Korea is likely to depend more on imported raw material drugs because of the dwindling number of local manufacturers, and the nation needs to nurture the related domestic industry, a lawmaker said.
Rep. Oh Jae-sae of the ruling Democratic Party of Korea made these and other points based on data from the Ministry of Food and Drug Safety. According to Oh, the number of local manufacturers of raw material medicine fell to 119 in 2018 from 381 in 2013, leading to far lower self-sufficiency in raw material drugs.
“Domestic pharmaceutical companies changed their strategy to import raw materials under the pressure of price competition, especially after the government lowered drug prices amounting to about 1.7 trillion won ($1.45 billion) in 2012. Consequently, the number of raw material drug manufacturers went down by 262 from 381 in 2013 to 119 in 2018,” Oh said.
The number of raw material drug items also declined from 41 in 2013 to 24 in 2018.
During the same period, raw material drug imports increased to 2.26 trillion won from 1.97 trillion won. The imports of Chinese-made products, which accounted for the largest share of the total, surged 58.6 percent to 798.8 billion won from 503.7 billion won, over the period.
The import of Chinese valsartan, the ingredient for hypertension treatment, also caused a nationwide recall due to carcinogen (NDMA) risk last year.
The U.S.-China Economic and Security Review Commission, a congressional commission of the U.S. government, raised concerns about Chinese regulation on exports of raw materials for antibiotics and pharmaceutical products on July 31.
“As Korea suffered retaliatory measures from China because of Seoul’s decision to install a U.S.-made anti-ballistic missile system in 2017, the nation needs to brace for China’s similar move in the pharmaceutical sector,” Oh said. “Nevertheless, the government decided to get rid of price benefits for drug companies that make raw material drugs, which could speed up the fall in the number of domestic raw material drug suppliers.”
Korea’s reliance on foreign raw material drugs is growing, and the number of manufacturers and product items is dropping. The nation should prepare for any shortage of imports and review nurturing the local raw material drug industry, the ruling party lawmaker emphasized.
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