India Pharma Giant Aurobindo Again Violates FDA Safety Regulations

Aurobindo Pharma continues to violate FDA safety regulations

Indian pharmaceutical manufacturer Aurobindo was yet again on the receiving end of three observations in a Form 483 issued by the FDA at one of their facilities. The Form 483 is issued when the investigator has found violations of U.S. law. These 483s are basically one step before a Warning Letter, which is issued to manufacturers for significantly violating FDA regulations.

The lab, located in the city of Pydibhimavaram, was given a Warning Letter on June 20, 2019 by the FDA. The facility was inspected again between July 25 and August 2, which is when the FDA found three additional problems at the facility. Concerningly, the FDA did not release publicly what problems the inspectors found at the lab, only that Aurobindo was told it had to remedy the situation.

Aurobindo is one of the biggest generic drug exporters to the United States. The Pydibhimavaram lab is a non-antibiotic active pharmaceutical ingredients (API) manufacturing facility. India is one of the world’s leading API suppliers.

Generic medicines account for roughly 90% of all prescriptions dispensed in the U.S. and are many of those drugs constitute what the FDA refers to as essential medication, mostly all of it in short supply in the U.S. Meanwhile, pharmaceutical companies continue to rely on outsourcing partners like Aurobindo, inspected by the FDA offices in India with a skeleton staff, instead of pursuing policies that would support domestic, generic drug makers, including those who are not readily subject to FDA warnings.

As it is, the U.S. is dangerously dependent on foreign manufacturers—particularly Indian and Chinese API. While Aurobindo is large enough that it is more likely to be under the FDA’s spotlight, dozens of smaller labs are not. Safety issues are harder to regulate and police abroad than they would be at home.

In recent decades, U.S. domestic production of generic drugs has been offshored to India and increasingly China. Subsidized foreign manufacturers have sought to eliminate U.S. competition by racing to the bottom in price, only to drastically increase and price gouge American patients once they have monopolized a product.

On Wednesday, Michael Wessel, commissioner of the U.S. China Economic and Security Review Commission noted that U.S. multinational drug makers were continually spending more in research and development of new drugs, in particular, in China.

“Commerce publishes info every year with a two-year backlog which has data on the activity of U.S. multinationals in R&D in China,” Wessel said. “We have seen that the rate of increase in spending is higher in pharmaceutical R&D there, than their investment on R&D here.”

This dependency on India, and soon – China -- has increased generic drug shortages in the U.S. Currently, the U.S. is reliant on imports for at least two-thirds of our generic medicines. Nearly 50% of all pharmaceutical products on the FDA’s essential medicines list are in short supply and come from Europe, India, Israel or China, where FDA inspectors are even less abundant than they are in India.

The U.S. once led the world in pharmaceutical manufacturing. Overdependence on foreign production has left America vulnerable to labs that have run afoul of FDA regulations. This will increase so long as the FDA needs to rely on overseas staff and contractors to review the dozens of labs in India alone that sell medicines to the U.S.

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We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.