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Pharma industry body proposes guidelines on data reliability

LiveMint logoLiveMint 23-02-2017 Isha Trivedi

Mumbai: The Indian Pharmaceutical Alliance (IPA), an industry lobby group, along with knowledge partner McKinsey & Company has devised guidelines on data reliability as part of its efforts to help improve quality systems at a time when domestic drug makers are facing challenges in dealing with the evolving quality compliance norms of global regulators.

The guidelines address six elements critical for data reliability such as technology systems, process design, risk management, governance, culture and capability, said Vikas Bhadoria, director at McKinsey & Company.

The data reliability guidelines were released on Thursday at the second edition of IPA’s quality excellence conference, India Pharmaceutical Forum 2017, in Mumbai.

The guidelines are available on the website of IPA for public.

Data reliability or data integrity is one of the crucial aspects of quality compliance at pharma companies and drug regulators pull up manufacturers for any lapses found in maintaining and disseminating data.

Of the 19 quality-related warning letters issued by the US Food and Drug Administration (FDA) globally in 2014, 10 had data reliability issue and in 2015 (up to August), nine out of 10 warning letters cited data reliability concerns, according to details on IPA’s website.

Over the last few years, Indian pharma companies, including leading firms like Sun Pharmaceutical Industries Ltd and Dr. Reddy’s Laboratories Ltd, have come under the glare of the US FDA due to breaches of manufacturing norms at their plants.

Other drug makers like Lupin Ltd, Cadila Healthcare Ltd, Cipla Ltd, Wockhardt Ltd, Ipca Laboratories Ltd and Aurobindo Pharma Ltd also faced regulatory issues.

The IPA formed a Quality Forum in March 2015 to identify and focus on key areas for improvement in quality.

In 2016, the group focused on developing data reliability guidelines, standardize quality metrics and collate best practices for investigations and process validation, and developing technical training modules and assisting companies to build quality culture. So far, the Quality Forum has spent Rs15 crore on various activities.

While continuing on last year’s activities, the group will focus on areas of batch failure investigations, market complaint investigations, and good documentation practices in the current year, D.G. Shah, secretary general of IPA, said adding that guidelines to investigate batch failures are also planned.

Shah also emphasized on the need to rationalize standard operating procedures by simplifying them and doing away with some redundant processes.

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.

The number of inspections conducted by the US regulator has also increased.

As per data on IPA website, the US FDA conducted an estimated 135 inspections in India, accounting for 11% of global inspections. This is higher than the average of 102 inspections carried out between 2011 and 2014.

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