Introduction to Pharma Industry
Health is wealth. And pharmaceutical companies are the key influencers of health outcomes that greatly impact health (and well-being).
The pharma industry is a ‘global healer’ and post COVID-19, we all know how they have been frontline heroes. Today, we realize the importance of not just pharma companies, but also the rise in demand for personalized medicines, hyper-responsive and patient-centric healthcare, cell and gene therapies, and the utilization of artificial intelligence (AI) platforms to analyze real-world data stored in the cloud. These are clear examples of the customized approach driving the pharmaceutical industry’s future.
Learning about the Pharma Industry in India
In the Indian context, the nation holds the title of the world’s top supplier of generic drugs. In the fiscal year 2024, India exported approximately 16 billion U.S. dollars of pharmaceuticals. Regarding volume, Indian drugs accounted for 20 percent of global generic drug exports, with North America having the largest share. (According to Statista)
From production challenges to global demands, pharmaceutical businesses require smart manufacturing advancements that accelerate production, improve efficiency, and optimize performance across the manufacturing lifecycle.
The Latest Pharma Advancements in India
In 2023, the government issued a directive that mandated all pharmaceutical companies in the country to align their processes with the revised Good Manufacturing Practices (GMP) guidelines, aligning them with global standards. This initiative aims to ensure the highest standards of quality control, documentation, and IT integration to safeguard the production of medicines.
This meant all companies with an annual turnover exceeding Rs 250 crore were required to adopt these changes within six months. Meanwhile, medium and small-scale companies with turnovers below Rs 250 crore have a one-year timeline for implementing these pivotal modifications.
Recently, the government also announced the launch of the fresh Pharmaceuticals Technical Upgradation Assistance (PTUAS) scheme, aimed at financially assisting drug manufacturers with annual turnover below Rs 500 crore to upgrade their facilities to meet global standards. This initiative follows the introduction of revised Schedule M guidelines for GMP compliance earlier this year.
The expanded scope of supported upgrades, aligned with global standards, and flexible finance options will enhance competitiveness and help the sector take significant strides in manufacturing quality medicines. The revised PTUAS will also facilitate investments in technologies, improve operational efficiency, and ultimately enhance the overall quality of Indian pharmaceuticals.
Technology Dosage: A Requisite for Pharma Industry
In an industry where quality and safety directly impact human lives, maintaining the highest standards is non-negotiable. The pharmaceutical sector operates under the vigilant scrutiny of regulatory authorities to ensure that products meet stringent quality and safety measures throughout their lifecycle – from development to distribution. The precise deployment of specialized software modules culminates in the establishment of a scalable, future-ready, and seamlessly integrated quality management and LIMS system, which can be validated in strict alignment with the guidelines of Good Automated Manufacturing Practice (GAMP) and Pharmaceuticals Technical Upgradation Assistance (PTUAS).
As pharma technically involves expansive, extensive and expensive development cycles, ever-evolving global demands, driven by trials and delivery, changes to pharmaceutical processes need the power of technology. Now, digital transformation is a thing of the past. It’s overused and has already been adopted by many companies. Today, pharma companies need deeper digitalization.
With technology, pharma companies should be able to respond more quickly with agility and flexibility- all with being compliant and resilient.
The need of the hour is to harness the power of configurable solutions and intelligent platforms to align pharma business processes with market demands and evolving regulations. This is the perfect moment to capitalize on automation expertise, stand out from the growing competition, and make the world a healthier, happier place.
Now is the era of PROGRESSIVE PHARMA TECHNOLOGY TRANSFORMATION.
But, what are the technology roadblocks in the pharma industry?
Pharmaceutical firms constantly seek to enhance their offerings and deliver superior drugs/medicines. However, conventional research and development methods are becoming outdated, prompting industry to undertake significant digital transformation efforts.
To stay relevant and competitive, large pharmaceutical enterprises must update their legacy applications to modern cloud technologies. This modernization offers several advantages, including enhanced quality assurance, competitive edge, improved product development, regulatory compliance, and sustained growth. But this modernization also comes with certain hurdles specific to the pharma industry:
Regulatory Compliance: Pharmaceutical companies must comply with myriad regulations, from clinical trials to manufacturing and distribution standards, to avoid costly penalties and reputational damage. The data must be updated on modern applications and should be secure.
R&D Costs: Developing new drugs/treatments is expensive and time-consuming, requiring companies to optimize resources and streamline research processes. As much as this calls for automation, careful implementation of tech and data analysis is required to curb costs.
Intellectual Property: Protecting patents is vital in the competitive pharma sector but enforcing them can be complex and costly.
Pricing Pressure: Companies face immense pressure to keep product costs low, leading to lesser profit margins and higher competition. Technology is needed to ascertain demand, forecast sales and keep pricing pressures in check.
