ABSTRACT

The pharmaceutical sector has emerged as one of the most critical pillars of public health and the economy in recent times, especially after the COVID-19 pandemic, which has also made people more aware of its importance in delivering safe medicines and life-saving vaccines. This article traces the legislative history of the Drugs and Cosmetics Act, 1940, first introduced in British India, through various amendments and reports by the expert committees on the effectiveness of its provisions. Over the decades, various committees and policy documents, from the Hathi Committee to the Mashelkar Committee, have highlighted systemic deficiencies and have recommended stronger oversight, culminating in amendments and reforms aimed at ensuring drug safety and quality. Despite these efforts, various challenges such as inconsistent enforcement across states, inadequate recall mechanisms, and weak regulatory autonomy have persisted. It critically assesses the need for legal frameworks that ensure both procedural efficiency and accountability in drug quality regulation to protect public health. Further, a comparative analysis of the law related to substandard drugs between developed nations like the USA and European countries, and India points to the systemic deficiencies within India’s drug regulatory apparatus and underscores the pressing need for enhanced regulatory measures to strengthen this framework and to maintain Good Manufacturing Practices.  The article also analyses possible implications of the amendments to the Drugs and Cosmetics Act, 1940 introduced through the Jan Vishwas (Amendment of Provisions) Act, 2023 which came into effect on 31st December 2024. Furthermore, this article addresses the Union Health Ministry’s recently proposed changes to the New Drugs and Clinical Trial Rules, 2019, focusing on streamlining regulatory approvals by allowing pharmaceutical companies to conduct certain bioavailability and bioequivalence (BA/BE) studies.

Keywords: Drugs and Cosmetics Act (1940), Substandard drugs, Good Manufacturing Practices, Jan Vishwas (Amendment of Provisions) Act (2023), New Drugs and Clinical Trial Rules (2019).

INTRODUCTION

The Drugs and Cosmetics Act, 1940 classifies offences related to drugs into various categories. In the Indian context, the focus has been on spurious drugs which has overshadowed the concerning prevalence of substandard drugs. This necessitates a deeper understanding of the subtle difference between these various categories of drugs.

“Spurious drugs”, or fake drugs, are manufactured with the sole intention of monetary profit and to deceive the customer by selling them as genuine. In contrast, substandard drugs are manufactured by licensed manufacturers in their own names but without the observing the Good Manufacturing Practices (GMPs). This non-compliance leads to proliferation of products that are either lower in potency compared to what is claimed on the label or contain toxic substances. Contrary to what many might imagine, the prevalence of substandard drugs is a much more serious problem than spurious drugs facing India.^[1]

The existing legal system classifies drug related offences with respect to quality and packaging of drugs into four categories: “misbranded drugs”, “spurious drugs”, “adulterated drugs”, and drugs that fail to meet the standards of quality as outlined in the Drugs & Cosmetics Act, 1940. Generally, “misbranded” means drugs that are mislabelled or have false or misleading representations of ingredients and falsely represent therapeutic value. “Spurious drugs” include false representations as to the identity of the manufacturer or to the nature or quantity of the ingredients. “Adulterated drugs” are those which contain filthy or decomposed substances, or which have been prepared in insanitary conditions. However, there is no definition of “substandard” drugs under the Act; Section 18(a)(1) only prohibits the manufacture of a drug which does not comply with the standards of quality. This lack of articulation arguably plays down the sizeable concern regarding poor-quality drugs in India’s drug supply chain.

^[1]Dinesh S. Thakur, ‘Enforcement measures under the Drugs & Cosmetics Act, 1940 – Part 13: What’s in the name?’, (DineshThakur, 10May 2016) <https://dineshthakur.com/2016/05/10/enforcement-measures-under-the-drugs-cosmetics-act-1940-part-13-whats-in-the-name/> accessed 20 July 2025.