News Excerpt:
The Department of Pharmaceuticals issued the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, specifying the rules for the use of the words “safe’’ and “new’’ for drugs and stating that medical representatives must not employ any inducement or subterfuge to gain an interview and that they must not pay, under any guise, for access to a healthcare professional.
Key highlights of the issued code for pharmaceutical firms:
- Engagement of the pharmaceutical industry with healthcare professionals for Continuing Medical Education (CME) should only be allowed through a well-defined, transparent, and verifiable set of guidelines, and the uniform code prohibits conduct of such events in foreign locations.
Continuing Medical Education (CME):
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- Companies or their representatives should not pay cash or monetary grants to any healthcare professional or their family members (both immediate and extended) under any pretext.
- Gifting is prohibited by any pharmaceutical company or its agent, that is, distributors, wholesalers, retailers, etc.
- Additionally, no pecuniary advantage or benefit in kind may be offered, supplied or promised to any person qualified to prescribe or supply drugs by any pharmaceutical company or its agent.
- The latest UCPMP notes that paid travel, hotel stays, etc., should not be extended to healthcare professionals or their family members by pharmaceutical companies or their representatives unless the person is a speaker for a CME, etc.
- The UCPMP is to be circulated for strict compliance, and all associations have been requested to constitute an Ethics Committee for Pharmaceutical Marketing Practices, set up a dedicated UCPMP portal on their website, and take further necessary steps for the code’s implementation.
- On drugs, the UCPMP states that the promotion of a drug must be consistent with the terms of its marketing approval, and a drug must not be promoted before the receipt of its marketing approval from the competent authority authorising its sale or distribution.
- Claims for the usefulness of a drug must be based on an up-to-date evaluation of all available evidence.
- The word ‘safe’ must not be used without qualification, and it must not be stated categorically that a medicine has no side effects, toxic hazards, or risk of addiction.
- The word ‘new’ must not be used to describe any drug which has been generally available or any therapeutic intervention which has been generally promoted in India for more than a year.
- All Indian pharmaceutical associations are to upload the UCPMP on their website along with the detailed procedure for lodging complaints, which will be linked to the UCPMP portal of the Department of Pharmaceuticals.
Recommendations made by a five-member committee headed by Vinod K. Paul to the Union government upon reviewing the Uniform Code for Pharmaceutical Marketing Practices (UCPMP):
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