Summary: Recently, the Central Drugs Standard Control Organisation (CDSCO) proposed a ban on the over-the-counter (OTC) sale of Emergency Contraceptive Pills (ECPs), like Levonorgestrel. These pills, currently sold without prescription, raise concerns over safety, with studies showing risks such as ectopic pregnancy and other adverse effects. We encourage the CDSCO's proposal, and demand for clear regulations and long-term studies on ECPs' impact. Additionally, we emphasize the importance of fertility awareness and education on safer contraception methods for women’s health and empowerment.

In India, various news outlets recently reported that the Central Drugs Standard Control Organisation (CDSCO) had proposed a ban on the over-the-counter (OTC) sale of Emergency Contraceptive Pills (ECPs) i.e., such as Levonorgestrel (1.5 mg either in a single dose or in a dose of 0.75 mg twice). Currently, these pills (like I-Pill, Unwanted 72, etc.) are available for OTC sale, although they are not explicitly listed under Schedule K drugs, which gives them their legal status as over-the-counter medication.

Amidst this confusion, various groups - including researchers, activists and NGOs have voiced concerns, advocating for clear regulations on ECPs and the continued OTC availability of ECPs. The argument they lay is that access to these pills falls under the purview of women’s reproductive rights and empowerment.

While we share concern for regulatory clarity on the sale of ECPs, we also consider it important that the demands being made be rooted in science and accurate information, ensuring that both public health and individual rights be taken into account.

Let's consider this assumption that is usually made: Making ECPs prescription-only threaten the health and autonomy of women.

Any drug must be assessed not only for its efficacy but also for its safety. Unfortunately, there are no long-term studies that ensure the safety of emergency contraceptive pills (ECPs) like Levonorgestrel on women’s health. In fact, a multicenter case control study of a large sample size revealed an association between the use of Levonorgestrel and an increased risk of ectopic pregnancy. Although these pills are effective in preventing pregnancy, in cases of failure to avoid fertilization, they can elevate the risk of subsequent ectopic pregnancy.

A systematic review and meta-analysis further identified multiple serious adverse events associated with ECPs, including convulsion, ectopic pregnancy, febrile neutropenia, stroke, abdominal hernia, anaphylactic reaction, cancer, ovarian cyst rupture, serious infections, and suicidal ideation. While the incidence of these events is relatively infrequent compared to other common side effects such as alteration of menstrual flow, hypomenorrhea, intermenstrual spotting, and early menstruation, headache, nausea, dizziness, vomiting, diarrhoea, and fatigue – the potential for serious consequences cannot be dismissed. 

Associations of Levonorgestrel with these adverse effects does not necessarily imply causation, however, these studies highlight the need for further research into these biologically plausible side effects of ECPs. In addition, the consumption of ECPs can be dangerous for women with existing gynecological issues or those at higher risk of clotting. Unfortunately, due to the OTC access to these pills, combined with the absence of a monitoring protocol, there is no reliable data to assess the women experiencing these side effects in our country.  

Far from supporting women’s autonomy, the current unregulated access to ECPs can pose risks to women’s overall health and well-being. Furthermore, Levonorgestrel can cause changes in the lining of the uterus, making it harder for a fertilized egg (a new unique human life) to implant – in cases where fertilization does occur. Given these concerns, requiring prescriptions from a registered medical practitioner adds an important layer of safety, allowing for monitoring and addressing potential side effects. Hence, we support the consideration of making ECP available by prescription only.

It is a biological fact that women are only fertile and capable of becoming pregnant for about seven days during their menstrual cycle. Unfortunately, very few women, regardless of their education or socio-economic background, have knowledge about basic fertility and their bodies. The promotion of hormonal contraceptives often occurs without sharing vital information on fertility, leading to a reliance on these contraceptives under the guise of women’s empowerment.

True women empowerment lies in fertility awareness. Informing women of the side effects of emergency contraceptives should be a crucial aspect of this empowerment. As individuals and organisations working towards women empowerment, we ought to take on this responsibility of ensuring women have comprehensive knowledge about their own bodies, and knowledge about different modes of contraception and their potential side effects.

We demand,

1.      The Central Drugs Standard Control Organisation (CDSCO) develops protocols to monitor adverse events among women who use ECPs. In light of this, we recommend the OTC ban of these drugs until we have greater clarity on the scope of possible side effects.

2.      Conduct long term studies to evaluate the scope of potential side effects through the use of hormonal contraceptives on women’s health.

3.      Launch awareness campaigns to educate women about fertility awareness, contraception methods that have no side effects, and other relevant topics.