US FDA turns to India for critical cancer drug as West Asia war deepens shortage crisis: Report

The United States is facing a shortage of a key cancer medicine and has turned to India to help bridge the supply gap.

The US Food and Drug Administration has asked the Indian Drug Manufacturers’ Association to help identify pharmaceutical companies capable of supplying ifosfamide injections, according to a report by Mint. The drug is used in the treatment of testicular, bladder and lung cancers.

IDMA, in a note to its members dated June 19, said, “IDMA has received a communication from the US FDA India Office seeking assistance in identifying potential manufacturers capable of supplying ifosfamide injection 1 g and/or 3 g to help address an ongoing drug shortage in the US,” Mint reported.

“The US FDA is interested in information from manufacturers that are currently producing or have the capability to produce these products for any market.”

What triggered the shortage

The shortage has been caused by two disruptions occurring at the same time.

Baxter International, the main supplier of ifosfamide in the US, faced a technical issue at one of its contract manufacturing facilities. At the same time, supply-chain disruptions linked to the ongoing conflict in West Asia have affected the movement of pharmaceutical ingredients and finished medicines.

The shortage is expected to continue through 2026.

A Baxter spokesperson told Mint that production had resumed but remained below the level required to meet demand.

“We are working urgently with our manufacturing partner, and in alignment with regulatory authorities, as well as other relevant stakeholders, to restore supply as quickly and responsibly as possible,” the spokesperson said.

As of June 12, several strengths of ifosfamide were listed on the FDA’s drug-shortage database as unavailable, in limited supply or temporarily on backorder.

The regulator cited “requirements related to complying with good manufacturing practices” as the reason for the disruption and estimated that supplies could begin recovering by October.

Indian drugmakers come into focus

Several Indian pharmaceutical companies manufacture ifosfamide, including Cipla, Zydus Lifesciences, Alkem Laboratories and GLS Pharma.

GLS Pharma sells the medicine in 1 g and 2 g vials under the brand name Ipoget.

India’s oncology drugs and cancer treatment market stands at a value of $947.84 million. The country exported anti-cancer medicines worth ₹4,356.48 crore to the US in FY26, accounting for 38% of its total anti-cancer drug exports of ₹11,430 crore, according to commerce ministry data.

In an unusual step, the FDA has indicated that it is willing to consider supplies from Indian facilities that are not registered with the US regulator, as well as products approved and sold in markets outside the United States.

“Preference will be given to products manufactured at US FDA-registered facilities. However, the US FDA has also expressed interest in information from facilities that may not be FDA-registered but have a demonstrated history of satisfactory regulatory compliance,” IDMA said.

The FDA has asked manufacturers to provide details such as the location of the production facility, the FDA establishment identifier number, available product strengths, the markets where the medicine is approved and sold, and the facility’s regulatory status.

“We have reached out to our members and are in the process of gathering information of firms that may be manufacturing the products and have site approvals to be able to supply to target markets,” Viranchi Shah, IDMA’s national spokesperson, told Mint.