Industry is at crossroads as the Union Health Ministry is being misguided with reference to putting in place the right regulatory regime to control nutraceuticals and drugs. A silent and yet intense anger is also raging in the industry in the absence of a clear regulatory regime today.  Industry insiders and experts have upped their ante against the intense lobbying related to delegating power to regulate nutraceuticals to a toothless body like Food Safety and Standards Authority of India (FSSAI).

Besides this, the Union Health Ministry is also being misguided to approve an irrational move to bring about certain amendments in the provisions of the Drugs and Cosmetics (D&C) Act towards regulating nutraceuticals on the premise of recommended dietary allowance (RDA) value without even informing and consulting industry. This probably according to industry insiders is happening as a part of lobbying at the Centre towards appeasing a section of people in the industry and Ministry.

This is also very much evident as the state licensing authorities (SLAs) are trying to enforce the ban invoked by the Centre in June 2019. Drugs and nutraceutical manufacturers have since then been defying the one-year old arbitrary and draconian ban on methylcobalamin due to dubious nature of Indian Council of Medical Research (ICMR) and FSSAI recommended dietary allowance (RDA) values and tolerable upper limit (TUL) even in major micronutrients like vitamin C.

The Central Drugs Standard Control Organisation (CDSCO) has also been following with FSSAI to take action against Gujarat based manufacturers for production and sale of methylcobalamin meant for therapeutic intervention in contravention to norms. In a recent representation made to Union Ministry of Chemicals And Fertilizers, industry has also once again recommended Drugs Controller General of India (DCGI) to be given the sole authority for implementation of nutraceutical policies and regulations, citing FSSAI and ICMR as toothless bodies, giving reference that ten years back nutraceuticals were under DCGI only and was properly regulated.

Gujarat based manufacturers have alleged that the dual standards of FSSAI is very much evident with the presence of already FSSAI approved brands available with 1500 microgram (mcg) quantity/per serving. Some of the widely sold brands are Locopen capsule, Neugaba M 75 capsule, Nervup 500 mcg injection, Nuroz Forte, Nurofine-2500 injection, Actavis 2500 injection, etc.

There are more than half a dozen other brands with the same formula. Rejunex CD3 of Intas is a FSSAI approved product containing 1500 mcg methylcobalamin. In a letter to the FSSAI, CDSCO had brought to the notice that various brands of products containing methylcobalamin are manufactured and sold having therapeutic intervention under the FSSAI license.

Nutraceutical and drug industry have alleged that FSSAI and CDSCO have been turning a blind eye to the contentious issues raised with reference to RDA values of vitamin C and other micro-nutrients like methylcobalamin which are vital for boosting immunity, mental health and other co-morbid chronic ailments in the crucial juncture of COVID-19 pandemic. The central government has also recommended 1000 mcg of vitamin C as prophylactic use against COVID-19 whereas its RDA is 40 mcg due to poor regulatory and policy interventions from apex and responsible authorities like ICMR, FSSAI and DCGI.

Unmindful of the concerns regarding RDA for mental health conditions and neurological disorders, industry has dubbed FSSAI as white elephant and urged the centre that there is no need of FSSAI as the authority is not competent enough to talk on technical and scientific aspects and only relies on the dictates of ICMR. It is a sheer wastage of public money which has been pooled in to maintain an authority which is doing more harm than good.

Industry players have also voiced concern that methylcobalamin’s RDA value has been approved by CDSCO up till 2000 mcg but FSSAI is approving only 1 mcg which is of no use. DCGI has approved 2,000 mcg of methylcobalamin even in injectable form and brands are available as patients take methylcobalamin based on the medical condition. Until and unless, FSSAI does not inform the industry that methylcobalamin is approved, there is no value of prescribing RDA value for the same.

Surprisingly the mails which we have received from FSSAI on methylcobalamin and cyanocobalamin, both have the same RDA value for manufacturing. Please be advised we are talking about per serving usage value which the manufacturer can refer to and not the RDA value for a healthy person.

FSSAI and CDSCO have been drawing flak from the industry as there is no clarity on TUL and RDA values of many micronutrients including vitamin C and methylcobalamin. The issue has been festering due to missing exact information on TUL of vitamin B12 [methylcobalamin to be specific] from the public domain. No adverse effect has been associated with excess methylcobalamin intake from food or supplements in healthy individuals.

