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Regulatory reforms in Nutraceuticals and Nutrition World

Introduction: 

Nutraceuticals and nutrition foods, though popular in other parts of the world, was a new concept in India when FSSAI started functioning on 5th August, 2011. USA, Europe, Japan, China and other developed nations were the only consumer of Nutraceuticals and Health Supplements. It was used mostly by the health conscious consumers who are affluent also.
With passage of time, these products find acceptability among a larger chunk of the health conscious populations. Credit goes to the medical professionals and nutritionists who advocated consumption of nutraceuticals and nutrition products. FSSAI has also notified Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food Regulations,2016. Since the regulations was new not only to the Food Business Operators (FBOs) but also to the Food Safety Officers (FSOs), enforcement of the regulations was effective from 1st January ,2018.
While implementing the regulations, a number of short comings have been noticed and need of the regulatory reforms has been discussed.

Recommended Daily Allowance for Indians (RDAI): 

As per Section 22(1)(a)(II), foods for special dietary uses or functional foods or nutraceuticals or health supplements may contain minerals or vitamins or proteins or metals or their compounds or amino acids ( in amounts not exceeding the Recommended Daily Allowance for Indians ) or enzymes ( within permissible limits ). RDA is different for different countries. USFDA have both minimum and maximum RDA whereas in India, we have no maximum and minimum limits.
Indian Council of Medical Research submitted a report of the expert group in 2010 to update the nutrient requirements and dietary allowance for Indians. FSSAI also adopted the RDAI recommendations of the National Institute of Nutrition – Indian Council of Medical Research (NIN-ICMR), Hyderabad.
Quantity of nutrients added to the articles of food shall not exceed the RDAI as specified by the ICMR and in case such standards are not specified, the standards laid down by international food standards body, namely Codex Alimentarius Commission, shall apply.
A nutraceutical which is not provided in these regulations, shall be manufactured or sold in India only on prior approval of the FSSAI which shall be accompanied by documented history of usage of at least fifteen years in India, or thirty years in the country of origin.

Need for Regulatory reforms

In the last few years, there have been tremendous growth of Health Supplements and Nutraceuticals business all over the world. A number of new ingredients / products have been found to be very effective on health related issues. Also, the present level of RDAI of ICMR appears to be insufficient to give desired effect.
NIN – ICMR conducted study to revise the RDAI. Meanwhile, they have submitted a report on Tolerable Upper Limit (TUL) for vitamins and minerals. FSSAI also issued a circular on TUL. However, Section 22(1)(a)(II) of the FSS Act, prohibits the use of more than one RDAI, TUL is of no help unless the FSS Act is suitably amended .
FSSAI also notified 400 botanical ingredients in Schedule IV of the regulations, which can be used as an ingredient in health supplements and nutraceuticals. For approval of any ingredient which is not specified in Schedule IV, application along with fees of Rs 50,000/ plus safety studies and regulatory status to be submitted to the FSSAI. Since some of the ingredients/products do not have documented history of use of 30 years in the country of origin, these are not allowed by the FSSAI. Even if these are available, FSSAI insists clinical trial of these products on Indian population which is time consuming and costly affair for the food business operators.
During the present COVID-19 Pandemic situation, a number of health supplements and nutrition products have been found to be effective immunity booster in overseas countries. But these products are not allowed by the FSSAI as these products have ingredients with higher RDAI. As per existing ICMR guidelines, RDAI for vitamin C is 40mg and zinc is 12 mg whereas most of these immunity booster contain 500/1000 mg vitamin C and 50 mg zinc.

Joint Parliamentary Standing Committee Report:
Department – related Parliamentary Standing Committee on Health and Family Welfare, presented 110th report on “Functioning of Food Safety and Standards Authority of India ” on 9th August, 2018 to the Rajya Sabha and Lok Sabha.
As former Director, FSSAI, I was an invited member and submitted my suggestions, most of which were considered and included in the report. The committee learnt about Health Supplements and Nutraceuticals regulations of the FSSAI.
The committee recommended that FSSAI should systematically evaluate the performance of the FSS Act, it’s rules and regulations. Amendments required in the FSS Act were also recommended.

Proposed Amendments of the FSS Act
Ministry of Health and Family Welfare, Government of India, vide its public notice of September 23, 2020 invited comments and suggestions on the proposed FSS ( Amendment  ) Bill, 2020.
It has been suggested that under Section 22(1)(a)(II) of the FSS Act, “in amounts not exceeding the Recommended Daily Allowance for Indians” to be deleted and replaced with by TUL as now it is officially determined by NIN-ICMR too.
All derivatives, salts, chelates, esters and related forms of vitamins and minerals mentioned in Schedule I of the Health Supplements, Nutraceuticals regulations may be used. Methylcobalamin, L- Methylfolate shall be included under vitamins as well as in the respective Schedule I and Schedule VI.
There is an urgent need to amend the regulations, particularly to allow novel food/ingredient which will be manufactured under the Prime Minister’s “Make in India” programme. In a rapidly changing world, we should not wait for documented history of usage of at least fifteen years in India, or thirty years in the country of origin. This condition should be deleted.

Conclusion
Regulatory reforms is a continuous process. Procrastination in granting approval of novel food/ ingredient hampers the economy of the country. Scientific evolution should be encouraged to boost the Health Supplements and Nutraceuticals industry which offers enough scope not only for domestic markets but also export.

The article has been written by Mr. Pradip Chakraborty (Former Director of FSSAI) and published by Interlink Insight Vol 19 issue 2. 

About Author: Pradip Chakraborty, Former Director, FSSAI
Email: pradipchakraborty91@yahoo.com

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Three Crucial Parameters for Sustainable Business Model

All organisations are looking for sustainability after pandemic and hence it is clear that each one of us need to articulate this model to sustain in our business.
Experience shows that it is always to be remembered that-

1) Who we are?
Are we deploying resources for today and tomorrow? It may need strategic thinking.

2) What are we doing?
Is each activity profitable?

