Published Sep 18, 2026 | 12:47 PM ⚊ Updated Sep 18, 2026 | 12:47 PM
Contraceptive pills.
Synopsis: Women buying emergency contraceptive pills in India may soon see three prominent warnings on their packs. But the draft rules will not take effect immediately.
Women buying emergency contraceptive pills in India may soon see a set of prominent warnings on their packs, including that the pills should be used only in emergencies, should not be treated as regular contraception and do not protect against HIV or other sexually transmitted infections.
The Ministry of Health and Family Welfare has proposed changes to the Drugs Rules, 1945, to bring levonorgestrel tablets of 0.75 mg and 1.5 mg under Schedule K with mandatory warnings on their packaging and package inserts.
The draft notification, issued as G.S.R. 792(E), was published by the Health Ministry on September 3. The government has invited objections and suggestions for 30 days before considering the draft for final notification.
Under the proposed rules, packs of levonorgestrel emergency contraceptive pills will have to carry three boxed warnings.
The first will state that an emergency contraceptive pill is meant to be taken only in emergencies and should not be used as a regular contraceptive.
The second warning will say that frequent use of emergency contraceptive pills may lead to side effects and advise women to visit the nearest health facility or a registered medical practitioner for regular contraception as soon as possible.
The third warning will make clear that the pill is not an abortion pill and does not provide protection against HIV or other sexually transmitted infections.
The proposed amendment does not move levonorgestrel emergency contraceptives into the prescription-only category.
Instead, the government is proposing to specifically include 0.75 mg and 1.5 mg levonorgestrel tablets as a new entry under Schedule K of the Drugs Rules, 1945, along with conditions governing their exemption from certain sale-licensing requirements.
This means that, if the draft becomes final, the basic experience of buying these emergency contraceptive pills is not expected to change. The major change will be the information displayed prominently on the packaging and in the package insert.
Levonorgestrel emergency contraceptives have been available in India for years and are sold under several brand names, including i-Pill.
The proposed labelling change follows a regulatory debate that has continued for several years.
The Drugs Consultative Committee, in its 67th meeting in November 2025, considered recommendations from an expert sub-committee examining issues related to contraceptives. The committee agreed that levonorgestrel tablets of 0.75 mg and 1.5 mg should be included as a new entry under Schedule K.
The committee also recommended three specific boxed warnings: that the medicine does not protect against HIV or sexually transmitted infections, that it should not be taken more than twice a month, and that women should consider alternative contraceptive methods in consultation with a registered medical practitioner.
The Drugs Technical Advisory Board subsequently considered the matter at its 93rd meeting on February 16, 2026.
The DTAB agreed with the DCC recommendations and recommended that the Drugs Rules be amended accordingly. Its minutes specifically recorded the proposed warning that the medicine should not be taken more than twice in a month.
However, the draft notification published by the Health Ministry uses different wording.
Instead of specifying a numerical limit of two uses per month, the proposed rule says that frequent use may lead to side effects and directs women towards a health facility or registered medical practitioner for regular contraception. It also adds two other warnings that were not worded in the same way in the DTAB recommendation: that the emergency contraceptive pill is not an abortion pill and should be used only in emergencies.
The labelling proposal follows an earlier debate over whether emergency contraceptives should remain available without a prescription.
In 2023, a proposal was considered to move emergency contraceptives from Schedule K to Schedule H, which would have made them prescription medicines. The regulatory process instead moved towards retaining levonorgestrel under Schedule K while introducing clearer warnings and instructions.
The DCC’s 2025 minutes also note that the DTAB had separately recommended including ulipristal in Schedule H. Ulipristal is a different emergency contraceptive and is treated separately from levonorgestrel under the proposed regulatory framework.
Emergency contraceptive pills are designed to prevent pregnancy after unprotected sex or contraceptive failure. They are different from abortion medicines, which are used to terminate an established pregnancy.
The proposed warning therefore seeks to address two different issues: inappropriate or repeated use of emergency contraception and misunderstanding about what the medicine can and cannot do.
The draft also explicitly states that the pill does not protect against HIV or other sexually transmitted infections, making clear that emergency contraception cannot substitute for barrier protection against infections.
For women who need regular contraception, the proposed label directs them towards a health facility or registered medical practitioner rather than relying repeatedly on emergency contraception.
The draft rules will not take effect immediately. The government has given a period of 30 days for objections and suggestions after the Gazette is made available to the public. The rules will come into force only from a date specified by the government when the final notification is published.
From our archives:
When no ban feels like a ban: Tamil Nadu’s morning-after pill confusion
Emergency contraceptive pills remain over the counter despite Tamil Nadu’s push for restriction
7 out of 1,000 women seek emergency contraceptive pills in India, 57 per cent obtain them from OTC
