Regulation of Ayurveda, Siddha and Unani (ASU) drugs: An overview of current framework, challenges and way forward

Abstract Drug regulation is an integral part of the public health policy of a country and India’s journey of drug regulation started in the third decade of the nineteenth century. Recognizing the growing need to create regulatory mechanisms or frameworks to prevent non-compliant drugs, the government passed the Drugs and Cosmetics Act, 1940 (DCA) after the recommendation of the Chopra Committee to have drug regulations in the country. To address increasing commercialization in the preparation and marketing of Ayurveda, Siddha, and Unani (ASU) drugs and to ensure the interests of the profession and public, the DCA was amended to include provisions of ASU drugs in 1964 wherein DCA comprises a dedicated chapter for regulatory provisions of ASU drugs. The recent expansion in the size of the Ayush market has reflected a strong need for strengthening of central and state drug regulatory framework, pharmacopeial standards, revision and updating Schedule I, Schedule E-1, and provisions related to good manufacturing practices (GMP), export of Ayush products so as to bring a paradigm shift in Ayush drug regulations and its global market. This article is designed to offer stakeholders an overview of the present landscape of ASU drug regulation. Further, this article is an attempt to identify and analyze the critical challenges being faced in the regulatory framework and propose actionable strategies to strengthen this system. Additionally, this manuscript consolidates the evolution and amendments of the DCA, and rules made thereunder, providing a detailed account of policy modifications over time.