3) How do we sustain and grow?
Do we disrupt our ways of deploying resources, methods of doing business, and retaining our customers to sustain?

‘Market transformation’ aids the business sustainability and competitive positioning of an organization. Nowadays, companies are not waiting for such market shifts. They are creating those market shifts to achieve desired level of organizational sustainability. This is possible because of a well featured business sustainability model. Many organizations are now developing various business models, following are the three crucial parameters which can be considered while designing organizational level sustainability model-

Sustainable Business Model should be-

1. Futuristically viable- Organization building based on limited resources will be a short-term yield. Availability and access to resources and its pricing are the constantly fluctuating entities. Sustainable business model should be designed in such a way that it should never be the waste in future.

2.Commercially profitable- Attracting new costumers and re-engaging old ones will always be the challenge for any organization. This strongly depends on the value proposition of business. Once the efficiency and effectiveness of your business is positively conveyed to the costumer, ground is yours! This vital point should never be ignored while developing sustainable business model.

3. Equipped with long term resources- Choosing accurate resources would be one of the important moves while operating any organization. Organizational management has to make a good choice between cheap resources with short term benefits and expensive resources with long term side effects. Organization’s decision-making abilities with situational analysis will play crucial role while looking for resources with long term benefits.

Every business needs a sustainable business model and polishing this model with newer and innovative concepts it is going to be a mandatory thing in coming years. With increasing development of sustainability strategies, products and services along with appointments of sustainability department and sustainability officers, new sustainable business models are expected to come up in this competitive era of businesses.

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Need for Regulatory Globalization in Nutra

With escalating awareness about Preventive care and health consciousness, Nutraceutical market is growing at a rapid pace in today’s world. The market worth more than $382.5 billion this year and it is expected to reach the market value of $722.4 billion by the end of 2025. Looking at the annual growth rate, in my opinion, Nutra market surely willmake impressive business in upcoming years.

Although the market is expected to strike gold in near future, the regulatory landscape of this sector is emerging as a ‘holding back factor’ for market’s growth. The Nutra regulatory system seem to evolve very slowly compared to the growing number of products being placed into the market. Looking at therisk of fake and unregulated product, market today is asking for strict regulation measures in this field. Being in the grey area between diet and drugs, it is important to clearly identify their specificity in view of their possible use and utility in the pharmaceutical arena.

Drawbacks in Nutra Regulatory framework:

1. No legally globalized definition:
The word ‘Nutraceuticals’ is coined by Stephen DeFeliceand according to him, Nutraceutical is “food or part of a food that provides medical or health benefits, including the prevention and/or treatment of a disease”. This was the basic definition available for nutraceuticals but is every country following the same definition? Absolutely not! Canada refers to nutraceuticals as “natural health products” while the United States calls them “dietary supplements.” So, while setting up a Nutra-marketing campaign in any particular country, finding a right legal definition used in that country becomes a greatest concern to reaches the right audience and avoids confusion. CHART 1 is consisting of definitions of various nomenclatures of Nutraceuticals in some major countries.

2. No uniformity in Regulations:
The lack of shared legislations around the world creates a big confusion while marketing Nutraceutical products worldwide. Proper understanding about the regulations and active regulatory bodies is mandatory for effective marketing. For example, according to Dietary Supplement, Health and Education Act (DSHEA) in US, a dietary supplement should be “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs or other botanicals; a concentrate, metabolite, constituent, extract or combination of the ingredients listed above.” Likewise, in other countries, the formula requirements for the Nutraceutical product might be much different than stated above. Same goes for labelling requirements, they also should be properly studied for the respective country before marketing.

3. Unsubstantiated health claims:
Lack of safety, efficacy and scientific data are the main hurdles while obtaining health claim approval for Nutraceutical products. Nutraceuticals generally are tested only in invitro studies whose evidences are pretty unreliable to comment on thesafety of product. Nutraceuticals are lagging far behind in the field of In vivoresearch, which are obligatory to pass any health claim. Scarcity of regulations in this field to hold back the false claims is still worsening the condition of regulatory landscape.
So, while marketing any Nutraceutical, to protect the sales and credibility of the company, care has to be taken that it should not be marketed as a ‘drug’ (because drugs undergo heavy research and in vivo studies to achieve the health claim).

Country Nomenclature for Nutraceuticals Definition
US Dietary supplements A product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamins, minerals, amino acids, herbs or other botanicals; a concentrate, metabolite, constituent, extract or combination of the ingredients listed above
European Union food supplements Food product whose purpose is to supplement the normal diet and which consists of a concentrated source of nutrients or other substances with nutritional effects or physiological, single or in combination, marketed in dosed formulations, such as capsules, tablets, tablets or pills, designed to be taken in small individual quantities measured
India Foods for special dietary use or functional foods or nutraceuticals or health supplements Each Nomenclature has different definition in FSSAI

(Website: www.fssai.gov.in)

Canada Natural Health Products Substances such as probiotics, herbal remedies, vitamins and minerals, Homeopathic medicines, traditional medicines such as traditional Chinese medicines and other products like amino acids and essential fatty acids
Japan Foods for Specified Health foods containing ingredient with functions for health and officially approved to claim its physiological effects on the human body
             CHART 1

4. Lack of Good manufacturing practices:
According to Nutraceuticals World, recent FDA GMP inspections indicated that a good number of dietary supplement manufacturers are not fully compliant with GMPs. Noncompliance with the specifications for ingredients as well as for finished product were investigated. Common violation in this field is failure in verifying purity, identity, composition and strength standards of product batch. This is the major concern seen in the Nutraceutical sector for years.

Owing to all such regulatory deformities, full export potential of Nutraceutical sector cannot be achieved which could be a serious issue with respect to country’s economic status. Sanjaya Mariwala, founder-president of the Association of Herbal and Nutraceuticals Manufacturers of India said, “The governing ecosystem for nutraceuticals needs a serious rethink along with clarity on defining the scope of the sector and its product portfolio. The need of the hour is the creation of a comprehensive HSN [Harmonized System of Nomenclature] repository, with prompt resolution of grievances and export promotion initiatives by a centralised regulatory body, to give teeth to the sector.” He also added, “with limited attention being accorded, the sector’s full export potential cannot be achieved.”

