Dossier
Drugs Rules, 1945
Coverage of Drugs Rules, 1945 in the Nexus archive.
- Govt. amends rules to strengthen regulation of drug formulations with high alcohol content
The government has amended rules to require licenses for high alcohol-containing drug formulations and restrict their dispensing to prescription under Schedule H1 of the Drugs Rules, 1945. This aims to strengthen regulation of such formulations.
- Centre amends Drugs Rules, 1945 to ensure uniform regulation of advance cell and gene therapies
The Centre has amended the Drugs Rules, 1945 to establish uniform regulation for advanced cell and gene therapies, including stem cell-based regenerative treatments and CAR-T cell therapies. These therapies are increasingly used to treat blood cancers like leukemias and lymphomas, and the amendment aims to strengthen regulatory oversight of emerging medical technologies.