Bangladesh's Incepta gets WHO nod for self-injectable birth control, offering women greater convenience
With support from the Children’s Investment Fund Foundation (CIFF) and the Gates Foundation, Incepta’s Medogen SubQ will give countries another trusted supplier and help make the product more affordable for health systems
The World Health Organization (WHO) has approved a generic self-injectable contraceptive developed by Incepta Pharmaceuticals, marking a step toward giving women greater control over their reproductive health with a convenient, long-lasting birth control option.
Incepta Pharma's Chairman Abdul Muktadir confirmed the matter saying that Incepta is the first company in the world to receive this approval.
"This is a major achievement for Bangladesh's pharmaceutical industry. As a result, global market access for Bangladesh has increased further," he added.
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The WHO issued its prequalification approval for this generic version under the brand Medogen SubQ, according to a press release.
Medogen SubQ is a long-acting contraceptive given as a self-injectable shot, providing 12-14 weeks of pregnancy protection and giving women a discreet, convenient option, especially for those in remote or underserved areas.
According to the WHO, this self-injectable contraceptive is a subcutaneous depot medroxyprogesterone acetate (DMPA-SC). It is a long-acting, injectable contraceptive that delivers the hormone medroxyprogesterone acetate just under the skin.
In other words, this is a long-lasting birth control shot that women can inject themselves under the skin to prevent pregnancy for several months.
With this approval, WHO meets international standards for safety, efficacy, and quality manufacturing toward increasing access to affordable, self-injectable contraceptives in low- and middle-income countries (LMICs), where more than 250 million women still have an unmet need for modern contraception, the media release states.
Originally developed and launched by Pfizer over a decade ago as Sayana Press, DMPA-SC has become a valued method of contraception due to its discretion, convenience, and potential for self-administration after proper training.
The new WHO prequalified generic version will offer health systems a more affordable option and provide a reliable alternative to the existing supply.
WHO prequalification is a global quality stamp that signals a medicine meets international standards for safety, effectiveness, and manufacturing.
This is for ensuring DMPA-SC reaches all women who wish to use it, reads the press release of an independent philanthropic organisation "Children's Investment Fund Foundation: CIFF".
With support from the CIFF and the Gates Foundation, Incepta's Medogen SubQ will give countries another trusted supplier and help make the product more affordable for health systems.
"This is a welcome development for Uganda, where unmet need for family planning remains high, especially among young women," said Dr Charles Olaro, director general Health Services at Uganda's Ministry of Health.
"The availability of a WHO prequalified generic DMPA-SC brings much-needed diversity to the market and will support our national total market approach efforts to expand access to self-care across the country."
