Amid US Cough Syrup Findings, Regulators Feel India Needs To Work On Perceptions But Also Make Improvements

In wake of the furore caused by OTC cough syrups made by two small Indian companies, former and current US FDA and MHRA officials say quality-related issues are not specific to India. However, while image management needs some work, manufacturers in the country also need to make further improvements to ensure quality.

Global Regulators At BioAsia 2023
L to R: Sarfaraz Niazi, Ekta Batra, Michael Cutter, Pavan Kumar Mocherla, Ian White, Sarah McMullen, Mark Abdoo, Carmelo Rosa at BioAsia • Source: Pink Sheet/Norstella

India is among the nations with the largest number of US Food and Drug Administration (FDA)-compliant plants - the 2020-21 annual report by the Indian government claiming the second-highest number of such facilities outside the US.

However, a furore over deaths in Asia and Africa last year reportedly caused by over-the-counter (OTC) cough syrups manufactured by a few small companies in India and Indonesia - as determined by the

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