What should be considered when developing a generic drug product for India?

Author : first copy | Published On : 16 Sep 2026

1. What should be considered when developing a generic drug product for India?

When developing a generic drug product for India, several technical, quality, and regulatory factors need to be considered. The generic drug development process should begin with selecting and evaluating the appropriate reference product, understanding the API properties, and defining the required quality and performance characteristics. During generic drug product development, formulation design, excipient selection, dissolution, assay, impurities, stability, packaging, and manufacturing processes should be carefully evaluated. Where applicable, bioavailability and bioequivalence requirements should also be assessed according to the relevant Indian regulatory guidelines. Developers should also consider the requirements of the Central Drugs Standard Control Organisation (CDSCO) and applicable Indian drug regulations when planning studies and preparing the regulatory submission. For generic product development, process development and scale-up are important to ensure that the product can be manufactured consistently at commercial scale. Stability studies should be designed according to the required storage conditions and intended shelf life. For solid oral dosage forms such as tablets and capsules, particular attention may be required for dissolution, drug release, formulation composition, and manufacturing process controls. Proper planning of these areas can help manage the generic drug development timeline, reduce development issues, and support a consistent and compliant product for the Indian market. Overall,