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Explained: How Is the Cancer Drug Shortage in the US Linked to India?

How did one FDA inspection in an Indian pharma plant lead to a widespread shortage of chemotherapy drugs in the US?

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It all started when the United States Food and Drug Administration (FDA) decided to inspect a manufacturing plant in Gujarat's Ahmedabad owned by Intas Pharmaceuticals that had been supplying medicines to the US.

In November 2022, the US FDA stated that upon inspection, the condition of the company were found subpar with next to no quality/safety checks of the products being carried out. Following this, the company indefinately shut down production.

This incident has since led to a snowball effect that has now caused an acute shortage of life-saving cancer medication in the US.

How does one Indian company's closure lead to a healthcare crisis in the US? Let's break it down.

Explained: How Is the Cancer Drug Shortage in the US Linked to India?

  1. 1. What’s Happening in the US Now

    According to reports from the US, 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 percent of cancer centres in the US said they were experiencing a shortage of Carboplatin, while 70 percent were low on Cisplatin.

    This is concerning because when it comes to cancer treatment, even short delays in medication can drastically worsen the patient's condition and increase the risk of death.

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

    Although the FDA has said that they are not equipped to deal with a shortage of this scale all by themselves, they have also said that they are looking to import these drugs from other international suppliers.

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

    However, according to experts, it's very difficult to close a shortage gap when one begins. These need to be prevented from happening at all in the very first place.

    Expand
  2. 2. How Is Intas Pharmaceuticals Involved?

    Ahmedabad-based Intas Pharmaceuticals is a manufacturer of generic therapeutic drugs. The company accounted for about 50 percent of Cisplatin supplied to the US.

    Apart from the evidence of safety and quality violations, the US FDA inspection of the plant where these drugs were being manufactured also found that the company had tried to destroy documents, reported the Washington Post.

    Following this, the company reportedly stopped production of key cancer drugs, with no confirmed date for when it will be restarted, the company's spokesperson Emily King was quoted as saying by CNBC.

    This started a domino effect. The Cisplatin shortage, in turn, has led to the shortage of Carboplatin, another chemotherapy drug that is often substituted for the former and was also made at the same plant.

    These particular drugs manufactured by Intas pharmaceuticals is not sold in the Indian market.

    Expand
  3. 3. The Problems With the Supply Chain of Critical Medicines

    A shortage in supply of drugs can be caused by a number of reasons such as natural disasters, a break in transportation, shipping issues, and most recently, the pandemic.

    This isn't the first time there's been a shortage in chemotherapy drugs, or even other essential generic drugs, in the US.

    Just in the past months, US has faced a shortage of common generic medicines from painkiller acetaminophen, to antibiotics amoxicillin, and Adarall used for treating attention-deficit/hyperactivity disorder (ADHD) in kids. 

    Generic drugs are a vital lifeline of the US healthcare system as they help make essential medication available at a low price.

    According to the Association for Accessible Medicines, generic medicines make up around 90 percent of the prescriptions in the country but less than 20 percent of the expenditure on prescription medicines.

    All these unrelated instances of shortage point to a critical ineptitude in the manufacturing and supply chain management of generic medicines in the country.

    According to experts, multiple factors including rising competition and lowering profit margins have left companies with little incentive to upgrade plants and production.

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

    And even when a drug is manufactured by multiple companies, they might all still get their active pharmaceutical ingredients (APIs) from the same few suppliers – creating a bottleneck of sorts.

    In this precarious situation, a disruption at a single plant can trigger a domino effect that leads to widespread shortages, especially since its not possible for other manufacturers to make up the difference quickly.
    Expand
  4. 4. Indian Pharmas Under Scrutiny

    Since the inspection at Intas, more Indian pharmaceutical companies have come under the scrutiny of the US FDA.

    Just last week, a plant run by Aurobindo Pharma Limited, one of India’s biggest drugmakers by revenue, was found to have 'deficient' manufacturing equipment cleaning and storage controls, according to a FDA report obtained by Bloomberg News.

    The report also said that raw materials in the facility were being stored in excessively hot and humid conditions that were not compliant with label storage requirements.

