Strategic Analysis of Regulatory Guidelines for Nutraceuticals In India

Ajay Pise, Sreedhar Manthan, Virendra Pradeep, N. Udupa*

Today healthcare market is flooded with different new terminologies such as Nutraceuticals, Cosmeceuticals, Dermaceuticals, Ayuraceuticals etc. ‘Nutraceuticals’ is a buzzword in global healthcare market. With the growing healthcare industry in India there is an emerging trend in growing consumerism for ‘Fast Moving Healthcare Goods (FMHG)’ worldwide popularly known as Nutraceuticals. Several scholars have given different definitions of Nutraceuticals, essence of all definitions remain same i.e. "ingredients with human health benefits beyond basic nutrition are called as Nutraceuticals". Group of researchers have categorized dietary supplements, functional foods, novel foods under the broad category of Nutraceuticals whereas few scientists have identified that the term Nutraceutical is different than the existing terminologies of dietary supplements, functional foods and novel foods. An objective of this research work is to analyse regulatory framework for Nutraceuticals in India. To achieve this objective detail information on the existing regulatory guidelines was collected from authentic secondary sources which include journals, magazines, text books and internet. Separate market research studies were conducted to identify and analyse manufacturing activities, labeling pattern, advertisement strategies, and sales of Nutraceuticals in India. Details of the conceptual regulatory framework is discussed in the ‘Results and Discussion’ section of this manuscript. Conclusion was derived after interpretation of the results and discussed in the section of ‘Conclusion’ part of this paper. Recommendations and Limitations of the study are discussed in the final part of this research work.
We understand that global Nutraceutical market is growing very rapidly. In the context of Indian scenario, Nutraceutical market is growing fast with the 20% CAGR. Increasing awareness about the health, disease prevention, high cost of the medication, and handy disposable income are the factors which contributed in increasing demand of the Nutraceuticals. Though the term of Nutraceutical is becoming more popular around the world, very few countries have officially adopted the terminology and framed regulations to control the manufacturing, advertisement, quality control, sales and use of the Nutraceuticals.
According to Cygnus (Market Research Agency) estimates, Nutraceuticals market in 2007 was INR18.75 billion and expected to grow at 20% CAGR3 to achieve a market size of INR27 billion in 2009. The US has been the major market for Nutraceuticals with India and China becoming fastest growing markets. Global Nutraceuticals market in 2007 is estimated to be USD120 billion5 and has been growing at a CAGR of 6.8%. The US has been the major market with 36% of market share in the global market followed by Asia at 30% and Europe at 24%. In Asia, Japan is the largest market at 70% market share3. Nutraceuticals are gaining acceptance globally for their ability to address several diseases. Vitamins, Minerals and Nutrients constitute about 85% of the global market while antioxidants and anti-agents account for 10% other segments such as herbal extracts occupy 5% of the market15. To explore this market, many Nutraceutical and Pharmaceutical companies have launched nutraceutical products in the healthcare market. Today, healthcare market in India is flooded with Nutraceutical products.



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