CDSCO has recently started conducting joint inspections of identified Drug Manufacturing Units along with the State Drugs Control Administration.
Why in news?
- A committee of two Joint Drugs Controllers has been constituted at CDSCO (HQ) to monitor the process of inspection, reporting & subsequent action.
What is CDSCO?
- It is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act of 1940.
- It works under the Ministry of Health & Family Welfare the National Regulatory Authority (NRA) of India.
- Under the Drugs and Cosmetics Act, CDSCO is responsible for -
- Approval of Drugs.
- Conduct Clinical Trials.
- Laying down the standards for Drugs.
- Control over the quality of imported Drugs in the country.
- Coordination of the activities of State Drug Control Organizations.
- Further CDSCO along with state regulators, is jointly responsible for the grant of licences to certain specialised categories of critical Drugs such as vaccines and sera, etc.
- The Indian government has announced plans to subject all medical devices, including implants and contraception, to CDSCO scrutiny.
- Drugs Controller General of India (DCGI): DCGI is the head of the department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
- DCGI also sets standards for the manufacturing, sales, import, and distribution of drugs in India.
Q1) Is CDSCO a statutory body?
CDSCO is India's Central Drug Regulator and is a Statutory Agency reporting to The Ministry of Health and Family Welfare, responsible for Approving Licenses for Specific Classes of Drugs having its Headquarters in New Delhi.