Publication:

Delayed availability of new antimicrobials in India

Background Considering the interplay of multiple factors involved in regulatory drug approvals, commercial market launching, patent regulations and drug pricing regulations on the accessibility to new antimicrobial drugs, their affordability and availability and the consequent impact on efforts to tackle antimicrobial resistance (AMR), it is prudent to examine the regulatory approvals of new antimicrobial drugs and their availability in India compared to U. S. Food and Drug Administration (USFDA).

Methods This was a cross-sectional study conducted in Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India between January 2025 and December 2025. Information on new antimicrobial agents (AMAs) approved for marketing by USFDA and CDSCO during the period 1970 to December 2025 were sourced from their respective websites.

Results The number of antimicrobials approved in India is considerably less compared to U. S. (74.0%-182/246) vs (90.7%-223/246). Antibacterials comprise about 52.2% (95/182) total AMA approvals, antivirals 27.5% (50/182). About 27.5% (36/131) antibacterials not approved in India vs 9.9% (13/131) in U. S. About 25.4% (17/67) antivirals not approved in India vs 4.5% (3/67) in U. S. About three fourth (72.3%-115/159) CDSCO approvals were delayed compared to FDA approvals. More than three fourth (76.6%) antivirals (36/47), (73.2%) antibacterials (60/82), (80%) anti TB drugs (4/5), (100%) antifungals (10/10), (40.0%) antimalarials (2/5)-CDSCO approval delayed. Median delay in CDSCO approval among antimicrobials approved after FDA approval was 4.0 years. The median delay was 5.0 years for antibacterials, 3.0 years for antifungals, 3.0 years for antivirals, and 9.0 years for anti-tuberculosis drugs.

Conclusions Along with a decrease in the number of new antimicrobial approvals in India, there appears to be delays in regulatory approval of antimicrobials as well when compared to USFDA. A reduction in the number of antimicrobials approved per year in India compared to U. S. may be interpreted as a reduction in the number of new antimicrobials submitted by pharmaceutical companies for CDSCO approval or increased time taken for the regulatory approval.