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 percent 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.
Today, companies with existing or anticipated concerns around data integrity should initiate regular proactive data integrity assessments, EY Fraud Investigation & Dispute Services partner Rajiv Joshi said.
"This will be beneficial even for companies that enjoy a good reputation in the market. These periodic assessments provide assurance to all stakeholders involved - customers, investors, regulators as well as reaffirms the management's commitment toward highest standards of quality," he added.
Ajaz S Hussain Advisor EY and Former Deputy Director Office of Pharmaceutical Science US Food and Drug Administration (US FDA) said the integrity of data is the foundation on which decisions on quality, safety and efficacy are made.
"Recording of data and information with accuracy protects life, without it, we cannot differentiate between counterfeit and authentic medicines," he added.
At the end, any lapse in the assurance of data integrity is a serious deviation from expected practices and can have adverse repercussions, Hussain said.
