Ensuring Drug Safety in India – Union Health Ministry Push for Revised Schedule M Norms

Ensuring Drug Safety in India Latest News

• The Union Health Ministry has intensified regulatory measures following reports of adulterated cough syrup leading to child deaths in Rajasthan and Madhya Pradesh. 
• The move underscores India’s efforts to strengthen pharmaceutical quality standards under the revised Schedule M norms of the Drugs and Cosmetics Act, 1940.

Key Developments

• Trigger event: 

• • Over 10 children died in Rajasthan and Madhya Pradesh after consuming cough syrups.
  • Investigations ruled out infectious diseases, and out of 10 samples tested, one—Coldrif cough syrup—was found with diethylene glycol (DEG) beyond permissible limits.

• Regulatory action taken:

• • Tamil Nadu Drugs Control Department ordered an immediate stop to production of Coldrif.
  • Inspection by the Central Drugs Standard Control Organisation (CDSCO) recommended cancellation of the manufacturing license.
  • Criminal proceedings initiated against the concerned unit in Kancheepuram.

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Revised Schedule M Norms

• About Schedule M: Schedule M defines the minimum standards for Good Manufacturing Practices (GMP) for pharmaceutical products in India under the Drugs and Cosmetics Act, 1940, and Rules, 1945, aligning with international standards.

• Revised norms:

• • Notified in (Jan) 2024, the revised norms introduce a comprehensive Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), and Product Quality Review (PQR).
  • Key updates also cover mandatory computerised storage systems, equipment and process validation, more specific rules for hazardous drug products, etc. 
  • It aims to improve product quality, safety, and international harmonisation, with phased implementation timelines based on manufacturer turnover.  
• Implementation deadline: December 31, 2025.

Government’s Directives

• Strict compliance: Licenses of non-compliant drug manufacturers will be cancelled.
• Enhanced surveillance: All States/UTs to ensure timely reporting of adverse drug reactions and deaths.
• Integrated monitoring: Use of the Integrated Disease Surveillance Programme (IDSP) and Integrated Health Information Platform (IHIP) for community-level reporting.
• Rational use of cough syrups: Awareness promoted among doctors and parents, especially for children, since most coughs are self-limiting.
• Inter-state coordination: Strengthened cooperation for early detection and joint action.

Way Forward

• Strengthening drug regulation: Ensure uniform enforcement of Schedule M norms across States.
• Capacity building: Training drug inspectors, upgrading labs, and digital monitoring systems.
• Industry compliance: Support pharmaceutical units in infrastructure upgrade for GMP compliance.
• Public awareness: Promote safe drug usage and discourage irrational consumption of cough syrups.
• International image: Restoring trust in Indian pharma exports by aligning with WHO standards.

Conclusion

• The Coldrif incident highlights recurring lapses in drug quality monitoring in India. 
• The Union Health Ministry’s push for strict compliance under revised Schedule M is a crucial step to safeguard public health, particularly children. 
• A coordinated approach will be essential to prevent future tragedies and strengthen India’s pharmaceutical reputation globally.

Source: TH