The government has urgently approved the import of about 130,000 bottles of Tylenol Suspension from Australia to relieve the short local supply amid the pandemic.
However, the nation has already passed the point of the extreme shortage of cold medicines in March and the government’s move is too late, pharmaceutical industry officials said.
Sources said on Wednesday that the Ministry of Food and Drug Safety (MFDS) designated Johnson & Johnson Korea’s Children's Tylenol Suspension 50㎎/㎖ (ingredient: acetaminophen) and Tylenol Tab. 500mg distributed in Australia, as “urgently requested drugs.”
Children's Tylenol Suspension 50㎎/㎖ will be supplied to pharmacies from the second week of May, and Tylenol Tab. 500mg, from June.
On Monday, the Korean Pharmaceutical Association (KPA) notified its branches in cities and provinces about the upcoming Tylenol supply.
KPA said pharmacists should provide medication guidance for consumers because Children’s Tylenol Suspension 50㎎/㎖ has a different concentration of the active ingredient, compared with Children’s Tylenol Suspension sold in Korea.
Johnson & Johnson Korea said the company was urgently supplying Children's Tylenol Suspension 50mg (in 200ml unit) and Tylenol Tab. 500mg to meet the rising demand for antipyretic analgesics and cold medicines caused by the surge in Covid-19 cases, after obtaining approval by the MFDS and Korea Orphan & Essential Drug Center (KODC).
“We are cooperating with the government’s policy to expand the supply,” the company said.
The government will help import 134,176 bottles of Children’s Tylenol Suspension 50mg for the urgent domestic supply.
drug is manufactured by Delpharm Orleans in France and imported from Australia, according to KODC.
The quantity of the import is subject to change depending on the situation of the manufacturer, Johnson & Johnson Korea said.
However, industry officials criticized the urgent supply of Tylenol because the shortage of pain relievers and cold drugs subsided after the peak in March when the pandemic was most raging.
“Pharmacies do not suffer from a shortage of cold medicines as they did in the past,” an official at the KPA said.
Another problem is that it took too much time from the urgent drug designation to the import of the drug.
The MFDS decided on the urgent import of the two Tylenol products on April 1 but scheduling alone took a month. To get Tylenol Tab. at a pharmacy, people have to wait for another month.
Local drugmakers are also unhappy about the government’s choice of Tylenol, a foreign drug, as a problem solver in the pandemic. The government neglected support for the production of Korean-made cold medicines but rushed to introduce the foreign medicine urgently, they said.
In 2021, the nation experienced a shortage of Tylenol after Korea Disease Control and Prevention Agency Commissioner Jeong Eun-kyeong said it was okay to take fever reducers such as Tylenol after getting a Covid-19 vaccine.
“When cold medicines were short, the MFDS would say to us, ‘if there is any problem, talk to us,’ but we didn’t get any help in reality,” an official at a Korean drug company said.
The MFDS said when the shortage of cold drugs peaked during the spread of the Omicron variant, the government came up with a list of countries and products to push for the import of urgent drugs.
“During this process, we heard from Janssen that it was possible to import the product from Australia. Then, we proceeded with the plan,” an official at the MFDS said.
“Although Tylenol Suspension has some different concentrations of the ingredient, it still contains acetaminophen only. Tylenol Tab. has the same concentration. So, both these drugs meet approval criteria,” the official added.
The official admitted that the urgent import of Tylenol products was somewhat belated.
He added that the government does not have any plan to import pain relievers or cold medicines from overseas.