Peru Takes Steps Against Bad Drugs

Government has announced a new factory inspection regime with an overhaul of the regulator also on the cards.

This article was written by Fabiola Torres, Jason Martínez, Paul Eccles and originally published by The Bureau Of Investigative Journalism.

“It was very distressing … It shakes you to your core.” That’s how student Hugo* felt when his third round of chemotherapy was delayed because of drug shortages in Peru.

In Hugo’s case, a shipment of the treatment he needed had been held back by the Peruvian medicine regulator because the drugs were found to be contaminated with foreign particles. But his story was part of a much larger issue.

Working with newsroom Salud con Lupa in Peru, we revealed last month that the Peruvian government has destroyed over 118,000 vials of imported chemo drugs since 2019. The drugs all needed to be scrapped because they had failed quality tests.

Just a week after our story was published, the Ministry of Health announced some changes. Peru’s drug regulator, Digemid, will inspect 26 overseas drug factories and check that they hold a particular certificate (GMP) guaranteeing that drug production meets international standards. None of the companies we found to have sold bad drugs to Peru were GMP-certified.

Among the factories it will be inspecting is one run by Kwality Pharmaceuticals, a company whose drugs we revealed were destroyed in 2024 after failing quality tests. In September that year, Digemid also cancelled the company’s GMP certificate. Yet, the following month, the government put in another order for 25,000 vials of Kwality cyclophosphamide – the same drug that had failed tests earlier that year.

Before stepping down as health minister on Thursday, Luis Quiroz told Salud con Lupa that plans to overhaul Digemid are underway. He said that the government supports a proposal to replace it with a new national authority for pharmaceutical products, medical devices and health products.

He said a draft bill, to be debated in Peruvian congress, has been finalised. “The text is ready,” he said. “I hope that it will be approved in the coming days so that the implementation of the reform can begin.”

Also since our story, Peru’s Ministry of Health released a statement from the body that buys and distributes medicines to the country’s public hospitals, which pointed out that the bad drugs revealed in our reporting were bought under the old administration.

That’s fair enough, but it doesn’t answer the other questions raised by our investigation. Why, for example, are some of the companies in question – namely Beta Drugs, United Biotech, Kwality Pharma, Vee Excel and Naprod Life Sciences – still authorised to sell medicines to the state?

In the last few days, Digemid’s director Lida Hildebrandt agreed to an interview to discuss this in detail with our co-reporters in Peru. Among various promises of reform, she said that Digemid expects to complete the certification of more than 180 plants within the year. “From then on, no medication will be allowed to enter the country without GMP certification issued by Digemid,” she said.

We’ll be watching to see if she makes good on those pledges. As it stands, the system that should ensure life-saving treatment for patients like Hugo is instead allowing dangerous drugs onto hospital shelves.

* Name has been changed