Clinical Trials of Traditional Herbal Medicines in India: Current Scenario and Challenges

Prof. Nhavale G. B., Dr. Abhishek Kumar Sen, Mr. Dnyaneshwar Pandit

Pratibhatai Pawar College of Pharmacy, Shrirampur, Ahilyanagar, Maharashtra, India-413739

*Correspondence: panditdnyaneshwar75@gmail.com

DOI: https://doi.org/10.71431/IJRPAS.2026.5310       

 INTRODUCTION  

In India, clinical trials of traditional herbal remedies are essential for confirming their effectiveness and safety for use in contemporary medical settings. For generations, many of these herbal remedies, which are sold as "traditional herbal medicines," have been ingrained in local customs. The phrase "traditional use of herbal medicines" refers to their long-standing historical importance. Three major indigenous medical systems—Ayurveda, Unani, and Siddha—have been practiced for around 5,000 years in India, a country known for its abundance of medicinal plants. These ancient knowledge-based systems are still in widespread use today, providing natural treatments for a range of illnesses and advancing research on plant-based medicine worldwide.                             

History

Indian Traditional Medicine, Ayurveda, is an ancient medical system with nearly 5,000 years of history, primarily practised in India. This holistic approach addresses the interconnection of body, mind, and spirit in both preventing and treating illness. Its therapeutic methods include herbal medicine and dietary interventions ³.

Traditional Japanese Medicine: Japanese traditional medical practices have historically integrated Chinese herbal remedies. By the ninth century, Japan had developed its first pharmacopoeia, which featured a systematic classification of indigenous herbs ⁴_.

Traditional Chinese Medicine remains extensively utilised throughout China today. More than half the population regularly relies on traditional remedies, with usage rates particularly high in rural communities. The country offers approximately 5,000 traditional remedies, which constitute roughly one-fifth of China's pharmaceutical market ⁵_.

Current State of the Herbal Industry                                                                              India's AYUSH and herbal products exports grew from $425.80 million (2019-20) to $651 million (2023-24), while the domestic market expanded from $2.85 billion (2014) to $24 billion (2024). After exceptional pandemic-era growth of 27% in 2021, the sector has stabilised with 3.6% growth in 2023-24. The USA and UAE remain top export destinations, with the Ayush Export Promotion Council (launched in 2022) driving quality standards and international compliance.

Herbal Drug Discovery:                                                                                                                                                  

The discovery of herbal drugs involves a systematic exploration of medicinal plants to identify bioactive compounds that can be developed into therapeutic agents. This process integrates traditional knowledge with modern scientific techniques, including phytochemical screening, bioassays, and molecular docking studies. Advances in ethnopharmacology and biotechnology have further enhanced the identification of potential herbal drugs. Standardisation, quality control, and clinical validation are critical steps in ensuring the safety and efficacy of these herbal formulations. The growing interest in herbal drug discovery has led to significant collaborations between traditional medicine practitioners, researchers, and pharmaceutical industries, fostering the development of plant-based medicines that align with global healthcare standards.

categories of Herbal Products³:  

Classification of Herbal Products into Three Categories:

Category A: Conventional Use Plants or extracts that are regularly used by traditional practitioners and have a recognised use in Ayurvedic, Siddha, or Unani medicine are assessed for the same indication mentioned in classical texts. Example: Turmeric

Category B: Innovative Utilisation or Adapted Planning Compounds or plant extracts from well-known plants are being tested for novel therapeutic uses that aren't included in conventional literature or are made in alternative ways. Prior to clinical review, they must be handled as novel chemical entities (NCE) and require acute, subacute, and chronic toxicity data. Example: Neem

Category C: Entirely new substances are plant extracts or substances that have never been utilised before and are not referenced in conventional literature. Prior to clinical review, they must be handled like new medications and go through all usual regulatory formalities. Example: Ashwagandha

Herbal medicines: "Herbal medicines" are "completed, labelled medicinal products that contain aerial or underground parts of plants, or other plant material, or combinations thereof, whether in the crude state or as plant preparations, as active ingredients," according to the World Health Organisation's definition. Plant material includes gums, fatty oils, essential oils, juices, and anything like that. Herbal medicines may contain excipients in addition to their active constituents. Herbal medicines do not include medications that combine plant material with chemically determined active components, including isolated plant constituents that have been chemically described. As is typical, naturally occurring organic or inorganic active ingredients that are not sourced from plants may also be included in herbal therapies in some countries²⁵.

