prasad1
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The WHO estimated that one in five drugs made in India are fake.
India, the second largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by US regulators for safety lapses, falsified drug test results and selling fake medicines.
Dr Margaret A Hamburg, the commissioner of the US Food and Drug Administration, arrived in India this week to express her growing unease with the safety of Indian medicines because of “recent lapses in quality at a handful of pharmaceutical firms.” India’s pharmaceutical industry supplies 40 per cent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for US consumers.
FDA investigators are blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.
Hamburg was met by Indian officials and executives who, shocked by recent FDA export bans of adulterated generic versions of popular medicines - such as the acne drug Accutane, the pain drug Neurontin and the antibiotic Cipro - suspect that she is just protecting a domestic industry from cheaper imports. The FDA’s increased enforcement has cost Indian companies dearly – Ranbaxy - one of India’s biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company. And many worry that worse is in store.
“If I have to follow US standards in inspecting facilities supplying to the Indian market,” G N Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.” The unease culminated Tuesday when a top executive at Ranbaxy - which has repeatedly been caught lying to the FDA and found to have conditions such as flies “too numerous to count” in critical plant areas - pleaded with Hamburg at a private meeting with other drug executives to allow his products into the US so that the company could more easily pay for fixes. She declined.
India’s Central Drugs Standard Control Organisation has a staff of 323, about 2 per cent the size of the FDA’s, and its authority is limited to new drugs. The making of medicines that have been on the market at least four years is overseen by state health departments, many of which lack the expertise to oversee a sophisticated industry.
India, the second largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by US regulators for safety lapses, falsified drug test results and selling fake medicines.
Dr Margaret A Hamburg, the commissioner of the US Food and Drug Administration, arrived in India this week to express her growing unease with the safety of Indian medicines because of “recent lapses in quality at a handful of pharmaceutical firms.” India’s pharmaceutical industry supplies 40 per cent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for US consumers.
FDA investigators are blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.
Hamburg was met by Indian officials and executives who, shocked by recent FDA export bans of adulterated generic versions of popular medicines - such as the acne drug Accutane, the pain drug Neurontin and the antibiotic Cipro - suspect that she is just protecting a domestic industry from cheaper imports. The FDA’s increased enforcement has cost Indian companies dearly – Ranbaxy - one of India’s biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company. And many worry that worse is in store.
“If I have to follow US standards in inspecting facilities supplying to the Indian market,” G N Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.” The unease culminated Tuesday when a top executive at Ranbaxy - which has repeatedly been caught lying to the FDA and found to have conditions such as flies “too numerous to count” in critical plant areas - pleaded with Hamburg at a private meeting with other drug executives to allow his products into the US so that the company could more easily pay for fixes. She declined.
India’s Central Drugs Standard Control Organisation has a staff of 323, about 2 per cent the size of the FDA’s, and its authority is limited to new drugs. The making of medicines that have been on the market at least four years is overseen by state health departments, many of which lack the expertise to oversee a sophisticated industry.
