Regulatory Landscape - Overview

Ayurvedic Products Drugs Regulatory Landscape: Product Overview

Ayurveda, the ancient Indian system of medicine, focuses on achieving balance in the body, mind, and spirit through natural remedies and holistic practices. Healthcare and consumer care Ayurveda products include a variety of herbal supplements like adaptogens (e.g., Ashwagandha), digestive aids (e.g.,Triphala), and essential oils for aromatherapy. Skincare offerings feature herbal creams and oils infused with neem and turmeric, while personal care products include hair oils and herbal toothpastes. Ayurvedic food and beverages, such as herbal teas and superfoods like ghee, align with dietary principles for overall wellness. Increasingly, consumers are drawn to sustainable, natural, and customizable remedies tailored to their unique dosha types (Vata, Pitta, Kapha). Regulatory authorities involved ayurvedic product approval to ensure its safety and efficacy is Ministry of Ayush, under Central Drugs Standard Control Organisation (CDSCO). According to the research study published by Ayush, around 25% of ayurvedic and herbal products were exported from India in 2023 in the U.S. market space.

Ayurvedic Product types

Based on product, the global healthcare and consumer care ayurveda product market has been segmented into Tablets and Capsules, Soaps and Shampoo, Body wash, Moisturizers & Lotions, Oil, Facewash, Toothpaste/Mouthwash, Creams & Serums, Aftershaves & Shaving Creams, Face Mask & Hair Mask, Dental Floss, Syrups, Powders, Others. Tablets and Capsules accounted for the largest market share in 2023, and Creams & Serums is projected to grow during the forecast period.

Form/ ingredients used

The ayurvedic personal care sector emphasizes the use of natural, plant-based ingredients to promote skin, hair, and overall body wellness. Products often feature herbal formulations that avoid harsh chemicals, appealing to consumers seeking gentle and effective alternatives. For skin care, ingredients like turmeric and neem are celebrated for their anti-inflammatory and purifying properties, while aloe vera and rosewater provide hydration and toning benefits. In hair care, herbal oils and treatments featuring bhringraj and amla are known for strengthening hair and preventing loss, addressing common issues like dryness and dandruff with natural cleansing agents. Body care products, including scrubs and moisturizers, utilize nourishing ingredients like coconut oil and shea butter, often incorporating aromatherapy principles to enhance relaxation and well-being.

Ayurvedic products mode of action

• Asparagus racemosus wild is also known as Shatavari is a potent ayurvedic product having rejuvenation effect- it can supply hormones to females, mainly suggested for those who have hysterectomies. It also has the ability to strengthen immune system, maintain urinary tract, and it can also purify blood.
• Commiphora Mukul Engl. (i.e. Guggul) is the major ayurvedic ingredient in the therapeutics of joint and immunocare. It works by increasing the count of WBCs to provide strong immune modulating properties, it can also show therapeutic effect for common cold, and many other health diseases, it can also lower the levels of cholesterol, Trglycerides.
• Cypes scariosus Br. (i.e. Nagarmusta) is beneficial for maintaining healthy genitourinary system and also show hepatoprotective properties.

Applications of Ayurvedic products

Based on application, the Global healthcare and consumer care ayurveda product market has been segmented into healthcare and consumer care.

• Ayurveda offers a range of tablets and capsules designed to promote overall health and address specific wellness needs. Common formulations include digestive aids like Triphala, which helps detoxify and improve digestion, and stress-relievers like Ashwagandha, known for its calming properties. For joint health, Boswellia and Turmeric are popular due to their anti-inflammatory benefits. Immune support can be enhanced with Amla capsules, rich in vitamin C and antioxidants, while Neem tablets are often used for skin health due to their purifying effects.
• Ayurvedic creams are typically designed to address specific skin concerns, such as dryness, aging, or uneven tone, while serums may focus on delivering concentrated nutrients and antioxidants deep into the skin. The use of natural ingredients allows these products to be gentle yet effective, making them suitable for a variety of skin types, including sensitive skin.
• Ayurvedic face washes are formulated to cleanse the skin gently while harnessing the power of natural ingredients known for their therapeutic properties. Key components often include neem, recognized for its antibacterial and acne-fighting benefits; turmeric, celebrated for its anti-inflammatory and brightening effects; and sandalwood, which soothes and hydrates the skin.