Methylcobalamin has a history of safe long term use as a therapeutic agent given in high dosage or via intramuscular injection for the treatment of disorders associated with impaired vitamin B12 absorption. Additionally, we had received a letter in December 2019 from FSSAI about methylcobalamin’s approved RDA value for neurological disorders by the technical committee but industry is yet to see the notification on the same.

Methylcobalamin is an essential nutrient and is required to treat vitamin B12 deficiency, in people with pernicious anaemia, diabetes and other conditions as well. It is important for the brain, nerves and for the production of red blood cells (RBCs). On January 7, 2020, FSSAI issued a notification regarding RDA of vitamin B12 which is specified as 1 mcg without mentioning type of vitamin B12 like methylcobalamin, adenosylcobalamin, hydroxycobalamin and cyanocobalamin.

Former CEO of FSSAI Pawan Agrawal had promised in December 2019 that methycobalamin has been approved by the scientific committee and will take due course of its time to be included in the gazette. Nevertheless, the industry has waited for almost 1 year without any progress for inclusion of methylcobalamin in the gazette.

Dr Sanjay Agrawal
Leading Pharmaceutical Consultant and Inventor
Editor-in Chief of IJM Today
6/146, Malviya Nagar ,
Jaipur, Rajasthan-302017
Phone : 0141 2550814

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Consumers here in India are now more aware of the importance of a healthy diet and a healthy lifestyle, they now know and understand how appropriate nutrition can help them prevent diseases, and deal with a lot of other health-related problems. This understanding has increased the demand for nutraceutical supplements, especially amongst the millennials (individuals between the age range of 24-40 years).

What are Nutraceuticals?

 Nutraceuticals are medically or nutritionally functional foods. These supplements sate your hunger, provide basic nutrition and also have medical benefits. For example, some nutraceuticals help prevent hypertension, high cholesterol, helps control weight, etc. They include functional foods such as nutritional supplements, vitamins and minerals enriched products, beverages as well as dietary supplements.

India holds up to 2% of the global nutraceutical market as of now, but the demand is rapidly increasing. The penetration rate is 6.32% in rural areas, but it is around 22.52% in the urban areas. This shows a high scope of growth in the near future.

 Popularity of supplements:

1. Open to experimenting for better health: For the social-media-savvy adults, healthcare is no longer restricted to hospitals, clinics, and pharmacies. Nutraceuticals in the form of health supplements added nutrition, and prevention of lifestyle diseases, are gaining prominence. Millennials are open to experimenting with these newly found ways to optimum healthcare and lifestyle.

2. Rise in disposable income: While the rising awareness and the access to the right nutritional products are a few reasons for the rise in this sector, a key reason also is the added disposable income. Now, this disposable income is the amount that you are left with after paying all your taxes, bills and other social security charges. Expansion of the salary bracket in almost every sector and industry in India has enabled millennials to have a decent amount of disposable income. With this increase, they can, without any worries, spend a little amount in experimenting with products that are beneficial for their health, and that is exactly what they’ve been doing, adding supplements to their daily routine.

3. Ease of access of supplements: These products are now very easily available. They are found in the local supermarkets, supplement stores, and even pharmacies. Some are available online as well. Increased digital presence is also creating awareness as well as increasing the demands of these supplements. Consumers can either go to their near-by supermarkets or buy the supplements on any e-commerce platform. This ease of access has also contributed to the growth in the popularity of these products.

4. Healthy inside and outside: Apart from all these factors, the fact that millennials now understand the correlation between the aesthetics outside and health – like for example, a healthy gut keeps the skin clean, improved collagen in the body helps with elasticity and anti-aging, etc is also a reason for the growth in the demand of nutraceutical supplements. They know that they need to have a healthy body and a healthy lifestyle to have attractive features. Looking good and having the perfectly toned body is one of the most important things for this current generation, but they lack the time to work for these desired features. Therefore, they are open to every option available and are open to experimenting as well. The nutraceutical supplements provide these millennials with all the appropriate nutrients that they need, and hence it is so popular amongst them.

