Table 1. Roles of various regulatory agencies.

Agencies	Role of agencies
Drug Controller General of India (DCGI)	Implementation the National Pharmacovigilance
Central Drugs Standard Control Organization (CDSCO)	Operate under the supervision of the National Pharmacovigilance Advisory Committee to recommend.
Department of Biotechnology (DBT)	Provides product evaluation and validation through support for limited and large scale field trials for agriculture products and clinical trials for health care products.
Ministry of Environment & Forests (MOEF)	Project advisory committee approves guidelines for making data entries of the information provided by the environmental experts through the field trials for agriculture products and clinical trials for health care products.
Indian Council of Medical Research (ICMR)	Brought out the 'Policy Statement on Ethical Considerations involved in Research on Human Subjects' in 1980 and revised these guidelines in 2000 as the 'Ethical guidelines for Biomedical Research on Human Subjects'.
Central Bureau of Narcotics (CBN)	Closely monitors all clinical trials, which require additional narcotics compliances relating to storage, import-export quotas and movement of the investigational drug.
Ministry of Health and Family Welfare (MHFW)	An autonomous body for setting of standards for drugs, pharmaceuticals and healthcare devices and technologies in India.
National Pharmacovigilance Advisory (NPAC)	Collates, analyzes and archives adverse drug Committee reaction data for creating healthy environment for the regulatory authorities to analyze the drug to be marketed in India.