The Central Authorities has notified a uniform code for advertising practices for the medical gadget trade geared toward curbing unethical practices, which incorporates deceptive commercial of the product, extending in depth hospitality, financial advantages to medical employees, and never following prescribed criticism redressal mechanisms.
In a notification, Division of Prescription drugs (DoP) has requested the medical gadgets associations to make sure that medical gadgets are usually not promoted previous to receipt of the product approval (wherever relevant) by the Regulatory Authority, authorizing its sale or distribution as per the provisions of the Medical Gadget Guidelines, 2017.
Additionally learn: Explained | What is the National Medical Devices Policy, 2023?
It added that corporations or their representatives, or any particular person performing on their behalf, mustn’t lengthen hospitality like resort keep, costly delicacies, resort lodging and many others., to healthcare professionals or their members of the family (each instant and prolonged) except the particular person is a speaker for a continued medical training programme and many others. Moreover, no financial grants needs to be given below any pretext.
It prohibits organising workshops overseas for healthcare professionals and mentioned that “all associations ought to represent an ethics committee for advertising practices in medical gadgets (ECMPMD), add it on their web sites together with an in depth process of complaints, which will likely be linked to the UCPMP portal of Division of Prescription drugs.”
The DoP has additionally sought disclosures kind medical gadgets corporations for particulars associated to distribution of analysis samples and bills incurred on conferences , workshops, seminars and many others. As a part of the code, a medical gadget should not be promoted previous to receipt of product approval by the regulatory authority, the notification mentioned.
It additionally famous that the phrases “protected” or “security” should not be used with out qualification, and it should not be acknowledged categorically {that a} medical gadget has no hostile penalties.
The DoP has requested medical gadgets corporations to add the Uniform Code for Advertising and marketing Practices in Medical Gadgets (UCMPMD) 2024 on their web site together with the detailed process for lodging of complaints with a hyperlink to the UCMPMD portal of the division. Earlier this 12 months, the DoP had notified the Uniform Code for Prescription drugs Advertising and marketing Practices (UCPMP) 2024.
Revealed – September 07, 2024 05:56 pm IST