Drug Regulation and Public Health
- India’s aspiration to become the “pharmacy of the world” and realize Atmanirbhar Bharat is being undermined by recurring incidents of poor-quality pharmaceuticals, especially cough syrups.
- Recent deaths of children in Rajasthan and Madhya Pradesh were linked to contaminated cough syrups containing diethylene glycol (DEG), a nephrotoxic (kidney-damaging) substance, detected in products from a Tamil Nadu manufacturer. Initial Health Ministry tests did not confirm DEG except in one batch, but further investigation by Tamil Nadu authorities revealed significant contamination.
Regulatory Response and Findings
- The manufacturing facility violated several Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), including the use of non-pharmacopoeial grade propylene glycol, which led to the contamination.
- The Central Drugs Standard Control Organization (CDSCO) recommended cancellation of the company''s manufacturing license, and the doctor responsible for prescribing the syrup was arrested under relevant legal provisions.
- The editorial condemns incident-driven regulatory action and highlights that these failures expose systemic gaps in India’s drug regulation regime, including lax enforcement, sporadic inspections, and poor inter-State coordination.
Policy Recommendations
- India must adopt a zero-tolerance policy toward substandard drugs to protect public health and credibility as a pharma exporter.
- Monitoring must be continuous ("hawk-like"), with surprise inspections, swift punitive action for every violation, and criminal liability for negligent manufacturers.
- Quality assurance should match manufacturing scale, and regulatory vigilance must shift from crisis management to proactive preventive surveillance.
- Recommendations include strengthening CDSCO and State drug regulators, technology-enabled traceability of drug batches, transparent publication of test results, and public accountability mechanisms.
Broader Implications
- Repeated lapses damage India’s international credibility, threaten public safety, and erode trust in the domestic healthcare system.
- Achieving "self-reliance" in manufacturing is not enough unless uncompromising standards of quality and public safety are maintained.
- The editorial’s tone is urgent, demanding structural reforms and rigorous accountability across the pharma sector.
To truly achieve Atmanirbhar Bharat and global leadership in pharmaceuticals, India’s regulatory regime must move from reactive “damage control” to proactive, non-negotiable standards of public safety and manufacturing quality.
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