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The impact of Covid-19 on API manufacturing & supply

As an industry, we continue to adapt to the global challenges faced during the COVID-19 pandemic and it is generally known that this will be felt for some time to come in the pharmaceutical industry.

Supply concerns are leading India to invest in local production:

The closure of several factories in China following the COVID-19 outbreak has been stated to have created the need for huge changes in the pharmaceutical industry. These factories make the basic raw materials and active pharmaceutical ingredients (APIs) important to providing patients with crucial medicines on a continuous basis. These closures have had a knock-on impact on global supply during such unpredictable and challenging times.

For around 70 percent of the APIs it uses in pharmaceutical manufacturing, India depends on China. China’s coronavirus pandemic could have theoretically turned the tables on India’s $39 billion drug development sector, and numerous meetings with stakeholders were held by India’s Department of Commerce and Pharmaceuticals to promote domestic API manufacturing. In response, the Indian government has set aside $1.2 billion for the pharmaceutical industry and announced the development of a production-related incentive scheme for essential drug and API manufacturing to change the country’s dependency on China’s supply of APIs.

There is tremendous growth in the Indian pharmaceutical industry and it is projected to rise from almost $34.3 billion in 2020 to more than $45 billion by 2025. As part of its’ China-plus-one’ strategy to fill supply gaps, the country is currently undergoing the development of 53 APIs. As India is a major supplier of generic medicines worldwide, these steps are primarily aimed at ensuring and sustaining the supply of medicinal drugs. India is currently projected to remain one of the world’s fastest growing economies.

Increased containment demand and sterile product transition in development

In addition, as pharmaceutical firms continue to hurry to create new medications, including the COVID-19 vaccine, manufacturers are looking at an increased need for sterile production capabilities. They also handle more highly potent active pharmaceutical ingredients (HPAPIs), a development in the industry that has been strengthened by current conditions. In line with this the global market for HPAPIs is projected to hit USD 34.8 billion by 2025, with a rise in rapid relief therapeutics expected to fuel this demand for HPAPIs in emerging countries such as India and China over the forecast period.

In the current pharmaceutical manufacturing climate, with such a rise in the use of HPAPIs and the need for sterile manufacturing expected to continue, pharmaceutical manufacturers need to achieve efficient, validated containment and sterile transfer, a challenge. It is a highly complex job to incorporate diverse technologies supplied by multiple manufacturers into contained and sterile production lines. Known validated split valve-based solutions for the development of common interfaces between different technologies can however, provide a cost-effective and scalable validated way to create a contained environment. In the months and years to come, such technologies will be crucial in preparing the industry for higher power and sterile production.

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Nutraceuticals & Nutrivigilance


The Nutraceutical industry is a booming field in India as the consumers are increasingly gaining exposure to various Dietary supplements and fortified products. Despite increasing awareness, nutrition remains an incompletely understood concept in India and a large portion of the population suffers from Malnutrition in one or the other form. As Nutraceuticals are presumed to be safe and are marketed without prescription in India, it is crucial to impose stringent guidelines and regulations over the active ingredients of nutraceuticals, identity, purity and bioavailability for the rationale use of nutraceuticals. Nutrivigilance is necessary to incorporate monitoring schemes to identify the adverse effects caused by nutraceuticals for the consumer safety.

Reporting by Healthcare providers:
Healthcare providers play a vital role as they are actively connected with patients and consumers. They are also aware of the health profile, history and current medication regimen of their patients. They can thus be tapped as influencers to educate the consumers about ensuring the right Nutrition.

Educating the consumer:
Providing Nutrivigilance guidance, awareness and updates as leaflets to consumers can improve awareness among them. Once again, healthcare providers can be instrumental in explaining potential side effects or inappropriate use and potentially risky combination of Nutraceuticals with other medicines.

