The Express Pharma – Nutrify Today Boardroom series offers 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.

The gender gap in the workplace, including the nutraceutical sector, is a significant issue that affects millions of individuals worldwide. Women often face obstacles such as unequal pay, disparities in promotions, incidents of sexual harassment, and racism. Despite more women entering the workforce, achieving gender equality remains a challenge.

In this video, Lynda Doyle, President and CEO, Avant Nutrition LLC moderates a discussion on how Women In Nutraceuticals (WIN) is helping to create an environment where all genders can thrive. In discussion with Heather Granato, Vice President, Partnerships & Sustainability Informa Markets; Gillian Fish, President & CEO, The 6AM Agency; Dr. Anand Swaroop, President, Cepham and Rajat Mittal Shah, Co-Founder & Executive Director, Nutriventia Healthcare, panellists celebrate some early success stories and best practices on how nutraceutical workplaces can reduce the gender gap.

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Express Pharma – Nutrify Today Boardroom series offers 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.

In a free-wheeling video interaction with Express Pharma, Sanjaya Mariwala, Executive Chairman and Managing Director, OmniActive Health Technologies, speaks on how new-age technologies are leveraging India’s traditional medicine knowledge, especially bioactives from natural products. Adopting the Intel Inside strategy, OmniActive’s bid to avoid commoditisation includes getting mentioned as a branded nutra ingredient on global labels. He also spells out what policy support is needed from government to ensure India’s nutra sector reaches USD 100 billion by 2030.

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Express Pharma – Nutrify Today Boardroom series offers 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.

In an unrestrained dialogue, Dr Anand Swaroop, President, Cepham Inc, a well-known nutraceutical ingredients developer and branded formulations owner in the US, engages with Vishrut Srivastava, Managing Director, Yodaplus, India, an experienced AI leader. The conversation navigates from AI discovery to its contrast with human intelligence, finally spotlighting its deployment in nutraceuticals through the case of the AI-driven Nutrify Genie engine.

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Express Pharma – Nutrify Today Boardroom series offers 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.

In this video, Rahul Adakmol, COO – International Operations & Business Development at Bharat Serums and Vaccines, speaks on the trends shaping the pharma and nutra sectors, ethical and responsible approaches for the pharma industry to leverage opportunities in nutraceuticals, BSV’s focus areas for growth, in a free-wheeling interaction with Express Pharma

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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.

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India is set to become a major player in the global nutraceutical industry, with a projected $100 billion valued market by 2030. But nutraceuticals lack the oversight of pharmacovigilance, a practice that is commonplace in pharmaceutical studies to ensure safety and efficacy of products before they are launched to retail consumers.

In this video, Amit Srivastava, Chief Catalyst, NutrifyToday.com talks about his transition from pure play pharma to setting up BioValley Incubation Council, Visakhapatnam, Andhra Pradesh, which could become the world’s largest nutraceuticals hub.

Taking the learnings from Biovalley he set up NutrifyToday.com, which democratises the journey from nutra innovation to commercialisation.

Success stories like NanoVeda are proof that NutrifyToday.com‘s model of showcasing and connecting evidence-backed nutra innovators to players across the world works very well indeed.

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The first edition of the Express Pharma – Nutrify Today Boardroom series was held on February 17, 2023, at St Regis, Mumbai to offer 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 experts and leaders from the pharma sector came together to explore approaches to build an ecosystem for developing, scientifically proven, evidence-based nutraceutical products. They also dived deep into the challenges in this field and the measures needed to enhance ethical standards in nutraceutical research, industry practices, and use.

In this video, one of the participants, Anand Swaroop, President, Cepham Inc talks about his transition from pharmaceuticals to nutraceuticals. As regulatory agencies turn a more critical gaze on this sector too, he reiterates that pharma companies are best suited to excel in nutraceuticals.

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The first edition of the Express Pharma – Nutrify Today Boardroom series was held on February 17, 2023, at St Regis, Mumbai to offer 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 experts and leaders from the pharma sector came together to explore approaches to build an ecosystem for developing, scientifically proven, evidence-based nutraceutical products. They also dived deep into the challenges in this field and the measures needed to enhance ethical standards in nutraceutical research, industry practices, and use.

