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 At the Cold Chain Leaders Conference & Excellence Awards 2026, powered by the National Accreditation Body for Cold Chain Management (NAB-CCM) and supported by the Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME), Dr. Santosh Indraksha, deputy drugs controller, Central Drugs Standard Control Organisation (CDSCO West), delivered a compelling call for strengthening cold chain management systems to safeguard pharmaceutical quality across India’s supply chain.
Dr. Indraksha emphasized that robust cold chain logistics are indispensable to ensuring drug safety and therapeutic efficacy. “The products, if taken through this kind of supply chain management system, would actually ensure the safety and its quality so that the ultimate end user has the better efficacy it was intended for,” he stated, underlining the regulator’s growing confidence in advanced, technology-driven logistics ecosystems.
The conference emerged as a pivotal platform initiating conversations on the future of temperature-controlled logistics across pharmaceuticals, biologics, vaccines, and biotechnology sectors. It highlighted how innovation, digital transformation, and regulatory alignment will shape the next decade of cold chain infrastructure.
Dr Indraksha drew attention to the CDSCO’s draft guidelines on Good Distribution Practices (GDP), released on September 25, 2018, to regulate pharmaceutical product quality throughout the distribution chain. He urged industry stakeholders to integrate these guidelines into their operational frameworks.
“We have published the GDP guidelines, and many of you may already be integrating them into your business systems. Those who have not should certainly revisit and adopt them,” he said.
He further noted that CDSCO has cross-referenced GDP provisions into its regulatory systems, reinforcing compliance expectations. However, he acknowledged the limitations in regulatory oversight stating, “We have control at the manufacturing and retail ends, but we do not regularly oversee the supply chain intricacies. We rely on the supply chain stakeholders to ensure that products are transported under intended conditions.”
Dr Indraksha in his address also highlighted the absence of a standardized certification system for cold chain logistics in India. “Currently, there is no certification system, and the industry relies on individual vendor qualification and vendor management systems,” he said.
He lauded NAB-CCM’s efforts in establishing evaluation and verification frameworks, suggesting that a formalized certification mechanism could significantly ease industry burdens. “If NAB-CCM provides a certification that is also regulated in process, it will be a big relief for the pharmaceutical industry,” he remarked, pointing out that such systems could reduce the need for repetitive, resource-intensive vendor assessments.
Dr Indraksha also highlighted the transformative impact of emerging technologies, including digital twins, artificial intelligence (AI), machine learning (ML), and sensor-based monitoring systems.
“There are innovations we had never thought of such as digital interventions and advanced monitoring systems, that give confidence to regulators like me,” he said. These technologies enable real-time tracking of environmental conditions, predictive analytics, and enhanced visibility across logistics networks, ensuring that product quality is preserved throughout transit.
Dr Indraksha stressed that infrastructure alone is insufficient without skilled manpower. He called for comprehensive training across all levels of the supply chain, from operators and drivers to warehouse personnel, to instill a culture of quality and compliance.
“The ultimate aim of ensuring product quality must percolate into every individual involved in the supply chain,” he said, emphasizing the importance of human capital in maintaining cold chain integrity.
Addressing environmental concerns, Dr Indraksha underscored the need for sustainable refrigeration technologies. “Cold chain logistics has a significant impact on environmental sustainability and ozone protection. We must adopt newer, eco-friendly refrigeration systems,” he urged.
He also advocated for public-private partnerships to accelerate the adoption of green technologies and strengthen the overall cold chain ecosystem.
Highlighting the scale of the industry, Dr Indraksha noted that cold chain logistics is a multi-billion-dollar sector with immense growth potential. He encouraged stakeholders to position India not only as the “pharmacy of the world” but also as a global leader in cold chain management. “There is a lot of opportunity to grow, improve, and lead globally in supply chain management systems,” he said.
Talking about NAB-CCM impactful initiatives, Dr Indraksha called for broader participation from pharmaceutical companies, quality assurance professionals, and logistics stakeholders in future engagements. “If needed, we can even make participation more structured to ensure wider industry involvement,” he added, reinforcing the regulator’s commitment to collaborative progress.
The conference concluded that the convergence of regulatory guidance, technological innovation, certification frameworks, and sustainability efforts will be central to building a resilient and future-ready cold chain ecosystem in India.
Key dignitaries in the event included Nilesh Gandhi, former joint commissioner, Maharashtra Food and Drug Administration (FDA) and Dharmesh Kharwar from FPME.
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