Regulating Ancient Practices: India and China’s Divergent Paths in Traditional Medicine
- Shivarpita Nailwal & Sayali Titre
- Sep 30, 2025
- 10 min read
The saying 'knowledge is of no value unless you put it into practice' is profoundly relevant for traditional knowledge. While indigenous communities have long applied their practices successfully, it is believed that greater benefits can be achieved by effectively integrating this knowledge into modern systems and sharing it more widely through respectful and equitable collaboration.
While traditional knowledge covers a wide range of technical knowledge held by a community about its environment, culture, and traditions, traditional medicine encompasses knowledge, skills, and practices used for the diagnosis, prevention, and treatment of illnesses. According to the World Health Organisation, traditional medicine is the sum of knowledge, skills, and practices based on theories, beliefs, and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health and the prevention, diagnosis, improvement, or treatment of physical and mental illnesses.
As the demand for traditional medicines increases, two main regulatory approaches have taken shape: integration and parallel systems. Each presents a distinct model for how traditional and modern healthcare systems can function alongside one another. An integrated system incorporates traditional medicine into the formal national healthcare system. On the other hand, in the parallel system, traditional medicine is recognised and regulated, but it operates independently from modern healthcare.
As ancient and complex medical systems, Traditional Indian medicine (led by Ayurveda) and Traditional Chinese Medicine (TCM) possess unique philosophies, diagnostic approaches, and a wide array of treatments, including herbal medicine, dietary regimens, and physical therapies. The drug approval pathways for traditional medicine in India and China reflect their unique historical, cultural, and regulatory landscapes.
China has a long and rich heritage of traditional medicines and has integrated them into its national health-care delivery systems to varying degrees. A major strategic focus has been placed on the TCM sector, with the government implementing a range of policies, regulations, and technical guidelines to stimulate the development and approval of new medicines.
In China, TCM products are regulated by the National Medical Products Administration (NMPA) under a distinct and rigorous framework. This system ensures TCM products meet modern pharmaceutical standards by emphasizing safety, efficacy, and quality. It uniquely integrates traditional principles with scientific methods—including randomized, double-blind, placebo-controlled trials—while also recognizing evidence from real-world use and human-use experience (HUE) data to support registration applications.
Before a TCM product can be legally marketed and sold in China, it must obtain marketing approval from the NMPA. Between 2013 and 2024, the NMPA granted marketing approvals for a total of 77 new TCMs[1].
The Special Provisions for Traditional Chinese Medicines Registration[2] were issued by China NMPA, which took effect on July 1, 2023. This provision includes general provisions, registration classification and marketing approval of TCMs, rational application of empirical evidence for human use, innovative TCMs, modified new drugs of TCMs, compound preparations of TCMs originated from classic recipes, TCMs with identical names and identical recipes, post-marketing changes, registration standards, drug names and package inserts of TCMs, etc. Such provision promotes the preservation, innovation, and development of TCMs in China.
TCM also enjoys strong political backing. The government’s “Healthy China 2030”[3] strategy explicitly includes TCM as a pillar of national health development. China's patent system recognises TCM as a valuable asset, leading to the development of numerous patent medicines.
In China, patent law protects new traditional medicine-based products, methods of process and new uses of traditional medicine, including herbal preparations, extracts from herbal medicines, foods containing herbal medicines, and methods for preparing herbal formulas[4].
In 2023, the high-tech TCM manufacturing sector in China submitted a total of 5,165 patent applications, an increase from 4,815 in 2021. The sector had accumulated about 14,500 effective patents as of the end of 2021[5].
In addition, China has focused significant attention on the development and approval of new traditional Chinese medicines (TCMs) and has actively introduced various policies, regulations, and relevant technical guidelines to encourage and support this sector.
India has a long and profound history of traditional medicine that dates back thousands of years. Rooted deeply in culture, philosophy, and spirituality, traditional Indian medicine encompasses a variety of systems that focus on holistic healing and natural remedies.
The practice of herbal medicine in India, encompassing Ayurveda, Siddha, Unani, and Homoeopathy, is regulated under a framework led by the Ministry of AYUSH and governed by the Drugs and Cosmetics Act, 1940[6]. Supporting institutions for this purpose also include the Central Council of Indian Medicine (CCIM) for education and practice, and research bodies like ICMR and CSIR[7]; Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), an umbrella organisation for Ayurvedic, Siddha, Unani and Homoeopathy Pharmacopoeia Committees; and National Medicinal Plants Board (NMPB), to coordinate with all matters relating to Medicinal Plants[8].
