Securing the supply chain, environmental sustainability and updation of technology infrastructure will be the buzzwords. By Usha Sharma
TRACK AND TRACE crucial for pharma supply chain
Global markets today are flooded with falsified medicines, posing a perilous threat to the pharmaceutical industry and patients alike. It tarnishes the goodwill of the pharma companies who are unaware about the counterfeits making their way to their supply chain system. This chain typically consists of manufacturers, wholesalers, distributors and pharmacies before the medicines are made available for the end consumers at the pharmacy store.
In such a scenario, track and trace technology plays a crucial role for any pharma supply chain. It avoids security lapses and works to the advantage of pharma companies. Track and trace regulation is one of the tools which aims to stop the illegal and dangerous counterfeit medicines from reaching the end consumers and ensures that all the products are easily identified. It helps in labelling the drugs and ascertains easy tracking at every level of the supply chain.
Report on track and trace in the pharma industry is based on the experience of the team at ACG Inspection in various countries across the globe, particularly, Brazil, China, India, the US, Turkey, Saudi Arabia and Europe.
Most of the regulatory authorities across the globe are creating a two-step policy to implement track and trace regulations. The first phase is to implement serialisation at multiple packaging levels. The second phase is to implement an electronic pedigree, where companies will create a relationship between various packaging levels and share data across the supply chain.
There are many regions where pharma regulatory systems are weak, due to which, the probability of spurious drugs increases. Globally, the importance of implementing a comprehensive track and trace system is to monitor the entire production and distribution cycle of pharma products has grown strong.
With disciplined rules and regulations, guiding the supply chain system of pharma companies, standardised identification solutions are sure to put an end to spurious medicines and secure the health of consumers worldwide.
The challenges, which the pharma industry face today, include counterfeiting, theft, diversion, and false returns to manufacturers. This is because the product passes through a complex distribution network where its authenticity at every level cannot be checked due to the absence of data-sharing systems. Serialisation makes every product unique and, therefore, it is believed that effective serialisation of medicines would cut down any chances of counterfeiting in the supply chain.
Serialisation involves printing a unique serial number on every product in addition to other details such as batch number, shelf life and Global Trade Item Number (GTIN). It provides visibility and full traceability throughout the supply chain. Many regulatory bodies have built their framework around the GS1 Standard.
Serialisation is done across various levels of packaging and these are defined under three specific categories — Primary, secondary and tertiary.
At the primary level, pharma companies use a GS1 2D Data Matrix to barcode products such as blisters, injections, mono-cartons, etc. (Currently, this is not being enforced in a majority of countries).
At the secondary level, all the primary level packs are clubbed together as a parent unit of primary level packs and only one barcode is given to it with complete essential information.
At the tertiary level, only the final packaging is chosen to identify every lot of the product, ensuring no malfeasance in the supply chain.
Success in serialisation is achieved through vigilance, planning and implementation. Serialisation, when followed diligently, results in economic benefits, better brand protection, and secures customers’ confidence in the brand as well as the company.
The pharma supply chain is really dynamic and complex, and although a majority of the prescription drugs consumed by patients are safe, there are several opportunities to introduce a counterfeit drug into the supply chain. Serialisation was the first step towards attacking the counterfeiting markets. With the first phase in place, a customer would be able to tell if the products were genuine or not, through a simple verification process.
When a spurious drug enters into the system, the first question that arises in our minds is where and how did it enter into the system? As the pharma supply chain is really complex, there are multiple potential places from where the counterfeit drug could have been introduced into the supply chain. This is due to the lack of information visibility throughout the chain. In order to address this, regulatory boards are enforcing the implantation of an electronic pedigree. This contributes to protect the supply chain from any mishaps. It also helps pharma companies to address problems of counterfeiting wherever and whenever it arises, as data is recorded and shared at each and every point in the supply chain.
An electronic pedigree encapsulates all the details from sales to purchases made as well as trading of the drugs and their date of transactions through an electronic medium. The main purpose of the electronic pedigree is to safeguard consumers from counterfeit medicines.
The electronic pedigree is an auditable electronic record to track and trace drugs as they move from manufacturing unit to the end users. Its accuracy ensures safe and healthy drugs for consumers.
