Govt Plans Central Licensing for Sterile Drug Makers

The government plans to bring all sterile drug products under a central licensing system to tighten oversight following quality lapses. Around 240 injection samples were found not of standard quality in FY26, prompting the move to shift licensing from state authorities to the Central License Approving Authority. The proposal aims to replace the fragmented state-level system with uniform approval and inspection standards nationwide. It would require amendments to the Drugs Rules, 1945, and is intended to strengthen confidence in the quality of injectables and other sterile medicines manufactured for domestic and export markets. Higher compliance requirements are expected to raise the regulatory bar for sterile drug makers, particularly smaller units. The initiative forms part of broader efforts to improve manufacturing standards and address quality concerns in the pharmaceutical sector. **Top stocks in the pharmaceuticals industry:** Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, and