In this video, one of the participants, Shriram Balasubramanian, Director Marketing and Business Development, Zuventus Healthcare talks about his company’s strategy for the nutra sector. One of the key elements of their success story is the groundwork that went into curating the scientific and medical information that goes into formulating their nutraceutical products

The post A nutra success story from India: Shriram Balasubramanian, Zuventus Healthcare appeared first on Express Pharma.

India is set to become a major player in the global nutraceutical industry, with a projected $100 billion valued market by 2030. But nutraceuticals lack the oversight of pharmacovigilance, a practice that is commonplace in pharmaceutical studies to ensure safety and efficacy of products before they are launched to retail consumers.

NutrifyToday’s NutrifyGenie, a ground-breaking AI-powered engine designed to facilitate the development of ethical nutraceutical formulations, hopes to cut time to market and deliver products fit for global regulatory and safety standards.

In this video, Amit Srivastava, Chief Catalyst, NutrifyToday.com explains how NutrifyGenie, which helps turn ideas into commercially successful nutraceuticals backed by scientific evidence, offers a value proposition for ethical nutraceutical development.

For more information, see the report: https://www.expresspharma.in/nutrifygenie-set-to-catalyse-mission-100-billion-nutraceutical-india-by-2030/

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As the resilience of life sciences companies continues to be tested, there is no dearth of technologies to strengthen the ecosystem. But do pharma honchos see enough value and ROI to onboard such systems? In the first of a series of thought leadership round tables, hosted by Express Pharma, as part of SAP India’s Industry Knowledge Exchange (IKEX) Series, in partnership with the Indian Pharmaceutical Alliance (IPA), life sciences leaders share insights on major pain points and some solutions

With a perfect storm of virus variants, geopolitical instability and stagflation, and much more, brewing, how do life sciences leaders transform their enterprises into more resilient and flexible entities?

Continuing the partnership with the Industry Knowledge Exchange (IKEX) Series, in association with the Indian Pharmaceutical Alliance (IPA) and SAP India, Express Pharma is organising a series of Thought Leadership Round Tables for pharma leadership across key functional areas. The aim is to understand their concerns and search for collective learnings and synergies.

Focusing on the theme, Driving Business Innovation in Life Sciences, the consensus at two recent engagements, (Bengaluru, May 11, 2022, followed by Mumbai, May 19) was that though the sector is faced with a plethora of opportunities, the challenge is to choose the right one, and the right path, to maximise chances of success.

Leaders at the Bengaluru round table spanned contract research (Dr Mahesh Bhalgat, COO, Syngene), big biopharma (Krishna Sai T, Head IT, Biocon), contract biopharma manufacturing (Sanjay Lodha, VP – Operations, Kemwell Biopharma), as well as supply chain and operational heads from pharma (Rajesh Kshirsagar, COO, and Jitendra Patel, Supply Chain Head, Micro Labs and Shailesh Siroya – Managing Director, and Bharath Bhushan D V – M&A and Investor Relations, Bal Pharma).

Round 2 in Mumbai had a similar mix, with stalwarts like Arvind Agarwal, CFO, Ajanta Pharma; Nihar Medh, Sr VP SCM, Global Head of Procurement, Cipla; Rohit Chugh, Head -Digital Transformation, Sun Pharma; Manish Kishore, Global Head – IT, Wockhardt; and Pankaj Agarwal, Operational Excellence, Lupin with Sudarshan Jain, Secretary-General, IPA giving an industry overview on recent policy interventions.

From challenges …

Supply chain and operational heads like Lodha of Kemwell Biopharma spoke about the disruptions of the COVID-19 pandemic, when India’s dependence on consumables like filters and raw materials crucial to the production of COVID-19 vaccines and other bio-therapeutics, created a backlog in production schedules and increased costs. The uncertainty of supplies and increase in freight surcharges, sometimes upto 12 per cent of the value of the consignment, led to the realisation that manufacturing of these inputs, be it equipment or ingredients, needed to shift to India.

However, this is easier said than done. Veterans like Agarwal of Lupin pointed how setting up API plants in the country has been next to impossible, resulting in India’s dependence on imports.

Micro Labs’ Kshirsagar spoke of how lead times increased, as pharma companies cannot change vendors as easily as other manufacturing sectors, due to regulations. The shortage of shipping containers continues even today, with delays of 45-60 days. His colleague Patel recalled how input costs increased prices while Bal Pharma’s Siroya commented on how the volatility impacted the ability to quote rates in tenders.

