Regulatory
CDSCO
Definition
The Central Drugs Standard Control Organisation, India's national regulator for drugs, medical devices and cosmetics imports.
CDSCO works under the Ministry of Health and Family Welfare and is headed by the Drugs Controller General of India. It approves new drugs and clinical trials, registers imported drugs and cosmetics, and works with state drug regulators that license manufacturing.
Imports of drugs, including many APIs, need registration and an import licence under the rules made under the Drugs and Cosmetics Act, 1940. Check with the importer and CDSCO guidance before shipping any API to India.
Related terms
- GMP (good manufacturing practice)Rules for making medicines, APIs, food and cosmetics so that every batch is consistently produced and controlled to its quality standard.
- WHO-GMPGMP based on World Health Organization guidelines, often certified by national regulators for exports under the WHO certification scheme.
- IP grade (Indian Pharmacopoeia)Material that meets the monograph of the Indian Pharmacopoeia, the legal drug standard in India.