The recent discovery of a nationwide counterfeit vaccine ring has revealed a gap in the distribution chain of vaccines in the country.
Authorities believe that fake vaccines could be circulating in hospitals, clinics and pharmacies because there is demand from patients to use imported vaccines, which can be procured through unofficial supply chains, unlike vaccines produced in the country.
“There is high demand from the upper-middle income bracket for alternative vaccines. If they want a polio vaccine, for example, they don’t want those produced by state-owned pharmaceutical company Bio Farma. They want the imported vaccine. That’s why there’s a gap,” Food and Drug Monitoring Agency (BPOM) chairman Tengku Bahdar Johan Hamid said.
The safety and authenticity of a vaccine could only be guaranteed if children were vaccinated through the government’s Complete Basic Immunization program, Bahdar added.
All vaccines used in the government’s immunization program, including Hepatitis B, diphtheria, pertussis and tetanus, measles and tuberculosis, are obtained from official distributors through a closely monitored distribution chain.
“Before the vaccines are distributed, we have to evaluate them. Each production batch has to be tested before they can be released,” Bahdar said.
The procedure to test the safety of the vaccines is even more rigorous than those of regular drugs.
“Then we carry out post-market monitoring by taking samples from those circulating in the distribution channel as well as in medical facilities and test them,” said Bahdar. “That’s the official distribution channel.”
To further ensure that no fake vaccines are distributed through the official distribution channel, the government also requires all public medical facilities to procure their vaccines through an e-catalogue.
Health Minister Nila F. Moeloek said e-purchases from producers were distributed by official pharmaceutical traders to regional health agencies and health facilities, including community health centers (Puskesmas) and integrated health service posts (Posyandu).
The case is different with unofficial distribution channels, but the BPOM has said there is not much it can do as its authorities are restricted.
“There are many regulations that restrict us from doing our job properly. For instance there is Health Ministerial Regulation No. 35/2014, which says we can only monitor drugs in pharmacies and not their procurement and distribution. Therefore, the House of Representatives recommends a bill on food and drug monitoring because they know there is a lot of territory we can’t enter,” Bahdar said.
He cited Pramuka Market in East Jakarta as a well-known source for fake drugs.
“The kiosks that sell medicine in Pramuka Market are not official. We never check that market because it’s not supposed to be selling vaccines. We acknowledge our mistakes,”he said.
Bahdar added that counterfeit vaccines could also enter medical facilities such as hospitals and clinics through freelance salespeople.
“There might be public hospitals that procure vaccines not from the government. And then there are freelance distributors that offer vaccines at low prices. The procurement of vaccines through such means is illegal,” he said.
The BPOM has detected 28 medical facilities, mostly private hospitals and private clinics, that have procured vaccines through unofficial channels, according to Bahdar.
These facilities are located in Jakarta, Surabaya, Yogyakarta, Mataram, Palu, Subang, Pekanbaru, Bandung and Denpasar.
“If the vaccines were obtained from unofficial sources at low prices, they could be fake,” Bahdar said.
The BPOM also determined that counterfeit versions of at least 12 vaccine brands had been circulating in the country. These brands are produced by Bio Farma, Sanofi Group and Glaxo Smith Kline (GSK).
Bio Farma said the company had implemented strict standards for its vaccine production and distribution, both in public and private medical facilities. Bio Farma corporate secretary M. Rahman Rustan said its vaccines were distributed by official distributors that were audited periodically in accordance to good distribution practices, such as 48-hour maximum delivery time.
“Therefore, there are no leaks in delivery that could be misused by other parties,” he said.