Online National Drugs licensing system (ONDLS) Platform

The Drugs & Cosmetics Act, 1940, and its rules assign responsibilities to both Central and State regulators to ensure the safety, rights, and well-being of patients through the regulation of drugs and cosmetics. CDSCO, alongside State Regulatory Authorities, strives to improve transparency, accountability, and uniformity in its services to ensure the safety, efficacy, and quality of medical products. The Online National Drugs Licensing System (ONDLS), developed by CDAC in collaboration with CDSCO, serves as a single-window platform for processing applications for manufacturing, sales licenses, and certificates. It establishes uniformity in documentation and licensing processes, ensuring consistent administration and promoting e-governance across India.

Use Cases

Enhanced Patient Safety: Ensures the safety, efficacy, and quality of drugs and cosmetics, protecting public health.
Improved Transparency: The ONDLS portal facilitates transparency in the licensing and regulatory processes, allowing for greater visibility of approvals and decisions.
Streamlined Processes: Simplifies application processes for manufacturing, sales licenses, and certifications like COPP, GMP, WHO-GMP, reducing bureaucracy.
E-Governance Integration: Utilizes modern technology to improve the administration of the Act, enabling better monitoring and decision-making.
Post-Approval Flexibility: Supports post-approval changes, ensuring compliance and adaptability in the regulatory process.
Accountability and Consistency: Enhances the accountability and consistency of State/UT Drug Control Authorities, ensuring reliable and uniform regulatory decisions across the country.

Salient Features

• Regulation of Drugs and Cosmetics: Entrusts Central and State regulators with the responsibility of ensuring safety, quality, and efficacy of drugs and cosmetics, safeguarding public health.
• Uniform Implementation: Ensures consistent enforcement of the Act and its Rules across India, promoting uniformity in the regulatory process.
• Transparency and Accountability: CDSCO and State Regulatory Authorities focus on improving transparency, accountability, and consistency in their decision-making.
• ONDLS Portal: A single-window online platform for processing applications related to manufacturing and sales licenses, including certifications like COPP, GMP, WHO-GMP.
• Consistent Licensing Process: Ensures uniform issuance of licenses and permissions by State/UT Drug Control Authorities nationwide.
• Improved Decision Making: Enhances the consistency and efficiency of decision-making, improving overall regulatory governance across India.