In a stinging rebuke, the US Food and Drug Administration has admonished Wockhardt, one of India’s largest drug makers, for a litany of quality-control gaffes at a US subsidiary.
At the same time, the agency took the opportunity to recount how such issues have plagued more than a half-dozen Wockhardt production plants over the last several years. This is a serious observation, because Wockhardt makes numerous medicines for India’s domestic market as well as generics sold in other countries. The latest warning comes amid ongoing concerns that some Indian drug makers have systemic quality-control problems.
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