Current and previous status:  

Several Clinical Research Organisations (CROs) have been established in response to considerable international interest in joint contract bids, and India's clinical research sector continues to grow rapidly. Over the past 20 years, market value, revenue, and personnel requirements have all grown dramatically, with growth rates consistently above 20 per cent annually. Significant pharmaceutical and biotechnology companies from all over the world are drawn to India because it has become a premier site for international clinical trials.

India has advanced domestic pharmaceutical innovation significantly in terms of developing new drugs. There is a growing pipeline of new treatments, and several IND compounds created in India are in different phases of clinical testing. Numerous government departments and ministries are still actively engaged in pharmaceutical research and development, with a special emphasis on lifestyle diseases like cancer, stomach ulcers, and dementia, as well as chronic conditions like diabetes, asthma, and hypertension.                                                                    India's AYUSH government has created comprehensive pharmacopoeia standards for traditional medicine. The Ayurvedic & Unani Pharmacopoeia of India, which is continuously being updated, contains standards for over 671 medicinal plant parts. In the Ayurvedic, Siddha, and Unani systems, more than 20 centrally funded laboratories actively carry out pharmacopeial research. National formularies, which contain standardised compositions of 1,696 multi-ingredient classical formulations from these traditions, have been published as official industry documents, acting as reliable guidelines for pharmaceutical manufacturing and quality control throughout India's traditional medicine sector ⁵. The regulatory approval of clinical studies is still the responsibility of the Drug Controller General of India (DCGI), who works with outside specialists and other government bodies to provide advice ⁸. These collaborations are essential to ensure that the evaluation process is thorough and adheres to the highest standards of safety and efficacy. By leveraging expert insights, the DCGI aims to enhance the overall integrity of the drug approval system in India. The Standing Committee on Alternate Systems of Medicine, which is chaired by the DG, ICMR, is constantly creating and improving guidelines for identifying new therapeutic systems in parallel with efforts to validate and integrate treatments from traditional systems of medicine to provide affordable therapies with few side effects. The Clinical Trial Registry of India (CTRI), a central database for all clinical studies in both traditional and modern medicine, is kept up to date by the Indian Council of Medical Research (ICMR). For monitoring clinical research activities and guaranteeing adherence to global trial registration guidelines, CTRI is a crucial instrument.   The World Health Organisation (WHO) and the Department of Science and Technology (DST) jointly support the program ⁵.

Clinical trial of herbal drugs:  

The Drugs Controller's office, which consults with outside experts, the Department of Biotechnology, and the Indian Council of Medical Research, has a three-month approval timeline for clinical trials in India. However, import and export permissions for trial samples can be unpredictable. Even though FDA approval in the US takes 30 days, American studies frequently have delays because there aren't enough eligible participants, but India's potential for quick recruiting may make up for regulatory delays.

Concerns about the predictability and burden of the regulatory environment have been voiced by pharmaceutical sponsors and CROs. In an effort to become a global centre for clinical trials, India has implemented reforms such as Good Clinical Practices guidelines, the removal of import duties for clinical trial samples, and the removal of restrictions on concurrent trials. When studies take place in allopathic settings, practitioners of traditional Indian systems must participate as co-investigators. Herbal medicines must adhere to GCP principles and the DCG(I) standards for allopathic use. In order to guarantee sufficient sample sizes for primary outcomes, all clinical trial stages must comply with GCP criteria, involve experienced conventional practitioners in protocol preparation, and contact a biostatistician. These measures are essential to ensure that the trials yield reliable data and can effectively inform future therapeutic practices. By integrating diverse medical traditions and adhering to rigorous standards, the research can contribute significantly to the advancement of holistic healthcare approaches ².

Phytopharmacological research timeline for Herbal Drug Development (2025)

Stages of clinical trial¹⁴:                                                                                                 

Phase I Studies: Phase I entails testing a novel medication or therapy on a small sample of 20–80 individuals, typically healthy volunteers. While examining medication toxicity and how drug levels react under different situations, such as fasted versus fed states or in cases of renal or hepatic impairment, the main objective is to establish tolerable doses and determine safety. The completion of phase I studies usually takes several months. For small monitored groups in Phase II studies, established dosing regimens offer a sufficient level of confidence in safety; hence, this phase is sometimes unneeded for traditional herbal medications.                           