In July 2024, Himalaya Wellness Company has expanded its babycare offerings with a new range of cow ghee products. This line includes a variety’ direct-to-consumer e-commerce store. This expansion reflects Himalaya's commitment to providing natural and nurturing products for infants and parents alike. In May 2024, Dabur India, a science-based Ayurveda company, has expanded its ‘hajmola Mr. Aam’ flavor that complements the tangy taste of Hajmola. The brand has also enlisted Kartik Aaryan as its ambassador. In April 2024, Lotus Herbals has introduced the UltraRx Sunscreen Serum SPF 60++++, designed to meet various skin needs while providing enhanced UV protection through an effective water-based formula. In June 2023, Patanjali Foods has introduced 14 new products as part of its strategy to premiumize its offerings. These products span various segments, including nutraceuticals, health biscuits, Nutrela millet-based cereals, and dry fruits. This move reflects the company's focus on catering to health-conscious consumers and tapping into the growing demand for nutritious and premium food options. The emphasis on millet-based cereals also highlights a trend towards more sustainable and traditional food sources. Ayurveda offers traditional medicine and other natural products which uses herbal, mineral, in their formulations. Individuals looking alternative for these products can be conventional allopathic medicines which are widely accepted and scientifically more validated worldwide medicine, proving faster therapeutic action and using precise dosages, when patient is suffering from chronic diseases to get quick relief these treatment options are more preferred.

Ayurvedic Products Development Steps:

Traditional Ayurvedic Drug development process includes following main steps:

• Bioactive compounds isolation and its synthetic modification
• Safety and effectiveness evaluation
• If new drug is developed, then getting regulatory approval for it
• Undertaking clinical trials for the new drug

ASU (AYURVEDA, SIDDHA, UNANI) Drug Development General Research Guidelines And Methodologies Preparatory phase – 1

• Survey of disease prevalence and drug formulation: on basis of proper literature review, ingredients previous clinical data, classical evidence

Drug development phases (2-8)

Drug development phase	Step details
Phase 2	Collection of raw drugs (on basis of ayurvedic textual methods, good agricultural and field collection practices)
Phase 3	Botanical, chemical study of drug ingredients or pharmacogenetic (Based on guidelines available and classical methods)
Phase 4	SOP formulation, performing standardisation, study of stability, checking quality of drug- (On basis of available physical, chemical and biological parameters which are used for standardisation, based on classical methods)
Phase 5	Pre-clinical study to ensure safety of drug (includes acute, subacute, chronic study as per use of drug)- (Using suitable animal models with appropriate animal ethical clearance as per guidelines)
Phase 6	Animal studies to check effectiveness and biological activity of drugs- (Study of mechanism of action for clinical corelation)
Phase 7	Study design and clinical process formulation- (Based on clinical guidelines)
Phase 8	Clinical trial execution- (Includes IEC/IRB and CTRI registration approval Conducting, monitoring, coordinating trial, Analysis of generated data, Publication)

Ayurvedic Products Market Size Overview:

As per MRFR analysis, the Ayurvedic product Market Size was estimated at 16,822.71 (USD Million) in 2024. The Ayurvedic Products Market Industry is expected to grow from 19,452.62 (USD Million) in 2025 to 88,872.15 (USD Million) till 2035, at a CAGR (growth rate) is expected to be around 16.41% during the forecast period (2025 - 2035). growing awareness of health and wellness benefits associated with ayurveda, increasing government support for Ayurveda Products, and growing adoption for ayurvedic products across the globe are the key market drivers enhancing the growth of the market.                                 
Source: The Secondary Research, Primary Research, MRFR Database and Analyst Review

Ayurvedic Products Regulatory Landscape:

Regulatory process for ayurvedic drugs in India is mainly governed by regulatory body such as central drugs control organization (CDSCO) which functions under regulatory ministry, directorate general of health services and ministry of health and family welfare. It serves as a national regulatory authority of India who is responsible for ensuring effectiveness, safety, quality of drugs including traditional ayurvedic therapeutics. US FDA is not directly involved in ayurvedic drug regulatory process, but it has a FDA India office in New Delhi working in partnership with India’s national and state regulatory authorities to understand country’s legal and regulatory rules and give suggestions or checking the quality of drugs to be sold in US market. FDA role is limited for Ayurvedic drugs only up to ensuring Safety and labelling of these products when they enter US market.

