Uniform Code For Pharmaceutical Marketing Practices, 2024, Puts Bar On Gifts To Doctors, Refrains Usage Of "Safe" And "New"

In a recent development, the Ministry of Chemicals and Fertilizers notified (on March 12) the Uniform Code for Pharmaceutical Marketing Practices (UCPMP). This uniform code aims to establish ethical marketing practices for pharmaceutical companies. Right at the outset, the code outlines that no pharmaceutical company or its agent should provide a gift for the personal benefit of any healthcare professional, including his/ her family. Additionally, it prevents companies and their agents from offering any pecuniary advantage or benefit. In this context, it may be noted that gifts are one of the important strategies deployed by pharmaceutical companies to promote their brands. Not only this, but UCPMP also restricts the Companies to extend travel facilities for attending conferences, seminars, workshops, etc. (unless the person is a speaker for a CME or a CPD Program), and hospitality like hotel stay, expensive cuisine, resort accommodation. Further, it stipulates that information about drugs must be balanced, up-to-date, verifiable, and not misleading. It must also be provided without delay at the request of the members of the medical and pharmacy professions. Limited Promotion At the outset, it has been stated that a drug's promotion must be consistent with the terms of its marketing approval. Further, a drug must not be promoted prior to receipt of its marketing approval from the competent authority authorizing its sale or distribution. Only where the purpose of promotional material is to provide sufficient information so a decision can be reached as to whether a drug can be prescribed the limited information like the name of a drug, its usage, warnings, precautions, and similar details be used. Besides this, promotional materials, including mailings and journal advertisements, must be identifiable and not resemble the editorial matter. “Promotional material must conform, both in text and illustration, to canons of good taste and must be expressed to recognize the professional standing of the recipients and not be likely to cause offence.,” the Code elaborates. Usage of Words “new” and “safe” It might be intriguing to note that the word "safe" must not be used without qualification. Following this, it must not be stated categorically that medicine has no side effects, toxic hazards, or risk of addiction. Similarly, the word "new" must not be used to describe any generally available drug. Is The Code Mandatory? What Is The Complaint Prescribed? The Code does not stipulate that it is mandatory; however, it clearly states that the company's Chief Executive Officer is responsible for adhering to it. In furtherance of this, he/she is required to submit a self-declaration in the format given under the code within two months of the end of every financial year. Further, the Pharmaceutical Associations are also requested to constitute an Ethics Committee and set up the UCPMP portal on their website. “All associations are requested to constitute an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), set up a dedicated UCPMP portal on their website, and take further necessary steps towards implementation of this Code.,” the code reads. One may ask what the committee's purpose is. It is responsible for handling complaints regarding breaches of this code. The limitation period prescribed for filing complaints is six months, with a one-time extension of another six months. It is noteworthy to mention here that even media reports claiming a company breach can be treated as a complaint. Moreover, the source or the correspondent can be treated as the complainant. The committee can punish the erring entity with suspension or expulsion from associations, reprimands, corrective measures, or the recovery of money given in violation of the code. Further, an appeal can be filed within fifteen days in the Apex Committee for Pharma Marketing Practices (ACPMP), the appellate committee. In the end, it may be noted that all Associations are required to upload a detailed procedure for filing complaints on their websites. One may also note that a similar code with the same title (Uniform Code of Pharmaceutical Marketing Practices) was also published in 2014 by the Ministry of Chemicals. The 2014 also prohibited any kind of quid pro quo between doctors and pharmaceutical companies. However, the catch is that this version had specifically stated that it is a “voluntary code for marketing practices.” Since no statutory code was followed, the implementation could not take place with full strength and was often flouted. Now that the current version of the code does not specifically use the word "voluntary" anymore, it remains to be seen whether this will have any legal backing and whether its implementation will be taken seriously.

Uniform Code For Pharmaceutical Marketing Practices, 2024, Puts Bar On Gifts To Doctors, Refrains Usage Of "Safe" And "New"

Gyanvi Khanna

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