As the world grappled with the COVID-19 pandemic, and now continues to deal with its aftermath, ‘immunity’ has become the new buzzword and the demand for nutraceuticals across the globe has increased manifold. This, in turn, has opened a huge opportunity for the nutraceuticals industry globally and India is uniquely positioned to become one of the most formidable players in this segment, with a projected $100 billion valued market by 2030. (Read: https:// www.expresspharma.in/six-reasons-why-india-is-poised-to-be-aglobal-leader-in-nutraceuticals/)

However, even as this industry booms and newer players enter the market, serious concerns are being raised about the research, regulation, development and consumption of these nutraceuticals. So, timely and pertinent measures are of essence to leverage the tremendous growth potential and eliminate bottlenecks that hinder the industry’s progress.

Express Pharma- Nutrify Today Boardroom series In a bid to examine and understand the prerequisites for the next leg of growth in nutraceuticals, Nutrify Today and Express Pharma came together to launch the Express Pharma- Nutrify Today Boardroom series. The aim was to create and build a platform for pharma industry leaders to initiate a dialogue that would assist the pharma industry to leverage growth through ethical nutraceuticals. It is also an endeavour to enable government bodies to shape effective policies that would help the growth of the ethical nutraceuticals industry in India through effective engagement with the pharma industry.

The first edition of the Express Pharma – Nutrify Today Boardroom series, held recently in Mumbai, offered a platform for meaningful dialogues on the vast ocean of opportunities for the Indian pharma sector to be reaped in nutraceuticals, provided the right course is set for long and sustainable growth.

An eminent panel of pharma experts and leaders came together to explore approaches to build an ecosystem for developing scientifically proven, evidence-based nutraceutical products. Dr Meenakshi Singh, Secretary Nutraceuticals Task Force under chairmanship to PSA to Government of India; Rahul Kulshreshtha, Strategic Alliances – Office of the Principal Scientific Adviser to the Government of India; Aditi Kare-Panandikar, MD, Indoco Remedies; Anand Swaroop, President, Cepham Inc; Rajaram Sankaran, Chief Strategy Officer – India, Torrent Pharmaceuticals; Shriram Balasubramanian, Director Marketing and Business Development, Zuventus Healthcare and Amit Srivastava, Chief Catalyst, Nutrifytoday.com were the participants in this round table moderated by Viveka Rowchowdhury, Editor, Express Pharma & Express Healthcare.

As the experts dived deep into the challenges in this field and the measures needed to enhance ethical standards in nutraceutical research, industry practices, and use, they also examined how a pharma-like approach in terms of regulation, quality assessment and safety profiles could benefit the nutraceuticals industry.

This article is a summation of the inferences drawn and lessons learnt from the views, concerns and insights shared by experts on this knowledge-sharing platform. And, we understand that gaining success through ethical nutraceuticals will largely hinge on the following factors:

◆ A clear and comprehensive regulatory framework: Experts emphasised that it is inadvisable to let nutraceuticals evolve without a clear regulatory framework since the lack of uniform, consistent or standardised regulations can prove detrimental to arrest the growth and adversely impact the credibility of this segment. Therefore, creating a separate set of laws and regulations to guarantee that nutraceutical products are safe, efficacious and meet high standards of quality is very critical. They asserted that strict guidelines and improved techniques must be adopted to ensure that there is enough evidence to validate the health claims made by different products, especially in terms of purity and safety. Discussing various aspects of dietary supplements, nutraceutical supplementation and pharmacological nutrition, experts stressed that while there have been some measures to improve the regulatory landscape in nutraceuticals, there are limitations and bottlenecks to overcome.

◆ A centralised regulatory body: Underpinning the importance of single-point ownership in the nutraceuticals sector, the experts pointed out that as the sector has often come under the ambit of different regulatory bodies like FSSAI, AYUSH, DCGI, MoFPI etc, grey areas continue to dog the progress of the sector. Time and again, there has been a call for setting up a centralised authority or creating a body like Pharmexcil to integrate government bodies to serve nutraceuticals. As the experts at this round table also discussed the need for such a centralised body, Srivastava, who was part of a meeting held by the Nutraceutical Task Force, informed that the formation of a nutraceutical panel in the Ministry of Commerce to ensure a nutraceutical industry-specific agenda is underway.

◆ Robust R&D and manufacturing policies: Speaking on the need for policies and regulations-led interventions to ease the growth of this industry, stakeholders of the pharma and nutra industry also discussed the value of incentives to encourage research in ingredients and formulations to drive ethical nutraceuticals. Apart from addressing the need to design and implement policies that encourage product standardisation, minimise product adulteration, and ensure that recommended daily allowance (RDA) and Tolerable Upper Limit (TUL) are met, the experts also discussed how the government’s plan to introduce a Research Linked Incentive (RLI) Scheme and Production Linked Incentive (PLI) scheme in nutraceuticals could give an added impetus to the sector’s growth by enabling sizeable investments.

◆ A robust nutrivigilance system: The experts at the round table unanimously believe that indiscriminate access and consumption of nutraceuticals without the support of the medical fraternity could turn into a huge health disaster. This view is supported by studies published in reputed journals like PubMed and BMJ that reveal that over 30,000 patients annually are admitted to the emergency ward due to the adverse impact of nutraceuticals. This, in turn, led to a discussion on the role and importance of a surveillance system akin to the pharma industry to monitor and record adverse events associated with nutraceuticals. The experts at the round table vociferously supported setting up a dedicated nutrivigilance system which can promote and implement a systematic, scientific and consistent approach to assess the risk–benefit ratio of nutra products, build up scientific evidence and proof of concepts, as well as initiate and chart risk alleviation strategies.

