Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024

Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024

News: The Department of Pharmaceuticals issued the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024. re draft this with slight changes to avoid plagiarism.

Background: 
Key Highlights of the UCPMP 2024 on Ethical Practices of Pharma Companies:
• Transparent and Clear Guidelines for Engagement: The pharmaceutical sector is expected to engage solely with healthcare professionals for Continuing Medical Education (CME) based on explicit, transparent, and verifiable regulations.
• Prohibition of Overseas Activities: It is strictly prohibited for pharmaceutical entities to conduct such activities in foreign countries as outlined by the regulatory framework.
• Restriction on Incentives: Medical representatives are barred from offering any form of incentives or compensations to gain access to healthcare practitioners.
• No Monetary Grants to Healthcare Professionals: Companies or their representatives are strictly prohibited from offering cash or monetary grants to any healthcare professional or their immediate and extended family members under any circumstances.
• Prohibition of Gifting: Any form of gifting by pharmaceutical companies or their agents (including distributors, wholesalers, and retailers) is strictly prohibited.
• No Inducements: Pharmaceutical corporations or their representatives are not permitted to offer, supply, or assure any financial or in-kind benefits to individuals authorized to prescribe or supply medications.
• Limitation on Paid Travel and Accommodation: Pharmaceutical entities or their agents are prohibited from providing paid travel or accommodation expenses to healthcare professionals or their family members, unless the individual is engaged as a CME speaker.
• Authorized Research Funding: Corporations have been granted authorization by the regulatory authorities to contribute research funds to healthcare experts, provided that such contributions are made in a transparent manner.
• Support for Approved Research Studies: The guidelines empower the industry to financially support research studies that have been duly approved by recognized organizations such as the Indian Council for Medical Research or the Drug Controller General of India. The application includes comprehensive data on the drug’s quality, safety, and efficacy obtained through pre-clinical and clinical trials.

Key Highlights of the UCPMP 2024 on Drugs:
• Alignment with Marketing Authorization: The UCPMP emphasizes that the promotion of a pharmaceutical product must align with the terms outlined in its marketing authorization.
• Evidence-Based Claims: Statements regarding the efficacy of a drug must be supported by a current and comprehensive assessment of all available evidence.
• Qualification of Safety Claims: The term safe should only be used with appropriate qualification, and it should not be unequivocally asserted that a medication is entirely devoid of adverse effects, toxic risks, or potential for addiction.
• Use of New Designation: Any drug or therapeutic intervention that has been extensively promoted in India for more than a year cannot be described as new.

Implementation of the UCPMP 2024:
• Establishment of Ethics Oversight: All organizations are mandated to establish an Ethics Committee dedicated to overseeing Pharmaceutical Marketing Practices, aimed at ensuring stringent adherence to the UCPMP.
• Creation of a Centralized Portal: Organizations are directed to develop a dedicated UCPMP portal on their respective websites and undertake necessary measures for the effective implementation of the code
• Addressing Grievances: It is mandatory for all Indian pharmaceutical associations to prominently display the UCPMP on their websites, accompanied by a detailed procedure for lodging complaints. These grievances will be channeled through the UCPMP portal of the Department of Pharmaceuticals for streamlined resolution.

Need for the UCPMP 2024:
• Implementation of Ethical Standards: The UCPMP 2015 for the Pharmaceutical and Medical Device Industry has been enforced since January 1, 2015, aiming to curb unethical practices within pharmaceutical enterprises.
• Lack of Legal Enforcement: Criticism surrounding this version of the code largely stemmed from its voluntary nature. Without legal backing, its provisions were deemed ineffective.
• Calls for Mandatory Guidelines: Numerous health advocates have persistently advocated for its mandatory implementation. The Department of Pharmaceuticals’ annual report for 2017-18 emphasized the necessity of this. Although the government has eliminated the term voluntary from the code, present in the previous version, it has refrained from instituting mandatory compliance.
• Government Appeal: Presently, the government has merely ‘requested’ pharmaceutical industry organizations to ensure the execution of the code.