Approve the world's only non-hormonal birth control pill for use in South Africa
Approve the world's only non-hormonal birth control pill for use in South Africa
The Issue
As women, many of us are frustrated with our lack of options for birth control. Barrier methods have low efficacy rates while hormonal birth control methods have health risks and cause side effects that can greatly affect our quality of life.
Ormeloxifene (also known as centchroman and under the brand names Saheli and others) is the world's only contraceptive pill that does not contain hormones. It provides effective pregnancy prevention by inhibiting the body’s reception of its natural estrogen without effecting estrogen levels meaning hormonal balance stays the same. For this reason, ormeloxifene does not cause any of the side effects traditionally associated with hormonal birth control pills such as bloating, mood swings, weight gain, nausea, low libido etc.
Ormeloxifene was approved by Indian authorities in 1990 and licensed for manufacture under the brand name Saheli. Since then, Saheli has been used by over 10 million women for more than 30 years and has been provided free-of-cost to the women in India by the government under the brand name Chhaya since 2018. The Indian government produces Saheli for its own people, and has no interest in marketing it internationally.
Ormeloxifene has been the subject of numerous research studies since its introduction in 1991. Studies from Johns Hopkins University and research published in renowned medical journals found ormeloxifene to be highly effective (1.63 pregnancies per 100 women), free from side effects commonly associated with steroidal oral contraceptives, does not delay return of fertility, maintains normal ovulatory cycles and is not associated with any serious complications (blood clotting etc.). Saheli is now part of the National Family Planning Programme as an oral contraceptive pill and the WHO has approved and assigned it the technical name ormeloxifene, which is now sold the world over as Novex-DS, or Sevista.
According to the South African Medicines Control Council (MCC), if a need for this contraceptive can be established, a treating practitioner can submit an application to the MCC for it to be registered in South Africa and permitted for import.
Women in South Africa should have access to a from of birth control that has both high efficacy (unlike barrier methods) and does not cause unwanted side effects (unlike hormonal methods). This need is currently not being met and I believe Saheli is the answer.
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The Issue
As women, many of us are frustrated with our lack of options for birth control. Barrier methods have low efficacy rates while hormonal birth control methods have health risks and cause side effects that can greatly affect our quality of life.
Ormeloxifene (also known as centchroman and under the brand names Saheli and others) is the world's only contraceptive pill that does not contain hormones. It provides effective pregnancy prevention by inhibiting the body’s reception of its natural estrogen without effecting estrogen levels meaning hormonal balance stays the same. For this reason, ormeloxifene does not cause any of the side effects traditionally associated with hormonal birth control pills such as bloating, mood swings, weight gain, nausea, low libido etc.
Ormeloxifene was approved by Indian authorities in 1990 and licensed for manufacture under the brand name Saheli. Since then, Saheli has been used by over 10 million women for more than 30 years and has been provided free-of-cost to the women in India by the government under the brand name Chhaya since 2018. The Indian government produces Saheli for its own people, and has no interest in marketing it internationally.
Ormeloxifene has been the subject of numerous research studies since its introduction in 1991. Studies from Johns Hopkins University and research published in renowned medical journals found ormeloxifene to be highly effective (1.63 pregnancies per 100 women), free from side effects commonly associated with steroidal oral contraceptives, does not delay return of fertility, maintains normal ovulatory cycles and is not associated with any serious complications (blood clotting etc.). Saheli is now part of the National Family Planning Programme as an oral contraceptive pill and the WHO has approved and assigned it the technical name ormeloxifene, which is now sold the world over as Novex-DS, or Sevista.
According to the South African Medicines Control Council (MCC), if a need for this contraceptive can be established, a treating practitioner can submit an application to the MCC for it to be registered in South Africa and permitted for import.
Women in South Africa should have access to a from of birth control that has both high efficacy (unlike barrier methods) and does not cause unwanted side effects (unlike hormonal methods). This need is currently not being met and I believe Saheli is the answer.
29
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Petition created on 24 March 2021