Poor compliance management, internal controls, secured data and quality systems and lack of skilled resources are big concerns for India's fast growing life sciences sector, according to a survey conducted by Deloitte.
About 30 per cent of survey respondents said they had experienced non-compliance with GxP guidelines (Good - x - Practice is based on guidelines for the pharmaceutical industry and covers all steps from drug development to production) in the last two years.
About 55 per cent of survey respondents indicated that their compliance teams were not adequately trained to address regulatory requirements. Around 48 per cent of survey respondents felt that compliance strategy was not a key area earmarked for investment in their organisations, indicating that perhaps the senior management did not consider this area as high-risk with serious consequences in the event of non-compliance, said the report.
India has about 546 facilities approved by the US drug regulator, the US Food and Drugs Administration (FDA) and 857 facilities have approval from the UK regulator MHRA. In the last two years, the US FDA and Canada's regulator Health Canada had banned or warned over 25 Indian drug firms for non-compliance with the standards. These include many leading drug companies like Sun Pharma, Ranbaxy and Wockhardt.
The report, 'Managing Growth Through Better Compliance Management' was released in Mumbai on Wednesday. The survey was done among 33 leading organisations which included MNCs with operations in India, said Deloitte.
Deloitte says the rise in regulatory non-compliance in the sector may be attributed to the evolving changes in regulatory standards, which have resulted in limited availability of compliance-management professionals equipped to manage these requirements. In the last two years, most regulatory bodies have introduced new areas of scrutiny beyond merely testing drug efficacy, and now involve risk management and mitigation programs for R&D laboratories, manufacturing facilities and procurement functions.
"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," said Rohit Mahajan, Senior Director, Deloitte Touche Tohmatsu India.
While 52 per cent respondents felt implementing GxP guidelines as a big challenge, 42 per cent respondents said complying with professional and industry body guidelines on pricing, sales, promotions is a big issue. About 61 per cent of the respondents felt poor internal controls as key contributor to malpractice and non-compliance.
Forty-five per cent felt poor data and quality systems and 42 per cent felt lack of skilled resources to manage compliance as major issues with the industry.