74% relying on imported substance at risk amid COVID-19

National Assembly Research Service publishes ‘National Assembly Audit Issue Analysis 2020’

“Need to diversify overseas supplier, essential substance should be manufactured domestically”

Preventive measures on incidents like Invossa and Meditoxin needed

While the domestic self-sufficiency of pharmaceutical substance has been constantly falling and 74 percent of the industry is relying on overseas-imported substances, experts warn the South Korean pharmaceutical industry may be at risk when the substance supply gets unstable amid COVID-19.

 

They advise the Korean government should set out a plan to promote diversification of overseas substance supplier and domestic manufacturing of essential substances, as well as to tighten safety management of the imported substances.

 

The experts also recommended the government to work on preventive measures as they had to revoke approved licenses on biopharmaceuticals like Kolon Life Science’ Invossa and Medytox’ Meditoxin.

 

On Aug.

 

10, the National Assembly Research Service published Health and Welfare Committee edition of ‘National Assembly Audit Issue Analysis 2020’ and gave advices to the government.

 

◆Dependency on imported pharmaceutical substance worsens: Pharmaceutical substances can be categorized either as an ‘active pharmaceutical ingredient (API)’ expressing the drug effect or an ‘intermediates’ essential for making APIs.

 

In last five years, Korea has been manufacturing 31.8 percent, 24.5 percent, 27.6 percent, 35.4 percent and 26.4 percent of pharmaceutical substances in year 2014 through 2018, respectively.

 

Korea’s pharmaceutical substance dependency on imported substances is as high as about 74 percent.

 

As of 2018, Korea has imported 33 percent of substances from China and 9.5 percent from India.

 

The Research Service predicted the pharmaceutical substance supply in Korea would suffer a major setback if COVID-19 pandemic lingers longer and disturbs the supply.

 

In fact, Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) conducted a survey in last February and reported Korean pharmaceutical and bio companies have stocks of pharmaceutical substances lasting two to four months.

 

In particular, the Research Service pointed out carcinogen contamination incidents occurred as the pharmaceutical companies neglected safety management in pharmaceutical substances although it can critically affect quality and safety in finished products.

 

In November 2019, Ministry of Food and Drug Safety (MFDS) has fully investigated valsartan, ranitidine and nizatidine when impurity in synthetic substances was discovered.

 

The National Assembly experts evaluate the pharmaceutical substance suppliers should be diversified and essential substances should be encouraged to be manufactured domestically.

 

And they also advised the Korean pharmaceutical industry to enhance safety measure in imported substances as the industry is heavily dependent on overseas suppliers.

 

The National Assembly Research Service recommended, “Some criticizes it is an excessive action to strengthen the management of substances imported from China and India, because of their low significance and risk.

 

But if the pandemic prolongs or another novel infectious disease breaks out, then the lack of good quality substance supply could delay production of finished products in Korea,” therefore, “The government should induce the industry to diversify overseas suppliers to maintain a good flow of supply and to manufacture essential substances.” The researchers added, “MFDS has disclosed plans to reinforce imported pharmaceutical substance safety control by introducing pre-registration system on overseas substance manufacturer to confirm Good Manufacturing Practice (GMP) compliance and to perform on-site investigation for quality control and management,” and “These pharmaceutical substances need more attention as the industry is relying heavily on India and China for importation of 715 cases (25.6 percent) and 227 cases (9.9 percent), respectively.” ◆Tightening pharmaceutical assessment procedure: The National Assembly Research Service has also urged the government to draw up a plan to prevent incidents like revoking the license on osteoarthritis gene therapy Invossa and botulinum toxin medicine Meditoxin for manufacturing and selling drugs different from the verified item.

 

The investigators not only reprimanded Kolon Life Science and Medytox for their unethical practices, but also criticized MFDS’ verification procedure.

 

Accordingly, MFDS presented their plan to strictly investigate and penalize such data manipulation cases with zero tolerance policy.

 

The researchers, however, pointed out the impact on patients’ safety should not be ignored regardless of MFDS stating the safety in Invossa and Meditoxin should not be a problem.

 

As a solution, the researchers recommended the government to tighten the GMP compliance management and adding more information on precautions when license revocation and recall recurs.

 

The National Assembly Research Service noted, “MFDS aims to conduct a randomized investigation even on drugs with first tier toxicity risk level to prevent data manipulation, and also raise the severity level of penalty on companies financially benefited from an item approved with data manipulation.”