Understand the legal rules and licensing requirements for wholesale sale of drugs under Indian drug law and regulatory frameworks.
Definition to Wholesale Sale of Drugs:
- Wholesale: The business of selling drugs in large quantities, typically to pharmacies, hospitals, or other retailers, rather than directly to the end consumer.
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Licensing Requirements:
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Wholesale License:
- Necessary for engaging in the wholesale distribution of drugs.
- Types of Wholesale Licenses:
- License A: For general wholesale of all types of drugs.
- License B: For the wholesale of specific categories, such as Schedule H or Schedule X drugs.
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Application Process:
- Submission of prescribed forms along with necessary documentation (e.g., premises details, qualifications of proprietor, etc.).
- Verification by local authorities to ensure compliance with the Act.
Conditions for License:
- Storage Facilities: Must have adequate and secure storage to maintain drug quality.
- Record-Keeping: Detailed records of all transactions must be maintained for inspection purposes.
- Location: Must be situated in an approved area, typically away from residential zones to prevent unauthorized access.
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