Pharmaceutical Monopoly Under The CDSCO Regulatory Framework
Aditya Vidyarthi, LL.M., NALSAR University of Law
Saumya Mishra, LL.M., NALSAR University of Law
ABSTRACT
Glucagon-like peptide-1 (GLP-1) receptor agonists have recently emerged as a significant advancement in the treatment of metabolic disorders, particularly Type 2 Diabetes and Obesity. Medicines such as Ozempic and Wegovy have gained global prominence due to their effectiveness in improving glycaemic control and facilitating weight management. However, the rapid rise in demand for these drugs has also raised critical concerns relating to pharmaceutical monopoly, drug pricing, and regulatory oversight. The patent protection and market exclusivity enjoyed by manufacturers, particularly Novo Nordisk, have resulted in limited competition, thereby enabling significant control over pricing and market supply.
In India, the regulation and approval of pharmaceutical products are governed by the Central Drugs Standard Control Organization (CDSCO) under the framework of the Drugs and Cosmetics Act, 1940. While CDSCO plays a crucial role in ensuring the safety, efficacy, and quality of medicines through drug approval processes, clinical trial supervision, and post- marketing surveillance, the growing prominence of GLP-1 medicines presents new regulatory challenges. These include concerns regarding off- label use for weight loss, increasing market concentration, and the broader implications of patent-driven monopoly in the pharmaceutical sector.
This paper examines the regulatory framework governing GLP-1 medicines in India and analyses the extent to which existing mechanisms effectively address issues arising from market dominance and limited competition. Through doctrinal analysis of statutory provisions, regulatory guidelines, and policy frameworks, the study identifies gaps in regulatory coordination and oversight that may allow pharmaceutical monopolies to influence access and affordability of these drugs. The research argues that a stronger and more coordinated regulatory approach is necessary to balance pharmaceutical innovation with public health interests. By exploring the intersection of drug regulation and monopoly power in the context of GLP-1 medicines, the paper contributes to ongoing discussions on strengthening India’s pharmaceutical regulatory system to ensure equitable access to emerging therapeutic treatments.