Phase II Studies: Phase II assesses the effectiveness and ideal dosage range in a moderate group of 100–300 patients who truly have the illness being treated. After determining the maximum tolerated dose from Phase I, researchers modify doses by scaling them upward if ineffective or lower if effective. These studies focus on confirming tolerance and thoroughly examining clinical safety factors, and they include comparison groups for standard treatment and placebo. Phase II trials can involve several hundred patients in various dosage groups and last longer than Phase I, lasting anything from a few months to several years.

Phase III Studies: Phase III involves large-scale clinical trials on hundreds to thousands of patients to confirm safety and effectiveness, using randomised, blinded studies comparing the new drug with standard treatments.                                                                                                

Phase IV Studies: In order to ensure sustained safety and identify uncommon side effects, Phase IV entails post-market surveillance of licensed herbal medications to track long-term safety, efficacy, and adverse effects in the general population.

Standardisation & Quality Evaluation of Herbal Drugs:

Herbal remedies have drawn a lot of attention worldwide because of their medicinal advantages. To guarantee their effectiveness and safety, standardization and quality evaluation are crucial. While quality evaluation assesses the identity, potency, and purity of herbal products, standardization ensures their consistency, safety, and efficacy. Compound authentication and quantification have been transformed by contemporary analytical methods such as HPLC, mass spectrometry, and DNA barcoding. National pharmacopoeias and WHO regulatory frameworks offer standards for contamination limits and manufacturing procedures. Strict testing procedures handle batch-to-batch variances brought on by processing techniques, harvesting season, and geographic origin. Supply chain transparency and advanced detection techniques are necessary to address adulteration concerns. Herbal medications are guaranteed to meet international quality requirements while maintaining their medicinal integrity by combining traditional knowledge with contemporary scientific confirmation.

FIG 3: Quality Evolution of Herbal Drugs

Challenges in Formulating Herbal Drugs:

1. Standardisation Issues

Variations in growth conditions, extraction methods, and plant sources lead to inconsistent active component concentrations across batches.

2. Quality Assurance

Maintaining purity and preventing contamination from pesticides, heavy metals, and microbial agents remains challenging.

3. Authentication and Identification

Accurate botanical identification is critical, as adulteration with morphologically similar species or misidentification can cause safety issues and therapeutic failures.

4. Stability and Shelf Life

Herbal formulations often degrade faster than synthetic drugs, requiring advanced preservation techniques and storage conditions.

5. Bioavailability and Absorption

Many herbal compounds exhibit poor solubility and low absorption rates, limiting their therapeutic efficacy.

6. Pharmacokinetics and Pharmacodynamics Studies

Understanding absorption, distribution, metabolism, and excretion (ADME) of complex herbal mixtures is difficult due to synergistic interactions among multiple active constituents, complicating dose-response relationships.

7. Herb-Drug Interactions

Potential interactions with conventional pharmaceuticals must be thoroughly evaluated before clinical application to ensure patient safety.

8. Scalability and Cost-Effectiveness

Large-scale production without quality compromise is challenging, particularly when sourcing rare or seasonally available botanical raw materials.

Awareness about Indian Traditional Herbal Medicines in India                                                     

With over 8,000 formulations governed by the AYUSH ministry and CDSCO guidelines that align herbal products with allopathic standards since 1993, clinical trials of traditional herbal medicines represent a growing field in India, propelled by the nation's rich Ayurvedic, Unani, and Siddha heritage25. As evidenced by studies on antidiabetic herbs and anti-inflammatory extracts, the current situation demonstrates a surge in trials— contributing significantly to Asia's 37.6% share of global herbal research—with an emphasis on standardization via markers like HPLC fingerprints and phases I–III evaluations for safety and efficacy7. Nonetheless, there are still issues, such as batch-to-batch variability brought on by complex plant extracts, limitations in producing indistinguishable placebos for studies, insufficient quality control in environments with limited resources, and moral conundrums in risk assessment for polyherbal

formulations. It is essential to address them through improved regulatory harmonisation, creative trial designs, and public awareness campaigns in order to mainstream evidence-based herbal medicines and connect traditional knowledge with contemporary science for safer, internationally recognised medical solution10.

