DGCI Approvals


The Indian drug regulatory approval involves a detailed journey, starting with a feasibility study across R&D functions-F&D, Analytical Development, Method Validation, Packaging Development, and Quality Assurance/Quality Control. Post-feasibility, non-clinical data, supported by CRO, undergoes scrutiny.

Following non-clinical evaluation, a dossier is prepared, incorporating new drug substances, fixed-dose combinations, and multi-drug formulations, submitted to the DCGI for approval. A Subject Expert Committee reviews the application, ensuring thorough examination of safety and efficacy.

Subsequent phases include Bioequivalence (BE) studies and Phase-III Clinical Trials. The final milestone involves DCGI approval for manufacturing and marketing new molecules and FDCs. This process underscores our commitment to the highest standards, ensuring the safety and efficacy of pharmaceutical products.

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