The benefits of an electronic pedigree
- Authenticates pharma products for safe consumption
- Automates internal procedures
- Improves efficiency and reduces cost of operating
- Improves accuracy and visibility of inventory information at various levels
- Improves inventory control
The overall opportunity v/s risk
We need to be aware about where these steps will lead to. A few basic assumptions are:
As regulators accede to industry demands, who is the apparent ultimate winner or loser?
What segment will be benefited or damaged? The consumer, as it exposes him to harm or the industry as it lags behind its global competitors? It mostly depends on how objectively the norms and the laws are designed and implemented. The expertise implicit in serialisation and secure packaging should be easy to understand and implement.
Harmonisation at global level will not only be beneficial to the consumer world, but will also help various industrial players to implement efficient and universally proven solutions. Further, it will also ensure secure traceability of the entire supply chain at a global level.
– Siddhant Bhambhani, Business Development, ACG Inspection Systems
Pharma industry needs to look at ENVIRONMENTAL SUSTAINABILITY
Pharma PET bottles containing liquid solutions were banned in India, though the scientific basis of it is still in doubt. National Green Tribunal and Supreme Court of India are pursuing cases against plastic and other solid wastes generated due to various packaging applications, especially against ‘single use’ packaging.
Regulation and sustainability
Regulation by courts, if not the governments, seems to be the future trend in waste management, water management and larger area of sustainability. It is the right point for companies and pharma industry to look and build structures, which not only comply with the present and upcoming regulations but reap them financial reward.
Energy, water and waste streams: Reducing energy footprint in manufacturing the packaging in partnership with the vendor would benefit both. More importantly, pharma waste disposal in water systems has a negative feedback effect on pharma industry across its value chain.
For instance if antibiotics waste is dumped in a river, downstream population using the water would become drug resistant over a period of time. Once the disease occurs taking a more virulent drug resistant form, the present drug sales will drop and the R&D investment would be lost. Even if the drug is generic, the sales drop would impact the companies’ manufacturing and selling this particular drug. They would lose the market. A simple act of dumping waste water done by an employee or a process would impact the company. This is the financial and economic impact of environmental sustainability.
Pharma packaging, communication and adherence to drug dosage
A peer-reviewed study published in Clinical Therapeutics of more than 3.1 million Walmart pharmacy patients and MWV’s Shellpak calendar blister packaging concluded that “a Shellpak-based adherence strategy could provide a substantial cumulative public health benefit when broadly implemented over a large population. Not only does increased medication compliance reduce hospitalisations, nursing home stays, lost work days, etc., but greater refill adherence can also result in financial benefits for pharma manufacturers—an increase of eight per cent to 14 per cent, estimates suggest. And industry knows the impact of eight to 14 per cent sales increase.
The above point has two components
- Firstly, the responsibility of the pharma companies is much more than just researching and manufacturing the drug
- Secondly, communicate through drug packaging in a way that the impact is felt across the value chain; the patients’ health, hospitals, doctors and the finally the company’s profitability.
Would not this be ‘real’ sustainability, the real profitability, rather the ‘true value’ of any drug? Can we start thinking in terms of ‘value’ rather than our cost-centric strategies?
Excess packaging and extended packaging
We see many pharma packs containing multiple layers of materials. Is this excess packaging really required? Rather than working on reducing the weight of each layer, can we work on reducing the number of layers? Can we use alternatives of PVC (a known carcinogen), such as PET, which by the way will also pre-empt the regulation against PVC blisters and its waste?
Can we work with the retailer to reduce, if not completely eliminate, polyethylene bags given with each medicine? Can we go beyond the manufacturer’s responsibility and contribute to reduce environmental degradation due to landfill waste?
Environmental sustainability includes financial sustainability. The pharma industry just has to look at environmental sustainability to see the reflection of profits and value delivered for all the stakeholders of its products, the life-saving drugs.
Implementing sustainability across the value chain
The pharma industry in India can embed environment sustainability strategy in its corporate strategy (first of which is appointing a Chief Sustainability Officer with cross functional expertise and authority). The question maybe asked, Why?
