Loan License and Repacking License

  • This topic explains the legal provisions for obtaining loan license and repacking license under Indian drug regulations and their specific requirements.
  • The Act provides provisions for Loan Licenses and Repacking Licenses to enhance flexibility and efficiency in drug manufacturing and distribution.

Loan License

  • A Loan License allows a license holder to permit another entity to use their manufacturing facility for producing specific drugs.
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Key Aspects of Loan License:

  1. Purpose:

    • Enables smaller manufacturers to utilize established facilities without investing in their own infrastructure.
  2. Conditions:

    • Specifies drugs to be manufactured, duration, quality standards, and compliance requirements.
  3. Responsibility:

    • The primary license holder remains responsible for ensuring compliance with all regulatory standards.
  4. Approval Process:

    • Requires approval from the Central Licensing Authority after verifying the qualifications of the secondary manufacturer.

Repacking License

A Repacking License permits an entity to repack drugs manufactured by another license holder.

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Key Aspects:

  1. Purpose:

    • Allows customization, such as different packaging sizes, local language labeling, or bundling for distribution.
  2. Compliance:

    • Ensures repacked drugs maintain quality, safety, and efficacy during the process.
  3. Conditions:

    • Defines the scope of repacking, quality control measures, and labeling standards.
  4. Oversight:

    • Requires adherence to Good Distribution Practices (GDP) and maintenance of records for regulatory inspections.

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