Drug Approval Process in India 
From Discovery to Market Authorization | CDSCO & DCGI
The drug approval process in India ensures every medicine is safe, effective, and high quality before it reaches patients. This process is regulated mainly by CDSCO under DCGI.
1) Drug Discovery & Development
- Identifying the target (disease)
- Selecting a promising drug molecule
- Lab-based research and screening
2) Preclinical Studies (Lab + Animal Testing)
- Pharmacology (how it works)
- Toxicology (safety testing)
- ADME studies (Absorption, Distribution, Metabolism, Excretion)
Goal: Confirm the drug is safe enough to test in humans.
3) Clinical Trial Application (CT Application)
The sponsor submits an application to CDSCO (via SUGAM portal) for permission to conduct human trials.
Includes: Protocol, preclinical data, investigator details, and trial product info.
4) Ethics Committee Approval
Before starting trials, Ethics Committee (EC) approval is mandatory to protect participant safety and rights.
5) Clinical Trials in Humans (Phase I–III)
- Phase I: Safety + dose (small group)
- Phase II: Efficacy + dose optimization (patients)
- Phase III: Large-scale confirmation of safety & efficacy
6) Manufacturing & GMP Compliance
The drug must be manufactured under GMP standards to ensure:
- Quality
- Consistency
- Stability
- Proper labeling & packaging
7) NDA Submission (Marketing Authorization Request)
After successful trials, the company submits a complete dossier for approval.
Contains: Clinical data + quality data + safety reports + labeling details.
8) CDSCO / SEC Evaluation
Applications are reviewed by:
- CDSCO experts
- SEC (Subject Expert Committee)
They may request additional clarification or data.
9) DCGI Approval (Final Authorization)
If benefits outweigh risks, DCGI grants marketing approval to sell the drug in India.
10) Post-Marketing Surveillance (Phase IV)
Even after approval, safety monitoring continues through Pharmacovigilance:
- ADR reporting
- Signal detection
- Risk management
- PSUR submissions
MBH/PS