Licensing is a critical component of Medicinal and Toilet Preparation Act-1955 Act, ensuring that only authorized entities can manufacture, distribute, or sell medicinal and toilet preparations.
Types of Licenses:
Manufacturing License: For manufacturing medicinal and toilet preparations.
Manufacturer A: Large-scale production.
Manufacturer B: Small-scale or specialized production.
In Bond License: Allows manufacturing without immediate tax payment, typically for export.
Outside Bond License: For manufacturing intended for domestic consumption, ensuring national standards.
Export License: Required for exporting alcoholic medicinal preparations, ensuring compliance with international standards.
Ayurvedic/Homeopathic/Patent & Proprietary License: For manufacturing traditional or proprietary preparations.
Application Process:
Submission: Complete prescribed forms with details about the manufacturing facility and safety measures.
Documentation: Include proof of ownership, equipment, raw materials, and compliance certificates.
Inspection: Licensing authority inspects the premises for compliance with hygiene, safety, and quality standards.
Approval and Issuance: License granted after successful inspection, specifying manufacturing conditions.
Conditions of License Under Medicinal and Toilet Preparation Act-1955:
Compliance with Standards: Adhere to prescribed quality, safety, and efficacy standards.
Proper Record-Keeping: Maintain records of production processes and raw materials.
Regular Inspections: Facilitate periodic inspections for ongoing compliance.
Renewal: Licenses require periodic renewal based on continued adherence to standards.
Modification and Transfer: Changes in ownership or processes need prior approval from the licensing authority.