Navigating Regulatory Hurdles: How Ayurveda and Wellness Startups Ensure Product Compliance

The growth of the wellness market has led to the revival of Ayurveda, one of India’s oldest traditional medical systems. As the influence of herbal medicinal remedies, supplements and other health products grows, Ayurveda-oriented wellness enterprises, businesses and corporations are on the rise.

However, with this growth, bureaucracy has also increased. New businesses in this sector face various challenges in trying to ensure that the products they offer or intend to offer are safe and compliant with many health and safety regulations.

In India, the Ministry of AYUSH regulates traditional medicines and Ayurveda products. Startups must follow the Drugs and Cosmetics Act, 1940, as well as specific guidelines for Ayurveda, Unani, Siddha, and Homeopathy (Ayush) products. Similarly, European markets have strict regulations for herbal products, requiring manufacturers to provide safety data and evidence of efficacy.

Here’s how Ayurveda and wellness businesses can overcome the hurdles posed by regulations in this industry and thrive in a business with very strict standards.

Key compliance areas for Ayurveda startups

To navigate these regulations, Ayurveda startups should focus on several key areas:

• Product Safety and Quality Control: Maintaining product safety is paramount. Ayurvedic products such as herbal supplements or topical treatments are made from natural plant ingredients that vary in potency and purity. Young companies should or should have adequate mechanisms to control quality and guarantee the safety of the finished product for all batches. This entails careful identification of reliable vendors for raw materials, laboratory tests to determine the level of impurities in the ingredients used, and adherence to Good Manufacturing Practices (GMP).

• Labeling and health claims: Labeling of product information should be carried out with utmost accuracy. Any health benefits associated with Ayurvedic products must be qualified with evidence from scientific research or clinical trials. False claims can lead to lawsuits or withdrawal of products from the market. For example, in the absence of any supporting clinical evidence, a company’s use of the word “treatment” associated with a product designed to treat chronic conditions may run into trouble with regulators.

• Certification and documentation: Certifications such as GMP, ISO, or organic certifications are helpful in ensuring product quality and safety. In Ayurvedic products, it is equally important to provide the source of ingredients, reports of manufacturing processes, and results of any tests conducted by external agencies to verify compliance. Startups are advised to maintain complete documentation of all these processes as a means of meeting regulatory requirements and ensuring clarity to the public.

• Risk Management: Effective risk management practices need to be implemented. Ayurvedic ingredients can also interact with allopathic medicines resulting in side effects. Startups must perform comprehensive toxicology studies, risk assessments, and post-marketing strategies to assess side effects of products after they are launched in the market.

Overcoming regulatory challenges

Although compliance with these regulations presents a major challenge, several protective measures can be taken to help startups comply and minimize risks:

• Engage legal and regulatory experts: It will be of great help to seek professional advice on food and drug policies, especially from those with expertise in Ayurveda and health. Such professionals should help startups understand the various aspects of regulation and the risks of getting it wrong.

• Invest in research and testing: One of the strategies to ensure compliance with regulatory standards is to focus on investing in scientific research, clinical trials, as well as laboratory testing to verify product claims. For example, startups that provide solid evidence to support their product claims win the trust of customers and regulatory authorities.

• Collaborate with industry associations: Joining industry groups or associations can provide valuable resources and insight into compliance best practices. Networking with other Ayurveda and wellness businesses can help startups stay informed about regulatory changes and challenges.

• Focus on consumer education: It is important to communicate effectively with consumers. Informing consumers about the benefits and safety of Ayurvedic products through blogs, social media, or webinars will run the risk of distortions and misconceptions. Openness in the supply chain, manufacturing and analysis of goods increases trust in customers.

The Ayurveda and wellness markets are expanding rapidly, however, with expansion comes compliance with strict regulations. Startups operating within this sector must ensure that all their products and services comply with legal requirements, both locally and internationally. By addressing safety issues in products, creating accurate labels, and maintaining documentation, Ayurveda startups can overcome regulatory challenges and, at the same time, gain a competitive advantage for sustainable growth. Given the right approach, these businesses can thrive, while providing consumers with quality health products that are safe and work.

(Pawanjot Kaur is the co-founder and CTO of Ayurveda wellness brand, AYUVYA.)