    Other pharmaceutical companies and manufacturing facilities in India have also been under the global scanner since the incident in the Gambia where over 66 children allegedly died as a result of contaminated cough syrup.

    Since then there have been a slew of cases of contaminated over-the-counter (OTC) drugs causing severe health issues and even death in various countries including Uzbekistan, Sri Lanka, Canada, and the US, putting India-made drugs under the radar of the WHO and other international health authorities.

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

    (At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)

    Expand

What’s Happening in the US Now

According to reports from the US, 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 percent of cancer centres in the US said they were experiencing a shortage of Carboplatin, while 70 percent were low on Cisplatin.

This is concerning because when it comes to cancer treatment, even short delays in medication can drastically worsen the patient's condition and increase the risk of death.

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

Although the FDA has said that they are not equipped to deal with a shortage of this scale all by themselves, they have also said that they are looking to import these drugs from other international suppliers.

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

However, according to experts, it's very difficult to close a shortage gap when one begins. These need to be prevented from happening at all in the very first place.

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How Is Intas Pharmaceuticals Involved?

Ahmedabad-based Intas Pharmaceuticals is a manufacturer of generic therapeutic drugs. The company accounted for about 50 percent of Cisplatin supplied to the US.

Apart from the evidence of safety and quality violations, the US FDA inspection of the plant where these drugs were being manufactured also found that the company had tried to destroy documents, reported the Washington Post.

Following this, the company reportedly stopped production of key cancer drugs, with no confirmed date for when it will be restarted, the company's spokesperson Emily King was quoted as saying by CNBC.

This started a domino effect. The Cisplatin shortage, in turn, has led to the shortage of Carboplatin, another chemotherapy drug that is often substituted for the former and was also made at the same plant.

These particular drugs manufactured by Intas pharmaceuticals is not sold in the Indian market.

0

The Problems With the Supply Chain of Critical Medicines

A shortage in supply of drugs can be caused by a number of reasons such as natural disasters, a break in transportation, shipping issues, and most recently, the pandemic.

This isn't the first time there's been a shortage in chemotherapy drugs, or even other essential generic drugs, in the US.

Just in the past months, US has faced a shortage of common generic medicines from painkiller acetaminophen, to antibiotics amoxicillin, and Adarall used for treating attention-deficit/hyperactivity disorder (ADHD) in kids. 

Generic drugs are a vital lifeline of the US healthcare system as they help make essential medication available at a low price.

According to the Association for Accessible Medicines, generic medicines make up around 90 percent of the prescriptions in the country but less than 20 percent of the expenditure on prescription medicines.

All these unrelated instances of shortage point to a critical ineptitude in the manufacturing and supply chain management of generic medicines in the country.

According to experts, multiple factors including rising competition and lowering profit margins have left companies with little incentive to upgrade plants and production.

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

And even when a drug is manufactured by multiple companies, they might all still get their active pharmaceutical ingredients (APIs) from the same few suppliers – creating a bottleneck of sorts.

In this precarious situation, a disruption at a single plant can trigger a domino effect that leads to widespread shortages, especially since its not possible for other manufacturers to make up the difference quickly.
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Indian Pharmas Under Scrutiny

Since the inspection at Intas, more Indian pharmaceutical companies have come under the scrutiny of the US FDA.

Just last week, a plant run by Aurobindo Pharma Limited, one of India’s biggest drugmakers by revenue, was found to have 'deficient' manufacturing equipment cleaning and storage controls, according to a FDA report obtained by Bloomberg News.

The report also said that raw materials in the facility were being stored in excessively hot and humid conditions that were not compliant with label storage requirements.

Other pharmaceutical companies and manufacturing facilities in India have also been under the global scanner since the incident in the Gambia where over 66 children allegedly died as a result of contaminated cough syrup.

Since then there have been a slew of cases of contaminated over-the-counter (OTC) drugs causing severe health issues and even death in various countries including Uzbekistan, Sri Lanka, Canada, and the US, putting India-made drugs under the radar of the WHO and other international health authorities.

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

(At The Quint, we are answerable only to our audience. Play an active role in shaping our journalism by becoming a member. Because the truth is worth it.)

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