Regulatory Challenges and Innovations in Herbal Medicine: A Path to Progress

Herbal formulations, defined as products predominantly originating from natural sources like leaves, roots, seeds, or flowers, have constituted the foundation of healthcare systems across for centuries (Sharma et al. 2021; Parveen et al. 2020). Historically practiced throughout several cultures, these formulas currently hold a significant position in contemporary health and wellness industries due to their perceived safety, natural origins, and therapeutic effectiveness (Qadir and Raja 2021). Consumers have increasingly sought herbal remedies as alternatives to synthetic medications, especially for controlling chronic illnesses such as arthritis, hypertension, and gastrointestinal disorders. The increasing popularity of holistic and preventative health strategies has further pushed this need, with herbal goods now spanning a diverse array of industries, including nutritional supplements, functional foods, cosmetics, and pharmaceuticals (Egbuna et al. 2020). The global medicinal plants market is experiencing significant growth. Recent projections indicate that the global herbal products industry is projected to exceed 5 trillion USD by 2050, with significant contributions from both developed and developing countries (Parvin et al. 2023). This expansion is driven by heightened consumer knowledge of natural health solutions, growing research on the effectiveness of diverse plants, and inventive product creation by various vendors (Chopra et al. 2022). The United States (US) and European Union (EU) markets have experienced robust demand for herbal products, which are promoted not just as ancient remedies but also as essential elements of contemporary health campaigns, including wellness tourism, organic diets, and veganism (Guptill et al. 2022; Agrodimou 2019). In these areas, the prevalence of herbal formulations is frequently associated with an increasing cynicism towards traditional medications, as consumers perceive plant-based alternatives to be milder on the body and more environmentally sustainable (Jansen et al. 2021). However, with this surge in market demand comes a complex array of regulatory challenges. While synthetic drugs undergo rigorous testing for safety and efficacy before they reach the consumer market, herbal formulations do not always face the same level of scrutiny (Abdel-Tawab 2018; Balkrishna et al. 2024). The regulatory landscape for these products varies widely across countries, ranging from highly structured systems, like those in the EU, to more lenient frameworks, as seen in certain Asian and African nations (Enioutina et al. 2017; Peralta et al. 2016). This lack of regulatory uniformity raises important concerns about product safety, quality control, and accurate labelling, leading to the pressing need for a more globally harmonized approach to herbal product regulation. While the U.S. classifies herbal products primarily as dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Pinco and Halpern 1999; Brown 2017), thus exempting them from stringent pre-market approval processes, EU follows the Traditional Herbal Medicinal Products Directive (THMPD) (Dhaenens 2010; Stemplewski 2018). This directive mandates the registration of herbal medicinal products that have been in use for at least 30 years, thereby offering a more regulated approach to ensure safety and efficacy. Meanwhile, Asian countries, such as China and Japan, integrate traditional knowledge systems such as Traditional Chinese Medicine (TCM) and Kampo into their regulatory frameworks, recognizing the medicinal value of centuries-old practices while enforcing modern safety standards (Payyappallimana and Serbulea 2013; Liang et al. 2021a; Ansari 2021). The global regulatory patchwork often results in inconsistent product quality, varying consumer trust, and challenges for international trade.

1.1. Indian Perspective

The subject of herbal formulations in India is profoundly anchored in the country's extensive heritage of natural medical systems, notably Ayurveda, Unani, Siddha, and Yoga (Khalikova 2018). These medical methods have been utilized for over 5,000 years and continue to be essential to India's healthcare framework, providing both preventive and therapeutic remedies for various maladies (Kizhakkeveettil et al. 2024). India, as the origin of Ayurveda, occupies a distinctive role in the worldwide herbal market, with the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy) responsible for the promotion, development, and regulation of traditional medicines and herbal products (Shankar and Patwardhan 2017; Rudra et al. 2017). The Indian herbal market is anticipated to expand significantly, propelled by domestic demand and export opportunities, as consumers increasingly favour natural therapies that resonate with India's philosophy of holistic wellbeing. The Indian government, acknowledging the economic and cultural importance of its traditional medicine systems, has made substantial investments in the promotion and standardization of medicinal herbs. India is enhancing regulation of its herbal business through programs like the National AYUSH Mission and the establishment of pharmacopoeia standards for Ayurvedic and Unani medicines. These initiatives seek to augment customer confidence, improve the export capacity of Indian herbal products, and establish India as a global frontrunner in herbal formulations. The government's emphasis on advancing research and development in traditional medicine, along with the standardization of Ayurvedic products, demonstrates its dedication to ensuring these formulations adhere to international quality standards, thereby enhancing their competitiveness in the global market (Tillu 2018; Samal and Dehury 2019). Nonetheless, India encounters different challenges regarding the regulation of herbal products. The Ministry of AYUSH establishes a comprehensive regulatory framework; nevertheless, the implementation of these norms at state and municipal levels frequently exhibits inconsistency (Lal 2018). The growing commercialization of Ayurveda and other traditional medical systems has raised concerns regarding the adulteration and contamination of herbal products, underscoring the necessity for more stringent quality control methods. The government has been promoting the implementation of Good Manufacturing Practices (GMP) and the development of more effective pharmacovigilance mechanisms to oversee adverse responses to herbal products in the marketplace (Singh et al. 2023; Parihar et al. 2023). Moreover, India's herbal product export market is set for significant expansion, with nations in EU, the Middle East, and Southeast Asia becoming prominent purchasers. Nonetheless, the disparate regulatory mandates of these global markets present considerable obstacles for Indian producers, who must manoeuvre through differing standards for safety, efficacy, and quality. Consequently, there is an increasing demand for enhanced harmonization of regulatory frameworks, both domestically in India and internationally, to promote seamless trade and guarantee that customers globally may obtain safe and effective herbal goods (Jadhav et al. 2020).