India has implemented the Biological Diversity Act, 2002[9] which is aligned with the Convention on Biological Diversity (CBD)[10], an international treaty aimed at promoting the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the use of genetic resources and traditional knowledge associated thereto. The Act established the National Biodiversity Authority (NBA)[11], which is tasked with managing and protecting its genetic resources and related traditional knowledge within its territory. Nowadays, any person or entity seeking to access its genetic resources and related traditional knowledge within India has to undergo strict approval by the NBA, which penalises violations in accordance with the law.
The Biological Diversity Act, 2002, has been recently amended as The Biological Diversity (Amendment) Act, 2023[12], which aims to promote the cultivation of medicinal plants by reducing the regulatory burden on practitioners and companies involved in the Indian systems of medicine, such as Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy (AYUSH), streamline research and patent applications, and increase foreign investment by encouraging the cultivation of medicinal plants and simplifying access to biological resources.
India has also established the Traditional Knowledge Digital Library (TKDL)[13], which is responsible for the systematic organisation and compilation of indigenous medicinal knowledge. It includes the structured and classified Indian Traditional Medicine System into several thousand subgroups for Ayurveda, Unani, Siddha, and Yoga.
When it comes to patenting traditional medicines, India and China take different approaches. China emphasises innovation while preserving traditions, whereas India focuses on protecting its cultural heritage.
In India, the patentability of traditional medicine is a contentious and multifaceted issue, spanning the domains of intellectual property, cultural heritage, biodiversity, and public health. A fundamental impediment is that Traditional Knowledge (TK) generally does not satisfy the key patent requirements of novelty and inventive step. As these medicinal formulations and practices have been in use for centuries, they are disqualified for lacking novelty. Their preparation and application are also viewed as obvious, drawing from a long-established body of knowledge.
Further, the Indian Patents Act has a unique provision under Section 3 (p) of the Indian Patent Act[14], wherein "an invention which, in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components" is not an invention and hence, not patentable, within the meaning of the Patents Act. To prevent biopiracy and the misappropriation of its cultural heritage, India's Patents Act explicitly excludes traditional knowledge from patentability under Section 3(p). This provision is enforced globally through the Traditional Knowledge Digital Library (TKDL), which has successfully preempted numerous illegitimate international patent claims. Furthermore, the TKDL serves as a global biopiracy watch system, actively monitoring patent applications worldwide related to Indian systems of medicine.
One of the most prominent cases that highlights the complex issues surrounding the patenting of traditional medicine in India is the patenting of turmeric[15]. Turmeric, a staple in Ayurvedic medicine for thousands of years, was patented in the US in 1995 by the University of Mississippi for wound healing—a use well known in India. This sparked controversy as turmeric’s medicinal use was already public knowledge. In 1997, India’s CSIR submitted proof from ancient texts showing prior use. The US Patent Office revoked the patent in 1998, recognising the traditional knowledge.
Similarly, the Neem case[16] exposed tensions between indigenous knowledge and global patent laws. In the 1990s, the European Patent Office granted a patent to the USDA and W.R. Grace for a pesticide extraction from Neem seeds. India, supported by NGOs, challenged the patent and succeeded in having it revoked in 2000.
These cases reflect India’s commitment to protecting its cultural heritage, preventing biopiracy, and ensuring fair use of traditional medicine worldwide.
Besides this, the Indian Patent Office has recently published the guidelines for examination of Ayush inventions on September 23, 2025, which can be accessed here, to cover inventions related to Ayush systems of healthcare and other codified/non-codified systems of Ayush related inventions.
The Guidelines cover the scope of research of Ayush-related inventions that can be granted IP protection. It includes:
· Ayush product(s) and Equipment(s) / Device(s)
· Value-added products related to Food recipes/ Nutraceuticals based on Ayush systems
It specifies that the inventions related to the aforementioned areas deserve IPR protection, subject to qualifying the criteria of patentability under Section 2 (1)(j) and Section 3 of the Patents Act, 1970.
The guidelines outline guiding principles for the assessment of patent applications related to:
· Extracts, alkaloids, or isolated active ingredients derived from plants;
· Combinations of ingredients from plant, mineral, or animal origin or existing formulations traditionally used to treat diseases;
· Combination products containing known active ingredients;
· Optimal or workable ranges of traditionally known components;
· Isolation of single components from known mixtures/ equipment/devices used for known procedures in Ayush systems.
The guidelines for processing patent applications in the AYUSH domain represent a considered effort to balance the protection of traditional knowledge with the encouragement of modern innovation.
A detailed comparison of the two traditional medicine regulatory approval processes sheds some light on the key differences and similarities between the two processes. China's system fully integrates Traditional Chinese Medicine (TCM) into its national healthcare system with a separate but parallel regulatory pathway. To ensure TCM's global credibility, China mandates rigorous quality control through detailed pharmacopoeia, agricultural practices, and digital supply chain traceability. On the other hand, India's system is a hybrid, managing traditional medicine through a separate department (AYUSH) that blends modern regulatory concepts with evidence of traditional use.
