The Indian pharmaceutical industry, reeling under the regulatory scanner of the US Food and Drugs Administration (FDA) for the past few years, is learning from their mistakes. Out of the 192 inspections held by the US FDA in India in 2017, only eight were referred for Official Action indicated (OAI) or found out objectionable conditions at the audit site. These were 10 a year ago (271 inspections), 11 in 2015 out of 272 inspections, and 21 out of 173 inspections in 2014. In the case of USFDA warning letters for non-US sites, India had only 29 per cent letters out of the 49 issued in 2017. The same was 39 per cent out of 18 letters issued in 2014. While Indian companies were responsible for 30 per cent of import alerts in 2017, Chinese companies were responsible for 50 per cent, said a MacKinsey-Indian Pharmaceutical Alliance (IPA) data presented in February.
It said while there has been a big reduction in data-related errors, which caused many Indian companies to face ban on their facilities, now source of non-compliance is seen mainly in investigations and root-cause assessments.
Data reliability and good documentation practices were responsible for 41 per cent of the FDA action required remarks in 2015. This was 46 per cent in 2016, but in 2017 it came down to 20 per cent. But investigations and root-cause assessment issues, which were only 18 per cent in 2015, contributes to the maximum errors with 28 per cent now.
Another issue that the Indian drug companies are facing right now is failure to establish laboratory control practices, which include scientifically sound and appropriate specifications, standards and sampling plans. However, inadequate controls of computer and other data systems, gap in prevention of unauthorised access, incomplete data in lab records, and incomplete data in batch production records are the issues yet to be addressed, said the report.
The Indian Pharmaceutical Alliance (IPA), a grouping of leading Indian domestic companies, had formed a quality forum with the technical help of MacKinsey in May 2015, following the recurring regulatory issues. The forum is led by six CEOs, 20 top CXOs and 25 plus other top executives. It developed guidelines for data reliability, investigations, process validation, batch failure investigations, good documentation practice, etc, and sensitised the members, informed DG Shah, Secretary General of the IPA.
Though many interventions are designed for new hires in middle-level management, who serve as the interface between senior leadership and operators, no capability programmes have been designed for this layer. This will be a prime focus area of attention. Going forward, the focus will be on digital and advance analytics tools to unlock a new wave of quality improvement, which can potentially result in 10-15 per cent reduction in deviations from guidelines and 15-20 per cent improvement in asset utilisation, said sources.