WHO Guidelines For Evaluation Of Drugs | Case Study Of Neem & Curcuma | ASU-DTAB | Unit 4 HDT
This is a comprehensive lecture on Unit 4 of Herbal Drug Technology, covering WHO and ICH guidelines for herbal drug evaluation, stability testing, patenting and regulatory requirements for natural products, biopiracy case studies of Neem and Turmeric, and regulatory bodies like ASU-DTAB and ASU-DCC under the Drugs and Cosmetics Act.
Summary
The lecture begins with an introduction to Unit 4 of Herbal Drug Technology, which covers three chapters: Evaluation of Drugs, Patenting and Regulatory Requirements of Natural Products, and Regulatory Issues. The instructor clarifies that herbal drugs are not crude plant materials but formulated products like Zandu Pancharishta, Ashwagandha tablets, and Amla juice, and that these also require quality control testing for safety, efficacy, and quality.
The WHO guidelines for herbal drug evaluation are discussed in detail, covering four major assessment areas: Quality Assessment (including pharmaceutical assessment, crude plant material, plant preparation, finished product, and stability), Safety Assessment (toxicological studies and safety based on traditional experience), Efficacy Assessment (activity, active constituents, and evidence supporting indications), and Intended Use (product information and promotion). Key points include the importance of botanical names for identification, voucher specimens for batch documentation, and the distinction between traditional evidence (sufficient for minor diseases) versus clinical evidence (required for serious diseases).
The ICH (International Council for Harmonisation) guidelines are also covered, noting they were primarily developed for synthetic drugs but apply to herbal drugs too, covering the same four areas: Quality, Safety, Efficacy, and Multidisciplinary guidelines.
Stability testing is explained as determining how long a drug maintains its original quality, safety, and efficacy under various storage conditions. Four types are discussed: Real-time (25°C, 60% RH, normal conditions), Accelerated (40°C, 75% RH, faster testing), Intermediate (30°C, 65% RH, used when accelerated testing fails), and Stress conditions (extreme temperature, humidity, light, oxidation). Parameters monitored include physical appearance, moisture content, pH, active constituent content, and microbial count.
The patenting and regulatory requirements section covers patents (20-year exclusive rights for novel, non-obvious, industrially applicable inventions), Intellectual Property Rights (patents, copyrights, trademarks, industrial designs, trade secrets), Breeder's Rights (legal rights for developers of new plant varieties, valid for 15-18 years), and Farmer's Rights (rights to save seeds, sell harvested crops, register varieties, and receive compensation for false claims).
Bioprospecting is defined as the scientific exploration of biological resources to identify valuable bioactive compounds, while Biopiracy refers to unauthorized use or patenting of biological resources and traditional knowledge without proper permission or benefit sharing. Two landmark case studies are presented: the Neem biopiracy case (where W.R. Grace and USDA obtained a European patent for neem-based fungicide in 1994, which was revoked in 2000 after Indian scientists provided evidence of prior traditional use) and the Turmeric biopiracy case (where the University of Mississippi Medical Center patented wound-healing properties of turmeric in 1995, which was cancelled after CSIR challenged it with ancient Sanskrit texts as evidence).
The regulatory section covers ASU-DTAB (Ayurvedic Siddha Unani Drugs Technical Advisory Board) which advises central and state governments on technical matters, and ASU-DCC (Drug Consultative Committee) which coordinates between central and state authorities. Finally, Schedule Z of the Drugs and Cosmetics Act is explained as specifying GMP requirements for ASU drug manufacturing, covering premises hygiene, worker health, water quality, storage areas, and record-keeping.
Key Insights
- The instructor explains that WHO guidelines require different levels of evidence depending on disease severity — traditional evidence is sufficient for minor diseases like common cold, but clinical trial evidence is mandatory for serious diseases like cancer, because anecdotal reports from a few cases cannot substitute for controlled clinical studies.
- The instructor explains that accelerated stability testing at 40°C and 75% relative humidity is used because if a drug survives these harsh conditions for 6 months, it can be inferred that the drug will last even longer under normal room temperature (25°C) conditions, thereby saving years of real-time testing.
- The instructor makes a critical distinction in Breeder's Rights: while a breeder has exclusive commercial rights to sell a new plant variety, farmers who purchase the seeds are legally permitted to save harvested seeds for future seasons and even exchange seeds with other farmers without payment — they just cannot sell them commercially under a brand name.
- In the Neem biopiracy case, W.R. Grace Company and the US Department of Agriculture obtained a European Patent Office patent in 1994 for neem-based fungicide, claiming it as their invention, despite neem's antifungal properties being documented traditional knowledge in India for thousands of years — the patent was revoked in 2000 due to lack of novelty after Indian farmers and NGOs challenged it.
- The instructor explains that Traditional Knowledge cannot be patented because it fails the fundamental patent requirement of novelty — the turmeric wound-healing patent granted to the University of Mississippi in 1995 was successfully cancelled by India's CSIR in 1997 by presenting ancient Sanskrit texts, Urdu and Hindi literature as evidence that this was pre-existing public knowledge.
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