Delayed availability of new antimicrobials in India
DOI:
https://doi.org/10.18203/2394-6040.ijcmph20260758Keywords:
Anti-infective agents, Drug approval, Drug and narcotic control, India, USFDAAbstract
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.
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References
Noncommunicable diseases. Available at: https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases. Accessed on 27 February 2026.
Gargate N, Laws M, Rahman KM. Current economic and regulatory challenges in developing antibiotics for Gram-negative bacteria. npj Antimicrob Resist. 2025;3(1):50. DOI: https://doi.org/10.1038/s44259-025-00123-1
Parasrampuria S, Murphy S. Comparing U. S. and International Market Size and Average Pricing for Prescription Drugs, 2017-2022: Issue Brief. Washington (DC): Office of the Assistant Secretary for Planning and Evaluation (ASPE); (HHS ASPE Reports); 2024.
Patent Reform and Public Health: India’s TRIPS Journey in Pharmaceutical Law | International Journal of Scientific Development and Research. Available at: https://ijsdr.org/viewpaperforall.php?paper=IJSDR2510049. Accessed on 27 February 2026.
CBCL. Regulating the Generic Drugs Market: Eliminating the difference between Branded and Unbranded Generics. NLIU CBCL. 2022. Available at: https://cbcl.nliu.ac.in/competition-law/regulating-the-generic-drugs-market-eliminating-the-difference-between-branded-and-unbranded-generics/. Accessed on 27 February 2026.
Mehta A, Nancy, Sonkala S, Mishra AK. Harmonizing Access to Medicine: Exploring India’s Process Patent in Intellectual Property Rights Amid Global Pressures. Int Tinnitus J. 2024;28(1):60-4. DOI: https://doi.org/10.5935/0946-5448.20240011
Balancing Innovation with Access to Generic Medicines. Available at: https://www.iiprd.com/ from-pharmacy-of-the-world-to-patent-prison-indias-shift-under-trips/. Accessed on 27 February 2026.
Chaudhuri S. Are Medicine Prices High And Unaffordable After Trips? Evidence From Pharmaceutical Industry In India. Commentary on India’s Economy and Society Series. 2019;10.
Bhaduri S, Brenner T. Determinants of drug launch delay in pre-TRIPS India: A survival analysis approach. Working Papers on Innovation and Space. 2011. Available at: https://ideas.repec.org//p/ pum/wpaper/2011-05.html. Accessed on 27 February 2026.
Bhaduri S, Ray AS. A game theoretic model of drug launch in India. Health Econ Policy Law. 2006;1(Pt 1):23-39. DOI: https://doi.org/10.1017/S1744133105001118
Cockburn IM, Lanjouw JO, Schankerman M. Patents and the Global Diffusion of New Drugs. American Economic Review. 2016;106(1):136-64. DOI: https://doi.org/10.1257/aer.20141482
Danzon PM, Wang YR, Wang L. The impact of price regulation on the launch delay of new drugs--evidence from twenty-five major markets in the 1990s. Health Econ. 2005;14(3):269-92. DOI: https://doi.org/10.1002/hec.931
Kataria BC, Mehta DS, Mehta SJ. Drug Lag For Antimicrobial Agents: Comparison of the US, EU and India Approvals. National J Med Res. 2012;2(03):264-8.
Narayan S. Price Controls on Pharmaceutical Products in India. Singapore: NUS Institute of South Asian Studies. Institute of South Asian Studies. 2007;46.
Joosse IR, Mantel-Teeuwisse A, Ham HA van den, Arevalo LC. Availability of essential medicines for non-communicable diseases: a scoping review of challenges and opportunities. BMJ Glob Health. 2025;10(11):e019634. DOI: https://doi.org/10.1136/bmjgh-2025-019634
Approved New Drugs. Available at: https://cdsco.gov.in/opencms/opencms/en/Approval_new/Approved-New-Drugs/. 2026. Accessed on 27 February 2026.
Drugs@FDA: FDA-Approved Drugs. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed on 27 February 2026.
Pharma Innovation vs Patient Access: Why Drugs Lag in India. Available at: https://www.mrmed.in/ health-library/health-care/pharma-innovation-vs-patient-access-india. Accessed on 27 February 2026.
Shrestha J, Zahra F, Cannady J. Antimicrobial Stewardship. In: StatPearls. Treasure Island (FL): StatPearls Publishing. 2025. Available from: http://www.ncbi.nlm.nih.gov/books/NBK572068/. Accessed on 27 February 2026.
Dutescu IA, Hillier SA. Encouraging the Development of New Antibiotics: Are Financial Incentives the Right Way Forward? A Systematic Review and Case Study. Infect Drug Resist. 2021;14:415-34. DOI: https://doi.org/10.2147/IDR.S287792
Jekunen A. Decision-making in product portfolios of pharmaceutical research and development-managing streams of innovation in highly regulated markets. Drug Des Devel Ther. 2014;8:2009-16. DOI: https://doi.org/10.2147/DDDT.S68579
Lanjouw J. Patents, Price Controls and Access to New Drugs. NBER. Available at: https://share.google/UenTDhGWEyLr1dCZs. Accessed on 27 February 2026.
Roy Chaudhury R, Mehta D. Regulatory developments in the conduct of clinical trials in India. Glob Health Epidemiol Genom. 2016;1:e4. DOI: https://doi.org/10.1017/gheg.2015.5
Shafiq N, Pandey AK, Malhotra S, Holmes A, Mendelson M, Malpani R, et al. Shortage of essential antimicrobials: a major challenge to global health security. BMJ Glob Health. 2021;6(11):e006961. DOI: https://doi.org/10.1136/bmjgh-2021-006961
Majumder MAA, Rahman S, Cohall D, Bharatha A, Singh K, Haque M, et al. Antimicrobial Stewardship: Fighting Antimicrobial Resistance and Protecting Global Public Health. Infect Drug Resist. 2020;13:4713-38. DOI: https://doi.org/10.2147/IDR.S290835
Drug Patent Watch. Transform Data into Market Domination. 2025. The Price of a Miracle: A Strategic Blueprint for Optimal Pharmaceutical Launch Pricing. Available at: https://www.drugpatent watch.com/blog/the-price-of-a-miracle-a-strategic-blueprint-for-optimal-pharmaceutical-launch-pricing/. Accessed on 27 February 2026.
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