Each the ONDLS and CAPA are provisions underneath the Central authorities’s revised Schedule M, which is a important replace to India’s pharmaceutical manufacturing rules. Picture for illustration.
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Whereas 18 State drug management authorities throughout the nation have adopted the On-line Nationwide Medication Licensing System (ONDLS) for processing drug-related licences, no State has but absolutely complied with the Corrective and Preventive Motion (CAPA) pointers, confirmed a supply within the Union Well being Ministry.
Each the ONDLS and CAPA are provisions underneath the Central authorities’s revised Schedule M, which is a important replace to India’s pharmaceutical manufacturing rules.
“CAPA is essential for making certain security and sustaining excessive requirements in regulated industries comparable to prescribed drugs. Whereas the ONDLS streamlines drug licensing and regulatory compliance, CAPA is a common high quality administration methodology for course of enchancment,’’ the official stated.
Voluntary compliance [with CAPA] is essential for high quality upkeep, he stated, whereas talking in regards to the latest deaths of kids in Madhya Pradesh and Rajasthan because of consumption of adulterated cough syrup.
Corrective motion
CAPA can also be a top quality administration idea that focuses on systematically investigating and resolving issues to stop their recurrence. “Compliance with CAPA will be certain that drug violation is registered and corrective motion is taken,’’ the official stated.
The ONDLS is a digital, single-window platform for processing numerous drug-related licences in India and has been developed by the Centre for Growth of Superior Computing (C-DAC) in coordination with the Central Medication Commonplace Management Group (CDSCO).
“The system is designed to create a uniform, clear, and accountable course of for drug licensing throughout all States and Union Territories. It handles purposes for manufacturing and gross sales licences, blood banks, and numerous certificates, comparable to WHO-GMP,’’ defined the official.
Information shared with The Hindu present that of the overall 5,308 MSME pharma corporations (with a turnover of lower than ₹250 crore) in India, 3,838 have already complied with the revised Schedule M GMP.
Printed – October 07, 2025 09:35 pm IST
