Manufacturing drugs for non-commercial purposes, such as testing, examination, and analysis, is allowed under specific conditions:
Key Provisions of Manufacture of Drugs:
Purpose-Specific Manufacturing:
Drugs must be used strictly for clinical trials, research, or quality analysis, not for commercial sale.
Approval and Licensing:
A special license or permit is required, indicating the drugs are solely for testing purposes.
Labeling Requirements:
Drugs must be clearly labeled as "For Testing Purposes Only" to prevent misuse.
Compliance with Standards:
Despite non-commercial use, these drugs must meet prescribed quality and safety standards.
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.