Supply Chain Management: Ensuring the quality and safety of pharma products throughout the supply chain is important, but challenging.
Data Security: Managing vast amounts of sensitive data securely is crucial amid cyber threats and data breaches.
Aging Population: With a larger global population aging, there is rising demand for quality treatments, posing challenges in developing and managing healthcare costs.
Personalized Medicine: Advances in technology offer opportunities for personalized treatments but come with significant costs and regulatory considerations.
Public Perception: Companies face scrutiny over issues like drug pricing and access to healthcare, necessitating a positive reputation.
Innovation: Staying competitive requires staying at the helm of new technologies and discoveries to meet evolving patient needs.
Reverse Logistics: This poses a significant financial threat to pharma manufacturers, with just product expiries resulting in approximately $300 USD loss in India. Addressing these limitations requires an exhaustive approach, including the implementation of a tech automation solution.
Additionally, a notable challenge is the reluctance to prioritize AI and machine learning (ML) systems, despite their potential to address data gaps and automate tasks, including predictive maintenance. This reluctance could hinder long-term competitiveness and innovation.
Nonetheless, adopting intelligent systems is just the beginning. The future lies in interconnected intelligent systems that can revolutionize industry.
ERP: A Panacea for Pharma Tech Challenges A Look at the Need for Pharma ERP Implementation
The pharmaceutical supply chain is not just critical; it’s a lifeline that directly impacts the well-being of millions. In the healthcare industry, businesses must have complete control and traceability of their supply chains to ensure QC and compliance with regulatory requirements. This is where Enterprise Resource Planning/ERP software steps in, playing a crucial role in achieving efficiency, traceability, quality, and delivery in the pharmaceutical supply chain.
A Pharma ERP software is not just a tool; it’s a solution that addresses supply chain challenges and ensures efficient, accurate, and transparent operations. It’s a game-changer that helps reduce costs, shorten lead times, and enhance customer service by improving information flow and control. While some businesses manage disparate IT systems or manual processes, these approaches are not sustainable in the long run. A Pharma ERP solution offers a single, scalable platform that is not just a luxury but a necessity for greater control, traceability, transparency, and visibility across the supply chain.
By maintaining records and meeting compliance requirements related to clinical trials and cGMP, an ERP for pharma is not just a tool; it’s a guardian that eliminates errors and prioritizes supply chain control and visibility for pharmaceutical manufacturers.
Features of Pharma ERP/ Pharma ERP Modules
Pharma ERP is a life-savior for pharma companies. It automates and streamlines most of the tedious, manual tasks. Some of the pharma ERP features include –
- Quality Assurance (QA) in compliance with cGMP norms
- Quality Control (QC) with sampling plan and stability testing
- FDA 21 CFR part 11 compliance, ensuring secured management of master data
- Raw material tracking, planning and procurement
- Inventory management, including classifications, lot potency, expiration dates, lot control, and varying units of measure
- Vendor/supplier management and qualification
- Third-party manufacturing and contract manufacturing support
- Formulation management, ensuring full formula privacy with audit trail as well as approval workflow
- Batch monitoring activities through inspection plans
- Electronic execution of SOPs using inspection checklists
- Electronic Weigh Sheet, Electronic Batch Ticket and Manufacturing Batch Record (MBR)
- Corrective and Preventive Action (CAPA) optimization
- Simple material substitutions
- Co-product and by-product management
- Myriad packaging of the same formulation
- Shelf life/drug expiration support
- Master Production Scheduling (MPS)
- Bi-directional lot traceability
- Lot recall
- Separate granular costing of formula and packaging material
- ‘What-if’ analysis
- Various costing methods for increased margins
- Adverse event reporting
- Complaint reporting
- Allergen tracing and management
- Mobile warehousing, using handheld RF devices for material movement and adjustments within facilities
- Material Requirement Planning (MRP)
- Dedicated module to handle complaints, returns, and recalls
Beyond the functions and features, ERP can play a major role in streamlining clinical trials with e-clinical platforms. ERP enhances trial speed and quality while managing costs efficiently. By simplifying data collection, analysis, and reporting, e-clinical platforms enable quicker decision-making at reduced expenses. It aids pharma companies by integrating various solutions into one platform, managing data effectively, assisting in trial planning and assessment, handling participant information and consent, and generating insightful reports.
ERP Implementation Advantages
ERP implementation offers multiple advantages, including streamlining operations, automating processes, improving efficiency, and speeding up decision-making. At Uneecops, we implement Enterprise Resource Planning (ERP) systems like SAP Business One and SAP S/4HANA for fast-growing, ambitious pharmaceutical companies. With features designed to support Good Manufacturing Practices (GMP) and ensure regulatory compliance, ERP systems help pharmaceutical companies adhere to industry standards. Additionally, ERP systems provide advanced analytics capabilities, real-time data processing, and scalability, enabling pharmaceutical companies to gain deeper insights, make faster decisions, and adapt to changing business needs. Uneecops’ specific pharma add-ons further enhance these advantages. Together, these advantages help pharmaceutical companies improve resource management, reduce costs, and drive growth in a competitive market.
