November 26, 2025 | 09:23 am
TEMPO.CO, Jakarta - The Food and Drug Monitoring Agency (BPOM) has issued the first generic drug permit in Indonesia containing dydrogesterone for infertility treatment. With the presence of generic dydrogesterone, patients with fertility problems have a more economical treatment alternative. This is expected to help couples undergoing pregnancy programs, including in vitro fertilization (IVF).
The Head of BPOM, Taruna Ikrar, stated that his team has a number of strategic steps to support the acceleration of access to innovative drugs. "This is done to support the improvement of public health quality. Therefore, BPOM is committed to continuously making various breakthroughs in the drug registration process, including making changes to regulations and promoting product innovation to increase the availability of new innovative drugs," said Taruna in a press release received by Tempo on November 24, 2025.
With this approach, the safety, efficacy, and quality of the product are guaranteed in accordance with international standards while expediting the drug approval process in Indonesia, especially for innovative drugs.
The President Director of PT Dexa Medica, V. Hery Sutanto, expressed appreciation for the steps taken by the Food and Drug Monitoring Agency (BPOM) in the support process until the issuance of the Marketing Authorization Number for generic dydrogesterone. "We express our utmost gratitude to BPOM for their support and trust in granting the marketing authorization number for dydrogesterone as the first generic drug in Indonesia," he said.
According to him, the presence of this drug with official BPOM approval is evidence of a harmonious synergy and cooperation in how BPOM provides clear technical guidance, conducts strict monitoring of quality, safety, and effectiveness. "This also proves that with good regulations, it can drive beneficial innovations directly for the people," said Hery.
According to the World Health Organization (WHO) data in 2023, about 1 in 6 adults in the world, equivalent to 17.5% of the world's population, has experienced infertility at some point in their lives. In Indonesia, data from the Ministry of Health in 2022 shows that about 10-15% or 4-6 million couples experience infertility and require medical treatment.
Infertility, or fertility problems, are differentiated into two categories: primary infertility (when a couple has never had a pregnancy) and secondary infertility (when a couple has had a child but experiences difficulty conceiving again or having subsequent pregnancies). The causes of infertility can come from various factors, including: about 20-30% of cases are due to physiological factors in men. In addition, about 20-35% of infertility cases are caused by physiological factors in women. Then about 25-40% of cases are due to disorders that occur in both partners and about 10-20% of other cases do not have a clear cause (unexplained infertility).
Dydrogesterone as an economical infertility therapy
Dydrogesterone is one of the hormone therapy options prescribed by doctors to support hormone regulation in managing infertility. This drug has been used for clinical purposes in oral form since 1960. Over the past 60 years, dydrogesterone has been used in many countries. Pharmacologically, dydrogesterone is very similar to endogenous progesterone and is generally indicated for therapy in progesterone deficiency.
As an infertility therapy, dydrogesterone is available in oral form, providing convenience and increasing patient compliance. The availability of oral dydrogesterone provides hope for couples hoping for offspring, as therapy becomes more accessible and affordable, thus potentially increasing the success of treatment.
However, the equivalence of efficacy between generic dydrogesterone and the originator product needs to be proven through adequate scientific data. Currently, bioequivalence test requirements for copy products are one effort to ensure that the product has efficacy and safety profiles equivalent to the originator product. If the copy product is proven to be bioequivalent to the originator product, then the product can be used as an alternative therapy because both have the same therapeutic effect.
"Therefore, the presence of bioequivalent generic dydrogesterone is expected to be an effective and economical solution in supporting the success of infertility therapy," said Hery.
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