The Drugs and Cosmetics Act, 1940 is an important social legislation and is a very effective tool for safeguarding the consumers’ interest. Provisions of Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules 1945 regulate the import, manufacture, distribution and sale of drugs and cosmetics in the country. Adulteration of drugs and production of spurious and substandard drugs causing serious threat to the health of the community are also sought to be prevented by application of the provisions of the Act. However, this performance audit of implementation of Drugs and Cosmetics Act in Maharashtra revealed that the Act has not been implemented effectively. The provisions of the Act regarding licensing and inspection of units, drawing/testing/reporting of samples, timely and effective actions against those manufacturing and selling substandard/spurious drugs were not implemented meticulously.