Combating adverse effects of Nutraceuticals:

  • Avoiding prolonged use of Nutraceuticals without guidance of healthcare professionals
  • Not taking Nutraceuticals to treat self-diagnosed conditions
  • Not consuming Nutraceuticals with, or instead of Prescription medications without
  • consulting a Healthcare professional
  • Consulting healthcare professionals about the supplements taken before a surgical procedure
  • Abstaining use of Nutraceuticals sold through improper and untrustworthy channels
  • Being cognizant of labels and information provided on Nutraceutical products

Regulatory perspective:
The Dietary Supplement Health and Education act as well as the Food Safety and Standards act have issued rules and regulations regarding registration and licensing of Nutraceuticals in India.
As per norms, the manufacturer:

  • Is accountable for product analysis, development, authentication and safety of Nutraceuticals
  • it makes and supplies
  • Must not print any misleading information on the labels
  • Must not claim that the product will diagnose, treat or prevent any disease
  • Must guarantee purity, composition and identity of their Nutraceuticals

Path Ahead:
The domestic Nutraceutical market is currently experiencing growth. Existing as well as new players are providing nutraceuticals and dietary supplements both locally as well as globally.
With this background, the standardization of these products is one of the valiant challenges for regulators and the industry stakeholders. The need, scope and importance of Nutrivigilance have to be accepted with paramount importance.

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COVID-19 & Digital Transformation- A Catalyst for Change

COVID-19 was a wake-up call for pharma companies to assess the digital sophistication of their company and the potential to serve customised experiences to consumers. COVID-19 has intensified pre-existing developments in several ways: an expansion in the usage of clinical technologies and telemedicine; a drop in access to sales reps; an emphasis on patient experience; the pace of digital innovation through pharmaceutical companies.

These developments were brought into sharper focus by the pandemic and added a sense of urgency; but they were already, by it and wide, in motion. COVID-19 pressed the accelerator rather than applying the brakes on these movements.

It has also uncovered new ways to overhaul a static status quo and make drastic changes in fields that have not yet received similar focus: opportunities to facilitate telemedicine and a wider connected health ecosystem; a move towards a data-driven, tailored concierge approach for reps; deeper reaching simulated medical events; improved patient service services (PSPs) observing data-driven, personalized concierge approach

Although these methods may have been seen in the past in tiny pockets of activity, they are the latest developments influencing the future of the company enterprise. Now is the time for digital transformation to double. It has been thought about by the pharmaceutical industry for years, but today, it must come out of necessity, faster and more thoroughly than anybody expected or was ready for.

The COVID-19 should provide pharmaceutical manufacturers with a wake-up call to assess their own digital sophistication and willingness to represent clients who are tailored to show that they fully understand their requirements. A fair evaluation of the organization’s modern marketing sophistication and a focus of changes are required to meet the evolving demands and responsibilities of sales managers, HCPs, patients and careers.

Marketing leaders must understand how good their business is in three main drivers when making this assessment:

  • Using data to support corporate and marketing strategy
  • To build personal experience for customers
  • Technology to meet consumer requirements

The combined sophistication of data, customer experience and applied technology demonstrates new marketing readiness for an organization; measures against and prioritizes its business objectives. When viewed in this way, it becomes clear where the potential of a business stands, and a course of rapid evolution can be drawn up.


Even before 2020, there were old ways of commercializing pharmaceutical products with brands of blockbusters, traditional releases, clear campaign combinations and generous budgets. The pandemic of COVID-19 has exacerbated these improvements and brought in many of them, including patient adherence, revised HCP practices and vanishing sales reps access. Although customer experience has once evaluated effect on the range of personal sales and frequency, its impact and importance are affected today. Customers – patients as well as HCPs – expect importance and need it more than ever before. Modern marketing impacts consumers who have customised interactions that reflect understanding and sensitivity to their needs.

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With Immunity in Mind, Nutraceuticals is the Keyword


There is no doubt that the world is in a very distinctive and perturb state right now. Health is at the top of everyone’s mind, remarkably immune health because of the growing covid-19 pandemic. The immune system supports your body to fight against disease and protect it from getting ill in the first place.

While things like season changing and pandemic may warn us of immune health, it is really of great importance all year long.

The excellent news is that even though some things are out of your control, there is still much that you can control, precisely what supplement you take, what you eat, and how you treat your body.

With no scientific evidence-based treatment for COVID-19 yet and a vaccine still in the Clinical trial stage, the keyword has been ‘Nutraceuticals’ and ‘Immune boosters’ during the past eight to nine months.

Nutraceuticals & Functional Food Use- A Focus on Self- Protection:

Just before the pandemic, many of us did not know about what the Nutraceuticals is?