Methodology: The study involved a survey in Ghaziabad district, Uttar Pradesh, India, to assess public awareness of plants used in Ayurveda for medicinal purposes. Respondents were questioned about the therapeutic uses of commonly available plants (turmeric, tulsi/basil, curcuma, ginger/sonth, flax/alsee, neem, raisins/munakka, harad, ajwain, fennel/soanf, rose/gulab, aloe vera/ghritkumari, Indian gooseberry/aanwala, nigella/kalonji, guava/amrood, fig/anjeer, nutmeg/jaiphal, and papaya) and lesser-known species (vajradanti, kasmard, lasoda, avena, bharangi, gurmar, shatavar, amaltas, adusa, ashok, bhringraj, mulethi, giloy, vacha, shirish, jatamansi, and nirgundi). Responses were aggregated and visualised in a bar chart. Based on the findings, an educational resource was developed to promote knowledge of under-recognised herbal remedies.

Observation and Results: According to the survey, only four commonly used herbal remedies—turmeric, tulsi, ginger, and neem—were recognised for their therapeutic qualities by more than half of the participants. With 60% awareness, Tulsi topped the list, with neem coming in second at 58.42%.

DISCUSSION           

India is home to one of the richest herbal medicinal traditions in the world, thanks to Ayurveda. 2,500 of the 21,000 medicinal plants treatments^1,9,17,19,24. Over 8,000 Ayurvedic formulas and 700 herbal medicines are documented in ancient book such as Charak, Sushruta, and Vagbhata. There are about 20,000 species of medicinal plants in India, according to recent records, but their usage as complementary medicine is still limited due to low public knowledge. Despite being used in 2019 good, many formulations, like Triphala (made from Bahera, Harad, and Amla), are well-known by name, yet most people are unaware of their constituents. India is the world leader in the production of medicinal herbs; around 6,000 plants are used to address 75% of the medical need of Third World.          

                 It supplies top global sellers like garlic, aloe, and ginseng, and opium exports (60% of total). Herbal medicines persist due to proven health benefits and cultural significance. However, while major companies profit from this plant, the general public lacks knowledge of their medicinal value and uses^11,18,20,21.

Opportunities

Globalisation has increased the popularity of traditional herbal medicines, with 60% of the world’s population using them for malaria. There is particularly high reliance in Africa (80%), Germany (80%), Canada (70%), France (76%), Australia (48%), the USA (42%), and China (30-50%). Additionally, 75% of HIV/AIDS patients in San Francisco, London, and South Africa utilize these remedies. Proven effectiveness, customer desire for natural remedies, mistrust of conventional medications because of their expense and adverse effects, increased safety thanks to contemporary technology, and strong media promotion are some of the major motivators ^28,15. With a growing budget of ₹1428.7 crore in 2017-18, the Indian Ministry of AYUSH is encouraging the integration of Indian Traditional Medicine (ITM), more than triple between 2013 and 2014, integrating AYUSH medications into national programs (NRCH, ICDS, JSY), guaranteeing quality standards, placing AYUSH practitioners in primary care, and advancing international research through programs like the University of Mississippi's Indo-US CRISM centre ⁴.

Opportunities in the field of Research, industry, education and practice:

Opportunities in research, industry, education, and practice abound in the rapidly evolving field of traditional medicine, with current hotspots centring on preclinical and clinical investigations, standardisation, and the formulation of herbal products. Numerous government and private institutions, including the Central Council for Research in Ayurvedic Sciences, Unani Medicine, Siddha, Yoga and Naturopathy, alongside the Council of Scientific and Industrial Research (CSIR), Central Drug Research Institute (CDRI), and Regional Research Laboratory in Jammu, are vigorously pursuing the development and promotion of conventional remedies. Notable breakthroughs from CDRI encompass the anti-hyperlipidemic Gugulipid (marketed as Guglip® by Cipla Ltd.), the semisynthetic antimalarial arteether (E-Mal by Themis Chemicals), the spermicidal Consap cream from Sapindus mukorossi, the hepatoprotective Picroliv from Picrorhiza serrata, a memory-enhancing extract from Bacopa monnieri, and the NSAID-rich Sallaki® from Boswellia serrata by RRL Jammu, while various CSIR laboratories have introduced herbal pain relievers, antifungals, and anti-dandruff formulations, including the recent anti-diabetic BGR-34 developed through NBRI-CIMAP collaboration. Initiatives such as the Golden Triangle Partnership between AYUSH, CSIR, and ICMR are bridging traditional wisdom with modern science to yield innovative drugs, as global pharmaceutical entities leverage cutting-edge technologies for phytoconstituent isolation, quality assurance, mechanistic elucidation, pharmacokinetic profiling, and toxicity assessment in both natural and semisynthetic production ^6,12,16,23. Ayurveda remains a cornerstone for novel drug discovery, bolstered by reverse pharmacology, which inverts the conventional ‘laboratory-to-clinic’ pipeline to ‘clinic-to-laboratory,’ prioritising clinical insights to validate safety, efficacy, and superior therapeutic leads ¹⁶.

