Indian States Struggle to Fully Comply with Revised Pharmaceutical Manufacturing and Drug Quality Norms
Despite the Union Health Ministry's efforts to upgrade pharmaceutical standards, no Indian state has fully complied with the Corrective and Preventive Action (CAPA) guidelines. These guidelines are a crucial part of the revised Schedule M of the Drugs and Cosmetics Rules, aimed at ensuring global quality standards. While 18 states have adopted the Online National Drugs Licensing System (ONDLS), the implementation of CAPA remains voluntary and slow. This lack of compliance is concerning given recent international incidents involving adulterated Indian-made cough syrups. The Ministry emphasizes that CAPA is essential for systematic investigation and resolution of manufacturing defects.
Key Points
- The revised Schedule M is a critical update to India’s pharmaceutical manufacturing regulations to ensure safety and quality.
- CAPA (Corrective and Preventive Action) is a universal quality management methodology for process improvement in the pharma industry.
- The ONDLS is a single-window digital platform developed by CDAC and CDSCO for transparent drug licensing across India.
- Out of 5,308 MSME pharma companies, only 3,838 have complied with the revised Schedule M GMP standards so far.
Exam Facts
- Regulatory Framework: Revised Schedule M of Drugs and Cosmetics Rules.
- Digital Platform: Online National Drugs Licensing System (ONDLS).
- Implementing Agency: CDSCO and CDAC.
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