India's top drug regulator has revealed that enforcement actions were taken against 90% of inspected high-risk pharmaceutical facilities, signaling a major shift in oversight for the country often called the “pharmacy of the world.” The crackdown follows international scrutiny after Indian-made cough syrups were linked to child deaths in Gambia, Uzbekistan, and Cameroon. Main Developments Since late 2022, regulators conducted over 960 risk-based inspections and audits. Around 860 resulted in enforcement actions, including stop-production orders, license suspensions, and cancellations for the most serious cases. Drugs Controller General of India Rajeev Raghuvanshi announced the figures at the Global Drug Regulatory Conclave in New Delhi on Thursday. He explained that facilities are assessed based on risks to patients and product quality, considering compliance histories, quality failures, recalls, and complaints. Read also: Why Jordan's interception of Iranian missiles matters now Raghuvanshi said authorities identify gaps, inform manufacturers, and give them time based on the severity of issues and their impact on medicine quality. The regulator also required drug manufacturers to align with World Health Organization standards, with a deadline that ended on December 31. Background India's pharmaceutical industry operates over 10,000 manufacturing facilities and about 1 million pharmacies, yet faces manpower constraints. This has increasingly forced reliance on risk-based inspections and digital monitoring to maintain oversight. The crackdown stems from a broader quality drive triggered by global health authorities linking Indian-made cough syrups to child deaths overseas. The incidents prompted heightened international scrutiny and domestic pressure to strengthen quality standards. Why It Matters India supplies a significant portion of the world's generic medicines, so quality failures there can have global consequences. The enforcement actions signal that regulators are moving beyond rhetoric to impose tangible consequences on non-compliant manufacturers. More than 99% of processes at the Central Drugs Standard Control Organisation have been digitised, improving transparency, monitoring, and approval timelines. The CDSCO is also piloting artificial intelligence tools to generate pre-inspection checklists, recommend regulatory actions, draft inspection reports, and classify facilities by risk levels. What's Next AI is being used to generate reports related to serious adverse events, according to Raghuvanshi. The regulator's enforcement actions are likely to continue as inspections expand under the risk-based framework. Manufacturers that failed to meet the December 31 WHO alignment deadline may face further scrutiny. The outcome of these efforts could determine whether India restores international confidence in its pharmaceutical exports or faces continued global pressure.