Pharma body comes up with new guidelines on data integrity

The Indian Pharmaceutical Alliance (IPA), an industry lobby group representing large domestic drug makers, on Thursday released guidelines on data reliability as part of its continuing efforts to help improve the overall standards of the Indian pharmaceutical industry. The 'Data Reliability Guideline' report, compiled in partnership with US-based consulting firm McKinsey & Company, was released during IPA’s second edition of India Pharmaceutical Forum 2017 in Mumbai. The guidelines deal with key aspects such as building culture, awareness and capability, process design, data reliability risk detection and mitigation, technology and governance. Data reliability or data integrity are often linked to allegations of data falsification or manipulation, which are cited as main reasons by US Food and Drug Administration for pulling up Indian companies as part of its regulatory scrutiny. According to McKinsey, data reliability issues contributed to 79 percent of warning letters in FY16.  Six IPA members including Sun Pharma, Dr.Reddy’s, Lupin, Cipla, Cadila Healthcare and Torrent Pharma came together to initiate a ‘Quality Forum’ in March 2015 to address regulatory issues at a time when the industry was combating a crackdown by the US FDA. The Quality Forum enlisted McKinsey as knowledge partner – and has suitably picked up data reliability as one of the key areas to focus on. The guidelines have been already implemented on pilot basis in 12 manufacturing units of six participating IPA members. In 2016, the group also focused on developing standardize quality metrics and collating best practices for investigations and process validation, apart from developing technical training modules and assisting companies to build quality culture.  This year, the group will focus on areas of batch failure investigations, market complaint investigations, and good documentation practices. “The areas of highlighted were prepared after getting it vetted by leading regulatory agencies such US FDA and MHRA (Medicines and Healthcare products Regulatory Agency),” said DG Shah, secretary general of IPA. Shah said the entire exercise could take at least five years to complete and he expects other members to join as they plan to roll out the guidelines across the industry. India has 573 US FDA-approved manufacturing sites—the highest outside the US—and the number of warning letters from US FDA to Indian plants has increased in the last five-six years.

During 2011-15, India accounted for 30% of 102 warning letters issued globally.