In December 2023, the government had amended the Drugs Rules 1945, revising Schedule M to mandate stricter quality control, equipment standards, and premises requirements. While 2,000 large manufacturers, with turnovers exceeding 250 crore, complied with the revised GMP guidelines by June 2024, the smaller firms were given until 31 December 2025, to upgrade their systems.
Govt mulls extension for pharma new manufacturing practice norms to bail out small firms
