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Indian Drug Plants Are Freaking Out the FDA

India is the second-largest provider of "drug products" to the US, but its pharmaceutical plants lead the way in American import alerts recommending that their products be “detained without physical inspection.”

by Sydney Lupkin
Sep 18 2015, 2:15pm

Photo via Flickr

This story is part of a partnership between MedPage Today and VICE News.

The United States has issued its 42nd import alert on an Indian pharmaceutical plant since 2010, shedding light on how globalized the drug supply chain has become. The Food and Drug Administration issues these alerts to recommend that drug products from these plants be "detained without physical inspection."

India is the country's second-largest provider of "finished drug products," but its drug plants lead the way in American import alerts, according to a VICE News/MedPage Today analysis of 114 plant alerts across 29 countries since 2010.

"The problems encountered by FDA investigators in India are similar to those seen around the world in manufacturing," said Food and Drug Administration spokesperson Christopher Kelly. "Common issues include inadequate or poor quality systems implementation, data integrity issues, inadequate validation of various processes used in manufacturing or testing, and product adulteration or contamination."

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China's drug factories are right behind India's, with the FDA issuing alerts on imports from 28 of its plants over the same time period.

Though import alerts sound scary, experts say that their imposition points toward better FDA inspection schedules and a safer drug supply chain, ensuring that the plants comply with current good manufacturing practices.

"Our drug supply — really, the world's drug supply — is very globalized," said Gabrielle Cosel, manager of the Drug Safety Project at Pew Charitable Trusts.

About 40 percent of the brand name and generic drugs taken by Americans are manufactured outside our borders, according to the FDA, and 80 percent of active pharmaceutical ingredients used in drugs made in the US were made in one of 150 other countries.

"It's a significant amount," Cosel said.

Prior to a tweak in the reauthorization of the Food and Drug Safety and Innovation Act in 2012, foreign drug plants were inspected once every nine years on average, according to Cosel. Now they're inspected about once every two years, like domestic plants.

In the year following the rule change, there were 39 plant import alerts in 2013. There have only been 20 so far this year, according to our analysis. Half of them occurred in India.

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The FDA published the latest alert on September 11 against Polydrug Laboratories Pvt. Ltd. in Mumbai. According to its website, it makes anti-hypertensive, anti-fungal, and anti-microbial preservative drugs as well as skeletal muscle relaxants, shipping them to 73 countries.

Polydrug Laboratories was not immediately available for comment. Industry trade groups Medindia and the Indian Drug Manufacturers' Association also did not respond a request for comment.

The largest finished drug product exporter to the US is Canada, but the US has only imposed import alerts on five of its plants since 2010, the most recent of which occurred in February, according to our analysis. Although this is in sharp contrast with India, which has already had 10 plant import alerts this year alone, Cosel explained that plants in India tend to be further up the supply chain than plants in Canada.

She said the pharmaceutical supply chain can vary in length and complexity, but there can be many players involved in getting the raw ingredients and crude materials before the active pharmaceutical ingredient is made and shipped to a finished drug processing plant. From there, it can go through brokers, wholesalers, and distributors.

"Before reaching a pharmacy or a hospital, it can change hands many times," Cosel said.

Vanderbilt University pharmacist Michael O'Neal has dealt with drug shortages, but said that he isn't sure whether an import alert has ever led to one. Though he hears about drug plant import alerts, he rarely knows whether the drugs he works with were made down the street or on the other side of the world. He said the alerts rarely impact his day-to-day job because they likely occur higher upstream in the supply chain, so they never make it to being a finished drug product that he would dispense.

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To understand why foreign import alerts are important, Cosel pointed to the uptick in adverse reactions — including deaths — related to an intravenous blood thinner called heparin starting in late 2007. Although neither the finished drug manufacturer nor the FDA were able to pinpoint at which point the drug became adulterated, they determined that it happened before the active pharmaceutical ingredients were manufactured in a Chinese plant.

"It made people look much closer and scrutinize the drug supply chains," Cosel said, noting that the US has one of the safest drug supplies in the world today.

Photo via Flickr