Over-the-counter sales of antibiotics for human use in India: The challenges and opportunities for regulation

Abstract

This article assesses the regulatory framework relating to over-the-counter (OTC) sales of antibiotics for human use in India. The OTC sale of antibiotics is recognised as a pathway for the emergence of antimicrobial resistance (AMR); a serious public health challenge in need of urgent regulatory responses. Analytically, this article identifies opportunities within existing laws in India and highlights gaps that need to be filled by modifying existing laws or developing new ones. Conceptually, it suggests a need to reflect on the limits of traditional, top-down, ‘command-and control’ regulation and to think about alternative approaches. The article therefore advocates for an approach to regulation that incorporates two elements. First, it argues for a broader concept of regulation that encompasses binding as well as non-binding regulatory instruments and initiatives aimed at influencing stakeholder behaviour (including soft regulation, economic incentives, information campaigns and uses of technology). Second, it makes the case for enhanced stakeholder participation in regulatory design. The article will be relevant for health policy and drug regulators in India and other low- and middle-income countries, as well as legal scholars, social scientists and others interested in the regulation of OTC sales of antibiotics for AMR containment.

Crossover-Use of Human Antibiotics in Livestock in Agricultural Communities: A Qualitative Cross-Country Comparison between Uganda, Tanzania and India

“…Antibiotics are prescription only medications for humans and animals in the three countries, with the exception of veterinary antibiotics ‘when contained in preparations for animal feeding stuffs’ in Uganda, which are allowed to be sold OTC [ 44 , 45 , 46 , 47 ]. However, in all three countries, veterinary and human antibiotics are frequently acquired OTC [ 38 , 40 , 61 , 62 ].…”

Antimicrobial Resistance and Community Pharmacists’ Perspective in Thailand: A Mixed Methods Survey Using Appreciative Inquiry Theory

“…Customers’ reasons to obtain antibiotics are the belief that antibiotics can speed up recovery and many keep leftover antibiotics for future use [ 46 ]. Losing income and clients has been a concern as commercial pressures drive overprescribed antibiotics [ 65 , 66 ]. In this research, some community pharmacists suggested that a substitutional strategy could compensate their income if they decrease antibiotic sales by rational antibiotic dispensing.…”

“…This study aimed at recruiting the part- and full-time registered practicing community pharmacists from all regions of Thailand. Based on the 2020 census, the population of Thailand was approximately 70 million and active social media users were 52.63 million [ 66 , 68 ]. The survey link and recruitment advertisement in social media (FacebookTM and LineTM) were shared with almost 13,906 community pharmacies across 77 provinces [ 72 , 74 ].…”

Recognizing and mediating bureaucratic barriers: increasing access to care through small and medium-sized private providers in Kenya

“…Finally, rather than placing the onus on individuals and individual institutions to fix the holes in a complex regulatory system, at a higher level we note that regulatory policy itself could be changed so that it is more responsive to on-the-ground implementation. Scholars working in India, for example, have recommended adopting a broader concept of regulation and enhancing the participation of key stakeholders in regulatory design to address similar issues of regulatory complexity ( Porter et al , 2021 ).…”