Friday, March 13, 2015

Satish Reddy, president of the Indian Pharmaceutical Alliance, said Indian drug manufacturers are b


New Delhi - India's second largest exporter of over-the-counter and prescription drugs in the United States, coming under increased scrutiny frasers centrepoint malls from US regulators for safety lapses falsified test results of the drug and the sale of counterfeit drugs.
Dr. Margaret A. Hamburg, Commissioner of the US Food and Drug Administration, arrived in India this week to express the growing concern of the safety of Indian drugs because of "recent frasers centrepoint malls cease in quality to a handful of pharmaceutical companies. "
Consumables pharmaceutical industry in India 40 per cent of over-the-counter and prescription generic drugs consumed in the United States, so that the increased control could have serious frasers centrepoint malls consequences for American consumers.
Investigators frasers centrepoint malls FDA blitzing Indian drug plants, frasers centrepoint malls finance inspections of some of the approximately $ 300 million in annual fees than the general manufacturers of medicines collected under Law 2012 requires frasers centrepoint malls increased control of overseas plants. The agency inspected frasers centrepoint malls 160 Indian drug plants last year, three times as many in 2009. The increased control led to a flood of new sanctions, including half of warning letters issued by the agency last year to drug manufacturers. frasers centrepoint malls
Media projection Start Ranbaxy, one of the largest drug manufacturers in India, pleaded guilty to felony charges and paid $ 500 million fine last year. Adnan Abidi / Reuters
Dr. Hamburg met with Indian officials and executives, shocked by the recent FDA ban on exports of generic frasers centrepoint malls versions of popular drugs - such as the acne drug Accutane, pain drug Neurontin and antibiotic Cipro - that the FDA had determined distorted suspect frasers centrepoint malls who is only to protect a domestic industry from cheaper imports.
Increased enforcement of FDA has already cost dearly Indian companies - Ranbaxy, one of the largest drug manufacturers in India, pleaded guilty to felony charges and paid $ 500 million fine last year, the largest ever levied against generic company. And many worry that worse is in store.
"If I have to follow US standards in inspection facilities frasers centrepoint malls supplying the Indian frasers centrepoint malls market," GN Singh, a top drug regulator of India, said in a recent interview with an Indian newspaper, "will be closed almost all of them."
This concern culminated Tuesday, when a top executive of Ranbaxy - which has repeatedly been arrested is the FDA and found to have conditions like flies "too numerous to count" in critical areas of the plant - pleaded with Dr. Hamburg to a private meeting frasers centrepoint malls with other drug officials to allow the products to the United States, frasers centrepoint malls so the company could more easily pay for corrections. She politely declined.
Pharmaceutical industry in India is one of the most important economic engines of the country, exporting $ 15 billion in products annually, and some of its factories are world class, almost undistinguishable from their counterparts in the West. But others suffer from serious quality control problems. The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 study of Delhi pharmacies found that 12 percent of the sample frasers centrepoint malls drugs were fake.
A widely used antibiotic was found to contain no active ingredient after random testing in a laboratory government. The trial was kept secret for almost a year, while about 100,000 useless pills continued to be distributed.
"Some of the fake tablets used by pregnant frasers centrepoint malls women to prevent postoperative infections," said Dr M. Ishaq Geer, assistant professor of pharmacology at the University of Kashmir. "This is very serious."
Satish Reddy, president of the Indian Pharmaceutical Alliance, said Indian drug manufacturers are better than the FDA now claims. "More rigorous enforcement is necessary, for sure, but this impression that India is forged with excess frasers centrepoint malls is unjustified," he said. Reddy.
But Heather Bresch, CEO of Mylan, which has factories in the United States and India, said regulatory control outside the United States was long. "If there were no cops around, would lead to all GPI

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