2. Regulatory Frameworks for Herbal Products

The regulatory frameworks for herbal products globally are as varied as the nations that enforce them which is elucidated in Figure 1. As the global market for herbal formulations expands, regulatory agencies are increasingly prioritizing the assurance that these medicines comply with essential safety and efficacy standards (Bhat et al. 2018). In contrast to conventional medications, which generally follow a standardized and rigorously controlled approval process, herbal drugs frequently encounter disparate regulatory frameworks based on the region which are listed in the Table 1(Chandra and Narayana 2023). This section will include a comparative review of regulatory frameworks across major global countries and provide insights into India's regulatory landscape for herbal products.

2.1. Worldwide Perspective

Herbal products are governed by diverse regulatory frameworks globally, mostly contingent upon each country or region's perception of herbal medicine within its healthcare system as illustrated in Figure 2. Regulatory frameworks can vary from stringent, where herbal goods are controlled akin to pharmaceuticals, to more permissive systems, where herbal products encounter fewer restrictions.

Figure 1.  Global Herbal Product Regulatory Pathway

In the United States, the regulation of herbal products is governed by the Dietary Supplement Health and Education Act (DSHEA) of 1994, enforced by the Food and Drug Administration (FDA) (Wallace 2015). Under DSHEA, herbal products are categorized as dietary supplements instead of pharmaceuticals, indicating they are exempt from the stringent pre-market approval required for pharmaceutical drugs. Manufacturers are accountable for guaranteeing the safety of their products prior to marketing, but the FDA possesses the right to intervene if items are deemed unsafe post-market entry. This post-market surveillance system has faced criticism for its reactive rather than proactive approach to consumer protection (Bailey 2020).  Moreover, labelling is a crucial regulatory element for herbal goods in the U.S., mandating producers to incorporate disclaimers indicating that the FDA has not assessed the product. Assertions on the product's advantages must be validated, however the standard for evidence is less stringent than that mandated for drugs. Notwithstanding these regulatory initiatives, the FDA's constrained oversight has resulted in occurrences of fraudulent claims and contamination inside the market (Sarma et al. 2023).

2.1.2. European Union

The EU adopts a more rigorous regulation framework for herbal goods. The Traditional Herbal Medicinal Products Directive (THMPD), enacted in 2004, regulates the sale of herbal medicinal products in EU member states (Dhaenens 2010; Stemplewski 2018). This regulation mandates the registration of all herbal medicines with the European Medicines Agency (EMA), specifically via the Committee on Herbal Medicinal Products (HMPC) (Clair 2019; Coppens and Pettman 2018). Herbal products must prove a minimum of 30 years of usage (including 15 years within the EU) and furnish evidence of their safety and efficacy derived from traditional use for registration. Products fulfilling this criterion can be released without necessitating new clinical trials, hence streamlining the regulatory process for numerous well-established herbs (Ameh et al. 2014). The THMPD framework prohibits high-level treatment claims without the completion of supplementary clinical trials. This constrains the marketing potential for herbal products in the EU relative to other regions, albeit it guarantees a superior safety standard for customers (Kathuria et al. 2024). Alongside the THMPD, the European Pharmacopoeia establishes quality standards for herbal constituents, thereby facilitating product uniformity throughout the region.

2.1.3. Asia

Asia presents a varied regulatory framework owing to the significant influence of traditional medicine systems such as Traditional Chinese Medicine (TCM) and Ayurveda (Wu et al. 2021). In China, the oversight of herbal medicines is managed by the National Medical Products Administration (NMPA), previously referred to as the China Food and Drug Administration (CFDA). Herbal goods, especially those linked to Traditional Chinese Medicine, are regulated like to pharmaceuticals, necessitating stringent clinical trials for new products and substantial evidence of safety and efficacy (Anjum et al. 2024; Zhang and Yang 2022). Products associated with traditional TCM treatments may face somewhat more permissive regulations due to past usage; nonetheless, new formulations are still subjected to clinical evaluation. Japan employs a comparable system for Kampo (traditional Japanese herbal medicine), wherein herbal products are classified as pharmaceuticals and are required to fulfil identical regulatory standards for approval (Arai 2021; Yoshino et al. 2023). The rigorous criteria in China and Japan demonstrate a significant focus on incorporating traditional medicine into a contemporary regulatory system. Other Asian nations, like as Thailand and Malaysia, are formulating legislation that integrate ancient knowledge with contemporary pharmaceutical standards (Liu 2021).

