The global resurgence of herbal medicines has created an urgent need for scientific evaluation, legal protection, and robust regulatory frameworks. While traditional knowledge forms the backbone of herbal drug use, modern healthcare systems demand evidence-based validation, quality assurance, and ethical commercialization. Unit 4 focuses on the evaluation of herbal drugs as per WHO and ICH guidelines, stability testing, patenting and intellectual property concerns, and the regulatory control of ASU (Ayurveda, Siddha, and Unani) drugs in India. This article presents a comprehensive overview in a news-style educational format.

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Evaluation of Herbal Drugs: WHO & ICH Guidelines

Need for Scientific Evaluation

Herbal drugs often contain complex mixtures of bioactive compounds, making their evaluation more challenging than synthetic drugs. Scientific assessment ensures safety, efficacy, consistency, and global acceptability of herbal medicines. International organizations like the World Health Organization (WHO) and International Council for Harmonisation (ICH) have developed guidelines to standardize herbal drug evaluation.

WHO Guidelines for Herbal Drug Assessment

WHO guidelines emphasize a holistic approach to herbal drug evaluation, including:

1. Botanical identification and authentication

2. Physicochemical parameters such as ash value, extractive value, and moisture content

3. Phytochemical profiling using chromatographic techniques

4. Microbial and heavy metal testing

5. Safety evaluation, including toxicity studies

These guidelines aim to integrate traditional knowledge with modern scientific validation.

ICH Guidelines and Their Relevance

While ICH guidelines were originally designed for synthetic drugs, many principles—such as quality, safety, and efficacy—are now applied to herbal products. ICH focuses on standardized documentation, reproducibility, and risk-based assessment, helping herbal medicines enter regulated global markets.

Stability Testing of Herbal Drugs

Importance of Stability Studies

Stability testing determines how herbal drugs maintain their quality, potency, and safety over time under various environmental conditions. Herbal products are particularly sensitive due to the presence of volatile oils, enzymes, and moisture-sensitive constituents.

Key Stability Parameters

Stability studies evaluate:

• Physical changes such as color, odor, and texture

• Chemical degradation of active constituents

• Microbial growth during storage

• Packaging compatibility

Accelerated and real-time stability studies help establish shelf life and appropriate storage conditions, ensuring consumer safety.

Patenting and Intellectual Property Rights (IPR) of Natural Products

Key Definitions

• Patent: A legal right granting exclusive use of an invention for a specified period

• IPR (Intellectual Property Rights): Legal protections for inventions and creative works

• Farmers’ Rights: Protection of farmers’ traditional knowledge and plant varieties

• Breeder’s Rights: Rights granted to plant breeders for new varieties

• Bioprospecting: Exploration of biological resources for commercial use

• Biopiracy: Unauthorized exploitation of traditional knowledge or biological resources

These concepts are central to ethical commercialization of natural products.

Patenting Traditional Knowledge & Natural Products

Challenges in Patenting Herbal Medicines

Traditional knowledge is often collective, ancient, and orally transmitted, making it difficult to fit into conventional patent frameworks. Modern patent laws require novelty, inventiveness, and industrial applicability—criteria not easily met by traditional remedies.

Case Study: Turmeric (Curcuma longa)

A U.S. patent was once granted for turmeric’s wound-healing properties. India successfully challenged this patent by presenting ancient Ayurvedic texts as prior art. This case highlighted the importance of documenting traditional knowledge to prevent biopiracy.

Case Study: Neem (Azadirachta indica)

Patents on neem-based antifungal products were revoked after evidence showed long-standing traditional use in India. These cases led to the creation of the Traditional Knowledge Digital Library (TKDL), protecting India’s heritage from exploitation.

Regulatory Issues in Herbal Drug Control

Regulatory Authorities in India

India regulates herbal drugs through dedicated bodies for traditional systems of medicine:

ASU DTAB (Ayurveda, Siddha, Unani Drugs Technical Advisory Board)

ASU DTAB advises the government on technical matters related to standards, quality control, and regulatory policies for ASU drugs.

ASU DCC (Drugs Consultative Committee)

ASU DCC ensures uniform implementation of regulatory provisions across states and facilitates coordination between central and state authorities.

Regulation of Manufacture of ASU Drugs

Schedule Z of Drugs & Cosmetics Act

Schedule Z outlines Good Manufacturing Practices (GMP) specifically for ASU drugs. It includes provisions for:

• Raw material quality control

• Manufacturing premises and hygiene

• Standard operating procedures

• Documentation and record maintenance

• Qualified technical personnel

These regulations ensure that traditional medicines are manufactured under scientifically controlled conditions while preserving their classical identity.

Global Perspective and Future Outlook

As herbal medicines gain global acceptance, harmonization of regulatory standards is becoming increasingly important. Countries are now aligning traditional medicine regulations with international norms to promote safety, efficacy, and ethical trade.