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.
Highlights
Antimicrobial resistance (AMR), which refers to the ability of a microorganism to resist an antimicrobial drug, is a very serious global public health challenge.[1]
The World Health Organization’s Global Action Plan on Antimicrobial Resistance (WHO GAP),[4] adopted by the World Health Assembly in 2015, recognises the need for regulation to optimise the use of antibiotics
If we adopt a broader view of regulation as ‘all mechanisms affecting behaviour – whether these be state-based or from other sources’,32 we find that a wide array of actors/institutions influence, and are affected by, the regulation of OTC sales of antibiotics for human use in India
Summary
Antimicrobial resistance (AMR), which refers to the ability of a microorganism to resist an antimicrobial drug (such as an antibiotic), is a very serious global public health challenge.[1]. In recent years, e-pharmacies or Internet pharmacies have emerged as an alternative, quick and easy source of access to antibiotics for consumers in India They operate, within a regulatory grey area.[86] In August 2018, the Ministry of Health and Family Welfare circulated a draft amendment to the DCR for the insertion of a new ‘Part VIB – Sale of Drugs by E-Pharmacy’ to regulate online sale of medicines.[87] This part will include provisions for registration of e-pharmacies, maintenance of record of cash or credit memo against which any drug is supplied, inspection every 2 years and monitoring. The sharing of information and experiences within and between countries will help governments and stakeholders resolve problems and adjust to using less familiar modes of ‘decentred’ regulation.[132]
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