2.2. Indian Perspective

India possesses a profound and extensive heritage of herbal medicine, predominantly through its systems of Ayurveda, Unani, Siddha, and Yoga. India, as a global leader in traditional medicine, confronts the problem of ensuring its herbal medicines comply with both domestic and international regulatory norms. The Indian government acted by establishing a comprehensive regulatory framework under the auspices of the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homeopathy).

Figure 2. Compliance Strategy for Herbal Product Manufacturers

2.2.1. National Regulatory Framework

In India, herbal products are classified as Ayurvedic, Siddha, and Unani (ASU) medications in accordance with the medications and Cosmetics Act of 1940 and the accompanying Drugs and Cosmetics Rules of 1945 (Sharma and Pundarikakshudu 2019; Gregorczuk 2024). The Ministry of AYUSH supervises the regulatory framework to guarantee the safety and efficacy of products. The government has created the Pharmacopoeial Laboratory for Indian Medicine (PLIM) and the Pharmacopoeial Commission for Indian Medicine & Homoeopathy (PCIM&H) to develop quality standards for herbal ingredients and products (Jayanthy et al. 2016; Rajeev et al. 2015). The legal framework mandates that herbal product manufacturers comply with Good Manufacturing Practices (GMP) to guarantee product purity and uphold stringent quality standards in production procedures. The Central Council of Research in Ayurvedic Sciences (CCRAS) and other research organizations endorse clinical trials and research initiatives to substantiate the effectiveness of traditional remedies (Organization 2020).

2.2.2. Export Challenges and Global Market Integration

A significant challenge for India's herbal product industry is complying with the regulatory standards of overseas markets. The stringent documentation and scientific evidence necessary for herbal medicines to access markets such as the EU and U.S. pose challenges for businesses dependent on traditional formulas with extensive historical usage but insufficient contemporary clinical validation (Bhat et al. 2018; Chaudhary 2023). Consequently, India has concentrated on standardizing its herbal products to comply with international safety and quality requirements. The Ministry of AYUSH is endeavouring to align Indian regulatory norms with foreign standards to promote the export of Ayurvedic products (Katiyar and Dubey 2023; White et al. 2017). This entails conforming to the WHO’s Traditional Medicine Strategy, which advocates for member nations to establish laws that guarantee the safety and efficacy of herbal products while honouring traditional practices (Organization 2022).

2.2.3. State-Level Variations and Challenges

Despite these progresses, the regulatory structure in India continues to encounter obstacles, especially regarding its implementation at the state and local tiers. Every state possesses regulatory authorities tasked with supervising the manufacturing and sale of herbal products, resulting in discrepancies in the implementation of legislation (Samal and Dehury 2018). This has elicited apprehensions regarding the quality and safety of certain herbal medicines, particularly those marketed through informal channels or by smaller producers who may not comply with GMP requirements.

Evaluating the safety and efficacy of herbal medicines is essential to ensure compliance with health standards and to ensure that they deliver the desired therapeutic benefits without negative side effects. In contrast to synthetic medications, which are subjected to stringent clinical trials and extensive regulation, herbal formulations may encounter a more intricate evaluation procedure owing to their natural origins, varied composition, and historical usage. This section analyses global approaches for evaluating the safety and efficacy of herbal products, emphasizing clinical trials, pharmacovigilance, and post-market surveillance, together with the specific obstacles encountered by the Indian regulatory framework.

3.1. Global Perspective

The international market for herbal products necessitates rigorous safety and efficacy evaluations, although the methodologies employed to attain these objectives differ markedly between regions. The dependence on historical usage, along with contemporary scientific methodologies such as clinical studies, establishes a varied evaluative framework. This analysis examines the predominant approaches employed globally to guarantee the safety and efficacy of herbal products.

3.1.1. Clinical Trials and Traditional Use

In many regions, clinical studies represent the definitive standard for validating the safety and efficacy of herbal products. In the US and EU, herbal goods intending to make health claims frequently must present clinical data comparable to that mandated for pharmaceuticals. The methodology varies considerably according to regional regulations and the historical application of herbs (Mukherjee et al. 2015; Indrayanto et al. 2021). In the US, pursuant to the DSHEA Act, herbal supplements are exempt from mandatory clinical trials prior to market entry. Manufacturers are required to guarantee the safety of their products and validate any health claims; however, clinical trials are not obligatory unless a product is identified for safety issues post-market release. This reactive safety strategy may result in deficiencies in consumer protection, as seen by numerous prominent instances of contamination and mislabelling in the US market (Brown 2017; Kennett 2019). Conversely, the EU prioritizes clinical proof, particularly for herbals that assert therapeutic claims. According to the THMPD, products are required to either complete clinical trials or provide proof of safe and effective traditional use for a minimum of 30 years, with at least 15 years within the EU. This permits the endorsement of herbal treatments grounded in historical evidence, but simultaneously necessitating compliance with contemporary safety requirements. St. John’s Wort, a prevalent herbal remedy for mild depression, is extensively endorsed in EU but is under clinical examination due to its interactions with various pharmaceuticals (Stemplewski 2018). Asian nations, notably China and Japan, incorporate clinical studies alongside traditional practices. In China, herbal goods, particularly those linked to TCM, are governed by the NMPA. These products must undergo clinical trials akin to medications unless their safety and efficacy are validated through extensive traditional use. This system guarantees that contemporary formulations or combinations of herbs undergo rigorous scientific evaluation, while simultaneously honouring the historical effectiveness of established medicines (Zhang and Yang 2022).

