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AuthorBrhlikova, Petra
AuthorMehta, Aashna
AuthorMcGettigan, Patricia
AuthorPollock, Allyson M.
AuthorRoderick, Peter
AuthorFarooqui, Habib Hasan
Available date2024-01-15T06:04:06Z
Publication Date2023-12-01
Publication NameJournal of Pharmaceutical Policy and Practice
Identifierhttp://dx.doi.org/10.1186/s40545-023-00644-y
CitationBrhlikova, P., Mehta, A., McGettigan, P. et al. Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics. J of Pharm Policy and Pract 16, 139 (2023). https://doi.org/10.1186/s40545-023-00644-y
URIhttps://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85176615647&origin=inward
URIhttp://hdl.handle.net/10576/50715
AbstractBackground: 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.
Languageen
PublisherSpringer Nature
SubjectFixed-dose combination (FDC)
India
Regulation
Systemic antibiotics
TitleRegulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics
TypeArticle
Issue Number1
Volume Number16
ESSN2052-3211
dc.accessType Open Access


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