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India inspects 200 drugs makers for poor –quality meds

FDA

The Drug Controller General of India is inspecting 200 drug makers, including leading manufacturers such as Cipla and Pfizer, for allegedly selling poor-quality medicines and failing to comply with manufacturing standards, the Times of India tells us. This is the first time that inspections on this scale have been undertaken by the regulator and follows ongoing concerns about quality-control problems at Indian facilities.FDA

Meanwhile, the US Food and Drug Administration has banned Phalanx Labs from shipping products to the United States after the Indian company, which makes pharmaceutical ingredients, refused to let inspectors visit its site in Visakhapatnam, InPharma Technologist reports. The refusal suggests the company makes products under insanitary conditions, according to an FDA notice.

Some Valeant Pharmaceuticals documents concerning its accounting practices are being withheld from public scrutiny by the US Securities and Exchange Commission, according to Wells Fargo analyst David Maris. He suggests the move means the drug maker’s accounting may have been “more problematic than previously thought or that broader regulations on (the) use of (non-standardized) accounting may be forthcoming.”

Takeda Pharmaceuticals has begun the world’s first field test of a norovirus vaccine, which will be compared to placebo in healthy volunteers who are recruited from US military training installations, PMLive says.

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