Why in News: The Union Health Ministry directed strict compliance with revised Schedule M norms after reports of diethylene glycol (DEG) contamination in Coldrif cough syrup made by a private firm.
Background and Issues
1. India, a major global drug exporter, has faced repeated quality scandals affecting its reputation.
2. The Tamil Nadu Drugs Control Department found non-pharmacopoeial grade propylene glycol used in manufacturing — causing toxic contamination.
3. Violations of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) were recorded.
4. The Central Drugs Standard Control Organisation (CDSCO) recommended cancellation of the firm’s licence.
5. The tragedy underscores systemic regulatory laxity and reactive enforcement.
Challenges in India’s Drug Regulation
1. Fragmented regulatory structure between Centre and States causes weak coordination.
2. Inadequate manpower and infrastructure for routine inspections.
3. Lack of stringent penalties for repeat offenders.
4. Absence of real-time surveillance or random batch testing.
5. Delayed responses—action taken only after fatalities occur.
Way Forward
1. Enforce zero-tolerance policy for substandard drugs with strict legal action.
2. Strengthen CDSCO and State regulators with digital monitoring systems.
3. Conduct surprise inspections and third-party audits of manufacturing facilities.
4. Promote mandatory pharmacovigilance and transparent public reporting.
5. Invest in capacity-building and quality-testing infrastructure under Atmanirbhar Bharat.
Conclusion
Ensuring drug quality is integral to public health and global credibility. India must shift from reactive to preventive regulation, making accountability and compliance non-negotiable pillars of its pharmaceutical ambition.
Mains Practice Question:
Q. “Ensuring the quality of medicines is not merely a regulatory necessity but a moral imperative.” Examine in the context of recurring incidents of contaminated drugs and the need for stronger pharmaceutical regulation in India.