Why in news?
Recently the Central Drugs Standard Control Organization (CDSCO) has red-flagged three brands of pacemakers from
US medical-device maker Medtronic.
More on news:
The development comes less than a fortnight after a similar safety alert was issued by the United States Food and Drug Administration (USFDA) on these heart implants over concerns that their batteries drain out with no warning to the patient.
- 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, 1940.
- Its headquarters is in New Delhi.
- It has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
- Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare.
- The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
- Its important functions include regulatory control over the import of drugs, approval of new drugs, clinical trials and approval of certain licenses.