Paper short abstract:

The paper seeks to provide a comparative understanding of the parametric variability among drug quality protocols enforced by different regulatory bodies in terms of the contestations over the norms invoked by the three interest groups – the pharmaceutical firms, regulatory bodies and consumer interest groups – involved in the crafting of drug quality norms.

Paper long abstract:

The present paper posits that the concept of drug quality in the pharmaceutical industry is a constructed one and hence variable across time and space. The tendency on the part of regulatory agencies in different countries to insist on stringent adherence to their specific set of quality protocols has led to the reification of drug quality in terms of certain physio-chemical parameters. Through case studies of two drugs, which have been the focus of quality related contestations in India and in Europe, the paper broadly seeks to provide a comparative understanding of the parametric variability among the drug quality protocols enforced by different regulatory bodies in terms of the norms invoked by the pharmaceutical firms at different stages of the drug discovery and development process and their justifications for invoking these norms. Further, the paper also examines how the other interest groups like regulatory bodies and consumer interest groups view the norms invoked by the industry and the extent of agreement between the norms adopted by the industry, those enforced by regulatory bodies and the norms espoused by consumer interest groups with respect to drug quality. The contestations over these norms have been broadly examined in terms of the system of meanings, values, worldviews and interests of these three groups, their organizational imperatives and the prevailing policy regimes in India and Europe. In doing so, the paper also posits a dialectical relationship between innovation and regulation in the pharmaceutical industry. The paper highlights the processes through which the contestations articulated by these three interest groups shape knowledge claims relating to therapeutic drugs in its journey from bench to bedside and the trade-offs between different value choices held by the contesting groups involved in the crafting of drug quality norms.