Govt Issues Uniform Code for Ethical Pharmaceutical Marketing Practices 2024

Anupriya Patel Announces New Guidelines to Promote Ethical Marketing and Responsible Practices.

In a bid to curb unethical marketing practices in the pharmaceutical industry and ensure responsible promotion of medicines, the Department of Pharmaceuticals has issued the Uniform Code of Pharmaceuticals Marketing Practices 2024 on March 12, 2024. This new regulatory framework sets clear guidelines for the interactions between doctors or registered medical practitioners (RMPs) and pharmaceutical companies, aiming to promote transparency and ethical behavior in the promotion of drugs and medical products.

Union Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, shared this information in a written reply in the Rajya Sabha today, emphasizing the government's commitment to integrating ethical marketing practices in the pharmaceutical sector.

The new Uniform Code of Pharmaceuticals Marketing Practices 2024 seeks to create a framework for the pharmaceutical industry that ensures the responsible promotion of drugs and eliminates conflicts of interest. Key provisions of the code include:

1. Prohibition on Gifts, Monetary Benefits, and Hospitality

• Pharmaceutical companies are prohibited from providing gifts, monetary benefits, or hospitality to doctors, registered medical practitioners (RMPs), or their families.
• This ban aims to reduce the influence of financial incentives in prescribing medications and to ensure that doctors make decisions based on clinical judgment rather than promotional inducements.

2. Pharmaceutical Companies' Accountability

• Pharmaceutical companies are held accountable for the actions of their medical representatives and other employees in their promotional activities.
• This includes ensuring compliance with the code across all levels of the organization, including marketing and sales teams.

3. Disclosure of Expenditures

• Companies are required to self-declare adherence to the code and disclose all expenditures related to conferences, seminars, workshops, and continuing medical education (CME) programs.
• This ensures transparency in the relationship between pharmaceutical companies and healthcare professionals and prevents undue influence through events and educational programs.

4. Audits and Monitoring

• Companies may undergo independent, random, or risk-based audits to ensure compliance with the guidelines.
• This mechanism ensures that companies remain transparent and accountable for their promotional practices.

5. Complaint Adjudication Process

• The code establishes a two-layer complaint adjudication process, providing a formal pathway for addressing grievances related to unethical marketing practices.
• Appeals will be handled directly by the Department of Pharmaceuticals to ensure fair resolution and accountability.

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Penalties for Non-Compliance

To enforce adherence to the code, penalties have been outlined for pharmaceutical companies found violating its provisions. These include:

1. Reprimand and Public Disclosure

• Reprimand of the pharmaceutical entity, with full details of the violation published publicly to ensure transparency and accountability.

2. Recovery of Violations

• Pharmaceutical companies will be required to recover any money or items given in violation of the code from the individuals concerned.
• The action taken will be notified to the Ethics Committee under the code for further scrutiny.

3. Corrective Statements

• If promotional material issued by the company does not comply with the code’s requirements, a corrective statement will be issued in the media to rectify misleading or unethical information.

4. Legal Action

• Pharmaceutical companies could face action under existing laws if violations are detected during the administration of the code, involving relevant government departments.

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Regulatory Framework for Doctors and Prescription Practices

In addition to the regulations for pharmaceutical companies, the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, provides a code of conduct for doctors and medical practitioners regarding their interactions with the pharmaceutical industry.

Key Provisions for Doctors:

• Generic Drug Prescription: Clause 1.5 of the regulations stipulates that doctors should prescribe drugs by their generic names (preferably in capital letters) to ensure rational prescribing and better accessibility to affordable medicines.
• The Medical Council of India (MCI) has issued multiple circulars over the years, reinforcing the requirement for doctors to comply with generic prescription guidelines. These include circulars from November 22, 2012, January 18, 2013, and April 21, 2017.

Disciplinary Actions for Non-Compliance:

• The National Medical Commission Act, 2019, empowers state medical councils and the Ethics and Medical Registration Board to take disciplinary action against doctors who violate these regulations.
• Regular prescription audits in public health facilities have been recommended to ensure adherence to the prescription of generic drugs.

Conclusion

The introduction of the Uniform Code of Pharmaceuticals Marketing Practices 2024 represents a significant step toward promoting ethical marketing and transparency in the pharmaceutical sector. By regulating the conduct of pharmaceutical companies and ensuring responsible interactions with doctors, the government aims to prioritize patient welfare and reduce unethical influences in medical practices.

These measures, coupled with strict guidelines for doctors and regular prescription audits, will ensure that the healthcare ecosystem continues to serve the best interests of patients and the public at large.