All spokespersons agreed that the regulatory diktat to trace the route of synthesis of each ingredient, after the nitrosamines linked to cancer were found in some input ingredients, added another layer of challenge. Supply chain disruptions constrained pharma companies to search and switch vendors.

Talking about the challenges of using digitisation strategies to meet these challenges, Biocon’s Krishna Sai pointed out that this magnified the need for documentation especially when companies change vendors due to scarcity. In the same vein, Wockhardt’s Manish Kishore highlighted the impact of dead inventory in the supply chain and the need to connect 3PLs across the chain.

… to innovative collaborations

But these constraints led companies to dig deeper for insights to find a way around these blocks. For instance, Dr Bhalgat spoke about how technology can be used to understand which ports are less congested than others so that supplies can be re-routed. He also commented about how technology is also being used for looking at equipment efficiency and making equipment monitoring automated and round-the-clock therefore permitting early interventions.

As companies chase limited input ingredients and the like, Medh pointed out that while companies continue to compete, the benefits of collaborating to sort out supply chain issues could perhaps be one of the biggest learnings of the pandemic.

Chugh highlighted that achieving scale, compared to peers in countries like China, was another big challenge. He also emphasised on the use of new technology- blockchain which holds a lot of promise in the pharma value chain to address the issues of counterfeit medicine and provenance. The overall thought process of implementing ‘digital transformation’ and how to bring about cultural change was debated.

Agreeing with this analysis, Ajanta Pharma’s Arvind Agarwal opined that unless large pharma companies collaborated with smaller ones, they would not be able to achieve scale. In the same vein, Kishore pointed out how collaborations with start-ups and smaller players could help India meet global pharma requirements.

From his perch as IPA Secretary-General, Jain highlighted that coordination and collaboration between companies and associations have been the hallmark for ensuring a consistent supply of medicine during the COVID-19 pandemic. Although all the companies aggressively compete in the marketplace, they have been sharing the learnings in terms of the safety of employees, digitalisation, common supply chain issues encountered during the pandemic and the situation in different parts of the country. They have been also coordinating closely with the ancillary industries and channel partners. The government has been a great support during this unprecedented time. All issues related to availability have been dealt with at high speed. This has been transcribed as a case study with IIM Ahmedabad.

Jain reiterated that we should leverage the learning going forward in the interest of public healthcare. Initiatives to supply medicines to Sri Lanka, Ukraine and Russia, is a great example of Indian pharma companies playing an important role in access to medicines. India can bring savings to healthcare systems across the world through the supply of affordable quality medicines. Recent FTAs with Australia and UAE are steps in the right direction. Going forward, he opines that digitalisation will play an important role in building productivity and efficiency in the supply chain and overall company operations.

Tech as an enabler

Commenting on the role of technologies, Lodha conceded that there were many technologies – both software and hardware- available, but obsolescence was a major problem. Replacing tech every 4-5 years made them prohibitively expensive. Krishna Sai too agreed with this assessment, that most tech needed to be replaced every 3-5 years but spoke of the benefits of harnessing the data for predictive analysis.

In the battle for resource allocation, justifying the value of technology to finance heads /CFOs is a tough sell. While leaders can sell on compliance, Dr Bhalgat pointed out that making a business case for tech spend should ideally package the cost as a value, which is possible if the benefits are clearly quantifiable.

While Kshirsagar threw up the need to integrate data across all manufacturing systems through Electronic Batch Records (EBRs), Siroya spoke on how high attrition meant that companies had to constantly train new recruits.

The threat of a limited talent pool was discussed at the Mumbai round table too, leading Medh to predict that companies which have been able to deploy technology, will be able to retain talent better.

The subtext of many conversations at both round tables was maintaining the delicate balance achieved during the pandemic, when companies pooled resources, whether it was to meet surging demand for COVID therapeutics or liaise with policymakers. And companies are aware that they need to continue to look for synergies. For instance, Medh suggested further areas of collaboration like using common vendor audits.

Companies like Sun Pharma are already harnessing technology, and Chugh gave an overview of how his company has digitised secondary sales data to gain visibility of stock beyond the factory gate.

