Central Drugs Standard Control Organisation (CDSCO) is the National Drug Regulatory Agency under Ministry of Health and Family Welfare, Government of India. It has been given the present name keeping the role in view when it was created. The present nomenclature is not reflecting its role and responsibilities. Over the years the role of CDSCO has expanded to several areas some of which are given below:
Regulation of new drugs including vaccines and clinical trials
All imports pertaining to drugs medical devices and cosmetics
Central Licensing Approval Authority for Blood Banks, Vaccines, LVP, Sera etc.
Setting of standards under the drugs and cosmetics act 1940
Coordinating the activities of the states and advising them on matters relating to uniform administration of the Act and Rules in the country
Laying down Regulatory measures and proposing amendment of acts and rules
Emerging areas such as stem cells e-pharmacy etc.
Dr R.A. Mashelkar in his report recommended creation of National Drug Authority (NDA) or Central Drug Authority (CDA). The Drugs Technical Advisory Board (DTA) be in its 75th meeting held on Date 03/01/2017 under the chairmanship of (DGHS) recommended renaming CDSCO to Indian Drugs Administration (IDA) other suggestions on the name include Indian Medical Products Administration (IMPA). In view of the above it was decided to rename CDSCO and also have a new logo of its own. The new name should reflect current role and responsibilities, Dr. S. Eshwara Reddy, Drugs Controller General (India) said in a circular.
The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has Six zonal offices, Four sub zonal offices, Thirteen Port offices and Seven laboratories spread across the country.
The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to Central & State Regulators for regulation of Drugs & Cosmetics. It envisages uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights and well being of the patients by regulating the drugs and cosmetics. CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.