This article explains about the legal provisions and procedures for export of alcoholic preparations under the Medicinal and Toilet Preparation Act 1955 in India.
Definition
- Alcoholic Preparations: Medicinal products containing alcohol, used for therapeutic purposes.
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Licensing Requirements
- Export License: Mandatory for manufacturers exporting alcoholic medicinal preparations, ensuring compliance with Indian and international standards.
- Documentation: Requires records of production, quality control, safety measures, and compliance with destination country regulations.
- Quality Assurance: Adherence to stringent quality control processes, regular audits, and inspections to meet importing country standards.
Regulatory Oversight
- Export Regulations: Compliance with the Foreign Trade (Development and Regulation) Act, 1992, and coordination with the Directorate General of Foreign Trade (DGFT).
- International Standards: Alignment with standards set by WHO and ICH.
- Customs Compliance: Ensures that products meet customs regulations and are free from prohibited substances.
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Benefits and Challenges
- Benefits: Expands market reach, enhances foreign exchange earnings.
- Challenges: Navigating complex international regulations and maintaining consistent quality standards.
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