This initiative is part of a larger strategy to enhance quality standards in India, often referred to as the ”pharmacy of the world,” following reports linking Indian-made cough syrups to child fatalities in countries such as Gambia, Uzbekistan, and Cameroon.
Since the end of 2022, over 960 inspections and audits based on risk assessments have been conducted by regulators. About 860 of these led to enforcement actions, which ranged from production halts and license suspensions to outright cancellations in severe cases, as stated by Drugs Controller General of India Rajeev Raghuvanshi.
”We pinpoint deficiencies, notify manufacturers, and allow time for resolution based on the nature of the issues and their potential impact on quality,” he remarked at the Global Drug Regulatory Conclave in New Delhi on Thursday.
The inspections fall under India’s risk-based inspection framework, which evaluates manufacturing facilities and testing laboratories for potential risks to patient safety and product quality. Compliance histories, quality failures, recalls, and complaints are considered during these assessments.
The regulatory body has mandated drug manufacturers to comply with World Health Organization standards as part of a comprehensive effort to enhance quality systems, infrastructure, and regulatory adherence, Raghuvanshi noted. The compliance deadline was set for December 31.
This enforcement action takes place while regulators manage oversight of over 10,000 manufacturing facilities and approximately 1 million pharmacies, despite limitations in workforce, leading to a greater reliance on risk-based inspections and digital monitoring.
According to Raghuvanshi, more than 99% of processes at the Central Drugs Standard Control Organisation have been digitalized, significantly enhancing transparency, monitoring, and efficiency in approval timelines.
The CDSCO is also experimenting with artificial intelligence tools that assist in creating pre-inspection checklists, suggesting regulatory actions, drafting inspection reports, and categorizing manufacturing facilities by risk level.
Additionally, AI is being utilized to compile reports related to serious adverse events, he added.
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