Opportunities Vs Challenges

With the government support and initiatives already in place from the regulatory agencies the nutraceuticals industry will see significant growth in the coming years, provided the companies stick to delivering consistent high quality and safe products.

The healthcare industry in India is showing great progress. There has been considerable increase in spending on healthcare backed by the growing purchasing power of individuals. Moreover, with a lot of importance being given to preventive medication, the nutraceuticals market in India is set to flourish. It is one of the booming markets in India. Predominantly vitamins and minerals derived from oral pills were used for curing certain diseases and ailments. People today are becoming more prone to consume immunity enhancing food supplements and wellness related products. This is promoting the growth of the industry with players diversifying into production of various new varieties of products. Further assistance from the government and increasing demand from consumers will fuel growth in this market, says Netscribes (India) report 2012.

The growth of the market is strongly driven by the increasing health consciousness, rising disposable incomes, increasing number of people being affected by lifestyle diseases resulting in healthcare spending, and the shifting age structure of the Indian population, like higher median age.

The nutraceuticals industry that is emerging rapidly also passes through various challenges and threats. Though challenges can be multifocal, Dr Baidyanath Mishra, Vice Prident, Product Development, Regulatory and Medical affairs, Katra Phytochem  said, “ it includes lack of clarity in regulatory system, centralization of approval process-thus delay in approvals affecting the business by Food Business Operator (FBO), poor awareness among the implementers, minimal access for modernization, higher taxation etc.”

Sharing her thoughts Dr Villoo Morawala-Patell, Chairman and Managing Director, Avesthagen said, “Financing, position and communicating the convergence of food and pharma, regulatory, non-transparency, too many exaggerated claims etc. are some of the key issues the industry is facing.”

Commenting on the challenges, the team working on chemicals, materials and foods practice at Frost & Sullivan said, “Currently nutraceuticals are positioned as ‘premium products’ and manufacturers assign high margins to the products and hope to recover their R&D costs faster. However, the high prices limit the adoption among the consumers. Now dietary supplement, which are available in pills or tablet format regarded as medicines, and treated with caution, as the concept of dietary supplements or tonics, like Chyawanprash, has existed for a long time.”

Says VS Reddy, chairman and managing director, British Biologicals, “Originally, the aim of nutraceuticals was as an adjunctive with regular medication. The world now, is moving towards preventive care. Never in history has the adage, “Prevention is better than cure” been better understood than in the age of nutraceuticals. With the passage of time and advance in nutritional studies at molecular level, nutraceuticals has carved its niche as a “wellness” supplement world over. Despite the above, the nutraceutical industry in India is facing numerous challenges as follows.” 

a) First and foremost, the benefits of nutraceuticals are not fully understood by the care givers as well as the patients. Even today, we see people chasing a curative process rather than a preventive approach to health conditions and illnesses. Secondly, there are too many misconceptions about nutraceuticals. Apposite information and education introduced at focal points in the system will certainly benefit the industry.

b) Affordability is major concern in the nutraceutical product market. The west looks at it as an investment in health, but India still seems to be catching up with it. A large part of our population which needs medical nutrition is sadly unable to afford it. This drawback can be overcome by government subsidies and aids. To site an example, the Government of Orissa procures B Protin (a high protein nutritional supplement meant for correction of malnutrition) from British Biologicals, to be disbursed to the tribal population under their health scheme. Such measures can be adopted at a national level, which then help a larger population to benefit from it.

c) Another key challenge is that the medical profession in India still considers nutraceuticals as “optional”. Contrary to this, specialized nutrition helps manage specific diseases or even delay the onset and progression of diseases- a fact that has been proven through continued research and testing.

d) The Indian sub-continent is vast and diverse. Distribution in such a large country is very challenging.

e) A classic difficulty that we very often face is convincing the medical profession on the fact that nutrition can help shorten a patient’s hospital stay. Enteral nutrition, which is offered to patients who are convalescing, speeds up their recovery.

f) India still does not have self reliance in raw material for nutraceuticals. We are unable to source Quality raw material of international standards domestically.

Regulatory changes 

To support this fast growing nutraceuticals industry, the government of India has established a regulatory body called Food Safety and Standards Authority of India (FSSAI) on August 5, 2011 under the Ministry of Health & Family Welfare. And also announced the Food Safety and Standards Act, 2006 which is a consolidating statute related to food safety and regulation in India. The Act officially repeals the regulatory framework established by the previously existing eight food laws, consolidating them into the Food Safety and Standards Rules and Regulations 2011 under a single regulator- The Food Safety and Standards Authority of India (FSSAI). As the Act is still new, the industry is taking its own time to understand the rules, regulations and guidelines of the Act and the government is also going slow in implementing it. 

“As a result of the slow implementation of Food Safety and Standards Act by FSSAI {as of March 2013, regulations for the FSSAI were being drafted} adulterated and ‘poser’ products are currently hurting the market, eating into the share of authentic nutraceuticals. For example, products like ‘herbal water’ are often positioned as premium products; however, neither the veracity (of the water being herbal) nor the benefits (of consuming herbal water) have been vetted by the FSSAI”, says an analyst with Frost & Sullivan.

Sharing his thoughts, Dr R K Sanghavi, Chairman – Nutraceutical Subcommittee, Indian Drug Manufacturers’ Association (IDMA) said, “The government needs to address many of the regulatory issues, which might come the way of growth of the industry. The issues include No separate rules and regulations for nutraceutical products; Product approval system instead of ingredient approval as is prevalent in regulated markets; Exhorbitant application fees for approval; Referral of product for Scientific Committee assessment (with additional equal fees paid extra) for simple nutraceutical ingredients which are already in market overseas, even in India since years and having ample documentation on net; Product approval required for site approval!; All operations are Delhi-based – very difficult for small and medium enterprises to co-ordinate; Spate of advisories – resulting in ridiculous need to change dossier already submitted (and also paying fees application again); Product rejection done without scientific reasoning or permitting FBO to represent the case; No revert by FSSAI to emails sent; appointments usually not given; no cell formed to address grievances and RDA for nutrients imposed rather than upper tolerable limits which is the international norm.”

Indian nutraceuticals market is still in nascent stage though it holds a strong position as one of largest suppliers of herbal extracts and raw materials for the dietary supplements in the world. With the government support and initiatives already in place from the regulatory agencies the industry will see significant growth in the coming years, provided the companies stick to delivering consistent high quality and safe products, to gain consumer trust on product quality and health benefits by overcoming the unstable economic condition and devaluation of rupees.

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