India, March 30 -- image credit- freepik

India's pharmaceutical regulatory framework has long operated through a dual structure, wherein State Food and Drug Administrations (FDAs) are responsible for granting manufacturing licences, while the Central Drugs Standard Control Organisation (CDSCO) exercises oversight on new drugs, including requirements under the New Drugs and Clinical Trials Rules, 2019.

While this shared model is intended to balance decentralised efficiency with central scientific oversight, a structural gap has persisted for decades. In practice, certain pharmaceutical products that qualify as "new drugs" under the 2019 Rules (and previously under Schedule Y) have, at times, received manufacturing licences from State FDA...