Counterfeit Keytruda Market in India: Healthcare Governance and Access Challenges

Indian Express - Explained · 14 Apr 2026 · 2 min read
Prelims · Health Mains · GS2 Governance High relevance

An investigation reveals a thriving black market for Keytruda, an expensive immunotherapy cancer drug, due to systemic loopholes and affordability issues, highlighting critical gaps in India's healthcare governance and drug access mechanisms.

Key points

Keytruda (pembrolizumab) is an immunotherapy drug manufactured by Merck & Co, priced at over Rs 1.5 lakh per 100 mg vial, making it unaffordable for most Indian patients, leading to a counterfeit market.

Checkpoint inhibitors like Keytruda block PD-1 receptors on T cells, enabling the immune system to attack cancer cells, offering targeted treatment with fewer side effects compared to chemotherapy.

GS2-Governance: The counterfeit market thrives due to hospital-level breaches, insider involvement, and lack of regulatory oversight, exposing systemic failures in drug distribution and healthcare governance.

Patient Access Programme by Merck offers 30 free vials after purchasing 5, costing Rs 10 lakh, but excludes patients with income or insurance above Rs 25 lakh, limiting accessibility.

GS3-Science & Technology: CAR-T cell therapy and mRNA vaccines represent advanced immunotherapies, but high costs and technological barriers restrict their availability in India.

Patent rights until 2028 keep Keytruda expensive, but generic versions post-2028 could reduce costs by 70%, addressing affordability issues.

Government health schemes like CGHS provide limited coverage for such expensive treatments, highlighting the need for expanded healthcare financing mechanisms.

GS3-Economy: The global market for Keytruda generated $29.5 billion in 2024, underscoring the economic implications of monopolistic drug pricing and the need for competitive generics.

Way Forward: India should strengthen regulatory frameworks to prevent counterfeit drugs, incentivize domestic production of biosimilars, and expand health insurance coverage to include high-cost immunotherapies.

Key terms

Checkpoint Inhibitors

Checkpoint inhibitors like Keytruda block proteins (PD-1/PD-L1) that prevent immune cells from attacking cancer cells. Their significance lies in revolutionizing cancer treatment by enabling targeted immune responses, though high costs limit accessibility in developing countries.

Patient Access Programme

A scheme by pharmaceutical companies to provide expensive drugs at reduced costs or free after initial purchases. It highlights the ethical dilemma of balancing drug affordability with corporate profitability, crucial for UPSC's governance and social justice topics.

CAR-T Cell Therapy

A personalized immunotherapy where a patient's T cells are engineered to attack cancer cells. Its high cost and complexity make it inaccessible in India, reflecting challenges in adopting cutting-edge medical technologies in resource-limited settings.

Monoclonal Antibodies

Laboratory-made proteins that mimic the immune system's ability to fight pathogens. Keytruda is one such antibody, exemplifying the intersection of biotechnology and healthcare policy, relevant for GS3 (Science & Technology) and GS2 (Governance).