Foreign Regulators Rap More Indian Firms Over Data Integrity
This article was originally published in PharmAsia News
Three more Indian pharmaceutical players have been pulled up by overseas regulators over data integrity issues in another blow to the reputation of the flagship industry.
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Dirty data issues continue to plague Indian contract research organizations, denting the reputation of the beleaguered local industry and piling up challenges for marketing authorization holders. The European Medicines Agency (EMA) has now suspended close to 300 products that relied on flawed bioequivalence studies done by the Bengaluru-based Semler Research.
Data integrity spotlight expands beyond cGMP as FDA finds Semler manipulated study subject samples in bioequivalence studies conducted at its Bangalore facility.
For the last few years, Indian generic companies have been making headlines for all the wrong reasons, rapped by the US Food and Drug Administration over problems ranging from fudged test results to poor-quality manufacturing standards. But lately, the firms have been enjoying a run of good regulatory tidings, giving a fillip to their share prices.