A Phase III Clinical and Bioequivalence Study to Evaluate Efficacy and safety of Antihyperparathyroidism and Antianginal drugs in Indian Population

Abstract

Various regulatory aspects related to drug import, manufacture, sale and advertising in India are covered under the Drugs and Cosmetics Act of 1940 and the ensuing Drugs and Cosmetics Rules of 1945, the Pharmacy Act of 1948 and the Drugs and Magic Remedies (Objectionable Advertisements) Act of 1954. Of these, the Drug and Cosmetic Act (Act) of 1940, which led to the Drugs and Cosmetics Rules (Rules) of 1945, is central legislation that regulates India s drug and cosmetic import, manufacture, distribution and sale. The Act s main objective is to ensure that available human drugs are safe and efficacious and conform to prescribed quality standards, and marketed cosmetics are safe for use. Over the years, the Act has been amended several times to address public concerns. newline