Both the ONDLS and CAPA are provisions under the Central government’s revised Schedule M, which is a critical update to India’s pharmaceutical manufacturing regulations. Image for representation.
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While 18 State drug control authorities across the country have adopted the Online National Drugs Licensing System (ONDLS) for processing drug-related licences, no State has yet fully complied with the Corrective and Preventive Action (CAPA) guidelines, confirmed a source in the Union Health Ministry.
Both the ONDLS and CAPA are provisions under the Central government’s revised Schedule M, which is a critical update to India’s pharmaceutical manufacturing regulations.
“CAPA is crucial for ensuring safety and maintaining high standards in regulated industries such as pharmaceuticals. While the ONDLS streamlines drug licensing and regulatory compliance, CAPA is a universal quality management methodology for process improvement,’’ the official said.
Voluntary compliance [with CAPA] is crucial for quality maintenance, he said, while speaking about the recent deaths of children in Madhya Pradesh and Rajasthan due to consumption of adulterated cough syrup.
Corrective action
CAPA is also a quality management concept that focuses on systematically investigating and resolving problems to prevent their recurrence. “Compliance with CAPA will ensure that drug violation is registered and corrective action is taken,’’ the official said.
The ONDLS is a digital, single-window platform for processing various drug-related licences in India and has been developed by the Centre for Development of Advanced Computing (C-DAC) in coordination with the Central Drugs Standard Control Organization (CDSCO).
“The system is designed to create a uniform, transparent, and accountable process for drug licensing across all States and Union Territories. It handles applications for manufacturing and sales licences, blood banks, and various certificates, such as WHO-GMP,’’ explained the official.
Data shared with The Hindu show that of the total 5,308 MSME pharma companies (with a turnover of less than ₹250 crore) in India, 3,838 have already complied with the revised Schedule M GMP.
Published – October 07, 2025 09:35 pm IST
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