UPSC CARE Mains Practice 7th october 2025
Topic – India’s pharmaceutical sector
Introduction
India is known as the “pharmacy of the world”, exporting affordable medicines and vaccines to over 200 countries. However, recurring incidents of contaminated cough syrups causing child deaths in Rajasthan and Madhya Pradesh have exposed serious flaws in drug quality control and regulatory enforcement. These events show that while India’s pharmaceutical base is vast, its quality assurance system still needs stronger institutional discipline and coordination.
Body
- Understanding Drug Quality Compliance
- The Problem: Poor Quality and Non-Compliance
- Policy Actions and Government Measures
- Persistent Challenges
- Way Forward
Conclusion
Drug regulation, placed in the Concurrent List, demands constant coordination between central and state regulators. India’s strength as the world’s pharmacy must rest not only on volume but on unquestionable quality. A modern, tech-enabled, and transparent regulatory culture can ensure that every “Made in India” medicine is safe, trusted, and globally respected — fulfilling the true spirit of Atmanirbhar Bharat in healthcare.
UPSC Syllabus
India’s pharmaceutical sector
Why was this question asked?
Q. What do you understand by fixed dose drug combinations (FDCs)? Discuss their merits and demerits. (2013)
Introduction
India is known as the “pharmacy of the world”, exporting affordable medicines and vaccines to over 200 countries. However, recurring incidents of contaminated cough syrups causing child deaths in Rajasthan and Madhya Pradesh have exposed serious flaws in drug quality control and regulatory enforcement. These events show that while India’s pharmaceutical base is vast, its quality assurance system still needs stronger institutional discipline and coordination.
Body
Understanding Drug Quality Compliance
- The Drugs and Cosmetics Act, 1940 ensures medicines sold in India are safe, effective, and of standard quality, supported by the Drugs and Cosmetics Rules, 1945, which define Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
- Constitutionally, drug regulation falls under the Concurrent List (Entry 19, List III), allowing both Centre and States to make laws.
- The Centre, through the Central Drugs Standard Control Organisation (CDSCO), regulates approvals, imports, and national policy.
- State Drug Control Departments oversee local manufacturing and distribution.
- The revised Schedule M (2025) aims to modernise production with improved facility design, documentation, and contamination control, applicable uniformly across India.
The Problem: Poor Quality and Non-Compliance
- Uneven implementation: State-level capacity varies, leading to gaps in monitoring.
- Unsafe ingredients: In the Coldrif cough syrup case, use of non-pharmacopoeial propylene glycol led to diethylene glycol (DEG) contamination.
- Inadequate labs: Many small manufacturers lack testing and quality control infrastructure.
- Reactive enforcement: Regulatory action often follows deaths or export bans instead of preventive monitoring.
- Weak accountability: Negligence extends to distributors and medical professionals who overlook safety warnings.
Policy Actions and Government Measures
- The Union Health Ministry directed full compliance with revised Schedule M norms.
- CDSCO and State Authorities have begun surprise inspections and licence cancellations.
- WHO partnership: India is working to achieve Global Maturity Level 4 in drug regulation.
- Plans for digital batch tracking, barcode verification, and an Integrated Management System (IMS) are being implemented to improve traceability and transparency.
Persistent Challenges
- Fragmented federal structure: Dual control under Centre and States causes overlap.
- Infrastructure and manpower deficits: Limited labs and few trained inspectors.
- Financial strain on SMEs: Smaller firms struggle to afford high GMP compliance costs.
- Post-incident action: Oversight often begins only after harm is reported.
Way Forward
- Amend the Drugs and Cosmetics Act, 1940 to include stricter penalties, mandatory recalls, and clear liability for both manufacturers and medical prescribers.
- Create a National Pharmaceutical Quality Authority (NPQA) to coordinate between CDSCO and States.
- Establish a single digital licence and inspection portal for all manufacturers.
- Use AI-based tracking, QR-coded packaging, and blockchain records for batch verification and traceability.
- Expand National Institute of Biologicals (NIB) and regional testing labs; train inspectors and chemists on modern testing standards.
- Align domestic GMP norms with WHO and US-FDA standards to boost both domestic safety and export credibility.
Conclusion
Drug regulation, placed in the Concurrent List, demands constant coordination between central and state regulators. India’s strength as the world’s pharmacy must rest not only on volume but on unquestionable quality. A modern, tech-enabled, and transparent regulatory culture can ensure that every “Made in India” medicine is safe, trusted, and globally respected — fulfilling the true spirit of Atmanirbhar Bharat in healthcare.
Topic – 2025 Nobel Prize in Physiology or Medicine
Introduction
The 2025 Nobel Prize in Physiology or Medicine was awarded to Mary Brunkow, Fred Ramsdell, and Shimon Sakaguchi for their discovery of regulatory T-cells (Tregs) and the FOXP3 gene, which explain how the immune system maintains balance and prevents it from turning against the body. Their work has transformed modern immunology by revealing that immune tolerance is not a passive process but an actively regulated mechanism essential for survival.
