The government’s ban of 128 antihypertensive drugs using valsartan manufactured by China’s Zhejiang Huahai is likely to take a heavy toll on the Korean pharmaceutical industry.
The Ministry of Food and Safety said Saturday it would prohibit sales of 219 products of 82 drugmakers, after detecting N-Nitrosodimethylamine (NDMA) in medicines containing valsartan from China. NDMA is classified as “2A” by the World Health Organization as a potential carcinogen for humans, citing a report by the WHO’s International Agency for Research on Cancer.
As of Monday, the ministry cleared 91 items by 40 companies of the sales, import, and manufacturing ban, as the 91 drugs did not contain the problematic valsartan. The government is investigating 32 products and plans to release the results immediately.
Valsartan is an ingredient in an antihypertensive drug. It needs a doctor’s prescription.
With the latest ban, the nation’s Drug Utilization Review (DUR) system automatically updates all the valsartan-containing medications to add the label, “prescription prohibited,” which makes it impossible to prescribe valsartan.
The ministry has not confirmed the amount of the detected NDMA or its risk. However, to protect consumers, the government ordered the discontinuation of the selling, importing, and manufacturing of the ingredient, the ministry said.
W90 billion-worth market to suffer a massive blow
With the food and drug safety ministry’s ban on 128 treatments that contained valsartan from China, the sellers of valsartan drugs are expected to suffer a massive blow, observers said.
The 128 products sold 87.86 billion won ($78.99 million) in outpatient prescriptions last year, according to UBIST data. In the first quarter, the prescriptions rose 17.9 percent (3.7 billion won) year-on-year to 24.4 billion won.
Among drug companies, Kyung Dong Pharmaceutical will be hit hardest, as the company sold more than 10.7 billion won worth valsartan-containing Valdipine. Valdipine’s outpatient prescriptions marked 2.7 billion won in the first quarter, selling the most among medicines that used valsartan imported from China.
The second-largest valsartan sellers such as HUTECS, Hanlim Pharm, Kolmar Korea, and CMG Pharma are likely to be negatively affected. They
Sales of HUTECS’ Exforte marked 2.2 billion won in the first quarter, up 26.7 percent from a year earlier.
Among those that marked more than 100 million won outpatient prescriptions, JinYang Pharm’s Amvaltan’s revenue spiked 268 percent in the first quarter from a year earlier.
The government, patients in panic due to Chinese valsartan
When the food and drug safety ministry announced the detection of a possible carcinogen in valsartan-using hypertension drugs on Saturday, the ministry’s website was temporarily inaccessible as too many users rushed to visit the site to check the list of the prohibited products.
On Monday morning, the homepage was down again after the ministry released the list of 91 products cleared of the sales ban.
On Cheong Wa Dae’s homepage, people are putting up an online petition to allow hospitals to contact patients and prescribe the drug.
Another petitioner, who demanded the “recall of hypertensive drugs that contained a carcinogen,” said that the government should not only ban the drug but order follow-up measures on each hospital.