Study: Shortfall of skilled inspectors in India hinders pharma industry

According to a new study, the pharmaceutical industry in India is facing regulatory hurdles in international markets--notably in the U.S.--because of a shortage of skilled drug inspectors. The study, conducted by Assocham and the research firm RNCOS, found there are about 1,500 inspectors for more than 10,000 factories that produce pharmaceuticals. "While at times the U.S. FDA gets into minute details which have more to do with the cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of the regulators at the national and state levels in sync with the best global practices," D.S. Rawat, Assocham's secretary general, said after releasing the study. The shortfall of inspectors has resulted in the recall and rejection of drugs made by even the most well known of companies, he said. Article

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