Pharmaceutical regulations in India

Abstract

India is globally recognized as the "Pharmacy of the World," largely due to its high volume, cost-effective production of generic medications and vaccines. Over the past several decades, the country has transitioned from a pharmaceutical importer to a global leader in the manufacture and export of affordable, quality-assured drugs. The aim of the study is to recognize the key improvements that took place in Indian pharmaceutical legislation throughout the years from its first enactment. This review further seeks to evaluate the robustness of the current regulatory framework. A literature review was done to thoroughly study the foundational drug regulations in India, those legislations that directly impact socio-economic construct and has strategic importance in practice. They include Drugs and Cosmetics Act 1940, Drugs and Magic Remedies (Objectionable Advertisement) Act 1954, Narcotic Drugs and Psychotropic Substances Act 1985, Patent Act 1970 and Drugs Price Control Order 1963. Webpages of Indian pharmaceutical organisations along with open access articles available from google was used in this study. The findings demonstrate significant progress in regulatory capacity and international harmonization, especially in relation to compliance with WHO and US FDA standards. India is moving beyond generics to become a significant player in production, export of large molecules and biologics, aiming to diversify its pharmaceutical portfolio. The study highlights achievements such as Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliance, cost effectiveness of Indian drug products enabled by factors including Section 3(d) in patent act against evergreening and rapid drug approvals during the COVID-19 pandemic. However, it also points out areas of concern like decentralised regulatory framework leading to inconsistent enforcement across states and thereby questioning the credibility of quality of products. Inadequate trained workforce further limits the integrity. Weak regulatory practices and lack of prescription tracking in India make it difficult to monitor and control medication misuse. India remains one of the leading countries in pharma sector worldwide. This reflects that India has established a high standard of regulatory framework for decades. Regulatory provisions that appear robust in design frequently fail to achieve their intended outcomes in practice, reflecting a significant divergence between formal legislation and ground level enforcement.