New analysis from Frost & Sullivan, World Pharmacovigilance Markets in Lifesciences, finds that the world pharmacovigilance market was worth $1859.9 million in 2008 and is estimated to reach $2252.2 million in 2015. In this study, Frost & Sullivan's expert analysts thoroughly examine the following technologies: drug safety database systems and signal detection systems.

"Regulatory bodies such as the Food & Drug Administration (FDA) and European Medicines Agency (EMEA) are intensifying safety regulations, thereby boosting the adoption rates of pharmacovigilance systems by pharmaceutical companies," notes Frost & Sullivan Senior Analyst E.Sujith. "The need to operate in a cost-effective way is inducing pharmaceutical companies to outsource/offshore their pharmacovigilance operations."

For large companies, the volume of adverse events is sizeable. Even a product from a mid-size company can generate a high volume of adverse events. There is significant potential for outsourcing/offspring for mid-sized companies as well.

Most top pharmaceutical companies have well-established systems and processes. Consequently, they are not willing to replace these systems as this entails high costs and is also time consuming. Moreover, the migration of data from one system to another tends to be expensive for most companies. Aligning existing processes to fit in the new system is difficult.

Vendors should educate pharmaceutical companies about technology implications and its importance in their day-to-day operations. This will be necessary to overcoming prevailing skepticism about a new technology and its merits. They should conduct seminars and conferences to trigger interest and make pharmaceutical companies understand that technology that functions optimally can offer substantial return on investments.

"There will be advances in data integration that will support more flexible decision making on drug safety issues," remarks Sujith. "There is significant scope to extend pharmacovigilance systems to boost their integration with a range of other data sources such as medical records and clinical data."

Information on Outsourcing in PV, global players, end users of services (drug companies)

No drug is absolutely safe; all drugs have side effects. "Safe" here means that the benefits of the drug appear to outweigh the risks. Drugs may contribute to 5-10 per cent of all hospital admissions; around 10-20 per cent of all inpatients may suffer a serious adverse drug reaction (ADR) in hospital. Some ADRs lead to death, and also may contribute 5-10 per cent of hospital costs. So the monitoring of the adverse effects of drugs becomes crucial for good medical practice. Therefore, the pharmaceutical industry has entered a new era of pharmacovigilance (PV).

Pharmacovigilance is relevant for everyone whose life is touched in any way by medical interventions. Pharmacovigilance provides comprehensive, risk-based, flexible solutions for the management of product safety, risk, and patient health during the entire life cycle of a medicinal product.

A series of high profile safety concerns, like withdrawal of certain drugs and the link between antidepressants and suicidal thoughts in children over the last three years, has made drug safety a major issue for governments, regulatory bodies and pharmaceutical companies. Hence, pharmaceutical companies are highly emphasizing pharmacovigilance in the wake of product recalls, “black box” warnings, and litigation.

An inventory of legislative requirements has been enforced during the last few years in the ICH regions. By now, pharmacovigilance planning has become a substantive issue for the long term success of any drug on the market, as malfunction of pharmacovigilance systems and communication channels may lead to license retraction. Recent instant communication channels rightly position manufacturers and marketers of medicinal drugs to report adverse drug reactions immediately to their competent authorities.

Present-day statute demands from the liable manufacturer to inform concerned authorities rapidly about serious adverse drug reactions (ADR) and other drug safety related events that are occurring during the developmental and marketing periods of a drug, such as Suspected Unexpected Serious Adverse Reaction (SUSAR) in clinical development or other immediately reporting events in later stages of a drug's life-cycle.

Non-compliance with these requirements could make the difference between keeping your drug on the market and being forced to withdraw it. Therefore, early planning of your pharmacovigilance strategy is essential to the success of pharmaceutical products.