◆ Evidence-based practices: The dearth of precise scientific data or raison d’être for the use of dietary supplements and nutraceuticals can have an adverse impact, caution industry experts. They recommend stringent guidelines to collect and propagate validated data on the safety, efficacy and claims made on the labels of nutraceuticals products. Long-term studies for clinical validation of ingredients or formulations in nutraceuticals, effective approaches to understanding the toxicology of active ingredients, interactions between drugs and dietary supplements, purity, and bioavailability of nutraceuticals etc are also imperative to drive ethical growth in the sector. Drawing comparisons between R&D and manufacturing practices in the pharma and nutra sectors, the experts said that nutraceutical manufacturers should ensure that only potent ingredients with the right dosages backed by clinical studies are used in their products. Better standardisation, cGMP practices and evidence-based approaches to ensure better product quality, stability, functionality, safety, solubility and acceptance among patients will be vital to the advancement of this sector. This, in turn, will help the nutra sector deal with increased scrutiny and surveillance from global regulatory agencies as well.

◆ Effective use of technology: Emerging technologies will play a crucial role in shaping the discovery, design and development of responsible and ethical nutraceutical products, opined the panellists at the first edition of Express PharmaNutrify Today Board Room series. They also examined how technology can be leveraged and effectively deployed to provide specific dosages and ingredients as per patients’ varying needs. For instance, AI can be deployed to select ingredients by matching data points from studies on nutrition and nutraceuticals and provide insights into commercial patterns, industry trends, etc. Automation and IIoT can enhance efficiency, cut costs and get products to market faster. A case-in-point discussed at the round table was Torrent Pharmaceuticals;’s NutrifyGenie, an AI-powered engine that can prioritise safety, efficacy and traceability in nutraceuticals.

India Pharma Inc’s tryst with nutraceuticals

Thus, amid the clarion call for better regulations, a clear road map and empirical data to validate claims of efficacy and safety made by the slew of products entering the market to build a clear and robust roadmap for the nutraceuticals sector in India, India Pharma Inc, backed by its science and research-oriented approach, has several comparative advantages when it came to nutraceuticals. Especially, since ensuring transparency and ethical approaches to making and marketing nutraceuticals will be pivotal to the long-term growth of the sector.

However, over the last few years, the pharma industry’s forays and experiments with nutraceuticals have evinced a mixed bag of results. The sector looks at the nutraceutical segment as an avenue to expand product portfolios by leveraging scientific credibility. But, the excitement to leverage the growth potential in nutraceuticals has been countered by challenges like the lack of an effective approach/guideline for clinical proofs, clinical trials, factory audit standards, bioactive standardisation, method validations, etc.

Companies like Dr Reddy’s, Sun Pharma, La Renon, and Zuventus have made sizeable investments and witnessed noteworthy growth in their nutraceuticals portfolio, but many others are still struggling to find the best approach to succeed in this space.

But, armed with the right partners and a robust entry strategy, the nutra space offers a great opportunity for the pharma sector to fill gaps for certain health conditions and problems, improve profit margins, increase customer base and grow in new markets.

However, pharma players, industry bodies and policymakers need to align and adopt a cohesive approach to bring more clarity to this industry and make it mainstream to make the most of its tremendous potential.

The post Ethical Nutraceuticals: Need of the hour appeared first on Express Pharma.

Considered as a mere subset of healthcare, women’s health has often been overlooked and underserved. Studies inform that modern medicine was developed with male physiology in mind and as a result, women have been underrepresented in clinical trials too. Social and cultural taboos that limit and hinder conversations on sexual and reproductive health have also acted as barriers to women’s health.

However, in the recent past, we have been witnessing a gradual shift, leading to the creation of an ecosystem which is more conducive to women and geared towards their better health outcomes. Novel products with superior routes of administration are being designed and launched specially for the female physiology.

Reenita Das, Partner, Senior VP, Healthcare and Life Sciences, Frost & Sullivan informs, “The market for female health products has received a wave of publicity recently. There is strong momentum in the larger market toward the ‘Sheconomy’ and the impact of women as consumers and commercial entities. Because of this wave of social trends, the focus on women’s health is center stage today.”

Expressing similar views in an earlier article covered in Express Pharma, titled, ‘Is Women’s Health Gaining Momentum, Suchi Ray, Partner, Deloitte says, “In today’s times, pharma companies in the women’s healthcare space are expanding their R&D base and increasing the efforts to expand beyond reproductive health into key women’s health areas.”

The industry seems to agree with these views. Yash Singh, Founder & CEO of Frimline, a company which recently launched a toothpaste specially designed to address oral issues of women, explains, “Addressing the unique healthcare needs of women has been gaining traction. The industry too is more conscious of the trend now.”

Winds of change
There are strong tailwinds spurring progress in this segment. A report from Fortune Business Insights informs that the India women’s health therapeutics market is projected to grow from $2.22 billion in 2022 to $5.98 billion in 2029, at a CAGR of 15.2 per cent in forecast period. While there are several factors contributing to the evolution of this segment, some of key drivers of this transformation are:

◆ Growing health awareness among women: A changing mindset led by education is helping women break taboos surrounding their health and enabling them to seek diagnosis and subsequent treatment for their illnesses at the right time. Women are now learning to prioritise their health and create a demand for healthcare products and services that are better suited for their well-being.

Singh outlines, “There is a growing awareness on health and well-being among the Indian women resulting in a rise in the demand for products that can help address their health issues. Even in the daily lives of women, there is significant opportunity to introduce self-care products that positively impact their well-being. For example, we recently launched Dente91 She, India’s very first toothpaste designed exclusively to address oral issues of women. The correlation between various hormonal changes women go through their lives, and its impact on women’s oral health is not widely known. This prompted the inception of product.”

◆ Advancements in R&D: A report from McKinsey on ‘Unlocking Opportunities in Women’s Healthcare’, states, “A suite of scientific advances can now be harnessed in women’s health. Recent advances in genomics, tissue engineering, and cell and gene therapy are ushering in a new wave of healthcare innovations that can be applied to underserved female-specific conditions. For example, researchers are studying transcriptomics (the study of all RNA molecules in a cell) for treating otherwise elusive conditions such as preeclampsia or preterm birth. Others are now using tissue engineering to create uterine organoids in order to push the knowledge frontier on endometriosis. The potential is vast to redefine a host of conditions, including endometriosis, preeclampsia, and unexplained infertility, and to achieve advances to the degree that researchers are already achieving with oncology and immunology. Investors, researchers, and companies alike have an opportunity to participate in this rising wave of innovation and to deliver a new era in women’s health.”

