Introduction
The intersection of traditional medicine and food regulation in India has created a complex legal landscape where jurisdictional boundaries remain contentious. The creation of a separate Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) in 2014 alongside the established Food Safety and Standards Authority of India (FSSAI) has given rise to significant jurisdictional conflicts regarding products that bridge the gap between traditional medicinal preparations and food supplements. These jurisdictional disputes directly impact thousands of manufacturers, affecting product formulation, licensing requirements, marketing claims, and ultimately consumer access. This article examines the legal dimensions of these jurisdictional conflicts, exploring the regulatory frameworks, key areas of contention, attempted resolutions, and their market impact.
Legal Framework Governing Dual Jurisdiction
The dual regulation of medicinal foods and supplements stems from two separate legislative frameworks with distinct historical origins. The Food Safety and Standards Act, 2006 established the FSSAI as the apex food regulatory body in India, consolidating various food laws that had previously been administered by different ministries. Section 16 of this Act empowers FSSAI to regulate and monitor the manufacture, distribution, sale, and import of food to ensure safety and quality, including items that may have health benefits. This broad mandate naturally encompasses traditional food products with health claims, including those with roots in Ayurvedic and other traditional medicinal systems.
Concurrently, the Drugs and Cosmetics Act, 1940, and its subsequent amendments provide the regulatory framework for traditional medicines, including Ayurvedic, Siddha, and Unani (ASU) products. The Ministry of AYUSH, established as a separate ministry in 2014 (previously a department within the Ministry of Health and Family Welfare), administers this Act for traditional medicine systems. Under Sections 33A to 33O of this Act, the manufacturing, labeling, and sale of ASU drugs are regulated, with licensing powers vested with state licensing authorities.
This dual regulatory framework creates inherent jurisdictional overlaps, particularly for products that could reasonably be classified as either foods with medicinal properties or medicines consumed as foods. The legal complexity increased with the notification of Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, which created a specialized category within the FSSAI framework for food products based on Ayurvedic texts, requiring collaboration between FSSAI and the Ministry of AYUSH.
Key Areas of Jurisdictional Conflicts Between FSSAI and Ayush
Product classification represents the most significant area of jurisdictional conflicts between FSSAI and the AYUSH Ministry. The legal distinction between a food supplement and an Ayurvedic medicine often hinges on interpretive factors rather than clear statutory boundaries. This classification dilemma was highlighted in a 2021 case involving Patanjali Ayurved, where the company challenged FSSAI’s classification of certain herbal products as food supplements requiring FSSAI licensing rather than as Ayurvedic medicines under AYUSH regulation. The Delhi High Court’s interim ruling emphasized the need for clearer classification criteria while allowing the products to continue selling under existing licenses pending final resolution.
Manufacturing license requirements create another layer of jurisdictional conflict. Until recently, manufacturers had to maintain separate facilities for producing FSSAI-licensed products and AYUSH-regulated medicines, significantly increasing compliance costs. On August 31, 2023, the Ministry of AYUSH issued a clarification stating that “there is no specific prohibition to use combined setup of manufacturing line and equipment for manufacturing products licensed under Ayurveda, Siddha, and Unani, and FSSAI.” This clarification resolved one aspect of the jurisdictional conflict but underscored the ongoing need for regulatory coordination.
The legal framework for labeling and health claims represents another contentious area. FSSAI regulations prohibit disease-prevention or therapeutic claims on food products, while AYUSH regulations permit such claims for registered Ayurvedic medicines based on references in classical texts. This creates a legal dichotomy where identical ingredients might face different claim restrictions depending on their regulatory classification. The ambiguity was partially addressed in May 2024 when the AYUSH Ministry explicitly warned manufacturers against claiming “nutraceutical value” for AYUSH drugs, emphasizing that they fall under different regulatory categories than FSSAI-regulated nutraceuticals.
Regulatory Convergence Efforts
Recognizing the challenges posed by jurisdictional conflicts between FSSAI and AYUSH in the regulation of overlapping products, both bodies have initiated formal convergence efforts. A significant milestone was the formation of a joint committee in 2022, comprising experts from both FSSAI and the AYUSH Ministry, to establish harmonized standards and approval processes for products caught in this regulatory overlap. This committee was given the mandate to provide recommendations on approval of claims and products while addressing concerns regarding registration, licensing, certification, laboratory accreditation, testing, and quality issues related to Ayurveda Aahara.
The most substantial regulatory convergence came with the notification of the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022. These regulations created a specialized category—”Ayurveda Aahara”—defined as “food prepared in accordance with the recipes or ingredients or processes as per methods described in the authoritative books of Ayurveda listed under Schedule A of the Drugs and Cosmetics Act.” This definition officially recognized a category of products at the intersection of food and Ayurvedic medicine, with a special logo to distinguish them in the marketplace. Section 5 of these regulations explicitly established that FSSAI would constitute an expert committee under the Ministry of AYUSH for evaluating these products, creating a formal collaborative framework.
Another convergence milestone was the AYUSH Ministry’s February 2020 announcement of collaboration with FSSAI for a new food regulation framework based on Ayurveda, acknowledging that many traditional food items evolved from kitchen practices rather than formal pharmaceutical processes. This conceptual shift recognized that many traditional preparations might be better regulated as foods with health-promoting properties rather than as medicines.
