CDSCO Guidelines
Central Drugs Standard Control Organisation - The national regulatory authority for pharmaceuticals, cosmetics, and medical devices in India.
90
Working Days CT
Zone IVb
Stability Zone
ACTD
Dossier Format
SEC
Expert Committee
Drug Approval Pathways
New Drug Approval
12-18 monthsFor drugs not previously approved in India. Requires complete safety and efficacy data including local clinical trials.
Key Requirements:
- Global clinical trial data
- Indian bridging/pivotal studies
- Stability data under Zone IVb conditions
- CMC data per ACTD format
Generic Drug Approval
6-12 monthsFor drugs with established safety profile. Bioequivalence based approval with reference to innovator product.
Key Requirements:
- Bioequivalence study in Indian subjects
- 3 exhibit batches
- 6-month accelerated stability
- DMF for API
Import Registration
6-9 monthsFor marketing of drugs manufactured outside India. Requires registration certificate from country of origin.
Key Requirements:
- Free Sale Certificate from CoO
- GMP certificate
- Product dossier in CTD format
- Authorized Indian agent
Clinical Trial Approval
90 working daysPermission to conduct clinical trials in India under New Drugs and Clinical Trials Rules 2019.
Key Requirements:
- Protocol and IB approval
- Ethics Committee approval
- Insurance/compensation provisions
- Investigator credentials
Submission Process
Pre-Submission Consultation
Optional meeting with CDSCO to discuss development plans and requirements
Application Preparation
Compile dossier per ACTD/CTD format with all required documents
SUGAM Portal Submission
Online submission through CDSCO SUGAM portal with fee payment
Scrutiny & Evaluation
CDSCO technical review and Subject Expert Committee (SEC) evaluation
Site Inspection
Manufacturing facility inspection by CDSCO inspectors
Approval/License
Grant of approval or import license for marketing
Reference Documents
New Drugs and Clinical Trials Rules, 2019
Comprehensive rules governing clinical trials and new drug approvals
Document Viewer
PDF documents will be displayed here. Upload or link your regulatory documents to view them directly in the browser.
CDSCO Guidance on Bioequivalence Studies
Guidelines for conducting BE studies in India
Document Viewer
PDF documents will be displayed here. Upload or link your regulatory documents to view them directly in the browser.
Key Regulations
Drugs and Cosmetics Act, 1940
Primary legislation governing drugs in India
Drugs and Cosmetics Rules, 1945
Implementing rules under the Act
New Drugs and Clinical Trials Rules, 2019
Comprehensive CT and new drug regulations
Schedule Y
Requirements for new drug approval
Schedule M
GMP requirements for manufacturing
Schedule H/H1/X
Prescription drug classifications
Zone IVb Stability
SUGAM Portal
All applications must be submitted online through the CDSCO SUGAM portal.