The Central Drugs Standard Control Organisation (CDSCO).        

Why in News?

• Government starts joint inspection of drug manufacturing units across the country to ensure high quality of medicines.
• The Central Drugs Standard Control Organisation (CDSCO) has started conducting joint inspections of identified Drug Manufacturing Units along with State Drugs Control Administration as per a risk-based approach.
• The Joint Inspections are being conducted all over the country as per the Standard Operating Procedures.
• A Committee of two Joint Drugs Controllers has been constituted at CDSCO Head Quarters to monitor the process of inspection, reporting, and subsequent action so as to ensure compliance with the Drugs and Cosmetics Act, 1940, and the Rules thereunder.

About the Central Drugs Standard Control Organisation (CDSCO):

• The objective of drug regulation is to ensure the safety, efficacy, and quality of the drugs available in the country. The drug control administration is required to ensure that manufacturing units comply with Drugs and Cosmetics Act, especially to the requirements of Good Manufacturing Practices.
• 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 in New Delhi 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 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.