Contents:
- Ban this carcinogenic ‘heart-burn’ drug
- Schooling in India in times of poor air quality
Ban this carcinogenic ‘heart-burn’ drug
Relevance : GS 2 (Health , Governance )
Practice Question: Discuss the regulatory challenges in India regarding drug safety, with reference to the Ranitidine carcinogenic drug.How to ensure better drug safety (250 Words )
GSK’s $2.2 Billion Settlement
- GSK settled lawsuits worth $2.2 billion in the U.S. regarding Zantac (Ranitidine).
- The drug was found to contain excessive levels of N-nitrosodimethylamine (NDMA), a potent carcinogen.
Findings by Valisure
- Tests revealed NDMA levels exceeding 3,000,000 nanograms in some Ranitidine samples.
- U.S. permissible limit for NDMA is only 96 nanograms.
- High NDMA levels are attributed to molecular stability issues, not specific to GSK.
Global Regulatory Response
- U.S. FDA and European Medical Agency (EMA) banned Ranitidine sales in 2020.
- GSK voluntarily withdrew Ranitidine products from India in 2020.
India’s Inaction
- India’s Ministry of Health has not banned Ranitidine despite global alerts.
- Other companies continue to manufacture and sell Ranitidine in India.
Key Concerns
- Why didn’t Indian regulators detect impurities in Ranitidine earlier?
- Why hasn’t India banned Ranitidine despite substitutes like famotidine, cimetidine, and omeprazole?
Regulatory Framework in India
- Indian Pharmacopeia Commission (IPC) under the Ministry of Health sets impurity limits and testing protocols.
- IPC provides reference standards for drug quality assessments.
Quality Control:
- State drug controllers issue manufacturing licenses.
- State and Central drug inspectors conduct random sampling and testing.
IPC’s Role in the NDMA Issue
- IPC failed to detect NDMA in Ranitidine or update permissible limits and testing protocols post-2020.
- Access to the Indian Pharmacopeia is restricted due to its high cost (₹50,000).
- Public health standards like the Pharmacopeia should ideally be accessible for free.
Enforcement Challenges
- Drug manufacturers failing to meet impurity standards should be prosecuted.
- Manufacturers must stop production of Ranitidine if standards cannot be met.
Ban on Drugs with Public Health Risks
- Only the central government can ban drugs under Section 26A of the Drugs and Cosmetics Act, 1940.
- The Drug Regulation Section in the Ministry of Health, often headed by non-specialists, lacks technical expertise.
Call for Action
- After GSK’s settlement, the Ministry of Health must ban Ranitidine immediately under Section 26A.
- Strengthening technical competence in regulatory bodies is necessary for public safety.
Schooling in India in Times of Poor Air Quality
Relevance : GS 2(Governance), GS 3(Environment)
Practice Question:Evaluate how school closures can help in combat against air pollution. Suggest effective policies . (250 Words)
- AQI Thresholds: Harm starts at AQI >50, but current focus on “severe” levels (>400) normalizes ongoing health risks.
- Impact on Children: Air quality is similar at home and school; school closures cause learning and nutritional losses.
Problems with Online Classes
- Not a substitute for physical learning; screen exposure harms young children.
- Loss of holistic development and mid-day meals for underprivileged students.
Face Mask Concerns
- Blanket mandates lack scientific basis, especially for children under 12.
- Masks are redundant in air purifier setting.
Recommendations
- Keep schools open: Avoid closures; halt outdoor activities during poor AQI.
- Personalized mask use: Follow medical advice, not uniform mandates.
- Enhance air quality in schools: Use purifiers and ensure sealed classrooms.
- Prioritize physical learning: Discourage hybrid/online models.
- Health support: Promote regular checkups and vaccinations for vulnerable groups.
Policy Perspective
- GRAP measures disproportionately harm the poor.
- Delink school closures from AQI-based triggers.
- Focus on scientifically informed, pro-children policies.
Conclusion: School closures may not serve the purpose efficiently. A nuanced and child centric approach is need of the hour.
