'No Protection From HIV': Morning-After Pill Gets Warning Labels As Govt Mandates Caution, Usage Cap

Last Updated:March 13, 2026, 09:15 IST

Critically, these pills remain over-the-counter drugs, but now with three mandatory boxed warnings on primary labels, carton labels, and package inserts.

The next time you pick up an I-Pill or Unwanted-72 from a pharmacy, the packaging will carry a blunt warning: this pill does not protect you from HIV or sexually transmitted infections — and you shouldn’t be taking it more than twice a month.

India’s top drug regulatory body has formally cleared new mandatory labelling rules for emergency contraceptive pills, a decision that closes years of regulatory ambiguity around one of the country’s most widely sold over-the-counter medicines, News18 has learnt.

The Drug Controller General of India – the country’s top drug regulatory authority – has now sent the minutes of the 93rd meeting of the Drugs Technical Advisory Board to all states and Union Territories for action, as of March 10. The minutes of the meeting are accessed by News18.

Now, what happens?

The Drugs Technical Advisory Board, acting on recommendations from the 67th meeting of the Drugs Consultative Committee held in November 2025, has directed that Levonorgestrel tablets (0.75mg/1.5mg) — the active ingredient in brands like I-Pill, Unwanted-72, and dozens of other morning-after pills — be formally added as a specific entry under Schedule K of the Drugs Rules, 1945.

Critically, they remain over-the-counter drugs, but now with three mandatory boxed warnings on primary labels, carton labels, and package inserts.

What Triggered This?

The road to this decision began in 2023, when concerns around “irrational usage" of emergency contraceptive pills prompted the Drugs Consultative Committee to constitute a six-member expert sub-committee — including gynaecologists and pharmacologists — to examine the matter over more than a year.

These pills were sold over the counter (without prescription), but had “no explicit stand-alone entry" in Schedule K (which allows sale without a sales license, not just without a prescription. It includes household remedies like aspirin and paracetamol) – creating ambiguity.

The panels considered proposals for moving them to Schedule H, which would have made them “prescription-only."

The committee ultimately “rejected" making them prescription-only but imposed strict new labelling requirements, settling a long-standing grey area. Now they are explicitly listed as OTC.

“Levonorgestrel Tablets 0.75mg/1.5mg that are emergency contraceptives shall be included/added as S.No.06 of entry No. 15 of Schedule K of Drugs Rules 1945," said the minutes of the meeting.

What Changes on the Box?

All emergency contraceptive pill brands must now carry three boxed warnings: that the pill offers no protection against HIV or sexually transmitted infections; that it should not be taken more than twice a month; and that women should consult a registered medical practitioner about regular contraception. The package insert must also carry detailed information as recommended by the sub-committee report.

“Do not take this medicine more than twice in a month. Use of alternative methods of contraception is encouraged in consultation with registered medical practitioners," document said.

For millions of women who rely on brands like I-Pill and Unwanted-72, the pill stays accessible without a prescription. But the new rules signal that regulators want its use better informed — not more restricted. States and Union Territories are now expected to ensure compliance by drug manufacturers and retailers within their jurisdictions.

News india 'No Protection From HIV': Morning-After Pill Gets Warning Labels As Govt Mandates Caution, Usage Cap

Read More