India’s drug exporters body Pharmexcil has alerted members to a shortage of intravenous (IV) fluids that the United States is facing in the aftermath of Hurricane Helene damage to a manufacturing facility, and urged them to explore the opportunity to chip in with supplies.
Manufacturers of intravenous fluids with approvals from the U.S. FDA/EU/SRA countries as well as the capacity to supply intravenous fluids to the U.S. are requested to submit their willingness, Pharmaceuticals Export Promotion Council of India Director General Raja Bhanu said.
The communication to members that was issued recently followed the Indian Embassy in Washington D.C. informing the exporters body under the Commerce Ministry about a critical shortage of IV fluids prevailing in the U.S. due to the serious damage Hurricane Helene caused to a Baxter International plant.
The U.S. President has declared a national public health emergency due to the shortage of the critical fluids that are required for surgeries and other medical procedures. Several hospitals have postponed non-essential medical procedures, while the U.S. FDA has also authorised import of the fluids from other countries, it said.
Hurricane Helene that raged through the country in late September was one of the deadliest storms to wreak havoc in the U.S. since Hurricane Katrina in 2005. According to reports at least 200 people died.
As another support measure, consequent to the shortage of the fluids, the U.S. FDA on October 28 announced extended use dates for some parenteral drug products, after a review of the stability data submitted by Baxter International, which is a leading manufacturer of the fluids.
Separately, in an update, the company said its North Cove manufacturing site was significantly impacted by the rain and storm surge from Hurricane Helene, which was unprecedented in Western North Carolina and resulted in water flooding the facility.
“We are encouraged to report that, barring any unanticipated developments, Baxter anticipates restarting the highest-throughput IV solutions manufacturing line this week. Initial batches will be manufactured concurrently with ongoing quality activities and would only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products. It is important to note that the earliest that new North Cove product could begin entering the distribution channel is mid- to late-November,” it said.
Published – October 30, 2024 02:09 pm IST