January 1, 2026, was a milestone of sorts in the Indian drug industry. As of that date, all manufacturers, small and large, are required to comply with the December 2023 amendments to Schedule M of the Drugs and Cosmetics Act, 1940, and Rules, 1945, that relate to Good Manufacturing Practices (GMP) and Quality Risk Management [1]. The amendments detail the requirements of premises, plant, and equipment for pharmaceutical production. The change, if implemented, is intended to upgrade Indian pharmaceutical manufacture to the standards of the World Health Organisation’s Guidelines on Production, that include GMP [2]. They would also move closer to the International Council Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH brings together regulatory authorities and the pharmaceutical industry to discuss issues relating to registration of drugs, and has developed quality guidelines based on GMP [3].