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Pharmaceutical Quality and Atmanirbhar Bharat: The Need for Zero Tolerance on Drug Safety

Reference Article: The Hindu

UPSC CSE Relevance:

– GS Paper II: Governance, public health, accountability
– GS Paper III: Indian industries, Make in India
– Essay Paper: Public trust and governance in industrial self-reliance

The vision of Atmanirbhar Bharat (self-reliant India) is rooted in building domestic capacity, innovation and global competitiveness. However, without a strong quality control and regulatory framework, self-reliance risks being undermined by unsafe and substandard production — particularly in sensitive sectors such as pharmaceuticals. India’s ambition of becoming the “pharmacy of the world” has been challenged by recurring episodes of poor-quality drugs, especially cough syrups contaminated with toxic chemicals.

Recently, the Union Health Ministry directed all pharmaceutical manufacturers to comply strictly with the revised Schedule M norms, following reports of deaths of children in Rajasthan and Madhya Pradesh linked to the cough syrup Coldrif. Tests conducted by the Tamil Nadu Drugs Control Department revealed diethylene glycol (DEG) contamination in samples, despite earlier tests ruling it out. Further inspection found non-compliance with Good Manufacturing Practices (GMP) and the use of non-pharmacopoeial grade propylene glycol, which likely caused contamination with DEG and ethylene glycol, both highly toxic substances. Consequently, the Central Drugs Standard Control Organisation (CDSCO) recommended cancellation of the firm’s licence, while legal action was initiated against a doctor involved in prescribing the syrup.

Key Issues Highlighted

  • Systemic quality lapses: Repeated violations in adherence to GMP and laboratory protocols.
  • Reactive regulation: Action follows fatalities rather than preventive oversight.
  • Fragmented enforcement: State-level drug control bodies often lack coordination and resources.
  • Reputation risk: Substandard exports threaten India’s credibility in global pharmaceutical markets.

The Way Forward

  • Zero-tolerance policy: Treat any breach in drug safety as criminal negligence.
  • Continuous surveillance: Surprise inspections and random testing of production batches.
  • Accountability at all levels: Penal action against both manufacturers and officials failing oversight.
  • Strengthen CDSCO and State Drug Control Departments: Ensure manpower, labs, and technology for real-time monitoring.
  • Global alignment: Enforce compliance with WHO and international GMP standards to sustain exports and trust.

Conclusion

Atmanirbhar Bharat cannot rest on compromised quality. The integrity of India’s pharmaceutical ecosystem must match its scale. A vigilant, science-based regulatory regime that prevents rather than reacts to violations is essential to protect lives, uphold public trust, and position India as a reliable health supplier to the world.

Sample UPSC Mains Question (GS Paper III):

Discuss how the recurring lapses in pharmaceutical quality control challenge India’s vision of Atmanirbhar Bharat. Suggest policy and institutional reforms to ensure global trust in Indian medicines.