Contents:

1. Ban this carcinogenic ‘heart-burn’ drug
2. 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.