In mid-March 2022, the Department of Pharmaceuticals (DoP) in India published a draft Uniform Code for Medical Device Marketing Practices (UCMDMP). Up until now – and until the draft is finalized – the marketing practices of the medical device sector are voluntarily regulated by the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP). The draft was created in response to requests from the medical device industry, which wanted its own voluntary regulatory requirements. The issuance of the draft indicates that the government does recognize that the medical device sector has different ethical marketing practice requirements.
The UCMDMP shares a structure and similarities with the UCPMP, published in 2014. Similar to UCPMP, the UCMDMP is voluntary and all medical device manufacturer associations will upload the document to their websites. If a complaint is submitted, the company’s CEO (or equivalent) will investigate, take any corrective action, and provide a response to the association. Those who wish to submit a complaint must make a refundable deposit of INR 1,000 ($13).
The UCMDMP notes that a healthcare provider’s “first and highest duty is to act in the best interests of their patients” and that medical device companies can help healthcare providers meet that duty “through necessary, collaborative interactions without interfering with their professional autonomy and the autonomy of the medical institutions that the HCPs may be associated with.”
The draft goes on to note that companies are permitted to collaborate with healthcare providers but “in no event” can those engagements and/or collaborations be “conditional upon any obligation for the HCPs to use, recommend, promote or purchase products of the Medical Device Companies or any of its affiliates or intended to influence HCPs to do so.”
The UCMDMP includes restrictions surrounding the provision of free samples, but makes a differentiation between samples and demonstration products, which are defined as “single use products, mockups, temporary software or equipment that are used for HCP and patient awareness and education.” Demonstration products are also returned to the company after the demonstration, though consumables are not usually able to be returned. Additionally, companies will need to identify and track identification products under the draft.
The portion of the UCMDMP that covers gifts differs from the existing UCPMP, as it bans gifts to healthcare professionals, their families, and other stakeholders (i.e., retailers). It states that companies shall not pay any cash or monetary grants to any healthcare provider for any individual purpose in individual capacity under any pretext. However, companies are allowed to provide occasional “modest, appropriate educational items to HCPs that benefit patients or serve a genuine educational function,” such as books, anatomical models, educational material related to the training, continuing medical education (CME), or in-hospital/in-clinic training. Companies may also provided branded items with a value of $13 or less (INR 1,000).
Pavan Choudary, Chairman & Director General, MTaI said, “The announcement that the govt is following through the implementation of the UCMDMP voluntarily (which is the right way to go about it) is heartening for every company which follows a high level of ethical standards. It will surely translate into more credible healthcare delivery as well as restrain the fly by night operators- who pose a great risk for patients and the reputation of the medical device industry.”
DoP is seeking feedback on the draft through April 15, 2022 via the email address indicated in the public notice.