Sudarshan Ananth, Territory Vice President and Business Head – HVAC & Transport, India Climate Business Unit, Ingersoll Rand, gives an insight about the critical role of robust cold chains in ensuring drug security in pharma industry
Indian pharma industry is burgeoning due to large demand both in terms of import and export. Safe delivery of drug is paramount to realise the benefit for the producer and user. Hence, there is opportunity for temperature-controlled transportation of pharma products from source/ manufacturing facility to storage, and from the manufacturing facility to the direct consumer, both for temperature-sensitive raw material and intermediate or finished product.
The domestic Indian pharma market is expected to reach $55 billion in 2020 at a compounded annual growth rate (CAGR) of around 15 per cent. The government has already unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacturing, thereby making this a highly lucrative sector for investments and growth.
The pharma industry is critically dependent on transport refrigeration units. Since pharma products are temperature-sensitive, all vaccines and medicines essentially need to be maintained at a certain temperature. In order to ensure this, it is of paramount importance that all the components of logistics are in place, with a robust mobile cold chain infrastructure.
The invention of the first mechanical transport refrigeration unit (TRU) in 1938 literally moved the refrigerated transportation industry out of the ice age, a period when using ice and salt was the only practical way to keep perishable shipments from spoiling.
The science of refrigerated transportation has advanced dramatically over the last 75 years, with innovations such as nose-mounted units, diesel-powered TRUs, stop-start temperature controls, auxiliary power units and advanced electronics taking mobile refrigeration to the next level. The next 75 years will no doubt bring about customer-driven innovations in technology, service and operations that are just as impactful.
Industry statistics indicate
- 25 per cent of vaccines reach their destination in a degraded state because of incorrect shipping
- Almost 30 per cent of scrapped sales at pharma companies can be attributed to logistics issues
- Almost 20 per cent of temperature-sensitive healthcare products are damaged during transport due to a broken cold chain
- Approximately 0.5 per cent of transported goods are damaged during transport through non-compliance to temperature guidelines.
(Source: World Health Organization (WHO), Parenteral Drug Association (PDA) and other industry estimates).
Companies in India are applying current and emerging technologies and practices to help their customers solve problems and achieve higher levels of performance with lower total cost of ownership.
The following points focus on the growing significance of mobile cold chain transportation for pharma products:
- India being the third largest producer of pharma products and responsible for eight per cent of the world’s production is a strategic market for such products, therefore with obstacles such as shortfall of power, minimum portability options and limited reefer rail options hovering over cold chain companies. It is imperative that organisations invest on technologies that are environment friendly and sustainable so as to address these issues more accurately and make their distribution more efficient.
- Fuel economy will be a big driver of innovation in the refrigerated transportation industry and with good reason. Fuel represents the largest component of total operating costs for most refrigerated fleet operators; fuel prices represent one of their least controllable expenses. TRU original equipment manufacturers will continue to look for ways to design and build more fuel-efficient engines and to use advanced electronic controls to improve engine performance and reliability and reduce fuel consumption
- Sustainability will be a watchword for the industry for some time to come. Original equipment manufacturers have introduced new products that use less fuel and therefore leave a smaller environmental footprint, which has allowed transportation of temperature-sensitive products through cost efficient ways
- Advances in prognostic capabilities will enable continuous improvement in TRU reliability. The use of predictive software and embedded sensors will detect issues before they become serious problems and monitor mission-critical components to maximise their service life and predict when they might fail so that a qualified dealer can intervene. This will mitigate the risk of transportation and prevent any foreseeable damage of pharma drugs
- Drug security has become a national priority, driven both by government regulation and consumer pressure. Regulated authorities such as the perishable cargo regulations have made conscious efforts to establish global best practices for perishable cargo operations that are essential for the transportation of healthcare and pharma products. These include a broad range of recommendations ranging from time optimisation to establishing an efficient model of supply chain management. Advanced TRUs include the capability to track, record and transmit data that can help fleet operators establish the location of a particular load at a particular time, as well as document conditions inside the refrigerated container, truck or trailer
- Whether they are hauling food, pharma, chemicals, cosmetics or some other temperature-sensitive load, operators are tapping into advanced tracking capabilities that use global positioning system data and advanced wireless communications technologies to provide operators with real-time and historical information about load temperature and asset location, for one trailer or an entire fleet, answering operators’ need for better safety, security and efficiency
- In addition, they can monitor temperatures and other variables, change set points and control parameters, download reports, change operating modes and respond to alarms using any computer, tablet or smart phone that is connected to their secure network. These capabilities take pressure off drivers who now can focus on the safe operation of their vehicles, rather than operating the TRU
- Intelligent solutions and advanced analytics give refrigerated fleet operators the opportunity to squeeze even more fuel economy from their TRUs. For example, fleet operators and their customers can work together using advanced analytics to determine the optimal set point and control parameters for a particular load. Industry analysis says raising the set point by a single degree can yield as much as a two per cent improvement in fuel efficiency
- There is a consensus that if the quality of pharma product shipments is compromised, the risk is more than loss of cargo, it can compromise the health and well being of patients. Hence, industry leaders are applying current and emerging technologies and practices to help their customers meet challenges and achieve higher levels of performance with lower total cost of ownership.
- The first step to compliance is to ensure that the vehicles transporting medical and biological products are equipped with the most reliable temperature control equipment available. Precise temperatures have to be maintained with minimal permissible temperature excursions, both for single product shipments and for those with a mix of medical and biological products. Regardless of ambient conditions, cargo has to be maintained at its optimum temperature regime, for example:
- Vaccines, biologics, monoclonal antibodies, recombinants: 2-8o celsius
- Molecules: 15-25o celsius
- Blood plasma: -30o celsius.
The need to move pharma and other temperature-sensitive goods from their point of production to their point of consumption will continue to grow in the years ahead, with no end in sight. As per recent NCCD data there are currently 7,000 – 8,000 reefer trucks in the country as compared to an estimated requirement of 20,000 – 25,000 which tells us that the demand for transporting such products is only expected to grow further in the coming years. A slower than expected recovery, volatile fuel prices and more stringent environmental and drug-safety requirements make this a challenging time for everyone in the cold chain market, including owners and operators of refrigerated fleets.
With innovative technology and efficient operating practices, the refrigerated transportation industry holds a strategic value in delivering perishable drugs to the vast rural and urban majority of this country and needs to take careful steps to implement a concrete supply structure. We are committed to playing a constructive role in developing a safe and efficient controlled environment for pharma industry.