3.1.2. Pharmacovigilance and Post-Market Surveillance

Pharmacovigilance, the surveillance of adverse effects post-market entry, is essential for maintaining the safety of herbal products. Regions like the US and the EU possess robust pharmacovigilance systems for the oversight of dietary supplements and herbal medications. In the US, the FDA's Adverse Event Reporting System (FAERS) enables consumers and healthcare professionals to report adverse events linked to herbal products (Timbo et al. 2018). The FDA may act, such as issuing warnings or recalls, if a product is associated with multiple adverse incidents. This method is crucial for safety monitoring but is frequently criticized for its underutilization, as many consumers lack awareness of the reporting procedure (Gonzalez-Hernandez et al. 2022). The EU employs a more systematic methodology, especially for herbal medical goods licensed under the THMPD. The EMA supervises pharmacovigilance for these medications, mandating manufacturers to uphold post-market safety data and report any adverse effects. This guarantees that even traditionally used herbal remedies are scrutinized for emerging safety issues that may occur in contemporary settings, like drug-herb interactions or contamination (Bhasale et al. 2021). China and Japan have comprehensive pharmacovigilance procedures for herbal goods, especially with TCM and Kampo. In China, the NMPA mandates producers to gather and submit adverse event data, but Japan’s Ministry of Health, Labour and Welfare implements post-market surveillance for Kampo products, assuring timely resolution of safety problems (Liang 2023).

3.1.3. Case Studies: Regulatory Successes and Failures

Numerous case studies illustrate the diverse effectiveness of regulatory frameworks in guaranteeing the safety and efficacy of herbal products. The instance of Hypericum perforatum also known as St. John's Wort in EU illustrates the advantages of a systematic regulatory framework. Authorized under the THMPD in Germany, St. John’s Wort has demonstrated efficacy for mild to moderate depression, with clinical trials validating its safety when utilized correctly (Ng et al. 2017). Nonetheless, it has had limitations owing to its interactions with other pharmaceuticals, highlighting the significance of post-market surveillance in ensuring the safety of herbal products. The ephedra case in the US underscores the dangers of insufficient pre-market safety evaluations. Ephedra viridis, an herb utilized for weight reduction and athletic enhancement, was associated with severe cardiovascular adverse effects, including myocardial infarctions and cerebrovascular accidents (González-Juárez et al. 2020). Notwithstanding its historical application, insufficient clinical evidence and inadequate post-market surveillance resulted in multiple adverse occurrences prior to the FDA's prohibition of its sale in 2004.

3.2. Indian Perspective

The evaluation of herbal product safety and efficacy in India is closely linked to the country's enduring traditional medical systems, notably Ayurveda, Unani, and Siddha. The government has acknowledged the necessity to modernize and standardize safety assessments in accordance with international principles, particularly as Indian herbal goods increase in worldwide market prominence.

3.2.1. National Approaches to Safety and Efficacy

The Ministry of AYUSH in India regulates herbal goods, emphasizing traditional knowledge alongside contemporary safety standards. Products categorized under Ayurvedic, Unani, and Siddha systems must comply with the Drugs and Cosmetics Act of 1940, which requires manufacturers to implement Good GMP (Charde et al. 2021). Although conventional usage constitutes a crucial component of the safety evaluation process, there is a growing focus on clinical studies and laboratory testing to ensure that products comply with international safety requirements. The Pharmacopoeial Laboratory for Indian Medicine (PLIM) and the Pharmacopoeial Commission for Indian Medicine & Homoeopathy (PCIM&H) are essential in establishing quality standards for herbal products. These organizations are tasked with evaluating herbal components for contamination, potency, and quality, ensuring that products satisfy requisite safety standards prior to consumer distribution. The Central Council for Research in Ayurvedic Sciences (CCRAS) is engaged in clinical research to substantiate the efficacy of traditional medicines (Rajeev et al. 2015).

3.2.2. Pharmacovigilance in India

Pharmacovigilance is an expanding domain within India's regulatory framework. The Ministry of AYUSH has launched the National Pharmacovigilance Program for ASU & H Drugs, which gathers adverse event data about Ayurvedic, Siddha, and Unani goods. This method is intended to oversee the safety of these goods once they enter the market, facilitating the detection of any adverse reactions or interactions between drugs and herbs that may arise. Nonetheless, the initiative remains in its nascent phase, indicating potential for enhancement in public awareness and reporting systems (Singh et al. 2023).

