Manufacture of New Drug

Understand the approval process and legal requirements for manufacture of new drug under Indian regulations and the Drugs and Cosmetics Act.

Manufacture of New Drug

• The manufacture of new drugs—not previously approved or registered—requires stringent regulations to ensure safety and efficacy.

Key Provisions:

1. Clinical Trials:

   • Comprehensive clinical trials are required to establish safety and efficacy, following Schedule Y

2. Approval from Licensing Authority:

   • Approval from the Central Licensing Authority is mandatory, supported by clinical trial data.

3. Manufacturing License:

   • A specific license must be obtained, detailing conditions for production, quality control, and post-marketing surveillance.

4. Post-Marketing Surveillance:

   • Continuous monitoring of the drug’s performance post-launch is required to detect adverse effects.

5. Compliance with GMP:

   • Manufacturing must follow Good Manufacturing Practices (GMP) to ensure consistent quality.

6. 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.

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