Manufacture of Drugs for Test Examination and Analysis

Learn the legal process for manufacture of drugs for test examination and analysis under Indian drug laws and regulatory provisions.

• Manufacturing drugs for non-commercial purposes, such as testing, examination, and analysis, is allowed under specific conditions:

Key Provisions:

1. Purpose-Specific Manufacturing:

   • Drugs must be used strictly for clinical trials, research, or quality analysis, not for commercial sale.

2. Approval and Licensing:

   • A special license or permit is required, indicating the drugs are solely for testing purposes.

3. Labeling Requirements:

   • Drugs must be clearly labeled as “For Testing Purposes Only” to prevent misuse.

4. Compliance with Standards:

   • Despite non-commercial use, these drugs must meet prescribed quality and safety standards.

5. Documentation and Reporting:

   • Manufacturers must maintain detailed records of production, usage, and distribution for regulatory inspections.

Purpose:

• This provision promotes drug development and testing while ensuring public safety.

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