For decades, India’s pharmaceutical industry has built its reputation on scale and speed, cementing its status as the “Pharmacy to the World.” At the heart of this success lies stringent quality control (QC), ensuring drug safety, efficacy, and compliance with global standards, optimal patient outcomes and access to lifesaving drugs. However, as automation, AI, and rapid microbiological methods reshape QC, a growing challenge leads to slow progress—a shortage of skilled professionals who are adept at operating these evolving systems.
Fresh graduates have theoretical knowledge, might have the intent and interest, but hands-on expertise is missing, while experienced professionals, trained in manual QC methods, struggle to keep pace with rapid digitisation. The result? A widening gap between cutting-edge technology and a workforce unprepared to manage it. This isn’t just about hiring—it’s about redefining how talent is developed, trained, and retained. In an industry where precision is everything, a skill gap isn’t just a workforce issue; it can pose a risk to public health.
Currently, India supplies over 60 per cent of global vaccine demand and 20 per cent of generic medicines worldwide. With the sector projected to reach a $130 billion valuation by 2030, maintaining strict safety and quality standards is more crucial than ever. As per the India Skills Report, the pharma sector had an employability rate of 37 per cent significantly below the national average of 46 per cent with a major skill gap in quality control and other key areas. As automation reshapes the industry, addressing this talent shortage is key to sustaining India’s global leadership in pharmaceuticals. Let’s dive deeper into the talent gap in quality control, the role of upskilling, and how we can address the same.
Evolving Skill Demands in Quality Control & Microbiology
For a long time, India’s pharmaceutical microbiology has been a labour-intensive domain, with stringent sterility requirements relying heavily on manual intervention. But the landscape is rapidly evolving. Advanced detection, enumeration, and identification (DEI) techniques are transforming quality control. Additionally, Rapid Microbiological Methods (RMMs) are reducing turnaround times, automated sterility testing is minimising human error, and AI-driven predictive analytics is making quality control smarter and more precise.
Despite these advancements, industry adoption remains conservative and cautious. Regulatory compliance frameworks, and financial support systems designed around conventional QC methodologies, have not kept pace with technological innovation. Furthermore, many pharmaceutical companies hesitate to transition due to a shortage of skilled professionals capable of managing and integrating these advanced systems. While automation and digital transformation are inevitable, a paucity of trained personnel could stifle progress.
The key challenge lies in bridging this talent gap. Without a workforce proficient in digital QC and microbiology automation, even the most sophisticated technologies will remain underutilised. The industry must address this issue head-on, ensuring that both new and existing professionals are equipped with the skills required to keep pace with global pharmaceutical standards.
Addressing the Skill Gap: A Three-Tiered Approach
Bridging this talent gap requires a comprehensive strategy that prepares new graduates, upskills existing professionals, and fosters a cross-skilled, agile workforce. We need a structured, forward-thinking approach that must focus on three key areas:
A major challenge in talent acquisition is the disconnect between academic training and industry expectations. While fresh graduates often possess strong theoretical foundations, they frequently lack hands-on experience in modern QC processes. Universities must reframe their curricula, beyond basic principles, integrating real-world applications in QC and microbiology while prioritising practical exposure.
Programmes like the six-month Student Training Programme in Quality Assurance & Quality Control at the National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad, and the Biotech Finishing programmes by the Karnataka Government, and the Quality Control Analytical and Applied Industrial Microbiology programmes of Biocon Academy serve as essential models, equipping graduates with industry-relevant skills. Strengthening internship and apprenticeship opportunities will further ensure that newcomers can seamlessly transition into the workforce, contributing effectively from day one.
While experienced professionals bring domain expertise, many remain unfamiliar with new-age technologies in automation, AI-driven monitoring, and rapid microbiology techniques. This knowledge gap slows adoption rates, preventing companies from fully leveraging real-time digital monitoring and automated sterility testing.
To bridge this divide, targeted upskilling programmes must focus on integrating automation and data analytics into QC workflows. By enhancing technical proficiency in these areas, companies can improve risk assessment, streamline process validation, and ensure higher-quality outcomes—enabling a smoother transition toward digital transformation.
Traditionally, the pharmaceutical industry has operated in silos, training and qualifying talents in particular domains and deliverables limiting workforce mobility and holistic understanding. As QC roles evolve to incorporate new technologies, a shift toward cross-skilling can build a more versatile and adaptable workforce.
Manufacturing microbiologists, such as fermentation specialists, can transition into QC roles, utilising their expertise to strengthen sterility assurance. Similarly, training production teams in rapid microbiology techniques foster a culture of continuous learning and innovation. This multidisciplinary approach enhances operational efficiency, ensures long-term sustainability in talent development, and helps future-proof the workforce for seamless integration of technological advancements in microbiological QC.
Role of Industry & Academia in Skill Development
Bridging the talent gap in pharmaceutical QC isn’t solely the responsibility of educational institutions. The industry must take an active role in nurturing a skilled workforce by investing in structured training programmes that go beyond standard operating procedures. Well-designed onboarding initiatives can significantly reduce the learning curve for new hires, accelerating their integration into highly regulated QC environments while ensuring competency in both traditional and emerging methodologies.
A stronger collaboration between academia and industry is essential to align curricula with evolving industry demands. As pharmaceutical microbiology rapidly advances, ensuring that graduates possess relevant, up-to-date knowledge is critical to maintaining quality and regulatory compliance. Establishing joint training programmes, industry-led workshops, and research partnerships can help bridge this gap, creating a workforce that is better prepared to navigate the complexities of modern QC.
Government initiatives also play a crucial role in bolstering industry capabilities and fostering self-reliance. Programmes such as the Production Linked Incentive (PLI) Scheme for Pharmaceuticals and the Scheme for Promotion of Bulk Drug Parks aim to strengthen infrastructure, drive domestic manufacturing, and enhance global competitiveness. Leveraging these initiatives for skill development can provide a much-needed boost to workforce readiness, ensuring that India remains at the forefront of pharmaceutical innovation and quality assurance.
Way Forward
Addressing the talent gap in QC and microbiology is imperative to sustain and strengthen India’s leadership in the global pharmaceutical sector. These fields must be positioned as high-value career paths to attract skilled professionals and drive innovation. Industry-academia collaborations are crucial in bridging this gap by aligning educational curricula with evolving industry needs.
A forward-thinking approach, one that prioritises skill development, embraces technological advancements, and fosters continuous learning will ensure that India not only meets current global standards but remains prepared for future challenges. By investing in talent today, the industry can solidify its reputation as the ‘Pharmacy of the World’ and continue to set new benchmarks in pharmaceutical excellence.
Salavadi Easwaran, Academic Dean, Biocon Academy
