Product Registration

Pharmaceutical product registration, also known as the drug approval process in India or drug registration, is governed by the Central Drugs Standard Control Organization (CDSCO), an Indian Health Authority operating under the Drugs and Cosmetics Act. The CDSCO oversees six (06) zonal offices, four (04) sub-zonal offices, thirteen (13) port offices, and seven (07) laboratories, managing various aspects related to drugs and cosmetics regulation.

The CDSCO's responsibilities encompass Regulatory control over the import of medicines, approval of specific licenses, authorization of new medicines, clinical trials, Subsequent New Drugs (SND), Fixed-Dose Combinations (FDC), and Investigational New Drug. Additionally, the CDSCO exercises authority over the Central License Approving Authority (CLAA), medical device classification, Drugs Consultative Committee (DCC) meetings, and Drugs Technical Advisory Board (DTAB) at the DCGI headquarters.