From being a voluntary code and good governance initiative to regulate marketing practices of pharmaceutical associations and companies to becoming a mandatory set of guidelines that need to be strictly adhered to, the Uniform Code of Pharmaceutical Marketing Practices (“UCPMP”) has recently experienced a dramatic shift in scope and applicability impacting the pharma compliances in India. Issued by the Department of Pharmaceuticals (“DoP”) on March 12th, 2024, as the Uniform Code for Pharmaceutical Marketing Practices 2024 (“UCPMP 2024”), the content of the Code remains largely similar to its decade old predecessor. However, apart from the key change of making the Code mandatory, UCPMP 2024 also incorporates modifications and introduces new provisions, particularly addressing brand reminders, Continuing Medical Education (CMEs), Continuing Professional Development (CPD) and research support.
In this blog, we have focused our attention on the provisions of the UCPMP 2024 and its implications specifically for pharmaceutical companies including companies engaged in the manufacture and distribution of medical devices.
Role of the management of a company in monitoring the pharma compliances in India
The UCPMP 2024 poses a direct responsibility on the Chief Executive Officer (CEO) of pharma companies to ensure compliance with the Code and mandates the CEO to furnish an annual self-declaration of adherence to the code by the month of May of each fiscal year to the pharmaceutical association for publication on their website or directly to the UCMP Portal of the Department of Pharmaceuticals if the company is not affiliated with any association or is affiliated with multiple associations.
Drug & medical device promotion
Drug promotions must align with marketing approval terms and must begin only after approval has been granted. Information about drugs must be balanced, current, verifiable, and free from misleading implications. Claims regarding drug efficacy must be substantiated by the latest evidence, and caution must be exercised when using terms like “safe,” avoiding misleading implications of absolute safety. Additionally, the term “new” cannot be applied to drugs or therapies available or promoted within India for over a year.
Promotional material must adhere to specific standards, including comprehensive drug information, avoidance of mimicking other companies’ styles, and appropriate labelling to indicate promotional nature. Healthcare professionals’ names or photos are not be used and audio-visual content must be supported by printed material evidencing compliance with UCPMP 2024’s requirements.
Further, comparisons between drugs must be factual, fair, and verifiable, with consent required before using brand names from other companies. Disparagement of other companies, their products, or promotions, as well as healthcare professionals’ clinical or scientific opinions, is strictly prohibited.
The conduct of medical representatives is also regulated, prohibiting the use of inducements to secure interviews or access to healthcare professionals. Companies will be held accountable for their representatives’ actions and must ensure compliance through employment contracts. Brand reminders are permitted within defined limits, with stringent regulations governing the distribution and reporting of samples.
Relationship with Healthcare Professionals
Ethical standards in relationships with healthcare professionals are underscored, prohibiting gifts, travel facilities, hospitality, or monetary grants except in specific circumstances outlined in the code.
There are a series of prohibitions on pharma companies and their agents regarding their associations with healthcare professionals including providing gifts for the personal benefit of healthcare professionals or their family members, no monetary or non-monetary benefits, no travel facilities, including transportation and accommodations are to be offered for attending conferences, seminars, workshops, etc., unless they are speakers for Continuing Medical Education (“CME”) or Continuing Professional Development (“CPD”) programs.
Hospitality offerings such as hotel stays, expensive dining, resort accommodations, etc., are also prohibited for healthcare professionals and their family members unless they are speakers for CME or CPD programs. Moreover, cash or monetary grants are strictly prohibited from being provided to any healthcare professional or their family members under any circumstances or pretext.
Pharma companies are now prohibited from conducting CME and CPD events abroad. Details of all such events conducted are to be published on the company’s website including the expenditures incurred thereupon as well as a statement of their funding sources which may be subject to special audits.
Brand reminders and medical samples
Brand reminders are permitted under the Code, in two categories: informational and educational items and free samples provided by companies to healthcare professionals. Informational and educational items include books, calendars, diaries, journals (including e-journals), dummy device models, and clinical treatment guidelines for professional use in healthcare settings, with a value not exceeding Rs. 1000 per item. Such items should not hold independent commercial value for healthcare professionals. The distribution of free drug samples is regulated to ensure responsible and ethical practices, with records of recipients maintained. A maximum samples size of 12 packs per drug annually per practitioner are permitted that too with details such as product name, doctor name, quantity of samples given, date of supply of free samples to healthcare practitioners etc, and the monetary value of samples so distributed is capped at 2% of the domestic sales of the company per year.
To facilitate collaboration between the pharmaceutical industry and academia in research and innovation, the Code mandates that, any research or studies undertaken must gain approval from competent authorities such as ICMR, DCGI, Ethics Committees, or Institutional Authorities, and should be conducted at recognized sites or locations. Additionally, engagement of healthcare professionals in consultant-advisory roles should be solely for genuine research services under consultancy agreements, with consultancy fees or honorarium-based payments. This ensures compliance with relevant Income-Tax Act provisions and NMC regulations, thus safeguarding patient interests and professional integrity.
Enforcement Mechanisms
To ensure adherence and address complaints, the UCPMP 2024 mandates the establishment of Ethics Committees for Pharma Marketing Practices (ECPMP) by Indian Pharmaceutical Associations. Complaint procedures are detailed, and associations are required to upload information on complaints and their resolutions on their websites.
The code also establishes clear consequences for breaches, empowering the Committee to propose various actions against offending parties, ranging from suspension or expulsion from the Association to issuing public reprimands with full disclosure. Additionally, corrective statements in media where promotional material was disseminated may be required, or further disciplinary actions recommended through relevant governmental agencies.
In conclusion, the Uniform Code for Pharmaceutical Marketing Practices 2024 represents a comprehensive framework aimed at promoting ethical practices and transparency within the pharmaceutical industry. By outlining clear guidelines, enforcement mechanisms, and avenues for addressing grievances, the UCPMP 2024 seeks to safeguard public health interests while fostering a culture of responsibility and integrity among stakeholders. However, its successful implementation will depend on effective enforcement and ongoing monitoring to ensure compliance across the industry.
Lexplosion has assisted a number of pharmaceutical companies through their journey of setting up compliance management software in India and their subsidiaries in other countries by setting up internal processes and implementing a regulatory compliance management system. Do reach out to us at inquiries@lexplosion.in for further details.
Written by: Ananya Shukla
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