Herbal Drug Evaluation, Patents & Regulations Notes [U-4]

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Evaluation of Drugs

  • WHO Guidelines for the Assessment of Herbal Drugs
  • ICH Guidelines for the Assessment of Herbal Drugs
  • Stability Testing of Herbal Drugs

Patenting and Regulatory requirements of natural products

  • Patent
  • Intellectual Property Rights (IPR)
  • Farmers’ Rights
  • Breeder’s Rights
  • Bioprospecting
  • Biopiracy
  • Patenting Aspects of Traditional Knowledge and Natural Products
  • Case Study of Curcuma (Turmeric)
  • Case Study of Neem
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Regulatory issues

  • ASU Drugs Technical Advisory Board (ASU-DTAB)
  • ASU Drugs Consultative Committee (ASU-DCC)
  • Regulation of ASU Drug Manufacture in India
  • Schedule Z of the Drugs & Cosmetics Act for ASU Drugs

Other Units of Herbal Drug Technology

Unit 1
Unit 2
Unit 3
Unit 5
Herbal Drug Technology
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Other Subjects of B Pharmacy 6th Semester

Medicinal Chemistry III

Topic wise notes of:

Medicinal Chemistry III

  • Antibiotics & Aminoglycosides
  • Antibiotics & Antimalarials: Structures & SAR
  • Anti-TB, UTI & Antiviral Agents
  • Antifungals, Antiprotozoals & Sulfonamides
  • Intro to Drug Design & QSAR Approaches
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Absorption & Distribution

Topic wise notes of:

Biopharmaceutics and Pharmacokinetics

  • Biopharmaceutics: Absorption & Distribution
  • Drug Elimination, Bioavailability & Bioequivalence
  • Pharmacokinetics Models, Dosing & Parameters
  • Multicompartment models
  • Nonlinear Pharmacokinetics
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Pharmacology III Respiratory and GI Tract

Topic wise notes of:

Pharmacology III

  • Respiratory & GI Tract Drug Pharmacology
  • Chemotherapy: Principles & Key Antibiotics
  • Chemotherapy: TB, Fungal & Parasitic Drugs
  • UTIs, Cancer Chemo & Immunopharmacology
  • Toxicology Basics & Chrono pharmacology
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Topic wise notes of:

Pharmaceutical Biotechnology

  • Introduction to Pharmaceutical Biotechnology
  • Genetic Engineering & rDNA Technology
  • Immunology and Vaccine Technology
  • Microbial Genetics & Biotransformation
  • Fermentation & Bioproduct Production
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Pharmaceutical Quality Assurance

Topic wise notes of:

Pharmaceutical Quality Assurance

  • Quality Assurance, GMP, ICH, QbD & Quality System
  • GMP: Personnel, Premises & Equipment Control
  • Quality Control and Good Laboratory Practice
  • Complaints & Document Management
  • Calibration and Warehousing
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Unit-IV: Evaluation and Regulation of Herbal Drug Notes Summary

This unit focuses on the quality evaluation, regulatory standards, and patenting aspects of herbal and natural products.

Key Highlights:
  • Evaluation Guidelines: Overview of WHO and ICH guidelines for quality assessment and stability testing of herbal drugs.
  • Patents and IPR:
    • Definitions of Patent, Intellectual Property Rights (IPR), Farmers’ Right, Breeders’ Right, Bioprospecting, and Biopiracy.
    • Patenting of Traditional Knowledge and Natural Products with case studies on Curcuma (Turmeric) and Neem.
  • Regulatory Framework:
    • Indian regulations for herbal drugs under ASU DTAB (Drugs Technical Advisory Board) and ASU DCC (Drugs Consultative Committee).
    • Regulation of ASU (Ayurveda, Siddha, Unani) drug manufacturing under Schedule Z of the Drugs & Cosmetics Act.

This unit ensures awareness of global and national standards in herbal drug development, protecting traditional knowledge, and promoting safe herbal medicine use

At FirstHope, we provide BPharm notes that are topic-wise, easy to understand, and designed strictly as per the AKTU and Other Universities, hence designed according to PCI syllabus.

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