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PharmaLytica 2023: Unlocking Doorway to a Comprehensive Understanding of Indias Evolving Pharma Landscape

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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The 9th edition of PharmaLytica, a premier pharmaceutical exhibition, commenced with an unwavering commitment to adapt to the changing healthcare landscape, and meet dynamic patient and business requirements. Organised by Informa Markets in India, the three-day event is taking place at HITEX, Hyderabad, hosting over 150 exhibitors. Allied to South Asia’s largest Pharma event, the CPhI & P-MEC India show, PharmaLytica is expected to witness over 6000 domestic and international visitors from 16 countries and 21 Indian states, and approximately 250 delegates over the duration of the expo.

This event serves as a testament to India’s vision of becoming the pharmacy of the world, providing a platform that contributes significantly to achieving this ambitious objective. The future of pharma will leverage Robotics and Digitalization to a significantly high degree. These include the use of automated systems, data analytics, and cloud-based architecture, which attendees can witness at PharmaLytica 2023.

The Event had participation from key stakeholders from the Pharmaceutical Industry including Chief Guest Shri Jayesh Ranjan, IAS, Principal Secretary, Industries & Commerce Dept, Government of Telangana; R.K. Agrawal, National President, Bulk Drug Manufacturers Association of India (BDMAI); Harish Jain, President, Karnataka Drugs & Pharmaceutical Manufactures (KDPMA); Avinash Kumar Talwar, Vice President, Dr. Reddy’s Laboratories, Shankar Gupta, Chief Sales Officer, ACG; Yogesh Mudras, Managing Director, Informa Markets in India and Rahul Deshpande, Senior Group Director, Informa Markets in India.

Highlighting the importance of technology, Shri Jayesh Ranjan, IAS, Principal Secretary, Industries & Commerce Dept, Government of Telangana said, “The pharmaceutical, biotechnology, and medical devices industry in Telangana has experienced remarkable growth, surpassing initial expectations. Initially projected to reach $100 billion in ten years, the industry has already reached a substantial size of $80 billion, prompting a revision of the target to $250 billion. This buoyancy reflects the industry’s potential and highlights the need for the sector to showcase advanced and sophisticated technologies, moving beyond bulk manufacturing. The pharmaceutical industry plays a pivotal role as part of the government’s “Atmanirbhar” strategy, necessitating introspection and revaluation to propel further growth. Additionally, the increasing importance of Environmental, Social, and Governance (ESG) standards, driven primarily by European buyers, is shaping the future trajectory of the pharmaceutical sector. The industry must prioritize the integration of cutting-edge knowledge and technology into their processes, and participants in this exhibition will greatly benefit from the extensive showcase of advanced technology, equipment, and machinery.”

R.K. Agrawal, National President, BDMAI said, “The pharmaceutical industry is moving towards transparency and visibility, where maintain comprehensive and digitalized records becomes imperative to showcase processes, testing and manufacturing to regulatory authorities during audits. Further, automation and technological advancements contribute to increased efficiency and reduced reliance on manual labor. Despite a highly regulated industry, with approximately 30 Government Departments monitoring operations, the Pharma sector has embraced stringent pollution norms, resulting in improved conditions within pharmaceutical plants. Furthermore, the Indian Government’s supportive policies such as streamlining regulatory processes, promoting research and development, and encouraging investments create a conducive environment for industry growth. India is already being recognized as the Pharmacy of the world, and the country is a net exporter of drugs to over 195 countries, which is widely accepted. The sector was growing at a rate of 5% during the Pandemic, and now expected to grow at a rate of 8 to 10%. The Indian drug industry can provide good quality drugs at an affordable price thereby changing the landscape of affordability by providing anti-viral drugs at 1/10th of price to countries like Africa. Bulk Drugs constitute 25% ($15 Billion) of the Indian Pharma industry. Also, once the new Pharma City comes up in Telangana, investment of more than INR. 15000-20000 crores are easily possible by the local API manufacturers, which will further attract more FDI.”

