Context:
The Department of Pharmaceuticals issued the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024.
Relevance:
GS II: Government policies and Interventions
Dimensions of the Article:
- Need for the UCPMP 2024
- Highlights of the UCPMP 2024 on Ethical Practices of Pharma Companies
- Highlights of the UCPMP 2024 on Drugs
- Implementation of the UCPMP 2024
Need for the UCPMP 2024
- Preventing Unethical Practices: The UCPMP 2015 was implemented to curb unethical practices by pharmaceutical and medical device companies. However, its voluntary nature meant that compliance was not enforced, leading to concerns about continued unethical behavior.
- Criticism of Voluntary Nature: The voluntary nature of the UCPMP 2015 attracted criticism, as there was no legal backing to its provisions. This lack of teeth rendered the code ineffective in addressing unethical practices effectively.
- Demand for Mandatory Implementation: Various health activists and stakeholders have long demanded that the UCPMP be made mandatory to ensure compliance and accountability within the pharmaceutical industry. Even the Department of Pharmaceuticals’ annual report for 2017-18 emphasized the need to make the code mandatory.
- Removal of Voluntary Status: In response to criticism and demands for accountability, the government has removed the word ‘voluntary’ from the UCPMP 2024. However, it falls short of making compliance mandatory and instead requests pharmaceutical companies’ associations to ensure implementation.
Highlights of the UCPMP 2024 on Ethical Practices of Pharma Companies
The Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024 addresses the need for ethical practices within the pharmaceutical industry and aims to prevent unethical behavior by pharmaceutical companies. Here are the highlights of the UCPMP 2024:
- Engagement with Healthcare Professionals (HCPs) for Continuing Medical Education (CME):
- Pharmaceutical industry engagement with HCPs for CME should only occur according to well-defined, transparent, and verifiable guidelines.
- Conducting such events in foreign locations is prohibited by the uniform code.
- Prohibition of Incentives and Payments:
- Medical representatives are prohibited from using any incentives or paying for access to healthcare practitioners.
- Companies or their representatives are prohibited from offering cash or monetary grants to any healthcare professional or their family members under any pretext.
- Prohibition of Gifting:
- Gifting by pharmaceutical companies or their agents to healthcare professionals or their family members is prohibited.
- 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.
- Restrictions on Travel and Accommodation:
- Paid travel and hotel stays 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 or similar event.
- Research Grants:
- Pharmaceutical firms are allowed to provide research grants for healthcare professionals, provided these grants are provided in a transparent manner.
- The guidelines permit the industry to support research studies authorized by bodies such as the Indian Council for Medical Research or the Drug Controller General of India.
Highlights of the UCPMP 2024 on Drugs:
- Consistency with Marketing Approval: The promotion of a drug must align with the terms of its marketing approval, ensuring that claims about the drug’s efficacy and safety are accurate and verified.
- Evidence-Based Claims: Claims regarding the usefulness of a drug must be supported by up-to-date evaluations of all available evidence, emphasizing the importance of evidence-based medicine in pharmaceutical promotion.
- Use of Terminology: Certain terms such as ‘safe’ must not be used without qualification, and it is prohibited to categorically state that a medicine has no side effects, toxic hazards, or risk of addiction. This aims to ensure transparency and prevent misleading information.
- Restriction on ‘New’ Claims: The term ‘new’ cannot be used to describe any drug that has been generally available or any therapeutic intervention that has been promoted in India for more than a year. This prevents misleading marketing tactics regarding the novelty of drugs or interventions.
Implementation of the UCPMP 2024:
- Circulation for Compliance: The UCPMP is to be circulated for strict compliance among pharmaceutical associations. They are required to ensure that all members adhere to the code’s provisions.
- Establishment of Ethics Committee: Pharmaceutical associations are requested to constitute an Ethics Committee for Pharmaceutical Marketing Practices. This committee will oversee compliance and handle any complaints related to unethical marketing practices.
- Dedicated UCPMP Portal: Associations are directed to set up a dedicated UCPMP portal on their website, providing information about the code and procedures for lodging complaints. This portal will serve as a centralized platform for monitoring compliance and addressing grievances.
- Transparency Measures: All Indian pharmaceutical associations must upload the UCPMP on their website, along with detailed procedures for lodging complaints. This information will be linked to the UCPMP portal of the Department of Pharmaceuticals, ensuring transparency and accessibility for stakeholders.
-Source: Indian Express
