‘IT’ is safe
Over the years Information Technology (IT) has had considerable impact on the way different industries function. Pharma industry is perhaps the biggest beneficiary of this revolution, as introduction of IT has made operations in the pharma industry more reliable. However, safety is arguably the most important contribution of IT to pharma operations. No wonder, pharma companies are heavily relying on IT solutions for all their safety related needs.
Take ‘IT’ safely
Taking medicines safely to the final consumer is perhaps more challenging than manufacturing them. IT comes to rescue here as well and helps in securing the passage of medicines up to its final consumer.
 “The IT system gives a unmistakable identity and location, computations and repetitive tasks are precise, human speed is no match to computer speed, unattended monitoring and recording for customer confidence gives security which can be verified.”Nitin Borkar CEO, Vergo Pharmaceuticals |
“Presently all machines, systems and processes are governed by IT solutions to maintain cGMP. In the US, e-pedigree, RFID-based drug-authentication are used to protect against counterfeit, subpotent, substandard, misbranded or expired products,” informs Nitin Borkar, Chief Executive Officer, Vergo Pharmaceuticals.
A company can have its own IT safety measures or it can outsource the same. Vergo Pharmaceuticals is a CRO which handles a considerable amount of sensitive data. Borkar says, “The contract research organisations handle multiple clients with utmost confidentiality. We have an in-house IT security infrastructure to protect our data.”
However, a company like Raptakos Brett and Co has an advanced IT security set up but they also seek additional assistance from a specialist IT company. Rajesh Rane, Senior Vice President, IT, Raptakos Brett and Co says, “We have a combination of both 60:40, major decisions and controls are taken in-house and additional support whenever required is taken from outsourced IT company.”
 “To ensure patient safety, pharma manufacturers urgently need to find ways to protect the integrity of their own products and keep counterfeit medicines out of the legitimate supply chain. IT can play a major role in serialisation and pedigree management easily and at a low cost.”Niraj Kaushik Vice President, Applications, Oracle India |
Oracle is an IT firm with global footprints and is renowned for its innovative offerings for the life sciences industry as well. Niraj Kaushik, Vice President, Applications, Oracle India, talks about uses of IT in preventing possible intrusion in the pharma supply chain. He says, “International trade in counterfeit medicines is rapidly increasing, presenting serious risks to public health around the world. To ensure patient safety, pharma manufacturers urgently need to find ways to protect the integrity of their own products and keep counterfeit medicines out of the legitimate supply chain.”
He adds, “IT can play a major role in this serialisation and pedigree management easily and at a low cost. Technology can enable pharma companies to combat the threat posed by counterfeit medicines today while creating a solid technological infrastructure for compliance with the likely regulatory requirements of tomorrow. To support pharma companies in their efforts to introduce electronic pedigree and serialisation capabilities into their manufacturing and supply chain operations, Oracle has developed a dedicated software application: Oracle Pedigree and Serialization Manager (OPSM). Supported by Oracle’s capabilities in data management, availability, performance, scalability and security, OPSM is the fastest and most cost-effective solution to combating the threat posed by counterfeit medicines, now and into the future.”
Reiterating Kaushik’s views, Rane says, “IT is helping in the distribution setup to achieve higher service levels, lower inventory and lower supply chain costs. IT contributions and implementations are discussed based on changes that have occurred in today’s economy which ultimately can result in better support to the end consumer. Each and every product batch is tracked from production to the stockist.”
Technology ‘can’ what human ‘can’t’
Elbert Hubbard, an American writer, had once said that, “One machine can do the work of fifty ordinary men.” Pharma industry understood the limitations of human intervention in safeguarding pharma products and this led to growing use of IT in this sector.
Kaushik says, “The sheer volume of information and speed at which it is being generated makes it impossible for humans to process it, and naturally securing that amount of information would clearly be out of question. Moreover, it is not humanly possible to keep a tab on the supply chain of medicines and track counterfeit ones. Without the deployment of technology solutions there is a high risk factor involved.”
Speaking about how extensively IT has replaced human intervention at his company, Rane informs, “Latest technologies are in place at all our plants. We have implemented Enterprise Resource Planning (ERP) solutions and modules like QC/ QA, maintenance and production. Every transaction is being tracked through the modules and various Management Information System (MIS) reports required by the users are generated. Access controls, CCTV and visitors management systems are in place at the plant locations.”
“The IT system gives an unmistakable identity and location, computations and repetitive tasks are precise, human speed is no match to computer speed, unattended monitoring and recording for customer confidence gives security which can be verified,” opines Borkar.
All said and done, no machine can completely replace human intervention. On the contrary, technology helps to optimise human efforts.
Hurdles to overcome
Though IT takes the driver’s seat as far as security measures are concerned, there are some areas where it hasn’t helped the pharma industry.
Borkar explains, “Some critical areas where IT solutions for safety needs to be developed are compliance of systems, storage of chemicals and test articles and integration of all video, audio and tracking system to develop authentic documentation.”
Pharma is a continuously evolving sector where innovation is key for survival. Hence IT technologies also need to transform constantly to meet the changing safety-related demands of the pharma sector.
Kaushik says, “Today, the pharma industry is dealing with one of the most serious challenges affecting the integrity of the supply chain; i.e. counterfeit medicines. As awareness of this issue grows among healthcare providers and patients, there is increasing pressure on the industry to put measures in place to protect patients from unscrupulous criminals who are responsible for this menace to public health.”
According to Kaushik, given the obvious threat to public health, patient safety remains the number one driver for increasing vigilance against counterfeit medicines. However, there are also significant business benefits to be gained from securing the supply chain against counterfeit products through IT solutions, including reducing reimbursement fraud against healthcare payers, protecting brand integrity, and gaining better insight into parallel trade activity.
While Kaushik’s main thrust is on supply chain related challenges, Borkar narrates some of the safety related challenges that may crop up within the plant. “Affordable integration of data systems with Laboratory Information Management Sustem (LIMS), ERP and Electronic Library Network (ELN) is going to be the key requirement of the pharma sector. Pharmacy informatics and computerised physician order entry are also crucial from the safety point of view where IT will have to offer effective solutions,” says Borkar.
Pharma industry’s dependance on IT for its safety related requirements is going to grow in future. Hence, the industry keeps exploring new ways of manufacturing effective medicines and this adds to complexities of day-to-day operations. Till now IT sector has developed satisfactory solutions for the safety needs of the pharma companies, however, the job is not done yet. With patent expiry and growing emphasis on biologics, coming years would be more challenging and complex for both, the pharma industry and the IT solution providers.
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