3 - Legal and regulatory scenario

Abstract

The Central Drug Standard Control Organization is the apex authority regulating India’s pharmaceutical and healthcare industry. It is headed by the Drugs Controller General of India and performs various functions at central and state level. The central legislation regulating drug and cosmetics import, manufacture, distribution and sales is the Drug and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, with various amendments. The Act’s main objective is to ensure that available human drugs are safe and efficacious and conform to prescribed quality standards and that cosmetics are safe for use. Amendments to the Act address public concerns about the existing framework for clinical trial research and concerns related to contract manufacturing conducted in India. The Act provides regulations that govern manufacturing of drugs in India, manufacture/import of new drugs and clinical trials. Various guidelines and schedules govern the conduct of clinical trials. The guidelines also require adequate compensation to be paid for participation in drugs research.