These may be due to any or a combination of the following factors. They are increasing or maintaining brand reputation/value (CIPLA); ambition for social and environmental leadership (P&G); need for competitive advantage; stakeholder pressure (as happened to Indian Pharma companies in the US, Russia etc.); rising energy costs (as in many units in Gujarat, reducing impact through solar and energy efficient installations), and last but not the least pre-empt regulatory compliances.
Challenges to implementation
- Budget challenges
- Difficulty in demonstrating Return on Investment (RoI)
- Fear of disrupting present processes and even mindset
- Lack of knowledge of implementation and its impacts
Action for implementation
- Incorporate sustainability matrix across the value chain
- Adopt or expand sustainable sourcing of materials and sustainable materials (like biodegradable plastics
- Implementing staff and customer collaboration and education initiatives
- Redesigning products
- Work on carbon, water and energy footprint
Impact of sustainability implementation
An Aberdeen Group, May 2009 report on sustainability states how profitability has been increased drastically by taking small steps by top 20 per cent of an industry. (Reduction in percentage is marked as –ve and increase as +ve)
Say, if one objective of compliance in packaging delivers better profitability and adherence to doses, thus greater value, then it should be considered as part of the whole healthcare economics analysis and not looked at as some add-on feature. Also, conflating CSR with environment sustainability is to be avoided, whether due to lack of knowledge or as a greenwash gimmick.
One thing sustainability creates is evaluation of all impacts and benefits side-by-side. Since medications have a much larger social, environmental and economic impacts, the pharma industry in India need to look at total value delivered to all stakeholders.
– Pranay Kumar, Chief Environment Officer, Vasudha Ecofriends Projects
The solution lies in CLOUD TECHNOLOGY
The Indian pharma industry contributes to research and development, clinical research and laboratory testing for a wide range of generic and branded drugs. This industry also exports such drugs globally, contributing to India’s international growth.
The global pharma industry includes countries that either manufacture or consume pharma and healthcare products/services. Globally, the industry is complex, and is characterised by varying standards of trade, operation, compliance and technology use. Typically, developed nations have better regulation and governance to manage citizen healthcare, but is accompanied by a high cost of healthcare. In comparison, growing nations typically have a lower cost of healthcare.
Technology and its role in the Indian pharma industry
Serialisation and track and trace technology is a big part of the global commerce industry, as well as for the pharma industry in India. With mega trends like big data, cloud and the Internet of Things, we anticipate that adoption will continue as the Indian pharma industry matures and as machine data generated reaches a tipping point that accelerates mass adoption.
As global and Indian pharma companies extend their reach, they will need to enable capabilities with these mega trends in mind that accelerate their success.
- Manufacturers being able to track and trace all goods in their supply chain and know who specifically to reach out to when a recall is required
- Stakeholders understanding the Chain of Custody at both the ingredient and finished goods level
- Stakeholders in the Supply Chain being able to identify whether a product is genuine or counterfeit
- Patients being able to scan a medicines and learn if they are likely to have an allergic reaction to specific ingredients in a drug they are purchasing
- Patient being empowered with information about the drugs they consume
- Doctors being able to monitor if their patients are on schedule with a prescribed course of the drugs
While India has created standards on serialisation and track and trace, many pharma companies are unable to comply because of limited investments in technological infrastructure, or in supply chain considerations including the size of existing packaging or additional packaging material – most of which is exceedingly high for generic drug manufacturers.
Pharma companies who have adopted such technologies are usually in the branded drugs space, and have to comply with regulations implemented by countries that they export to. The local industry is lagging in this area due to considerations including price sensitivity. That said, we have seen an encouraging trend of drug companies transforming their technological infrastructure, and enjoying huge advantages when exporting to a global audience.
While we believe that India will see a fair share of serialisation and track & trace technology adoption in the future, there needs to be the ‘tipping point’. There are two primary factors to this tipping point. First, clearly visible use cases which benefit the consumer beyond just drug regulation and second, increased consumer education to improve their expectations on drug companies and the medication they provide.
In fact, there are already existing technologies and services which reduce the high initial overheads that pharma companies incur in serialisation and track and trace, and the solution for this lies in the adoption of cloud technology.
– Kingshuk Ghosh, Manager, HPE Software Professional Services, Asia Pacific & Japan, Hewlett Packard Enterprise