India Cracks Down on 90% of High-Risk Pharma Plants, Regulator Reports

The Central Drugs Standard Control Organisation (CDSCO) conducted inspections of 400 high-risk pharmaceutical manufacturing units across the country, leading to enforcement actions such as product recalls, suspension of manufacturing licenses, and regulatory warnings. The initiative, which began in early 2023, targeted facilities identified as high-risk based on past compliance records, market complaints, and product categories.

According to the regulator, the inspections were part of a broader strategy to strengthen drug quality oversight after a series of global concerns about Indian-made pharmaceuticals. The CDSCO has also increased the number of inspectors and adopted a risk-based approach to prioritize facilities with a higher likelihood of non-compliance.

The enforcement actions have resulted in the shutdown of several plants, with some manufacturers facing legal proceedings. The regulator has also issued guidelines for corrective actions, requiring companies to submit remediation plans and undergo re-inspection before resuming operations.

The crackdown is expected to continue, with the CDSCO planning to inspect all high-risk facilities by the end of the fiscal year. The regulator has emphasized its commitment to ensuring the safety and efficacy of drugs manufactured in India, which supplies a significant portion of the global pharmaceutical market.