◆ Rise in FemTech: FemTech, a word to describe tech-enabled solutions addressing women’s health, has a gained a lot of prominence in the recent times. A report from McKinsey called, ‘The dawn of FemTech revolution, reveals, “FemTech’s current market size range from $500 million to $1 billion. Forecasts suggest opportunities for double-digit revenue growth. On the digital health front, FemTech companies currently receive three per cent of all digital health funding. In our scan of hundreds of FemTech companies, we found concentration in maternal health patient support, consumer menstrual products, gynecological devices, and solutions in fertility. Funding reached $2.5 billion by early December 2021.”

Express Pharma’s article on ‘Is Women’s Health Gaining Momentum’, also quotes Arvind Sharma, Partner, Shardul Amarchand Mangaldas and Co, who says, “With 50 per cent of the population as target customers, and with the women’s healthcare market expected to reach $50 billion by 2025, FemTech is the key focus area in the women’s health market, and this is the right time for pharma companies to increase presence in this sector. In this tech-dominated scenario, connected devices and mobile applications will provide key and timely solutions to women. New business models such as telemedicine and remote monitoring platforms will emerge and are expected to play a key role in the women’s health segment. There is a lot of potential in the women’s healthcare segment in India, and this will attract top global investors.”

Das from Frost & Sullivan enlightens, “Trends toward using digital technologies for monitoring, prevention and personalisation through apps or digital devices are becoming commonplace. Patients are getting empowered about their health and starting to use online forums and chats to get information. There is the emergence of a new woman who is highly influenced by social media. In fact, 80 per cent of all decisions that women make today are driven by social influencers.” FemTech is definitely bringing about a revolution in women’s health.

Rapid growth
Existing and emerging companies have begun expanding their offerings to cover a wide range of women’s health issues like menstruation, skin and hair care, PCOS, mental health, sexual health, reproductive issues, fertility and pregnancy.

Let’s take a look at some of the subsets where we are seeing phenomenal growth:

◆ Feminine hygiene and menstrual health: A report by Mordor Intelligence predicts that India’s feminine hygiene market witness a CAGR of 14.7 per cent over the next five years. As per market analyses, rising awareness about intimate hygiene and innovations in menstrual products like sanitary pads, tampons and panty liners, are contributing towards the growth of feminine hygiene market in India. Government initiatives to promote menstrual awareness among women and adolescent girls have also helped.

As a result, a lot of newer entrants in this segment such as Avni, Milder Cares, Nua, Padcare, The Woman’s Company etc. Leading brands are also entering and expanding their offerings in this space. For instance, Cipla unveiled ‘Evexpert’, its range of feminine hygiene products in March last year, while FMCG major Dabur forayed into this space with its new brand ‘Fem’ inZ December 2022. Piramal Pharma also forayed into the feminine intimate care category in 2021. Existing products like J&J’s Stayfree and P&G’s Whisper have also introduced product variations and innovations to deal with growing competition.

Sujata Pawar, Co-founder & CEO at Avni, a feminine hygiene and menstrual healthcare startup, shares more details about the growth drivers in this space. She points out, “Over the last decade, the feminine hygiene market has experienced consistent growth. The key growth drivers are increasing female literacy, rising disposable income among women, growing awareness of intimate health issues, and better access to menstrual products. The acceptance and prominence of new-age sanitary products have also contributed to the elimination of many menstrual taboos.”

“The availability of safe and affordable menstrual and reproductive products reduces their risk of infection. This has the potential to have a cascading effect on overall sexual and reproductive health, such as lowering teen pregnancy as well as aiding in maternal decisions, and reproductive success,” she adds.

“The market for feminine hygiene is now characterised by continuous expansion. Menstrual cups, sanitary pads, toilet hygiene, tampons, and other feminine products are the most often used products that fall under the disposable category. A highly dynamic market has resulted from customers’ recent shift in behaviour towards environmentally friendly options. The market for feminine hygiene is characterised by a variety of novel goods, including tampons and menstruation cups made of organic or biodegradable materials,” reiterates Sandeep Vyas, Founder of Mild Cares and GynoCup.

◆ Female contraceptives: As Indian women get empowered to own certain choices about their health and body, there is a growing demand for safe, sustainable contraceptive tools as well. So, we are seeing the emergence of several options in this space such as female condoms, intrauterine contraceptive devices (IUDs), wider range of birth control pills, injectable contraceptives, hormone-releasing contraceptive devices like implants and vaginal rings, patches that can prevent pregnancies etc. Some of the players in this space include Bayer, Pfizer, Merck & Co, CooperSurgical, Reckitt Benckiser, AbbVie, Johnson & Johnson, Lupin Pharmaceuticals, Viatris (Mylan Laboratories), Church & Dwight, The Female Health Company, Mayer Laboratories, Durex, Mankind etc.

A study published in The Lancet on worldwide contraceptive use last year reveals, that women of reproductive age (15-49) in India who need to prevent pregnancies but have no access to contraceptives have come down by over 13 percentage points between 1970 and 2019. The study also informs that over 160 million adolescents (15-19 years) and women (20-49 years) “remain with unmet need for contraception worldwide”, however ‘demand satisfied’ category has increased from 55 percent in 1970 to 79 per cent in 2019.

◆ Infertility treatments:
The demand for fertility treatments and services is growing in India.

Das reiterates, “Infertility is becoming a big issue globally, including in emerging markets, where the rates are increasing drastically. Because of this, access to infertility treatments and monitoring is going to become very important, with lots of focus on wellness, diet and nutrition.”

According to a report published by Allied Market Research on India’s in vitro fertilisation market, “Women comprise the largest market share of nearly two-thirds of the total market revenue in 2020, and are expected to exhibit prominent growth during the forecast period, 2021-2030.”

