Tuesday, July 26, 2016

Indonesia - Asia Regulatory Roundup: Indonesia to Overhaul Drug Regulator (20 July 2016)

Indonesian President Promises to Overhaul Drug Regulator Amid Fake Vaccine Scandal

The president of Indonesia has committed to overhauling the country’s drug regulator in response to a counterfeit vaccine scandal. Joko Widodo took the action following weeks in which public outcry has increased in lockstep with awareness of the scale of the scandal and the regulatory shortcomings it has exposed.

Officials at the Indonesia National Agency of Drug and Food Control (NA-DFC) became the focal point for public anger after they were accused of first learning of the fake vaccine problem in 2013. If true, the accusation would mean some regulatory officials knew for several years about a syndicate that imported fake vaccines and supplied them to hospitals, pharmacies and clinics, but did little to stop the criminal activity until a police investigation forced their hands. The syndicate is reported to have operated for a decade.

Police stumbled upon the vaccine ring after arresting a pharmacist on suspicion of operating without a license in May. This led to an investigation and close to 20 more arrests. Now, with Widodo trying to show he has a grip on the situation, the fallout is set to reshape NA-DFC. “We can't be half-hearted with this vaccine problem,” Cabinet Secretary Pramono Anung said in a statement to Reuters to confirm the president’s intention to fix shortcomings at the regulator. “With this we hope that this kind of thing won't be repeated.”

While Widodo has gone after NA-DFC, parliament has been pressuring the ministry of health to share information about which hospitals and clinics procured the fake vaccines. The ministry responded this week by releasing a list of 14 health facilities in the Jakarta area that are thought to have bought and administered fake vaccines. Each of the health facilities is a private operation. The ministry claims the supply chains used by government-owned facilities were free from the counterfeit vaccines.

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