Feature | India (AYUSH Systems) | China (Traditional Chinese Medicine - TCM) |
Governing Body | Ministry of Ayush (Independent ministry since 2014), Central Council of Indian Medicine (CCIM), Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), National Medicinal Plants Board (NMPB)[17]. | National Medical Products Administration (NMPA), under the same umbrella as Western drugs[18]. |
Primary Legislation | ||
Approval Pathway | Dual Pathway: 1. Based on Classical Texts: For drugs mentioned in authoritative ancient texts (e.g., Sushruta Samhita, Bhavaprakasha). Simplified process requiring proof of textual reference and safety data. 2. Patent/Proprietary Medicines: For new formulations. Requires detailed data on safety, efficacy, and quality, including pharmacological studies and clinical trials. A manufacturing license is a must to manufacture or market the herbal medicines | Dual Pathway: 1. Category 1 (Classical Formulas): For well-documented formulas from classical TCM texts. Requires evidence of safe historical use but may be exempt from complex clinical trials. 2. Category 2 & 3 (New TCMs): For new formulations or new uses. Requires comprehensive non-clinical and clinical trials similar to chemical drugs, but with TCM theory as a basis. |
Key Evidence Requirement | Proof of Traditional Use is central, especially for classical medicines. For proprietary medicines, safety is paramount, with a growing emphasis on efficacy data from clinical trials. | Historical Literature & Clinical Experience is heavily weighted for classical formulas. For new drugs, rigorous clinical trials are mandatory, though the trial design may be adapted to TCM principles (e.g., syndrome-based diagnosis). |
Quality Control | Pharmacopoeial Standards[23]: The Ayurvedic Pharmacopoeia of India (API), Unani Pharmacopoeia of India (UPI), etc., set standards for raw materials and finished products. Good Manufacturing Practices (GMP) are mandatory (Schedule T). | Pharmacopoeial Standards[24]: The Pharmacopoeia of the People's Republic of China has a dedicated volume for TCM, setting stringent standards for identification, testing, and heavy metals/contaminants. |
Integration into Healthcare | Separate but Co-existing. AYUSH has its own hospitals, colleges, and research councils. Efforts are being made for integrated medicine, where AYUSH practitioners work alongside allopathic doctors in some public hospitals. | Fully Integrated. TCM hospitals and departments are standard parts of the public health system. TCM doctors are trained in both TCM and basic Western medicine. It is a mainstream, first-line treatment option. |
Initiatives | Promoting AYUSH globally through initiatives like the International Day of Yoga and establishing AYUSH academic chairs in foreign universities. Seeking regulatory acceptance in other countries. | Actively driving TCM globalization. The WHO's inclusion of TCM diagnoses in its International Classification of Diseases (ICD-11) was a major milestone. Pushing for TCM product approvals in Western markets. |
Conclusion:
The regulatory landscapes for traditional medicine in India and China reflect their unique historical contexts and contemporary priorities. China's approach is characterized by systematic integration, where Traditional Chinese Medicine (TCM) is a mainstream component of the national healthcare framework, supported by a unified regulatory pathway that emphasizes modernization and global outreach. India's model, centred on its AYUSH systems, focuses on preservation and parallel development, maintaining the distinct identity of each tradition while working to strengthen its regulatory and scientific foundations.
Each represents a different strategy for managing the complex interplay between cultural heritage and contemporary science. China's integrated system has facilitated a more rapid and standardized path to international recognition. India's approach, while presenting greater challenges for global harmonization, emphasizes the individual philosophical integrity of its diverse medical traditions.
Looking forward, the continued evolution of both the AYUSH and TCM systems will contribute significantly to the global understanding of traditional medicine, offering valuable insights into different models for validating and integrating ancient healing knowledge into the future of healthcare worldwide.
Shivarpita Nailwal
Partner
Sayali Titre
Managing Associate
[3] https://www.who.int/teams/health-promotion/enhanced-wellbeing/ninth-global-conference/healthy-china
[4]https://www.wipo.int/edocs/pubdocs/en/wipo-pub-rn2023-5-6-en-intellectual-property-and-traditional-medical-knowledge.pdf
[5] TCM patent applications in China 2011-2023| Published by Wenyi Zhang, Jun 30, 2025
[7] [Sahane MB, Basarkar GD. A Review of Herbal Regulations and Approval Process in India and Europe. Int J Drug Reg Affairs [Internet]. 2023 Dec 15 [cited 2023 Dec 15]; 11(4):25-33]
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