Growing incidence of male and female infertility, late pregnancies, technological advancements in ART procedures, increasing rates of success in IVF, and rise in disposable income in India etc are contributing to advancements and growth of this market. While reports inform that while the paradigm of fertility drugs haven’t witnessed drastic change, the market today definitely has better versions of the original fertility drugs. Moreover, rising number of fertility clinics and opportunities in emerging markets are expected to help market expansion in future.

Women’s nutrition
The women’s nutrition market in India is also seeing a boom. Alongwith major players such as Abbott, GNC Holdings, Amway India, Bayer, Danone, Unilever, Nestlé, GSK, etc., this field also has seen a lot of new entrants such as Kapiva, Sudeep Nutrition, Chicnutrix, Oorah Nua and others offer products that serve women’s needs ranging from PCOS to pregnancy, menopause and motherhood. Swelling demand for healthy lifestyle choices and growing vitamin deficiencies in women are also driving robust growth in the women nutrition market.

In Express Pharma’s earlier article titled, ‘Evolving landscape of Women’s Nutrition’, Shanil Bhayani, ED, Sudeep Nutrition informs, “Women are growing aware of the importance of consuming essential nutrients in the right quantity. As it stands, many women have incorporated nutraceuticals in their daily lives to treat menstrual disorders as it has anti-inflammatory and smooth muscle relaxing properties. We are witnessing a growing trend for cranberry and bearberry-based nutraceuticals that are preferred by young adults to treat urinary tract infections, a common bacterial infection in women. We have seen many women who have turned to nutraceuticals to stimulate milk production in pregnancy. A lot of women are opting for nutraceuticals such as melatonin, vitamin E, chasteberry, flaxseed, etc. to manage life-altering symptoms of menopause.”

Also quoted in the article is Ameve Sharma, Co-founder, Kapiva, who states, “To say that the women’s nutrition market is ever-evolving would be an understatement. Every year, we see a new selection of ingredients and trends rise to prominence in this industry. With each passing day, women are becoming more and more conscious towards their lifestyle choices.”

White spaces in women’s health
Though women’s health segment is clearly poised to grow and evolve, challenges continue to exist. But, the challenges faced by the women’s health as a segment can also present opportunities to create value and serve women’s healthcare needs through innovative solutions.

Frost and Sullivan recently forecasted the growth opportunities in this field. (See the top 10 in Figure 1) The McKinsey report on ‘Unlocking Opportunities in Women’s Healthcare’, also highlights, “The current global innovation pipeline reveals mismatches between health investments and health needs. The gap highlights some remarkable opportunities for improving women’s health within female-specific conditions (See Figure 2)” So, industry stakeholders outline some measures to optimise the growth potential in this segment.

◆ Ramping up awareness and education: Recommending awareness and education as the tools to deal with the issues and challenges women face today, Das says, “Many women suffer for almost two decades from menopause, and they are not even aware of or prepared for these debilitating symptoms. It is important to provide systematic education. Second, governments and the private sector need to provide tools that women can access easily. Regular screening is also important, along with monitoring. Infertility insurance needs to be updated, and employers need to include it in plans so that employees can access infertility treatments easily.”

◆ Increase in clinical research on women-centric diseases: “Traditionally, women’s health has been viewed as being synonymous with gynaecology and motherhood. However, the healthcare needs of women go much beyond. For example, heart diseases, joint health, oral health etc. have very different implications for women as compared to men. An increase in clinical research on women-centric diseases and introduction of appropriate treatment options and products that fill the whitespaces will help drive growth in this segment. It also requires replacing the gender-agnostic approach with a gender-specific lens,” says Singh.

He adds, “Women are most affected by non-communicable diseases (NCDs) such as heart diseases and cancer besides gynaecological and fertility-related issues. Anemia is also a major concern for women across all age groups while osteoporosis and osteoarthritis are more prevalent among older women. While there are numerous products available in the market, there is still an immense scope to introduce more products to address these issues.”

◆ Investments and policies to promote women’s health: There is a clear uptake in investments in women’s health and many start-ups have sprung to cater to this segment. Many leading pharma companies have also expanded their offerings in this segment.

To cite a few examples:
◆ Bharat Serums and Vaccines (BSV) acquired Tidilan (Isoxsuprine hydrochloride), a brand in women’s health, from Jagdale Industries in 2022

◆ Dr Reddy’s and Mayne Pharma have signed an agreement in February 2023 to buy the latter’s generic products portfolio which includes about 45 commercial products, including a number of generic products focused on women’s health.

However, despite a few measures in the right direction, we need a lot more investment both at the public and private stakeholder level. There are significant white
spaces that need to be filled to expand access and availability of women’s health. Adequate ‘gender budgeting’ is also an imperative to enable sustainable progress in women’s health.

As a report from Emcure released in 2021 finds, “There is a need for women, organisations and the society at large, to become proactive when it comes to managing their health and nor maliase conversations around critical aspect of women’s health. For every being, physical, mental and sexual health is inter-related. Greater investment is required in women’s health including more research to unlock new insights that could lead to new and innovative solutions for women.”

Protecting the future
Since the link between women’s health and economic growth of communities and countries is undeniable, it is time to prioritise women’s health and wellness through
investment, and research.

lakshmipriya.nair@expressindia.com

The post Women’s Health: On The Cusp Of A Revolution? appeared first on Express Pharma.

As a part of the Express Pharma’s January 2023 cover story, Nisschal Jaain, Co-Founder and CEO, Shypmax, shares his views below.

The pharma supply chain is performing below par while being a $50-billion industry in India. The COVID-19 pand emic has uncovered the dent in the pharma supply chains with a lack of skilled personnel and digital transformation. Inventory turnovers are behind schedule, demand fulfilment is inefficient, and overall process capacity and efficiency trail far behind those of a top-tier manufacturing facility.

The sector’s top executives believe there is a need for better visibility, cooperation and control. For instance, they require real-time information on the location and status of a shipment. They also want capacity data and production projections. Such information is frequently on paper, in excel format, or in traditional data management systems, which are difficult to find. Things are changing since the century’s worst tragedy, the pandemic, hit the globe.

