Building Strong Partnerships
Since 2008, the FDA India Office in New Delhi has worked to build strong partnerships with India’s national and state regulatory authorities. This collaboration helps the FDA understand India’s legal and regulatory frameworks and share information about FDA’s science-based regulations and requirements. A key focus area is herbal and Ayurvedic products, which are deeply rooted in Indian culture and the marketplace. Director Gregory Smith and Sr. Technical Advisor Dr. Pankaja Panda discuss these efforts in a recent blog.
The Role of Ayurveda in India
India is the birthplace of Ayurveda, a traditional medical system. Ayurveda, meaning “science of life” in Sanskrit, is widely used in India for treating chronic diseases and enhancing overall health. Herb-based formulas are one of the many modalities in Ayurveda.
U.S. Market and Safety Concerns
In 2023, the U.S. market accounted for more than 25% of the Ayurvedic and herbal products exported by India, according to the Indian Ministry of AYUSH. However, the FDA has raised safety concerns about some of these products, particularly regarding the presence of heavy metals like lead, mercury, and arsenic.
Regulatory Challenges
Educating Indian regulators, manufacturers, and exporters about FDA requirements is challenging due to the differences in how these products are used and regulated in India compared to the U.S. In the U.S., Ayurvedic products can be regulated as drugs, dietary supplements, conventional foods, cosmetics, or even devices, unlike in India where they are regulated as traditional medicines.
Recent Engagements and Findings
At the 3rd International AROGYA Conference in Lucknow, India, earlier this year, various Ayurvedic medicines were displayed, including herbal products with claims for treating diabetes, high blood pressure, GI issues, heart health, and fertility. Such claims are generally allowable in India but not in the U.S. without FDA approval.
FDA’s Regulatory Perspective
Products intended for the Indian market may not meet U.S. legal standards, leading to detentions at U.S. entry points for being “unapproved new drugs” or “misbranded drugs.” The FDA requires specific evidence for product approval, which can be a delicate topic given the long history of Ayurvedic use.
Educational Efforts
The FDA India Office (INO) actively works to understand the herbal products industry in India and communicate FDA perspectives. Participation in events like the AROGYA Conference allows FDA staff to educate the industry on U.S. regulatory expectations for herbal and Ayurvedic products.
Training and Good Practices
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.
Navigating U.S. Regulations
Given the complexity of the U.S. legal landscape, companies and individuals in India looking to sell FDA-regulated products in the U.S., as well as importers, should seek advice from experts in U.S. food and drug law. Such experts can help ensure that herbal and Ayurvedic products are marketed legally in the United States.
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Read the full FDA article here.