 "Need for innovative cold chain transport solutions in pharma industry")
Prime Minister Narendra Modi, in an attempt to catch the industrial revolution which we bypassed and boost the economic turnaround of the country, recently launched the ‘Make in India’ initiative. If the industry were to lap it up, a certain vertical (read pharmaceutical industry) of the manufacturing industry would grow up rapidly and India would occupy the dominant position of being one of the largest producers of generic drugs in Asia. Having said that, there are serious loopholes in the system which could potentially still persist and pose as a serious threat to this pharmaceutical produce. This is because, a big chunk of this medicinal produce would lay to waste due to exposure to inappropriate temperatures during transport.
An industrial estimate states that as much as 80% of the drugs produced in India lose their potency due to lack of handling capacity which has to ensure a temperature controlled logistic procedure right from the packaging floor to the customer’s end. Sadly, not much is being done in this regard due to a lack of push from the Government and due to the general apathy of the pharma companies that are looking at profit maximisation but are ending up losing money on recalled goods due to unstandardised transportation procedures.
Medicines and serums used to develop vaccines are highly sensitive to temperature shocks and often end up losing their potency owing to exposure to temperatures outside the acceptable range of 18ºC to 25ºC or 2ºC to 8ºC laid down by the WHO. Due to lack of standardisation there is never a sure shot way to know whether a vaccine or drug being administered to a patient is really even strong enough to fight the disease in itself.
The only options present are gel packs which is essentially water with a thickening agent packed in pouches. These gel packs though effective over a certain period of time, often pass as cheap solutions for maintaining temperature in the absence of active cooling without much adherence to any standard rules of temperature maintenance laid down by international organizations for pharma transport. Since there is effectively no temperature measuring device in place pharma transport companies essentially hoodwink the process and let this most unscientific method pass as ‘safe method of transport’ in turn escalating their profit margins.
The other solution which comes in handy to maintain sub-zero temperatures for certain types of drugs is not just a threat to the drug in itself but poses as a serious environmental hazard - dry ice. Dry ice takes the temperature of the drug well below its acceptable level of cooling to almost -60ºC which in itself is highly unacceptable for any drug or medicine.
Phase change materials or PCMs have the potential to nullify the threat posed by the existing choices of pharma transport and offer a scientific alternative to these methods. Phase change materials are chemicals that help maintain a certain required temperature range by absorbing large amounts of heat thereby acting as thermal batteries which once charged adequately can help maintain the temperature of the payload for as many as 100 hours.
The change of phase in these substances help absorb large amounts of heat from their surroundings but owing to their high latent heat do not change their temperature hence helping to maintain the required temperature over long periods of time. Essentially pharma products are transported over 3 broad temperature ranges: +2 to +8ºC ; +18 to +25ºC and -18 to -25ºC; in each case there are PCMs of the right temperature profile which perfectly suit the application.
Most pharmaceutical companies outsource the responsibility of transporting their produce to freight forwarder companies which operate in a fiercely competitive market and hence cut corners to carve out whatever little margin they can by compromising with the quality of transportation chain. Phase change materials can not only help maintain the requisite range of temperature but also use just 3/4th of the volume of conventional gel packs thus providing a lower volumetric weight advantage to the freight forwarders and also making the payload lighter and portable on the whole.
Phase change materials coupled with proper insulation can help prevent the breakage of cold chain without or with minimal exposure to higher temperatures hence ensuring the quality of the drugs being transported.
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Samit Jain is the Director of Pluss Polymers
Sagar Chatterji is the Executive BD - PCM at Pluss Polymers
An industrial estimate states that as much as 80% of the drugs produced in India lose their potency due to lack of handling capacity which has to ensure a temperature controlled logistic procedure right from the packaging floor to the customer’s end. Sadly, not much is being done in this regard due to a lack of push from the Government and due to the general apathy of the pharma companies that are looking at profit maximisation but are ending up losing money on recalled goods due to unstandardised transportation procedures.
Medicines and serums used to develop vaccines are highly sensitive to temperature shocks and often end up losing their potency owing to exposure to temperatures outside the acceptable range of 18ºC to 25ºC or 2ºC to 8ºC laid down by the WHO. Due to lack of standardisation there is never a sure shot way to know whether a vaccine or drug being administered to a patient is really even strong enough to fight the disease in itself.
The only options present are gel packs which is essentially water with a thickening agent packed in pouches. These gel packs though effective over a certain period of time, often pass as cheap solutions for maintaining temperature in the absence of active cooling without much adherence to any standard rules of temperature maintenance laid down by international organizations for pharma transport. Since there is effectively no temperature measuring device in place pharma transport companies essentially hoodwink the process and let this most unscientific method pass as ‘safe method of transport’ in turn escalating their profit margins.
The other solution which comes in handy to maintain sub-zero temperatures for certain types of drugs is not just a threat to the drug in itself but poses as a serious environmental hazard - dry ice. Dry ice takes the temperature of the drug well below its acceptable level of cooling to almost -60ºC which in itself is highly unacceptable for any drug or medicine.
Phase change materials or PCMs have the potential to nullify the threat posed by the existing choices of pharma transport and offer a scientific alternative to these methods. Phase change materials are chemicals that help maintain a certain required temperature range by absorbing large amounts of heat thereby acting as thermal batteries which once charged adequately can help maintain the temperature of the payload for as many as 100 hours.
The change of phase in these substances help absorb large amounts of heat from their surroundings but owing to their high latent heat do not change their temperature hence helping to maintain the required temperature over long periods of time. Essentially pharma products are transported over 3 broad temperature ranges: +2 to +8ºC ; +18 to +25ºC and -18 to -25ºC; in each case there are PCMs of the right temperature profile which perfectly suit the application.
Samit Jain, Director, Pluss Polymers Pvt Ltd
Most pharmaceutical companies outsource the responsibility of transporting their produce to freight forwarder companies which operate in a fiercely competitive market and hence cut corners to carve out whatever little margin they can by compromising with the quality of transportation chain. Phase change materials can not only help maintain the requisite range of temperature but also use just 3/4th of the volume of conventional gel packs thus providing a lower volumetric weight advantage to the freight forwarders and also making the payload lighter and portable on the whole.
Phase change materials coupled with proper insulation can help prevent the breakage of cold chain without or with minimal exposure to higher temperatures hence ensuring the quality of the drugs being transported.
We are increasingly heading towards high health costs. Prevention of diseases is no longer an option, but a necessity. For this, it is important that pharma and vaccine companies, voluntary adopt ethical practices in transportation of medicines and vaccines. Innovative solutions such as PCMs can genuinely contribute in ensuring drugs are maintained at the right temperature from start to end and reduce the drug wastage a few notches thus helping in reducing healthcare costs and making healthcare accessible to all.
With a population the size of India serious thought needs to be paid both by pharmaceutical companies and the administrators on ways to prevent their pharmaceutical produce to go bad, so that they are in a position to tackle threats from epidemics and deadly diseases who’s threats loom large on our country’s citizens and its future. Capitalism and profits at the cost of health will cost the country dear.____________________________________________________________________________________________________
Samit Jain is the Director of Pluss Polymers
Sagar Chatterji is the Executive BD - PCM at Pluss Polymers