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Lookup NU author(s): Professor Allyson PollockORCiD, Peter Roderick
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 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.
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
Data Access Statement: The data that support the findings of this study are available from PharmaTrac but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available (https://www.aiocdawacs.com/(S(0vvl5kmxue1kguc4ljbksdcc))/ProductDetail.aspx). In the publicly available study appendices, we provide full details of the systemic antibiotic formulations and aggregate volume data collated from PharmaTrac.
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