The House of Representatives has urged the Health Ministry to loosen regulations on medical equipment testing to allow ventilators made by local manufacturers to be used in treating COVID-19 patients as soon as possible.
he House of Representatives has slammed the Health Ministry for slowing down the development of ventilators done by the Research and Technology Ministry’s COVID-19 research consortium to help meet skyrocketing demand during the outbreak.
Maman Abdurrahman, a member of House Commission VII overseeing research and technology, took issue with the Health Ministry’s slow process in approving the medical equipment’s development.
As of Tuesday, only two out of 27 ventilators developed and proposed by domestic manufacturers had passed the Health Ministry’s health facility security center’s (BPFK) performance test.
“We already have the devices; the prototypes are ready. [...] However, we are hampering ourselves from saving our citizens from COVID-19 with administrative reasons,” the Golkar Party politician said during a meeting with the Health Ministry, Industry Ministry as well as Research and Technology Ministry on Tuesday.
The BPFK had approved continuous positive airway pressure (CPAP) ventilators developed by the University of Indonesia, as well as another one produced by West Java-based Bandung Institute of Technology (ITB) and Padjadjaran University.
The equipment would also need to pass the Health Ministry’s clinical test and acquire marketing authorization before they can be used in hospitals and other health facilities.
Read also: PTDI, Indofarma, universities working on ventilator prototypes
Health Ministry pharmaceutical and medical devices director general Engko Sosialine Magdalene previously said only ventilators made by ITB and Padjadjaran University had entered early clinical trials.
“The Health Ministry must speed up the verification process,” Maman said. “I see indications of [cartel] practice in manipulating the system to prioritize imported products over domestic ones.”
Research and Technology Minister Bambang Brodjonegoro added the pressure on the Health Ministry, urging its minister to relax the long clinical trial period stipulated in a regulation on manufacturing medical equipment as the government scrambles to fulfill nationwide demand.
Bambang pointed as an example to the United States’ Food and Drugs Administration (FDA), which authorized the emergency use of unapproved medical equipment, including ventilators. Such a policy allowed ventilators made by non-pharmaceutical companies, such as the National Aeronautics and Space Administration (NASA), to be used in treating patients during the pandemic.
“We expected special treatment like the one given by the FDA,” Bambang said, adding that the Health Ministry should prioritize the authorization of the equipment.
The House Commission VI overseeing trade and industries as well as Commission IX overseeing health and manpower have also urged the Health Ministry to relax medical equipment testing regulations and protocols during the health crisis.
Read also: ICU ventilators: What they are, how they work and why it’s hard to make more
Engko responded by saying that the ministry had already relaxed some regulations. For example, it no longer requires developers to have the Good Manufacturing Practice for Medical Devices certification.
She went on to say that the clinical trial on patients would also be done on only 30 ventilators made by a manufacturer, allowing the test to be completed in two days.
The ministry has also increased the working hours of its officials to speed up the approval of such equipment.
According to data from the Health Ministry, 8,413 ventilators are ready to be used in 2,867 hospitals across the country. Some provinces such as Central Kalimantan, North Maluku and Gorontalo, however, still lacked equipment.
As of Tuesday, Indonesia has recorded 12,071 confirmed COVID-19 cases with 872 fatalities and 2,197 recoveries.
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