Focused on achieving the aspirational growth, Harish Jain, President, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA), said, “India’s aspirations in the pharmaceutical industry go beyond its current ranking of 14th in value. The aim is to break into the top five and elevate its position in the value chain. While India is poised for a substantial 8 to 10% volume growth, the focus lies on achieving aspirational growth through innovation rather than traditional generics. This entails embracing new drug delivery systems to propel the industry forward. Research and development, along with awareness of cutting-edge equipment and testing methods, play a crucial role in realizing this vision. Events like PharmaLytica serve to enhance awareness about the latest advancements in equipment, testing methods, and machinery, enabling us to stay informed about emerging technologies.”

Mr. Avinash Kumar Talwar, Vice President, Dr. Reddy’s Laboratories said, “Hyderabad is the biggest market for pharmaceuticals, and the city is known as the Pharma hub of India. The Indian Pharmaceutical industry is valued at around $50 Billion and is expected to grow at a CAGR of 10.7% by 2030. The pharmaceutical market in India is expected to reach $65 Billion by 2024, and $130 Billion by 2030. As the growth of Pharma market is coming from complex molecules, it will force them to invest and build future state-of-the art labs. The demand for sophisticated equipments and instruments to aid in the process of drug discovery, development, analysis and modelling of the compounds will continue to grow at the same pace. We should be proud that in total there are 214 US FDA approved facilities in Hyderabad which is impressive and that is another reason why Hyderabad is known as the Pharma hub of India. There are many small laboratories in Hyderabad and other South Indian cities like Chennai and Bengaluru who probably cannot visit the overseas equipment manufacturers and other such great expos. Hence, events like PharmaLytica will help provide them with the opportunity to participate and modernize their labs with technologies that will be displayed during the exhibition. Buyers and sellers can exchange their views and explore business opportunities through this event. Pharma packaging involves all the operations, from productions to drug distribution channels to the end customer. Factors such as rising number of pharmaceutical industries in an emerging economy, and rising demand for drug deliver devices, packaging are the major drivers for the pharma packaging market. The current challenge for the packaging industry is to have sustainable packaging at the optimum price along with new industry trends like ESG, and I am sure events like this would help the industry align better and take it to new heights.”

Shankar Gupta, Chief Sales Officer, ACG said, “We are proud of India’s pharmaceutical industry, which has gained immense recognition during the COVID-19 pandemic. Our country has earned global fame by supplying medicines, including COVID vaccines, not only to our own citizens but also to people worldwide. The pharmaceutical industry in India is experiencing remarkable growth, being the third largest producer by volume and 14th largest by value. However, we strive to further expand our presence and increase the value of our products. Going global is crucial for this endeavor. Events like the one organized by Informa Markets are instrumental in promoting the Indian pharmaceutical industry on an international scale. The tremendous footfall and networking opportunities at this event are a testament to the team’s remarkable efforts. We are determined to seize this opportunity and propel ourselves to greater heights”

PharmaLytica featured a wide array of industry-leading exhibitors showcasing their innovations. Notable participants included Advanced Expertise Technology, Allyone Environmental Technologies, Burkert India, IFB Industries, Indu IonPure, Integrated Cleanroom Technology, Labtop Instruments, Lennox Clean Air Technologies, Nicomac Taikisha Clean Rooms, NKP Pharma, Peppermint Robots, Petals Engineers, Scientific Research Instruments Company, Standard Group of Companies, TESTO India, Watermass Systems, and many more.

On the 9th edition of PharmaLytica, Mr. Yogesh Mudras, Managing Director, Informa Markets, India, stated, “With a current value of around $50 billion, India is the third largest pharmaceutical industry in the world. Current projections state this will grow in revenue to $130 billion by 2030. As the Indian pharmaceutical industry charts its path towards becoming a global powerhouse, this expo stands as a crucial event for industry players, investors, and stakeholders to come together, capitalize on the projected revenue growth, and contribute to this remarkable success story. All this is made possible through the expo’s pan-India footprint ensuring unparalleled exposure and access to a broad range of industry professionals from around the world which we witnessed here. The growth potential of the Indian pharmaceutical industry is attributed to its large domestic market, cost-effective manufacturing capabilities, and skilled workforce. Supported by the government’s policies and initiatives like ‘Pharma Vision 2020’ and ‘Make in India’, India aims to become a global pharmaceutical hub. PharmaLytica 2023 offers a unique platform to explore the factors driving the industry’s growth and foster discussions, collaborations, and partnerships.”

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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