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Regulatory Focus™ > News Articles > Asia Regulatory Roundup: Indonesia to Overhaul Drug Regulator (20 July 2016)

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

Posted 20 July 2016 | By Nick Paul Taylor 

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

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

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.

MoH Statement (Indonesian), Reuters, More (Indonesian)

DCGI Sets Deadlines for Requests for Clarifications to Speed Regulatory Processes

The Drug Controller General of India (DCGI) Dr. GN Singh has capped the time applicants have to respond to regulatory queries at 45 days. Singh implemented the time limit to stop tardy applicant responses from causing undue delays to the processing of regulatory submissions.

Prior to the adoption of the policy, applicants theoretically had an infinite amount of time to respond to requests for clarification from the Central Drugs Standard Control Organization (CDSCO). Faced with such a liberal approach to timelines, “a large number” of applicants were failing to respond to CDSCO requests “within a reasonable time,” Singh wrote in a letter to pharmaceutical trade groups and regulatory officials. Singh thinks this situation was hindering CDSCO’s ability to process applications in a timely manner.

In response, Singh has implemented sanctions against applicants that fail to respond to requests for clarification within 45 days. If this amount of time elapses without an applicant either submitting the requested information or asking for an extension to the deadline for doing so, CDSCO will presume the organization no longer wants to pursue its submission. In this scenario, “It would be disposed of based on the merit of the application,” Singh wrote. This approach has the potential to help CDSCO reduce its backlog of applications.

Singh proposed the time limit on responses alongside another initiative designed to speed up regulatory approval processes. “All applicants could seek an appointment with the concerned Joint Drugs Controller (India) or [DCGI] in cases where the applications submitted by them are not disposed of within two-thirds of the timelines specified for the purpose,” Singh wrote.

DCGI Letter

CDFA Continues Struggle to Increase Adverse Event Reporting by Manufacturers

China Food and Drug Administration (CFDA) has once again bemoaned the failure of manufacturers to file adverse event reports. In 2015, as in each of the two previous years, drug manufacturers accounted for 1.4% of all adverse event reports sent to CFDA, a proportion it thinks should be higher. 

The proportion of adverse event reports that originate at drug manufacturers has been remarkably consistent over the past few years. In 2013, 2014 and 2015, CFDA said 1.4% of the reports it received came from drug manufacturers. The proportion coming from other sources, such as medical centers, has fluctuated over that time, but the figure for manufacturers has remained constant. In the 2015 report, CFDA notes that the proportion coming from manufacturers is low.

CFDA highlighted some bright spots from the latest figures, such as an increase in the number of reports from the top 30 manufacturers, but the overall situation is unchanged. The release of the data comes six weeks after CFDA published a report about adverse events linked to medical devices, in which it noted that the proportion of filings originating at manufacturers fell for the second year running. CFDA has criticized drug and device manufacturers but the situation has not improved.  

While CFDA was once again dissatisfied by the number of adverse event reports it received from drug manufacturers, most reporting metrics are trending upward. CFDA received 1.4 million incident reports in 2015, an increase of 5% over the previous year. The number of annual reports has levelled out after the rapid increases seen between 2010 and 2012. One metric that ticked downward in 2015 was the proportion of adverse event reports involving pediatric populations.

CFDA Report (Chinese)

CFDA Offers Training to Drugmakers to Support Generic Drug Conformance Assessments

CFDA has initiated a training program to help manufacturers run generic drug conformance tests. The training program is part of a broader attempt in China to improve the safety, quality and efficacy of the generic drugs produced and sold in the country.

Regulatory officials are trying to support this process by running a series of training events at locations across the country over the next few weeks. At the events, which CFDA is offering free of charge, drug manufacturers, researchers and technical staff will have the chance to learn about the procedures that go into performing a generic drug conformance test. CFDA will work toward this goal by going through the working paper on conformance testing with attendees.

CFDA also plans to cover the regulatory aspects of conformance assessments. Officials have set aside time for the dossier requirements associated with such assessments and the factors inspectors will evaluate when visiting a testing facility. The sessions will also go into technical details, such as how to determine and compare the dissolution profiles of solid oral drugs and evaluate the consistency of bioequivalence tests and clinical trials.

Manufacturers are being pushed to improve their understanding of such tests as part of a campaign initiated by senior officials in the Chinese government to improve the quality of generic medicines made and sold in the country.

CFDA Circular (Chinese)

Other News:

CDSCO has canceled a further three subject expert committee meetings. The latest meetings to be canceled are “analgesic and rheumatology,” “dermatology and allergy” and “endocrinology.” News of the cancellations comes one week after CDSCO called off a meeting of the neurology and psychiatry committee because of a shortage of experts. CDSCO Alert

The Drug Pricing Committee of Pakistan has met to discuss annual changes to the cost of drugs sold in the country. Meeting Agenda


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