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CDSCO

Definition

Central Drugs Standard Control Organization, headquartered in Delhi, headed by the Drugs Controller General of India (DCGI). The federal regulator under the 1940 Act.

Full form
Central Drugs Standard Control Organization
Headquarters
Delhi
Head
Drugs Controller General of India (DCGI)
Governing law
Drugs and Cosmetics Act, 1940
Role
Federal drug regulator

Common questions

How does CDSCO's role differ from a state drug control authority?+

CDSCO handles central functions such as new drug approvals, clinical trial oversight and import licensing, while state authorities license manufacturing and sale within their own territory. The two work under the same 1940 Act but at different levels.

Why does CDSCO matter in a forensic toxicology case?+

It sets the approved formulations, scheduling and manufacturing standards that a forensic toxicologist references when assessing whether a seized or ingested substance is a legitimate pharmaceutical, an adulterated batch, or an unapproved product.

Related terms

Drugs and Cosmetics Act 1940
Central statute governing the import, manufacture, sale and distribution of drugs and cosmetics in India. Read with the Drugs and Cosmetics Rules...
NDPS Act 1985
India's Narcotic Drugs and Psychotropic Substances Act 1985, the primary statute governing drug offences, establishing small and commercial quantity thresholds that determine...
Poison Act 1919
Seventeen-section central statute empowering state governments to notify substances as 'poisons' and to license their sale, possession and import. Still in force.
Schedule H
List of prescription drugs under the 1945 Rules; sold only on a registered medical practitioner's prescription. Includes most antibiotics, sedatives, antipsychotics and...
Schedule H1
Forty-six substances notified by the 2013 amendment (Drugs and Cosmetics Fourth Amendment Rules, 2013, GSR 588(E) dated 30 August 2013, in force...
Schedule X
Psychotropic substances and narcotics notified under the 1945 Rules. Stored under double lock, register retained for two years, copy of prescription retained.

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