- 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.
Key Aspects of Loan License:
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Purpose:
- Enables smaller manufacturers to utilize established facilities without investing in their own infrastructure.
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Conditions:
- Specifies drugs to be manufactured, duration, quality standards, and compliance requirements.
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Responsibility:
- The primary license holder remains responsible for ensuring compliance with all regulatory standards.
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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.
Key Aspects:
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Purpose:
- Allows customization, such as different packaging sizes, local language labeling, or bundling for distribution.
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Compliance:
- Ensures repacked drugs maintain quality, safety, and efficacy during the process.
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Conditions:
- Defines the scope of repacking, quality control measures, and labeling standards.
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Oversight:
- Requires adherence to Good Distribution Practices (GDP) and maintenance of records for regulatory inspections.
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