Reliable Cold Chain Solutions for the Pharmaceutical and Medical Industries

jesal

India is home to an extraordinary variety of climates and extreme temperatures. Thus, when it comes to enabling exceptional medical care, the country’s distribution of vaccines, medicines, biological samples, and organs plays a crucial role. The lengthy distribution channels and varying ambient temperature conditions demand an effective and efficient cold chain solution from the start till the end. Vaccine administration centres, blood banks, organ preservation facilities, sperm banks, stem cell repositories, and laboratories rely on good distribution practices and efficient cold chain management solutions.

Numerous documents from reliable sources such as the WHO and the CDC highlight proper storage and distribution techniques. Their research has identified several areas that could be improved, from the cold chain management solutions used for training the medical staff, to the handling of various types of biological scenarios. To build a state-of-the-art medical distribution and logistics system in India, these factors must be considered for proper solution deployment. Out of all of the identified elements that require improvement, cold storage remains one of the most crucial.

According to the cold storage report 2021, it has been estimated that India possesses a cold storage capacity of 37 million metric tonnes, out of which only 1% is employed for pharmaceutical needs. Another report argues that there is a huge potential for growth in the organised cold storage or ‘palettized’ cold storage space in tier-I cities like Mumbai, Delhi-NCR, Bengaluru, Chennai, Pune, Kolkata, and Hyderabad, and tier-II cities such as Lucknow, Kanpur, Ranchi, and Patna. Moreover, in the next two to three years, an additional 1.5 lakh to 2 lakh pallet capacity (frozen and chilled) is expected to be installed.

However, in many tier III cities and rural areas, it has been observed that when medical-grade carrier boxes are unavailable, conventional and, therefore, less reliable solutions are frequently used instead. As the temperature inside these products can fluctuate drastically, it could impair the efficacy of the substrate stored inside them, thus leading to potential harm to the patient. For example, suppose a person has been inoculated with a vaccine requiring a low storage temperature that was transported in a standard ice box. In that case, there is a distinct possibility that the vaccine was spoiled at the time of the jab. This is an example of how attempting to save money on medical cold chain transportation solutions can be extremely detrimental to healthcare systems as a whole and is a poor practice given the high value of these biological products.

Numerous instances have led to a discussion on whether it is acceptable to store vaccines in domestic refrigerators or not. Nevertheless, the challenges do not only lay with the use of proper cold chain storage solutions. Although cold storage is one of the vital pillars of good distribution practices in the pharmaceutical and medical industry, transportation remains the most pressing challenge in the sector to build a comprehensive cold chain network. Transporting temperature-sensitive drugs or biomedical materials is just as critical as storing them when it comes to preserving their potency.

Medical-grade carrier boxes are one of the most crucial pieces of equipment for reducing the uncertainty associated with substance deterioration and degradation due to high-temperature exposures. Maintaining an appropriate temperature of any pharmaceutical product or biomedical substance throughout the storage and transportation process is critical in ensuring higher effectiveness.

Following the COVID-19 pandemic, India required the strengthening of its logistics system with medical-grade solutions offering temperature-controlled environments capable of efficiently extending the life of the SARS-CoV-2 vaccines, enabling healthcare workers to reach the country’s most remote regions. The central government has committed about INR 35,000 crore for the development and distribution of the COVID-19 vaccines.

However, the cold chain requirements for each vaccine differ according to their composition. There are many live-virus vaccines that can tolerate freezing temperatures and rapidly deteriorate once defrosted, while deactivated vaccines more commonly require stable temperatures of 2°C-8⁰C and are damaged at extreme temperatures. For instance, the ongoing COVID-19 vaccines available at large in India — Covishield and Covaxin — require a refrigeration temperature of 2°C-8°C, both for transportation and storage during the immunisation session or within four hours of opening the vials, whichever occurs first, as they are sensitive to freezing. On the other hand, the Sputnik V vaccine requires storage at -18 °C.

Even in the case of non-COVID vaccines like diphtheria (DT), tetanus (Td), or pertussis, the refrigeration temperatures should be between 2°C-8°C. However, vaccinations that contain lyophilized varicella should remain frozen in a range between -15°C to -50⁰C. The commonly managed measles, mumps, rubella (MMR) vaccine can be stored either frozen or refrigerated, while the MMRV vaccine that also contains the live varicella virus must be frozen.

Recently, the online pharmaceutical start-up industry has emerged as one of the biggest potential distribution channels for medicines and vaccines in India. However, these companies still lack proper cold chain infrastructure to efficiently distribute pharmaceuticals and biologicals safely across the country. This large distribution channel could be a game-changer if companies and organizations were able to provide reliable cold storage and supply chain solutions.

Equipment such as medical transport boxes, solar vaccine refrigerators and freezers, remote temperature monitoring devices are necessary to extend the cold chain logistics in tier-III cities and rural areas. Moreover, solar freezers and refrigerators become very useful in areas where a continuous supply of electricity cannot be guaranteed.

Finally, given that vaccines and other medical products may be thermosensitive and should therefore not be exposed to varying temperatures for extended periods of time, high-quality medical-grade storage boxes and solar freezers should be the top priority when establishing a safe and reliable cold chain in India. This would eliminate any doubts about the medical product’s potency and ensure their successful distribution, no matter their provenance and their final destination.

Jesal Doshi, CEO, B Medical Systems

ABS ABS

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