India Takes Enforcement Action Against 90% of High-Risk Pharmaceutical Facilities in Nationwide Quality Drive

Following global scrutiny over child deaths linked to Indian-made cough syrups, India's drug regulator has taken enforcement action against 90% of high-risk pharmaceutical facilities. Since late 2022, the Central Drugs Standard Control Organisation has conducted over 960 risk-based audits, resulting in 860 enforcement actions. To manage over 10,000 facilities, the regulator has digitized 99% of its processes and is piloting AI tools.

India pharmaceutical quality enforcement

• ▪Since late 2022, Indian regulators have conducted more than 960 risk-based inspections and audits, with around 860 resulting in enforcement action.
• ▪India has taken enforcement action against approximately 90% of inspected pharmaceutical facilities identified as high-risk under a nationwide quality drive.
• ▪Enforcement actions against Indian pharmaceutical facilities ranged from stop-production orders and license suspensions to cancellations in the most serious cases.

Cough syrup child deaths

• ▪The Indian pharmaceutical quality crackdown follows global scrutiny of Indian-made drugs after child deaths were linked to Indian-made cough syrups.
• ▪Indian-made cough syrups were linked by global health authorities to child deaths in countries including Gambia, Uzbekistan, and Cameroon.

Risk-based inspection framework

• ▪India's risk-based inspection framework assesses manufacturing sites and testing labs based on risks to patients, product quality, compliance histories, recalls, and complaints.
• ▪Indian regulators oversee more than 10,000 manufacturing facilities and approximately 1 million pharmacies despite facing manpower constraints.

WHO standards alignment requirement

• ▪The deadline for Indian drug manufacturers to align with World Health Organization standards ended on December 31, 2025.
• ▪The Central Drugs Standard Control Organisation required drug manufacturers to align with World Health Organization standards to improve quality systems.

CDSCO digitization initiatives

• ▪The Central Drugs Standard Control Organisation relies on digital monitoring and risk-based inspections to manage oversight of pharmaceutical facilities.
• ▪More than 99% of processes at the Central Drugs Standard Control Organisation have been digitized to improve transparency, monitoring, and approval timelines.

AI tools for inspections

• ▪The Central Drugs Standard Control Organisation is piloting artificial intelligence tools to generate pre-inspection checklists, recommend regulatory actions, and draft inspection reports.
• ▪The Central Drugs Standard Control Organisation is piloting artificial intelligence tools to classify manufacturing facilities by risk levels and generate reports on serious adverse events.