Modern Methods of Contraception in India The Potential of Progestin-Only Pills and Centchroman April 2016 Table of Contents Executive Summary -------------------------------------------------------------------------------------------------- 3 Introduction ------------------------------------------------------------------------------------------------------------ 5 The Facts ------------------------------------------------------------------------------------------------------------ 7 Progestin-Only Pills -------------------------------------------------------------------------------------------- 7 Centchroman ----------------------------------------------------------------------------------------------------- 8 Introduction of Progestin-Only Pills and Centchroman into the Basket of Choice: considerations --------------------------------------------------------------------------------------------------------- 9 Progestin-Only Pills -------------------------------------------------------------------------------------------- 9 ‐ Global Experiences ---------------------------------------------------------------------------------------- 9 ‐ Global Evidence ------------------------------------------------------------------------------------------- 10 ‐ Indian Scenario -------------------------------------------------------------------------------------------- 13 Centchroman ---------------------------------------------------------------------------------------------------- 11 ‐ Global Experiences --------------------------------------------------------------------------------------- 11 ‐ History in India --------------------------------------------------------------------------------------------- 12 ‐ The Evidence from India -------------------------------------------------------------------------------- 12 ‐ The Opportunities in India ------------------------------------------------------------------------------ 18 Policy considerations: The Way Forward ---------------------------------------------------------------------- 20 ‐ Technical Issues -------------------------------------------------------------------------------------------- 20 ‐ Building the Evidence/Operations Research -------------------------------------------------------- 20 ‐ Introduction of additional methods into the national program ----------------------------------- 21 ‐ Communication Strategy --------------------------------------------------------------------------------- 21 ‐ Multipronged Strategy for Service Delivery ---------------------------------------------------------- 21 ‐ Build and Leverage Public-Private Partnerships --------------------------------------------------- 21 ‐ Task Shifting for Service Delivery ---------------------------------------------------------------------- 21 ‐ Operational Plan for Implementation & Monitoring ------------------------------------------------ 21 References ----------------------------------------------------------------------------------------------------------- 22 2 EXECUTIVE SUMMARY A paradigm shift in India’s national policy from the “population control” approach (focused on sterilization), to a reproductive rights-based approach that seeks to empower couples to take informed decisions about timing of births and family size is evident. Under the National Health Mission (NHM), family planning is now positioned as a critical intervention for improving women’s health and reducing maternal and child mortality. The focus is on increasing access, expanding choices of available methods and improving the quality of family planning services. International data over a period of twenty-seven years shows that expansion of the contraceptive method mix in low and middle-income countries has a positive relationship with contraceptive use. Use of contraception may be increased by extending the availability of current methods, by improving features of current methods, or by introducing new methods. A wider choice of methods also improves the ability to meet the individual needs of women and couples. The strategic framework of the Reproductive Maternal Newborn Child + Adolescent Health (RMNCH + A) program offers a fresh paradigm for family planning interventions. The time is opportune for expanding access of women to a wider modern method-mix of contraceptives. A significant development in the recent past has been policy decisions of the Government of India to expand the basket of choice of modern methods of contraception available in the public health system by introducing newer contraceptives such as the injectable contraceptive Depot Provera or Depot Medroxy Progesterone Acetate (DMPA), the non- steroidal and non-hormonal contraceptive Centchroman, and Progestin – Only Pills (POPs). The exponential increase in institutional deliveries to more than 80%, accords an opportunity to increase the choices on offer to women in the postpartum period. In addition to postpartum sterilization and postpartum Intra Uterine Contraceptive Device, the potential of POPs as a non-invasive option for spacing births in the postpartum period, particularly for breastfeeding women, has been accepted. The recently revised World Health Organization’s Medical Eligibility Criteria (WHO MEC 2015) for contraceptives have endorsed POPs for use in breastfeeding women in the immediate postpartum period (< 6 weeks) as the advantages are said to outweigh the risks during this period. Availability of POPs has till now been restricted to the private sector in India. Centchroman (Ormeloxifene) is another promising option for spacing, referred to as the once-a- week non-steroidal oral contraceptive available under the brand name ‘Saheli’.This was developed indigenously in India by the Central Drug Research Institute in the 1980s, approved for marketing in 1990 and is available at a subsidized rate through the social marketing scheme of the Government of India since 1995. This paper presents the global and national historical experience with POPs and Centchroman as credible methods of reversible contraception. It presents a summary of the scientific evidence that testifies to the safety, efficacy and acceptability of these products and is the basis of the policy initiative of the Government of India to include them in the basket of contraceptive choices for clients in the public health system. It also explores the programmatic opportunities and issues, for consideration, for taking these methods to scale in the country. 3 List of Abbreviations ARC – Advocating for Reproductive Choices ASHA – Accredited Social Health Activist AUB – Abnormal Uterine Bleeding API – Active Pharmaceutical Ingredient BMD – Bone Mineral Density CDRI – Central Drug Research Institute COC – Combined Oral Contraceptive CSIR – Council of Scientific & Industrial Research DCGI – Drug Controller General of India DGHS – Director General of Health Services DLHS – District Level Household Survey DMPA – Depot Medroxy Progesterone Acetate DTAB – Drugs Technical Advisory Board DUB – Dysfunctional Uterine Bleeding FDA – Food and Drug Administration FP – Family Planning FOGSI – Federation of Obstetrical and Gynecological Societies of India ICMR – Indian Council of Medical Research ICT – Information Communication Technology INN – International Nonproprietary Name MEC – Medical Eligibility Criteria mCPR – Contraceptive Prevalence Rate, modern methods MF – Method Failure NGO – Non-Governmental Organisation NHM – National Health Mission OCP – Oral Contraceptive Pill PI – Pearl Index POP – Progestin Only Pills RMNCH+A – Reproductive Maternal Newborn Child and Adolescent Health SIDA – Swedish International Development Cooperation Agency SRS – Sample Registration system TFR – Total Fertility Rate UF – User Failure USG – Ultrasonogram 4 Modern Methods of Contraception in India The Potential of Progestin - Only Pills and Centchroman Introduction Twenty per cent of the world’s eligible couples with an unmet need for contraception live in India. In 2007-08, the country had an unmet need of 21.3 % and only 47.1% of eligible couples were reported to be using a modern method of contraception.12 In 1952, India became the first country in the world to launch a national family planning program. One of the goals enunciated in the National Population Policy 2000, is to stabilize the population at a level consistent with the requirement of the national economy and achieve the replacement level Total Fertility Rate (TFR) of 2.1 by the year 2010.20 Several interventions have contributed to the secular decline of TFR, however it was still 2.3 per woman in the year 2013.8 The high unmet need for family planning and the still relatively high TFR have triggered strategic change over a period of time. A paradigm shift in national policy from the “population control” approach (focused on sterilization), to a reproductive, rights-based approach, that seeks to empower couples to take informed decisions about timing of births and family size, is evident. Under the National Health Mission (NHM), family planning is now positioned as a critical intervention for improving women’s health and reducing maternal and child mortality. The focus is on increasing access, expanding choices of available methods and improving the quality of family planning services. India’s commitments made in the London Summit on Family Planning are articulated in “India’s Vision FP2020”.18 These include: Ensuring access to family planning services to an additional 48 million women by 2020 Increasing financial commitment on family planning to more than