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FDA inspection likely for plants exporting drugs to US

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Lalit K Jha PTI Washington

Leading US Senators announced yesterday they are introducing a legislation in the Senate which would make mandatory US inspection of drug manufacturing plants anywhere in the world that supply medicines to them.

Since, India and China account for major quantum of medicine supplied to the US, drugs manufacturing plants in the two countries would be majorly affected by this legislation if passed by both the houses of the Congress.

If signed into law, all such plants would have to be mandatorily subject to inspection by the Food and Drug Administration or FDA of the US Government.

"There will be inspections of every facility and approval by the FDA for every facility that -- where we import these medications, because we think that that is the appropriate approach to take when it comes to this critical legislation," Senator Olympia Snowe, one of the co-sponsors of the legislation, said a press meet.

 

Besides Snowe, the press meet was jointly addressed by Senator John McCain and Senator Byron Dorgan ¿ the two sponsors of the legislation. The legislation has the backing of the White House, the Senators claimed, as last year the US President, Barack Obama, then as an Illinois Senator had co-sponsored an identical bill.

"We have, you know, had so many medications or ingredients of medications manufactured in foreign plants. And there are very few inspections that take place in those foreign plants. In fact, it could be as much as 20 years in between inspections, if at all. And 40 per cent of ingredients are manufactured in China and in India," he said.

"Therefore, we happen to believe that we should require that there are inspections of these facilities," Snowe said, adding: "Global outsourcing, you know, the production of pharmaceuticals to a lower-cost country means that FDA should be required to inspect every facility."

Senator McCain said the legislation would significantly bring down the cost of drug prices in the US; which at present is several times than those available in other parts of the world.

The bill, said Senator Dorgan: "allows the American people to have access to lower-cost prescription drugs, identical drugs, FDA-approved, produced in FDA-inspected plants."

The difference is that the American people pay the highest prices in the world for prescription drugs while people in other countries pay a much lower price, he argued. "We want to bring opportunities to the American people to pay that lower price, which we believe would force a re-pricing of that drug in our country," he said.

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First Published: Mar 05 2009 | 5:07 PM IST

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