Customised Software Solution for Outsourcing in Regulated Pharmaceutical Industry in the Post TRIPS Scenario in India

Research and development is the key to success of the biotechnology/pharmaceutical industries in the world, including India. India's leading pharmaceutical industries recognised that without active research programmes, it would be difficult for them to compete globally. In the present review, we have tried to analyse post TRIP Research & Development scenario in India. Because of lack of technology support and resources required for upgradation and expansion of their internal R&D facilities, there is urgent need for SMEs to opt for novel strategies.

Global recession and M&A (Merger and Acquisition) activities have adversely affected the economy the world over. Not surprisingly, the regulated markets are still endorsing stability (Guptaet al., 2007). For example, healthcare sector has great potential in terms of business for countries like India and China, who have advantage of both scope and scale (Singh, 2007). In the post TRIPS(Trade-Related Aspects of Intellectual Property Rights) scenario, pharmaceutical industries are having their own challenges as well as opportunities. Technology transfer, IPR, and cost effectiveness are all the more important than ever before. Thriving BPO industry has opened flood gate of opportunities for entrepreneurs specially the big players (Cavalla, 2007). The scope of outsourcing is rather vast, encompassing the whole range of activities in the value chain viz. discovery research, process development, authorisation, licensing, compliance, manufacturing, marketing and distribution etc. That is equally applicable in regulated markets like ICT (Information Communications Technology) as well as healthcare. CRAMS (Contract Research&Manufacturing Services) and CDMOs (Contract Development&Manufacturing Organizations) are providing plethora of services from idea development as well as other nuances of marketing. CRAMS are proliferating in unchartered territories (as a sunrise industry) due to strong HR base in countries like India (Clark&Newton, 2009). An entrepreneur, even with limited resources can achieve success in a small time frame, thanks to CDMOs. Established players need CRAMS to thwart market pressure (Higgins&Rodriguez, 2006). Small Biotechnology or Pharma industries can always rely on expertise of CDMOs for harvesting quick commercial gains. As pharmaceutical manufacturing is constantly challenged to meet the rising standards of GMPs concerning quality&safety through rigorous regulatory requirements ensuring regulatory compliance and managing a myriad of validation documents, outsourcing comes handy to meet the challenges efficiently.

Since the early 90's, outsourcing has become the buzz word for the industrially advanced countries, while India and China have become major hub for CRAMS. Operational efficiency, cost effectiveness, economic resources as well as speedy growth are key factors in the success of BPO. The size of CRAMS business in India was around US $3.8 bn in 2010 and is expected to double in 2014. The MNCs are outsourcing many ancillary services to focus on core competencies. Transparency, control of power allocation of resources and geographical distances are major issues in a successful joint venture. Information technology offers good support tothe cause of CDMOs (Hohman et al., 2009). The need of an efficient tool for applications delivery especially specialised function is of immense importance. A customised software is a better tool designed specifically for CRAMS. The customised software application package developed to support CRAMS helps to improve the communication between the teams or departments, irrespective of geographical location, can manage task in hand more efficiently, track&monitor all team activities, as data and action are recorded in the system for effective supervision by experts&management (Williams, 2007). Allocation of resources&scheduling of tasks to various partner teams help in smooth running of the business as stipulated. New tasks are assigned, contingency plans are booted smoothly, all that without hiccups. Popularity andpotential of enterprise resource planning (ERP) adoption and implementation in CDMOs areanother positive development. Integrated nature of ERP system, which require an organisation to adopt standardised business processes reflected in the design of a software. The "fit" between the characteristics of the adopting organisation and the standardised business process designs embedded in the adopted ERP systems affects the likelihood of implementation success or failure.

There are many software products developed in the markets to help the business partners. These software applications help in tracking the progress of each ongoing tasks, deadlines, cost priorities&resources with regard to specific projects using formats like reports, calendars, scheduling rosters etc. The implementation is short and easy, and ensures quality products as well as services.