Industry

India's traditional medicine sector thrives with over 10,000 manufacturing units generating approximately $1 billion in annual revenue through Indian Systems of Medicine (ISM) and herbal products, while AYUSH facilities have demonstrated consistent yearly increases in output over the past twenty years. Ayurvedic remedies are produced in traditional formats—such as tablets, powders, medicated oils, decoctions, fermented preparations, and ghritas—as well as modern adaptations including capsules, syrups, lotions, liniments, ointments, granules, and creams, all governed by the Drugs and Cosmetics Act of 1940 and its 1945

rules, with mandatory adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) enforced by regulatory bodies for all entities engaged in the production of herbal and traditional therapeutics¹³.

Education and Practice

The Central Council of Indian Medicine (CCIM) oversees the standardization and expansion of education in traditional healthcare, fueling a marked surge in AYUSH institutions over the past twenty years, with approximately 500 undergraduate colleges accommodating more than 25,000 students annually by 2013; premier canter’s include the National Institute of Ayurveda in Jaipur, the Institute of Postgraduate Teaching and Research in Ayurveda in Jamnagar, the National Institute of Unani Medicine in Bengaluru, the National Institute of Siddha in Chennai, and the All India Institute of Ayurveda, offering diverse programs ranging from diplomas and bachelor's degrees to postgraduate MD,     MS, and PhD qualifications across various traditional disciplines. Nationwide, around 3,100 AYUSH hospitals with 57,056 beds and over 26,000 dispensaries deliver essential primary care, improving the doctor-patient ratio from 1:1,700 (allopathic only) to 1:800 when AYUSH practitioners are included—surpassing the WHO's 1:1,000 benchmark—while addressing acute shortages of conventional physicians in rural and remote areas, where traditional healers predominate. Globally, traditional medicines are gaining traction for their accessibility, diversity, cultural resonance, adaptability, minimal side effects, and affordability, creating pathways for their integration into mainstream healthcare systems through targeted strategies and evidence from pilot studies affirming their value in primary Medicare services²².

Future prospect

The future of clinical trials for traditional herbal medicines in India holds immense promise, contingent upon addressing current systemic challenges through multifaceted strategic interventions.

Establishing robust regulatory frameworks that harmonise traditional knowledge with modern scientific standards will be crucial, requiring collaboration between AYUSH, CDSCO, and international regulatory bodies to develop standardised protocols specifically tailored for polyherbal formulations and individualised Ayurvedic treatments.

Investment in infrastructure and capacity building must be prioritised, including the creation of dedicated centres of excellence for herbal medicine research equipped with state-of-the-art analytical facilities, alongside comprehensive training programs for researchers in ethnopharmacology, phytochemistry, and evidence-based trial methodologies.

Integration of advanced technologies such as artificial intelligence for drug discovery, metabolomics for identifying active compounds, and blockchain for ensuring data integrity and transparent documentation of traditional knowledge presents transformative opportunities.

Public-private partnerships and increased government funding through initiatives like the National Mission on AYUSH can accelerate translational research, while international collaborations will facilitate knowledge exchange, multicenter trials, and global acceptance of Indian herbal medicines.

Development of innovative trial designs, including pragmatic trials, N-of-1 trials, and whole-systems research approaches that respect the holistic nature of traditional medicine systems, will be essential for generating meaningful evidence.

Intellectual property rights through patents and geographical indications, coupled with benefit-sharing mechanisms with indigenous communities, will ensure ethical research practices while incentivising commercial investment

A comprehensive digital repository of clinical trial data, traditional formulations, and ethnobotanical knowledge will serve as a valuable resource for future research, fostering a sustainable ecosystem where traditional wisdom and modern science converge to validate and globalise India's rich herbal heritage for improved healthcare outcomes.

CONCLUSION

Clinical trials of traditional herbal medicines in India integrate ancient systems like Ayurveda, Unani, and Siddha with modern scientific approaches, supported by regulatory bodies such as Ministry of AYUSH and Central Drugs Standard Control Organization; however, challenges like poor standardization, complex polyherbal formulations, contamination risks, and low public awareness remain, and addressing these through stronger regulations, advanced quality-testing technologies, improved research infrastructure, and awareness initiatives can position India as a global leader in safe, evidence-based herbal medicine.         

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