2 measures implemented to address IV fluid shortage in Taiwan: TFDA

Taipei, May 23 (CNA) The Taiwan Food and Drug Administration (TFDA) announced Wednesday that two measures have been implemented to increase intravenous (IV) fluid supplies after a halt in production by Taiwan's major saline supplier sparked concerns about a shortage of the medical resource crucial for surgery.

Y F Chemical Corp., which produces around 70 percent of Taiwan's IV fluid, was ordered by the TFDA to cease operations after May 10, the day the company's Medicinal Products Manufacturing License expired, after it was found to be in violation of the Good Manufacturing Practice (GMP) established by the Pharmaceutical Inspection Convention and Co-operation Scheme.

The shortage of IV fluid has created a crisis, as major hospitals may need to halt surgeries and admitting patients due to the essential nature of IV fluid for various surgeries and patient care during hospitalization, according to a press release by the Federation of Taiwan Pharmacists Associations on May 18.

TFDA Deputy Director-General Wang Te-yuan (王德原) said that among the 20 types of IV fluid manufactured by Y F Chemical Corp. that have ceased production, only supplies of large-bag saline for injection, standardized at 500, 1000, or 2000 cubic centimeters (cc) per bag, will be significantly tighter after mid-June.

If converted to 500 cc per bag, Y F Chemical Corp. supplies 1.96 million large-bag of saline for injection per month. It is estimated that stocks of that type of IV fluid will run out in around mid-June, resulting in a shortage of 1.1 million bags in June and 1.5 million bags starting from July.

Although the TFDA expects the shortage of large-bag saline for injection to last until October, Wang said that if the domestic production of saline can be further increased or Y F Chemical Corp.'s deficiencies can be corrected, the supplies of large-bag saline for injection will return to normal.

As to the two measures implemented to address the shortage over the next few months, Wang said that qualified manufacturers are helping to increase the production of large-bag of saline for injection, while other companies have expressed a willingness to import that type of saline from other countries under a special scheme.

If permits are successfully issued and imports proceed as planned, the supply of large-bag saline for injection will be sufficient to meet demand until the end of June, Wang added.

Regarding demand from July onward, Wang said the Ministry of Labor has relaxed overtime restrictions for several qualified saline manufacturers, potentially allowing for a significant increase in production capacity.

When asked about the deficiencies with Y F Chemical Corp., Wang said TFDA inspectors conducted inspections on Jan. 22 to 24 and Feb 21 to 23, at which time the company was found to be in serious violation of the GMP.

The inspectors requested the company implement corrective actions to comply with the GMP after both inspections, Wang noted.

According to an announcement made by the TFDA on April 30, Y F Chemical Corp.'s violations included falsification of experimental data during product testing and the inability of staff members to effectively perform product anomaly detection.

According to the information on TFDA's online platform about the recall of medications, the product "Amolin Powder for oral suspension 50mg/ml (Amoxicillin)" manufactured by Y F Chemical Corp. was recalled on March 26, noting "the company voluntarily recalled the product as it failed to meet the specifications for content uniformity testing."

Expecting Y F Chemical Corp. to ramp up production significantly before its Medicinal Products Manufacturing License expired on May 10, the TFDA sent inspectors to the company from May 1 to May 10 to ensure manufacturing processes adhered to regulations, Wang said.

"We verified that their production adhered to regulations and that subsequent inspections met the standards. Only then did we allow the products, including those in inventory and those produced before the license expired, to be sold on the market," Wang added.

Meanwhile, Deputy Health Minister Lin Ching-yi (林靜儀) said that while a warning mechanism for monopoly concerns exists for certain drugs, government intervention with private manufacturers of IV fluid has been minimal as there are many suppliers in the market.

In the future, the authorities are expected to be more proactive in terms of management and establishing a warning mechanism if any one manufacturer gains a significant share of a specific market, she said.