Considering the growth in technology and the increased usage of social media, we can say that India’s nutraceuticals industry will be huge in the coming years. It is expected to grow up to $18 billion by 2025. The nutraceutical market is becoming an integral part of the preventive healthcare industry. More and more players are getting in the race and exploring new opportunities in this exciting market. With the growing awareness, there’s no doubt that this sector will expand at the speed of light.

Mr. Sushil Khaitan

CEO & Director – Purenutrition.me

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It is common knowledge that the best source of nutrition for the body comes from the traditional foods such as fruits and vegetables made at home with great care and love. But over the past few decades, changes in the method of growing crops by using harmful chemicals and pesticides, artificial ripening of fruits and vegetables have depleted the nutritional values in our regular foods. Our body needs the daily dose of nutrition in the form of vitamins, minerals, proteins, carbohydrates, fats and other nutrients for it to sustain. While the result of a scarce supply of the required daily dose of nutrients to the body may not be seen immediately, it ultimately will manifest itself in the form of various ailments in the long run. The lack of nutrition coupled with lifestyle changes, improper eating habits, stress, pollution, shorter sleep cycles and the unhealthy foods that we consume today has led to the advent of many lifestyle disorders, the most common ones being obesity, diabetes and cardiovascular ailments to name a few.

Nutraceuticals play a prominent role in preventive healthcare:

These unwelcome changes have also had a significant bearing on medical expenses going through the roof. Keeping in line with the adage “Prevention is better than cure” nutraceuticals play a prominent role in preventive healthcare. Nutraceuticals are dietary supplements that have a good safety record and may compensate for a poor diet and / or promote health. They can be divided into various categories namely vitamins, minerals, protein supplements, energy drinks, probiotics and growth supplements. Nutritional care which forms an integral part of preventive healthcare is undergoing a transformation in India. The current generation is looking for preventive healthcare measures rather than remedial reactions. Due to higher disposable incomes and growing awareness about preventive healthcare, the Indian consumer is actively considering various options to improve his / her health and lifestyle.

Globally and in India the nutraceuticals segment has undergone its fair share of churn.  From a one-solution-fits-all scenario, the space has witnessed mushrooming of various products to address specific needs – bone health, calcium supplements, weight management, proteins and immunity boosters according to age, to name a few. Nutraceuticals can be broadly divided into:

1. Dietary supplements (including vitamins and minerals)

2. Functional foods and beverages (such as energy and sports drinks, probiotics, products fortified with omega-3 fatty acids and herbal formulations)

According to a joint study by The Associated Chambers of Commerce and Industry of India  (ASSOCHAM) in association with its knowledge partner RNCOS, the Indian nutraceutical market is poised to grow from $2.8 billion in 2015 to $8.5 billion by 2022. India which accounted for a share of around 2% of the global market in 2015 is estimated to increase its share of market to 3% by 2022 owing to the country’s large population base, increasing urban belt and increasing awareness, according to the study. Functional food & beverages are expected to grow with a higher growth rate due to the increasing visibility of such products in modern retail formats and promotional activities.

Few key drivers for growth of nutraceuticals in India :

1. Increased awareness – Growing concerns about nutrition and health thanks to digitization and social media has led consumers to look for preventive healthcare measures

2. Affordability – High hospitalization costs and complex medical procedures which can be avoided are driving consumers towards health supplements and nutraceuticals

3. Increase in lifestyle diseases – Stress factors due to a busy lifestyle which leads to changing dietary patterns has led people to look for alternative food supplements to enhance their health

4. Inferior food quality – The lack of nutritious food has made people to turn to nutritional supplements to meet their dietary requirements and protect against nutritional deficiencies.

5. Healthy appearance- Looking and feeling good is another significant driver for the nutraceuticals space to witness a robust growth. Body weight, hair growth and a glowing skin are top priorities for today’s consumer. Remedial cost far outstrips preventive measures and this is where nutraceuticals comes in.

Key challenges faced by nutraceuticals segment in India :

Lack of a clear regulatory framework which has been a major challenge to the growth and wide spread acceptance of nutraceuticals as a segment in India. Counterfeit products which are unregistered and unapproved has led to scepticism and lack of trust from consumers as well as within the industry trade community In the past urban India, or more precisely the metros, were the target markets for nutraceutical sales, but consumption patterns have witnessed a shift with a steady increase in demand from Tier II and Tier III cities. This trend will only gather momentum especially because of the large-scale digitization happening in India. To sum up, this is one of the most exciting times to be part of the nutraceutical industry with new players entering the market and rapid innovation happening within the industry.

