Government Mandates Strict Compliance with Revised Schedule M Norms for Pharmaceutical Quality Control
The Union Health Ministry has directed drug manufacturers to strictly comply with the revised Schedule M norms under the Drugs and Cosmetics Act, 1940. This move follows reports of toxic cough syrups causing child deaths in Madhya Pradesh and Rajasthan. The revised norms mandate enhanced quality systems, including Pharmaceutical Quality Systems (PQS) and Quality Risk Management (QRM). Non-compliant units face license cancellation. The goal is to align Indian manufacturing standards with international Good Manufacturing Practices (GMP) to ensure product safety, prevent contamination like diethylene glycol (DEG), and maintain the global reputation of Indian pharmaceuticals.
Key Points
- Schedule M of the Drugs and Cosmetics Act, 1940, prescribes the Good Manufacturing Practices (GMP) for pharmaceutical products in India.
- The revision introduces computerized storage systems and equipment validation to prevent contamination.
- Recent investigations found high levels of diethylene glycol (DEG) in 'Coldrif' cough syrup, leading to immediate production stops.
- The compliance deadline for these enhanced quality standards is December 31, 2025.
- The Central Drugs Standard Control Organisation (CDSCO) recommended the cancellation of manufacturing licenses for non-compliant units.
Exam Facts
- The revised Schedule M is part of the Drugs and Cosmetics Act, 1940.
- Diethylene glycol (DEG) was the toxic contaminant found in the banned Coldrif syrup.
- The compliance deadline for the revised norms is December 31, 2025.
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