CDSCO Approved (India)
Oral Tablet

Saheli (Ormeloxifene)

The only approved non-hormonal contraceptive pill in the world. Available in India, not FDA-approved in the US.

Last updated: July 17, 2026

Method
Pill
Delivery ChannelTelehealth Prescription
Product info
SO
Efficacy Profile
91%(Perf: 98%)

Effective: over 90 out of 100 people successfully prevent pregnancy per year.

Phase III trials in India reported method-failure Pearl Index of 1.83 to 4.2 per 100 woman-years (96% to 98% perfect-use). Actual-use Pearl Index including user failures was about 9 per 100 woman-years (91% typical-use). A 2025 real-world study of 148 women reported a Pearl Index of 2.1 with 88.5% compliance.

Clinical EvidenceBMJ Open scoping review of ormeloxifene Phase III trials (2019)
Cost & Insurance
Contact provider/monthly

Not available in the US. In India, Saheli costs roughly Rs. 2-3 per tablet (about $0.03-0.04). Distributed free as Chhaya at government health facilities.

Insurance CoverageVaries
Duration & Reversibility
Typical LifespanWeekly oral tablet (ongoing)
Reversibility
Reversible
STI ProtectionNo
How It Works
Active CompoundOrmeloxifene (centchroman)
Biological Mechanism

Ormeloxifene (centchroman) is a selective estrogen receptor modulator (SERM) that prevents pregnancy by inhibiting implantation of a fertilized egg in the endometrium. It does not suppress ovulation and contains no estrogen or progestin.

Regulatory Details
FDA Regulatory StatusCDSCO Approved (India)
FDA Approval Date1990-01-01
ManufacturerHLL Lifecare Limited
Supporting Your Body & What to Expect
  • Menstrual irregularities (delayed or altered periods)
  • Headache
  • Nausea
  • Abdominal discomfort
  • Breast tenderness
Safety & Suitability
  • •Polycystic ovarian disease (PCOS)
  • •Recent history of jaundice or hepatic impairment
  • •Renal impairment(Reduced kidney function or kidney disease)
  • •Cervical hyperplasia or chronic cervicitis
  • •Pregnancy
  • •Hypersensitivity to ormeloxifene
Editorial Curation

Clinical Commentary & Context

What it is

Saheli is the brand name for ormeloxifene, also called centchroman. It is a non-steroidal selective estrogen receptor modulator developed by India’s Central Drug Research Institute (CSIR-CDRI). Indian regulators approved it for contraception in 1990, and it has been on the market there since 1991. It is the only non-hormonal oral contraceptive approved anywhere in the world.

How it works

Ormeloxifene prevents pregnancy by inhibiting implantation of a fertilized egg in the endometrium, the lining of the uterus. It does not suppress ovulation. It does not contain estrogen or progestin. It does not interfere with the hypothalamic-pituitary-ovarian axis, the hormonal feedback loop that combined pills act on.

Dosing

The standard schedule is one 30 mg tablet twice weekly for the first 12 weeks, then once weekly after that.

Efficacy

Phase III trials in India reported a method-failure Pearl Index of 1.83 to 4.2 per 100 woman-years, which corresponds to about 96% to 98% perfect-use efficacy. Actual-use failure rates including user error were higher, with a Pearl Index around 9 per 100 woman-years (about 91% typical-use efficacy). A 2025 real-world study of 148 women reported a Pearl Index of 2.1 with 88.5% compliance. All efficacy data comes from Indian studies. No US trials have been conducted.

Availability

Saheli is not FDA-approved and is not available in the United States. It is sold in India under the brand names Saheli, Saheli Plus, Novex, and Novex-DS by HLL Lifecare Limited, a Government of India enterprise. Since 2016, the Indian government has distributed it free of cost at public health facilities under the brand name Chhaya. Torrent Pharmaceuticals sells the same molecule as Sevista for dysfunctional uterine bleeding, a separate indication.