Roadmap to Strengthen India’s Pharmaceutical Cold Chain Takes Shape

Refrigerating medicines is not enough to maintain their quality and safety: it takes a coordinated cold chain ecosystem with well-trained personnel, standardized processes, and better compliance to achieve this goal. The National Accreditation Board for Cold Chain Management (NAB-CCM) just released a white paper that offers a clear blue path to enhancing the processes of cold chain and distribution throughout India’s pharmaceutical supply chain.

The report identifies a number of ongoing issues that are impacting on the sector. They encompass: inconsistencies in storing as observed from various actors in the supply chain; lack of awareness about storage conditions among front line handlers and pharmacists; lack of harmonized competence assessment and qualification of logistics and service providers; and inconsistent monitoring of the temperature excursion. It also identifies shortcomings in the retail and hospital level storage control and the absence of a common certification system to assure product integrity from retail to hospital.

To help resolve these problems, the white paper outlines a four-stage implementation path.

The first phase is about raising awareness through training programmes, competency building and simplified operational guidelines. The second phase suggests implementing vendor qualification systems, certifications, and standardizing monitoring systems for increased uniformity.

The third phase involves increased industry adoption of certification systems, increased auditing, and increased compliance requirements, and the final phase involves ongoing advancement through policy review, policy changes, and increased technology use for real-time monitoring and traceability.

The cold chain infrastructure is gaining importance as the pharmaceutical industry in India is moving ahead with its global initiatives and demand for medicines transporting at cold chain conditions such as biologics, vaccines, and specialties is increasing. The NAB-CCM white paper maps out the way forward for how the pathway to reliable Good Storage and Distribution Practices will be accomplished through a coordinated approach between regulators, logistics providers, healthcare institutions, and pharmaceutical companies in building a more resilient and compliant supply chain.

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