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Amrit Karmarkar and Pratik Mahadik March 01 , 2015
Abstract
Today, health is being given a deeper and thorough emphasis due to hectic, rapid, and demanding and nerve-racking lifestyle.

In fact, both younger and older generations have become aware of laying a strong emphasis on health.

Along with other investments, they have started investing in health because investment in health pays the best interest. And if such investment in nutrition starts from early childhood, it can incontrovertibly will lead to a guaranteed strategy for getting incredibly high returns.

Nutraceuticals is a combination of  nutrition and pharmaceuticals. Nutraceuticals deal with curing and prevention of disease and enrolls food concepts such as designer foods, health foods, functional foods, fortified foods, dietary supplements, medi foods, vita foods, beverages and so on. Present article highlights various concepts in the nutraceuticals sector from process engineering (GMP, quality control, machineries, packaging), market trends. Top nutraceuticals  companies, nutraceutical products, regulations and their upcoming value in the near future.

Understanding process engineering
Process engineering is a path which is followed after product engineering and it deals with the sequence of operations in manufacturing, process control, process design, product volume, production rate, equipment requirements, functioning of the equipments, cost planning and so on.

The term nutraceuticals was coined in the year 1989 by Stephen DeFelice who was the creator and chairman of the Foundation of Innovation Medicine. As quoted by Hippocrates (father of Western medicine) ”Let food be thy medicine” and various other civilisations such as Chinese, Indians, Egyptians, Sumerians used food as medication and vice versa.

Market statistics
Nutraceuticals is one of the promising  growing markets across the world. USA leads this market followed by Asia-Pacific. According to Transparency Market Research, this market is forecast to grow from $142.1 billion in 2011 to $204.8 billion by 2017 reflecting a CAGR of 6.3% annually. Rising income and intensifying lifestyle supports this growth. Dietary supplement market from nutraceuticals sector will be among fastest growing. Proteins and peptides categories from dietary supplementary market will help the market to achieve the fastest growing economy by listing a CAGR of 6.6% from 2012 to 2017. Worldwide demand for nutraceutical ingredients will be rising upto 7.2% annually and expecting to conquer a market of $30 billion in 2017 as per report from ReportLinker. According to Euromonitor and BCC Research, functional beverages sector will show a prosperous bloom in growth. From nutraceuticals arena in India, functional food contributes to a larger market of around 54%,  while dietary supplements and functional beverages share a market of 32% and 14% respectively.

Regulatory scenario
As such in India there are no such proper regulations. Different jurisdictions have different regulations for nutraceuticals segment. The main aim of the regulations in nutraceutical market is to make certain that the products are safe and properly labelled.

From an above-mentioned overview it is clear that there are various regulatory bodies governing this market which sometimes makes it complicated to evolve in different regions. As a result there is a need to harmonise the regulatory authorities.

GMP in Nutraceuticals
According to WHO, cGMP is defined as guideline which ensures products are consistently produced and controlled to meet quality standards appropriately and encompasses  their  intended use and specifications.  GMP covers specific systematic procedures, processes and documentation so that safety, effectiveness, consistency, reliability, identity and strength are maintained to a better extent.

The key areas of cGMP, which help  nutraceutical ingredients in maintaining all the above-mentioned qualities are as follows:
  • Sanitation and hygiene (building and premises)
  • Skilled, trained and educated staff
  • Proper and systematic installation of design qualification, installation qualification, operational qualification and performance qualification as per the latest reviewed SOPs in the firm (qualification and validation records)
  • Maintenance of batch manufacturing records, batch process records
  • Keeping records of market complaints
  • Packaging records and quality risk management
  • Maintenance of all the records for a specific duration.
ISPE guidelines
These are covered under the GMP part. ISPE acts as a baseline principle for oral solid dosage forms, sterile facilities etc. It offers  certain levels of protection which are denoted by zones or area.
  • Common housekeeping and Maintenance (Black area/zone)
  • Grey area – Precautions taken to prevent exposed product or material from getting part of contamination
  • White zone – Preventing contamination from specific environmental conditions which becomes part of the product or material. Monitoring is carried out in this zone
  • Red area/zone – Area requiring specific attention
  • Yellow area/zone – This area puts impact to design
  • Green area/zone – This area can be considered as a safe area where the problem usually does not occur
Quality control
The nutraceuticals industry is rapidly achieving success because of  commitment of assurance pertaining to nutraceuticals ingredients and the quality control segment plays a vital role in cementing this assurance.

There are various aspects in nutraceuticals products which need to be identified, assured as well as tested such as heavy metal analysis, melamine testing, microbiological testing,  irradiation testing, bioactive ingredients analysis, pesticide residue analysis, solvent analysis, detection of foreign materials, analysis of nutritive content, physicochemical analysis as an organoleptic property. Instruments such as UV/VIS, infrared radiation, atomic absorption, pH metre, TOC analysers, HPLC, GC, water content, conductivity, sieve shaker  serves all the testing of nutraceutical ingredients.

Machineries
Production of nutraceutical products equipped with proficient guidance, engineering superiority, cutting technology and professional approach enhances the productivity with efficient swiftness.

Daily used machineries in this sector are rapid mixer granulator, dry mixer and granulator, fluid bed drier, octagonal blenders, cartoning machine, mechanical shifter, tablet counting and polishing  machine, capsule filling machine, packaging machine, automating labelling whereas the liquid section covers manufacturing vessels, homogeniser, stirrer, filter press, container capping machine.

Packaging
As a wide array of nutraceuticals  products are being processed each and every year the demand for packaging material also rises which in turn creates an added livelihood. Different sizes of packaging have cemented their roots in the market. They are used for packaging extracts from herbal origin, dietary supplements, vitamin, minerals, probiotics, antioxidants, meal replacement and so on. Tetra Pak, Vernon Hills, IL, Xela Pack, Saline, MI, Alpha Packaging, and Winston Packaging are some of the frontiers in nutraceuticals packaging. Most of these players are also switching to eco-friendly packaging process from plastics to paper. Innovations in packaging industry are now targeting packaging of coconut water.

Top nutraceutical manufacturers
Johnson and Johnson, Monsanto, Cipla, Ranbaxy, Himalayas, Novartis, Dabur, Glaxo, Dupont, American Home Products, Warner-Lambert, and SmithKline Beecham, are some of the clients topping the charts of the nutraceuticals sector.

Conclusion
Rising population, income and a health-conscious approach among pupils will no doubt help the industry to flourish. Yet there are some hindrances which can block their successful run such as lack of harmonised regulations regulating this field, lack of visionary to distinguish between nutraceutical products and drugs, and inability to maintain a green valued environment. Government initiatives can also proliferate this sector to a superior extent. Present industry can achieve the forecasted success if all these factors will go hand in hand.

(The authors are pharmacuetical and clinical consultants and can be contacted at abkarmarkar@gmail.com)

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