A recent Deloitte India survey of risk and compliance professionals at India-based pharmaceutical companies found that a shortage of skilled manpower is cited as the leading reason that India drug companies are unable to keep pace with rapidly changing regulatory environments.
According to the survey results, 64 percent of survey respondents attribute non-compliance to shortage of skilled staff (on their risk and compliance teams), followed by challenges in implementing cGXP guidelines (52 percent), complying with professional association guidelines (42 percent), and poor fraud risk management systems (36 percent).
Additionally, close to 50 percent of survey respondents indicated that data management systems and pharma quality systems were a concern. This too can largely be attributed to the skill deficit in handling these issues in the sector.
The survey analysis points to the the lack of a zero tolerance approach to non-compliance and malpractice among senior management in India as a serious challenge to the growth of India pharma.