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. This 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.
Regulatory Efforts
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.
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 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.
Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.
