Boxed Warning Proposal For Emergency Pill

The emergency contraceptive pill levonorgestrel may soon carry prominent boxed warnings, indicating to the users that it is for emergency use only. And that it is not an abortion pill and does not protect against HIV or other sexually transmitted infections (STI).

The warnings are part of a Union Health Ministry proposal to bring levonorgestrel tablets in 0.75 mg and 1.5 mg strengths under Schedule K of the Drugs Rules, 1945. The draft notification was issued on September 3 and is now available for public objections and suggestions for 30 days.

The proposed change would also tell users not to take the medicine more than twice a month and encourage them to consult a registered medical practitioner about regular contraception. These conditions were recommended by the Drugs Consultative Committee (DCC).

Levonorgestrel is a hormone used for emergency contraception after unprotected sex or contraceptive failure. It mainly works by preventing or delaying ovulation.

It does not cause an abortion and cannot end an established pregnancy, according to the World Health Organization (WHO). It is meant as a back-up method, rather than a regular form of contraception.

WHO recommends levonorgestrel emergency contraception as a single 1.5 mg dose or two 0.75 mg doses taken 12 hours apart. It should be taken as soon as possible and within 120 hours, or five days, after unprotected intercourse.

The proposal is largely about clearing up a regulatory overlap. “Schedule K contains certain drugs that are exempt from some prescription-sale requirements, subject to conditions. Some chemical contraceptives listed under Schedule K had also appeared under Schedule H, which covers drugs subject to prescription-sale requirements,” said an official from the Ministry.

This created confusion for manufacturers and regulators, he explained.

The DCC subsequently recommended adding levonorgestrel 0.75 mg and 1.5 mg emergency contraceptive tablets as a separate entry under Schedule K. It also recommended the boxed warnings and information to be provided with the medicine.

The latest proposal is therefore aimed at putting these two emergency contraceptive strengths clearly within the Schedule K framework, along with conditions for their labelling and use, said the official.

Emergency contraceptive pills are widely available internationally, with access without a prescription recommended by WHO.

WHO's 2024 guidance says levonorgestrel emergency contraceptive pills are registered or available in at least 146 countries. In at least 85 countries, levonorgestrel emergency contraceptive pills can be obtained without a prescription.

The way they are supplied differs. In some countries, the pills can be bought directly from pharmacies or shops. In others, they are available from a pharmacist without a doctor's prescription.

As per the WHO, emergency contraceptive pills can prevent more than 95% of pregnancies when used within five days, with effectiveness generally higher the sooner they are taken.

The copper IUD remains the most effective form of emergency contraception. WHO says it can be inserted within five days of unprotected intercourse and is more than 99% effective in preventing pregnancy. It also provides continuing contraception.

If the proposal gets the go-ahead, the packaging will make it explicit that levonorgestrel emergency contraception is a backup option — not an abortion pill, not protection against STIs and not a substitute for regular contraception, the official maintained.