Manufacture of New Drugs
The manufacture of new drugs—not previously approved or registered—requires stringent regulations to ensure safety and efficacy.
Key Provisions:
Clinical Trials:
Comprehensive clinical trials are required to establish safety and efficacy, following Schedule Y guidelines.
Approval from Licensing Authority:
Approval from the Central Licensing Authority is mandatory, supported by clinical trial data.
Manufacturing License:
A specific license must be obtained, detailing conditions for production, quality control, and post-marketing surveillance.
Post-Marketing Surveillance:
Continuous monitoring of the drug’s performance post-launch is required to detect adverse effects.
Compliance with GMP:
Manufacturing must follow Good Manufacturing Practices (GMP) to ensure consistent quality.
Labeling and Documentation:
New drugs must be labeled with detailed information, including clinical trial results, for healthcare professionals and consumers.
Purpose:
This strict process ensures that new drugs are safe, effective, and reliable before entering the market.