3.2.3. Challenges in Safety and Efficacy Assessments

Despite India's advancements in establishing safety and efficacy evaluations for herbal drugs, many challenges persist. A key concern is the absence of extensive clinical studies for numerous conventional formulations. Although these medications have been utilized for centuries, the lack of robust scientific evidence may impede their popularity in global markets. The disparity in quality requirements among states and the unregulated production of herbal medicines may result in contamination and inconsistent efficacy (Panda and Kar 2021).

4. Compliance Strategies for Industry

In a market characterized by large regional disparities in regulatory frameworks for herbal formulations, it is imperative for producers to implement effective compliance measures. Successfully navigating the intricate regulatory framework necessitates a comprehensive awareness of both domestic and international legislation pertaining to herbal products, alongside the capacity to adhere to safety, efficacy, and quality benchmarks as detailed in Table 2. This section offers a comprehensive review of compliance techniques for herbal product makers, emphasizing best practices for regulatory conformance, negotiating diverse worldwide standards, and circumventing frequent pitfalls. The distinct difficulties and potential within the Indian herbal sector are also examined.

4.1. Worldwide Perspective

The global herbal product market is varied, featuring a multitude of restrictions that differ by both area and product kind. This variability necessitates that manufacturers implement adaptable compliance techniques that may be customized to the distinct requirements of each target market.

4.1.1. Best Practices for Regulatory Compliance

Manufacturers must use a proactive approach to ensure regulatory compliance across many markets, commencing from the first phases of product development. A variety of best practices can assist herbal product makers in managing regulatory challenges, including Interacting with regulatory authorities during the development stage of an herbal product is crucial. This ensures that manufacturers comprehend the precise criteria for safety, efficacy, and labelling in each target market (Thakkar et al. 2020). For instance, EU, herbal goods are required to be registered under the THMPD prior to marketing. Early engagement with the EMA enables companies to optimize the registration process and mitigate delays. Companies must either present clinical study data or exhibit long-term conventional use to substantiate the safety and efficacy of their products, contingent upon the market. In the EU, herbal medications that have been utilized for a minimum of 30 years, including 15 years within the EU, may circumvent certain clinical trial prerequisites if they adhere to traditional usage criteria (Petkova-Gueorguieva et al. 2019). In the US, producers are obligated to verify that their claims adhere to the DSHEA, which mandates the substantiation of safety, notwithstanding the absence of obligatory clinical trials (Prabhakar and Mamoni 2021). Maintaining product quality via GMP is essential for regulatory adherence in numerous jurisdictions. GMPs are mandated in the US under the Current Good Manufacturing Practice (cGMP) laws, as well as in the EU and other markets. These criteria encompass all aspects from raw material procurement and production procedures to packaging and labelling, guaranteeing that products are uniform, safe, and devoid of contamination (Bunn 2019).

4.1.2. Navigating Global Standards

Manufacturers of herbal products targeting at various international markets must contend with a complex array of distinct and frequently conflicting regulatory criteria. Although the worldwide harmonization of regulations remains nascent, organizations can use techniques to assure adherence to varying legal standards. One of the most efficacious tactics for market entry is to customize items to comply with the distinct regulatory criteria of each country. An herbal concoction advertised as a dietary supplement in the U.S. may require registration as a traditional medicinal product in the EU, where it would be governed by more rigorous laws. Comprehending these distinctions and modifying labelling, assertions, and phrasing properly is essential for compliance (Krishna et al. 2024). Regulatory agencies across various nations may impose differing documentation requirements, encompassing clinical trial outcomes, evidence of traditional usage, and pharmacovigilance information. Companies must ensure the preparation of region-specific dossiers that comply with the requirements of local regulators. In Asia, traditional herbal remedies in China and Japan are regulated akin to pharmaceuticals, necessitating comprehensive safety and efficacy data for market approval. Collaborating with local professionals who comprehend the intricacies of compliance in each market often enhances firms' success in navigating regional regulatory landscapes (Enioutina et al. 2017). Regulatory consultants can elucidate local legislation, enhance communication with regulatory authorities, and aid in the submission of necessary documentation. This is especially significant in places such as China, where the amalgamation of ancient knowledge and contemporary regulatory norms generates a difficult landscape for international enterprises.

4.1.3. Common Pitfalls and Recommendations

Despite their best efforts, numerous herbal product businesses encounter compliance difficulties when entering new markets. Inconsistent labelling and unverified health claims are prevalent problems that may result in regulatory intervention. In the US, the FDA mandates that manufacturers affix a disclaimer on herbal supplements indicating that the product is not meant to diagnose, treat, cure, or prevent any disease unless such assertions are supported by strong scientific evidence (Smolla 2015). Noncompliance may lead to admonitory letters, product withdrawals, or litigation. Noncompliance with GMP may result in significant regulatory sanctions, such as product recalls and prohibitions. Inconsistent production processes frequently lead to contamination, unpredictability in product potency, and mislabelling of items. Consistent audits and compliance with GMP processes are crucial for guaranteeing that products satisfy regulatory standards in various regions (Ratanavinitkul and Nawatrakulpisut 2019). A prevalent error committed by manufacturers is the underestimation of regulatory disparities among markets. A product that receives prompt approval in one region may necessitate substantial adjustments to obtain clearance in another. The rigorous criteria for clinical studies of herbal medical products in the EU are significantly more exacting than the comparatively relaxed post-market surveillance regime in the U.S. Organizations must allocate resources to comprehend these distinctions to prevent expensive delays and rejections.

