I

n the wake of a major drug distribution scandal that has left many parents fearful over their young children’s immunity, the government is preparing a regulation that will enable the Food and Drug Monitoring Agency (BPOM) to sanction violators.

The government is drafting a presidential regulation (Perpres) and a bill on food and drug monitoring that will give the BPOM the power to impose heavy fines on official institutions that breach procedures and standards.

BPOM chair Penny Kusumastuti Lukito, who was recently appointed by President Joko “Jokowi” Widodo, admitted that the agency had failed to prevent the nationwide spread of fake vaccines, with hundreds of babies receiving false immunization over the course of the last 13 years.

“No matter how many resources we deploy to monitor [food and drugs], without a strong deterrent effect, it means nothing,” Penny told a press conference on Monday.

Penny noted that the power to impose heavy sanctions, such as heavy fines, would be integral to one of the agency’s most urgent tasks: ridding the market of ersatz vaccines.

The fake vaccines sparked national outrage among parents who feared their children had been exposed to the fakes after the National Police uncovered a counterfeit vaccine operation ring.

So far, fake vaccines have been found in seven locations, including Banten, Jakarta and West Java. The BPOM previously reported that it had found five types of counterfeit vaccines, namely Tuberfullin, Pediacel, Tripacel, Harfix and Biosef, all of which were discovered in each of the three provinces.

The scandal was the pinnacle of a series of mishaps that have dogged the nation’s health care of late.

Last year, the inadvertent substitution of anesthetic Buvanest Spinal for antihemorrhagic Asam Tranexamat Generik caused the deaths of at least two patients in a hospital.

During its investigation, the BPOM discovered that the producer of the drugs, Kalbe Farma, the largest pharmaceutical firm in the country, was responsible for the accidental swap during production.

However, the agency only ordered the company to recall and temporary stop producing the drugs.

Penny said the agency had limited authority to impose sanctions and limited resources, given its lack of a firm legal basis.

She said the BPOM is generally only able to issue administrative sanctions in the form of recommendations. “Our recommendations are supposed to be followed up by local administrations, but only around 14 percent are. As such, it would be better if the body that monitors [food and drugs] were able to issue heavy punishments,” she said.

Indonesian Health Consumers Empowerment Foundation (YPKKI) chairman Marius Widjajarta said that the agency in fact already had ample capacity to carry out its tasks. “The regulations on food and drug monitoring are already good, the BPOM only has to enforce them,” he told The Jakarta Post.

For instance, he said, the BPOM should punish producers and distributors of drugs that fail to submit their reports on drug distribution and logistics every three months, as required.

“Most of the reports don’t have any substantial content, and the BPOM should therefore punish them,” Marius said.

Meanwhile, House of Representatives Commission IX overseeing health and manpower said that the BPOM was weak and needed reinforcement.

“Why was the BPOM established in the first place simply to be hamstrung?” Irma Suryani Chaniago of the NasDem Party asked the Post.

For instance, Irma said, the BPOM usually only seizes illegal food and drug for a limited period of time. “Usually just three months. The agency is also unable to monitors the sanctions given by the police.”
_______________________________________