Regulatory requirements can make the process of drug discovery and research analysis slow and tedious. However, pharmaceutical companies are using technology to speed up the process, retrieve data in real time and gain better control over inventory, says Abhinav Singh.
While the end-products of AstraZeneca, Biocon and Sami Labs vary substantially, the process of drug discovery is nevertheless the same.
Many pharmaceutical companies are now into drug discovery and development. But identifying a new molecule and then performing clinical trials on it is a complex endeavour. The company has to meet various regulatory requirements (FDA 21 CFR Part 11, EPA and OSHA). The pressure to get a drug into the market before a competitor does is tremendous. Data gathered from clinical trials comes in large quantities. This data is analysed using off-the-shelf or in-house enterprise applications that are specific to the pharmaceutical industry. As these applications are Web-based, distributors, stockists and manufacturing plants can be linked to them. This creates a network that resembles an integrated supply chain. Research cycles are rapid; vast amounts of data that have to be analysed are available online on a real-time basis to the research department of a pharmaceutical company.
Multiple data streams
Pharma companies may work on 40 to 50 different drugs simultaneously, and they have to monitor and track the different stages in the development of those drugs. Explains C A Anzar, Director, Sami Labs, "Because we handle multiple products at any point of time, we need to know the progress of a drug during each stage of its production. The research data is continuously uploaded to our in-house ERP system." The data analysis conducted by its system is so precise that the company has been able to speed up its research activities, and thereby its drug development.
Pharma companies also need to ensure that drug research data is integrated and available for its manufacturing units as and when required. Sami manufactures from multiple locations; it has a manufacturing plant in Bangalore, and has outsourced production to a company in Hyderabad. It also has operations in China and Japan, and needs to keep track of its operations and gain access to an integrated, unified pool of information. That is what the company’s home-grown ERP system offers.
Biocon's project tracking has been streamlined with an in-house enterprise application. Radhakrishnan G, Senior Manager-Systems at the company, says, "When we start a new project with a view to discover a drug, the complete project history from start to finish is entered into the ERP system; this history can be used for future reference." It helps the project team to gain control and monitor research projects running across the organisation. Even more significantly, it helps them plan better for their future projects.
Some IT initiatives by pharmas
||Uses the financial module of the Oracle e-Business Suite. It also uses in-house software called Vision that helps it integrate the ERP systems of its manufacturing plants located across the globe
||Has deployed an in-house ERP system that helps it streamline production. Also has plans to integrate operations through the ERP solution
||Has an in-house ERP system with modules such as accounts, HR, administration, quality assurance and purchase
Indian pharmaceutical companies have streamlined their production schedules using enterprise applications. Radhakrishnan of Biocon explains, "Our production department is able to schedule its activities in a better manner on account of the improved information flow across our organisation due to the efficient use of business applications." Biocon's inven-tories have shrunk as the production department has been able to plan its capacity. This in turn has streamlined the time-to-market. Different departments involved in drug manufacturing have real-time access to information from the research departments, and they can plan their production accordingly.
AstraZeneca's drug manufacturing plant at Bangalore works in close conjunction with its 31 manufacturing plants located across the globe. All these plants have an ERP system, which helps in production management and planning. These systems have been customised as per the differing requirements in different countries. The company has an in-house software, Vision, that helps integrate different ERP applications running across its many manufacturing plants. Comments R S V Rao, who heads the company's supply chain, "The pharma industry is growing by 60-70 percent every year, and there's a change in therapy patterns from time to time as patients and doctors experiment with new drugs for faster recovery. To be successful, pharma companies need to change their approach every now and then." ERP and supply chain systems help a company analyse market trends and manage its inventory pipeline better so that it can manufacture drugs as per requirements and specifications.
Many pharma companies in India that run in-house ERP systems have plans to go in for Web-based solutions so that they can extend the ERP solution to their suppliers and (outsourced) manufacturers, and take advantage of an integrated environment. Biocon, for instance, plans to make its in-house ERP system into a Web-based product so that employees can access information remotely.
IT has also helped these companies improve their decision-making. Biocon is running an in-house Labo-ratory Information Manag-ement System developed using Visual Basic and the SQL Server database. The system helps the company capture clinical and lab data that's required during drug research. It can accurately analyse this data so that retrieval happens in a jiffy, as does the generation of reports for the production team. These reports are sent to clients for their approval. The same applies for the quality checks that are done on certain drugs. These drugs can only be despatched after the quality department gives its nod. Through the ERP system, quality results are imm-ediately made available to the despatch department, and the drugs are then promptly shipped out. Also, invoices entered by the despatch department into the system bring in transparency.
With increasing comp-etition in the Indian pharmaceutical sector, IT can be the enabler that helps companies stay ahead. As they become more tech-savvy, they can reap the benefits of adopting enterprise applications.