Ideally, gone should be the days, when the temperature control pharmaceuticals products are taken out from the freezers and thrown in a cardboard box along with a few frozen/refrigerated gel packs and distributed…but have these days really gone or are pharmaceutical companies still following the same practices?
Before going into the current practices being used, let’s review the pharmaceutical landscape in India, as per OPPI white paper published in 2019, India is home to the highest number of US-FDA compliant Pharma plants (more than 262 including APIs) outside of the USA. More than 2000 WHO- GMP approved sites and 253 European Directorate of Quality Medicines approved sites. Domestic production span nearly 60,000 generic brands across 60 therapeutic categories and around 500 different APIs. The market size of India’s API manufacturing in 2019 was valued at USD 9.8 billion, accounting for 57% of the APIs on the WHO pre-qualified list.
Not only this, India’s Pharmaceutical industry is 3rd worldwide by volume and 14th by value of total global production. India caters to 50% of global demand for vaccines and we are world’s largest provider of generic drugs. With experts suggesting that the pharmaceutical industry could grow to USD 100 billion in size by 2025, the need to level up for India when it comes to following best of the distribution practices cannot be overstated. We should be on the top of our game when it comes to global and domestic distribution.
The aim of Good Distribution Practices is to establish the framework to ensure that the efficacy of the product is maintained and thereby ensuring the safety of patients. Since pharmaceutical supply chain is highly complex, global regulators have tried to fill in by giving the Good Distribution Practices for their respective jurisdiction. For eg USFDA,PIC/S, WHO, EU.. India’s GDP initiative came from CDSCO by issuing the draft guidelines in 2018.
When it comes to global distribution of the pharma products, Indian pharmaceutical companies have no choice but to follow the rigorous good distribution guidelines applicable to the pertaining country. Failing which can cause expensive return processes, loss of the complete batch of the product impacting overall reputation and not to mention financial strains on the pharma companies. Tracking and tracing becomes an important part of it. Temperature loggers are used to ensure the continuous monitoring of the temperature in pharma product and any kind of temperature and other deviations may be determinantal.
Are we following the same process when it comes to domestic distribution of pharmaceutical products within India?
The domestic distribution framework is as complex as global distribution framework or may be even more complex. The idea is to have complete visibility and control over the complete supply chain, from manufacturing to CFAs and 3PL warehouses to the last mile logistics to the actual patient. There are number of stakeholders involved in the later part of the supply chain like stockists, retailers, individual distributors and any loose end from any of the stakeholder has the direct impact on the product integrity and patient safety.
Regulators have made the manufacturer responsible to ensure that the GMP/GDP guidelines are followed and to ensure that the quality and efficacy of the product is maintained. In order to ensure that, implementing and following given guidelines becomes really important. The GDP guidelines in general talk about Organisation and Management, Personnel, Quality Systems, Premises Warehousing and Storage, Temperature, Environment and Storage Control, Transportation, Shipment containers and Labelling, Dispatch and Receipt, Documentation, Complaints, Recalls/Returns, Spurious Pharma Products, Importation, contract activities and Self inspection.
Each of these parameters would need separate SOPs (made to specific Organisation) to be followed to ensure that guidelines are followed. For eg. If only to cover storage and transportation, SOPs must be made to ensure that the products are kept in correct temperature while it is kept in the pharmaceutical warehouses. The temperature of the cold rooms/freezer rooms must always be monitored a few times each day. For the transportation, either Temperature Controlled Vehicle with strict temperature monitoring must be used or correct packaging must be chosen to ensure that the temperature of the pharmaceutical product is maintained throughout when it is transported via normal vehicle via road or by air. Always ensuring that the calibrated temperature loggers are used for storage and transportation.
The current technology gives us the option to not only check and monitor the temperature but also other parameters like GPS, humidity, shock, light etc.. Real time loggers provide another technical advantages. It is extremely important to choose the correct packaging for transportation and then to ensure that the packaging system is qualified enough for the time and temperature that it will endure during the transit. Not only choosing the correct packaging is important, equally important is to ensure that the package is properly prepared before loading the product in the prepared box.
To prepare the packaging well, the storage of the refrigerants like ice packs/gel packs/PCMS must also be stored at the right temperature in freezer/cold rooms, only then they will perform to their qualification. Not only for 2 to 8 C temperature but also the regulations are getting stringent or CRT ( 15 to 25 C) temperature range. Back in days, the best available solutions for packaging were ice packs/gel packs with cardboard/EPS boxes, but now thanks to the new technologies, zero wastage/zero emission packaging systems are available too. Only if the pharma companies, which are not already doing it, decide to explore those choices and give them a chance not only for global distribution but for domestic distribution too.
The opinions expressed in the article are solely the author’s own and do not express the views or opinions of his employer.