Ayurvedic pProducts Guidelines: Eligibility:

Ayurveda offers traditional and natural treatment options, so it is generally considered safe treatment option for broad population, they are often used as an alternative to conventional products, people prefer ayurveda for some benefits like no side effects, natural healing, they even support conventional treatment. For example, most of the cancer patients in India use ayurvedic medicines as an immune booster along with their oral drugs or other cancer treatment medications which help them fight with cancer more effectively.

Dosage:

Dosage and method of administration of ayurvedic drugs varies based on the use of the product and its formulation and individuals need. For example, ayurvedic medicines have certain ways of administration which must be followed to get effective treatment, like herbal powders or their tablets are sometimes advised to specifically take with warm water only or honey, or milk once or twice daily as per Ayurvedic Vaidya’s consultation.

Ayurvedic Products Classification of The Product: Ayurvedic Products Regulatory Process Overview, By Country:

Ministry of Ayush under central drug standard control organization (CDSCO) is responsible for development, education, research, in the areas of ayurveda, yoga, naturopathy, Unani, siddha and Homeopathy traditional therapeutics. The drugs and cosmetic act 1940 and drugs and cosmetic rules 1945, has all the guidelines for the Ayurvedic, Siddha, Unani (ASU) drugs, manufacturers must comply with these drugs to ensure product quality, efficacy and safety. There is Drug Policy Section (DPS) under Ministry of Ayush which looks after regulatory and quality control functions for ayurveda also is involved in implementing drug related initiatives. This section act as central drug control framework of ASU&H drugs, which coordinates with state licensing authorities/drug controllers also with ayurvedic drug manufacturers to provide regulatory guidance, clarification, direction, legal provisions for development of ayurvedic products. Government of India has formed 2 organizations namely Pharmacopoeia Commission for Indian Medicine and Homeopathy (PCIM&H) an autonomous body and pharmacopoeia Laboratory for Indian Medicine (PLIM) for Pharmacopoeia standardization of Ayurvedic drugs. They have also issued 2 voluntary certification schemes for ayurvedic products, which includes following:

1. Quality Council of India (QCI) Certification scheme, which is an autonomous body

This scheme provides two types of certificates:

• For ayurvedic products which comply with domestic regulations, will get “AYUSH Standards Mark”.
• For ayurvedic products which comply with international norms, will get “AYUSH Premium Mark”.

1. Certificate of Pharmaceutical Products (CoPP) for Ayurveda product, which is issued by Drug Controller General of India (DCGI) under CDER from CDSCO.

Ayurvedic drugs to be exported needs to get certificate of pharmaceutical product (COPP) grant as per WHO-GMP Certification scheme. This certificate ensures that product meets international standards, for acceptance in global market.

Ayurvedic Products who have got COPP grant as per WHO-GMP Certification scheme of CDER

• Anantavati Tablet
• Nokamen Tablet
• Senadexin Ananta Tablet
• Artrex Tablets
• Artovid-20 Tablets

Ayurvedic Products Regulatory Updates and Amendment’s:

US FDA in 2023, discovered safety issues with some of the ayurvedic products example they found concerning levels of heavy metals in ayurvedic products exported to U.S. market such as lead, mercury, arsenic, whether it is a ingredient of the age old ayurvedic formula or as a contamination in product it will cause poisoning risk in consumers, and their presence was not disclosed on the labels, US FDA has warned that no ayurvedic drug is approved by them and consumers should consider the risk of taking it. FDA says it cannot ensure its safety. In 2023, the FDA India Office co-hosted training for growers and producers of spices, herbs, and botanicals. The training focused on Good Agricultural Practices (GAPs) and Good Manufacturing Practice (GMP) requirements to ensure the safe production of botanical products. In the year 2022 Food Safety and Standards Authority of India (FSSAI), consulting with Ministry of Ayush has issued Food Safety and Standards (Ayurveda Aahara) Regulations, which are notified in official gazette on 5th May 2022, including the regulations of addition of vitamins and minerals and covering health claims.

