Herbal Drug Industry & Schedule T – GMP for ISM
The concluding unit provides an industry and regulatory perspective: (1) The herbal drugs industry in India — its current scope, market potential, challenges, and future prospects. A brief account of major plant-based industries and research institutions working on medicinal and aromatic plants. (2) Schedule T — the Good Manufacturing Practice (GMP) standard for Indian Systems of Medicine as mandated by the Drugs & Cosmetics Act. This section covers every component of Schedule T including infrastructure, equipment, SOPs, quality control, hygiene, and documentation.
Syllabus & Topics
- 1Herbal Drug Industry – Present Scope: India is the largest producer of medicinal herbs (‘Botanical Garden of the World’). ~7,500 medicinal plant species used. Indian herbal market: ~₹30,000 crore (2024), growing at 15-20% CAGR. Global herbal market: >$100 billion. India exports to: USA, EU, Japan, Middle East. Major sectors: Ayurvedic medicines, nutraceuticals, herbal cosmetics, herbal extracts & phytochemicals. Key advantage: rich biodiversity, traditional knowledge base, lower production costs.
- 2Indian Herbal Industry – Major Players: Dabur (oldest — Chyawanprash, Hajmola, herbal personal care). Himalaya Drug Company (Liv.52, herbal wellness). Patanjali Ayurved (massive growth since 2006, diverse FMCG). Hamdard (Unani — Rooh Afza). Emami (Zandu, BoroPlus). Baidyanath (classical Ayurvedic formulations). Sandu Brothers. The Arya Vaidya Pharmacy (Kerala Ayurveda). Export companies: Natural Remedies, Sabinsa Corporation (standardized extracts — Curcumin C3 Complex, BioPerine). Herbal extract industry: growing segment supplying to global pharmaceutical and nutraceutical companies.
- 3Future Prospects: (1) Growing global demand for natural/organic products. (2) WHO Traditional Medicine Strategy → governments integrating traditional medicine. (3) India’s AYUSH Ministry actively promoting — AYUSH visa, international cooperation. (4) R&D in evidence-based herbal medicine (clinical trials). (5) Reverse pharmacology approach: traditional use → clinical validation → mechanistic studies. (6) Phytopharmaceuticals regulations (2015): allows herbal drugs to be developed as ‘phytopharmaceuticals’ with Phase II-III clinical trials → prescribed by modern medicine practitioners. (7) Digital health platforms expanding reach of AYUSH. Challenges: quality standardization, clinical evidence gaps, regulatory harmonization, sustainable sourcing, trained manpower.
- 4Plant-Based Industries & Institutions in India: Research Institutions: CIMAP (Central Institute of Medicinal and Aromatic Plants, Lucknow) — agrotechnology, processing, product development. NBRI (National Botanical Research Institute, Lucknow) — taxonomy, conservation, ethnobotany. CDRI (Central Drug Research Institute, Lucknow) — drug development from natural sources. IHBT (Institute of Himalayan Bioresource Technology, Palampur) — high-altitude medicinal plants. CCRAS (Central Council for Research in Ayurvedic Sciences, New Delhi) — Ayurvedic drug research. CCRUM (Central Council for Research in Unani Medicine). NMPB (National Medicinal Plants Board) — policy, conservation, cultivation promotion.
- 5Industries on Medicinal & Aromatic Plants: Essential oil industries: Mentha (menthol — UP, India is world’s largest producer), Lemongrass (Cymbopogon — Karnataka, Kerala), Eucalyptus, Citronella. Oleoresin industries: Spice oleoresins (pepper, turmeric, chili) — Synthite, Plant Lipids (Kochi). Herbal extract industry: Standardized extracts (Ashwagandha withanolides, Bacopa bacosides, Boswellia boswellic acids) — Sabinsa, Natural Remedies, Arjuna Natural. Plantation crops: Tea, Coffee, Rubber (formal crop but with medicinal value — latex). Floriculture: Jasmine, Rose (essential oil, gulkand).
- 6Schedule T – GMP for ISM: Schedule T appended to the Drugs and Cosmetics Act prescribes Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani drugs. Analogous to Schedule M (GMP for modern drugs). Objective: ensure quality, safety, and efficacy of ASU drugs by setting minimum standards for manufacturing facilities and practices. Applicable to all licensed ASU drug manufacturers. Compliance mandatory for granting/renewal of manufacturing license. Updated periodically — current Schedule T (Second Amendment, 2018) with enhanced requirements.
- 7Schedule T – Infrastructure Requirements: (1) Location: away from pollution sources, clean environment. (2) Building: adequate space, well-lit, ventilated, pest-proof, separate areas for manufacturing, packing, storage, QC lab. (3) Floors: smooth, washable, non-porous (concrete/tile). (4) Walls & ceilings: smooth, painted with washable paint. (5) Drainage: effective, no stagnant water. (6) Separate areas: raw material storage, finished product storage, rejected material area, dispensing, manufacturing, packaging, QC lab, washing area. (7) Clean room/controlled area for sterile ASU preparations.
