Pharmacy Freak Editorial Team

Introduction: The WHO guidelines on safety monitoring of herbal medicines provide a global framework for pharmacovigilance of herbal products, emphasizing standardized reporting, product identification, quality control, and signal detection. B.Pharm students should understand adverse event documentation, causality assessment (WHO‑UMC), risk minimization, herb‑drug interactions, contamination/adulteration risks, and the role of national pharmacovigilance centres. Key concepts include … Read more

Regulatory requirements for herbal medicines in India MCQs With Answer Herbal medicines in India are governed by a specific regulatory framework covering quality, safety, labeling, manufacturing and clinical evaluation. B.Pharm students must understand the Drugs and Cosmetics Act, Ministry of AYUSH norms, Schedule T GMP standards, phytopharmaceutical regulations, Ayurvedic Pharmacopoeia monographs, GACP for raw materials, … Read more

Introduction: The Drugs & Cosmetics Act and Rules provide the regulatory framework for manufacture, sale, labeling, quality and safety of herbal medicines in India. B.Pharm students must understand key provisions such as classification of herbal products, applicable pharmacopoeias (Ayurvedic, Unani, Siddha), GMP standards (Schedule T for traditional systems, Schedule M for modern pharmaceuticals), licensing and … Read more

Introduction: Good Manufacturing Practice (GMP) requirements for herbal product manufacturing ensure quality, safety, and regulatory compliance throughout production. B.Pharm students should learn GMP principles including raw material sourcing and botanical identification, Good Agricultural and Collection Practices (GACP), documentation and record-keeping, sanitation, validation (process and cleaning), quality control testing (assay, HPLC, TLC, heavy metals, pesticides, microbial … Read more

Preparation of export registration dossier for herbal drugs is a crucial topic for B. Pharm students focused on pharmaceuticals and international trade. This concise guide emphasizes regulatory requirements, dossier structure, quality control documentation, safety and efficacy evidence, Good Manufacturing Practices (GMP), stability studies, labeling, and pharmacopoeial standards essential for marketing authorization abroad. Key documents such … Read more