Various countries do have some well-designed regulations for Nutraceuticals but lack of efficient implementation of these guidelines leading to fluctuating outcomes when compared with pharmaceutical sector.
Following are some of the suggestions if implemented can show some positive moves in regulatory framework of Nutraceutical:

  • Globalization of guidelines: By executing a well-planned analysis ofexisting regulations employed in various countries and selecting the best approaches can achieve uniformity in regulatory framework worldwide. 
  • Like Pharmacopeia, why not Nutracopeia? :An official publication containing a list of natural drugs with their effects, directions for use, tests, etc. can be generated to implement consistency in the regulatory field like pharmaceuticals. 
  •  Implementation of transparency by governing bodies
  • Risk assessment and verification technologies tied up with more solid inspections and stringent audits
  • Like for pharmaceuticals, well-developed laboratories for effective testing and evaluation can be generated to maintain the standards of Nutraceuticals. 
  • Internationalization of business to sustain the credibility of employed regulations. 
  • Executing regular surveys to assess the degree of improvement 

A restructuring of the entire regulatory framework of Nutraceuticals is necessary to put forth their different purposes and universal definition.Also, to assess their specific role in the prevention and treatment of pathological conditions whichcan be proven by sound scientific and clinical data. A clear and shared regulation system that clearly indicates requirements for quality, efficacy, mechanism of action, safety and a better control can lead to higher quality productswhich could benefit potential consumers as well as the industry.
On the door of 2021, we can clearly see the bright future of life sciences industry ahead, but only when abide by updated regulations. Many more regulations are obliged to come with hidden procedural challenges for compliance. Manufacturers have to be awake with their eyes wide open while launching and marketing products in the presence of new and varying regulations. Keeping track of changing regulatory system is the only way to be updated and profited.
The article has been written by Dr. Smarta-CMD Interlink and published by Saffron Media.

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Volume to Value Shift

With the transforming behaviour and needs of consumers, reforming healthcare and new trends in industry, pharma business models are moving on from their traditional way of working towards a more promising and persistent approach of functioning. Adaption of a value-driven business model is what an industry is exploring nowadays which is of course much profitable and sustainable in many aspects for the business. 

Why ‘Volume to value’ shift is happening? – 

It is very essential in today’s market place that the company should explore new ways to tighten the bond between their brand and target audience. Ethics, feeling of surety and reliability is what today’s generation consumer is looking for along with quality, quantity and functionality of the brand. 

Evolving mindsets of consumers from ‘Spending on volume’ to ‘Spending on value’ is making pharma companies adaptive toward patient’s changing needs. This abruptly changing mindsets making pharma companies to rethink and develop in terms of building Value proposition which can sustain their business in the longer run. 

What are the ways to create value for your customers? 

Understanding customer’s changing needs- In today’s world, One-size-fits all approach will never lift you up at any cost. Customers are evolving, their needs are changing and they are the sole decision makers whose assessment is one of the primary tasks which no one can afford skipping. Identifying customer interest and strategizing the way of delivering value will never disappoint any business.

Educating the customer segment to make a right choice- Educating customers is one of the game changing strategies which a company can follow to improve the engagement of customers. Many consumers could not make a better purchase owing to the lack of exposure to all the attributes of products or services, or they might be also having some misconceptions about the product/service, we never know!!

Sharing valuable content like case studies, infographics, articles, guides, etc via emails, blogs will create a necessary brand awareness and will promote value of your brand. An intensive approach and strategic implementation in this regard can influence consumers to get engaged with your product/service. 

Prolonging the engagement of customers- It is always beneficial to engage the existing customers in more fruitful manner than searching for new ones. Presenting discounts, giving special offers, subscription services and many other ways which can be employed to make your customers believe in your values. Promoting loyalty programs to make them realise that how much you value them is an essential tactic which every business should follow in order to deliver the value.  

Company’s value proposition has got immense importance like never before. Customer’s upgrading mindset resulting in market transformations which are inclining more towards brand value. This shifts in market positively boosting the growth of deserving products/services and customers are delivered with best possible outcomes. Gathering market insights is crucial in this scenario if we want to stay dynamic in the Value-driven industry and make profit.

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Indian Advantage: Nutraceutical Industry

As the world was already combating different economic, religious and geographical issues, a virus swiftly crept in and helped us realize what matters. Health undoubtedly is the only wealth we have. With the second wave on the door, people are now fully aware what immunity exactly stands for. With World Health Organisation (WHO) recommending herbal ways to fuel our immunities, we are now adjusting the focus of our lenses toward Nutraceutical industry in a different and modern ways. Preventive care rather than curative care is now establishing all over world.

Understanding Nutraceutical in Global Terms:

Being relatively new entrant in the field of health, Nutraceuticals is always merged with different streams of knowledge such as Pharmaceuticals, Food or even Traditional Medicines (Ayurveda). The line between Nutraceuticals and these streams is so blurred that it is always difficult to differentiate. Let us take an example of Tryptophan; it is present in milk as a nutrient and when the dose exceeds its activity can be drug-like. It is used as pre-cursor of Serotonin to treat patients of insomnia.

Basically all over world, the definition of Nutraceutical is based on two aspects: first is its origin and second is its health benefit. Now let us see nomenclature of nutraceuticals in various countries. The United States describes them as “Dietary Supplements,” in Canada they’re notified as “Natural Health Products” and in Japan those are listed as “Foods for Special Health Use (FOSHU)”.

