Govt needs to support generic drug industry to ensure stable supply

The insufficient supply of generic drugs, which are cheaper than their original counterparts, is increasingly serious. The government and manufacturers should hurry to establish a system that will minimize the impact on patients and ensure a stable supply.

The situation was triggered by an incident in which an ingredient used in a sleep-inducing drug was mixed into a generic drug manufactured by Kobayashi Kako Co. in Fukui Prefecture to treat such conditions as onychomycosis, a fungal disease of the toenails. A total of 245 people have complained of health problems, and two of these people died. Kobayashi Kako was ordered to suspend its operations in February.

A series of irregularities later occurred at leading generic drug maker Nichi-Iko Pharmaceutical Co. and other manufacturers, and shipments began to be delayed from spring. A fire last month at a large warehouse storing pharmaceuticals in Osaka is said to have exacerbated the shortage.

According to the Health, Labor and Welfare Ministry, as of the end of August, there was insufficient supply of about 3,100 products, mainly generic drugs, and it was expected to take one or two years to resolve the shortage.

The impact on patients is worrying. When generic drugs are out of stock, pharmacies often switch to brand-name drugs with the same ingredients or other generic drugs.

Many people may feel anxious about taking an unfamiliar drug. If people use more expensive brand-name drugs, this will strain the financial situation of the health insurance system and put a greater burden on people’s household finances. The government, manufacturers and distributors must work together to solve the shortage.

This month, the ministry requested an industry organization to increase the output of products whose supply has decreased significantly since last year. Many manufacturers are believed to be restricting shipments in order to maintain a certain amount of inventory, and the ministry also asked them to stop this.

In consideration for the health of patients, limiting shipments cannot be allowed. Each manufacturer must come up with ways to increase output, such as reviewing their production systems.

The usage rate of generic drugs has reached about 80% thanks to the government’s measures to promote their use. Many manufacturers are thought to have expanded production without setting up an internal governance system, in order to cope with the rapid expansion of the market.

Trust in generic drugs has been shaken by the series of irregularities involving manufacturers. Strict compliance with laws and regulations must be ensured and information proactively disclosed to eliminate the distrust. It is also essential to improve the monitoring function of the government, such as by strengthening on-site inspections.

Generic drugs are indispensable in curbing the growing cost of medical care. However, many generic drug makers are small-scale and their financial situation is not strong.

The challenge is encouraging continued investments to ensure a stable supply. The government must foster the industry from a medium- to long-term perspective. It may also be necessary to implement measures to encourage the strengthening of companies’ financial bases, including realignment and overseas expansion.

— The original Japanese article appeared in The Yomiuri Shimbun on Dec. 30, 2021.