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Objective To analyse sales of fixed-dose combination and single antibiotics in India in relation to World Health Organization (WHO) recommendations and national regulatory efforts to control antibiotic sales. Methods We extracted data on sales volumes of systemic antibiotics in India from a market research company sales database. We compared the market share of antibiotic sales in 2020 by WHO AWaRe (Access, Watch and Reserve) category and for those under additional national regulatory controls. We also analysed sales of fixed-dose combinations that were: formally approved for marketing or had a no-objection certificate; on the national essential medicines list; and on the WHO list of not-recommended antibiotics. Findings There were 78 single and 112 fixed-dose combination antibiotics marketed in India, accounting for 7.6 and 4.5 billion standard units of total sales, respectively. Access, Watch and Reserve antibiotics comprised 5.8, 5.6 and 0.1 billion standard units of total market sales, respectively. All additionally controlled antibiotics were Watch and Reserve antibiotics (23.6%; 2.9 billion standard units of total sales). Fixed-dose combinations on the WHO not-recommended list were marketed in 229 formulations, with 114 formulations (49.8%) having no record of formal approval or no-objection certificate. While there were no not-recommended fixed-dose combinations on the national list of essential medicines, 13 of the top-20 selling antibiotic fixed-dose combinations were WHO not-recommended. Conclusion The sale of Watch group drugs, and antibiotics banned or not approved, needs active investigation and enforcement in India. The evidence base underpinning formal approvals and no-objection certificates for not-recommended fixed-dose combinations should be audited. [ABSTRACT FROM AUTHOR]

Objective. To investigate equity in the geographical distribution of community pharmacies in South Africa and assess whether regulatory reforms have furthered such equity. Methods. Data on community pharmacies from the national department of health and the South African pharmacy council were used to analyse the change in community pharmacy ownership and density (number per 10 000 residents) between 1994 and 2012 in all nine provinces and 15 selected districts. In addition, the density of public clinics, alone and with community pharmacies, was calculated and compared with a national benchmark of one clinic per 10 000 residents. Interviews were conducted with nine national experts from the pharmacy sector. Findings. Community pharmacies increased in number by 13% between 1994 and 2012 – less than the 25% population growth. In 2012, community pharmacy density was higher in urban provinces and was eight times higher in the least deprived districts than in the most deprived ones. Maldistribution persisted despite the growth of corporate community pharmacies. In 2012, only two provinces met the 1 per 10 000 benchmark, although all provinces achieved it when community pharmacies and clinics were combined. Experts expressed concerns that a lack of rural incentives, inappropriate licensing criteria and a shortage of pharmacy workers could undermine access to pharmaceutical services, especially in rural areas. Conclusion. To reduce inequity in the distribution of pharmaceutical services, new policies and legislation are needed to increase the staffing and presence of pharmacies. [ABSTRACT FROM AUTHOR]