Explained: How is the US cancer drug shortage linked to India?

How did an FDA inspection of an Indian pharmaceutical plant lead to a widespread shortage of chemotherapy drugs in the United States?

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The shortage of cancer drugs in the US has been linked to Indian pharmaceuticals.

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The shortage of cancer drugs in the US has been linked to Indian pharmaceuticals.

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It all started when the US Food and Drug Administration (FDA) decided to inspect a manufacturing facility in Ahmedabad, Gujarat, owned by Intas Pharmaceuticals, which was supplying medicines to the US.

In November 2022, the US FDA said that, at the time of inspection, the company’s condition was found to be poor with almost no product quality/safety checks taking place. Subsequently, the company ceased production indefinitely.

This incident has since led to a snowball effect that has now caused a severe shortage of life-saving cancer drugs in the United States.

How does the closure of an Indian company lead to a health crisis in the US? Let’s analyze it.

What is happening in the US now

According to reports from the United States, there is currently a shortage of at least 14 cancer drugs in the country, including cisplatin and carboplatin, the most widely used chemotherapy agents.

In fact, a recent survey conducted by the National Comprehensive Cancer Network found that 93% of cancer centers in the United States reported experiencing a carboplatin deficiency, while 70% were low on cisplatin.

This is concerning because when it comes to cancer treatment, even brief delays in treatment can dramatically worsen a patient’s condition and increase their risk of death.

Such tragedies are actually avoidable because these drugs aren’t necessarily expensive or cutting-edge treatments. Instead, they are the cheap ones that have been around for decades.

While the FDA said it was ill-equipped to address a shortage of this magnitude on its own, it also said it was looking to import these drugs from other international suppliers.

The FDA has reportedly allowed a Chinese company to sell cisplatin in the country.

However, according to experts, it is very difficult to fill a shortage gap when starting out. These must be avoided altogether in the first place.

How is Intas Pharmaceuticals involved?

Intas Pharmaceuticals, headquartered in Ahmedabad, is a manufacturer of generic therapeutic drugs. The company accounted for approximately 50% of the cisplatin supplied to the United States.

In addition to evidence of safety and quality violations, the US FDA’s inspection of the facility where these drugs were manufactured also found that the company had attempted to destroy documents, the report said. Washington Post.

As a result of this, the company reportedly halted production of key cancer drugs, with no confirmed date for restart, company spokeswoman Emily King said. CNBC.

This started a domino effect. The cisplatin shortage, in turn, led to the shortage of carboplatin, another chemotherapy drug that often replaces the former and was also manufactured in the same factory.

These particular drugs manufactured by Intas Pharmaceuticals are not sold in Indian market.

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Problems with the critical drug supply chain

A shortage in the supply of medicines can be caused by a variety of reasons such as natural disasters, transportation disruption, shipping problems and most recently the pandemic.

This isn’t the first time there has been a shortage of chemotherapy drugs, or even other essential generic drugs, in the United States.

Just in recent months, the United States has faced a shortage of common generic drugs, from the pain reliever acetaminophen, to the antibiotics amoxicillin and Adarall used to treat attention deficit hyperactivity disorder (ADHD) in children.

Generic drugs are a vital lifeline to the US healthcare system as they help make essential medicines available at low prices.

According to the Association for Accessible Medicines, generic drugs make up about 90 percent of prescriptions in the country, but less than 20 percent of prescription drug spending.

All of these unrelated cases of shortages point to critical ineptitude in manufacturing and managing the generic drug supply chain in the country.

According to experts, multiple factors, including increased competition and shrinking profit margins, have left companies with little incentive to improve facilities and production.

With many players dropping out of the race, few companies end up needing to cover a major portion of demand for a drug.

And even when a drug is manufactured by multiple companies, all of them may still get their Active Pharmaceutical Ingredients (APIs) from the same few suppliers creating something of a bottleneck.

In this precarious situation, an outage in a single plant can trigger a domino effect leading to widespread shortages, especially since it is not possible for other manufacturers to quickly make up the difference.

Indian pharmacies under scrutiny

After the inspection at Intas, multiple Indian pharmaceutical companies came under the scrutiny of the US FDA.

Just last week, according to an FDA report obtained by Bloomberg News.

The report also stated that raw materials at the facility were being stored in excessively hot and humid conditions that did not meet label storage requirements.

Other pharmaceutical companies and manufacturing plants in India have also come under global scrutiny since the Gambia incident, where more than 66 children are reported to have died from the tainted cough syrup.

Since then there have been a number of cases of contaminated over-the-counter (OTC) medicines causing serious health problems and even death in various countries including Uzbekistan, Sri Lanka, Canada and the United States, putting Indian-made medicines under the radar of WHO and other international health authorities.

(Written with input from the Washington Post, Bloomsberg News and CNBC.)

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