There are many ways that treatment can be impacted by changes in the way products are manufactured, delivered and handled, including through proper temperature control and storage. In the case of medical treatments, the proper handling, storage and distribution of the product ("cold chain management") will have a dramatic impact on its efficacy.

Medical products commonly requiring a cold chain are those that require refrigeration such as vaccines, drugs, biological products, diagnostic devices and blood products; therefore, health care providers must implement a comprehensive and reliable cold chain management system to ensure that patients receive the safest and most effective treatment possible, which will ultimately lead to increased confidence in their providers. The rapid growth of the healthcare market in India has resulted in increasing demand for advanced and automated systems for cold chain management.

Understanding the Healthcare Cold Chain

In the healthcare industry, the cold chain is defined as the complete process of managing temperature-sensitive products including receiving from manufacture... storing in the warehouse... transporting and ... arriving at Healthcare Providers (HCPs) and finally (and indefinitely) to a patient who will receive the product. Most healthcare products must be kept within their defined temperature range (+2°C and +8°C), with certain products requiring freezing and ultra-low temperature storage.

Temperature excursions (defined as any temperature deviation from the defined range) at any point in the cold chain can adulterate product quality, potency and/or cause the product to become unsafe for use. Damage caused to many products during shipping and receiving may not be immediately evident, which is why effective monitoring and traceability procedures are considered essential to the continued security of these products during transit.

Why Temperature Stability Matters

Temperature stability, is not an isolated logistical concern but also an overwhelming clinical necessity. Any temperature variation, however slight, can have a pronounced effect on a particular class of products in the healthcare realm, as evidenced by the following examples:

• When a vaccine or biologic is subjected to temperatures above or below the acceptable range of temperatures recommended by the manufacturer, the vaccine or biologic may experience a decrease in potency, leading to reduced immunity or treatment failure.

• When insulin and/or specialty drugs are subjected to temperature variations, the integrity of the medication may be compromised; thus, the risk for patients who take those medications is increased since those medications require very specific dosing.

• If diagnostic reagents and sample materials are subjected to temperature variations, the results derived from those diagnostic reagents and sample materials may not accurately represent the true clinical status of a patient; consequently, clinical decisions made based on unreliable information are jeopardized.

Estimates from global health sources indicate that annually a large portion of the temperature-sensitive healthcare products will be wasted as a result of insufficient or missing cold chain practices resulting in not only significant costs but also delays in treatment of patients, negative health outcomes for patients and additional pressure on healthcare systems.

Cold Chain Challenges in the Indian Healthcare Landscape

Cold chain logistics must be designed to overcome the various challenges posed by India's geographic diversity and infrastructure barriers. The scale of demand for healthcare access in India adds to the severity of these challenges. For example, healthcare providers operating in metropolitan cities have access to advanced technology for monitoring and storing products; however, providers in rural and semi-urban populations have difficulty because of inconsistent power supply, limited cold storage, and fragmented logistics networks to support their needs.

In addition, a well-defined regulatory framework and documentation processes and the provision of real-time cold chain visibility are critical to the success of cold chain logistics operations. In the absence of these systems to monitor cold chain products, healthcare providers are at risk of administering compromised products, which places patients in jeopardy. Integrated HealthTech solutions encompassing hardware, software, and data intelligence must be developed to solve the cold chain logistics problems that face India.

Technology as the Backbone of a Reliable Cold Chain

Technological advancement is driving modern day cold chain management; with emerging technologies including IoT-enabled sensors, real-time temperature monitoring, automated alerts and data analytics, we now have dramatically different ways in which healthcare organizations manage temperature-sensitive products.

Technology-led cold chain systems provide several benefits, including:

•          Continuous monitoring during all phases of storage and transit

•          Immediate alerts for temperature deviations

•          Traceability and compliance reporting

•          Minimization of both waste and operating expenses

•          A heightened level of safety and confidence among patients

 The proactive nature of using technology allows for the preservation of product quality throughout the entire lifecycle, instead of waiting for damages to occur before taking action.

How MarkEn Is Strengthening India’s HealthTech Cold Chain

MarkEn is dedicated to making significant contributions toward improving the cold chain quality in Indian healthcare through our focus on reliability, visibility and scale through HealthTech-oriented solutions. MarkEn helps healthcare providers bridge the most important gaps in temperature management that directly affect how patients get care.

MarkEn’s focus is on:

• Maintaining product temperature stability during storage and transportation.

• Utilizing data-driven insights to identify potential risks before they result in lost products.

• Providing compliance-ready systems for meeting regulatory requirements and for being prepared for audits.

• Providing scalable solutions that can operate in both urban healthcare systems and in challenged remote locations.

By authorizing healthcare organizations to effectively control temperature, MarkEn can help reduce waste due to loss of valuable medical products while simultaneously improving the overall efficiency of the healthcare product supply chain. Most importantly, the MarkEn solution is an equitable solution for accessing, utilizing and effectively delivering safe and effective treatments to patients throughout India, no matter where the patient resides.

India is experiencing rapid growth in immunization programs, chronic disease management, and complex therapies, and MarkEn is proud to be part of a solution that will enable the country to build a resilient, technology-driven, effective healthcare ecosystem.

The Broader Impact on Public Health and Growth

While a dependable cold chain is an assurance of product integrity, it also contributes significantly to improved public health. Reliable cold chain performance means that temperature sensitive medicines can be received by patients in the best possible conditions, resulting in higher success rates of treatment. In addition to improved success rates of treatments, when temperature-sensitive medications are delivered in optimal condition, people have more confidence in the healthcare system and healthcare resources are used more efficiently.

Cold chain reliability supports:

•          Stronger Immunization Program Development

•          Improved Chronic Disease Management

•          Reducing Wasted Healthcare Resources

•          Growth of Biotech and Pharmaceutical Innovations

Health Tech companies such as MarkEn are critical partners in closing the gap between innovation and practice.

Conclusion

Stable Temperature Environments are absolutely critical for the true impact of today's evolving and innovative medical technologies to be realized in the delivery of quality medical care. As the Indian healthcare system continues to expand and advance, the role of technology-based Cold Chain Service Providers within that system will grow exponentially. In addition to providing precision, transparency, and reliability, MarkEn Technology is committed to building an environment where every healthcare product is distributed safely, effectively, and with absolute certainty. As a result, the MarkEn Technology solution is the foundation of India's growing, advanced HealthTech ecosystem.