The logistics industry has quickly adapted to the changing needs of the pharma industry in the post-pandemic phase. It has embraced many new ideas about building and strengthening the supply chain for effective distribution in the pharma industry. Globally, the industry has been forced to innovate and adapt to demand, highlighting how inter-dependent countries are for a continuous and smooth supply chain. Moreover, the industry has understood the adaptation of cutting-edge technology, which has played a curious role during the pandemic.

The technology adoption rates by the logistics industry are increasing for things such as Artificial Intelligence (AI), cloud computing, blockchain and the Internet of Things (IOT).

The next generation of logistics solutions is building a more customer-centric and sustainable global supply chain. Digitisation provides a sustainable solution for pharma industry’s supply chain challenges. Acquiescence, traceability, end-to-end visibility, limiting error, quality assurance and process efficiencies are some crucial challenges that can be addressed through advanced technology. End-to-end supply chain visibility is only possible with digitalisation and capturing data from various sources. In order to provide a comprehensive picture of a supply chain, end-to-end monitoring enables data to be consolidated, transmitted and evaluated across different layers.

Every supply chain partner can access a single digital file containing up-to-date and accurate data, whenever required.

Blockchain is another evolving technology that can be transformative in improving the quality of the network as a whole. It can add better value to tracking, monitoring and reducing issues in the supply chain and make logistics seamless, easier and quicker by creating platforms where logistics players can share the details in real-time. It can also enhance the security, integrity and data privacy of the pharma supply chain because of its transparent, binding and auditable nature.

It also permits all the stakeholders involved in the supply chain to update and share real-time and precise information via software. Additionally, it can secure the supply chain processes and improve their integrity, data derivation, functionality and traceability until the point of delivery.

The effort put out to comprehend various stakeholders, the data they require, the channels for collaboration that are available, as well as the technology, are crucial components of effective end-to-end control. Companies may improve sustainability and cut costs by addressing the inefficiencies in their current processes with the help of end-to-end supply chain visibility and stability data. By providing pertinent information to all parties, including producers, wholesalers, distributors, pharmacies, customers, hospitals and other medical facilities, a control tower offers visibility from beginning to finish. Operators can then monitor shipments during their voyage and ensure that the patients receive the packages in sound condition.

To read mores stories in the January 2023 edition, read our digital issue at: https://www.expresspharma.in/express-pharma-january-2023/

The post Boosting stakeholder supply chain visibility and enhancing pharma logistics through internet appeared first on Express Pharma.

As a part of Express Pharma’s January 2023 cover story, Nikkhil K Masurkar, CEO, Entod Pharma, shares his views below.

The pharma sector has evolved rapidly during the COVID-19 pandemic and became more agile and responsive to the new market realities and demands of healthcare across the globe. As digitisation transformed the whole healthcare sector across the globe, technology disruption in pharma also contributed to new developments in this space. The sector is now increasingly looking at new strategies and approaches to enhance the process and product efficiency.

Top trends in pharma marketing in 2022 like patient-centricity, personalisation in healthcare solutions and changing relationships between healthcare providers and patients will continue to dominate the sector in 2023 as well. The pharma sector is an evolving space with a focus on improving the expertise of human resources, leveraging technology to optimise both, cost and quality of outcomes, as well as encourage scientific innovation.

As we step into 2023, the trends that will take centre stage in India’s pharma setup and the new market realities for the sector are:

Digital transformation (Use of AI and other new-age technologies): With the pandemic having a ripple effect, the digital transformation of the pharma sector will take a centre stage in 2023 as one of the trends. There is no doubt that the latest technologies such as Artificial Intelligence (AI), AR/VR, Machine Learning (ML) and additive manufacturing are helping pharma companies. This includes conducting trials in less time, improving the R&D process and adding innovation to the products as well as improving compliance and efficiencies in manufacturing.

More innovation and R&D: To move up the value chain, the pharma industry needs to focus on innovation. The sector needs new product launches and a strong innovation pipeline every year, along with more Research and Development (R&D) for emerging diseases or infections. The idea should be to have a core focus on patient needs while enhancing pharma’s significance in new drug development, biologics and innovation. Pharma companies are also expected to put more focus on the usage of technology, biological sciences, and cell and gene therapy, as part of the trend.

Personalised medicine: When medication is produced based on a specific patient diagnosis, it refers to personalised medicine. The purpose is to ensure the drug is tailored for optimal effectiveness and patient outcomes. Reportedly, precision medication has demonstrated a higher level of effectiveness than other options. However, the problem that manufacturers are facing is that a smaller quantity of medication is produced, which means there is more than one-treatment variation. The production of precision medicine requires facilities that are specialised and smaller than most factories. The year 2023 is expected to give space to this trend as the methods used to produce precision medicine are refined, though it has posed problems for manufacturers.

Regulators and industry stakeholders need to align with each other: To take on the new challenges and grab opportunities in 2023, regulators and industry stakeholders can align with each other, to chart an impressive growth trajectory. The pharma industry in India is the third largest by volume across the world and the 14th largest in terms of value. As per the Economic Survey of 2021-2022, the Indian pharma industry is expected to reach $65 billion by 2024. Keeping this in mind, a close-knit association between regulators and industry leaders or stakeholders is imperative, but, at the same time, no compromise on quality should be made for the sake of competition.

To read more stories in the January 2023 edition, read our digital issue at: https://www.expresspharma.in/express-pharma-january-2023/

The post Top trends in pharma marketing in 2022 will continue to dominate the sector in 2023 appeared first on Express Pharma.

As a part of Express Pharma’s January 2023 cover story, Raheel Shah, Director, BDR Pharma, shares his views below.

The pharma industry has experienced tremendous growth in recent years, and the outlook for 2023 remains optimistic. By the following year, the industry is expected to be worth more than $1 trillion. This is due in part to the thousands of compounds currently in the final stages of clinical development, as well as hundreds of new products with approvals expected in 2023 and beyond. This level of pharma products is unusual, and hasn’t occurred in over a decade.

AI is a term that is gaining traction across all industries. It is the use of computer systems to perform tasks that would normally require human intelligence. Decision-making, speech recognition and visual perception are examples of such tasks. It also allows for information to be translated between different languages. The use of AI in pharma industry is expected to expand in various roles, such as accelerating drug discovery and development. clinical trials, fraud detection and overall medication improvement are some of the areas that will benefit from AI.

