INDIAN DRUG APPROVALS FROM 2014 TO 2024: INSIGHTS INTO REGULATORY AND THERAPEUTIC SHIFTS

Objective: To analyse the trends and patterns in drug approvals granted by the Central Drugs Standard Control Organization (CDSCO) in India from 2014 to 2024, with a focus on dosage forms, routes of administration, therapeutic areas, and the role of xed-dose drug combinations (FDDCs). Materials and Methods: Data was analyzed from the Central Drugs Standard Control Organization (CDSCO) new drug approvals between 2014 and 2024. A comprehensive review of dosage forms, routes of administration (ROA), therapy areas, single drug approvals, Fixed-Dose Drug Combinations (FDDCs), and yearly approval trends was conducted. Results: Between 2014 and 2024, a total of 304 drugs were approved, with a mean of 27.6±7.3 per year. The highest approvals occurred in 2014 (n=44). Single drugs accounted for 278 approvals, while 26 were FDDCs. The most frequent therapeutic areas were oncology (n=53) and infectious diseases (n=44). Oral dosage forms were predominant (190; 62.5%), especially tablets (n=145; 47.7%), followed by parenteral formulations (69; 22.7%) and injections (50; 16.4%). Conclusion: Drug approvals in India over the past decade show a predominance of oral dosage forms and therapies for cancer and infections, reecting national health priorities. The cautious but consistent inclusion of FDDCs highlights regulatory emphasis on evidence-based combinations while balancing innovation and patient safety.