What is the Origin of CDSCO?

The term is an abbreviation of the organization's full name, which was established under the Drugs and Cosmetics Act of 1940. As India's pharmaceutical industry expanded globally, the need for a robust and standardized regulatory framework became increasingly apparent. CDSCO's establishment reflects a global trend toward centralized governmental oversight of therapeutic agents to protect patient populations.

What is the Mechanism of CDSCO?

The CDSCO operates through a hierarchical structure, led by the Drug Controller General of India (DCGI), to implement the provisions of the Drugs and Cosmetics Act. Its function involves evaluating pre-clinical and clinical data for new drug applications to grant marketing authorization. Furthermore, it monitors post-market safety through pharmacovigilance and conducts inspections to ensure compliance with Good Manufacturing Practices (GMP) across all production facilities.

CDSCO ∞ Area

CDSCO

Meaning

CDSCO is the acronym for the Central Drugs Standard Control Organisation, which serves as the national regulatory body for pharmaceuticals, medical devices, and cosmetics in India. This organization is fundamentally responsible for ensuring the safety, efficacy, and quality of drugs manufactured and imported into the country. Its regulatory oversight includes the approval of new drugs, the conduct of clinical trials, and the maintenance of drug standards, playing a critical role in public health protection.