The CDSCO is the main regulatory body for the regulation of pharmaceuticals, medical devices, and clinical trials. The head office of CDSCO is located in New Delhi and it is functioning under the control of the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.
Drug Controller General of India (DCGI): He/She is responsible for the approval of new drugs, medical devices, and clinical trials to be conducted in India. The person who is appointed by the Central Government under the DCGI the state drug control organization will be functioning. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
Zonal Office: Mumbai, Kolkata, Chennai, Ghaziabad, Ahmadabad, Hyderabad. These centers are involved in GMP audits and inspection of manufacturing units of large volumes, parental, sera, vaccine, and blood products.
Sub-zonal Office: Chandigarh, Jammu, Bangalore. These centers are coordinated with state drug control authorities under their jurisdiction for a uniform standard of inspection and enforcement.
Central Drugs Testing Laboratories:
1. Central Drugs Laboratory, Kolkata.
2. Central Drugs Testing Laboratory, Mumbai.
3. Central Drugs Testing Laboratory, Chennai.
4. Central Drugs Laboratory, Kasauli.
5. Regional Drugs Testing Laboratory, Guwahati.
6. Regional Drugs Testing Laboratory, Chandigarh.
These laboratories are responsible for the quality control of Drugs and Cosmetics in India.
Functions of CDSCO
1. Approval of new drugs and clinical trials.
2. Import Registration and Licensing.
3. Licensing of Blood banks, LVPS, Vaccines, Pie-DNA products, and some medical devices and diagnostic agents.
4. Amendment to D and C Act and Rules.
5. Banning of drugs and cosmetics.
6. Grant to Test license, Personal License, NOC’S for export.
7. Testing of drugs by Central Labs.
8. Publication of Indian Pharmacopoeia.
9. Monitoring adverse drug reactions.
10. Guidance on a technical matter.
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