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'Pharma industry grappling with pricing, regulatory issues'

Press Trust of India  |  Mumbai 

The buoyant pharmaceutical industry is still struggling to deal with the challenges around pricing in the domestic market, increased regulations as well as data integrity, says an EY survey.

It is one of the most dynamic sectors in the country, said the survey, but its compliance structure is more complex, given that several regulators such as the Indian Food and Drug Administration, the US Food and Drug Administration, the UK Medicines and Healthcare Products Regulatory Agency guard it.

The sector is grappling with various compliance challenges like increased regulation, mergers and acquisitions, push toward harmonisation and the endemic data integrity concern, it said.

Data integrity reviews are conducted to evaluate if data records are accurate, complete, attributable, legible and maintained within their original context in electronic or paper form, it added.

Over 30 per cent of the respondents stated that they have received inspectional observations by regulators, it said, adding that this was despite signing their understanding and compliance with Good Manufacturing Practices norms.

Arpinder Singh, Partner and National Leader, Fraud Investigation & Dispute Services, EY said: "The pharmaceutical industry has been a buoyant sector in the eyes of domestic as well as foreign investors.

"But at the same time, the industry is still struggling to deal with challenges around pricing in domestic market, increased regulations as well as data integrity."

Companies need to take these issues seriously, especially those around data integrity as it is a critical aspect within the overall compliance framework, he added.

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First Published: Wed, June 03 2015. 18:48 IST