India takes action against 90% of inspected high-risk pharmaceutical facilities, regulator says

NEW DELHI: India has taken enforcement action against about 90% of inspected pharmaceutical facilities identified as high-risk under a nationwide quality drive, the drug regulator’s chief said, as authorities step up oversight following global scrutiny of Indian-made drugs.

The crackdown is part of a broader effort to strengthen quality standards in India, often called the “pharmacy of the world”, after Indian-made cough syrups were linked by global health authorities to child deaths in countries including Gambia, Uzbekistan and Cameroon.

Since late 2022, regulators have conducted more than 960 risk-based inspections and audits. Around 860 resulted in enforcement action, ranging from stop-production orders and licence suspensions to cancellations in the most serious cases, according to Drugs Controller General of India Rajeev Raghuvanshi.

“We identify gaps, inform manufacturers and give them time depending on the kind of issues and the severity of the impact on medicine quality,” he said at the Global Drug Regulatory Conclave in New Delhi on Thursday.

The inspections were conducted under India’s risk-based inspection framework that assesses facilities such as manufacturing sites and testing labs based on the risks they may pose to patients and product quality. The inspections account for compliance histories, quality failures, recalls and complaints.

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The regulator has also required drug manufacturers to align with World Health Organization standards as part of a wider effort to improve quality systems, infrastructure and regulatory compliance, Raghuvanshi said. The deadline for that ended on December 31.

The enforcement comes as regulators oversee more than 10,000 manufacturing facilities and about 1 million pharmacies despite manpower constraints, increasing reliance on risk-based inspections and digital monitoring.

More than 99% of processes at the Central Drugs Standard Control Organisation have been digitised, Raghuvanshi said, helping improve transparency, monitoring and approval timelines.

The CDSCO is also piloting artificial intelligence tools that offer support such as generating pre-inspection checklists, recommending regulatory actions, drafting inspection reports and classifying manufacturing facilities according to risk levels.

AI is also being used to generate reports related to serious adverse events, he said.