As blockchain technology has grown in popularity in the financial sector, companies in the pharma industry have begun to explore new applications for it. The primary goal of blockchain technology is to simplify transaction processing while also improving security and transparency without the need for a third party. Blockchain technology, when used by pharma companies, can help boost efficiency by streamlining processes. This is true for transactions involving medical clinics, hospitals, regulators and other stakeholders. It can also improve the results of research and development.

Medication pricing will occasionally make headlines, especially when there is the outrage over the high cost of life-saving drugs. The examination of drug prices and continued scrutiny to detect impropriety will continue in 2023.

One of the operational trends that will grow in 2023 is the use of digital training to ensure the proper and efficient use of implemented technologies. This is also done to ensure regulatory compliance. Pharma companies and pharmacy employees, like those in any other industry, must be well-versed in regulations and be able to navigate the various systems put in place in a way that complies with them.

There is a greater emphasis on the worth of medications. As a result, pharma companies are more concerned than ever about ensuring that research and development are directed in the right direction. There is an effort to improve effectiveness and efficiency in meeting patients’ needs while also protecting the bottom line.

To read more stories in the January 2023 edition, read our digital issue at: https://www.expresspharma.in/express-pharma-january-2023/

The post By 2023, pharma industry is expected to be worth more than $1 trillion appeared first on Express Pharma.

As a part of Express Pharma’s January 2023 cover story, Saransh Chaudhary, President, Global Critical Care, Venus Remedies, and CEO, Venus Medicine Research Centre, shares his views below.

New-age technologies like Artificial Intelligence (AI) and Machine Learning (ML) are poised to play a transformational role in the growth of the Indian pharma industry by expediting drug development and discovery and enhancing efficiencies. While leading global pharma giants have already started using AI in a big way, Indian pharma majors are also fast catching up.

AI, coupled with big data and ML, is veritably the future of pharma. Encompassing all pharma processes ranging from drug research and manufacturing to marketing and supply chain management, AI applications are proving instrumental in bringing down costs, supporting a profit-driven innovative ecosystem and enhancing productivity, thereby, business outcomes, as more and more Indian firms jump on the digital bandwagon.

They have started leveraging the power of AI by analysing vast amounts of data to improve business processes through decisive insights, boost the success rate of new drugs through quality control and address supply chain issues in the production line, thus cutting down on wastage. AI tools also help minimise the scope of human error to ensure greater efficiencies, reduce operational costs through predictive maintenance and make way for more cost-effective drugs by streamlining the working processes. Evidently, AI-powered analytics can go a long way in improving the value proposition by creating innovative business models.

Pharma companies are also increasingly using AI to streamline the drug discovery process by simplifying the practice of identifying complex patterns from datasets to assess the safety and efficacy of drug candidates and applying them to solve problems involving complex biological networks. The predictive and data analytics capabilities of AI enable drug researchers to assess the implications, benefits and success rate of new drugs by analysing dataset patterns.

Likewise, machine learning also plays a crucial role in real-world evidence studies and clinical trials through techniques like few-shot learning, which involves inferring the results on the basis of restricted data in the process of testing experimental drugs and zeroing down on drug candidates with the highest potential. These technological interventions not only do away with the need for large datasets, but also put the drug discovery and development process on fast track.

Going beyond drug discovery, AI can also help analyse and improve upon marketing campaigns by providing measurable results and accurately predicting the success rate of marketing activities. Likewise, it is redefining the scope of interactive digital tools in the consumer healthcare space.

Companies catering to consumer healthcare are increasingly opting for data-driven personalisation and immersive technologies like Virtual Reality (VR) and Augmented Reality (AR) to enhance patients’ experience by interacting with them and providing solutions based on their feedback. Automated patient-decision aids, for instance, employ cognitive AI with evidence-based insights gained from patient history or interactive questionnaires to understand the critical issues that need to be discussed with physicians. Going a step further, we also have technologies like precision health, virtual health assistant and emotion AI, also referred to as affective computing, which will also be crucial in improving targetted and personalised care for critical diseases, another key area that will witness an upward trend in coming years.

To read more stories in the January 2023 edition, read our digital issue at: https://www.expresspharma.in/express-pharma-january-2023/

The post The power of AI is the future of pharma appeared first on Express Pharma.

As a part of the Express Pharma’s January 2023 cover story, Pratima Reddy, Managing Director, Merck Specialities, shares her views below.

The pharma industry has undergone tremendous change due to the pandemic in the past few years. In 2023, the pharma sector will focus on sustainability, mainly on sustainable packaging of the products while balancing consumer safety as the eco-friendly option, equity in health and accessibility for patients.

The world is moving towards a greener tomorrow with the concept of sustainability, where the need of the hour is met, but without compromising the needs of the generations to come, ensuring that there is always a balance between the advancement of technology and the well-being of the environment. At the forefront of the pharma sector, work on sustainable packaging is in the works as the packaging creates the first impression of the brand and its transparency towards its claims of sustainability and aesthetic appeal. Still, the pharma industry is moving at a relatively slower pace than the other packaged goods sector due to consumer safety of the products standing at the forefront of the issue. The level of exposure to different environmental factors, temperature, oxygen, sunlight etc., plays a significant part in protecting the patient by ensuring that the product is being consumed safely.

Recently, there have been developments in the area, which give us hope that we will soon be able to shift to a biodegradable form of packaging completely. This will be done without hindering the safety standards of the products by optimising the dimensions and recyclability of our packaging while keeping our products fit for consumption. At Merck, we aim to reduce any adverse impacts our medicines may have on the environment during their development, manufacture, transportation, use and disposal.

Accessibility to healthcare for patients has always been at the forefront of the company, but, at the same time, we are striving towards equity in health. This not only helps the patients enormously, but, at the same time, equity will ensure that every pharma company will have a level ground to establish itself in the market. In addition, the sector holds the capacity to identify needs according to age, geography and treatable and untreatable health conditions to identify their target markets across the globe.

