Why Over-The-Counter Emergency Contraceptives Must Stay

A few days ago, news surfaced about the Central Drugs Standard Control Organisation (CDSCO)  planning to recommend a ban on the over-the-counter sales of emergency contraceptive pills or morning-after pills. This recommendation will likely be made by a six-member expert subcommittee consisting of an obstetrics and gynaecology doctor from Lady Hardinge Medical College and members of the ICMR and DGCA, among others. 

The reason suggested for the ban on over-the-counter sales was that irrational and excessive use of the morning-after pill might lead to health complications for women. It is speculated that obtaining a doctor’s prescription would safeguard women’s health and avoid complications due to unnecessary use of emergency contraceptives.

Given this context, there is a need to discuss what the scientific evidence from India suggests about the safety of over-the-counter availability of emergency contraception.  Is there any scientific justification for such a ban? At the same time, it is also important to anticipate the problems this ban will create.

Are emergency contraceptives safe?

While several chemical formulations, like mifepristone, levonorgestrel, and ulipristal can be used as morning-after pills, the only one approved for sale over the counter in India is Levonorgestrel. Levonorgestrel is found under the famous brand names of Ipill or Unwanted 72. This pill which contains Levonorgestrel at the dose of 1.5mg, when taken within the 72-hour window after intercourse, prevents around 89% of pregnancies. 

The side effect profile of Levonorgestrel includes only nausea, vomiting as well as some minor bleeding after taking the drug. The drug also has a half-life of 20-60 hours, which means that the drug is cleared from the body completely within five days to two weeks, leaving no residual effects. Currently, there is no evidence to indicate that repeated use of this pill would lead to its accumulation in the body or worsen the side effect profile.

The worst-known side effect of emergency contraceptive pills is anaphylaxis, a severe allergic reaction, which occurs when you are allergic to something and consume it anyway. However, that is only applicable to people with a history of allergy to the emergency pill. Such a risk exists with nearly every drug in the world. 

Only a single case report exists associating an emergency pill with a blood clot in the eye, one with a venous blood clot in the brain, and one with a stroke. However, an association between progesterone-only emergency pills and clot formation can not be established based on these case reports of three individuals. Moreover, ample evidence has established that progesterone-only emergency contraceptive pills DO NOT lead to clot formation.

The other possible side effect that could be cause of concern is menstrual irregularities. While these are common -  15% of all cases - they tend to normalise in the next cycle without any treatment.

The only absolute contraindication of the use of levonorgestrel pills is confirmed pregnancy, but even in women who had taken a pill and were later found to have been pregnant, the pill caused no issues to the mother or the baby during the pregnancy.

It is by far considered one of the safest contraceptive options by WHO, even approved in breastfeeding women. 

Though it is licensed for usage only in emergencies, some people might likely take to using morning-after pills as a regular form of contraception, which appears to be the concern that made the Tamil Nadu government suggest this ban on over-the-counter sales in the 62nd Drugs Consultative Committee meeting conducted in 2023. 

Dr. S.A.S Hafeezullah, an MD physician and the state deputy secretary of the ruling party DMK’s media relations wing, Tamil Nadu, quoted in his tweet, “Irrational use of emergency contraceptives has adverse health effects and continuous use may expose them to fatal illness. These pills are an absolute contraindication in some illnesses,” an opinion that has no scientific evidence whatsoever. 

When we look through the WHO fact sheet and guidelines on contraceptive eligibility, which determines which women are at risk for ill effects on repetitive use of a particular type of contraception, we note that levonorgestrel-based contraception is safe for all women for repetitive use, though not ideal. The ideal scenario is using emergency pills as a bridge to either regular barrier method use, regular combined oral contraceptive use, or another form of contraception such as IUDs or sterilisation. 

How will the ban impact access to emergency contraceptives?

While we speak about the safety profile of the emergency pill, it is worth it to note that there is rampant misinformation about the pill, even among doctors, as proven by studies. 

In a study done in Uttar Pradesh, 96% of the doctors did not know the correct information about how the emergency pill acts. Another study by the Population Council Institute among gynaecologists also revealed that even among specialists,  96% of doctors were unaware of the accurate mechanism of action. They believed that it prevents the embryo from implanting in the woman’s uterus, while overwhelming global evidence suggests that they act by preventing ovulation from occurring at all. 

This widespread misbelief that emergency contraception prevents uterine implantation leads to the false belief that it causes ectopic pregnancy, a potentially life-threatening condition. Some doctors even go so far as to spread this misinformation on media platforms. A paper analyzing 136 studies shows no evidence that emergency contraception can lead to ectopic pregnancy. Additionally, there is no biological basis for levonorgestrel-based contraception to cause ectopic pregnancy. 

Lack of access to information has also led some doctors to believe that the morning-after pill can cause life-threatening blood clots. However, only pills that have the hormone estrogen are associated with causing these blood clots. Estrogen is found in the combined oral contraceptive pills that are prescribed for everyday use. Levonorgestrel is a synthetic form of the hormone progesterone, which, when taken on its own, has no chance of causing blood clots.

