New Delhi: The US Food and Drug Administration (US FDA) has reached out to Indian pharmaceutical manufacturers for a critical cancer medicine that is currently in short supply, according to two Indian government officials and a document reviewed by Mint.
The US FDA sent an SOS to the Indian Drug Manufacturers’ Association (IDMA) to identify potential manufacturers capable of supplying ifosfamide, which is used to treat testicular, bladder and lung cancers.
“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,” the IDMA said in a communication dated 19 June 2026 to its members, which Mint reviewed. “The US FDA is interested in information from manufacturers that are currently producing or have the capability to produce these products for any market.”
Indian manufacturers of ifosfamide include Cipla, Zydus Lifesciences, Alkem Laboratories and GLS Pharma, with India’s oncology drugs and cancer treatment market valued at $947.84 million. GLS Pharma makes 1g and 2g vials of ifosfamide branded Ipoget, according to the company’s .
A technical disruption at a contract manufacturing site of Baxter International Inc., the Deerfield, Illinois-based company that is the primary supplier of ifosfamide in the US, and supply chain disruptions caused by the war in West Asia resulted in the shortage of the drug, the officials said. The limited supply of ifosfamide injection is expected to continue through 2026.
The FDA said it is even willing to procure ifosfamide from non-FDA-registered Indian manufacturing facilities and products approved and marketed outside the US, according to the IDMA communication.
“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,” the IDMA said. “Products approved and marketed outside the US are also of interest.”
Collecting information
IDMA is now gathering details from manufacturers that produce or have the capability to produce ifosfamide for any market. The information sought by the IDMA includes the manufacturing site location, FDA establishment identifier number, product strength available, current markets where the product is approved and marketed, and the regulatory status of the manufacturing facility.
“We have reached out to our members and are in the process of gathering information of manufacturers who may be manufacturing the products and have site approvals to be able to supply to target markets,” Viranchi Shah, national spokesperson of the IDMA, told Mint.
Various dosages of ifosfamide were listed as unavailable, on limited availability or temporarily on backorder on the drug shortages of the FDA as of 12 June. The reason for the shortage was stated as “requirements related to complying with good manufacturing practices,” with recovery estimated in October.
In response to queries emailed on 19 June, a US embassy spokesperson sought time till Monday to respond. The embassy did not respond to Mint‘s queries till press time. Queries emailed to the US FDA on Sunday remained unanswered.
Queries emailed to the India’s ministry of external affairs, and the Pharmaceuticals Export Promotion Council of India (Pharmexcil) on 19 June afternoon remained unanswered till press time.
Cipla did not respond to queries sent on 19 June. Queries emailed to Alkem Laboratories on Sunday did not elicit any response. Zydus Lifesciences did not respond to questions emailed on Monday. GLS Pharma couldn’t be contacted either by phone or email.
A Baxter spokesperson said in an emailed response to Mint that although production has resumed, it is operating at reduced capacity, which does not meet current demand, resulting in limited supply throughout 2026.
“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. We have implemented a detailed quota system to distribute available supply fairly among customers, according to previous usage,” the Baxter spokesperson said.
India drug exports
Over 2 million new cancer cases were estimated in the US in 2025, according to the National Cancer Institute at the National Institutes of Health.
India exported anti-cancer drugs worth ₹4,356.48 crore to the US in FY26, which accounted for 38% of India’s total anti-cancer drugs exports of ₹11,430 crore, commerce ministry data showed.
India has roughly 10,500 pharmaceutical manufacturers units, of which over 350 are US FDA registered and certified. The Indian pharmaceutical industry accounts for a fifth of the world’s generic medicines supplies and ranked third globally by volume.
India exported medicines worth ₹75,803.50 crore to the US in FY26, which accounted for about 35% of the country’s total medicine exports of ₹2.18 trillion, as per commerce ministry data.
Experts said India’s pharmaceutical ecosystem is uniquely positioned to address critical global shortages, including life-saving oncology therapies like ifosfamide.
“Our vast manufacturing capability, specialized climate zones for complex synthesis, and proven track record including our global vaccine delivery during covid-19 demonstrates our reliability in times of crisis,” said Dr Mohsin Wali, senior consultant and director in the department of medicine at Pacific OneHealth, a multispeciality hospital in Delhi.
High-quality biologicals and anti-cancer formulations can be produced here affordably, easing the immense disease burden both domestically and globally, Dr Wali said. Partnering with the US FDA to bridge this gap reinforces India’s enduring role as the “pharmacy of the world,” stepping forward with standard-compliant, cost-effective solutions to ensure uninterrupted patient care across borders, he said.