- 8Schedule T – Working Space, Storage & Equipment: Working space: adequate for each manufacturing activity, separate rooms for different dosage forms (Asava-Arista room, Bhasma manufacturing, Churna grinding, tablet compression). No cross-contamination. Storage: raw materials stored in clean, dry, well-ventilated rooms. Herbs stored off the floor on racks/pallets. Temperature and humidity controlled for sensitive materials. FIFO (First In First Out) principle. Equipment: appropriate type and capacity for the manufacturing process. Mortar & pestle (traditional), pulverizer, mixer-grinder, compression machine (tablets), boiling vessels, fermentation vessels (for Asava/Arista), muffle furnace (for Bhasma preparation). All equipment: stainless steel/non-reactive material, calibrated, qualified.
- 9Schedule T – SOPs, Quality Control & Documentation: Standard Operating Procedures (SOPs): written procedures for EVERY operation — raw material receipt, storage, manufacturing, packing, cleaning, equipment maintenance, sampling, testing, complaint handling. Must be current, approved, and followed consistently. Quality Control: in-process testing at each stage, finished product testing as per pharmacopoeial standards (API/IP/USP). Parameters: identity, purity (ash values, heavy metals, microbial limits), content (marker assay), stability. QC Lab: equipped with analytical instruments — balance, pH meter, microscope, TLC, HPLC, UV-Vis spectrophotometer, dissolution apparatus.
- 10Schedule T – Health, Hygiene & Documentation: Personnel hygiene: medical examination of employees at recruitment and periodically. Clean clothing (aprons, caps, masks, gloves). No eating/drinking in manufacturing area. Handwashing before entering production. Training: all personnel trained in GMP requirements, manufacturing processes. Documentation & Records: Master Formula Record (MFR) for each product. Batch Manufacturing Record (BMR) for each batch. Raw material and finished product register. Quality control test records. Distribution records (for recall traceability). Complaint register. Self-inspection reports. Records retained minimum 5 years.
- 11Schedule T – Key Differences from Schedule M: Schedule T (ASU drugs) vs Schedule M (Modern drugs): (1) Schedule T permits traditional manufacturing methods (open fire Bhasma preparation, earthen pot fermentation) with appropriate controls — Schedule M requires formal process validation. (2) Schedule T requires qualified Vaidya/Hakim — Schedule M requires qualified pharmacist. (3) Schedule T references Ayurvedic/Siddha/Unani Pharmacopoeias — Schedule M references Indian Pharmacopoeia (IP). (4) Schedule T has specific provisions for unique dosage forms (Bhasma, Asava-Arista, Parpati, Kupipakwa Rasayana). (5) Both require documentation, quality testing, hygiene — but Schedule T’s requirements have been historically less stringent (being upgraded).
Learning Objectives
Exam Prep Questions
Q1. What is Schedule T?
Schedule T is a schedule under the Drugs and Cosmetics Act, 1940 that prescribes the Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, and Unani (ASU) medicines. It is considered the traditional medicine equivalent of Schedule M, which applies to modern allopathic drugs. Schedule T outlines the requirements related to factory premises, equipment, raw material quality, manufacturing procedures, quality control testing, personnel hygiene, standard operating procedures, and proper documentation. Compliance with Schedule T is mandatory for obtaining and renewing manufacturing licenses for ASU drug products.
Q2. What is a Phytopharmaceutical?
A phytopharmaceutical is a purified and standardized extract obtained from a medicinal plant and developed using modern scientific methods. Unlike classical herbal formulations, phytopharmaceuticals undergo systematic pharmacological screening, preclinical testing, and clinical trials to establish safety and efficacy. In India, regulations for phytopharmaceutical drugs were introduced in 2015 and later incorporated into the New Drug and Clinical Trial Rules, 2019. These products must meet quality standardization requirements and provide clinical data similar to conventional new drugs, although certain regulatory relaxations exist. Once approved, phytopharmaceuticals can be prescribed by modern medicine practitioners.
Q3. Why is India called the “Botanical Garden of the World”?
India is often referred to as the “Botanical Garden of the World” because of its exceptional plant biodiversity and extensive traditional medicinal knowledge. The country contains about 16 agro-climatic zones and more than 45,000 plant species, of which over 7,500 are used for medicinal purposes. India also has a long history of traditional medicine, particularly Ayurveda, which has been practiced for more than 5,000 years. The Traditional Knowledge Digital Library (TKDL) has documented more than 360,000 traditional formulations. Additionally, India possesses diverse ecosystems such as the Western Ghats, Eastern Himalayas, deserts, tropical forests, and mangroves, many of which are recognized global biodiversity hotspots. The country is also one of the largest producers of several medicinal plants, including mentha, senna, isabgol, and legally cultivated opium for pharmaceutical use.