Article 3: Challenge of Affordable Cancer Care in India
Why in News: An investigation has highlighted rising use, high cost, and counterfeit risks of Keytruda (a cancer immunotherapy drug) in India, raising concerns about access and regulation.
Key Details
- Keytruda is an immunotherapy drug used in treating various cancers by boosting the immune system.
- It belongs to monoclonal antibody-based therapies, offering targeted treatment with fewer side effects than chemotherapy.
- High cost (₹3 lakh/month approx.) and limited insurance coverage restrict accessibility in India.
- Investigation reveals counterfeit drug circulation, exposing regulatory and hospital-level gaps.
Cancer Burden in India
- Rising Incidence: India recorded about 14.1 lakh cancer cases in 2022, projected to rise by ~73% to 24.5 lakh by 2045 (GLOBOCAN), indicating a growing public health challenge.
- Increasing Rate: Cancer incidence increased from 84.8 per 100,000 (1990) to ~107 per 100,000 (2023), reflecting lifestyle changes, ageing population, and environmental factors.
- Comparative Perspective: While India’s incidence (~98.5 per 100,000) is lower than developed countries like Australia (~462 per 100,000), the absolute burden is high due to population size.
- Mortality Concerns: High mortality (over 9 lakh deaths annually) reflects late diagnosis, poor access to treatment, and affordability issues.
Immunotherapy: Concept and Advantages
- Definition: Immunotherapy refers to treatments that stimulate the body’s immune system to recognise and destroy cancer cells, unlike traditional therapies.
- Difference from Chemotherapy/Radiotherapy: While chemotherapy kills both healthy and cancer cells, immunotherapy is targeted, reducing collateral damage and improving quality of life.
- Effectiveness in Advanced Cancers: Studies show immunotherapy can extend survival and even eliminate tumours in certain late-stage cancers, marking a paradigm shift in oncology.
- Precision Medicine Approach: It aligns with the concept of personalised medicine, where treatment is tailored based on genetic and molecular characteristics.
Keytruda and Monoclonal Antibodies
- Mechanism of Action: Keytruda (Pembrolizumab) is a PD-1 inhibitor, a monoclonal antibody that blocks immune checkpoints, enabling immune cells to attack cancer.
- Targeted Therapy: It specifically binds to cancer-related proteins, making treatment highly precise and efficient compared to conventional therapies.
- Global Significance: Widely used in treating cancers like lung cancer, melanoma, and head & neck cancers, it represents a breakthrough in modern medicine.
- High Manufacturing Complexity: Unlike simple drugs (e.g., Paracetamol), monoclonal antibodies require advanced biotechnology, increasing production costs.
Other Emerging Immunotherapies
- CAR-T Cell Therapy: Patient’s T-cells are genetically modified to attack cancer cells. India’s indigenous therapy NexCAR19 reflects progress in biotech innovation.
- mRNA Cancer Vaccines: These vaccines train the immune system to identify neoantigens, helping prevent relapse and offering long-term immunity.
- Combination Therapies: Immunotherapy is often used along with chemotherapy and radiotherapy, improving overall treatment outcomes.
- Global Research Trends: Rapid advancements in genomics and biotechnology are making immunotherapy a key pillar of future cancer treatment.
Accessibility and Affordability Issues in India
- High Cost Barrier: Keytruda costs around ₹3 lakh per month, making it unaffordable for most patients without insurance or assistance.
- Limited Insurance Coverage: General health insurance provides partial coverage, while specialised cancer policies are not widely accessible.
- Patient Access Programme: Pharmaceutical companies offer schemes (e.g., free vials after initial purchase), but eligibility restrictions limit reach.
- Public Health Schemes: Some support is available under schemes like CGHS, but coverage remains inadequate compared to demand.
Patent, Pricing and Market Dynamics
- Patent Protection: High prices are largely due to patent monopolies, limiting competition and keeping drug costs elevated.
- Expected Price Reduction: Keytruda’s patent expiry in 2028 may reduce prices by up to 70% due to generic entry.
- Government Intervention: India has removed basic customs duty on certain cancer drugs to improve affordability.
- Global Inequality: Access to life-saving therapies remains uneven, highlighting disparities between developed and developing countries.
Counterfeit Drug Issue and Regulatory Gaps
- Fake Drug Market: Investigation reveals a growing counterfeit market for expensive cancer drugs like Keytruda.
- Systemic Failures: Issues include hospital-level breaches, insider involvement, and weak supply chain monitoring.
- Patient Risk: Counterfeit drugs can lead to treatment failure, health complications, and loss of trust in healthcare systems.
- Regulatory Challenges: India faces gaps in drug traceability, enforcement, and quality control mechanisms.
Health Governance and Ethical Concerns
- Right to Health: High cost of life-saving drugs raises concerns about equity and access, central to Article 21 (Right to Life).
- Public vs Private Healthcare: Dependence on private sector for advanced therapies increases out-of-pocket expenditure (OOPE).
- Ethical Issues: Profit-driven pricing of essential medicines raises questions about pharmaceutical ethics and global justice.
- Need for Regulation: Stronger oversight is required to balance innovation incentives and public health needs.
Conclusion
India must adopt a multi-pronged approach to address cancer care challenges. This includes promoting generic drug production, strengthening regulatory mechanisms, expanding insurance coverage, and investing in public healthcare infrastructure. Enhancing drug traceability systems and encouraging domestic innovation in immunotherapy can improve accessibility. Ultimately, ensuring affordable and safe cancer treatment is essential for achieving universal health coverage and equitable healthcare delivery.
EXPECTED QUESTIONS FOR UPSC CSE
Prelims MCQ
Q. Keytruda is associated with:
(a) Antibiotic therapy
(b) Monoclonal antibody-based cancer treatment
(c) Vaccine for viral diseases
(d) Hormonal therapy
Answer: (b)
Descriptive Question
Q. Examine the regulatory and ethical issues associated with high-cost life-saving drugs in India. Suggest measures to ensure equitable healthcare access. (250 Words, 15 Marks)