Many natural products, such as Azardicaindica, Curcuma longa, and Ocimumsanctum, are often used as immunomodulators. The increased prevalence of chronic diseases, along with the negative effects of synthetic immunomodulators, has resulted in the establishment of a global natural immunomodulator market. For researchers, complementary and alternative medicine provides a new target for drug discovery approaches and medication development. Ayurveda, Homeopathy, Naturopathy, and the Chinese medicine system are examples of complementary and alternative medicine approaches. Phytoconstituents with therapeutic action are included in the Complementary and Alternative Medicine (CAM) categories of natural goods. In Europe, natural immunomodulators are considered food supplements, while in the United States, they are utilized as dietary supplements. In India, it is controlled by the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy). With the help of the literature findings, we understand that even natural phytoconstituents also require and must undergo well-defined regulatory approval processes to launch in the market. But the regulation slightly differs as per the country and region. With the help of all the findings, one can conclude that the regulation of natural immunomodulators is equally important to set its marketing strategies as well as for its post-marketing surveillance as compared to the synthetic molecules. With this objective, the primary goal of this chapter is to draw more attention to the regulatory aspects of natural immunomodulators by comprehending the information on natural immunomodulator marketing strategy as well as the legislation that governs it.
Keywords: Guidelines, Legislation, Marketing Strategies, Natural Immunomodulators, Regulatory Agencies.
