India has taken enforcement action against about 90 per cent of high risk pharmaceutical manufacturing facilities inspected under a nationwide quality drive, as authorities intensify oversight following global concerns over the safety of some Indian made medicines.
According to Drugs Controller General of India Rajeev Raghuvanshi, regulators have conducted more than 960 risk based inspections and audits since late 2022, with around 860 facilities facing enforcement measures ranging from stop production orders and licence suspensions to licence cancellations in the most serious cases.
The crackdown forms part of a broader effort to strengthen pharmaceutical quality standards in India, often referred to as the “pharmacy of the world”, after Indian manufactured cough syrups were linked by global health authorities to child deaths in countries including The Gambia, Uzbekistan and Cameroon.
Speaking at the Global Drug Regulatory Conclave in New Delhi on July 30, Raghuvanshi said regulators identify quality gaps, notify manufacturers and provide time to correct deficiencies based on the severity of the issues and their potential impact on medicine quality.
The inspections are conducted under India’s risk based inspection framework, which assesses manufacturing plants and testing laboratories according to factors such as compliance history, product recalls, quality failures and consumer complaints.
The regulator has also required pharmaceutical manufacturers to align their operations with World Health Organization (WHO) standards as part of wider reforms aimed at improving quality systems, infrastructure and regulatory compliance. The compliance deadline expired on December 31.
India’s pharmaceutical regulator oversees more than 10,000 manufacturing facilities and about one million pharmacies, increasingly relying on risk based inspections and digital monitoring to improve efficiency despite manpower constraints.
Raghuvanshi said more than 99 per cent of processes at the Central Drugs Standard Control Organisation (CDSCO) have now been digitised, helping improve transparency, regulatory oversight and approval timelines.
The CDSCO is also piloting artificial intelligence tools to assist regulators by generating pre inspection checklists, recommending regulatory actions, drafting inspection reports and classifying manufacturing facilities according to their risk levels.
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