Who gains from birth control becoming ‘prescription-only’? No one female

The Central Drugs Standard Control Organisation (CDSCO) is likely to recommend banning the over-the-counter (OTC) sale of all hormonal contraceptives, including emergency contraceptive pills (ECPs) — a move that has sparked significant criticism from healthcare specialists and gynaecologists.

An expert sub-committee formed by the CDSCO is expected to advise that the Drugs and Cosmetics Rules of 1945 be amended to classify these drugs as prescription-only. The panel is set to submit its report soon.

Currently, under the National Reproductive and Child Health Programme, the Drug Controller General of India (DGCI) permits the sale of 0.75mg levonorgestrel tablets as an emergency contraceptive without a prescription. Emergency contraceptive pills, commonly known as the morning-after pill, were introduced in India in 2002 and can prevent pregnancy if taken within 72 hours of unprotected sex.

While some experts argue that making the drug available OTC helps prevent unwanted pregnancies and reduce the need for abortions, access to emergency contraceptive pills remains shadow-banned in states such as Tamil Nadu, where they are hard to find at pharmacies.

Other hormonal contraceptives available OTC include the combined oral contraceptive (containing oestrogen and progestin) and the progesterone-only pill, which are designed to be taken daily and prevent ovulation and fertilisation, respectively.

Levonorgestrel is a steroid preparation which is a progestin used in both regular oral and IUD contraceptives and in higher doses in the emergency contraceptive pill. Also known as the morning-after pill, the last levonorgestrel formulation group is the first-line oral emergency contraceptive pill approved by the World Health Organization (WHO) to prevent pregnancy.

The six-member CDSCO expert sub-committee was established after the Tamil Nadu government proposed a ban on OTC hormonal contraceptives, citing concerns over "irrational usage" during the 62nd Drugs Consultative Committee Meeting in September 2023. The sub-committee's role is to review the matter and recommend whether such a ban is necessary.

Dr Pinkee Saxena, professor in the department of obstetrics and gynaecology at Lady Hardinge Medical College, Delhi, chairs the sub-committee. Other members include M.N. Sridhar, joint director of Drugs Control, and a representative from the Indian Council of Medical Research (ICMR).

According to Sridhar, levonorgestrel has been excluded from Schedule K of the Drugs and Cosmetics Act, 1945, which lists drugs exempted from certain regulations.

"It has to be included in Schedule H, as it is a steroid. Experts from AIIMS-Delhi suggested banning the sale of OTC emergency contraceptive pills, citing potential side effects like heavy bleeding. After deliberations, this recommendation is now under consideration," said Sridhar.

From the sub-committee, the proposal will first go to the Drugs Controller General of India (DCGI), and then a legal opinion will be sought before any further action is taken.

The expert panel has suggested moving these drugs to Schedule H, which would require a doctor’s prescription before pharmacists can dispense them. If the DGCI accepts the recommendation, it will be sent to the union ministry of health and family welfare for an amendment to the D&C Act.

However, the push to regulate emergency contraceptive pills in particular and hormonal birth control in general raises concerns about the priorities and underlying intentions of those advocating for the change, as underscored by Dr Suchitra Dalvie, coordinator of the Asia Safe Abortion Partnership.

The timing of this move is particularly noteworthy, coming shortly after the union government informed the Supreme Court that while the rape of a woman by a stranger should be met with severe punishment, a husband's rape of his wife should not face the same level of punishment, as it is apparently the woman’s duty to make herself available sexually.

India faces numerous pressing issues, including a lack of formal sexual education, prevalent child marriages, dowry-related violence and the continued criminalisation of marital rape.

Meanwhile, contraceptives are often unavailable in public healthcare facilities, and the emergency contraceptive pill has been one of the few accessible options for women.

Recognised by the WHO and other leading medical bodies, the morning-after pill has no harmful effects and has been available OTC for years.

