REGULATORY BODIES IN INDIA

                                    REGULATORY BODIES IN INDIA

 In India, the central government, via the Central Drugs Standard Control Organization under the Ministry of Health and Family Welfare, largely works on developing standards and regulatory measures for drugs, diagnostics and devices; laying down regulatory measures by amending acts and rules; and regulating the market authorization of new drugs – all in an effort to standardize clinical research in India and bring safer drugs to the market.

CDSO Head Quarters New Delhi

Regulatory bodies in India involved in pharmaceutical regulation
	Body	Function
DCGI	Drug Control General India	Regulatory apex body under the government of India that oversees all
ICMR	Indian Council of Medical Research	Apex body that formulates, co-ordinates and promotes biomedical
GEAC	Genetic Engineering Approval Committee	Consists of experts in the field of genetic engineering and molecular biology; clinical trials involving the use of biotech products would be referred by DCGI to GEAC for recommendations
DBT	Department of Biotechnology	Apex body that oversees the new impetus to develop the field of modern biology and biotechnology in India
AERB	Atomic Energy Review Board	Authority that exercises regulatory control over the approval of new types of radiation equipment, and for the registration/commissioning of new radiation equipment, inspection and decommissioning of installations
BARC	Baba Atomic Research Centre	Apex body that oversees and approves all radiation related projects in India. DCGI refers all clinical trials that involve the use of radiopharmaceuticals to BARC for its expert opinion
DCC	Drugs Consultative Committee	Provides technical guidance to the Central Drugs Standard Control Organization
CDL	Central Drugs Laboratory	National statutory laboratory of the Indian government for quality control of drugs
DTAB	Drugs Technical Advisory Board	Provides technical guidance to the CDSCO