The pharmaceutical industry has realised the need to move up the IT scale and the implementation goes on at a never-before pace. Automation of all hitherto manual operations is adding speed to the overall functioning of the sector. Right from the stage of research and development to numerous purchases to production to distribution â everything is getting digitised for ensuring smooth functioning of pharmaceutical units and improving efficiency, accuracy and decision making, writes Romiya Das of Elets News Network (ENN)
The Indian pharmaceutical industry is third-largest in terms of volume and 13th largest in value. While the India exports are expected to account for 72 per cent of the total pharma production, in terms of value, it is likely to reach US$40 billion by 2020, according to latest reports. Out of US$40 billion, 70 per cent of the revenue is expected to come from generic drugs, 21 per cent from overthe- counter sale of drugs and the rest from patented drugs.
Currently, India has the secondhighest number of the US Food andDrug Administration (FDA)-approved manufacturing units, only after the US, and accounts for 22 per cent of overall USFDA-approved facilities. The industry is fragmented among more than 20,000 manufacturing units spread in the organised as well as unorganised segments.
To reduce manual work, facilitate faster documentation and to beat the competition by reaching the market in minimum possible time, an urgent need for implementation of information technology tools was felt by the pharmaceutical sector. Accordingly, various IT applications are being used in this domain to connect with clinicians, prevent medication errors, store and retrieve pharma data, and data analytics is applied. There are applications such as Computerised Physician Order Entry (CPOE), Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Customer Relationship Management System (CRMS), Sales Force Automation (SFA), Electronic Batch Records (eBR) and many more. These applications have specific functioning areas that help in storing, maintaining and analysing data related to the specific functional area.
CPOE includes both in-patient orders and electronic ordering of outpatient prescriptions referred to as e-prescribing. With this, both physicians and care-givers can give orders directly into the computer, thereby eliminating problems with writing legibility and order transcription. It allows physicians to make better clinical decisions based on patients e-records. It also helps in online verification of the pharmacist, computerised warnings of drug allergies, automated label generation, etc.
The ERP system integrates all the data and processes of an organisation reducing information silos in various departments. It facilitates flow of information between all business functions inside the boundaries of the organisation and manage connections with external stakeholders. ERP consists of various modules, such as production and inventory management, weighing and dispensing, e-batch and e-packaging records, financial accounting, personnel management, and training and development.
To manage the information flow within a lab, LIMS can be made use of for connecting the lab with the rest of the organisation. LIMS automates lab processes to increase productivity, efficiency, and quality analysis. It helps from sample request to sample registration, sample collection, automatic calculations of tests methods, specification maintenance, assigning properties to those tests, recording results, generating reports, issuing COAs, et al.
eBR software is required for the online management of batch manufacturing and packaging records. It converts bulky documentation work into the centralised automatic version. It aggregates data from across various silos of stored information and contextualises it into one consolidated record for the lot produced.
A complete churning of the pharma industry is taking place through IT, in keeping with the varying requirements of the global market. India being the third-largest manufacturer, the pharma companies here must adapt themselves to overcome the challenges, such as compliance issues and good manufacturing practices. Certain other challenges like a highly fragmented industry with an overloaded market of generic drug manufacturers, low-profit margins due to government pricing policy, and low input for research and development due to the pricing norms can also be better addressed with enhanced application of information technology tools. Having said that, what needs to be added is that the industry needs stronger IP regulations to channelise its potential.
To reduce manual work, facilitate faster documentation and to beat the competition by reaching the market in minimum possible time, an urgent need for implementation of information technology tools was felt by the pharmaceutical sector
IT in Pharma Industry
- Computerised Physician OrderEntry (CPOE)
- Enterprise Resource Planning(ERP)
- Laboratory Information Management System (LIMS)
- Customer Relationship Management System (CRMS)
- Sales Force Automation (SFA)
- Electronic Batch Records (eBR)
- Clinical Trial Management System (CTMS)
- Corrective Action and Preventive Action (CAPA)
- Distributed Control System (DCS)
- Computerised Maintenance Management System (CMMS)
The pharma companies are recognising the efficiency of a digitised ecosystem, and realising the importance of Big Data. The industry is also moving towards cloud technology to fulfil the desired requirement of the life sciences, also to overcome the IP and security issues, and also to reduce the operating costs. Additionally, there is also an increasing realisation about how the social media presence is impacting its customers.
An apparent paradigm shift can be seen with the advancement as well as adoption of IT applications in this sector. There are numerous technology solutions which can trigger the growth of the industry, including Big Data and Analytics, which can play a vital role in identifying the best target and costeffective therapies.