Saheli – The non hormonal contraceptive (Weekly oral contraceptive pill)
Central drug Research Institute (CDRI), Lucknow has developed the molecule ‘Centchroman’ which was marketed by HLL under the brand name Saheli. Introduced in 1991, Saheli has the unique distinction of being the world’s first non-steroidal oral contraceptive pill. It is also unique since it is an indigenously developed drug – the first of its kind. For being non –steroidal, Saheli does not have the short term side effects like nausea, vomiting, weight gain etc. which are commonly reported with the other oral contraceptive pills. The only side effects reported with Saheli (Centchroman) is the delay in the menstrual cycles in around 8% of the cases. Besides its use as a safe contraceptive for long term use, Saheli is also shown to be beneficial for treating dysfunctional uterine bleeding, osteoporosis and pre-menstrual syndrome and as a drug for lowering lipid levels in the blood.
Composition: Each tablet contains centchroman 30 mg
Active Ingredient: Ormeloxifene is a SERM, or selective estrogen receptor modulator. In some parts of the body, its action is estrogenic (e.g, bones), in other parts of the body, its action is anti-estrogenic (e.g., uterus, breasts. It causes an asynchrony in the menstrual cycle between ovulation and the development of the uterine lining, although its exact mode of action is not well defined. In clinical trials, it caused ovulation to occur later than it normally would in some women (Singh 2001), but did not affect ovulation in the majority of women, while causing the lining of the uterus to build more slowly. It speeds the transport of any fertilized egg through the fallopian tubes more quickly than is normal (Singh 2001). Presumably, this combination of effects creates an environment such that if fertilization occurs, implantation will not be possible.
Mechanism of Action: The molecule centchroman offers a unique combination of weak estrogenic and potent anti estrogenic properties. Due to this subtle mix of estrogenic and anti estrogenic action it inhibits the fertilized ovum from nidation and thus prevents pregnancy, but at the same time, it does not appear to disturb the other estrogen effects. Use of Saheli (Centchroman) as a contraceptive has been extensively evaluated in more than 2000 women of the reproductive age groups who wanted to space their children. Intensive monitoring by clinical examination, hematology and biochemical tests as well as laparoscopy and ultra sonographic examinations of ovaries and uterus have shown the drug to be quite safe. Babies born to use failure cases have shown normal milestones. The contraceptive effect is readily reversible and subsequent pregnancy and its outcome is normal. It scores over steroidal contraceptive pills because it does not disturb the endocrine system and the normal ovulatory cycle is maintained.
Dosage: This pill is to be taken twice a week on fixed days for the first three months, followed by one pill in a week thereafter. The main USP of the product is about the complete freedom from the side effects with the ease and convenience of the dosage. Moreover, Saheli does not cause nausea, vomiting, dizziness and break through bleeding and has no adverse effect on lipid profile and platelet function as is seen with steroidal contraceptives.
Target audience for Saheli is literate women in the age group of 20-45 years.
Price: Saheli is priced at Rs.16/- for a cycle of 8 pills.