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:
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.
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.