The Indian definition (as per the Food Safety and Security Act, 2006-FSSA) is as follows:

Foods which are specially processed or formulated to satisfy particular dietary requirements which exist because of a particular physical or physiological condition or specific diseases and disorders and which are presented as such, wherein the composition of these foodstuffs must differ significantly from the composition of ordinary foods of comparable nature, if such ordinary foods exist, and may contain one or more of the following ingredients, namely:

  1. plants or botanicals or their parts in the form of powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination;
  2. minerals or vitamins or proteins or metals or their compounds or amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits);
  3. substances from animal origin;
  4. a dietary substance for use by human beings to supplement the diet by increasing the total dietary intake

In 2016, FSSAI has also differentiated definition of Nutraceutical from Health Supplements, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food under section 22.

Indian Nutraceutical Industry: Roots from Ayurveda, Stems of Nutraceuticals:

India has a rich heritage of herbal, Ayurvedic medicines and spices that can stand the country’s nutraceutical industry in a good way for expansion and progress. The herbal segment is likely to contribute 30 % of the dietary supplements market in India, expected to grow CAGR of 20 % from 2015 to 2023.

Source: Interlink Knowledge Cell  
Fig. 1.1 Ayurveda- Pharma-Nutra Coexistence

Today India’s Government is devoted in providing a critical thrust to Ayurveda, Nutraceuticals, Pharmaceuticals, and Homeopathy. Primarily driven by key players like Dabur, Himalaya and the Baidyanath group, the industry has also seen relatively new, increasingly dominant entrants such as Patanjali. They play a crucial role in popularising Ayurveda and giving the sector a boost.

The Ancient Ayurvedic practices, Pharmaceuticals, and Nutraceuticals co-existence has been the cornerstone of India’s wellness (Fig 1.1). The industry has a distinct opportunity to propel the global acceptance of this co-existence.

Market Size:

Global Nutraceuticals market is poised to grow by USD 180.38 bn during 2020-2024, progressing at a CAGR of almost 9% during the forecast period, according to Technavio report.

Before Pandemic, India’s Nutraceutical market was worth USD 5 bn in 2019 and held only a 2% share of the global Nutraceuticals market. According to the research, the consumption level of nutraceuticals in India was 37% in the pre-COVID-19 days; this consumption rate will surely rise in the coming months or years as there is an increasing demand for preventive measures and also consumers are adopting a ‘pathy-agnostic’ attitude.

Out of this dietary supplements comprise almost 63 % of market share amounting to USD 3.16 bn and remaining 37% of the market share equivalents to USD 1.82 bn is captured by functional foods and beverages as shown in figure 1.2.

Source: Assocham Report 2019
Fig. 1.2 Indian Nutraceutical Market Size in Rupees K Cr (2019)

During the COVID-19 period, India has taught the world importance of Ayurveda and other medicinal plants like Ashwagandha. India has shown the world evidence-based Nutraceuticals, which are modernizing through current evidence gathering methodologies.

Top Indications in India:

  1. Immunity Building: This area definitely will make a huge amount of money in 2021, as being all-equipped for any uncertainty like Covid-19 is what we have learnt this year. Looking at current situation of ‘Prevention is better than cure’, supplements like Amul’s ‘Haldi Dudh’, Dabur’s products like Chawanprash, Giloy Ghanvati, Amla juice, Giloy-Tulsi-Neem juice, Ashwagandha, have reported a strong growth and will continue to grow in upcoming years. According to reportlinker.com, Indian immunity boosting packaged products market is projected to reach USD 347 mn by FY 2026 owing to increasing consciousness and focus towards preventive health.

The Ingredients like Vit D, Vit. C, Zinc. Curcumin, Selenium and Probiotics have seen surge in market demand. Along with these, other ingredients like Asthaxanthin, Polyphenols from pomegranate, Glutathione and extracts of Indian spices like Ginger and Garlic and are also considered to be important ingredients to build immunity.

  1. Cognition: The Global Brain Health Supplements Market is anticipated to reach USD 5,813 mn by 2023, growing at a CAGR of 8.8% from 2017 to 2023. Nowadays, this segment is gaining popularity among many people due to rise in willingness to enhance brain functions, surge in number of self-directed consumers, and increased awareness among the students about brain health supplements. We can expect a good business in these area from the supplements containing ingredients like ginseng, Ginkgo biloba, curcumin, lion’s mane, Bacopa monnieri, acetyl-L-carnitine, alpha GPC, citicoline, docosahexaenoic acid (DHA), huperzine A, etc. Looking at evolving mindsets and health consciousness in people, contribution of above discussed segments will have a substantial impact on growth of Indian Nutra industry.
  2. Stress Management: Stress a major culprit in everyone’s life, not only physical but also mental stress. Ashwagandha, widely known as Indian ginseng, which has been used in Ayurvedic medicines for centuries. Rhodiola, also known as Golden Root, is an adoptogenic herb and used for energy enhancement, to reduce stress and to deal with fatigue.
  3. Gut Health: Since our digestion is associated with overall health of human body, gut health is very important foundation in managing the various lifestyle diseases. Probiotics are the live beneficial bacteria which internally cover our digestive tract and aid digestion of food and absorption of nutrient. Probiotics build our immunity system and help synthesizing essential vitamins. Factors like excessive stress and overdose of some antibiotic can kill these good bacteria and compromises the gut health. To avoid all this, probiotics such as yogurt, kefir, idli, paneer and fermented soyabeans are rich sources of probiotics. Having this in our daily diet help fighting obesity symptoms, immunity problems and various cardiovascular diseases. Vit. Bs, Vit. C, and Vit. D are some essential vitamins in maintaining the gut health. As B vitamins are water soluble, they can’t be stored in body cells and need to supply externally. Vit. B1, B3, B6, biotin and Vit. B12 can be gained regularly with having a diet rich in fish, poultry, meat, and dairy products, as well as leafy greens and beans.
  4. Nutrients in Skin Health: Healthy skin reflects the status of our entire body, healthy skin-healthy body! If right nutrient is supplied, it will not only make your skin healthy but also it makes you look younger which further boosts our self-confidence. Discussed below are some dietary supplements essential in maintaining skin health.

