About CDSCO

• The Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) of India.
• CDSCO as the Central Drug Authority discharges functions assigned to the Central Government under the Drugs and Cosmetics Act, 1940.

Major functions of CDSCO

• Regulatory control over the approval of new drugs and clinical trials.
• Laying down the standards for Drugs and control over the quality of imported Drugs.
• Meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB).
• Approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.
• Coordination of the activities of State Drug Control Organisations and providing expert advice with a view to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.

About DCGI

• Drug Controller General of India (DCGI) is the head of the CDSCO.
• DCGI is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.
• Dr.V.G.Somani is the current DCGI.

Why in News?

• Bharat Serums and Vaccines Ltd. (BSVL) has received approval from DCGI to conduct phase III clinical study on Ulinastatin for mild to moderate Acute Respiratory Distress Syndrome (ARDS) patients with COVID-19.

News in Detail

• The mortality risk is higher when an individual with COVID-19 infection develops ARDS and pneumonia.
• ARDS causes dry cough, heavy breathing, breathing difficulties and increased heart rate.
• In such a case, Ulinastatin can be administered as a remedy to combat the underlying inflammatory condition related to ARDS in COVID-19 patients.

Clinical Trials in India

• CDSCO regulates the clinical trials for drugs and medical devices in India.
• Demonstration of safety and efficacy of the drug product for use in humans is essential before the drug product can be approved for import or manufacturing and marketing in the country.
• Any drug has to pass through four phases of clinical trials from I to IV to get approved.

References:

https://www.thehindu.com/business/bsvl-gets-nod-for-trial-of-ulinastatin-for-covid-19/article31789918.ece

https://cdsco.gov.in/opencms/opencms/en/About-us/Introduction/

https://morulaa.com/indian-medical-device-market/clinical-trials-in-india-document-requirements/#:~:text=CDSCO%20regulates%20the%20clinical%20trials,and%20marketing%20in%20the%20country.