Coronavirus has done an excellent job of opening consumers’ eyes to the power of food and its function. Some findings are consistent with google and taste wise research, which demonstrates a rising trend for vitamin C, D, zinc, elderberries, rosemary, melatonin, collagen, mushroom, and Nutraceuticals. This finding is of note also because of the notable increase in the prevalence of internet searches for ‘food’ and ‘Immune system,’ which rose 670% globally in the first two weeks of March’20. In India, according to the google trend data the index search for immunity, gut health and nutraceuticals rose by 100%. 

This urgent requirement for a solution is reflected on the individual level by an unprecedented rise in consumer sales of supplementary nutrients, nutraceutical products, Ayurvedic concoctions, and functional products, which were considered effective against influenza, SARS virus, which has been on the front burner during this pandemic as well. However, consumers are seeking to use any functional food that is used to self-medicating their moods.

At a particular time in the past, traditional Indian homemade food was healthy and owned unbelievable health benefits. Indian food played a vital role in inflammation, immunity, brain function and people were healthy. The scene across the globe has changed, and India has also become a part of it. The nutraceutical market is flourishing predominantly in the United States, India, and European countries. When it comes to health and immunity, the first thing that comes to everyone’s mind is ‘Nutraceuticals & Immune boosters’. It will continue as people have shifted towards prevention is better than cure.

The breakthrough in grasping the connection between health and nutrition gave an impulsion to the concept of nutraceuticals as a feasible and definitive perspective to meliorate health and lessen the peril analogous with certain diseases.

Increasing health awareness, drift in population disease demographics, where younger people are affected, lifestyle alterations, escalated purchasers’ opulence, and high life expectancy is responsible for increasing the market for nutraceuticals in India. 

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Digital Patient Engagement-The future of healthcare


Digital patient interaction is among the top ways to create outstanding contact with patients in the new era of pharmaceuticals. Digital patient interaction, no longer a distant concept, is a fact for payers and clinicians who strive to build better patient interactions.

Here are some of the top reasons why digital patient engagement is important and why it will continue to be relevant in the times to come.

Patient expect digital patient engagement:

We exist in an instant age, whether we like it or not. Watching the new video, ordering lunch or getting directions to the closest bar can all be done from a tablet, and patients want their healthcare providers to have the same capability. When it turns out, 54 % of people choose to connect with their healthcare provider via their phones. In addition, to make decisions about their wellbeing, they use this knowledge. 79 % of patients are more likely to choose a healthcare provider that helps them to access their healthcare records online or by phone, according to study. 

There is an emerging healthcare advertising-millennials, and their demands are much greater because they are an internet-first generation. In reality, 60 per cent of millennials favour telehealth to office visits, according to Salesforce. Patients place greater focus on digital participation across the board, and any healthcare professionals who do not keep up are at risk of being drowned by the competition.

Best way to connect with millennial:

Millennials represent the largest demographic at the time of writing. Described as individuals between the ages of 21 and 37, they will continue to be the main demographic group until 2050, as older generations decrease in number. Using digital patient experience technology to connect with millennials is up to healthcare providers, since they have a number of distinguishing characteristics that set them apart from other generations. 

Digital era will help to improve health literacy:

The key explanation for the use of interactive patient engagement programmes is that patients want to remain informed about the course of their care. However, there is more to it-how can patients grasp strategies for digital patient interaction if they lack basic health literacy? One of the most convincing cases of digital patient engagement is that it can boost health literacy, offering a range of benefits, from patients, payers, providers, doctors, all the way to pharmaceutical firms, to any stakeholder.

Typically, people living in rural areas with limited access to health education and living conditions that are not optimal are the communities struggling with health literacy the most. Healthcare services should set up digital patient interaction platforms that make a difference in order to help these patients out. This is the perfect medium for digital patient interaction and improving health literacy, considering how widespread the use of smartphones is. Educating patients on their diagnosis, condition and recovery is one of the most cost-effective ways to increase health literacy. This can be done through posters, website pages, webinars, or videos of medical explanators. In particular, videos are a fantastic solution for explaining a lot of data in a very short period of time, so that patients can easily access it through their phones.