Show RoI and benefits

Giving a CFO’s perspective, Agarwal of Ajanta Pharma referred to the benefits of digitization of inventories, suggesting that the pharma sector can learn from other sectors, especially FMCG, one of the first sectors to embrace this approach.

Given the stress on margins and the inability to pass on costs to the end-user/patient, many participants wondered if India could afford to continue to be the low-cost pharma manufacturing destination of the world. The answer would be to scale up fast, using smart technologies to do more with less.

Given the theme was Driving Business Innovation in Life Science, tech experts from SAP India like Sudakshina Ghosh, Industry Business Architect, Team Lead, Industry & Customer Advisory Practice, SAP India, Rajesh Kuppuswamy, Life Sciences and Health Care Industry Advisor, SAP India and the team from Tenthpin Management Consultants gave an overview of how pharma companies can transform their organizations into intelligent enterprise by achieving value with intelligent ERP systems

SAP’s Kuppuswamy gave examples of how SAP is incorporating user feedback to build India-centric solutions using the SAP global ecosystem, co-developing solutions with strategic partners like Tenthpin Management Consultants who have complementary expertise in niche areas.

Further expanding on this partnership, Raghuram Janapareddy, Partner & Managing Director India, Tenthpin Management Consultants who moderated both engagements, supported by team members Rama Rao Jupelli and Vishal Pratapwar, explained how SAP along with Tenthpin is building a comprehensive life sciences eco-system for collaborative innovation, wherein they invite pharma companies to be part of an advisory council to identify common business requirements and build them in a collaborative manner.

Tech solution providers like SAP and their partners like Tenthpin Management Consultants are building robust cloud-based business solutions needed by pharma companies, hoping to get more companies on board and help them find ways of harnessing their strengths.

But given the constraints, will more pharma companies invest deeper in such technologies, with an eye on future gains? And do they have a choice, if they want to not just survive, but thrive and move to the next level?

Express Pharma, SAP India, and IPA look forward to continuing this dialogue with pharma leaders at forthcoming round tables. Watch this space for more insights!

Siesmic shifts in life sciences

Resilience of the Supply Chains are being stretched to the boundaries, with multiple external factors, which are changing dynamically every day. Shorter delivery time lines, varying demand for new drugs, Expiration of stocks, theft & counterfeits, loss of potency due to failures in expected controlled environment, geo-political situations, natural calamities, etc. are impacting the supply-chains.

Inbound Logistics: The recent Pandemic has exposed the inbound supply chain challenges extensively. Shortage of APIs, extensive delays in shipments, numerous quality check for onboarding new vendors, ever-changing prices for the raw materials, raising costs etc. are impacting the supply of raw materials and intermediates for manufacturing.

Production (Manufacturing): The manufacturing process is becoming more and more complex. Distributed Manufacturing, Customized batch sizes, complexities in labelling requirements, batch traceability, cold chain monitoring are some of the challenges that pharma companies must handle. The manufacturing lines are not geared up for varying batch sizes. Capital investments are a deterrent for investing in flexible manufacturing machinery.

Marketing, Sales and Distribution (Outbound Logistics): With extreme competition and growing demand for generics, economic crisis in few countries and inflation effecting the consumer buying behaviour etc. are putting extreme pressure on the pharma companies for the growth, and sometimes their sustenance. Spurious and counterfeit drugs are compounding these woes. Due to these dynamics, it takes a lot of time to recover the investments into the R&D, which impacts the profitability and cash flow.

In addition, the involvement of multiple external players such as, Third-party Packing Agents, Logistics depots, Cold Chains service providers, 3PL, Export agencies, Airports, Ports, Customs, Marketing Agencies bring their own complexities to the outbound supply chain.

Quality and GXP: With intense scrutiny from the regulatory, changing international regulatory compliance requirements, constant surprise inspections, need for submission of enormous amount of documentation and data, expiring IP timelines are some of the macro challenges that Pharma companies are facing. In addition, there are also need for maintaining the books and records for the internal quality processes, need to prove the compliance to the SoPs and Quality Management System, managing the quality compliance by the external partners such as CROs, ensuring constant quality surveillance to avoid DS/DP expiry, managing the batch genealogy, proactive quality surveillance are some of the challenges the companies face.

(Source: Tenthpin Management Consultants)

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