India’s Medical Device Marketing Code Needs Enforcement

India’s Medical Device Marketing Code Needs Enforcement

New Delhi (ABC Live): India’s Medical Device Marketing Code: India’s medical device market is rapidly expanding. Specifically, it was valued at nearly ?12,000 crore (USD 1.5 billion) in 2023–24 and is expected to reach ?50,000 crore (USD 6 billion) by 2025. Given this fast growth, ensuring ethical marketing practices has become crucial. Therefore, the government

New Delhi (ABC Live): India’s Medical Device Marketing Code: India’s medical device market is rapidly expanding. Specifically, it was valued at nearly ?12,000 crore (USD 1.5 billion) in 2023–24 and is expected to reach ?50,000 crore (USD 6 billion) by 2025. Given this fast growth, ensuring ethical marketing practices has become crucial. Therefore, the government introduced the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) in September 2024. However, legal experts and industry leaders caution that without stronger enforcement, the code may not achieve its full potential.

Overview of the Medical Device Marketing Code

The Medical Device Marketing Code aims to regulate promotional activities by:

  • Prohibiting gifts, incentives, and hospitality to healthcare professionals

  • Requiring annual self-declarations from companies confirming compliance

  • Mandating disclosure of marketing and sponsorship expenses

Challenges in Marketing Compliance and Enforcement

Despite the code’s introduction, challenges remain:

  • India imports 80–85% of medical devices, totaling over ?68,000 crore in 2023–24.

  • Medical device companies spent approximately ?1,200 crore on marketing in 2023.

  • Only 45% of companies consistently comply with self-declaration rules.

  • Detailed disclosures of marketing expenses are rare, limiting transparency.

Legal Framework Supporting Ethical Marketing

Senior Advocate Jatinder Kaur highlights key rulings reinforcing the need for regulation:

  • Johnson & Johnson Medical India Pvt. Ltd. vs. Union of India (2019) emphasized regulating medical device marketing to protect patients.

  • GlaxoSmithKline Pharmaceuticals Ltd. vs. Union of India (2017) underscored truthful claims by manufacturers.

Criticisms of the Medical Device Marketing Code

The voluntary nature of the Medical Device Marketing Code raises concerns:

  • Lack of statutory enforcement limits its effectiveness.

  • Ethics Committees cannot impose fines, only reprimands or suspensions.

  • Third-party distributors and marketing agents are not covered, creating loopholes.

  • No public reporting of payments to healthcare professionals reduces accountability.

Expert Views on Marketing Compliance Improvements

Advocate Jatinder Kaur states:

“Without statutory enforcement and audits, the code risks being ineffective. Legal support and transparency are essential for protecting patients.”

Sunita Sharma, CEO of a major device company, adds:

“Clear penalties and stronger government backing are needed to promote fair competition and ethical marketing.”

International Standards for Medical Device Marketing

Unlike India’s voluntary code, countries like the US use laws such as the Physician Payments Sunshine Act to enforce transparency, reducing unethical inducements by up to 30%. This comparison highlights the benefits of strict marketing compliance measures.

Conclusion: Strengthening India’s Medical Device Marketing Code

In summary, India’s Medical Device Marketing Code is a positive step toward ethical marketing in the growing medical device sector. Nevertheless, stronger enforcement, legal authority, transparency, and broader coverage are crucial for the code to truly protect patients and promote fair industry practices.

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