Pharmaceutical News
Drug industry needs to find alternative supply sources to avoid the risk of API shortage
2022/12/17

The recent surge in COVID cases in China has an impact on the global drug supply chain.   In Taiwan, about 50% of APIs are imported from China.  If China decides to suspend exports, Taiwan will surely be affected.  Victor Wang, Commander of the Central Epidemic Command Center (CECC), expressed that the health authority will continue to monitor the situation and to help drug companies to find new sources of supply. 

As COVID continues to spread in China, many Chinese citizens have begun stockpiling medicines, such as fever relief, pain relief and cold medicine.   If the situation continues, it will lead to a global drug shortage.

Victor Wang said in a daily press conference that the authority has advised pharmacies to create a mechanism for monitoring drug use.  Also, the authority has asked the pharmaceutical industry to find new sources of supply and make preparation.

According to Lin Bang-Der, a MOHW official, about 50% of the APIs in Taiwan come from China.  At the beginning of the COVID outbreak in 2019, there was a drug shortage in China.  At that time, in response to the shortage problem, the MOHW immediately held talks with pharmaceutical associations and urged drug companies to quickly find alternative sources of supply, for example from India, France or Italy.

The TFDA also gives priority to drug companies who want to add new sources of materials.  The TFDA intends to make it easier for drug companies to add new sources of supply by simplifying the verification procedure and relaxing some regulations.  Now, drug companies tend to keep a 6-month of supply; hence, there should not be a major disruption in the short term, said Lin. 

Lin also mentioned that the TFDA has already established a drug shortage reporting system.  Drug companies should notify the TFDA of potential drug shortage problems at least six months in advance and start finding alternative suppliers.  Special pathways for manufacturing and importation are also in place to help alleviate the problem. 

Most drug companies are aware of the high degree of uncertainty in drug supply from China and are taking corresponding measures.  Drug shortage is a global issue.  The TFDA will continue to update the information of countries approved for supplying APIs and make the information available online.

Since the changes of API sources may affect the manufacturing cost, the Director General of the NHIA, indicated that drug companies can issue an official letter to the NHIA to request a price review and adjustment. 

【2022-12-15 / Central News Agency】