Regulatory requirements are the boon or bane of any industry depending on which side of the fence you are. This is far more relevant for the pharmaceutical industry where you have to follow stringent guidelines laid down by the FDA and other regulatory bodies.
For instance regulatory requirements can make the process of drug discovery and research slow and tedious. From isolating a new molecule and performing multi-tired clinical trials, to getting a drug out in the market before your competitor, there are predefined guidelines to be met within stipulated timeframes.
This necessitates the use of Information Technology (IT) in the modern Pharma enterprise.
Enterprise-wide IT is the panacea for most of the problems facing the industry—whether it is complying with regulatory procedures, improving productivity or faster time to market of the final molecule.
Clinical research organisations across the board today have elaborate data management centres. They streamline information capture and retrieval on a need based to extrapolate and predict study results sooner than ever before, in a much safer manner. As Dr Srinivas, Executive Vice President-Drug Development Dr Reddy's says electronic documentation makes inspection simpler and thorough. The same is true of the manufacturing and supply chain data generated in pharma companies.
Our Management Cover Feature—'Blending IT with Pharma'—provides a perspective on how companies like AstraZeneca, Biocon and Sami Labs have implemented ERP and supply chain solutions to crunch vast amounts of real-time clinical data, seamlessly integrate your suppliers and distributors to micro-manage the inventory pipeline and manufacture drugs as per regulations and specifications.
IT apparently is one department a number of companies are investing in, however, cost effective manufacturing for most companies is a result of more than compliance with regulations. About five to ten percent of all medicines produced do not meet quality standards and have to be discarded resulting higher production costs. Process enhancement tools like Six Sigma to ensure that drug meets quality standards without an increase in manufacturing cost.
That is why, this fortnight Sapna Dogra explores results of implementing Six Sigma as the folks at Zydus Cadila, Eli Lily and Manipal Acunova in her story—'Juggling with quality tools for productivity'. In the present context if Indian pharma has to retain its reputation as a producer of cost effective quality products, abiding by such standards could make all the difference.
The other partly neglected department is the Human Resource. Indian pharma has to face unusual challenges such as centrally unionised workforces and an ongoing need for training as product portfolios change. These are issues that formerly did not fall under the purview of the personnel department, are to be dealt by the HR department. The role of HR has changed, and as companies get younger and flatter, it will be that much more important to have an effective HR in place. Take a look at our story—'The HR Symphony: Linking People, Strategy and Performance'—to discover the redefined role to HR in pharma organisations.