Last Updated on October 21, 2025 by The Health Master
Cocrystals
In a significant twist to the Indian drug development scenario, the Central Drugs Standard Control Organization (CDSCO) has provided a crucial clarification about Cocrystals that is bound to affect the future of drug development in the country.
In a recent notification, effective September 15, 2025, the CDSCO has clarified that pharmaceutical cocrystals made from approved active pharmaceutical ingredients (APIs) shall be considered “new drugs“, therefore requiring companies to follow a more extensive regulatory pathway to ensure approval.
This crucial clarification about Cocrystals comes after representations were made from stakeholders in the industry for a clarified approval route for these substances.
The notification impacts any drug manufacturer practicing formulation and crystal engineering and requires compliance with the more extensive New Drugs and Clinical Trials Rules, 2019.
What are Cocrystals?
Pharmaceutical cocrystals are solid crystalline materials made up of two or more different molecules and are generally defined as having an active pharmaceutical ingredient (API) complex with a coformer or another molecule held together in a ratio through a non-covalent bond.
This non-covalent bond allows an excellent approach to modifying the physical properties of a drug without potentially changing its chemistry.
Pharmaceutical Cocrystals Provide the Following Benefits:
- Drug Bioavailability Enhancements: This means that the dissolved state of the cocrystal can enhance how well the drug works once absorbed.
- Improved API Stability: Should help to keep drugs safe from environmental effects.
- Better Processability: It generally makes processes easier.
What Changes in the Approval Process for Pharmaceutical Cocrystals?
Thus far, if companies were to incorporate an existing drug in pharmaceutical cocrystals, they would not have to assess this as a new drug.
However, now, the New Drugs and Clinical Trials Rules stipulate that an application for a pharmaceutical cocrystal must be treated as a new drug application.
This includes submissions to see if the following studies prove to show:
- Manufacturing Process Validation Studies—consistent methods of repeatability must show acceptance.
- Stability Studies—shelf life under varying degrees of temperature and environments must be reported.
- Additional Clinical and Non-clinical Studies—more than just simple indications must prove established safety and efficacy.
- Bioavailability/Bioequivalence (BA/BE) Studies—studies in the bioavailable/bioequivalent field must prove this form is superior to just an equally proportioned compound of components.
This clarification applies to state-appointed drug controllers and union territories on September 15, 2025, so all CDSCO zonal and port offices should also comply.
Q: What is the bottom line to take away from cocrystals ?
Any cocrystals made from approved active substances will not be considered as adjustments. They will be regarded as a new classification, meaning they must go through the New Drugs and Clinical Trials Rules, 2019.
Q: Why are they doing this?
To provide a clear and concise regulatory pathway for cocrystals, the rules were established so that the New Drugs and Clinical Trials Rules, 2019 would allow for specific safety and efficacy determinations resulting from more than just general data assessments.
Q: What studies must be obtained to consider approval?
Certain studies need to be undertaken, such as validation of the manufacturing process, stability studies, additional clinical and non-clinical studies, and bioavailability/bioequivalence (BA/BE) studies. The applicant must prove this new “drug” has more value than just an easy physical mixture of both components.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
Indian Drug Regulation Goes 97% Digital: CDSCO
New Draft Standards for TB IVD Medical Devices: CDSCO
New Draft Standards for IVD Medical Devices: CDSCO
CDSCO Approval: Panel Nod For Alfuzosin-Tadalafil FDC PMS Study
NPPA fixed retail price of 9 formulations: September 2025
USFDA issued Form 483 to Reddy’s with 5 observations: Hyderabad
USFDA approval granted for blood clotting drug: Alembic
USFDA puts import Alert on Sun Pharma: Halol
Indian Drug Regulation Goes 97% Digital: CDSCO
5 Northern State SDCs Unite Against Counterfeit Drugs
USFDA issued Form 483 to Biocon with 5 observations
USFDA issued Form 483 to Aurobindo with 8 observations
