India – a hotspot for pharmacovigilance services

The emerging markets are rapidly evolving to compete with the standards set by the developed world. Many life sciences companies in India are now focusing strongly on drug safety management and pharmacovigilance. Tarun Pandotra explores this new strategy and shares his thoughts on how pharma can address drug safety issues in order to maximise patient safety.

Demand from emerging markets is opening up various opportunities across multiple sectors. Life sciences companies have several compelling reasons to build a presence in emerging markets.

For example, emerging market countries are set to add 1.4 billion people to their middle classes during the next decade and will account for more than 60 percent of global gross domestic product growth between 2010 and 2016. Multi-national companies expect about 70 percent of world growth over the next five years to come from emerging markets. India and China will account for 40 percent of this.

In industries, such as life sciences where scale is important, the volume potential of emerging markets is essential to recover fixed costs and achieve competitive scale. Emerging market multi-nationals are themselves powerhouses of innovation when it comes to developing new products for these markets — and are beginning to compete strongly in developed markets as well. Western companies would do well to establish a "listening post" in the markets where these new contenders operate.

"Multi-national companies expect about 70 percent of world growth over the next five years to come from emerging markets."

India is the second most preferred destination for clinical trials in emerging markets and seems to be focusing on drug safety management. So far in India there are approximately 30 pharmacovigilance centers, but in the next one year this number will reach 100, according to member of the Central government's pharmacovigilance committee.

Indian companies are well positioned to reach the performance bar set by current global players. Two groups of providers — contract research organizations (CROs) and traditional business process outsourcing organizations (BPOs) — offer pharmacovigilance services in India. Both companies differ in background, scope, scale and global footprint. CROs are well versed in managing drug development through all the stages and have an established history of working with pharmaceutical companies. BPOs on the other hand are better equipped to handle professional services at a much larger scale and breadth. Therefore, they are in much stronger position to ramp up their operations if required by global accounts. New business models are fast developing, as Indian companies organize to meet their clients' operational scale and scope requirements.

"Indian companies are well positioned to reach the performance bar set by current global players."

It means that pharmacovigilance is expanding in India in a big way, which was not the case previously. Here's why:

• In September 2010, Accenture reportedly partnered with the Institute of Clinical Research in India (ICRI) to jointly develop a pharmacovigilance and clinical research programme for the Indian market. They (Accenture) come and teach on the programme to train people for their requirement in pharmacovigilance. Accenture had earlier signed a $550 million deal with pharma major Bristol-Myers Squibb.

• Wipro Technologies launched Wipro Clinical Collaboration Portal to reportedly help drug development owners, clinical research organizations and regulators to improve collaboration for multi-region clinical trials.

• iGate Clinical Research International, formerly a subsidiary of iGate Corporation, is now considered a premier clinical trial management company.

• TCS describes itself as a leading clinical research and drug development service provider in India. It serves a range of global pharma firms and has on board healthcare professionals, doctors and PhDs in life sciences and pharmacology.

• Genpact boasts of a 500 plus personnel shouldering its clinical data intelligence service.

• Cognizant has recently become a preferred partner with Novartis and Astra Zeneca for Data Management services. Cognizant's website page gives the clinical research services it offers ranging from epidemiology study to forecasting expected volumes of patients for clinical trials.

Industry experts say that pharmacovigilance and clinical data management as a sector is growing at a feverish pace, with some pegging the growth rate at a whopping 100%.

"...pharmacovigilance and clinical data management as a sector is growing at a feverish pace..."

Today's zero-tolerance drug safety environment requires pharma and CRO firms to adopt new strategies to quickly identify health safety concerns. They need more progressive thinking and business-IT models to address ever-evolving issues such as:

• New compliance requirements for risk management

• Pressure to cut drug discovery costs

• Maintaining uniformity and consistency across global pharmacovigilance processes

• Integrating safety data from disparate sources

Approaching pharmacovigilance as an enterprise-wide business strategy still is not the norm, but is quickly becoming so. Life sciences companies that embrace this shift will be able to meet near-term demands for drug safety assurances from a range of global stakeholders. Most approved products are subjected to risk mitigation plans of some sort. Simultaneously, life sciences companies are staking out a competitive advantage in the form of more and better data, used intelligently to help evaluate and direct future clinical development and for post-marketing evaluation of comparator products. The net impact will be that life sciences companies will be in a better position to deliver the higher quality, lower cost products the market requires and deliver ultimately better quality of life to patients.

About the author:

Tarun Pandotra is a clinical operation professional with over sixteen year's experience of clinical research in project management, clinical operations and regulatory affairs roles. Involvement in phases I – IV with experience from study start up through to close out. Tarun has a wide experience of therapeutic area indications most recently in oncology, hematology and cardiology.

Tarun has worked with many pharma companies like AstraZeneca, UCB Pharma and CROs like PPD and PRA. He is currently working as Director Clinical Operations India and South East Asia.

He has extensive international experience, with commitment to delivering quality results, establishing ethical guidelines, and motivating staff for peak performance and program success.

You can find Tarun on LinkedIn.

How can Indian pharma companies further develop their pharmacovigilance strategies?