Drug Approval Process in India: Simplified Steps

Getting a new drug approved in India involves multiple steps to ensure safety, effectiveness, and quality. Here’s a simplified overview:

1. Pre-Clinical Testing

• Laboratory Testing: Conducted on cells and animals to study safety and effectiveness.
• Objective: Establish a foundation for human trials.

2. Investigational New Drug (IND) Application

• Submit pre-clinical data, manufacturing details, and proposed clinical trial plans to the CDSCO.
• Approval is required before moving to human testing.

3. Clinical Trials

• Phase I: Small group testing (20-80 people) to check safety and dosage.
• Phase II: Larger group (100-300) to assess efficacy and side effects.
• Phase III: Large-scale trials (1,000-3,000) to confirm effectiveness and monitor adverse effects.

4. New Drug Application (NDA)

• Submit all trial data, manufacturing details, and proposed labeling.
• CDSCO reviews the data to evaluate safety and effectiveness.

5. Approval and Marketing

• After approval by the Drug Controller General of India (DCGI), the drug can be marketed.

6. Post-Marketing Surveillance

• Conduct Phase IV trials to monitor the drug’s long-term safety and rare side effects.