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Pharma companies must be audit enabled and not just audit ready: Expert
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Nandita Vijay, Bengaluru
August 29 , 2016
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Pharma companies in the country must be audit enabled and not audit
ready, going by the pace of global inspections taking place here, said
Edsel Pereira, senior vice president, IT, global CIO, Glenmark
Pharmaceuticals.
In this regard, companies are making strategic
investments in information technology (IT) for supply chain management.
The move is also in sync with the new regulations including the trace
and track.
Technology is evolving fast even before companies are
able to realize the return on investment (ROI). There is considerable
uncertainty about the future, on the new technology solutions that will
need to be installed and on the changes in norms, some of which overlap.
The need of the hour is to ensure integration of processes in the
pharma industry. The implantation of trace and track too has also added
pressure on the cost conversion, he added.
Another issue
confronting the pharma industry is talent retention. The sector is
putting up with a churn of movement of human resources, Pereira said in
his presentation on 'An IT day in life sciences’ at the recently
concluded DIA event on IT-enabled business for life sciences in
Bengaluru.
An emerging trend is verticalization with the right
technology for which expectations by the company are huge. Therefore the
IT industry working for pharma companies has tremendous pressure on
interpreting R&D, IP, regulatory, pharmacovigilance, financials,
costing, sales and distribution.
“Companies like Glenmark have
already embarked on infrastructure upgrade to ensure network
consolidation. We focused on enterprise storage, back-up, digital media
to ensure safety and security”, he said.
Future opportunities
have emerged in the area of sensors and digital services for
personalized care that enable direct engagement of physician with the
patients through Skype. Health ‘gamification’ has led people to use apps
for to improve quality of life and prevent diseases.
There is a
profusion of body sensors, like for instance contact lenses embedded
with internet of things (IoT), wrist band heart monitors and blood
pressure patches. The evolution of 3D printing has now revolutionized
surgical interventions with organ printing enabling perfect transplants.
Nano-robotics has enabled early diagnosis and targeted drug-delivery
for cancer care. Then there are insole sensors to measure weight balance
and temperature, he said.
There is no dividing line for IT
because it is beginning to be a forerunner in business of life sciences.
With US and EU inspections taking place at frequent intervals in India,
the compliance requirements are not coming one a time by flooding and
overlapping. The evolving regulations are making the pharma industry
dynamic. This is where pharma companies must ensure that they are audit
enabled and not just being audit ready, said Pereira.
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