18 States Adopt ONDLS, CAPA Compliance Pending

India has made strides in modernising its pharmaceutical regulatory framework in 2025. The adoption of the Online National Drugs Licensing System (ONDLS) by 18 State drug control authorities marks a move towards digital governance. However, full compliance with the Corrective and Preventive Action (CAPA) guidelines remains pending across all States. These reforms form part of the Central government’s revised Schedule M, which updates manufacturing and quality standards in the pharmaceutical sector.

Online National Drugs Licensing System (ONDLS)

The ONDLS is a digital platform developed by the Centre for Development of Advanced Computing (C-DAC) and the Central Drugs Standard Control Organization (CDSCO). It offers a single-window system for processing drug-related licences uniformly across India. The platform manages applications for manufacturing licences, sales licences, blood bank certifications, and WHO-GMP certificates. This system aims to create transparency, accountability, and efficiency in drug licensing procedures.

Corrective and Preventive Action (CAPA) Guidelines

CAPA is a quality management approach focused on identifying, investigating, and rectifying issues to prevent their recurrence. It is critical in regulated industries like pharmaceuticals to maintain safety and product integrity. CAPA ensures that any violation or defect in drug manufacturing is formally recorded and addressed through corrective measures. Voluntary compliance with CAPA is essential to uphold high standards and protect public health.

Revised Schedule M and Its Impact

Schedule M is a regulatory framework that sets Good Manufacturing Practices (GMP) for pharmaceutical companies. The 2025 revision strengthens quality control and safety protocols. Over 3,800 micro, small, and medium enterprises (MSMEs) in the pharmaceutical sector, out of 5,308, have complied with the new GMP standards. This compliance is vital for ensuring the safety of medicines and preventing incidents like the recent adulterated cough syrup tragedy in Madhya Pradesh and Rajasthan.

Challenges in Implementation

Despite technological advances with ONDLS, no State has fully implemented the CAPA guidelines. This gap marks challenges in regulatory enforcement and quality assurance. The lack of mandatory CAPA compliance risks repeated safety failures. Strengthening regulatory oversight and encouraging uniform adherence to CAPA are necessary steps to safeguard the pharmaceutical supply chain.

Significance for Public Health

The reforms under Schedule M, including ONDLS and CAPA, aim to enhance drug safety and quality. Efficient licensing combined with robust quality management reduces risks of substandard and adulterated medicines. This is crucial to protect vulnerable populations, especially children, from harmful pharmaceutical products. The government’s focus on digitalisation and quality control reflects a commitment to modernising healthcare regulation.