Pharma industry body scouts for Indian suppliers as US faces cancer drug shortage

The Indian Drug Manufacturers' Association (IDMA) has approached its members to identify manufacturers of the cancer drug ifosfamide after receiving a request from the US FDA's India Office to help address an ongoing shortage of the chemotherapy medicine in the United States, according to a communication accessed by Business Today.

The move has also prompted consultations with industry bodies, with the Indian government asking IDMA and similar associations to identify manufacturers capable of supplying the drug, Dr Viranchi Shah, National Spokesperson and Immediate Past President of IDMA, told Business Today.

"The government has asked IDMA and other similar industry bodies to identify manufacturers who can supply ifosfamide," Shah said.

According to the communication circulated among IDMA members, the US FDA is seeking information on manufacturers that are currently producing Ifosfamide Injection in 1 gram and/or 3 gram strengths or have the capability to manufacture the product for any market.

Ifosfamide is a chemotherapy medicine used in the treatment of several cancers, including testicular cancer, soft tissue sarcoma, bone cancers and certain lymphomas. The injectable drug forms part of multiple cancer treatment regimens and is widely used in oncology care.

The US has been grappling with shortages of several sterile injectable medicines in recent years, particularly older generic drugs produced by a limited number of manufacturers. Industry experts have attributed such shortages to manufacturing disruptions, quality-related issues, supply chain constraints and concentration of production among a handful of suppliers.

Like other oncology drug shortages, a prolonged disruption in the availability of ifosfamide could affect treatment schedules for cancer patients. Against this backdrop, the US FDA is seeking information on manufacturers capable of producing the drug, including products approved and marketed outside the United States.

The communication reviewed by Business Today shows that the regulator is seeking details on manufacturing locations, product strengths, regulatory approvals, markets where the product is approved and marketed, and available manufacturing capacity.

The US FDA has indicated that preference will be given to products manufactured at US FDA-registered facilities. However, it has also expressed interest in facilities that may not be FDA-registered but have a demonstrated history of satisfactory regulatory compliance.

The development also drew investor attention to pharmaceutical companies with sterile injectable and oncology manufacturing capabilities. Shares of Piramal Pharma were among those in focus on Tuesday, while market participants tracked other drugmakers with exposure to regulated markets and complex injectables businesses for potential opportunities arising from the shortage.

Analysts cautioned, however, that any commercial benefit would depend on manufacturing capacity, regulatory clearances and whether companies are ultimately identified as potential suppliers.

India's large pharmaceutical manufacturing base and its significant role in global generic drug supply chains make it a key source of alternative supplies when shortages emerge in overseas markets. Industry executives said the current exercise is aimed at identifying manufacturers that could support supplies of the oncology drug to the US market, subject to regulatory and commercial requirements.