India ranks among the foremost global producers of herbal products, boasting a rich heritage of traditional medicinal systems including Ayurveda, Siddha, and Unani. With the expansion of the herbal product sector in India, manufacturers are increasingly confronted with the issue of adhering to both domestic and international regulatory standards. The Ministry of AYUSH is pivotal in regulating and promoting herbal goods; yet, the changing global market necessitates that enterprises implement new compliance measures.

4.2.1. National Compliance Strategies

The Ministry of AYUSH in India requires herbal product makers to comply with Good Manufacturing Practices as stipulated by the Drugs and Cosmetics Act. GMP compliance guarantees that products are produced in a sanitized and regulated environment, devoid of contamination, and with uniform quality (Katiyar et al. 2023). The PCIM&H establishes norms and criteria for Ayurvedic and herbal goods, which companies must comply with to obtain regulatory clearance. Due to the extensive history of Ayurvedic, Siddha, and Unani medicine in India, producers frequently utilize traditional use documents to substantiate safety and efficacy (Chandra and Narayana 2023). India is striving to enhance its herbal product exports and is stressing the necessity for further clinical evidence to comply with international regulatory standards, especially in the EU and the US, where traditional usage alone may not suffice for market authorization. The expanding export market for herbal products in India encounters the issue of adhering to various international standards. The Ministry of AYUSH is diligently striving to match Indian rules with international norms, particularly in accordance with the WHO’s Traditional Medicine Strategy. This effort seeks to enhance the safety, quality, and efficacy of herbal products, hence allowing their access to international markets. Nonetheless, further advancement is required in establishing comprehensive pharmacovigilance procedures and guaranteeing uniform enforcement of GMP requirements throughout jurisdictions (Jauhri and Pathak 2022).

4.2.2. Challenges and Opportunities

The Indian herbal enterprises have achieved notable progress in regulatory compliance, however numerous problems persist. A primary concern is the absence of extensive clinical trials to substantiate the effectiveness of traditional mixtures (Katiyar and Dubey 2023). Despite India's extensive traditional knowledge, the lack of robust scientific proof may impede the acceptance of these goods in international markets, especially in areas such as the EU, where clinical data is essential for product registration. The Indian government is promoting research and development in partnership with universities and research organizations to produce the requisite clinical evidence (Krishna et al. 2024). Moreover, the Indian herbal market is significantly fragmented, with small and medium companies (SMEs) frequently deficient in resources to comply with GMP and international regulatory norms. The government is offering financial incentives and technical assistance to enable smaller enterprises to enhance their facilities and comply with global standards. This will subsequently augment the competitiveness of Indian herbal items in the worldwide marketplace (Parveen et al. 2020).

5. Consumer Perspectives and Market Dynamics

The demand for herbal goods is primarily influenced by customer perceptions and preferences, which subsequently define the dynamics of the worldwide herbal industry. The increasing consumer interest in natural, plant-based alternatives to traditional medicine, alongside the emergence of wellness trends, has substantially enhanced the global herbal sector. Market dynamics are influenced by regulatory compliance, product safety, and the capacity to innovate in response to changing consumer expectations, which are listed in Table 3.

5.1. Worldwide Perspective

The global market for herbal goods is marked by a rising desire for natural medicines, driven by increased scepticism towards synthetic drugs and heightened knowledge of preventive healthcare. Consumers are increasingly knowledgeable and selective regarding the items they utilize, demanding transparency, effectiveness, and safety in the herbal products they get.

5.1.1. Consumer Perceptions of Safety and Efficacy

The growing demand for herbal products is mostly driven by the belief that they are safer and less detrimental than synthetic medications. Consumers frequently see herbal formulations as "natural" options, linking them to less side effects and a comprehensive approach to health. Research suggests that several consumers perceive herbal products as facilitators of the body's innate healing mechanisms, offering a milder and more sustainable approach to health management than traditional pharmaceuticals (Obahiagbon and Ogwu 2024). Nonetheless, although some customers presume that herbal products are intrinsically safe, this is not invariably true. The absence of uniform rules across various markets results in not all herbal products receiving thorough safety evaluations (Alostad et al. 2018).  In areas with less stringent laws, such as the US, herbal products are frequently marketed without prior approval, resulting in possible hazards such as contamination or unverified health assertions. The inconsistency in regulatory requirements undermines consumer trust and underscores the necessity of informing customers about the potential risks linked to herbal mixtures (Adusei-Mensah et al. 2019). Within the EU, herbal products are subject to stringent regulations under the THMPD, ensuring that customers can rely on the safety and efficacy of these products prior to their market availability. This systematic methodology bolsters consumer confidence and facilitates greater consistency in product quality (Gatt et al. 2024). In markets such as China and Japan, where herbal remedies are included into the conventional healthcare system and regulated similarly to pharmaceuticals, customer trust is typically elevated (Teng et al. 2016).

