DoP releases Uniform Code for Pharmaceutical Marketing Practices 2024
New Delhi: With the intention of monitoring medical device marketing practices, through a recent notice, the Department of Pharmaceuticals (DoP) has released the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024, urging all Medical Devices Associations to ensure the standard code is strictly followed.
The notice states,
"All associations should constitute an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD), upload the UCMPMD on their website along with the detailed procedure for lodging of complaints, which will be linked to the UCPMP Portal of the Department of Pharmaceuticals."
The notice further added, "In exercise of the powers conferred by Para 14.1 of the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024, the Department requires disclosure from Medical Devices companies of particulars related to distribution of evaluation samples and expenses incurred on Continuing Medical Education Continuing Professional Development/ Conferences/ Workshops/ Trainings/ Seminars etc. The format for such disclosure is also enclosed. The particulars are to be filled on an ongoing basis and mandatorily within two months of the end of every financial year on the UCPMP portal of the Department within the time limit fixed for submitting self- declaration under Para 14.3 of the Code."
The updated regulations mandate the setting up of the Ethics Committee for Marketing Practices in Medical Devices (ECMPMD) and the public inclusion of comprehensive data pertaining to assessment samples and costs associated with professional activities and continuing medical education (CME).
Regarding the relationships with healthcare professionals, the updated regulations highlighted that no gift should be offered or provided for personal benefit of any healthcare professional or family member (both immediate and extended) by any Medical Device Company or its agent, viz. distributors, wholesalers, retailers, etc. similarly, no pecuniary advantage or benefit in kind may be offered, supplied or promised to any person qualified to prescribe or use Medical devices by any Medical Device Company or its agent viz. distributors, wholesalers, retailers, etc.
Furthermore, it added that companies or their representatives, or any person acting on their behalf, should not extend travel facilities inside or outside the country, including rail, air, ship, cruise tickets, paid vacations, etc., to healthcare professionals or their family members (both immediate and extended) for attending conferences, seminars, workshops, etc., unless the person is a speaker for a CME or a CPD Program or a participant in a training program for which specific approval has been obtained from the Department.
In addition, the code stated that companies or their representatives, or any person acting on their behalf, should not extend hospitality like hotel stay, expensive cuisine, resort accommodation etc., to healthcare professionals or their family members (both immediate and extended) unless the person is a speaker for a CME or a CPD program or a participant in a training program for which specific approval has been obtained from the department,
In continuation, the code further added that companies or their representatives should not pay cash or monetary grant to any healthcare professional or their family members (both immediate and extended) under any pretext.
In line with the handling of complaints, the code stated, "All the Indian Medical Device Associations will upload the UCMPMD on their website along with the detailed procedure for lodging of complaints, which will be linked to the UCPMP portal of the Department of Pharmaceuticals."
"There will be a committee for handling complaints named the "Ethics Committee for Marketing Practices in Medical Device (ECMPMD) in each Association, chaired by its Chief Executive Officer. The Committee will have three to five members, and its composition will be approved by the Board of the Association and prominently placed on its website." the code added.
The Department of Pharmaceuticals has enclosed the 2024 Uniform Code for Marketing Practices in Medical Devices (UCMPMD).
To view the notice, click the below link:
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