USFDA warning on Indian drugs

Between 2011 and 2016, as many as 27 drug manufacturing plants in India got FDA warning letters for data integrity violations

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The US Food and Drug Administration (FDA) wants Indian drug manufacturers to get their act together, citing instances of sale of drugs which lack the stated content and complaints of medicines not delivering desired results.

Between 2011 and 2016, as many as 27 drug manufacturing plants in India got FDA warning letters for data integrity violations. And 15 of these had import alerts issued against them, according to a Nomura Research report. None of the alerts has been withdrawn, resulting in delayed product approvals or restrictions in export to the world's largest pharmaceutical market.

Matthew Thomas, director, FDA's Indian office said, "I had the opportunity to test some of the products with a rapid test tool. I got a blister pack of paracetamol and the test showed there was no drug in it."

He also said, "I Occasionally got samples from the US embassy's health unit in Delhi and the complaints are usually about the medicines not giving the desired results. I do not think any one of us wants to take such drugs which lack efficacy."

"Further tests would be required in laboratories to ascertain whether these drugs are non-standard. What we are telling Indian companies is that they need to take the onus of developing quality products, and investigate and follow up on complaints", he added

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