The Indian government has issued the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024, aiming to regulate and curb unethical practices in the medical device industry.
Ethics Committees to Oversee Complaint Handling
As part of the new code, all medical device associations must establish an Ethics Committee for Marketing Practices in Medical Devices (ECMPMD). These committees will be responsible for handling complaints related to any breaches of the UCMPMD, with a mandate to resolve them within 90 days. The code also requires associations to upload the full UCMPMD and complaint procedures on their websites, linking them to the Department of Pharmaceuticals’ UCPMP portal.
Transparency in Medical Device Promotion
UCMPMD 2024 sets strict guidelines for medical device promotion, ensuring that promotions align with regulatory approvals, product registration documents, and the Instructions for Use (IFU). Medical device companies are now required to ensure all claims are backed by evidence, and no misleading information is provided.
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Restrictions on Gifts and Hospitality for Healthcare Professionals
Under the new code, medical device companies are prohibited from offering gifts, monetary benefits, or hospitality, such as travel or expensive accommodations, to healthcare professionals (HCPs) or their families. Exceptions are made only for approved Continuing Medical Education (CME) or Continuing Professional Development (CPD) programs.
Mandatory Disclosure of Expenses
Companies must disclose details about their spending on evaluation samples, conferences, workshops, and other educational activities. The disclosure must be made on an ongoing basis and submitted within two months of the end of the financial year.
Key Highlights of UCMPMD 2024:
- Mandatory formation of ethics committees for complaint handling.
- Strict regulations on medical device promotion to prevent misleading claims.
- Prohibition of gifts, travel, and monetary grants to healthcare professionals.
- Required disclosure of expenses for educational activities and product evaluations.
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