Published on: April 19, 2022

UNIFORM CODE FOR MEDICAL DEVICE MARKETING PRACTICES

UNIFORM CODE FOR MEDICAL DEVICE MARKETING PRACTICES

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The Department of Pharmaceuticals (DoP) recently published the draft Uniform Code for Medical Device Marketing Practices (UCMDMP)

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DEFENITION

Health care professional

  • Any person or entity that is authorized 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
  • Includes individual medical and healthcare practitioners, clinical establishments and pharmacies, and the administrative personnel at such establishments
  • Excludes HCPs who are bona fide employees of the company, while acting in that capacity

Promotional material

Materials used by a medical devices company for the commercial promotion of its products and services either to an HCP or to a patient directly

AIM

  • Voluntary code to regulate fair marketing practices by the medical device industry
  • Giving the industry an identity, apart from influencing the marketing dynamics of the pharmaceutical industry

INDUSTRY-SPECIFIC FEATURES

  • 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
  • Promotional material should be in consonance with the documents submitted for obtaining these registrations and licenses, and the claims for usefulness must be consistent with the Directions for Use that accompany the device
  • 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
  • Prohibits the direct or implied disparagement of competitor’s products, services or promotions
  • Any discussion and substantiation in this regard shall be based on available and published evidence.
  • Medical device representatives are expected to provide technical support to HCPs on the safe and effective use of the devices, which may include explaining the unique setting and technical control functions, making recommendations, or assisting the HCP in clinical/operating rooms to ensure that the appropriate range of devices and accessories are available for a procedure.
  • 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
  • Permits medical devices companies to collaborate with HCPs for activities such as consulting services, clinical studies and research, participation in company-conducted training and continued medical education sessions
  • Permits companies to fund only medical research and studies at approved institutions, the UCMDMP also permits companies to provide educational grants to medical training institutions to support their legitimate scientific, educational, and training programs
  • Medical devices companies may provide modest items to HCPs such as product manuals, anatomical models, e-books, subscriptions to online portals that provide medical content, etc
  • HCPs may occasionally also be provided with brand recall items having value less than one thousand rupees (Rs. 1000)