State Drugs Control Administration

Department of Health & Family Welfare

GOVERNMENT OF ASSAM

EODB

ABOUT US

The organizations for Drugs Control exist at two levels i.e. at the Central and State Government level.
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control. Major functions of CDSCO: 1. Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licences as Central Licence Approving Authority is exercised by the CDSCO hqrs.
It deals in licensing work such as approval of licence meant for manufacture of Large Volume Parenteral, Vaccine & Sera, Blood Bank and Blood Components, Medical devices and products manufactured by Recombinant technology. It also deals with new drug clearance, clinical trials, import registration, import of drugs etc., and inspections.
On the other hand, the State Drug Controller deals with licensing of both manufacturing and sales premises of drugs & cosmetics.

Functions & Activities:

» Analytical quality control of drugs and cosmetic manufactured within the country on behalf of the Central and State Drugs Controller Administration.

» To assists the Central Drugs Standard Control Organization in the testing of Drugs and Cosmetics

Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. 

Vision:

To Protect and Promote public health in India

Mission:

To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.