According to the WHO, drugs used for emergency contraception do not harm future fertility. There is no delay in the return to fertility from ECPs (unlike daily contraceptive tablets). The hormone used in the ECP, progestin, is also present in daily contraceptives (albeit at different dosage levels), and has no evidence of widespread harm.

Side effects from the use of ECPs are similar to those of oral contraceptive pills in general, such as nausea and vomiting, slight irregular vaginal bleeding and fatigue. The side effects are not common, they are mild and will normally resolve without further medications, WHO guidelines state.

Dr Dalvie, a former medical director at the Family Planning Association of India, adds, “The move to regulate the emergency contraceptive pill appears to be a response to moral concerns rather than public health needs.

“Public healthcare in India is often under-resourced, with limited access to doctors and facilities, particularly in rural areas. Placing the ECP under prescription control would make it more difficult and costly to obtain, especially for those who need it most,” she continues.

This shift is seen by many as part of a broader moral panic aimed at restricting the sexual autonomy of unmarried women and girls.

In a country grappling with multiple health challenges, it is ironic that the contraceptive pill is being singled out for tighter regulation, especially when it is one of the safest and most commonly used forms of contraception worldwide.

Banning the ECP will likely lead to an increase in unwanted pregnancies and unsafe abortions, resulting in higher morbidity and mortality, experts argue, which would far outweigh any potential risks of the pill itself.

It is clear that there are two main issues at play: a moral panic over the perceived 'misuse' of freedoms by women, and a disconnect between some decision-makers and the scientific evidence on the birth control pill.

WHO guidelines recommend that the pill be available OTC, and if it were truly as harmful as some suggest, we would have seen widespread evidence of its dangers in countries where it is far more commonly used—but this has not been the case.

Though the debate appears to centre on the emergency contraceptive pill, it is really about controlling women’s autonomy, sexual freedom and agency in general. The morning-after pill has been available without prescription for over 20 years, and the sudden push to restrict access raises serious questions. In a patriarchal society where violence against women remains pervasive and gender inequality is entrenched, this move feels like a step backwards.

Adsa Fathima, of the Sama Resource Group for Women and Health, expressed concern over the policy: “Do women, girls and trans men in this country not have an equal right to their health and life? They say that irrational use of emergency contraceptives is a concern, but how does restricting access to them become rational?

“Instead of addressing the real task of promoting health education and comprehensive sexuality education, we see these unscientific shortcuts where bans and restrictions are seen as easy solutions,” she added.

“I mean, whose emergency is it, anyway?” she continued. “The data is right in front of us to make better decisions.

“NFHS-5 shows the persistent gender burden of contraceptive use on women in this country. Despite 97 per cent of men having knowledge about condoms, the utilisation rate is merely 10 per cent. We need to look at the real problem and its causes.

“Emergency contraception is essential for many people in many compelling circumstances. At the least, we could show care and sympathy for these situations, not marginalise them,” she concluded.

Avali, a sexual and reproductive health and rights advocate currently working with the Asia Pacific Transgender Network, also highlighted the importance of ECP access for trans people: “The sale of ECPs is critical for trans individuals.

“For trans-masculine people like myself, doctor consultations often become an access issue. The added expense, combined with healthcare professionals’ biased perspectives on trans people, can limit access. Doctors often fail to consider that even trans men can get pregnant, which makes restricting access to emergency contraception even more harmful.”

In light of such concerns, the push to regulate the emergency contraceptive pill highlights the broader issue of access to reproductive health, particularly for marginalised communities, in a patriarchal context.

The risk of restricting access to such a vital health resource far outweighs any perceived benefit, and could lead to greater harm, especially for those already facing significant barriers to healthcare.

In this context, the focus should be on improving women’s and marginalised groups' rights and access to healthcare, not imposing further restrictions on safe, effective contraception.

If the government’s priority is to ban the emergency contraceptive pill—one of the few accessible options for so many—it suggests a troubling trend towards further control over women’s and trans people’s bodies and lives, said Dalvie.