How Covid reset the rules of drug development

Hindustan Times

30-04-2025

More than a public health triumph, it became a blueprint for how drug development can be reimagined. As we mark five years since the onset of the pandemic, the question isn't whether we can move faster. It's whether we can make this pace sustainable.
Before the pandemic, clinical development was often slowed by sequential processes, siloed operations, and rigid regulatory frameworks. Covid-19 shattered that inertia. In its place emerged a more integrated and agile system. Regulatory bodies shifted from a conservative, gatekeeping stance to one of partnership, engaging early with manufacturers, enabling overlapping trial phases, and embracing real-time data reviews. This parallel approach drastically reduced delays and enabled faster decision-making at every stage.
Government funding and support also played a crucial role as well. In India, the government took decisive steps to ensure rapid vaccine development and manufacturing. Initiatives like Mission Covid Suraksha provided direct funding to indigenous vaccine developers. Many vaccine providers received both financial and infrastructural support from the Department of Biotechnology, which helped accelerate the development of vaccines. Emergency approvals based on interim trial data also streamlined regulatory processes and enabled timely public access to vaccines.
Besides, the Government of India's release of the Pandemic Preparedness and Emergency Response Framework (PPER) in August 2024 marks another significant milestone in institutionalizing this collaborative spirit. Recognizing the importance of readiness, the PPER outlines a proactive 100-day response roadmap for any future outbreak. Its four pillars include:
· Governance, legislation, finance and management: Establish clear command structures for emergencies, including empowered decision-making bodies, rapid response protocols, and a dedicated fund to ensure that action isn't delayed due to financial bottlenecks.
· Data management, surveillance and forecasting: Focus on unifying data streams from hospitals, labs, communities, and genomic networks into a cohesive system that enables early detection, predictive modelling, and faster interventions.
· Research, innovation and infrastructure: Accelerate the development of diagnostics, vaccines, and therapeutics through mission-driven R&D, supported by platform technology hubs, advanced manufacturing capacity, and trained scientific talent.
· Partnerships and community engagement: together aim to make India's pandemic response not only faster, but smarter. Emphasizes trust-building and collaboration by formalising engagement with the private sector, frontline workers, and international partners, while ensuring that risk communication is timely, clear, and consistent.
The framework also proposes a dedicated Public Health Emergency Management Act to clarify mandates across government agencies, ensure rapid decision-making, and embed accountability mechanisms. A Pandemic Preparedness Fund has been recommended to ensure that financial resources are ready to deploy at the first signs of an emerging threat—eliminating one of the biggest friction points seen during Covid.
This collective effort proves that vaccine development could be significantly shortened without compromising safety or efficacy.
The success of mRNA vaccines during Covid-19 didn't just change public health, it reshaped the entire drug development landscape. mRNA technology represents a major leap in how we approach disease prevention and treatment. Instead of delivering a protein or weakened pathogen, mRNA therapies provide genetic instructions that prompt the body's own cells to produce the required protein, triggering an immune response or therapeutic effect.
The post-pandemic horizon now includes mRNA-based solutions for cancer, genetic disorders, and chronic diseases. With faster design cycles and lower manufacturing complexity, mRNA represents a leap forward in both speed and precision.
One of the most significant culture shifts was observed in how regulators engaged with industry. For years, regulatory timelines were treated as immutable. But during the pandemic, that paradigm shifted. Agencies like the US The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and India's Central Drugs Standard Control Organisation (CDSCO) began to work proactively with manufacturers, offering early scientific advice, hosting rolling reviews, and creating bespoke pathways for promising candidates. This allowed industry players to make informed decisions quickly, and more importantly, de-risk innovation. We should recognise this not as a temporary deviation, but as a valuable framework for future drug development. Regulation can still be rigorous without being rigid.
Another defining move during the pandemic response was the large-scale integration of digital tools. From remote monitoring in clinical trials to Artificial Intelligence (AI)-assisted data analysis, technology played a vital role in accelerating every stage of vaccine development. We also saw a significant shift toward decentralised trials, where patients could participate from home using telemedicine and wearable devices. This not only expanded access and diversity in trials but also introduced efficiencies that are now being embraced across therapeutic areas beyond infectious disease.
As we look ahead, the challenge will be to ensure that these innovations are not viewed as temporary fixes, but as permanent upgrades to our health care infrastructure.
The urgency of the Covid-19 pandemic led to a phenomenal acceleration in drug development, but the real challenge is sustaining that momentum beyond crisis conditions.
The fast-track approvals, cross-sector collaborations, and funding surges that enabled rapid vaccine deployment must evolve into long-term strategies. Regulatory frameworks need to balance speed with safety, ensuring that innovation continues without reverting to slow, outdated processes. Public-private partnerships must continue driving research and development, not just for pandemics but for a broader spectrum of diseases. Equally important is investing in next-generation drug discovery platforms—such as AI-driven research and scalable mRNA production—to ensure the healthcare system remains agile in the face of future health challenges.
Covid-19 was a test case for fast-tracking drug approvals. It showed us what's possible when barriers are lowered and collaboration is prioritised. The industry now stands at a crossroads, we can either preserve the gains made during the pandemic or slip back into outdated, linear models of drug development. If we choose the spirit of shared purpose, scientific openness, and regulatory agility into our systems, then the next breakthrough won't take a decade. It might just take a year.
This article is authored by Aditya Sharma, head, Process Solutions, India Region, Merck Life Science, New Delhi.