Current Affairs

NUTRACEUTICALS

WHAT ARE NUTRACEUTICALS

  • The term “Nutraceuticals” was coined from “Nutrition” & “Pharmaceutical” in 1989 by Stephen DeFelice MD, Founder and Chairman of the Foundation for Innovation in Medicine (FIM).
  • Offers health benefits and are majorly used to prevent from lifestyle disorders (CVD, Diabetes, and malnutrition among others).
  • Plants, Animals and Micro-organisms are the source of Nutraceuticals ingredients.
  • Vitamins, Minerals, Proteins, Probiotics, Fatty acids, Amino Acid are some of the major ingredients.
  • Formulations are available in the form of Powder, Pills, Tablets, Capsules, Bars, Food and Drinks.

 

“Nutraceuticals” vs “Pharmaceuticals”

Parameters Nutraceuticals Pharmaceuticals
Prevention and Wellness Primary FOCUS Secondary FOCUS
Medical Supervision Not Required Required
FDA Approval Not Required Required
Prescription Not Required Required
Results Slow but effective Fast; may have side effects

 

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The core factors promoting the growth of this industry include:

  • Increasing health consciousness
  • Ageing population
  • Rising personal disposable income
  • Increasing penetration of large retail set-up, such as hypermarkets and supermarkets
  • Marketing and promotional activities by companies

 

GLOBAL  NUTRACEUTICAL MARKET

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  1. The U.S. has the largest market for nutraceuticals, followed by Asia-Pacific and European Union.
  2. Functional food is the fastest growing segment in the U.S. nutraceuticals market. Germany, France, the U.K. and Italy are the major markets in the European Union for nutraceuticals.
  3. Japan (14 per cent) is the major consumer of nutraceuticals in Asia-Pacific, followed by China (10 per cent).

 

INDIAN NUTRACEUTICALS MARKET

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  • India accounts for 1.5 per cent of the global nutraceuticals market.
  • Due to rising awareness about health and fitness and changing lifestyle, India’s nutraceuticals market is likely to cross $6.1 billion by 2020 from the current level of $2.8 billion growing at compound annual growth rate (CAGR) of about 17 per cent
  • Heinz, Kellogg’s, Nestle, Hormel, Unilever, Johnson & Johnson and GlaxoSmithKline Pharmaceuticals are key players in this field.

Industry Drivers:

  • Ageing Population: Elderly population to reach 143 Million by 2021 from current 100 Million
  • Increasing Co-prescription: In 16% of the prescriptions, a multivitamin product is prescribed
  • Focus on Preventive Healthcare: Consumers have started realizing the importance of nutraceuticals in dealing with health issues
  • Rapid Retail Growth: India’s retail market to double to US$ 1.3 Trillion by 2020 from US$ 600 Billion in
  • Changing lifestyle; increasing sedentary jobs propelled the incidence of lifestyle diseases.
  • Rising health awareness among consumers providing platform for nutraceuticals to grow

Regulatory Framework for Nutraceuticals

  • Nutraceuticals have been categorized as non-standardized/special food products under Section 22 of Food Safety & Standards Act, 2006.
  • These products are regulated under the guidelines of FSSA, 2006 amended in 2011 for registration, licensing, approval, labelling and packaging, import, marketing & distribution, laboratory testing such as conventional food products.

Regulatory Implications

  • Better clarity in the definition of nutraceuticals
  • Products which need to undergo a stringent approval process under the drugs and cosmetics act will not be available in the market as a dietary or nutraceuticals
  • All manufacturers of nutraceuticals in India will be required to take NOC and approval prior to manufacturing and marketing such products
  • No activity will go unaccounted; it would become easy to track the market information

ISSUES

  • Currently, there are no regulatory norms for the approval or monitoring of nutraceuticals, herbals and functional food.
  • In the absence of regulations, the products take much longer to reach the market. For industry growth, it is utmost necessary to give faster approvals for eligible nutraceuticals.
  • In urban India, penetration is around 22 per cent, whereas in rural it is as low as 6 per cent. Lack of awareness is the major reason.
  • The nutraceuticals and dietary supplements industry has potential to grow to USD 12.2 billion in the next five years, about 60-70 per cent supplements in the market are fake and such unregistered and unapproved products need to be recalled.

SUGGESTIONS

  • Small committees should be built at block level to check counterfeit products in the market and immediately discard them.
  • For faster growth of the domestic market, both private players and government should create awareness about the health benefits of nutraceuticals among masses through campaigns, social media and television.
  • Considering very low penetration of nutraceuticals in the country, the government should provide special incentives and subsidies to emerging companies for the industry growth and create awareness about the health benefits of these products. The funding will help companies to use improved process technology and come up with quality nutraceuticals.
  • Financial support will also help Indian talent to innovate cost effective nutraceuticals. The products available in the market are majorly targeted to upper-middle class leaving a vast potential. To catch the masses, nutraceuticals for all should be the target concept.
  • Government should introduce various functional foods and beverages in Midday Meal schemes to address child malnutrition.
  • FSSAI should come up with properly framed guidelines related to manufacturing, storage, packaging and labelling, distribution, sales, claims and imports. This will bring clarity to the industry stakeholders and they can invest into the industry with no fear of counterfeiting
  • All products, before reaching the market should go through rigorous testing and it should not be compromised at any cost. An exponential growth has been noticed the number of food testing labs.
  • Food safety regulator FSSAI should at the earliest lay down rules for giving approval of dietary supplements and nutraceutical products manufactured and marketed in the country- ASSOCHAM
  • “Nutraceuticals are gaining popularity but its growth is restrained by lack of a solid regulatory framework which is crucial for medial credibility”.

 

SC RULING

A recent Supreme Court ruling has brought some relief to food and nutraceutical companies that were unable to sell their products due to a “product approval process” introduced by the food safety regulator.

Last week, the apex court quashed a product approval advisory from the Food Safety and Standards Authority of India (FSSAI) that required food companies to seek approval on a broad spectrum of products, including those already available/being consumed.

With the court rendering the product approval system (of May 2013) “defunct” (except on new products) companies will be able to bring products that had been held up due to delays in the approval process back into the market

Several products, including Ranbaxy’s Revital (now owned by Sun Pharma), had been caught in this net and are now back in the market. Packaged food manufacturers are however, wary, preferring to wait for more clarity before bringing their products back.

The apex court’s order will allow health supplements, nutraceuticals and so on to enter the market in line with globally prevalent practices.

Question:

"Nutraceuticals can play an important role in India's social sector.Elucidate"

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