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Manufacture In Bond and Outside Bond

Manufacture In Bond

  • Definition: Manufacturing in medicinal preparations under a bond, primarily for export purposes.

Key Features:

  • Bonded Premises: Facilities authorized to produce goods for export without immediate payment of duties or taxes.

  • Tax and Duty Exemptions: Exemptions or deferments on taxes until products are sold domestically.

  • Quality Control: Strict adherence to international standards for export.

  • Record-Keeping: Detailed documentation of production, raw materials, and exports is mandatory.

  • Regulatory Oversight: Enhanced monitoring by national and international regulatory bodies.

Benefits:

  • Encourages export-oriented manufacturing.

  • Reduces financial burden by deferring tax payments until domestic sale.

Manufacture Outside Bond

  • Definition: Manufacturing medicinal preparations for domestic consumption within the country.

Key Features:

  • Domestic Focus: Products intended for sale within the domestic market.

  • Compliance with National Standards: Adherence to quality, safety, and labeling standards as per Indian regulations.

  • Taxation: Manufacturers are liable for taxes and duties on their products.

  • Quality Assurance: Implementation of Good Manufacturing Practices (GMP) for safety and efficacy.

  • Distribution Control: Regulated distribution to prevent counterfeit products.

Benefits:

  • Ensures high-quality medicines for the domestic market.

  • Supports local pharmaceutical industries and economic growth.


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