Enhancing Clinical Trial Supply Chain Resilience to Address Global Disruptions in India

In an interaction with India Pharma Outlook, Sanjay Vyas, President, Global Head of Safety Services & Clinical Logistics, and Managing Director, India at Parexel, discusses ways in which Indian pharma firms strengthen clinical trial supply chains by diversifying sourcing, enhancing cold chain logistics, and leveraging AI-driven analytics for precise forecasting. He emphasizes decentralized trials to enhance accessibility and highlights strategic collaborations to boost resilience amid global disruptions. With over two decades of expertise, Sanjay leads a global team of 6,500+ and has been recognized for innovations in clinical trials, operational excellence, and advancing healthcare accessibility.

How are Indian pharmaceutical companies adapting clinical trial supply chains to mitigate geopolitical and regulatory uncertainties impacting global drug development timelines?

The global pharmaceutical landscape is undergoing a fundamental transformation in how clinical trial supply chains are managed. Geopolitical tensions, ever-changing regulatory environments, and the growing complexity of drug development have all played a part in reshaping the industry.

Trade restrictions, evolving policies on Active Pharmaceutical Ingredient (API) imports, and shifting global regulations are directly affecting trial timelines and supply chain reliability. In response, Indian pharmaceutical companies are taking decisive steps to diversify their supply networks, bolster local manufacturing capabilities, and harness digital technologies to build a more resilient clinical trial process.

There is a clear market trend toward minimizing reliance on single-source suppliers by adopting dual or multi-sourcing strategies. Many companies are now exploring regionalized supply chain models, ensuring that key components—ranging from investigational drugs to biologics—can be procured from various geographies.

Indian companies are raising quality standards to meet international benchmarks and leveraging innovative technologies to streamline their supply chains. They are also forging partnerships between multinational and local players to secure market access across both regulated and emerging markets, while logistics providers offer rapid, on-demand shipping tailored to modern trial needs.

What role do decentralized trials and direct-to-patient models play in enhancing supply chain agility for clinical research in India?

Decentralized clinical trials (DCTs) and direct-to-patient (DTP) models are transforming clinical research in India by boosting supply chain agility. These approaches offer flexibility and adaptability, which is crucial for managing the changing demands of DCTs and hybrid trials. This ensures consistency and quality while meeting the needs of sites, patients, and sponsors, by minimizing the reliance on traditional site-based visits, these approaches streamline logistics, reduce costs, and improve patient engagement.

Hybrid trials, incorporating DTP logistics, involve shipping investigational drugs directly to participants' homes. This requires robust logistics solutions providers to coordinate multiple focal points, including manufacturers, CROs, local pharmacies, and home nursing providers.

DCTs reduce the need for frequent visits to clinical sites, enhancing the diversity and inclusivity of the study population. By integrating transport, management, data gathering, and home healthcare services, a consolidated supply chain is better equipped to adapt to interruptions. Overall, DCTs and DTP models streamline processes, expand patient access, and improve the efficiency of clinical trials in India.

How is India addressing the challenge of cold chain logistics and temperature-sensitive biologics in clinical trials amid rising global supply chain disruptions?

India is actively addressing the challenge of cold chain logistics and the transportation of temperature-sensitive biologics in clinical trials by taking significant steps to improve its infrastructure and processes. 

Currently, nearly 20 percent of temperature-sensitive healthcare products in India suffer damage or degradation due to broken or insufficient cold chains—a significant challenge. One contributing factor is the heavy reliance on road transport for over 71 percent of freight, which can often struggle to maintain the necessary conditions for these sensitive products. 

To tackle this, India is making considerable investments in enhancing cold chain capabilities. This includes establishing state-of-the-art refrigerated storage facilities and implementing advanced temperature-controlled transport systems. Additionally, the integration of technologies like IoT sensors and GPS tracking is enabling real-time monitoring of temperature-sensitive shipments, ensuring early detection of any potential discrepancies. These advancements not only help preserve the integrity of biologics but also ensure that clinical trials are conducted in a reliable, efficient, and compliant manner amidst rising global supply chain disruptions.

With increasing digitization, how are AI-driven predictive analytics transforming clinical supply chain forecasting and risk management for Indian manufacturers?

With the ongoing digital transformation, AI-driven predictive analytics are reshaping clinical supply chain forecasting and risk management for Indian manufacturers. industry forecasts project that the global AI in the supply chain market will reach $20.2 billion by 2028, growing at an impressive 20.5% CAGR, and nearly three out of four companies now trust AI to optimize their supply chains.

In practical terms, advanced AI models analyze enormous datasets—from historical trial records and seasonal demand patterns to real-time logistics updates and shifts in regulatory or geopolitical conditions. This comprehensive analysis enables more accurate demand forecasting and inventory optimization, reducing waste and ensuring that drugs for clinical trials are available when needed.

Furthermore, AI-powered risk management tools help manufacturers proactively spot potential disruptions, such as raw material shortages or bottlenecks, allowing them to adjust sourcing strategies quickly. In the realm of cold chain logistics, where maintaining the integrity of temperature-sensitive biologics is critical, real-time monitoring and predictive alerts ensure that any deviations are identified and corrected promptly, preserving product quality throughout the supply chain.

What collaborative models between pharma companies, CROs, and logistics providers are proving most effective in strengthening supply chain resilience for trials in India?

Pharma companies, CROs, and logistics providers in India are increasingly forming strategic alliances to address longstanding supply chain challenges. Currently, with 61% of pharmaceutical manufacturing handled by CDMOs, the industry faces issues like low On-Time In-Full (OTIF) delivery rates (30–40%), prolonged inventory holding periods (150–180 days), and extended supply lead times (90–120 days).

To counter these challenges, stakeholders are emphasizing real-time data sharing, joint forecasting, and proactive risk management. Integrating AI-driven analytics and digital platforms has helped some organizations cut operational lead times, enabling more precise and agile management. These collaborative models not only streamline regulatory compliance and enhance transparency but also build trust and responsiveness across the supply chain.

At Parexel, we view these integrated, technology-enabled partnerships as essential to delivering resilient clinical trial operations that ultimately benefit patients and all stakeholders.

Looking ahead, what long-term structural shifts are necessary to future-proof India's clinical trial supply chain against evolving global disruptions?

Future-proofing India's clinical trial supply chain requires a comprehensive transformation that blends advanced technology with strategic operational improvements. 

Robust digital integration through AI-driven predictive analytics, IoT-enabled real-time tracking, and blockchain for enhanced transparency empowers organizations to anticipate disruptions and react swiftly. Significant investments in modern logistics infrastructure, particularly in enhancing cold chain capabilities and boosting local manufacturing of critical trial components, are essential to minimize external dependencies. 

Moreover, many regulatory and quality challenges stem from internal shortcomings such as inadequate data validation, insufficient product testing, and subpar equipment standards; aligning domestic regulatory frameworks with global benchmarks can streamline compliance and reduce delays. 

Strengthening collaborative partnerships among pharma companies, CROs, and logistics providers, while simultaneously developing a highly skilled workforce, will cultivate an agile and resilient ecosystem ready to adapt to evolving global challenges.