Source: Trial Site News
Indonesia’s now in the middle of its most severe wave of the COVID-19 pandemic. Now thanks in part to a wealthy entrepreneur presently serving as the Minister for State Owned Enterprises (SOE), the country’s national drug regulator authorised the use of ivermectin on an off-label basis targeting COVID-19. In 2020, the Indonesian government brought in a wealthy, dynamic, and aggressive businessman to shake up and turn around state-owned enterprises known as “SOE.”
Now they’ve turned Erick Thohir loose on COVID-19, and there’s nothing but business. A pragmatic yet big thinker, the new SOE Minister of the Food and Drug Supervisory Agency, known for the acronym BPOM, issued a distribution permit for ivermectin, meaning the regulatory body for this Southeast Asian nation of 270 million, the worlds’ fourth most populous nation, has authorised the use of the generic, low-cost drug as a therapeutic for COVID-19.
Based on the results of a study, this BPOM action led to a distribution license to PT Indofarma Tbk; and production now has commenced with plans for distribution of over 4 million units per month.
This fascinating and unfolding situation is the result of the dynamic SOE minister driving state enterprises to solve the COVID-19 crisis as the BPOM still takes the position that the treatment is accepted but on an off-label basis. But BPOM has declared formally that ivermectin is now authorised as a therapy for COVID-19.
For months, India’s national authorities have authorized ivermectin as a regimen to be included targeting COVID-19 yet this authorization was then removed due in part to both internal and external political pressure. Now the world’s fourth most populous nation’s regulatory authority has authorised ivermectin’s use in a major breakthrough for the drug’s role in the COVID-19 pandemic.
To date, only 12.6 million people have been fully vaccinated in Indonesia, representing about 4.7% of the population. In the meantime, the country now enters its worst phase of the pandemic, a third spike where on June 23 a record number of daily cases, 15,308, were recorded.
Presently, 60 studies have produced overwhelmingly positive data indicating ivermectin-based efficacy and safety signals in the context of COVID-19. A generic drug industry won’t make a huge return with this drug hence despite mounting evidence and large trials now in both America and England, a confluence of factors and forces have served to inhibit ivermectin’s potential in the richest economies.
TrialSite’s shared that the market for early-onset, mild-to-moderate COVID-19 could easily total $3-$5 billion per annum for the pharmaceutical company that can come up with the first compelling product. Presently, the top contenders are Roche, Merck, and Pfizer but each one of these firms’ investigational products show potential limitations.
TrialSite’s been the only life science-dedicated media and social network platform tracking the results of ivermectin studies since the Spring of 2020.
While authorising the use of ivermectin off-label for COVID-19, BPOM declared a number of points. The regulator declared that due to the pandemic, the state must find either new drugs or use repurposed drugs to treat the viral infection. While BPOM acknowledges ivermectin’s antiviral qualities, they declared that there’s still a need for compelling scientific safety and efficacy data through additional clinical trials. Undoubtedly, this statement ensured that BPOM could align with Western regulatory agencies, such as the U.S. FDA and Europe’s EMA.
BPOM declared that ivermectin 12 mg tablet is now registered in the nation for the indication of helminthiasis (Strongyloidiasis and Onchocerciasis). The product label calls for a dose of 150-200 mcg/kg body weight with the use of once per annum. It’s only available in Indonesia via a licensed physician’s prescription.
Moreover, although they’ll allow physician-driven off-label usage, this falls under the condition of a clinical trials program led by the Health Research and Development Agency, Ministry of Health of the Republic of Indonesia, involving a number of major hospitals.
Side Effects with Uncontrolled, Long-Term Use
The drug regulatory agency cautioned that ivermectin’s long-term, uncontrolled use could lead to side effects including muscle/joint pain, skin rash, fever, dizziness, constipation, diarrhea, drowsiness, and Stevens-Johnson Syndrome.
BPOM’s responsible for the ongoing oversight of the off-label use of the drug targeting COVID-19. The regulatory agency committed to ongoing communication with the World Health Organization (WHO) and regulatory authorities around the world.
No Over-the-Counter or Online without Prescription
BPOM was also clear, via a request to the public, not to buy ivermectin over-the-counter without a physician’s prescription. This includes the use of online platforms and caution that business ventures set up to sell the drug online without a licensed physician’s prescription would violate the law, leading to regulatory-imposed sanctions.
BPOM makes itself available to the public via a number of channels, including a primary contact, lapor.go.id, HALOBPOM Contact Center (call center) 1-500-533 (local credit), SMS 0812-1-9999-533, WhatsApp 0811-9181-533, email [email protected], Instagram @BPOM_RI, Facebook Fanpage @bpom.official, Twitter @BPOM_RI, or Consumer Complaints Service Unit (ULPK) at Balai Besar/Balai/Loka POM throughout Indonesia.
Spreading via Social Media
Now Indonesia and soon the world is buzzing with this news. An Indonesia-based YouTube channel clarified the news with SOE’s Special Staff of the Minister Arya Sinulingga.
TrialSite’s Indonesia POV
TrialSite published a special on Indonesia, highlighting that this diversified, dynamic, and growing economy with big middle-class aspirations demands attention. TrialSite’s founder Daniel O’Connor shared that “the Indonesian SOE minister has serious business pedigree, brings a unique combination of vision, statecraft and pragmatic ability to the effort of fighting COVID-19.” O’Connor continued, “BPOM stepped up in a big way, paving the way for other regulatory agencies to both progress the research imperative while also in parallel, imminently serving the human health interest in response to this devastating global pandemic and associated public health crisis.”
In addition to the distributor, a number of other pharmaceutical companies operate in the country including Kalbe, Dexa Medical Group, Bio Farma, and Kimia Pharma as examples of local producers. Foreign ventures including GSK, Roche, Astellas, Apotex, Sirtex, Dong-A-ST Co., and Sanaria Inc.
Now PT Indofarma Tbk will be producing at least 4 million batches per month. This local producer got its start back in 1918 as a medical supplies producer. By 1950, it became a state-owned enterprise and by the year 2000 became ISO certified. Since then ,the company’s achieved a number of accomplishments from additional quality certifications and accreditation for the production of pharmaceuticals, pharmaceutical, and medical instruments, bioavailability/bioequivalence (BA/BE) test laboratories, and other specialized services.
SOE Minister Erick Thohir has had a fascinating journey to get to this point. The 51-year old businessman founded and chairs the Mahaka Group, a holding company that focuses on media and entertainment. With a resume that includes ownership of professional soccer (Inter Milan and D.C. United), he’s also the President of the Indonesian Olympic Committee. Again by October 2019, he became the Minister of State Owned Enterprises in a bid to reform, rationalize, and turbo-charge Indonesian business. He owns an Indonesian soccer club with Kaesang Pangarep, a young Indonesian entrepreneur and YouTuber who also happens to be the youngest son of Joko Widodo, a former Indonesian president.
Call to Action: Other regulators should consider what BPOM has done, maintaining a stance that ongoing research is necessary while, at least during the public health emergency, allowing for controlled off-label use of ivermectin for the COVID-19 indication.