Definition
Alcoholic Preparations: Medicinal products containing alcohol, used for therapeutic purposes.
Licensing Requirements of Alcoholic Preparations
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.
Benefits and Challenges
Benefits: Expands market reach, enhances foreign exchange earnings.
Challenges: Navigating complex international regulations and maintaining consistent quality standards.