Vitamins are highly essential for our body and unavoidable part of our daily diet. Variety of vitamins carry out variety of bodily functions. Our skin also requires sufficient quantity of vitamins to be healthier and younger. Vitamins C, E, A, K, and B complex are some skin benefiting vitamins should be there in our meal. L-ascorbic acid is a good source of Vit. C. It can penetrate our skin and serve the antioxidant properties and benefits of Vit. C. Vitamin A is required for the maintenance and repair of skin tissue so it should also be provided through diet.

What lies ahead?

With growing importance of naturally derived ingredients, scientific understanding of plant extracts and globally evolving regulations, a budding export market is opening up for Indian Nutraceuticals. Coupled with this, products innovated as per consumer preferences; creative packaging and innovative delivery systems have already started gaining market share.

India having heritage of Ayurveda, ethnopharmacological advantage, technological skills from pharmaceutical industry, rich availability of raw availability, increase in technology access like nanotechnology, reverse pharmacology knowledge have skills to bring quality and safe products to the world.

Looking at all these satisfactory reasons, it’s not wrong to state that the future of Indian Nutraceutical sector in upcoming years would be as Glorious as our Pharmaceutical sector. Let’s just simply rely on our royal heritage of herbal medicines to work efficiently in this field and see the magic happening.

The article is written by Dr. Smarta and is published by Pharma Times.

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Practice Changing Initiatives

Physical appointments and even the referrals have been declined due to pandemic as there was no active and physical consulting going on. This is leading to increased adaptiveness toward Telehealth platforms which are emerging at a rapid pace in various hospitals and private clinics, enabling the hospitals to expand their services in multiple and beneficial ways.

Tele-ICUs are one of the biggest examples arising in today’s scenario, where number of hospitals placed at distant from one another, are able to communicate with hospital critical care units and achieve real-time services via technological advancements.  

Surging incidences of infectious disease is the factor which shaping patients’ mindset in such a way that they obliged to choose such virtual platform which making hospitals to rethink about their old practice and service models. Although, quite a good number of healthcare systems have become well-equipped with this new platform, many are still struggling to maintain their identity in this new normal of healthcare practices. Reasons might be many- lack of right awareness about the platform, over reliance on old-practice and service model, weak promotional tactics, etc. 

So, following are the components of Telehealth through which hospitals are evolving and will continue to evolve in 2021 and beyond…

Tele-appointments-

They have turned out as an amazing option in pandemic. Tele-appointment is the facility which was earlier seen at the hospitals with huge infrastructure. But the situation is different and evolving nowadays. Many reasons associated with Covid fear are the fuelling factors for hospitals to adapt Tele-appointment technology even if the infrastructure is not huge. 

Afterall everyone wants to be in the race!  

Physicians who are carrying out telemedicine appointments, penetrating into their patient’s health without ever having to see them in the hospital. This is actively helping elders and patients with chronic conditions, making a big revolution in healthcare practices. 

This technology is making impressive moves in providing services and giving entry to the medically inaccessible areas such as rural areas where hospital services are difficult to reach, which is ultimately propelling the establishment of telemedicine hospital centres in various rural areas. 

Tele-diagnosis-

With increasing work load as hospitals turning into Covid centres, tele-diagnosis is reducing the burden on hospitals. Screening multiple patients is now possible while maintaining the treatment of others. Many technologies such as china’s virtual diagnosis of coronavirus using 5G network are rooting in hospitals giving relief to physicians, hospital staff and patients regarding possible spread of infection.  

Nowadays, ESA-supported robotics technology making good moves in radiology examination. This system is already in force in Europe and Canada and examining heart, abdominal, pelvic, and urinary tract diseases remotely. Being on the video conferencing, radiologists and cardiologists are remotely moving robotic arms and adjusting settings to capture best possible images. These technologies are incredibly helpful while dealing with Corona-patients with other allied health issues. 

Number of researches are going on to develop the best technology-based methods to provide virtual diagnosis, where necessary hardware installation in hospitals to make tele-diagnosis possible will always be the matter of concern for many under-developed hospitals. 

Tele-treatments & surgeries- 

Real time interaction with the specialists providing ease in getting proper and timely treatment and therapies making patients and hospitals more adaptive toward telehealth. 

Many hospitals have adopted the digital way of prescribing i.e., E-prescribing which is constantly increasing and the market is its expected grow at a CAGR of 23.3%, will reach USD 3.3 billion by 2025. So ultimately, Tele-treatments are making the doors wide open for already emerging E-pharmacy sector. 

Various E-therapies are becoming more and more promising in today’s scenario. Much impressive moves are seen in E-psychotherapy, where psychiatrists are directly engaging themselves in patients’ room virtually and taking deep insights about patients’ problems and recovery.

Although many delicate surgeries are performed aboard, Tele-health and technologies associated with it are helping patients and surgeons in the hospitals to be at their own county and operate the surgeries efficiently. 

Hospitals having 5G network and robot-assisted equipment and hardware will provide fast data transfers with little to no latency in the procedure giving excellent outputs while performing virtual surgeries. 

Tele-monitoring & E-rehabilitation-

Post-surgery monitoring is always important when patient is discharged, hospitals are now evolving in the field of post-surgery consultation. Tele-monitoring provides a better option to virtually meet the physician while lying on to the bed at home, without struggling with paining stiches on the way to hospital. Elderly patients or patients with decreased mobility are extensively monitored with these technologies, helping them to recover much faster.

E-rehabilitation is much useful for patients with musculoskeletal conditions, multiple sclerosis, osteoarthritis, and recovery of motor function. Doctors in hospitals can monitor the movements of patients in Yoga and provide therapy in much effective manner, allowing patients to recover much faster than expected. 

 

Although many hospitals are actively participating and adopting all these technologies, few are still not using it to its full potential. Many hospitals are well-equipped with all the technologies, hardware, infrastructure, etc but the factor which drags down the profit of some of the hospitals is- poor marketing of hospitals’ services. 

Telehealth and technology related to it are the practice changing initiatives taken by many hospitals in 2020. It is a reality and every hospital need to accept and adopt it. Old hospital practice models will no longer remain superior. Years coming ahead are already showing the clear picture of technology-based services in every part of industry, healthcare is not an exception, hospital managements have to be ready to absorb and emit all these changes efficiently and wisely.   