Figure 3. Consumer Decision-Making Process for Herbal Products

Consumer preferences are influencing the development and marketing of herbal products. The current wellness movement, prioritizing preventive health, nutrition, and self-care, has broadened the range of herbal products beyond conventional medicine. Herbal supplements, functional meals, and beauty items using herbal components are increasingly significant development sectors within the market (Tulunay et al. 2015). These items attract people aiming to include natural cures into their everyday routines, either for health preservation or beauty improvement. Herbal remedies purporting to strengthen immunity, improve digestion, or augment cognitive function are in significant demand, particularly in the aftermath of the COVID-19 epidemic, which increased public awareness of immunological health (Demeke et al. 2021).  Likewise, the natural cosmetics and beauty industry has experienced a rise in popularity, as consumers are more drawn to goods that provide reduced chemicals and synthetic ingredients. Ingredients such as Curcuma longa, Aloe barbadensis Mill, and Camellia sinensis are frequently used in these products, indicating market demand for the integration of health advantages with cosmetic uses. Moreover, there is an increasing demand for openness and sustainability within the herbal business. Consumers are more concerned with the origin and sourcing methods of their herbal ingredients, preferring goods that are ethically manufactured and environmentally sustainable (Bareetseng 2022; Al-Harrasi et al. 2022). The transition to sustainable and responsible consumption is impacting the supply chain, prompting corporations to implement practices like organic farming and fair-trade sourcing. Organizations that emphasize transparency, traceability, and sustainability are acquiring a competitive advantage in the market.

5.1.3. Impact of Regulatory Compliance on Consumer Trust

Regulatory compliance significantly influences consumer trust in herbal goods. In areas with strict laws, such as the EU and certain parts of Asia, consumers may be assured that the herbal products they buy have undergone thorough safety and efficacy evaluations. This bolsters the reputation of herbal products and fosters greater adoption within conventional healthcare. In contrast, in areas with less severe regulations, people may exhibit greater scepticism regarding the safety and usefulness of herbal remedies. The absence of pre-market approval for herbal supplements in the US necessitates that consumers depend on third-party testing or certifications to ascertain product quality. This may result in confusion and distrust, especially when items include unknown components or do not fulfil label assertions (Dewi 2024).

In India, customer opinions of herbal products are significantly shaped by the nation's enduring heritage of traditional medicines, especially Ayurveda, Siddha, and Unani. These conventional medical systems are broadly recognized and incorporated into healthcare procedures in both rural and urban settings. The Indian customer base is increasingly acquainted with herbal formulations and typically has confidence in their efficacy and safety. The Indian herbal industry is among the rapidly expanding industries in the nation, propelled by a blend of cultural inclination towards traditional medicine and an increasing knowledge of preventive health measures.

5.2.1. Consumer Perceptions of Traditional Medicine

In India, the familiarity and cultural endorsement of traditional herbal systems, especially Ayurveda, significantly influence consumer perceptions of herbal goods. A significant number of customers consider Ayurvedic formulations essential to their health and wellness regimens, employing these products for purposes ranging from normal health maintenance to the treatment of specific conditions. The Ministry of AYUSH enhances this cultural trust by promoting traditional medicine and aggressively endorsing the incorporation of herbal items into conventional healthcare. Nonetheless, similar to other industries, there is an increasing desire for scientific validation of herbal medicines, especially in urban and foreign markets. Informed consumers are progressively demanding proof of safety and efficacy, leading Indian firms to allocate resources towards clinical trials and contemporary research to substantiate traditional remedies (Srivastava and Wagh 2018). This tendency corresponds with India's overarching objective of establishing itself as a global leader in the herbal sector by ensuring its goods comply with international standards.

5.2.2. Market Dynamics in India

The Indian herbal market is experiencing tremendous expansion, driven by domestic demand and export opportunities. In recent years, India has experienced a rise in the popularity of Ayurvedic supplements, functional foods, and cosmetic items. The COVID-19 pandemic significantly expedited this tendency, resulting in a considerable increase in sales of items such as immunity boosters, herbal teas, and Ayurvedic medicines. Consumers are progressively opting for herbal products for both therapeutic and preventive healthcare, in accordance with worldwide wellness trends. Ayurvedic cosmetics and personal care products have experienced substantial growth, as people choose natural alternatives to synthetic beauty items. Formulations frequently use ingredients such as neem, turmeric, and sandalwood, attracting consumers who value purity and little chemical application. This transition to natural cosmetics reflects global trends in the beauty sector, as customers increasingly scrutinize the substances used on their skin and hair (Dias and Joshi 2024; Bhat et al. 2018).

