The Department of Pharmaceuticals (DoP) has released the draft Uniform Code for Medical Device Marketing Practices (UCMDMP) vide dated 16-03-2022, a voluntary code laying standards for promotion, marketing and sales of the medical devices prohibiting distribution of gifts or benefits to healthcare professionals (HCPs), but allowing “modest, appropriate educational items” and “brand recall items” worth less than Rs. 1,000 occasionally.
The draft has been published after consultation with the industry and is open for wider stakeholder consultation. The feedback has to be sent to the department by not later than April 15, 2022.
Commenting on the draft National Medical Device Policy released by the DoP, Pavan Choudary, chairman, Medical Technology Association of India, said, “While we are still studying the draft policy and consulting with our members for their responses and suggestions, we are encouraged to see that the policy wants to build an enabling ecosystem for medical device manufacturing & research within the country and create a robust regulatory and skilling framework to ensure the quality and safety of these life-saving products. The Central government’s latest act of releasing a draft national policy and a uniform marketing code for medical devices industry shows that the government is focused on systemically nurturing and developing the sector to realise its true potential and to curb unethical practices to bring in more credible health delivery”.
The draft policy is focused on systematically nurturing and developing the MedTech sector to realize its true potential. Medical technology is an intrinsic sector and is highly capital and technology-intensive. It has long gestation periods and also requires constant training of health care workers to adapt to these new technologies.
“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,” he added.
Medical device industry is an important keystone in the healthcare delivery system and is inherently different from pharmaceuticals. The issuance of draft UCMDMP indicates that the government has taken cognizance of the fact that a separate code is needed which can accurately capture the ethical marketing practice requirements for the medical device sector.
While the UCMDMP is envisaged as a voluntary code initially, the draft says that the DoP will make it mandatory if there are violations reported on the Code. The marketing practices of the medical device sector are currently being voluntarily regulated by Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) which is a code based on the marketing dynamics of the pharmaceutical industry.
“We hope that in the future, it will sort the grain from the chaff, giving ethical players the public respect they deserve. Its impact will hopefully spill over and check those operators who have found a means to get beyond the government’s pricing controls on scheduled medical devices,” added Choudary.