The article is written by Dr. Smarta and published by Asian hospital healthcare management in Jan’21 

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Reasons to Update Company’s Value Proposition

The Pharmaceutical industry is one of those industries for which developing a value proposition is not very simple and linear task. Targets are not just patients but a vast spectrum of health-care providers, payers and a number of other prospects which need to be targeted through our so-called value proposition.
Moreover, at the initial stages, when the company successfully launches its value proposition, it doesn’t mean that the purpose is fully achieved… As the product becomes mature in the market, companies have to rethink in terms of evolving their old value proposition which will no longer safeguard their product in the market.
Let’s see some reasons to update pharma value proposition when the business reaches significant heights—

1. Value proposition should not get stale – Looking back to the days when you started your business, gathered tremendous knowledge and built a value proposition which paid very well to your overall struggles. But as you grew older in the industry, became more knowledgeable than earlier, this is the point where revitalization of your overall business becomes mandatory. Revamping the old value proposition will not only reshape the current business but also re-engage you in that business in a more fruitful manner.

2. Maintaining competitiveness – It’s not even surprising that once your business grows older in the market, competitors pop-up. I think these competitors are enough to make you rework your earlier strategies towards your older value proposition in order to remain competitive in the market.

3. Necessity to tap newer segments – In the pharma industry, there are a number of segments in which a company needs to enter owing to one of the crucial factors called ‘sustainability’. In simple words, exploring different (but of course allied) segments is obligatory to march toward sustainable business in the near future.

4. Consumers may evolve – Consumer behaviour is one of the decision-making as well as erratic factors in any industry which every entrepreneur is aware of. Businesses are built upon consumers – I don’t think this needs any further explanation. It is necessary to go with the flow if you want to survive, and this flow is decided by the pool of consumers which are always ready to switch to newer, profitable and meaningful investments.

So, finally, I would say, to survive and to be unique, every company is supposed to play its card well at every single stage in their business. Value proposition is the only way to promote your business, and it has to be handled wisely.
Ask yourself why you update to newer applications in your mobile, and you will get enough reasons to update your company’s value proposition…

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Women’s nutrition in New Normal Era

“Communities and countries and ultimately the world are only as strong as the health of their women.” – Michelle Obama

I think, this single sentence is enough to portray woman’s stance as a family member and as a citizen of any country she is living in. There would not be deeper explanation of how important her health is. Women are keys in maintaining healthy families, access the health system more than men, both for themselves and on behalf of their children. Many become pregnant and give birth, then typically become their child’s primary caregiver, a role that greatly influences household health overall. No doubt, during all this, they undergo significant health events, they surely require Extra-pro-nutrients to fulfil their body demands. Every point in women’s lifespan asks for different nutrition and attitude toward it. No matter what her age is, it’s important to be aware of how one’s needs evolve.

With evolving world, woman is also evolving. While running behind kids and family, she is also fulfilling her financial and social responsibilities very efficiently. In the race of highlighting her identity, for ages, modern woman is facing many health issues which is the greatest concern for her as well as for the society.

Source: Interlink knowledge cell

Img. 1.1 Top 3 health issues which women should take care of

Stress a major culprit in everyone’s life, women are at the peak of it. Not only physical but also mental stress. With increasing demand of women in various industries, her stress is proportionally increasing. Women are more prone toward heart diseases and diabetes than men, which is the risk factor arising due sleep problems, anxiety, mood disturbances (due to hormonal changes), depression, etc. Being engaged in number of responsibilities, many women struggle with eating a healthy diet, getting plenty of sleep, exercising regularly, talking to friends or a mental health professional, and engaging in relaxation techniques and meditation. Due to this reason, it’s important to get accompanied with some nutrients while living in this competitive world.

Ashwagandha, widely known as Indian ginseng, which has been used in Ayurvedic medicines for centuries. If women take some powdered Ashwagandha accompanied with milk, it can help her with fighting both physical and mental stress. Same as Ashwagandha, Rhodiola is an adoptogenic herb, also known as Golden Root, is used for energy enhancement, to improve mood, and most critically, to reduce stress.

Along with all the above nutrients, women can focus on intaking a good amount of Vit. B complex rich food, magnesium supplements, and valerian root powder. All these are proven to help fighting with stressors and improve quality of life.

Heart disorder is one of the major concerns and women are most susceptible to it. Increased blood cholesterol, diabetes, and hypertension are the underlying disorders arise with it. Thyroid is also one of the major reasons stimulating heart disorders in women. To fight with this, women should have EPA, DHA and flavonoids rich foods, which are great antioxidants. A higher intake of folate, polyphenols rich diet, ascorbate, tocopherol, minerals (selenium, magnesium) which are capable of scavenging free radicals and reducing bad cholesterol, can improve overall cardiovascular health.

Anaemia and women make an unbreakable bond if proper nutrients are not supplied. Menstruating and loosing plenty amount of iron every month, women are majorly vulnerable to iron deficiency anaemia. Adolescent girls, women at childbearing age and pregnant women are always at the high risk. Having a diet containing a good amount of iron along with a source of Vit. C which increases absorption of iron can help preventing anaemia at all the stages of women’s life. Beans, lenticles, dark green leafy vegetables such as spinach, fortified breakfast cereals, baked potatoes, chicken, etc are some of the easily available natural sources of iron which can maintain levels of iron balanced in women’s body.

Nutrition for girls in childhood and early teenage

Calcium in early teenage: It’s true that calcium is the nutrient which is important for women in all ages, but it’s still more important for girls during adolescence and early adulthood as this is the age when their bones absorb maximum amount of calcium. RDA for girls in age of 9 to 18 is 1300 mg a day which can be fulfilled by having low-fat dairy products such as Milk, yogurt, cheese and vegetables like broccoli, kale, cabbage, etc. Consuming adequate amounts of calcium along with vitamin D can encourage healthy bone growth and reduce the risk of osteoporosis and fractures later in life.

