IT services in pharma
Dr Appaji PV, Director General, Pharmexcil says that IT plays a big role in the pharma sector, especially drug discovery, drug candidate designing, clinical research etc. It is also used for the submission of applications for overseas drug registrations in the common technical document (CTD) format. “IT has several applications in the drug standardisation/identification procedures as well,” he adds.
According to Anagha Vyas, PaxPro Business Unit, Persistent Systems, India has been the preferred location for multinational drug manufacturers since the last few years. Now, they also look towards India for areas like discovery research, clinical trials and other administrative activities; and the use of IT would help to sustain this interest. PaxPro is a provider of Brand Lifecycle Management (BLM) solutions for the FDA regulated industries. She says, “IT services can largely be used in clinical and biotechnical research for drug development, medical devices, regulatory compliance management, supply chain management, data management, pharmacovigilance, business process outsourcing and IT infrastructure management.”
Dr Appaji PV Director General, Pharmexcil |
Realising the growth potential in the Indian pharma sector, IT solution providers are also introducing innovative and tailor-made solutions to keep up the growth momentum. “The IT solutions today provide comprehensive services around acceleration of drug discovery, enhance clinical trial efficiencies, maximise manufacturing productivity, improve sales and marketing effectiveness, and manage the end-to-end product development. However most of the domestic pharma companies seek IT services for order planning, procurement, end-to-end sales cycle, better analysis of sales funnels, budgeting and resource allocation etc. Abstract enterprise applications that address sales and distribution, financial planning, supply chain, material management and warehousing solutions are also in demand in the Indian context,” informs Utkarsh Palnitkar, Head, Life Sciences, KPMG, India.
Pharma needs more IT
Utkarsh Palnitkar Head, Life Sciences, KPMG, India |
IT is doing wonders for the pharma industry, but it is no where near sectors like financial services (banking, insurance, mutual funds), telecom, retail and the government who make up the key consumers of IT services in India. According to Palnitkar, these sectors command a lion’s share of current $10.2 billion domestic IT services. He informs, “As per the Datamonitor Global IT-BPO Services Forecast report, the Indian pharma IT services market is estimated to be at $ 443 million growing at 14 per cent year-on-year (YOY).”
Palnitkar adds, “Though the life sciences industry is behind the top tier sectors, the mid level pharma companies are now fast realising the benefits of IT services so as to achieve cost efficiencies, streamline operations and more importantly meet the emerging stringent compliance guidelines. This would peg the addressable market size for IT service in pharma to be around 2X-3X times the current market size.”
Thus, Indian pharma companies are slowly and steadily but definitely becoming more IT-savvy. However pharma MNCs, with their technology friendly attitude, are likely to constitute the major client base for IT solution providers, atleast for some more years to come.
Market drivers
Today, by volume Indian pharma industry is the third largest in the world. Almost every country in the world consumes some form of medicine manufactured in India. There is cut throat competition among Indian companies to gain a bigger share in the global market. Therefore, pharma companies have no option but to become more productive, internationally more acceptable and operationally more efficient; a goal that cannot be achieved without the help of the requisite IT services.
Anagha Vyas PaxPro Business Unit, Persistent Systems |
According to Vyas, pharma companies are vying with each other to explore new drugs. They are rapidly moving from clinical pilots to commercial scale manufacturing. She says, “A head start in launching a new product brings in significant return on investment (ROI). In this race to reduce the time to market, it is imperative to safeguard against errors that lead to recalls. The opportunity to leapfrog the competition is by adopting automation. We believe that pharma companies today need to automate or they will perish. High order of compliance and lengthy review cycles across multiple departments make the whole product development cycle longer and difficult to manage without automation.”
She illustrates her point recounting how a Paxpro customer mentioned that they could triple their product releases with zero increase in headcount across departments just by implementing Paxpro. Spelling out the advantages, she says the customer now has better control of their entire process automation to replace manual review and inspection tasks, greater collaboration through online tools, and one ‘system of records’ through integration with their other systems.
IT solutions for regulatory challenges
Pharma regulatory requirements in overseas countries are always considered more stringent than in India. Use of IT services would perhaps play a major role in projecting Indian pharma industry as more quality conscious and serious about its business, a reason why pharma players in India have become more conscious of their IT deployment.
Palnitkar says, “IT services have evolved over the past decade and today offer integrated solutions right from product development to post marketing surveillance. These services can be classified into research, compliance and post marketing activities. Discovery and pre-clinical solutions address lab automations (Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), Clinical Data Management System (CDMS), Scientific Data Management System (SDMS), compound registration systems), biomarker research, decision support systems as well as bio and chemo informatics areas. These solutions help achieve decreased clinical cycle times, optimise the work flow between various streams, standardise the process across trial locations and hence better present the metrics/data to regulators.”
He adds, “Compliance services include audits that cover process adequacy, maturity, physical infrastructure, information security and IP protection. The solutions provide submissions management, labelling and digital asset management, application development and maintenance services that are fully 21 CFR 11 and CSV compliant etc. which expedite regulatory clearances by ensuring compliance. Finally, there are solutions for pharmacovigilance that help address the vigilance roadmap, maturity and gap analysis, product evaluation and vendor identification, signal detection, regulatory and business risks etc. that aid in compliance, faster reporting and corrective measures.”
According to Vyas, the primary role of the regulatory teams is to ensure that products comply with the regulations and laws designed by the government to protect public health and she asserts, “Automation of the business processes forms a major part of this initiative to prevent errors due to mundane and repetitive work and improve quality. Automated environments have strict audit trails and security policies in place. These reduce the efforts needed to prove compliance to regulatory bodies enabling shorter approval cycles.”
More to come
Though Indian pharma firms lag behind their global counterparts as far as R&D is concerned, we are trying to catch up and launch more innovative products. A surge in R&D activity is bound to generate a lot of data. Managing this data without automation, will be an uphill task. Hence, this will open up more growth opportunities for the IT sector and R&D is just a fraction of operations that take place within the pharma industry.
Vyas reveals more, “What we are seeing now is the next wave of technology investments by the pharma companies where they are trying to automate and connect the various lines of business such as packaging, graphics, R&D, regulatory affairs, finance, together to name a few onto a single platform. This is where business process automation (BPM) solutions come into the picture. BPM solutions that are custom developed for the pharma industry is something that the pharma CIO’s are looking for.”
She adds, “Cloud and mobile services are becoming key enablers for pharma companies. Cloud today enables CIOs to quickly roll out solutions across business lines with zero IT investment. Similarly, mobile solutions enable shop-floor workers and the mobile workforce to be more productive and connected with the rest of the organisation, thus improving productivity and morale.”
Shyamanta Phukon Project Manager, Enterprise IT Consulting, Blue Star Infotech |
According to Shyamanta Phukon, Project Manager, Enterprise IT Consulting, Blue Star Infotech, IT services have been constantly evolving in delivering value to the pharma industry and played a strong role in business enablement. He says, “The relationship from vendor-client has transformed to a partnership model. There are already major IT service providers that have entered the pharma space and are playing key roles in the areas like medical writing, pharmacovigilance, bio stats etc.”
He adds that a decade ago these would have been core areas for the pharma industry but now they are a part of the IT services offered. “The existing partnership saga would continue to evolve, and with further innovation, there would be more areas in the drug development lifecycle that IT services would penetrate for enabling more business.”
Thus, the current scenario offers synergistic growth for both IT and pharma sectors.
India is a cost-effective destination for drug manufacturing, a great lure for foreign players. Moreover, if the government does decide to relax FDI norms further, with the requisite conditions, more MNCs could make India their base. It will be interesting to see how the IT sector responds to this development.