Dr. Muhammed Majeed

Sami-Sabinsa Group’s Founder & Chairman

The post Nutraceuticals for good health appeared first on Health Vision.

• Glutathione: Known as the body’s Master Antioxidant, Glutathione mimics body’s own indigenous antioxidant properties. It is present in every cell of our body and, and is responsible for various functions, including boosting stamina, reducing stress and maintaining an optimum level of antioxidant in the body reserves. Glutathione levels are often impacted due to stress, aging process, alcohol consumption, and smoking, sleep deprivation, and other lifestyle associated factors. This can reflect in a dull and tired skin, puffiness, and lack of glow. New innovations that have leveraged bio-engineering to harness Glutathione are helping to create a sustainable, healthy, and holistic approach to overall wellbeing, resulting in a beautiful and healthy appearance. Ingesting Glutathione as a nutraceutical also directly helps in flushing out toxins and promoting a lighter, glowing skin that is radiant and healthy from within.
• Ceramosides: Dryness is a very common skin condition. A well hydrated skin, which is actually supposed to be a result of nutritious diet, adequate water intake and a balanced lifestyle, is today mostly achieved only through the superficial application of moisturising creams and lotions. Skin dryness can lead to not only loss of elasticity and radiance but also contributes to aging and may lead to conditions like psoriasis and dermatitis. Ceramosides, a globally acclaimed wheat derived neutraceutical ingredient can help boost skin’s hydration level and it also improves radiance and glow. Innovations such as these are leading to creation of nutraceuticals, in the form of oral moisturisers, would help fix these problems intrinsically, allowing for a holistic wellbeing.
• Vitamin C infused nutraceuticals: The revered lifestyle antioxidant and skin rejuvenating properties of Vitamin C are well known. Your skin is always busy fighting with the enormous quantities of free radicals produced by virtue of biological reactions and critically because of external insults such as UV radiations, pollution, and chemicals. This free radical overload (FRO) interferes in the cellular metabolism as well as leads to collagen degradation and melanin over production. Balancing this FRO is important to ensure health of the skin and also to prevent the loss of collagen. A nutraceutical rich in Vitamin C helps protect  natural beauty by reducing melanin pigment, increasing production and transfer of anti-ageing protein, exerts photo-protective effects by neutralising free radicals and helps boost collagen.

Apart from wellness and beauty, nutraceuticals have also been found to address issues related to certain skin conditions, like acne and fungal infections, which are currently treated using strong anti-acne or anti-fungal treatments with antibiotics. With the increasing challenges of antibiotic resistance and the strong side-effects, has led to the search for alternatives which can actually address the internal problems, instead of just fixing them with antibiotics. Leveraging natural compounds or solutions which tap into the intrinsic intelligence of the body, are slowly emerging as a trusted alternative.

With the advances in bio-wellness and the emphasis on holistic solutions which offer beauty from within, the future trends point towards a more evolved and authentic approach to beauty and health. From the cosmetic approach to skin care and hair, we are steadily moving towards innovative approach which can harness the body’s intrinsic compounds, helping us achieve a state of overall wellbeing. So while you brighten up the party venues with your beautiful positive presence, ensure your body too is rejuvenated and glows with beauty from within, adding to the warmth and joy of your near and dear ones!

Mr Sushant Raorane

 Director of Adroit Biomed

The post Must have Nutraceuticals for beautiful skin appeared first on Health Vision.

If you are planning to get hitched soon and life is a frenzy with all its preparations which seem most tedious and confusing, we are here to ease a bit of your stress with this pre-wedding beauty regime that is effortless. With just a bit of discipline, you could be ensured of a healthy and glowing skin not just for the D-day but for months later too. While adequate sleep, drinking sufficient water, adding antioxidants to the diet, regular spa and using nourishing skincare products should be a part of your regime, however, sometimes it becomes difficult to manage time out of a busy schedule to pursue the demanding skincare routine. Luckily one can get beautiful from inside out, with the best nutraceuticals, which will not only give a glowing complexion but also long-lasting healthy skin. The ideal time for a bride or groom-to-be can be anywhere from 6 months to a year before the wedding. And if you follow these basic tips then there would be absolutely no difficulty to manage this significant part of your to-do list prior to your wedding!

