Why in news?

• Eighteen states have adopted the ONDLS portal for processing drug-related licenses, marking a significant move towards nationwide digital governance for pharma regulation.
• Despite this adoption, no state is yet fully compliant with the Corrective and Preventive Action (CAPA) guidelines, which are essential for quality management and ensuring corrective actions after lapses.

Key Features and Functions of ONDLS

• ONDLS is a single-window online system developed jointly by the Centre for Development of Advanced Computing (CDAC), Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, and State/UT Drug Regulatory Authorities.
• It streamlines applications for manufacturing, sales, and blood bank licenses, as well as certificates like COPP, GMP, WHO-GMP, Market Standing, and supports post-approval changes.
• The portal ensures transparency, uniformity, and accountability in documentation and licensing requirements nationwide

Benefits

• Enhanced patient safety through better regulation and traceability.
• Efficient, transparent, and accountable licensing process nationally.
• Easier compliance monitoring and post-approval flexibility for regulatory changes.

This system plays a crucial role in modernizing India’s drug licensing ecosystem, supporting e-governance, and making regulatory processes more reliable and accessible.

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