Recently, we helped Sharika Lifesciences implement ERP with GMP (Good Manufacturing Practice) compliance, highlighting the transformative power of ERP in the pharmaceutical industry. Sharika Lifesciences has improved inventory management, ensured regulatory compliance, and enhanced overall productivity by integrating its operations with ERP. This successful implementation highlights how ERP can revolutionize operations and drive growth in highly regulated industries like pharmaceuticals.
Analytics: A Cure for Pharma Data Deciphering Need for Pharma Analytics Implementation
Now that all processes are streamlined, the next step is data handling. Consider tech like a vicious circle. If ERP is a game-changer in terms of ops visibility, analytics is the key to conquering pharma data challenges.
Visual analytics helps pharma enterprises derive insights from vast datasets and confidently make decisions. Data strategies are pivotal to delivering accurate results and life-saving treatment – especially in the face of massive adversity and pharma breakthroughs that have followed in recent years. As pharma sets the pace to pave the way for the future of health, data culture in medicine is the key to navigating supply chain complexities and delivering speed and agility in healthcare.
The vast amount of pharma data generated today often exceeds the capabilities of standard laptops. Handling such data requires specialized processing tools like Tableau core, which are designed to efficiently manage and analyze large volumes of data, enabling businesses to derive meaningful insights and make informed decisions.
Analytics and BI (Business Intelligence), powered by data analytics platforms like Tableau and Power BI help create better patient outcomes, instilling better decisions at every stage of drug development, from research to marketing.
To know more about data and dashboards for pharma analytics, read the in-depth blog.
Analytics Implementation Advantages
Analytics brings data + decisions together for greater impact. This includes the development of dashboards to track patient data and diagnosis and to identify ways to have faster, smarter clinical trials that result in groundbreaking medical cures against diseases.
More advantages of pharma analytics include:
Optimizing R&D Efforts: By analyzing market trends and clinical trial data, pharma analytics helps identify promising drug candidates more rapidly, reducing the time and cost of research and development.
Improving Drug Efficacy and Safety: Analytics can ascertain patterns and correlations in real-world patient data, enhancing drug safety monitoring and ensuring the effectiveness of pharmaceutical products.
Enhancing Market Access Strategies: Understanding patient demographics and market dynamics through analytics aids in developing targeted marketing strategies and optimizing pricing and reimbursement models.
Compliance and Risk Management: Analytics tools can identify potential risks and monitor regulatory compliance, helping pharma companies mitigate legal and financial liabilities.
Forecasting and Resource Allocation: Predictive analytics enables accurate demand forecasting for pharmaceutical products, optimizing inventory management and resource allocation.
Pharma analytics empowers companies to stay ahead of competitors by identifying market opportunities, predicting trends, and adapting strategies accordingly.
Browse through an interesting case study of Mankind Pharma, as Uneecops + Tableau became their means for reducing reporting time by 50% and automating analytics by as much as 70%!
Modern Trends in Pharma Analytics
Utilizing DataOps for scaling analytics and data projects can significantly enhance the integration and management of data, fostering a more cohesive data environment. In the pharmaceutical industry, this translates to expedited insights and refined decision-making, ultimately leading to safer and more efficacious patient care. DataOps facilitates progressive pharma tech transformation by:
- Extracting enhanced value from data
- Fostering innovation powered by data
- Building a data driven GTM strategy
- Establishing performance metrics and clear milestones
Moreover, incorporating Artificial Intelligence/AI and Machine Learning/ML into pharma data analytics expediates the decision-making processes. AI and ML algorithms can swiftly analyze vast datasets, facilitating crucial decisions such as identifying drug candidates, predicting outcomes, and optimizing coordination. Adopting AI-ML technology ensures improved patient care and heightened treatment outcomes. AI and ML applications in pharma streamline various processes, including:
- Conducting trial simulations to ensure participant safety
- Anticipating and mitigating supply chain challenges proactively
- Predicting patient reactions accurately
- Selecting trial participants aligned with overarching objectives
In essence, the integration of DataOps and advanced technologies like AI and ML paves the way for unprecedented efficiency and effectiveness in pharmaceutical endeavors, benefiting patients and healthcare outcomes.
‘No one would swallow a pill without trust.’
For Customers + Trust: CRM Therapy Need for Pharma CRM Implementation
Processes are automated. Data analytics is in full swings and decision-making is swifter, insight based. Now comes customers + trust.
