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Regulations for nutraceuticals products in India
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Thursday, 16 August, 2018, 08 : 00 AM [IST]
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Sateesh Kulkarni
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Introduction:
Global scenario
The medical definition of nutraceuticals is a food or part of a food that allegedly provides medicinal or health benefits, including the prevention and treatment of disease. Nutraceuticals may be a naturally nutrient-rich or medicinally active food, such as garlic or soybeans, or it may be a specific component of a food, such as the Omega-3 fish oil that can be derived from salmon and other cold-water fish.
The global nutraceuticals market currently was estimated at US$215 billion and growing at a compounded annual growth rate (CAGR) of 6.5%. The United States and Europe are the major manufacturing centres as well as consumers. However, demand is growing quite significantly in other emerging markets as well, as a result of increasing disposable incomes which has further led to higher standards of living in these countries.
Globally, the health supplements and nutraceuticals sector is classified under the following three heads: 1) Functional/ fortified foods comprising nutrition fortified foods like fortified flour, fortified oil, fortified malted powder, breakfast cereals, probiotic foods like yogurt, etc.; 2) Functional beverages comprising sports and energy drinks, fortified juices, glucose powder, etc.; and 3) Dietary supplements viz, vitamin supplements, minerals supplements, macronutrients, antioxidants, tonics, herbal extracts, non-herbal extracts like cod liver oil.
While, overall, the global nutraceuticals market is expected to grow at a CAGR of 6.5%, the functional beverages is expected to have approximately nearly half the total share of this sector by 2019.
Nutraceuticals sector in India – A perspective
In comparison to global standards, in 2015, India accounted for a share of around 2% of the global market. By 2022, this share is anticipated to increase to a value of approximately 3% owing to country’s large population base, increasing urban density and awareness. India’s nutraceuticals market is expected to touch US$5 billion by 2020 and to around US$8 billion by 2022 and exhibit strong growth on account of the strong demand for dietary supplements from the upper and middle class. According to the industry body Drug Marketing & Manufacturing Association (DMMA) estimate, nutraceuticals sector is estimated to grow at a compounded annual growth rate (CAGR) of about 16% in the next five years.
Segments
The Food Safety and Standards Authority of India (FSSAI) regulates nutraceuticals through Food Safety and Standards Act (FSS Act) and the regulations framed thereunder. As per the press note on nutraceuticals regulations issued by the FSSAI, India has notified the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, in the Gazette of India on December 23, 2016.
These regulations cover eight categories of food. These categories are as follows: 1) Foods for special dietary uses; 2) Nutraceuticals; 3) Health supplements; 4) Foods for special medical purpose; 5) Foods with added probiotic ingredients; 6) Food with added prebiotic ingredients; 7) Novel food; 8) Specialty food containing plant or botanical ingredients.
At a macro level, all three segments of the Indian health supplements and nutraceuticals market i.e., fortified/ functional packaged food, dietary supplements and functional beverages are registering a double-digit growth.
Major players
In the functional or fortified foods category, which has a market size of about US$2 billion, probiotic drinking yogurt has shown the highest growth. Among the major players in this segment are Cargill, Britannia, Glaxo, ITC, Nestle, Patanjali, Yakult, and PepsiCo.
In the dietary supplements segment, fish oils/ Omega fatty acids is the fastest growing product category. In this segment, the major players are Amway, Dabur, Novartis and Himalaya.
The functional drinks market has a market size of about US$550 million. Within this segment, energy drinks is the biggest product category, accounting for nearly 2/3rd of the total market value. Among the leading players are Red Bull, PepsiCo, Coca Cola, Glaxo, Patanjali and Dabur.
Growth drivers
Economic progress and development has, in its wake, brought about significant changes in the lifestyles of people across the world. India too has had to bear this impact of globalisation and at times an adverse impact. The country currently has now started witnessing a spate of lifestyle diseases like diabetes, blood pressure, obesity, and cardiovascular problems. These new-age ailments have led to an increased demand for supplements and health foods. Also, with more awareness, there has been an increasing concern about nutrition, and thereby an access to information.
Also, the increasing cost of hospitalisation and medical treatment is driving consumers towards health supplements and nutraceuticals. The demand for the vitamin and mineral supplements is likely to increase in the future due to the unhealthy eating habits and stress in daily lifestyle. People may benefit from the extra nutrients found in these supplements. A multivitamin and mineral supplement helps in safeguarding against periodic nutrient shortfalls in the diet.
In the present scenario therefore, consumers are looking for products to boost energy and enhance physical stamina, endurance and overall physical wellness. Dietary supplements in the form of tablets, capsules, powders, liquids, soft caps and soft gels are now becoming increasingly popular.
Policy framework
While the nutraceuticals sector has a good growth potential with a strong and growing demand, the industry in India lacks a dedicated law guiding the sector or rules that defines the composition of nutraceuticals. However, the gazette notification issued by FSSAI in recent times, states, these foods should “Consist of a composition delivering the desired level of energy, proteins, vitamins and minerals, and other essential nutrients required for the respective age group, gender and physiological stage in accordance with the guidelines made by the Indian Council of Medical Research.”
The regulations cover the eight categories of food (mentioned above) and is defined based on their contents and use. Further, FSSAI, vide its directions issued on May 19, 2017, has released the Food Safety and Standards (Fortification of Foods) Regulations, 2017. This regulation prescribes standards for fortification of oil, salt, milk, vanaspati, atta, maida and rice and operationalised by FSSAI with effect from April 17, 2017. The new policies on labelling and a regulatory framework for “nutraceuticals” manufacturers are slated to be implemented from this year (2018) onwards.
FSSAI notified the Food Safety and Standards (approval of non-specified food and food ingredients) Regulations, 2017. “Non-specified food” means any food other than proprietary food or food ingredients, including additives, processing aids and enzymes for which standards have not been specified in any regulation made under the FSS Act. All the food business operators have to now submit applications for prior approval of non-specified food and food ingredients.
Challenges
While the demand and growth of this sector is not disputed, the future of this sector hinges on strict implementation of the rules and regulations. The nutraceuticals market in India is fragmented and the growth potential restricted to certain segments only. A study by Associated Chambers of Commerce & Industry of India had revealed that 60% to 70% of dietary supplements sold across India are fake, counterfeit, unregistered and unapproved and are extremely difficult to identify. The implementation and execution of the regulatory framework will therefore be critical. Affordability and availability will also be a key factor for success. The country’s food regulator now also wants to curb the use of prohibited performance-enhancing substances by sports professionals through nutritional supplements.
(The author is senior adviser, Corporate Catalyst India)
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