Bridal Care before 1 year of marriage: The right time to start the skin-care regime is a year prior to the wedding day. Skin-concerns such as acne, fungal rashes, wrinkles, blemishes, redness and sagging skin should be identified and consulted with the doctor as certain skin problems can take a long time to be completely treated. This is the time when one should chalk down the skincare schedule, accumulate items like sunscreens, eye creams etc. and start following a healthy discipline. Also, regular body-massages should be a part of this skin-care regime.

Bridal care before 9 months of marriage: Nine months before the wedding, is relatively the best time to start on some healthy habits and lifestyle. Whatever one eats reflects on the skin and hence it is crucial to identify the right diet which will have a good impact on the skin health. One can consult a dietician to adumbrate a proper diet-chart. The diet chart must contain anti-oxidants and vitamins to help in case of any deficiencies. Proper nutrition is the requisite for flawless glowing skin and one can use supplements like glutathione, ceramides and Vitamin C infused nutraceuticals to help in achieving that.

Bridal care before 6 months of marriage: Six month before the wedding is the time when one should start focusing on de-stressing the skin. De-stressing would help in controlling break-outs. Stress causes acne breakouts and other skin and hair problems Meditation is a proper way along with regular spa visits and massage.

Bridal care before 3 months of marriage: Three months before the wedding is the best time to start getting monthly facials. There are several in clinic customs that will enhance the wedding day glow. Operations like laser hair removal, derma rolling, peels, mask and exfoliation should be done as directed by experts. While your dermatologist would recommend various in-clinic procedures that will enhance your wedding-day glow, Glutathione skin lightening treatment helps achieve lighter and even tone throughout the body.Glutone tablets are available in the market and the same can be made a part of your regular intake or as per instructions by your dermatologist.

Bridal care before 1 months of marriage: Now, it’s time for make-up and hair-style trials. Regular hair spa is a must. Between the hustle and bustle of the wedding preparation it’s easy to forget something as simple as drinking water. It is very important to keep the body hydrated and getting enough sleep to look fresh.

The D-Day: One should be prepared for the wedding day stress and make-up which can cause unsought allergic reactions. A skin-care kit should be kept handy for avoiding such circumstances as are all ready for your big day.

Very clearly, focusing on a beauty regime that takes care of your skin health from inside out will be your key to a beautiful glowing skin. And to help you in doing so would be the regular intake of certain key neutraceuticals. In fact, Glutathione is a wonder molecule, popularly known as “Bridal PILL”, these are available as Glutone 1000 tablets and helps rejuvenate the skin and makes it look younger and lighter

How does Glutathione work?

Glutathione works by terminating melanin synthesis. Melanin gives skin its colour and Glutathione helps in inhibiting melanin formation. Thereby bringing the skin to its fairest tone. One of the most important neutraceutical, it is also called the body’s master antioxidant.  Glutathione essentially helps flush the body toxins and eliminates free radicals. Apart from its action on toxins and free radicals, it also boosts immunity while working towards creating an even skin tone and radiance. Including synthetic Glutathione, available as tablets or in the form of serum, to the pre-wedding skin care regime, can help transform your skin into a glowing, youthful radiance from within.

Skin benefits of Glutathione:

• The only method of safe skin radiance enhancement
• Helps remove acne marks and diminish scars
• Helps improve overall confirmation of skin tone by removal of melasma& dark spots
• Encourages lighter skin pigmentation production
• Reduces wrinkles and improves skin elasticity
• Overall complexion improvement – get skin radiance

Nutraceuticals, in the form of Glutathione, not only act as supplements and make up for low mineral content in the body, ensuring a healthy skin, but they also enhance the beauty, radiance and glow of the skin. When wedding preparations are in full swing, it is imperative to keep a check on the overall health of the skin, not compromising it by exposing it to harmful products. So, as much as it is desired to look beautiful on the day, it is just an added advantage that you’ll be just as healthy and radiant from within, while enjoying long lasting beauty.

Sushant Raorane – Co-founder Director

Adroit Biomed-Mumbai

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