The Central Drugs Standard Control Organisation (CDSCO) has issued a clarification stating that cocrystals of already approved active substances will be treated as new drugs under Indian regulations. Companies seeking approval for such products must submit applications in line with the New Drugs and Clinical Trials Rules, 2019.

The clarification follows stakeholder requests for clarity on the regulatory pathway for cocrystals. According to CDSCO, if the solid-state structure and properties of a cocrystal are established using methods such as single-crystal XRD, powder XRD, electron diffraction, or spectroscopic analyses like IR, Raman, near-IR, or NMR, the formulation will qualify as a pharmaceutical cocrystal or supramolecular complex drug. Otherwise, it will be treated as a fixed-dose combination (FDC) or a mixture of APIs.

Since these cocrystals are considered new drugs, they may require validation of the manufacturing process, stability data, additional clinical and non-clinical studies, and bioavailability or bioequivalence studies to demonstrate safety and efficacy.

Pharmaceutical cocrystals, composed of an API and a coformer in the same crystal lattice, are known to improve bioavailability, stability, and processability during manufacturing. They also allow the development of solid-state forms for APIs that lack ionizable functional groups, which are usually required for salt formation.

Regulators emphasized that applicants must demonstrate superior physicochemical and pharmacokinetic properties of the cocrystal compared to a physical mixture of the same components. Applications will now be processed as those for new active substances under existing regulatory norms.