1) Ayurvedic Preparations
Definition:
Medicinal products based on Ayurvedic Preparations, an ancient Indian system of medicine.
Manufacturing Guidelines:
Compliance with Ayurvedic Standards: Follow standards prescribed by the Ministry of AYUSH.
Raw Material Sourcing: Use authentic and quality natural ingredients.
Quality Control: Adhere to Good Manufacturing Practices (GMP) specific to Ayurveda and test for purity, potency, and contaminants.
Labeling: Indicate Ayurvedic nature, ingredients, and usage instructions.
2) Homeopathic Preparations
Definition:
Medicinal products based on homeopathic principles, involving dilution and succussion processes.
Manufacturing Guidelines:
Adherence to Homeopathic Pharmacopeia: Comply with standards in the Homeopathic Pharmacopeia of India (HPI).
Dilution and Potentization: Follow precise methodologies for dilution and succussion.
Quality Assurance: Implement GMP and regular testing for potency, purity, and stability.
Labeling: Include homeopathic nature, dilution levels, and usage guidelines.
3) Patent Preparations
Definition:
Proprietary medicinal products protected by patents.
Manufacturing Guidelines:
Intellectual Property Compliance: Respect patent rights and obtain authorization from patent holders.
Quality Control: Maintain high-quality assurance standards.
Regulatory Approvals: Obtain necessary approvals for manufacturing and distribution.
Labeling and Packaging: Ensure accurate representation of patent information.
4) Proprietary Preparations
Definition:
Medicinal products with unique formulations not covered under patents.
Manufacturing Guidelines:
Formulation Development: Develop unique, reproducible formulations with therapeutic benefits.
Quality Assurance: Implement GMP and regular testing for potency, purity, and stability.
Regulatory Compliance: Obtain necessary licenses and approvals.
Labeling: Clearly indicate proprietary nature, ingredients, and usage instructions.