Nutrition for women in 20-30s and pregnancy

20-30s is the whole roller-coaster in any woman’s life where major changes are happening including the most important i.e., Pregnancy. Having a life (or lives) in their bellies and making a whole human out of it is not an easy task to handle. Lots of hormonal changes, mood swings and variety of body changes happen during this phase, no doubt her body and mind will demand for more and advanced nutrition. Even if she is not pregnant, 20-30s is the phase which requires proper attention in terms of nutrition to avoid future health problems

Folate & other essential vitamins: A very important nutrient which is must in these years as it is responsible for DNA replication and it helps reduce the risk of neural tube defects in the foetus. Most doctors recommend women take a supplement containing folic acid or folate before trying to get pregnant to help reduce the risk of these complications. spina bifida and anencephaly in foetus are some neuronal defects associated with folate deficiency.  Many of our foods, particularly cereals, are fortified with folic & leafy vegetables are best source of folate. RDA of folate during pregnancy is 600 mcg.

Omega 3s and choline: Omega 3s, healthy oils, especially EPA and DHA,  have been shown to reduce the risk of heart disease, the number one killer of women. They help building healthy brain and nerve cells and also can help prevent preterm births. They are also highly anti-inflammatory and are found in foods like fish, walnuts, and flaxseeds.  Taking omega-3s regularly can improve symptoms of depression and anxiety and can even make skin look better by reducing acne and wrinkles. The recommended total amount of omega-3s per day for women is 1.1 grams per day which can be fulfilled by diet and recommended supplements. Increased risk of neural tube defects in foetus is one of the major consequences of low choline uptake by pregnant women. It’s easy to get enough choline from our diet as eggs, milk, peanuts are excellent source of Choline.

Nutrition for women in their 40s and beyond:

Managing decreasing hormone levels as well as maintaining bone health, heart diseases and autoimmune diseases are some of the biggest concerns for women at this phase.

After menopause, estrogen production declines and bone breakdown accelerates, increasing the risk of developing osteoporosis. Women between the ages of 40 and 70 need 1200 mg of calcium and 600 IU of Vitamin D a day. Because the skin becomes less efficient at converting sunlight to vitamin D as we age, low levels of vitamin D have been linked to multiple diseases from breast cancer to diabetes and high blood pressure. Vitamin D is also critically important for helping maintain bone health.

Curcumin, an active component of turmeric, known to have many anti-inflammatory benefits. Women at this stage require supplements to support brain and joint health, curcumin can help with it. Alzheimer’s disease, one of the biggest enemies at this age can be prevented with this magical phytochemical. Curcumin is especially powerful for menopause because it is a phytoestrogen, meaning it can act as an estrogen in the body. This can help alleviate common menopause symptoms, such as hot flashes, mood swings, and sleep disorders, by slowing the decrease in estrogen. RDA of curcumin in this age is 1.4mg per pound of body weight.

women’s control over resources and their ability to make decisions, is crucial. Combining nutrition-specific interventions with measures for empowerment of women is essential. Improvement in health services of women, prevention of early age marriage and conception, completion of secondary education, enhancement in purchasing power of women, reduction of work drudgery and elimination of domestic violence deserve special attention. A range of programme platforms dealing with health, education and empowerment of women could be strategically used for effectively reaching out women’s health and helping them to build a better and healthier society.

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4 Principles of Sustainability Execution

In Covid context for many companies, it will be first priority of sustaining last year business plus growth and working on vision of the company on costumer base and productivity to improve.
Creating long term value with building competitive landscape will always be a superior factor for every organization to sustain themselves in the race. Ensuring the viable future, business ethics and sustainability management are the key factors should be considered while developing business growth strategy.

“Implementation of all those important and future building
strategies need a well-organized execution plan with participation of every single element of an organization.”

Following are the 4 principles to keep in mind while executing the sustainability initiatives-
1. Strategy alignment with clear goals- An organizational management should always focus on the alignment of proposed strategy with sustainability initiatives. Prioritization and real business commitments will hold good only when there is no divergence between business strategy and sustainability efforts. And on the top of all this, organization should have a proper and realistic goal before designing any strategy which will keep everyone in an organization moving in a right direction.
2. Sustained journey of improvement- No organization is going to strike gold in very first effort of execution (except some organizations), but all that matters is- sustained journey of improvement throughout the program. Small improvements will always help in growing faster and keep motivated while working for the livable future of an organization.
3. Polishing the supply chains- To support an efficient performance base of any organization and to fuel sustainability operations, supply chain of an organization should be well-equipped and promising. Discovering new options for necessary supplies and ensuring the authentication of available supplies will make sure the sustainable development of an organization in many aspects.
4. Employee engagement- Staff is not always about ‘ships working on the field’. Engagement of the staff is always worthwhile as they sometimes come-up with some innovative and productive ideas which could boost the business to the next level.
Transparency would be a crucial factor in here and it should be maintained to derive positive and business propelling outcomes from the staff.
Efficient execution of forward-thinking sustainable policies will surely result in impressive and profitable performance of any business. Sustainability is a trend which cannot become substandard for the life of an organization and it should be handled likewise.

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Indian Nutraceutical Needs in 2021

With the second wave on the door, people are now fully aware what immunity exactly stands for. With WHO recommending herbal ways to fuel our immunities, we are now adjusting the focus of our lenses toward Nutraceutical industry in a different and modern way. Preventive care rather than curative care is now establishing in the Indians’ mindsets. Amidst pandemic, immunity has become a topmost concern and consumers’ reliance on Nutraceuticals has increased. This shifting consumer behaviour toward Nutrition which will definitely be the story changing script for Indian Nutra industry in 2021.

