Panacea Biotec is a research-based health management company based in New Delhi, India. The company researches, manufactures, and sells branded pharmaceutical formulations, vaccines, and natural remedies, including prescription products for pain management, diabetes, cardiovascular health, renal disease management, osteoporosis, and gastro-intestinal care.
Panacea Biotec has manufacturing plants in Baddi, Delhi, and Lalru, and research and development centers in Delhi, Lalru, Mohali, and Mumbai. The company employs around 3,800 employees in India—including 300 scientists—and has affiliates in Germany, Switzerland, the United Arab Emirates, and the U.S. It has filed more than 1,200 patent applications and holds 382 product patents, which are valid in 68 countries.
Panacea Biotec subjects all its products to rigorous safety testing. As the company tests the various pharmaceutical product components, it keeps a record of any reported side effects and unexpected occurrences that may or may not be directly associated with the product, such as an adverse reaction following an immunization. These are known as adverse events (AEs). The event is checked against a list of known AEs associated with the component, and if the AE is occurring for the first time, it is added to the list and flagged as suspect.
The company traditionally used spreadsheets to record listed and new AEs during safety monitoring. However, it was becoming difficult to perform the necessary duplicate AE checks and searches, and because a number of staff within the safety department had access to the spreadsheets, there was a high risk of human error. As it became harder to manage the data, it also became more difficult to generate accurate reports detailing listed AEs, which are required by international governments and regulatory authorities, such as the European Medicines Agency and the U.S. Food and Drug Administration.
Panacea Biotec needed a comprehensive management system to integrate AE data, complete detailed searches, and produce accurate regulatory reports. In July 2010, the company engaged Oracle Partner HCL Technologies to implement Oracle Argus Safety and Oracle Argus Interchange.
“As a pharmaceutical manufacturer and researcher, it is vital that we report adverse events that result from the use of our products to comply with competent authority regulations,” said Dr. Mudgal Kothekar, deputy general manager, pharmacovigilance, Panacea Biotec. “Oracle Argus Safety is an organized, manageable application that enables our staff to easily perform duplicate searches, raise automated queries, and validate data about adverse events to ensure the safety of our products
Oracle Argus Safety provides Panacea Biotec with an integrated repository for safety lists and reports required by international governments and regulatory authorities.
Previously, the company had to enter results into a spreadsheet and generate reports manually, which was a slow process and prone to errors. Now, it produces detailed safety lists in one day rather than two to three days, and the reports are more accurate.
Panacea Biotec has also halved the time it takes to produce aggregate reports, which are used to determine the risks and benefits of individual pharmaceutical components by analyzing safety results collected over a specified period—six months or one year, for example. These aggregate reports must include specific details regarding each component, as required by international regulatory authorities.
Previously, it took 30 to 45 days for the company to extract the safety test results and AEs from separate cases and spreadsheet reports, countercheck the information, and create the aggregate reports manually. Now, most of the reports can be generated automatically using the aggregated reports feature in Oracle Argus Safety, so the whole process, including counterchecking, takes 15 to 20 days, and the quality and accuracy of the reports have greatly improved.
“As a pharmaceutical manufacturer and researcher, it is vital that we report adverse events that result from the use of our products to comply with competent authority regulations,” said Dr. Mudgal Kothekar, deputy general manager, pharmacovigilance, Panacea Biotec. “Oracle Argus Safety is an organized, manageable application that enables our staff to easily perform duplicate searches, raise automated queries, and validate data about adverse events to ensure the safety of our products.”
Panacea Biotec is also using Oracle Argus Safety to create separate risk evaluation reports, which it couldn’t do previously. The monthly reports cover a specified period of time—which can be easily changed within the system—and compare a component’s AEs with those during a previous period of time to check for any changes.
In the past, the company had to use the aggregate reports to identify and monitor these changes manually. Automatically generating separate risk evaluation reports has cut the time and effort it takes to monitor these events and also reduces the risk of human error.
Oracle Argus Safety has enabled Panacea Biotec to submit its industry-standard electronic E2B files to pharmaceutical regulatory authorities directly, saving staff a significant amount of time and effort. The files include standard reports covering individual case safety information. Each file may have to be sent to the regulatory authorities multiple times, depending on how many follow-ups the authorities send to request extra safety monitoring information.
Previously, Panacea Biotec was generating paper-based reports and sending them to an affiliate organization, which transferred the data into an XML format and submitted the reports electronically to the authorities. Depending on the individual case, the process could take hours, as the reports had to be generated twice. This also increased the risk of errors. Now that data is validated onsite, the reports are more accurate and the company can submit them to national and international authorities on time.
Panacea Biotec has also implemented Oracle Argus Interchange, which will soon enable staff to exchange safety results and test case information electronically with affiliate companies and industry regulators worldwide.
Panacea Biotec evaluated several other companies offering pharmaceutical industry-standard software, but decided on Oracle as it proved more cost-effective and user-friendly.
Oracle has a strong reputation in India and Panacea Biotec was impressed by Oracle’s established partner network. The company’s staff also had experience with Oracle Argus Safety and other AE management systems in previous roles and felt that Oracle Argus Safety best met the company’s needs, by offering a more comprehensive system that would support the end-to-end pharmacovigilance program.
Panacea Biotec engaged Oracle Partner HCL Technologies to implement Oracle Argus Safety and Oracle Argus Interchange in July 2010.
HCL migrated data from Panacea Biotec’s development, validation, and production environments in four stages, addressing several issues encountered in the initial migration from the development platform to ensure the same problems were not encountered in the subsequent data migrations.
Oracle Argus Safety went live in December 2010. The company plans to go live with Oracle Argus Interchange in mid-2012.
HCL Technologies spent almost five months working onsite with Panacea Biotec to implement Oracle Argus Safety and ensure the pharmacovigilance management system was tested thoroughly before going live.
“To ensure we effectively helped Panacea Biotec improve its business processes and adopt new technology to conform to industry regulations, we carried out a careful evaluation of its current system, data usage, and technical data,” said Alamelu Balaji Ganesh, associate project consultant, HCL Technologies. “We created a detailed data migration strategy and worked closely with Panacea Biotec to resolve any issues and ensure it could easily generate reports.”
HCL carried out four data migrations and ensured problems encountered in the first instance were addressed before the second migration. The partner also helped Panacea Biotec create the required regulatory, aggregate, and E2B electronic reports.
HCL carefully planned the go-live approach to avoid any last minute surprises and offered Panacea Biotec advice and support throughout this crucial time. After the system went live, HCL provided training to staff in Panacea Biotec’s pharmacovigilance division and offered remote support for four months until employees were completely comfortable with the system.