• Regulations state that no manufacturing or selling of Ayurveda Aahara for infants up to age 24 months by the companies. And no addition of vitamins, minerals, amino acids in Ayurveda Aahara, only if vitamins, minerals are naturally present in product they are allowed and can be mentioned on labels.
• Products covered under this should only include the approved ingredients, and some of which include guar Arabic, pectin, konjac flour, honey, date syrup, curcumin, turmeric, rose oil, rosemary oil.
• In addition, they have rule which state that the labelling used for product or its presentation and advertisement of Ayurveda Ahara should not claim to prevent, treat or cure human disease or refer such properties. Label should include target consumer group and intended purpose, duration of use and other specific information

Ayurvedic Products Regulatory Challenges:

Strict safety and quality standards pose significant challenges to the growth of the Ayurvedic products market. Stringent regulatory guidelines for product approval require rigorous testing and scientific evaluation by authorities, focusing on purity, ingredient integrity, and manufacturing processes. In the United States, the Food and Drug Administration (FDA) also plays a crucial role in regulating Ayurvedic products, ensuring they meet safety and efficacy standards. As well, manufacturing companies cannot get license approval for the ayurvedic products until they are approved by the Food Safety and Standards Authority of India (FSSAI). For instance, in May 2022, the Ministry of AYUSH and the Food Safety and Standards Authority of India (FSSAI), both under the Ministry of Health and Family Welfare, Government of India (MoHFW), prepared regulations for safety and quality standards for food products for "Ayurveda Aahara" category. Such stringent regulatory measures are significantly restricting market growth due to the complex requirements involved in the manufacturing and licensing processes for Ayurvedic products. The extensive testing and scientific evaluations mandated by regulatory authorities necessitate a considerable investment of time and resources. Manufacturers must navigate intricate protocols to ensure compliance with safety, quality, and efficacy standards, which can vary by region and regulatory body. Like conventional therapeutics, ayurvedic medicines don’t have extensive clinical trials to validate their efficacy and safety. In India Ayush and CDSCO looks after approval and regulation of ayurvedic products but to take this in harmony with global standards like FDA is a challenge. Ayurveda provides traditional therapeutics and other products widely accepted in India, but its global acceptance is a challenge.

Possible Risk in development of Ayurvedic Products

Development of ayurvedic products has several risks of standardisation, difficulty in dosage determination, risk of new drug failure. Voluntary product recalls by market players are restraining the growth of the global healthcare and consumer care Ayurveda products market by creating concerns over product safety and quality. When a company initiates a recall, it often stems from issues related to contamination, mislabeling, or adverse effects reported by consumers. Such incidents can undermine consumer trust in Ayurvedic products, leading to decreased demand and heightened skepticism regarding the efficacy and safety of these offerings. For instance, February 2022, Health Canada issued a warning regarding unauthorized Ayurvedic medicinal products sold by Kerela Ayurvedic & Natural Herbal Consultation in Toronto, ON. In an update, Health Canada announced that testing of products seized from the clinic revealed unacceptable levels of heavy metals, including arsenic, mercury, and lead, in 14 out of 15 samples tested. Additionally, three products were found to contain prescription drugs—diclofenac, dexamethasone, progesterone, as well as cetirizine. Selling unauthorized health products is illegal in Canada, and these items have not been assessed for safety, effectiveness, or quality. International acceptance of traditional ayurvedic drugs is also a major problem manufactures face as guidelines of traditional drug development of ayurveda are different than global modern drug regulatory guidelines.

Ayurvedic Products Competitive Landscape Dashboard: Companies With Marketed Ayurvedic Products Products

• Dabur Ltd.
• Patanjali Ayurved Limited
• Himalaya Wellness Company
• Maharishi Ayurveda
• Lotus Herbals
• Emami Limited
• Baidyanath
• Hamdard
• Vicco Laboratories
• Kerala Ayurveda Limited