This may indicate areas of concern which may require closer attention by a potential sponsor. The pharmaceutical companies in Europe and US usually outsource a part or sometimes much of its pharmacovigilance system due to lack of experience and resource, especially with commercial pressures to get the product to market. Sometimes, all the necessary parts of the system cannot be implemented in time by a company as first-time marketing authorization holder. However, additional factors may drive outsourcing in India, such as neither a physical presence nor a cultural experience as well as reduced costs, so that even call centers acting for Western Europe may be placed in India. As regards development in general, it is hoped that the Indian research environment may help to solve enrolment challenges on large multinational phase III studies or indeed be a source of treatment-naive patients for phase II or III. A robust pharmacovigilance is critical to ensure quality and to protect the interests of patients whether this applies to investigational and marketed products. However, both the observational and interventional clinical researches are governed by the internationally applicable Declaration of Helsinki. Similarly, if the results from Indian trials are to be used for regulatory submission in the West, then good clinical practices (GCP) compliance is essential.

Challenges in operating PV Unit

In fact, pharmacovigilance is an activity that has international significance. Pharmacovigilance involves proficient individuals, from registered nurses to specialist doctors who are performing relatively clerical functions, such as sifting through data and probing case reports; but despite the clerical nature of the work, it requires such a high level of competency that a company must pay lavishly for it if the work is done domestically.The requirements, and the stakes, of this kind of work continue to rise. Every new drug is put under dissection, wound up by negative media coverage. The volume of events to be reviewed and addressed is going up at an astounding rate, and so is the cost.

Cost Effectiveness

The era of outsourcing has enabled pharmaceutical companies to hire third party vendors to perform non-core processes at lower cost and higher quality. Outsourcing of the pharmacovigilance process provides a cost effective solution, especially for small and medium sized pharmaceutical companies. This would avoid the high upfront investments and fixed over-head costs connected with setting up an in-house drug safety system. Along with meeting the regulatory requirements, outsourcing would allow immediate participation in the efficiencies provided through the looming implementation of electronic SAE (Serous Adverse Event) reporting. Even if a pharmaceutical company decides to develop their own drug safety group in-house over time, often there is need for external advice and possibly provisional coverage until the team gets up to speed.

Why to Outsource PV System

The use of an offsite pharmacovigilance system may be less expensive than in-house system. The most important benefits for an outsourcing solution are the ease of managing certain peaks and new demands, and the reduced cost for database infrastructure and license cost for software programmes. These key benefits allow a firm to keep the internal headcount low, as negligible corporate infrastructure is required. Outsourcing can provide an immediate, multi-location pharmacovigilance network with minimal IT investment.

Usually the pharmacovigilance provider lacks the specific product knowledge, and so an effective transfer of drug information data is necessary. This can be facilitated when liaising with a structurally competent partner who is able to assimilate the necessary product knowledge easily; for example, with a comprehensive training programme and regular interactions with the core product team of the pharmaceutical firm.

Moreover, this field opens to unfamiliar grounds of difficult legal ramifications requiring high levels of inter disciplinary know-how. As legislation and regulatory bodies are increasingly demanding more and more functions and tools to detect and to respond to safety concerns with any drug, the benefits of pharmacovigilance outsourcing become more evident.The first significant pharmacovigilance outsourcing deal in the industry was the Bristol-Myers Squibb agreement with Accenture, in which the work is being done in India.As pharmacovigilance is a relatively new function in terms of outsourcing, there are not a large number of providers presently able to do the work. In essence, there are two classes of providers capable of moving tactically:

Role of Contract research organizations

These companies are focused on drug development and managing trials through their various steps and processes, and so are well suited to step up and address pharmacovigilance. These cover Quintiles, Covance, and MDS Pharma Services.

Role of Business process outsourcing

These include those organizations particularly based entirely in India. Examples are Cap Gemini, Tata Consultancy Services, Infosys, Cognizant, Icon and Keane.

Scope of PV outsourcing in India

India is well known for delivering high quality IT and IT-related services, and now India is becoming the most obvious choice for offshore outsourcing of pharmacovigilance activities and responsibilities.India-based operations have tremendous language skills, superb education, and a large number of doctors who are looking for higher-dollar work in a related field. Here’s one more instance in which what is considered in India to be expensive, high-dollar work is, by US standards, inexpensive.

Vendor Offerings: Outsourcing pharmacovigilance can help companies manage workloads, tap expertise and remove the need to add in-house capacity. Also, a pharma company, which outsources 15 percent of pharmacovigilance, explains that it uses vendors for risk evaluation and mitigation strategies. The firm reasons that it is uneconomical to employ a full time REMS specialist who will only be needed a few times a year.