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India Cracks Down on Substandard Drugs, Hundreds of Factories Face Closure
11 Nov
Summary
- States issue closure warnings to drug firms not meeting new quality standards
- Deadline for compliance is December 31, 2025
- MSME drug makers represent 80% of India's 10,000+ pharma manufacturers
As of November 11, 2025, drug regulators in several Indian states have initiated a crackdown on pharmaceutical manufacturers that are not complying with updated Good Manufacturing Practice (GMP) guidelines. The Drugs Controller General of India (DCGI) has directed all state authorities to conduct urgent inspections and take action against non-compliant firms.
States like Delhi, Himachal Pradesh, Uttarakhand, and Rajasthan have already started issuing closure warning notices to companies that fail to meet the new GMP standards. These firms have been given a deadline of December 31, 2025, to upgrade their facilities and operations. Failure to do so will result in the shutdown of their manufacturing units.
The push for stricter quality control comes after recent incidents where drugs from India were linked to the deaths of children in Gambia and Uzbekistan. While larger pharmaceutical companies had to comply with the new GMP guidelines earlier, Micro, Small, and Medium Enterprises (MSMEs) were given an extension until the end of 2025. However, only a limited number of MSME firms availed of this provision, and regulators are now conducting comprehensive inspections of the remaining units.
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Regulators emphasize that the goal is to ensure the production of safe, effective, and high-quality medicines, both for domestic consumption and exports. India holds a dominant position as the world's largest provider of generic medicines, and strengthening GMP adherence is crucial to maintaining the country's global reputation in the pharmaceutical industry.
