‘No State has fully complied with key drug quality norms’, Pg12

Key Highlights:

• 18 State drug control authorities in India have adopted the Online National Drugs Licensing System (ONDLS) for processing drug licences.
• No State has fully complied with the Corrective and Preventive Action (CAPA) guidelines, as per the Union Health Ministry.
• ONDLS and CAPA are provisions under the Central government’s revised Schedule M, an update to pharmaceutical manufacturing regulations.
• Out of 5,308 MSME pharma companies in India, 3,838 have complied with the revised Schedule M GMP.

Detailed Insights:

• CAPA is essential for ensuring safety and maintaining high standards in the pharmaceutical industry through process improvement.
• Voluntary compliance with CAPA is crucial for quality maintenance and preventing incidents like the recent deaths of children due to adulterated cough syrup.
• ONDLS is a digital platform developed by the Centre for Development of Advanced Computing (CDAC) in coordination with the CDSCO.
• ONDLS aims to create a uniform, transparent, and accountable process for drug licensing across all States and Union Territories, handling applications for manufacturing and sales licences.
• Schedule M of the Drugs and Cosmetics Rules, 1945 prescribes Good Manufacturing Practices (GMP) for pharmaceutical products.
• Revised Schedule M mandates advanced quality management, testing of raw materials, and stability studies, aligning Indian standards with global benchmarks like those of the WHO.

Key Concepts Involved:

• CAPA (Corrective and Preventive Action): A quality management methodology used to systematically investigate and resolve problems.
• ONDLS (Online National Drugs Licensing System): A digital single-window platform for processing drug-related licenses in India.
• Schedule M: Part of the Drugs and Cosmetics Rules that outlines Good Manufacturing Practices for pharmaceutical production in India.
• GMP (Good Manufacturing Practices): A system for ensuring that products are consistently produced and controlled according to quality standards.