The Central Drugs Standard Control Organisation (CDSCO), headed by the Drugs Controller General of India, is India's central regulator for drugs, medical devices and cosmetics. It approves new drugs and clinical trials, issues import licences and registrations, licenses higher-risk medical devices, and registers imported cosmetics. Most applications are filed online through its portals.
Key CDSCO approvals
- New drug and clinical trial approvals
- Drug import licences
- Class C and D medical device licences, and all device imports
- Cosmetics import registration
- Test licences
Central vs state roles
States license manufacture and sale of most drugs and lower-risk devices; CDSCO handles imports, new drugs and higher-risk devices.
Process
- Identify the approval type.
- Prepare dossier.
- Apply online with fees.
- Respond to queries and inspections.
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Get expert help →Compliance
Pharmacovigilance, labelling and periodic reporting.
Frequently asked questions
Does CDSCO license pharmacies?
No. Retail and wholesale licences are issued by state drug controllers.
Is CDSCO needed for cosmetics made in India?
Domestic cosmetic manufacturing is licensed by states; imports need CDSCO registration.
What is SUGAM?
CDSCO's online portal for many applications.
How long do CDSCO approvals take?
From weeks to months depending on approval type.
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