The Uttar Pradesh study also revealed that around one-fourth of the doctors incorrectly believed that repeated use poses health risks and could also cause infertility. However, their beliefs were not supported by any evidence. Another study revealed that two-thirds of health providers believed that emergency pills are unsafe during breastfeeding, which also is incorrect.

In the context of such widespread misinformation even amongst healthcare providers, making prescriptions necessary could curtail access to contraceptive care for people who genuinely need it.

Biases against users of emergency contraception

The belief that emergency contraception prevents implantation could also be fuelling physicians’ bias against its use by making them think it causes abortion as well, thus raising some moral qualms for pro-life doctors. The Uttar Pradesh study suggests that some doctors believed that the morning-after pill is an abortifacient. But, as mentioned previously, the mechanism of action is the prevention of ovulation, which means that the levonorgestrel pill cannot cause abortion. 

A study from north India reported that more than half the doctors also believed that people seeking emergency contraceptive pills are likelier to engage in premarital sex (53%) and three-fourths believed that its use will lead to sex with multiple people. Nearly half of the doctors considered ECP seekers as promiscuous in another study. 

An investigative story in The News Minute shows two undercover reporters trying to access prescription emergency contraception from a government hospital in Chennai. While doing so, they experience a dehumanising ordeal of being disrespected and moral policed by doctors and nurses alike for several hours before being handed the pill. This paints a snapshot of what might be the new normal for women moving forward if the over-the-counter sale of emergency contraceptive pills is banned.

Global perspective on emergency contraceptives

The World Health Organisation strongly recommends over-the-counter availability of emergency contraceptive pills. Furthermore, 112 countries allow over-the-counter sales, with Argentina and Japan joining the list as recently as 2023. This reveals that globally, the trend is towards allowing sales.

Levonorgestrel-based emergency contraceptive pills also fulfill the Food and Drug Administration (FDA) criteria for drugs that can be allowed to be sold over the counter. It was approved by the FDA for over-the-counter sale in 2013. 

Potential negative impacts of the ban on emergency contraceptives

There is a high burden of unsafe abortions in India. A study published in the British Medical Journal in 2019 reported that from 2007 to 2011, more than two-thirds of abortions in India were hazardous and led to an average of eight deaths per day in the country. The study also showed that marginalised and disadvantaged women were disproportionately affected. As per another study in The Lancet Global Health, in 2015, 8 lakh unsafe abortions were carried out in India. 

People who try to access abortion care mention that their experiences are rife with stigma and disrespect. Given this, easy access to emergency contraception could help in preventing unwanted pregnancies and thus unsafe abortions that threaten the life of women. 

Therefore, a ban on over-the-counter emergency contraceptives could worsen maternal deaths in India by increasing unwanted pregnancies and unsafe abortions. This ban could also increase the demand for black-market alternatives to emergency contraceptive care. Knowing the lack of regulation and quality control in the black market, a ban may create additional problems due to substandard or counterfeit emergency contraceptives. 

Moreover, over-the-counter access helps women from various socioeconomic strata access contraceptive care while fostering autonomy and privacy, according to an ethnographic study done in Dehradun. Especially in India, where condom usage is very low (only 9.5%), and many women (including those married) find it difficult to negotiate condom usage with their partners, the emergency pill offers them an option that they can use to protect themselves without the shame and disrespect that might come from going to doctors for a prescription or an abortion. 

One can only remember the scene in Alankrita Shrivastava’s “Lipstick Under My Burkha” where Konkana Sen Sharma’s character repeatedly goes in for abortions to a local healthcare provider, citing that her husband doesn’t like using condoms. One of the safest contraceptives in the world, a levonorgestrel-based emergency contraceptive, definitely seems like the better option in that scenario, doesn’t it?

No policy based on speculation

India is a country where lethal substances like tobacco, alcohol, and even pesticides - a common means of self-harm with 100% mortality that has been banned in 66 countries - can be purchased easily without any ID proof. However, there is speculation on the misuse of this very safe drug that supports sexual and reproductive health and a plan to ban it from over-the-counter use. 

It is clear that there is no evidence to back this recommendation from a scientific point of view. Additionally, the registered medical practitioners who are called to write prescriptions for these drugs do not seem to have a good idea about what these drugs do and believe that they cause more side effects than they do. They may also lack adequate gender sensitivity training to address and overcome biases related to individuals seeking emergency contraception.

In the current scenario, it is evident that speculations, and not scientific evidence, are guiding a potential policy change. Despite the existing evidence, if strong doubts persist, population-based studies need to be conducted to prove that emergency pills are being misused in India and causing widespread side effects before a recommendation for an over-the-counter ban can be made.

Rather than restricting access, India should focus on educating both the public and healthcare professionals about the correct usage and safety of emergency contraceptives to ensure women can make informed decisions about their reproductive health.

Dr. S.A.S Hafeezullah has qualified his position as being pro-women, in a tweet. He tweets that emergency contraceptives must be banned because  “Why should the onus of contraception be put only on a woman?” But if almost 90% of the men in the country are unwilling to step up and use safe barrier methods like the male condom or undergo vasectomies, is it pro-women to restrict the options that women have to protect themselves?

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Edited by Radhikaa Sharma and Parth Sharma.

Image by Janvi Bokoliya.