5.2.3. Challenges and Opportunities in the Indian Market

India's herbal market possesses considerable growth potential, although it encounters hurdles. A primary concern is the absence of standards and quality control among smaller manufacturers. Numerous herbal products, especially those available in informal marketplaces, lack thorough safety testing, resulting in apprehensions regarding contamination and variable product quality (Krishna et al. 2020). This presents a barrier to customer confidence, particularly as India aims to enhance its herbal product exports to areas with more stringent regulatory requirements, such as the EU and US. The Indian government, via the Ministry of AYUSH, is proactively tackling these difficulties by advocating for the standardization of Ayurvedic products and pushing the implementation of GMP. These programs seek to enhance the quality and safety of herbal products for both domestic customers and the export market. Moreover, India's robust heritage in herbal medicine and increasing investment in research and development present substantial prospects for expansion in the global herbal industry (Katiyar et al. 2023).

6. Future Directions and Recommendations

The growing popularity of the worldwide herbal product market necessitates the establishment of unified laws, new research, and enhanced safety and efficacy standards. The future of the herbal product business is optimistic, necessitating collaborative efforts among regulatory agencies, the industry, and researchers to ensure safe, effective, and accessible herbal goods for customers globally as listed in Table 4. The Indian herbal industry is positioned to significantly impact the global market, contingent upon its ability to overcome significant challenges and conform to international norms.

6.1. Worldwide Perspective

The global herbal market is anticipated to persist in its growth in the forthcoming years, propelled by consumer demand for natural and preventative healthcare options, alongside breakthroughs in product creation and scientific inquiry. The disjointed regulatory framework and the necessity for enhanced safety standards pose persistent issues that demand innovative solutions.

6.1.1. Harmonizing Global Regulatory Frameworks

A primary difficulty confronting the herbal product sector is the absence of uniformity among regulatory frameworks across different domains. At present, laws differ significantly, with certain areas imposing rigorous standards for safety and efficacy, whereas others adopt more permissive frameworks that depend mostly on post-market monitoring. Standardizing these laws would streamline the market entry process for businesses and ensure that customers globally may obtain safe and effective herbal products. Initiatives to standardize regulations are now in progress in several areas (Thakkar et al. 2020). The World Health Organization (WHO) has formulated the Traditional Medicine Strategy 2014-2023, which advocates for member nations to establish policies that endorse the safe and effective utilization of traditional medicine, including herbal products. This strategy promotes the incorporation of traditional medicine into national healthcare systems and urges the establishment of established norms for the manufacturing, safety, and efficacy of herbal formulations (Barkat et al. 2021). Furthermore, regional entities such as the International Conference on Integration of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Association of Southeast Asian Nations (ASEAN) are endeavouring to synchronize regulatory practices for herbal medicines. Nonetheless, significant advancements remain necessary, especially in guaranteeing that safety and efficacy evaluations are uniform across international boundaries. Harmonization would advantage firms by simplifying the navigation of many regulatory systems and bolster consumer trust by guaranteeing that products adhere to consistent safety standards (Izah 2024).

6.1.2. Embracing Technological Advancements in Herbal Research

The incorporation of contemporary scientific instruments and technical innovations is essential for the improvement of herbal manufactured goods. Traditional knowledge underpins numerous herbal formulations, while contemporary research techniques like genomics, metabolomics, and bioinformatics provide innovative insights into the mechanisms of action and therapeutic efficacy of herbal compounds (Vyshnava et al. 2020). These instruments can additionally be employed to detect and measure active constituents in herbal goods, guaranteeing uniformity and efficacy across several batches. Furthermore, breakthroughs in nanotechnology are facilitating novel opportunities for the creation of herbal products, especially in medicine delivery systems. Nanotechnology can boost the bioavailability of herbal substances, facilitating their more effective absorption by the body (Vyshnava et al. 2023; Chekuri et al. 2023). Nano-encapsulation techniques can enhance the solubility of poorly soluble herbal compounds, hence increasing their efficacy at reduced dosages. These improvements enhance the medicinal efficacy of herbal medicines and assist manufacturers in complying with stringent regulatory criteria by assuring consistent quality (Jamal 2023; Saggar et al. 2022).

6.1.3. Expanding Clinical Research and Evidence-Based Approaches

As customer demand for scientifically verified herbal products increases, the necessity for rigorous clinical research will intensify. Although some herbal products have been utilized for centuries in traditional medicinal practices, the absence of extensive clinical trials has constrained their acceptance in certain areas, notably within the EU and the US (Wang et al. 2023). Manufacturers must invest in clinical research that adheres to contemporary scientific standards to bridge this gap.  A promising avenue is the proliferation of randomized controlled trials (RCTs), regarded as the gold standard for assessing the efficacy of medical interventions. Implementing randomized controlled trials on herbal medicines can furnish the requisite evidence to substantiate medicinal claims and secure regulatory approval in markets with stringent safety and efficacy standards (Kalachaveedu et al. 2023). Furthermore, observational studies and meta-analyses can assess the long-term effects and safety profiles of herbal products, offering a thorough understanding of their health impacts.

Figure.4. Displays the market share for each region in 2023, showing the proportional distribution.

Figure.5. Horizontal Bar Chart (Right): Represents market share as bars, with annotations indicating the projected growth trend (e.g., "Steady growth," "Fastest-growing") for each region. The bar colors correspond to the growth descriptors.