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Sunday, October 30, 2016

Indian pharma keen to identify and mitigate risks in audit management at its production plants

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Indian pharma sector is now keen to identify, assess and mitigate various risks in audit management at plants. In the wake of US regulatory surprise checks across production units in the country, the companies constantly want to perform internal audits, risk assessments and collaborate across departments to ensure timely and effective handling of issues and risks.

The companies in India need to adopt a structured approach to quality management and demonstrate their maturity to regulators. Therefore, we see a large untapped market for our solutions in governance, risk and compliance (GRC) for quality management, Shellye Archambeau, CEO, MetricStream told Pharmabiz.

GRC helps pharmaceutical companies to be prepared at all the times for a regulatory inspection. We already have multiple large pharmaceutical customers in India. These include Aurobindo Pharma which has been our client since 2007 and the erstwhile Dabur Pharma, now Fresenius Kabi Oncology as our customer since 2009, she added.

Globally, MetricStream serves Johnson & Johnson and its multiple subsidiaries across the world to lead them through GRC methodology. A leading pharmaceutical company in Europe uses the MetricStream Third-party Management app to evaluate potential risks and supply chain disruptions. Another leading US-based pharma major has adopted MetricStream app to manage ethics and compliance programs.

However, India is extremely important and it is our global innovation centre. Here products are designed, marketed, implemented and supported. It is also our largest base outside the US and EU representing ample scope for business development. The domestic pharma growth along and the advances in medical infrastructure are driving up the India demand, she noted. 


India has also evolved as one of the key hubs for generic drug manufacture and development. The global dynamics of generic drug demand has led the Indian pharma industry to expand, but managing the operations is seen to become more complex. It is even harder to function in a non-automated manner because the risks increase. “This makes the sector look for automated solutions to manage better. We serve large companies but the small and medium enterprises are offered the training and thought leadership support,” said Archambeau.

Over 90 per cent of MetricStream employees are in Bengaluru which is a centre of excellence accounting for a 1,800 workforce. Hence “India is mainly attractive for its  talent expertise, business dynamics, hub for  innovation and cost. Right now in our plans India is our priority. We have invested and will expand our sales-marketing efforts, besides build strong partner channels in India and globally”.

Source: Pharmabiz


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