Identifying such factors has equipped pharma companies to invest more effectively in their areas of expertise as it varies from region to region drastically. In economies like India, where there is a vast potential to expand the market, the value proposition from approaching equity in health becomes beneficial while inducing much-needed trust among the citizens.

Accessibility of patients in healthcare is the ultimate aim of every pharma company as patients are the centre of everything that we do for patients to trust us and our research to cure the unique problems of the healthcare community.

Within the pharma industry, accessibility to patients has always been defined as a service that the sector can provide to patients in need, a provider of medication, an institution to approach in distress and the appropriate services that can address the needs of the patients. The sources of healthcare are to be distributed across the areas with the resources to resolve the healthcare issues. Merck has initiated the National Payers Partnership programme on cancer care, an avant-garde programme in the oncology segment with a focus on capability building by creating partnerships with National payers such as Employees State Insurance Corporation (ESIC), under the Ministry of Labour and Employment and the Ministry of Railways to develop pathways for access. These strategic partnerships with multiple state governments to include our medicines under the access initiatives have helped us reach out to the remote areas of the country with the quality drugs that patients around the nation need.

These factors and the choice of each company in the pharma industry will have a lasting impact on the patients we serve across the world. Especially, post the COVID pandemic, the industry has introduced new focus areas.

To read more stories in the January 2023 edition, read our digital issue at: https://www.expresspharma.in/express-pharma-january-2023/

The post Post the COVID-19 pandemic, pharma industry has introduced new focus areas appeared first on Express Pharma.

As a part of Express Pharma’s January 2023 cover story, Suresh Pareek, founder, Ideal Cures and co-founder, Elephant Canvass, shares his views below.

As COVID-19 becomes an endemic virus and economic considerations keep revenue and margins under pressure, new regulatory developments are emerging. Although the lifescience industry has never been at the forefront of digitisation, the COVID-19 pandemic has pushed it to catch up swiftly. The sector now recognises the value of delving deeply to learn about standardising and modernising insight-gathering procedures, embracing novel strategies for problems, and implementing purpose-built technology throughout the drug- and device-development process, from early-stage R&D through post-market surveillance.

Digital transformation paves the way for the quick implementation of Industry 4.0 pillars and concepts in pharma manufacturing. In the digital age, new concepts and methods are required to compete in business and support the economy. Robotics, Artificial Intelligence (AI), Machine Learning (ML), blockchain and the Internet of Things (IoT) are just a few of the technologies that the digital transformation has introduced to the industries and which aid businesses in improving their levels of performance, transparency and security. However, blockchain technology has the potential to have the biggest impact of all by managing logistics and inventories as well as reducing challenges with forging and theft. In the pharma supply chain, this is indeed important.

A few of the major trends will have a huge impact on how the pharma sector is going to transform in the future.

A competitive shifting landscape: Pharma businesses across the world are using cutting-edge ML algorithms and AI-powered platforms to accelerate the drug discovery and development process. Additionally, it simplifies and lowers the cost of cohort identification. As a result, pharma companies are looking at ways to use these technologies to address a range of problems, including the automation and optimisation of manufacturing processes for higher productivity, more efficiency, and a speedier turnaround on the production of life-saving drugs.

Rising role of precision medicine: When compared to other approaches, using precision medication has proved to be more successful. With the help of data analytics, researchers may be able to develop personalised treatments using an ever-growing collection of medical data. Precision medicine’s speciality is shortening clinical trials’ duration, expense and failure rate. Even though there is not much competition in the industry currently, given the opportunity and the size of the market, it’s likely that mid-sized and smaller enterprises will enter it and provide new technology. The number of investors that support precision medicine has exceeded expectations.

Programmatic Clinical Trials (PCTs): Conventional drug trial models were put to test by the spread of COVID-19, necessitating a change to more patient-centred clinical trial designs, a rewriting of protocols to allow remote volunteer monitoring and in-home delivery, as well as the implementation of other digital capabilities, like telemedicine, to maintain clinical research viability. Programmatic Clinical Trials (PCTs) are outcomes-based, patient-centred investigations that compare the benefits and drawbacks of therapeutic interventions to support clinical and/or policy decision-making. Companies may engage with patients and inform them about each phase of the investigation process through the usage of blockchain technology. The technique can facilitate clinical study because it stores patient data. Clinical trial procedures can also be made more understandable to patients and other stakeholders.

Evolving regulatory landscape: The sector was undergoing significant regulatory change prior to the pandemic; in the post-COVID-19 environment, it now faces new challenges and priorities. Drug counterfeiting is a significant problem for the industry, and regulators continue to put pressure on businesses to lower their pricing. Because of this, the sector now needs to create tighter supply chains to ensure complete traceability at every stage. Given all the operational and regulatory constraints placed on the supply chain operations, it is imperative to include blockchain technology to resolve these problems and bring quality-driven, cost-effective products back to the market. The Regulatory Information Management (RIM) framework’s simplicity is another issue the sector has. The industry requires solutions that can help with precise event capturing, action triggering, workflow management, notification management and record update control, all the way down to process automation. In order to accomplish long-term goals, these procedures can be streamlined using a variety of automation technologies, including cognitive and deep Machine Learning (ML), Robotic Process Automation (RPA) and cognitive automation.

Accuracy and transparency in supply chain: The most significant challenge facing every industry is effective supply chain management. The lifesciences industry, however, is more advanced and vulnerable since a contaminated supply chain might endanger patient safety. Particularly in pharma, there are numerous stakeholders and stages involved, i.e., from the API source to the drug manufacturer, packaging and distribution businesses and regulators, all the way through to hospitals, pharmacies, and finally, the patient. With so many intermediaries, the distribution chain is more likely to become complicated, making it challenging to track and verify authenticity. Blockchain technology would be able to demonstrate the provenance of products and offer higher security. In the pharma supply chain, it can control inventory and lessen difficulties with theft and counterfeiting.