Pharma companies are stepping up:

Realizing that healthcare professionals will not take care of it on their own, several pharmaceutical firms have made efforts to develop resources for digital patient interaction that support patients and doctors. In other words, the value of digital engagement platforms has also been taken up by pharmaceutical firms, and they have double the benefits. Next, they optimise the health benefits of patients. Second, due to the available communication resources they can demonstrate to their patients, they make an impact with doctors, who are more likely to prescribe their products.

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Update on COVID-19 Treatment around the Globe


Demand for repurposed drugs to continue even after launch of COVID-19 vaccines: Experts

Experts says that the demand of repurposed drugs are important to continue even after the COVID 19 vaccines come to the Indian markets. The founder of the Pronto Consult, Dr. Hari Natarajan & Dr. Karishma Shah commented that ‘use of repurposed drugs is likely to be continued until the entire population is vaccinated or there is some other drug that would take care of it’.

FDA Approves First Treatment for COVID-19

Veklury is the first treatment for COVID-19 to receive FDA approval. Only in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care should Veklury be given.

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Indian Nutra Regulatory Update In Next Normal


07th November 2020: Registration is obligatory for all home chefs

One of the pragmatic outcomes of the pandemic was the upsurge of several home chefs across the country. It has recently disclosed that all home chefs are required to have an FSSAI (Food Safety and Standard Authority of India) registration number.

According to the F & B consultant Neeta Bhoopalam, people need not panic and apply for the registration as per the rules. 

There are two types of FSSAI no. that people need to look at manufactured by and marketed by. Those who are preparing food from scrape and peddle need to apply for a ‘manufactured by’ FSSAI numbers. Those who are obtaining materials from someone else and peddling need to have ‘marketed by’ FSSAI numbers. Depending on the number of years one wants to opt for the registration (can be from 1-5 years), the fees for the same, counting the department charges and government fee, range from Rs 1,500 to 5,000.

Neeta further adds that those who have Turnover below Rs 12 lakh per annum need to have a state license and central license for those above 2 lakh turnover per annum.


19th October 2020: FSSAI is now all set to extend FoSCoS to the entire country with effect from 1st November 2020.

It is an online FLRS (Food Licensing and Registration System) since 2011 and is the licensing ecosystem’s soul. While over 40 lakh licenses/ registrants are actively transacting, 70 lakh licenses/registration have been issued to date and operational in all states.

A cloud-based, upgraded new food safety compliance FSSAI has launched an online platform called FoSCoS (URL-, which will replace the existing FLRS (URL-

FoSCoS is externalized to bestow one point stop for all espousal of a food business operator (FBO) with the department for any regulatory compliance transaction.

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Malnutrition, the Silent Pandemic

Experiences from previous pandemics have shown that, when such outbreaks evolve, there is an urgent need to expand public health activities beyond urgent clinical management. Also, the 2020 pandemic ‘COVID-19 outbreak’ is not an exception!

This pandemic has brought a new set of challenges for the individual to maintain a healthy mind and
body. In the starting phase, many of the countries have announced lockdown around the globe.
Citizens were asked to stay at home for the community spread of virus. These measures of social
distancing have severe repercussions on both Physical as well as Mental well-being.

If we look at physical health, the food and health nutrients supply chain was hampered due to
insufficient transportation. Even, the confinement to home has directly affected one’s physically
working patterns and eating habits. For working class people, adapting to ‘Work from Home’ norms
brought very low energy expenditure.

Even COVID-19 has implications on mental health. It has been seen, fear and anxiety about this
pandemic has changed diet pattern around the globe. Compelling evidence showed that dietary
habits are affected by conditions of stress, distress, and emotional disturbance, whereby elevated
distress levels are associated with unhealthy dietary patterns and poor quality of the diet.

Malnutrition: The silent pandemic in India
Global Hunger Index has shown India is a home for about 30% of world’s stunted children and 50%
of severely wasted children. In addition to this, other factors like anaemia and obesity are increasing
burden on hidden huger.
The recent pandemic has brought serious threats to nutritional rights of malnourished individuals.
The lockdown has disrupted access to essential services including mid-day meals, vaccinations and
also supply of health supplements to the needy.

Mitigating COVID-19 impact:
To fight against upcoming pandemic of Malnutrition, one needs to tackle of four levels; individual,
community, national and global.

Individual stance:
At individual level, the responsibility lies in making an effort to choose a healthy lifestyle with right
diet and exercise.

