Morning-after pills could soon be available over the counter in India without prescription

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Emergency contraceptive pills, popularly known as morning after-pills are likely to be sold over the counter (OTC) in India soon. This move will result in easy availability of the pills at chemist as well as regular stores without doctor's prescription.

The drug regulator authority is planning to list out certain contraceptive drug strengths under Schedule K, which will make them available OTC without prescription. Currently, access to morning-after pills isn't as smooth and is largely dictated by the discretion of chemists or stores.

The easy access, public health experts believe, will eventually help counter the increase in adolescent pregnancies across India. The rise in such cases is linked to early sexual activity, limited contraceptive awareness, inadequate sex education in schools and restricted access to confidential reproductive health services.

All emergency contraceptives — including Levonorgestrel and Ulipristal — will however need to carry boxed warnings. According to a report in The Economic Times, these warnings must appear on the primary pack, the carton label, and the package insert, stating that the pills do not protect against HIV or other sexually transmitted infections, should not be taken more than twice a month, and that alternative contraception methods should be used after consulting a registered medical practitioner.

People aware of the development said the boxed warning and insert will be available in all major regional languages and accessible via a QR code. It is mandatory for the packs to also carry detailed information on the contraceptives.

What's the govt proposal?

The Union Ministry of Health and Family Welfare has put forward a proposal to the Drugs Consultative Committee (DCC) emphasising that even with OTC status, the pills must carry strict warning labels.

"Suitable amendments in the Drugs Rules, 1945 for sale of Levonorgestrel 0.75mg/1.5mg tablets by retail with regard to the need of prescription or otherwise," the agenda document for the panel discussion stated.

It added, "Levonorgestrel Tablets 0.75mg/1.5mg that are emergency contraceptives shall be included/added under entry No. 15 of Schedule K of Drugs Rules 1945. The package insert of the drugs shall contain the details as mentioned ... sub-committee report date 28.01.2025."

Prescription-only list

The expert panel also proposed adding Ulipristal, another emergency contraceptive, to the prescription-only list under Schedule H. It recommended reorganising existing hormonal drug categories to eliminate overlaps.

Ulipristal is used for emergency contraception and treating uterine fibroids by modifying the action of progesterone, a natural female hormone.

What is morning-after pill?

Morning-after pill is a kind of emergency contraception used to prevent pregnancy after unprotected sex or when regular birth control options fail.