Nutraceuticals market is poised to grow by USD 180.38 billion during 2020-2024, progressing at a CAGR of almost 9% during the forecast period, according to Technavio report. Prebiotics and probiotics sector is expected to contribute maximum over the forecast period owing to the increasing usage of probiotics as a primary ingredient among majority of food manufacturing companies.4 areas of growth for 2021 nutraceuticals:
1. Probiotics: According to the report by Knowledge sourcing.com, Indian Probiotics Market is expected to grow at a CAGR of 13.56% to reach a market size of US$ 961.856 million in 2025 from US$ 448.456 million in 2019. This growth is fuelled by factors such as increasing health consciousness for healthy living, rising awareness of preventive and natural healthcare treatments, growth in functional food industry, growing obese population and adoption of probiotics in paediatric healthcare. Mother dairy as a major player in probiotics followed by Amul, Danone Yakult, Nestle, Tablets India, Dr Reddy Laboratories, Unique Biotech, Zeus Biotech, etc. are expected to make a big business in 2021.
2. Immunity building ingredients: This area definitely will make a huge amount of money in 2021, as being all-equipped for any uncertainty like Covid-19 is what we have learnt this year. Looking at current situation of ‘Prevention is better than cure’, supplements like Amul’s ‘Haldi Dudh’, Dabur’s products like Chawanprash, Giloy Ghanvati, Amla juice, Giloy-Tulsi-Neem juice, Ashwagandha, etc have reported a strong growth and will continue to grow in upcoming years. According to reportlinker.com, Indian immunity boosting packaged products market is projected to reach $ 347 million by FY 2026 owing to increasing consciousness and focus towards preventive health.
3. Vitamins & Minerals Supplements (VMS): Number of new launches are taking place in this segment of Nutraceutical market in recent years. Exposure to direct sunlight is rare because of lockdown, which might result in increased demand of Vit. D supplements in 2021. Vit. C, B & B12 are proven to have Immunity-boosting properties will occupy the Nutra market along with Vit. A, Multivitamin supplements and essential minerals like manganese, calcium, iron, zinc, etc. Nutraceutical gummies, which were once considered a health supplement for kids, is now making significant moves into the adult VMS category.

Source: Interlink knowledge cell
Img. 1.1 Four areas of growth for 2021 Nutraceuticals

4. Cognition related products: The Global Brain Health Supplements Market is anticipated to reach $5,813 million by 2023, growing at a CAGR of 8.8% from 2017 to 2023. Nowadays, this segment is gaining popularity among many people due to rise in willingness to enhance brain functions, surge in number of self-directed consumers, and increased awareness among the students about brain health supplements. We can expect a good business in these area from the supplements containing ingredients like ginseng, ginkgo biloba, curcumin, lion’s mane, bacopa monnieri, acetyl-L-carnitine, alpha GPC, citicoline, docosahexaenoic acid (DHA), huperzine A, etc.
Looking at evolving mindsets and health consciousness in people, contribution of above discussed segments will have a substantial impact on growth of Indian Nutra industry.
Now, let’s have a look at the reasons behind people’s evolving mindset toward Nutra industry:
In countries like U.S., China, and India, awareness regarding calorie reduction and weight loss is on the peak. These countries are expected to promote the application of nutraceuticals and in-turn will be witnessing the growth in this area.
Growing trend among consumers to alter dietary habits as improper diet results in increased expenditure on pharmaceuticals.
Malnutrition and undernutrition are some of the major causes which are weakening Indian’s health status. The Indian government and private stakeholders have been undertaking several measures in the recent years to improve the nutritional status in the country, as a result helping Nutra sector to grow.
Key Nutraceutical players like Dabur, Himalaya and the Baidyanath group are showing-off a rich heritage in herbal and Ayurvedic medicines of India for ages. New and increasingly dominant entrants such as Patanjali are also playing a crucial role in popularising Ayurveda and giving the sector a boost.
Our land has an ability to grow botanicals under very controlled conditions to meet organic and other claims, we also know how to produce superior ingredients from these botanicals and robust clinical research industry. With abundant availability of ingredients, expert agricultural research infrastructure and a growing number of qualified individuals in the field, India is well poised to be a leader in the nutraceutical ingredient space.
We are ‘Pharmacy of the world’ and are well equipped to produce high-quality and low-cost generic drugs. Our manufacturing expertise and excellence hold good for Nutra sector as well. Many of the Nutra-technologies are same as of pharma technologies, no doubt we are going to lead Nutra-manufacturing too. Low cost-high quality manufacturing will help us to highlight our identity in the finished product space.
The rise and evolution of wellness focused diets, such as keto and paleo, are driving food producers to cater their products in this direction.
To reduce the risk of cardiovascular diseases and develop the quality of intestinal microflora, probiotics and omega-3 are highly used in yogurt and fish oils. This is further projected to fuel the market growth of the nutraceutical products over the coming years.
Another major factor in propelling the growth of this sector is ‘Evolving treatment protocol’. Healthcare practitioners are making nutraceuticals part of their treatment regime to improve outcomes. Pharma-Nutrition is emerging as a vital field in our health sector.
Busy lifestyles sometimes never let us sit and have our balanced meal, making a window for nutraceuticals to meet our daily nutritional needs.
Considering the side-effects of prescription drugs, and the failure of modern treatments in delivering safe results, consumers nowadays are shifting to nutraceuticals.
Nutraceuticals are no longer just the part of preventive and curative regimen but also are employed for losing weight, make the hair grow better, or to get glowing skin. Also combating diseases like thyroid, nail disorders, diabetes, arthritis, etc.
Rise in disposable income, increasing consumer awareness about health issues, rapid urbanization, positive outlook towards medical nutrition owing to the increasing weight management programs, along with cardiovascular diseases, is anticipated to propel the demand for nutraceuticals.
Increasing costs of hospitalisation and access to information have helped consumers to look at health supplements and nutraceuticals in a broader way.
Looking at all these satisfactory reasons, it’s not wrong to state that the future of Indian Nutraceutical sector in upcoming years would be as Glorious as our Pharmaceutical sector. Let’s just simply rely on our royal heritage of herbal medicines to work efficiently in this field and see the magic happening.
The article is written by Dr. Smarta and published by Saffron media.

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