Enhancing production efficiency: Lifescience organisations utilise cutting-edge technologies to streamline their production procedures as competition heats up and regulatory requirements change. Businesses must evaluate how they can use their limited resources effectively as the scenario continues to change. Re-evaluating the ratio of internal capabilities to strategic outsourcing relationships may lead to both, opportunities and useful solutions. For instance, the manufacturing process for pharma is intricate and comprises a variety of equipment, including auxiliary equipment, building systems, and heating and cooling systems that can increase production. Rather than purchasing new machinery, organisations should focus on effective maintenance programmes and strategies to make the most of the existing equipment and increase output.

Reassessing the business model: Technology developments and the rise of digital platforms are transforming how businesses operate in the global market. In order to increase the productivity and efficiency of enterprises, the new- age technological explosion has made it possible for business and the digital platform to be considered interchangeable terms. Finance teams can more successfully use past data records in the future by utilising business intelligence techniques and tools like ML and advanced analytics. This makes it feasible to develop sophisticated forecasting models that produce insights that are more accurate. Importantly, this transition to a data-driven decision-making process will formalise the significance of clean and accurate data in all decision-making.

Conclusion
Lifescience organisations need to master not only the science and the ability to innovate, but also the capacity to scale up to industrial levels to compete. Assessing the direct and indirect effects on a company’s operations can help companies decide whether to invest in or source out the new biocapabilities that are coming into the market. Regardless of the decision that turns out to be the best one, businesses will need to increase their understanding of the new-age revolution to recognise, evaluate and operate in this growing market. Similar to their digital predecessors, businesses with expanding biological data sources are now incorporating automation and ML to hasten and diversify scientific findings. Blockchain will eventually modernise the industry and integrate into every major pharma company.

To read more stories in the January 2023, read our digital issue at: https://www.expresspharma.in/express-pharma-january-2023/

The post Digital age requires new concepts and methods to compete in business and support economy appeared first on Express Pharma.

As a part of the Express Pharma’s January 2023 cover story, Vivek Sehgal, Director General (DG), Organisation of Pharmaceutical Producers of India (OPPI), shares his views below.

For the pharma industry, maintaining a reliable supply of high-quality medications for the patient population and other end users is a top concern. One scrutiny by the US Trade Representative (USTR) found over 20 per cent of the drugs in the Indian market to be fake. According to a report by the non-profit Authentication Solution Provider’s Association (ASPA), incidents of substandard and falsified products increased by 47 per cent during the peak of the pandemic from 2020 to 2021.

It is of prime importance to ensure that the quality of the processes that manufacture these drugs, along with the quality of the drugs, is maintained, as this will only help India achieve its health goals faster and more efficiently. Moreover, sub-standard drugs can have a catastrophic impact on human health as they can cause diseases to run a longer course and contribute to the escalating incidence of anti-bacterial resistance.

Current issues: Counterfeiting drugs is a global menace that is estimated to cost the Indian economy Rs 1 trillion annually. While falsified drugs resemble the original brand in looks, they are nowhere as efficacious, and can have an adverse impact as they contain poor doses of the prescribed active pharma ingredient. The pharma industry in India has, however, recognised the need for a proactive and unified quality management approach to mitigate risks and deliver breakthrough drugs. Industry standards such as Good Manufacturing Practice (GMP) and Schedule M (of the Drug and Cosmetics Act 1940), which lay down quality control metrics for production, facilities and equipment, laboratory controls, materials, packaging and labelling, are already in place. Moreover, the Indian government has set up a seven-member panel to prepare the country’s first-ever National Drugs Database. The registry will empower consumers and improve monitoring by providing information such as on a drug’s dosage, form, strength, manufacturer, marketer and importer. On the other hand, the health ministry has also changed the Drugs and Cosmetics Rules to make marketing companies equally accountable for drug quality, apart from the manufacturer. This will also call upon small manufacturers to up their quality game and take a stand against fake and spurious medication.

Future recommendations: It’s crucial to serialise or provide the smallest usable unit of a pharma product, a distinct identity. It makes it possible to discover the product’s past and present locations throughout the whole supply chain. Even blockchain technology might be taken into consideration for the entire network of medicine manufacturing, distribution and sales, preventing the entry of counterfeit and subpar medications. From an overarching perspective, the pharma production process itself needs to be subjected to stricter inspection and control to prevent the deterioration of the quality at any step. In the coming year, as a step towards enhancing the overall quality, providing financial assistance through loans and subsidies for pharma industry units to upgrade their manufacturing, infrastructure and systems to prevent the quality from depreciating right from the development of the pharma product to the last-mile delivery to the end customers: patients, could help. India is taking strides in the right direction, with a lot more focus on product monitoring and quality of APIs. Stakeholders and policymakers also need to take collective action to ensure regulation and compliance. Both the industry and the government are driving the quality revolution in India by making it a cornerstone for the industry’s and the nation’s progress.

To read more stories in the January 2023 edition, read our digital issue at : https://www.expresspharma.in/express-pharma-january-2023/

The post It’s crucial to serialise the smallest usable unit of a pharma product, a distinct identity appeared first on Express Pharma.

The pharma playbook is evolving rapidly to become more agile and responsive to the new market realities and demands of healthcare across the globe. The sector is increasingly looking at new strategies and approaches to enhance process and product efficiencies, improve the expertise of human resources, leverage technology to optimise both, cost and quality of outcomes, as well as encourage scientific innovation.

So, as we enter a new year, Express Pharma’s January 2023 issue, which is also our Anniversary issue, examines and explores trends which will take centre stage in India Pharma Inc’s advancement. The issue analyses how regulators and industry holders can align with each other to chart an impressive growth trajectory.

Read more:

It’s crucial to serialise the smallest usable unit of a pharma product, a distinct identity

Digital age requires new concepts and methods to compete in business and support economy

Post the COVID-19 pandemic, pharma industry has introduced new focus areas

The power of AI is the future of pharma

By 2023, pharma industry is expected to be worth more than $1 trillion

Top trends in pharma marketing in 2022 will continue to dominate the sector in 2023

Boosting stakeholder supply chain visibility and enhancing pharma logistics through internet

The post Pharma Playbook 2023 appeared first on Express Pharma.