Community stance:
At community level, people should avoid stock buying. Those who can afford can stock extra food or
other essential materials, which increases stress on supply chain. Therefore, at a community level, it
is crucial to spread awareness against ‘Panic-buy’.

Image 1: Mitigating COVID-19 impact

National Stance:
All nations around the globe are experiencing burden on healthcare services so national economy as
well. To avoid the shortage of essential services including foods and medicines, government should
invest in planning of resources, formulation of policies to support the production and distribution.
Even the public private partnership has become imperative to build etweorks with private sector,
the international agencies, and local communities. Even as social level, running public awareness
campaigns, nutrition education, emergency news bulletins, radio and TV announcements can create

Global Stance:
COVID-19 has shown a global threat requires global action. There is a need to work together and
coordination among countries to ensure supply of essential goods and medicines and making sure
that humanity emerges from this pandemic with the least possible losses.
In nutshell, when entire world is engaged in vaccine research, the influence of this pandemic on
nutrition and dietary intake has already gone beyond the individual and the community to reach
national and global levels. The main aim should be to maintain the physical and mental well-being
individuals with resilience of communities, and national and global food security.


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Post COVID-19 era in Pharmaceutical Industry

A whole new challenge has been posed by Coronavirus; the industry is at a standing start in terms of a vaccine and needs to prepare more efficiently than ever, against particular constraints and obstacles. The capacity of the industry to articulate the innovations, challenges and opportunities it poses in multiple languages is almost as difficult as developing a vaccine itself. Yet pharmaceutical firms are working hard to find how they can partner successfully with each other and continue to create market momentum well into the future, as well as educating the media and public about how viable a vaccine is and when it may be available.

The pharmaceutical industry landscape looks very different than how it did at the beginning of the year, whether it is postponed conferences, simulated gatherings, distribution reps unable to visit their clients, or analysts needing to focus on tech to communicate with their team and other associations and institutes. Pharmaceutical firms are adapting to the rapid changes that emerge from changes in supply chains and the need to adapt business procedures during these extraordinary times.
Healthcare services have experienced convulsive changes and are now undergoing them. Let me focus on how the pharmaceutical industry has evolved and will evolve.

  • Research & Development:
    Projects such as the EU-EFPIA public-private alliance with the IMI (Innovative Medicines Initiative) have paved the foundations for what we are seeing now: the old business model of the industry is being changed. Where there was once a cut-throat struggle to find, create and sell drugs, former competitors, such as vaccine manufacturers GlaxoSmithKline and Sanofi, who have joined forces to develop a safe and efficient coronavirus vaccine partnering through IMI ventures in this current scenario. This extraordinary focus on teamwork and cooperation goes straight around the board. From exchanging databases of validated therapies with researchers and others and seeing if the worst consequences of the current coronavirus can be mitigated, to having access to expertise, research results, development capacities and embracing risk sharing with the public sector.
  • Clinical Trials & Regulations:
    The focus must change to decentralized / near-patient / site-less-trials on sites and investigators. We need patients not only to stop attending hospitals where they may be infected or where they “steal” services from those in need, we really need to catapult to a paradigm focused on demographic data to classify and attract patients. Recruitment may no longer rely on the capacity of doctors to remember and locate qualifying patients. There is a chance to change health science, then. Similarly, in an outbreak situation and when businesses have to collaborate on master protocols and platform trial designs, this pandemic will force a new approach to vaccine trials.
  • Supply Chain & Resources:
    In the current situation, the Government of India should take crucial measures to eliminate the technological and financial obstacles that will spur the pharmaceutical industry to increase the production of APIs, thus reducing the pharmaceutical industry as a whole’s reliance on the Chinese market, which is heavily affected. Recently, the Indian government has taken applaudable measures by introducing an incentive package of 13.76 billion Indian Rupees (approximately $181 million) to encourage domestic production of essential starting materials, drug intermediates, APIs & medical devices.
  • Shift to consumer centric:
    In this covid 19 scenario, consumer has become very sensitive to information. There is a need to serve the demand of information through digital tools. The increased use of digital technologies, telehealth, and app-based environments makes patient-level data more available. Hence, it important that patient-centered supply chains should understand how this need can be met. Major improvements in telemedicine, video conferencing, remote-working software, and clinical-decision-support tools have helped doctors to cope up with the fast spaced transformed evolution in the field of medical technology. Increased supply chain transparency and information will be required by consumers and patients, and this transition to telehealth and app-based environments will require a tech-enabled distribution model.

