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India’s drug controller will keep falsified meds out of EU, but GMP standard may be lower

This article was originally published in Scrip

Executive Summary

India has confirmed that the Central Drugs Standards Control Organization (CDSCO)/Drugs Controller General of India (DCGI) will be the agency designated to certify active pharmaceutical ingredient (API) exports to the EU. However, GMP equivalence issues have yet to be resolved. Indian industry has suggested that the WHO GMP standard for those ingredients, which differs from the EU GMP standard, would be appropriate. It is not clear that the EU accepts this view.

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