Current Nutraceuticals Regulatory Landscape— India And Key Export Markets

An excerpt from 'Indian Nutraceuticals Industry - Building Global Momentum amid Regulatory Challenges', a report released by ASSOCHAM and Sathguru Management Consultants encompassing various national and global regulatory provisions dealing with the Nutraceuticals Landscape

The term nutraceuticalsis perceived to include different product types in different geographies across the world and the sheer lack of standardization in global definition of nutraceuticals is one of the key challenges faced by manufacturers wanting to export products. For example, nutraceutical derived supplement products are referred to as “dietary supplements” in the US, “Natural Health Product (NHP)” or “traditional herbal medicine” in the European Union and “complementary medicine” in Australia. The regulatory stipulations for nutraceuticals becomes more complex if in addition to being dietary supplements, they are also based on traditional systems of medicine such as TCM in China and Ayurvedic/Unani/ Siddha medicine in India.

Thus differentiation between the manner in which nations regulate the practice of medicine and the manner in which they regulate products used in medicine and food is important. In India, there is central regulation for the whole country when it comes to practice of medicine as well as the food and drugs, unlike in the US, where practice of medicine is regulated by the state authorities and the marketing of food and drugs is regulated by the central FDA.

Codex Alimentarius refer to a set of international guidelines followed by national regulatory bodies and manufactures of international quality food products. It has blanketed Food for special dietary needs to include food specifically processed and formulated for satisfying the dietary requirements of people with special physiological or physical issues. These also include food for special medical purpose which covers food formulations for people with specific diseases and disorders and the composition of such food formulation must be different from ordinary food products.