Therefore, we can say that the COVID-19 pandemic is transforming the nature of world order and control, forcing leaders around the world to rethink their strategies for business and development. India certainly stands to benefit from such a restructuring with its deep expertise in the manufacturing of medicines, highly trained scientists and technological advancement.

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The “Next Normal” of Indian Nutraceutical Industry

The “Next Normal” of Indian Nutraceutical Industry

Indian Nutraceutical market is about to reach USD 10 Bn, which is 2% of Global Nutraceutical market pegged at USD 388 Bn. Even with such a small percentage, the Domestic market is poised to witness a substantial growth when consumer is moving towards pathy-agnostic attitude and increasing demand of preventive medicines. This shift will stimulate the demand for nutraceuticals containing products in near future.

The pandemic has also been the foundation stone and there has been a positive impact of COVID-19 on this industry. The Nutrition Business Journal 2020 predicted the sales of immunity supplements will spike over 25% in 2020 from 8.5% growth of 2019. 

Although Indian Nutraceuticals finds its root in Ayurveda, it has not been leveraged its potential in this marketplace.

India, to be a Nutraceutical hub and to explore the opportunities for expansion, the promise should be made with science based products, end-to-end supply chain capability and reformations in regulations.

Consumer Demand:

In India 150 mn people are consuming various Nutraceutical products. Pandemic situation has brought more focus and acceptance towards Nutraceuticals. The “next normal” way of living with preventive medicines will be one of the driving factors which will accelerate a growth rate up to 30%-50% higher than pre-pandemic times.

Regulatory Reforms:

The pandemic is also the foundation stone of the start of regulatory reforms in terms of responsible nutrition, bursting invalid claims as well as bringing up awareness by conducting training programs like FoSTaC (Food Safety Training and Certification). FSSAI (Food Safety and Standards Authority of India) now is non-negotiable terms on clinical evaluation of products, safety, efficacy and compliance with RDA.

Digital Transformation:

India being a youthful nation always attracted many marketeers. Likewise one of the lucrative markets is “e-Commerce”. From ordering e-pharmacies to having affinity towards digital entertainment platforms like Netflix, Indian population has always shown higher acceptance towards makeover with Digital solutions. And “e-Commerce in Nutra Space” is also not an exception. Pandemic has changed the market dynamics completely. e-Commerce has seen multi-fold surge. Yet, “Products with Trust” remains an issue with spurious brands.

Ensuring Supply Chain:

India to be a Nutraceuticals hub should ensure end-to-end supply chain capability. It is possible only when Pharma – Nutrition scenario gets built up. Automatically, the supply chain issue gets transformed and smooth supplies would flow.

With existing knowledge and available resources, existing players will have to expand via backward or forward integration. Increasing the raw material output by expanding cropping region, continuous availability of labour, adopting technology and being innovative will together develop an integrated model that will make Indian Nutraceutical industry grow.

Technology Convergence:

Adoption of newer technologies such as “Block-chain” will enable tracking the journey of ingredient/formulation from “farm to capsule”. This will ensure timely delivery of product and sufficiency of active ingredients. Even few of the AI (Artificial Intelligence) tools can be used to create an awareness to find out deficiencies in micro-nutrients.

Towards a Brighter Future:

Correlation between health and nutrition was a breakthrough for Nutraceutical industry. This science has given an impetus to the belief that it can provide preventive measures and reduce the risk associated with certain diseases.

With the evidence based approach Nutraceutical stakeholders are acquiring new scientific ways to educate consumers by sharing detailed information about the product and its benefits. Also, with newer technology, industry players are working towards improving quality standards of the product, enhancing transparency and giving competitive pricing.

In terms of Indian Nutraceutical regulations, if we can match with International standards then foreign investment and entry of new players will double the valuation in multi-folds.

Thus, with trust in products, Nutraceuticals are set to become a common part of Indian households in the near future!


  1. Nutraceuticals in India: A game changing opportunity in the healthcare and food industry.
  2. Nutraceuticals: From Alternative to Mainstream.
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