Pharmaceutical companies are expected to suffer massive losses due to the regulator’s order to kick heartburn treatment ranitidine drugs out of the market. The recall order came after the authorities detected a potentially cancer-causing chemical N-Nitrosodimethylamine (NDMA) in ranitidine medicines.
Unlike the valsartan recall last year, the regulator is likely to ban ranitidine for good, and it will deal a massive blow to drugmakers. Some firms said the recall was unfair because only the pharmaceutical companies had to suffer losses.
The Ministry of Food and Drug Safety Thursday offered a briefing to pharmaceutical firms over the suspension of ranitidine-containing heartburn treatments on Thursday. More than 200 industry officials attended the hastily arranged briefing.
After the valsartan recall last year, pharmaceutical companies have been bracing for a similar event. They could do so particularly because the U.S. Food and Drug Administration and the European Medicines Agency announced on Sept. 13 that they detected low levels of NDMA in some ranitidine drugs.
The food and drug safety ministry did not found any excessive NDMA in the first inspection. However, it did in the second test, and the response was two weeks late than those of the U.S. and Europe.
On a comment by a ministry official that the government is not likely to allow the resale of ranitidine, pharmaceutical firms expressed shock.
In the case of valsartan, a company could sell valsartan drugs to treat hypertension if it could prove in a test that its products with three consecutive manufacturing numbers had less NDMA than the standard of 0.3 ppm.
In the case of ranitidine, a company can resume the sale if it proves the safety, technically. However, it is almost impossible to do so because no one knows what caused NDMA in ranitidine.
The ministry presumed that NDMA was generated as nitrites and dimethylamine in ranitidine were decomposing and combining themselves over time, or nitrites were unintentionally mixed in the manufacturing process. NDMA could be made not only in manufacturing but in storage or distribution, and the ministry could not guarantee the safety of ranitidine due to its unstable condition, it said.
“The ministry has to secure the safety first and approve the sale, but honestly, we cannot guarantee the safety of ranitidine,” said Kim Myung-ho, director of the ministry’s Pharmaceutical Policy Division.
“Other countries are withdrawing ranitidine as well,” he added, signaling that Korea would follow suit.
Even though the regulator has not investigated finished products containing ranitidine, it presumed that NDMA would be detected in them, too, just like what happened during the valsartan recall. The ministry is encouraging pharmaceutical firms to recall all of their ranitidine-containing finished drugs voluntarily.
Currently, 133 drugmakers are selling and distributing 269 ranitidine drugs – 175 prescription drugs by 113 companies and 94 over-the-counter medicines by 73 companies.
According to the food and drug safety ministry, the 269 ranitidine drugs sold 270 billion won ($225.2 million) last year, and 244 billion won, 90 percent of the total, came from prescription drugs.
Among local drug companies, Daewoong Pharmaceutical and Ildong Pharmaceutical are leading the sales of ranitidine drugs. Daewoong’s three-in-one combo Albis and Albis D sold 37 billion won last year, according to IQVIA data.
Ildong’s monotherapy Curan sold 19.3 billion won last year. Albis’ generic drug Rabis by Daewoong Bio and Rubis by Hutecs Korea Pharmaceutical sold 9.2 billion won and 5.7 billion won, respectively.
Some companies cannot help but suffer losses up to scores of billions of won due to ranitidine recall. However, the government said it “could not help it.”
One pharmaceutical industry official who attended the briefing said, “Most local companies import ranitidine raw materials. Even though our contracts state compensation, we sometimes cannot receive compensation because the other party is outside the country.” “We asked the government to support us so that we can deliver the contract well but received a reply that that would be impossible.”
Another official at a drugmaker criticized the government for demanding the recall only and providing no help. “All the damages will fall on us. If the government took a radical measure to ban the resale permanently, it should provide practical support for us, too,” he said.
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