Co-crystal: CDSCO states it is a new drug, while the patent office might disagree and say it is not a new drug.
The Central Drugs Standard Control Organisation issued a document on 15 September 2025 that clarifies the regulatory pathway for cocrystals in India. It addresses representations seeking clarity on the approval process for cocrystals. The document defines cocrystals as crystalline materials composed of two or more different molecules, typically an active pharmaceutical ingredient (API) and a coformer. It highlights the advantages of cocrystals, such as enhanced bioavailability, stability, and processability of APIs. The applicant must demonstrate that the physicochemical and pharmacokinetic properties of the cocrystal are superior to those of a physical mixture of the same chemical components. Characterisation methods like X-ray diffraction and spectroscopic analysis are used to define the cocrystal. If these criteria are met, it's considered a pharmaceutical cocrystal; otherwise, it's treated as a mixture. For cocrystals of already approved active substances, additional val...