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Need for safety and efficacy of nutraceuticals
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Thursday, 26 February, 2015, 08 : 00 AM [IST]
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Dr Muhammed Majeed
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fiogf49gjkf0d Good nutrition contributes to healthy population that can lead the country towards better socio-economic conditions. Countries do formulate dietary guidelines on a regular basis, to enable its population to lead a healthy life. Nutritious foods support lives, physical growth, development, maintenance of body functions and health. An ideal diet plan should provide all essential nutrients in the required amounts which of course will vary with age, gender and physical activity levels. Major food concerns focus on insufficient or imbalanced food and nutrients. To add to this, food science experts in India have also expressed concerns over the quality of food, the hygiene both while cooking and packaging.
National Nutrition Monitoring Bureau (NNMB) of India surveys reveal that the daily intake of food, including cereals and millets in Indian households is lower than the Recommended Daily Allowance (RDA). Common nutrition related problems include low birth weight, protein energy and micronutrient malnutrition, chronic energy deficiency in adults and diet-related non-communicable diseases. Factors such as explosion in population, urbanisation, moving away from traditional habits, developing unhealthy lifestyle and dietary practices, lack of physical activity and urbanisation contribute to diet-related chronic diseases.
Dietary supplements and overall health
Nutraceuticals include dietary supplements (vitamins and mineral supplements, herbal supplements, protein supplements and so on), besides functional foods and beverages. These are believed to help the population to counteract diseases or delay the onset of certain diseases’ conditions, such as joint pains, cardiovascular health, obesity, insomnia, rheumatoid arthritis, and cancer to a great extent. Besides being popular in developed countries, there is an increase in demand from developing nations for such supplements. Consumers want to include the supplements in their daily diet plan to improve overall health, fitness and vitality. Years of existence of alternative medicine in India, with millions of Indians’ trust in them will provide a strong foundation for the nutraceutical market. However, the Indian consumer’s awareness is limited to nutraceutical ingredients such as Omega-3 fatty acids or lutein and the manufacturers have to take up the cause and create substantial awareness on supplements that have such ingredients. Moreover, India is also emerging as a key sourcing destination globally for natural ingredients, especially for plant extracts, although it is still a nascent market for nutraceuticals.
Urgent need to ensure efficacy of supplements
The nutraceutical market in India is growing at a CAGR 18.5% and clocked around US$3 billion in 2013-14, according to a recent report. The urban-centric nutraceutical market is gradually gaining traction in the rural region as well. The Indian market currently holds 2% market share of the global nutraceutical market and is expected to double in the next 5 years. Reduction of faith in Western or modern medicines will also drive the dietary supplements’ market here.
As there is this growing awareness on health with abundant information and products easily accessible online, there is also a rising need and obligation by the government and manufacturers to ensure regulating the standard as well as quality and safety of nutraceuticals more specifically dietary supplements. Besides this, India is becoming a global source for natural ingredients and these should be processed under stringent conditions to ensure increasing the global market share for these.
The Food Safety & Security Act, 2006, and the regulation that came into force in 2011 lists down ingredients that a product should have besides specific general properties of nutraceuticals and labelled appropriately. However, this is yet to match the international standards of the US and Europe in overall implementation. Agencies such as HADSA (Health Food & Dietary Supplements Association), NIN (National Institute of Nutrition), and NMB (Nutrition Monitoring Bureau) are together working to continuously modify the guidelines for the nutraceuticals and dietary supplements industry.
Quality control and assurance are fundamental to cGMP
Dietary supplements include vitamins, minerals, herbs, enzymes, amino acids, and extracts from plants and animals. They help in reducing the risk of specific diseases, relieve the effects to some extent but not intended to treat or cure the disease completely. They should be formulated under careful conditions in clean, controlled laboratories and should be labelled accurately with the ingredients that are actually present in the product. Quality Assurance is the basis to Current Good Manufacturing Practices (cGMP) compliance. The quality of the dietary supplements should meet established specifications for identity, purity, strength and composition. The limits of contaminants such as heavy metals, solvent residues and harmful microorganisms should be specified accurately. Heavy metals such as lead, cadmium, arsenic and chromium are toxic when consumed by humans. They can be carcinogenic, have adverse reproductive effects, produce negative impact on nutrition and can displace other useful metals such as calcium and zinc.
Both raw materials and finished products should be analysed in the laboratory which has adequate facilities to perform the necessary tests and examinations. Analytical methods and equipments should be carefully selected with product-specific testing methodology designed and implemented by qualified and relevant manpower. A quality manual should be in place that addresses all critical aspects of laboratory operations. The manual should clearly specify the lab’s staff organisation, responsibilities and ownership. Procedures should be clearly defined for sample control and documentation, analytical methods, calibration, internal quality control, audits, preventive maintenance, corrective actions, data validation and reporting.
It is important to consider into account the products from a reputed manufacturer or distributor as they are more likely to have been formulated under tight quality controls.
With the nutraceutical market expected to reach US$5 billion by 2015 in India, showing great growth potential, there is an increasing need for regulatory clarity and its implementation. The future for the industry seems promising with exponentially increasing consumer base and export markets. Both government and manufacturers should take sure steps towards regulation and standardisation of dietary supplements, besides developing innovative delivery mechanism to specific target markets.
(The author is founder and managing director, Sami Labs)
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