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Regulatory Environment of Clinical Research in India

The history of Drug regulation in India dates back to the British rule when majority of the drugs were imported from abroad. The Drugs and Cosmetic Act, 1940 came into force from 1st April 1947. Later on, Government in 1962, extended the regulatory provisions to the cosmetics, and finally the Act came to known as Drugs and Cosmetic Act 1940. Drugs and Cosmetic Act has been divided in Chapters, Rules and Schedules and is amended from time to time to control the safety, efficacy and quality of the drugs. Under Chapter Two of this Act, one statutory board and a committee have been framed called Drugs Technical Advisory Board (DTAB) and Drug Consultative Committee (DCC).

The Indian government, realizing the potential of Clinical Research for new therapies, has modified and amended Schedule Y to the Drug and Cosmetics Rules of 1945. Schedule Y establishes a set of guidelines and requirements for clinical trials. The Indian Council of Medical Research (ICMR) issued the Ethical Guidelines for Biomedical Research on Human Subjects in 2000 and CDSCO released Indian Good Clinical Practice (GCP) guidelines in 2001.

Recently Indian government has strengthened CDSCO and Drug Controller General of India (DCGI) office by expanding and reorganizing it along the line of Food Drug Administration (FDA), the drug regulatory body of United States. In 2007, ICMR started an online registration system of clinical trials known as ‘Clinical Trial Registration-India (CTRI). In 2008, the CDSCO started inspection of Clinical Trials in India. CDSCO has also started a Clinical Trial Inspection Programme and have released a guidance document for clinical trial inspection of the site of clinical trial, Sponsor and Contract Research Organisations (CROs) facilities. As per opinion of the experts, India still needs to frame a more systematic review process of drugs before approval.

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