Market Impact and Compliance Challenges
The jurisdictional ambiguities have created significant market challenges, particularly regarding labeling compliance and permissible claims. In May 2024, the AYUSH Ministry issued a directive specifically prohibiting AYUSH products from claiming “nutraceutical value,” emphasizing that such terminology belongs to the FSSAI regulatory domain. This directive highlighted the ongoing effort to establish clearer boundaries between the two regulatory spaces while acknowledging their inevitable overlap.
The risk of enforcement actions against products making unauthorized claims creates substantial legal uncertainty for manufacturers. FSSAI has been particularly active in monitoring and penalizing misleading claims, with numerous enforcement actions against products making disease-prevention claims without proper authorization. In one notable case, FSSAI took action against a manufacturer marketing products with Ayurvedic ingredients but making claims that crossed into therapeutic territory without proper AYUSH authorization, imposing penalties under Section 53 of the FSS Act for misleading advertisements.
Consumer protection concerns further complicate the regulatory landscape. Both regulatory frameworks emphasize consumer safety, but their differing approaches to evidence requirements create potential gaps. FSSAI generally requires scientific evidence for health claims, while AYUSH permits claims based on references in classical texts. This difference in evidentiary standards creates a potential legal loophole where manufacturers might seek the less stringent pathway for bringing products to market.
Legal Liability Distribution
The question of legal liability distribution in this dual regulatory environment remains particularly complex. Under Section 27 of the FSS Act, liability for food safety violations extends to manufacturers, distributors, and sellers. Similarly, the Drugs and Cosmetics Act imposes liability on manufacturers and sellers of medicines that violate standards or make false claims. However, when a product falls into the regulatory gray area between these frameworks, determining the applicable liability provisions becomes challenging.
The Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 partially addressed this issue by explicitly stating that these products must comply with FSSAI’s food safety standards while meeting the ingredient and formulation requirements of Ayurvedic texts. This creates a hybrid liability framework where both sets of safety requirements must be satisfied, but enforcement authority remains divided.
For manufacturers, this often results in a defensive strategy of seeking dual licensing—obtaining both FSSAI approval and AYUSH licensing—to minimize liability risks. This approach, while legally prudent, increases compliance costs and administrative burdens. Small and medium enterprises particularly struggle with navigating these complex requirements, potentially limiting innovation in traditional products with health benefits.
Enforcement authority also remains a contentious issue. Food Safety Officers appointed under the FSS Act and Drug Inspectors appointed under the Drugs and Cosmetics Act have overlapping inspection powers for products in the gray area. This can lead to conflicting enforcement actions, with manufacturers potentially facing penalties from both authorities for the same violation, raising questions of double jeopardy and proportionate enforcement.
Conclusion and Future Outlook
The jurisdictional conflicts between FSSAI and the AYUSH Ministry regarding medicinal foods and supplements reflect the challenges of integrating traditional knowledge systems into modern regulatory frameworks. While significant strides have been made toward regulatory convergence, particularly through the Ayurveda Aahara regulations, substantial legal ambiguities remain. These conflicts directly impact manufacturers’ ability to innovate and bring traditional products to market, potentially limiting consumer access to beneficial traditional preparations.
Moving forward, further regulatory harmonization will be essential. This may require legislative amendments to more clearly delineate jurisdiction based on product characteristics rather than historical regulatory divisions. Additionally, establishing unified inspection and enforcement protocols for products in the overlapping space could reduce compliance burdens while maintaining necessary safety standards.
The ongoing dialogue between the two regulatory bodies represents a positive development, acknowledging that the traditional separation between food and medicine categories may not adequately reflect the holistic approach of traditional Indian medical systems. As this regulatory landscape continues to evolve, manufacturers and legal practitioners must stay vigilant to changes in both frameworks while advocating for greater clarity and consistency in regulations governing these unique products.
References
- Food Safety and Standards Act, 2006, No. 34, Acts of Parliament, 2006 (India).
- Drugs and Cosmetics Act, 1940, No. 23, Acts of Parliament, 1940 (India).
- Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, Gazette of India, Part III, Sec. 4 (India).
- Ministry of AYUSH. (2023, August 31). Clarification regarding manufacturing of FSSAI licensed products in AYUSH approved facilities. F. No. L.4012/04/2023.
- Ministry of AYUSH. (2024, May 1). Directive on nutraceutical value claims for AYUSH products. Circular No. Z.28015/32/2024-DCC.
- Patanjali Ayurved v. Food Safety and Standards Authority of India, Delhi High Court, Writ Petition (Civil) No. 7688 of 2021.
- Food Safety and Standards Authority of India. (2020, February 17). Memorandum of Understanding between FSSAI and Ministry of AYUSH for regulation of Ayurveda Aahara. F. No. RCD-01/34/2020.
- Manorama Yearbook. (2022, May 14). AYUSH ministry, FSSAI formulate regulations for ‘Ayurveda Aahara’ products.
- NutraIngredients-Asia. (2023, September 13). FSSAI-licensed products could be made in AYUSH-approved facilities.
- Corpseed. (2023, October 31). Difference Between FSSAI License and Ayush License.
