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Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics

Lookup NU author(s): Professor Allyson PollockORCiD, Peter Roderick

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2023, The Author(s).Background: In India, states have licensed the manufacture of large numbers of fixed-dose combination (FDC) drugs without the required prior approval of the central regulator. This paper describes two major regulatory initiatives to address the problem, which began in 2007 and 2013, and examines whether they have been sufficient to remove centrally unapproved systemic antibiotic FDCs from the market. Methods: Information was extracted from documents published by the central regulator and the ministry of health, including the National List of Essential Medicines (NLEM), and court judgments, and analysed alongside sales volume data for 2008–2020 using PharmaTrac market dataset. Results: The regulatory initiatives permitted 68 formulations to be given de facto approvals (‘No Objection Certificates’) outside the statutory regime, banned 46 FDCs and restricted one FDC. Market data show that FDCs as a proportion of total antibiotic sales increased from 32.9 in 2008 to 37.3% in 2020. The total number of antibiotic FDC formulations on the market fell from 574 (2008) to 395 (2020). Formulations with a record of prior central approval increased from 86 (2008) to 94 (2020) and their share of the antibiotic FDC sales increased from 32.0 to 55.3%. In 2020, an additional 23 formulations had been permitted de facto approval, accounting for 10.6% of the antibiotic FDC sales. Even in 2020, most marketed formulations (70.4%, 278/395) were unapproved or banned, and comprised a 15.9% share of the antibiotic FDC sales. The share of NLEM-listed antibiotic FDC sales increased from 21.2 (2008) to 26.7% (2020). Conclusion: The initiatives had limited impact. Regulatory enforcement has been slow and weak, with many unapproved, and even banned, FDCs remaining on the market.

Publication metadata

Author(s): Brhlikova P, Mehta A, McGettigan P, Pollock AM, Roderick P, Farooqui HH

Publication type: Article

Publication status: Published

Journal: Journal of Pharmaceutical Policy and Practice

Year: 2023

Volume: 16

Issue: 1

Online publication date: 10/11/2023

Acceptance date: 21/10/2023

Date deposited: 28/11/2023

ISSN (electronic): 2052-3211

Publisher: BioMed Central Ltd

URL: https://doi.org/10.1186/s40545-023-00644-y

DOI: 10.1186/s40545-023-00644-y

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