'Life sciences sector growth outpaces compliance management'

The fast pace of growth in the life sciences sector in India appears to have outpaced compliance management processes, according to Deloitte India's latest survey report released here.
The report, 'Managing Growth Through Better Compliance Management', said the rise in regulatory noncompliance in the sector may be attributed to the evolving changes in regulatory standards.
This has resulted in limited availability of compliance management professionals equipped to manage these requirements.
About 55 per cent of the survey respondents have indicated that their compliance teams were not adequately trained to address regulatory requirements.
"In the last two years, most regulatory bodies have introduced new areas of scrutiny beyond just testing drug efficacy and now involve risk management and mitigation programmes for R&D laboratories, manufacturing facilities and procurement functions," Deloitte Touche Tohmatsu India Senior Director Rohit Mahajan said.

"For compliance management professionals to familiarise themselves with these changes and become adequately trained in them requires time. In the interim, companies could be exposed to vulnerabilities arising from non-compliance," he said.

Besides talent shortage, lack of an efficient internal control/ compliance system, inadequate utilisation of technology to identify red flags and lack of a zero tolerance approach towards noncompliance and malpractice were indicated as key contributors to noncompliance and malpractice in the sector, the report said.
When asked how organisations detected fraud, noncompliance and malpractice, 76 per cent of respondents indicated relying on whistleblowing channels.
Upon detection of fraud 85 per cent of respondents said they launched an internal investigation by a specially appointed committee, while 82 per cent confirmed that some form of disciplinary action was initiated as per existing policies and fraud and compliance risk management frameworks.