Body
- Concept and Background
- How Tregs Work and the Role of the FOXP3 Gene
- Scientific and Medical Significance
- Challenges and Ethical Concerns
- Global and Collaborative Dimensions
Conclusion
The Nobel-winning discovery of Regulatory T-cells and the FOXP3 gene represents a defining leap in biomedical science. It shows that health depends not only on fighting infection but also on maintaining immune restraint. For India, it calls for deeper investment in immunology research, bioethics, and affordable biotechnology. This milestone reminds the world that the essence of medicine lies in balance — between protection and peace within the human body.
UPSC Syllabus
2025 Nobel Prize in Medicine
Why was this question asked?
Q. The Nobel Prize in Physics of 2014 was jointly awarded to Akasaki, Amano and Nakamura for the invention of Blue LEDs in 1990s. How has this invention impacted the everyday life of human beings? (2021)
Introduction
The 2025 Nobel Prize in Physiology or Medicine was awarded to Mary Brunkow, Fred Ramsdell, and Shimon Sakaguchi for their discovery of regulatory T-cells (Tregs) and the FOXP3 gene, which explain how the immune system maintains balance and prevents it from turning against the body. Their work has transformed modern immunology by revealing that immune tolerance is not a passive process but an actively regulated mechanism essential for survival.
Body
Concept and Background
- The immune system protects the body from pathogens but must also recognise its own tissues as “self.”
- When this recognition fails, autoimmune diseases such as Type 1 diabetes, lupus, or rheumatoid arthritis occur.
- Earlier, scientists believed that self-reactive T-cells were simply deleted during immune development in the thymus.
- However, Shimon Sakaguchi’s research in the 1990s proved there was an additional layer of control in the periphery — a mechanism that constantly monitors and restrains immune activity. This led to the discovery of Regulatory T-cells (Tregs), the body’s natural moderators of immune response.
How Tregs Work and the Role of the FOXP3 Gene
- Suppressing Overactive Immunity:
Tregs function as the immune system’s “brake pedals,” suppressing excessive immune responses once an infection has been cleared. - Releasing Inhibitory Molecules:
They secrete anti-inflammatory cytokines like Interleukin-10 (IL-10) and Transforming Growth Factor-Beta (TGF-β), which deactivate other immune cells and prevent collateral tissue damage. - Maintaining Immune Tolerance:
Tregs ensure tolerance to harmless substances — such as food proteins, friendly gut microbes, and environmental allergens — preventing allergic and autoimmune reactions. - Preventing Chronic Inflammation:
Without functional Tregs, the immune system loses its internal restraint, leading to uncontrolled inflammation and multi-organ damage. - Discovery of the FOXP3 Gene:
Around the same period, Mary Brunkow and Fred Ramsdell, working in the biotech industry, observed that “scurfy” mice developed fatal autoimmunity. They traced this to a mutation on the X chromosome, identifying a new gene — FOXP3 (Forkhead Box P3). - Function of FOXP3:
FOXP3 acts as a master genetic switch, instructing developing T-cells in the thymus to become regulatory T-cells. When FOXP3 is defective, Tregs fail to form, resulting in immune collapse. - Human Link – IPEX Syndrome:
Mutations in FOXP3 were later discovered in boys suffering from IPEX syndrome (Immune dysregulation, Polyendocrinopathy, Enteropathy, X-linked), confirming its vital role in maintaining immune self-control.
Scientific and Medical Significance
- Redefining Immunity: The discovery shifted the view of the immune system from an on/off switch to a self-regulating network.
- Autoimmune Therapy: Experimental treatments now aim to expand or stabilise Tregs to control conditions such as multiple sclerosis and Type 1 diabetes.
- Organ Transplantation: Engineered Tregs are being used to promote graft tolerance and reduce rejection.
- Cancer Research: Selective depletion of tumour-associated Tregs enhances the immune system’s ability to attack cancers.
- Gene Therapy: FOXP3-based interventions are being explored to restore immune balance in genetic autoimmune disorders.
Challenges and Ethical Concerns
- High Costs: Treg-based and gene therapies remain extremely expensive, restricting accessibility.
- Technical Risks: Long-term stability and safety of modified Tregs remain under study.
- Ethical Oversight: Manipulating human immune cells requires robust ethical and clinical trial guidelines.
- Access Inequality: Advanced immunotherapies risk widening the global health divide if not made affordable.
Global and Collaborative Dimensions
- International Trials: The U.S., Japan, and EU are testing Treg-based therapies for autoimmune diseases and cancer.
- WHO Immunotherapy Roadmap (2024–2030): Advocates equitable access to emerging cell-based treatments.
- Collaborative Model: The laureates’ success—spanning academic and industrial research—demonstrates how innovation flourishes through cooperation.
- India’s Global Role: With its expanding biotech infrastructure, India can serve as a regional hub for affordable immunotherapy in the Global South.
Conclusion
The Nobel-winning discovery of Regulatory T-cells and the FOXP3 gene represents a defining leap in biomedical science. It shows that health depends not only on fighting infection but also on maintaining immune restraint. For India, it calls for deeper investment in immunology research, bioethics, and affordable biotechnology. This milestone reminds the world that the essence of medicine lies in balance — between protection and peace within the human body.