The Medical Device 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.  it forms an important pillar in the healthcare industry system along with healthcare providers pharmaceuticals and health insurance industry thereby helping achieve the key values enshrined in the National Health policy 2017 in terms of the provision of good quality affordable and comprehensive health care to all. the marketing practices of the medical device sector are currently being voluntarily regulated by uniform code for pharmaceutical marketing practices.

The Department of Pharmaceuticals (“DoP”) has recently issued Draft Uniform Code for Medical Devices Marketing Practices (“UCMDMP”).

Key Features of the UCMDMP:

1. Some of the key definitions like HCPs, Promotional Materials, Third Party Programme etc. There is departure from UCPMP which prohibits hospitality, travel, and meal, however, while participating in any CME or conference on Medical Devices HCPs can be granted food, travel and hotel stay. There are separate annexures which describes kind of hospitality can be given to HCPs. This is a welcome step to promote science and R&D with respect to Medical Devices.
2. A Medical Device must not be promoted prior to receipt of the product registration (wherever applicable) by the Regulatory Authority, authorizing its sale or supply as per the Medical Device Rules
3. The promotion of a Medical Device must be consistent with product registration or licenses to manufacture, import and sell these Medical Devices in India; and specifically, the Instructions for Use (IFU)/Directions for Use (DFU) of the relevant product.
4. Product Information about Medical Devices is aligned with UCPMP
5. Claims for the usefulness of a Medical Device must be based on evaluation of the available and published evidence and/or IFU/ DFU of the relevant product and aligned with UCPMP.
6. Comparisons of Medical Devices are aligned with UCPMP
7. Advertisements/ Promotional Material containing comparisons with other manufacturers, suppliers, producers or with other products, including where a competitor is named is permitted in the interest of promoting competition, where—
   1. the features of the competitor’s product being compared to the features of the advertiser’s products are specified clearly within the advertisement.
   2. the subject matter of the comparison is not of such nature so as to confer an artificial or unjustifiable advantage upon the advertiser; and
   3. the nature of comparisons is such that they are factual, accurate and capable of being substantiated.
8. Free evaluation samples of Medical Devices shall not be supplied to any person other than HCPs or as per hospital protocol to reach the HCPs
9. 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.
10. All other provisions on Gifts for the personal benefit of HCPs and family members are prohibited.
11. Companies may occasionally provide modest, appropriate educational items to HCPs that benefit patients or serve a genuine educational function for HCPs.

12. Companies should maintain adequate records to support any expenses on above educational material.
13. Companies may occasionally provide modest, appropriate brand recall items/ brand reminders, which are customary business courtesies and are reasonable in value and frequency UPTO INR1000.
14. Companies may collaborate with HCPs and engage in activities including but not limited to providing consulting services, conducting clinical studies, and doing research, participate in Company conducted training & education (physical and digital platform) including continued medical education, product trainings, business meetings, webinars etc. In no event, the engagements/collaboration with the HCPs shall be conditional upon any obligation for the HCPs to use, recommend, promote, or purchase products of the Medical Device Companies or any of its affiliate’s or intended to influence HCPs to do so.
15. Companies directly or in collaboration with health care professionals/ certain third parties conduct educational activities like Company conducted Product and Procedure Training programs/ In-Service program, Company’s Promotional Event, third party conducted Continued Medical Education (CMEs) activities sponsored/ funded by Company (wholly or partially). HCPs may participate in above programs either as a faculty/Trainer/Proctor or as a delegate/Trainee.
16. Companies may provide educational grants to training institutions (such as medical schools, teaching hospitals, hospitals & institutions having approved teaching seats) and to other third-party entities in support of their legitimate scientific, educational, and training programs
17. Companies may engage HCPs to provide a wide range of valuable, bona fide consulting services for education purposes under a consultancy contract/ agreement involving consultancy fee/ Honorariums based payment to HCPs based on fair market value for the specific scope of services.

Enforcement: Though the code is voluntary, however , DoP has set out a procedure for lodging complaint on company’s website including sending report to National Pharmaceutical Pricing Authorities (“NPPA”) . The notification from DoP has set a date for feedback by 15^th April 2022 from the association and manufacturer and other stake holders .

This code is also aligned with applicable laws and industry codes of western countries on the promotion and marketing of Medical Devices .