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 validation of manufacturing, stability studies, clinical and non-clinical studies, and bioavailability/bioequivalence studies may be required. Such cocrystals are considered new drugs, and their applications are processed accordingly, adhering to the New Drugs and Clinical Trials Rules, 2019. The CDSCO document can be accessed here. While the CDSCO document treats cocrystals of approved substances as new drugs, the Indian Patent Act has historically been more restrictive in granting patents for them, specifically under Section 3(d). This section of the act prevents the patenting of a new form of a known substance unless it significantly enhances its known efficacy. Since cocrystals are often considered a new solid-state form of an existing API, they can be denied patents on the grounds of lacking novelty or inventive step. This creates a contradiction: a substance is considered a "new drug" for regulatory approval by the CDSCO, but may not be considered "new" enough to be patented under the Indian Patent Act. The regulatory body acknowledges the potential for enhanced efficacy. Still, the patent office may not see this enhancement as sufficient to meet the strict criteria for a patentable invention, creating a disconnect between the two legal frameworks.