Trust means garnering pharma stakeholders’ confidence, managing compliances, combating regulatory risks, adhering to legal and tax compliances, and ensuring the quality efficacy of the new drugs. For customers, it means building relationships and consistently delivering curated, customized experiences for patients.
To enhance patient services, connected technology comes into picture. Here, CRM (Customer Relationship Management) tools amp up productivity and reduce budget by getting your providers and patients close –in real-time.
Salesforce CRM, the world’s #1 CRM is a sales, marketing and service armor that must be injected into every pharma business process. In the pharmaceutical industry, the need for Salesforce CRM is paramount due to its robust capabilities tailored specifically to address the unique challenges and requirements of this sector. With stringent regulatory compliance standards such as HIPAA and GDPR governing the collection, storage, and sharing of patient data, Salesforce CRM offers advanced security features and compliance controls to ensure adherence to these regulations while facilitating seamless data management.
CRM Pharma Modules/Offerings
Health Cloud: Elevates outcomes by seamlessly integrating data and teams, streamlining processes, and tailoring interactions on an intelligent platform- changing the way pharma companies connect and engage with customers.
Marketing Cloud: With personalization as a weapon, Marketing Cloud empowers pharma companies to craft unique customer journeys and optimize campaigns across channels and devices with innovative data-centric solutions.
Experience Cloud: Swiftly deploy data-driven portals, websites and apps that resonate across every touchpoint of the customer experience journey.
MuleSoft Anypoint Platform: Effortlessly integrate data from disparate systems to expedite mission-critical projects, all consolidated within a single platform for APIs and integrations.
Pharma CRM Analytics: Drive informed decision-making across your organization with CRM Analytics for Health Cloud, enabling your team to uncover valuable insights and take proactive, data-driven actions.
Plus, elevate operations with Uneecops’ specialized pharma in-house add-ons and accelerators, injecting personalized automation to drive efficiency and innovation like never before.
CRM Implementation Advantages
Furthermore, Salesforce CRM’s sophisticated data analytics tools enable pharmaceutical companies to gain deep insights into their customer base, including healthcare providers, patients, and payers. This allows for targeted marketing efforts, personalized engagement strategies, and more effective sales interactions, ultimately leading to increased market penetration and revenue growth.
Moreover, Salesforce CRM’s flexible architecture facilitates seamless integration with existing systems and data sources, enabling pharmaceutical companies to leverage their existing infrastructure while enhancing interoperability and data exchange capabilities.
Thus, Salesforce CRM becomes indispensable for pharmaceutical companies seeking to navigate the complex regulatory landscape, optimize customer relationships, and drive growth through data-driven strategies tailored to the unique demands of the industry.
Read one of our case studies where we cured user adoption challenges with Salesforce:
https://www.uneecops.com/case-study/indias-top-medical-equipment-and-healthcare-venture-cured-user-adoption-challenges-with-salesforce/
Cloud Implementation Advantages
Implementing cloud solutions, such as those offered by AWS and Microsoft Azure, brings numerous advantages to pharmaceutical companies. With AWS and Azure’s robust infrastructure and global reach, organizations can achieve enhanced scalability, reliability, and security for their critical data and applications. Moreover, cloud-based analytics tools enable real-time insights and predictive analytics, empowering pharmaceutical companies to make informed decisions and drive continuous improvement in their operations.
Formulating Pharma Industry Success: A Wrap
The drive towards progressive tech transformation in the pharmaceutical industry isn’t just about adopting technology for the sake of it. It’s about strategically deploying multiple digital tools to accelerate processes, connect crucial dots, and unleash untapped potential.
Forward-thinking companies are poised to invest in cutting-edge technologies like AI, data analytics, and machine learning to expedite drug development, harness predictive insights, and optimize operational efficiencies across the entire product lifecycle.
Yet, incremental shifts will not suffice to meet the demands of the market and patients. True transformation is imperative for achieving substantial growth both in the short and long term.
Innovation must permeate every facet of the business model, starting from R&D investment strategies. Leaders must reassess their investment balance between established areas and uncharted territories to break free from the cycle of margin compression and subpar returns.
To harness the power of next-generation technology effectively, executives must have:
- A sharp vision of new gen tech
- A roadmap for interconnecting tech and creating progressive transformation
- A strong, ethical framework
- A powerful portfolio of transformative use cases, and scalable digital infrastructure
- A backbone that can guide end-to-end deployment, like a verified strategic business process partner
Embracing cutting-edge technology isn’t about staying ahead; it is about redefining the future of pharmaceuticals and delivering impactful solutions that drive growth and enhance patient outcomes.
As you set to break new ground in the pharma space with progressive technology transformation, embark on a journey with Uneecops’ dynamic suite of analytics, CRM, ERP, and cloud solutions. From pioneering drug development to fostering patient-centric care, unleash the power of innovation and efficiency with our transformative tech arsenal.