Pharmaceutical Regulation, Drug Pricing And Access To Medicines In Keralam: A Constitutional, Statutory And Institutional Analysis
Adv. Aiswarya R. Babu, B.Com., LL.B., LL.M., Sree Narayana Guru College of Legal Studies, Kollam
ABSTRACT
Access to medicines is meaningful only when patients can obtain treatment that is safe, effective, therapeutically appropriate, continuously available and affordable. India has developed a substantial legal framework for regulating drug quality, controlling prices, identifying essential medicines and balancing pharmaceutical patents against public-health needs. In Keralam, however, the effectiveness of this framework also depends on the performance of public procurement and distribution systems, particularly the Kerala Medical Services Corporation Limited (KMSCL), alongside the regulatory functions of the State Drugs Control Department. This article combines constitutional and statutory analysis with an institutional examination of medicine procurement. It argues that price control, although indispensable, cannot by itself ensure access: medicines may remain unavailable because of inaccurate forecasting, unsuccessful tenders, supplier non-performance, payment delays, weak inventory management or distribution failures. It further analyses the Kerala High Court’s September 2026 decision concerning government use under Section 100 of the Patents Act, 1970. The article proposes an access-oriented framework built around transparent procurement, real-time stock monitoring, quality assurance, accountable emergency purchasing and reasoned assessment of unaffordable patented medicines. It concludes that pharmaceutical governance should be assessed by patient-level outcomes rather than by the mere existence of regulations, price notifications or procurement procedures.
Keywords: Right to health, Essential medicines, Drug pricing, DPCO 2013, NLEM 2022, NPPA, KMSCL, Procurement, patents, Keralam.
