Health Ministry Proposes Schedule K Exemption, Boxed Warnings for Levonorgestrel Pills
New Delhi: The Union Health Ministry has proposed that packs and package inserts of levonorgestrel emergency contraceptive tablets (0.75 mg and 1.5 mg) carry boxed warnings stating that the pill is for emergency use, should not be used as regular contraception, may cause side effects if used frequently, is not an abortion pill, and does not protect against HIV or other sexually transmitted infections.
The Union Health Ministry has proposed adding levonorgestrel emergency contraceptive tablets in 0.75 mg and 1.5 mg strengths to Schedule K of the Drugs Rules, 1945. If finalized, the amendment would exempt these tablets from provisions requiring a sale license, subject to a condition that their packaging and package inserts carry boxed warnings on emergency use, frequent use, abortion, and protection against sexually transmitted infections.
The Central Government issued the draft after consulting the Drugs Technical Advisory Board, under Section 12(1) and Section 33(1) of the Drugs and Cosmetics Act, 1940.
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Schedule K specifies which drugs receive exemptions from particular provisions of the Act and Rules, and the conditions attached to those exemptions.
The notice stated that the following draft of certain rules further to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by subsection (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, is hereby published for information of all persons likely to be affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public.
"Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government," the notice added.
In line with the above, the draft rules added
1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2026.(ii) These rules shall come into force from the date as specified by the Government at the time of final publication of the rules in the Official Gazette.2. In the Drugs Rules, 1945, in Schedule K under entry No. 15 and entries relating thereto, the following entry shall be inserted, namely: ―
Class of Drugs
Extent and Conditions of Exemptions
(6)
After serial number 5, the following serial number and entry shall be inserted: -Levonorgestrel Tablets 0.75mg/1.5mg
After the words “the provisions of Chapter IV of the Act and the rules made thereunder which required them to be covered by a sale license” the following shall be inserted: -
(a) For Levonorgestrel Tablets 0.75mg/1.5mg, the following boxed warnings shall also be provided on packaging as well as in the package insert: Emergency contraceptive pill is only to be taken in emergency situations, not to be used as a regular contraceptive.
(b) Frequent use of the emergency contraceptive pill may lead to side effects. Visit the nearest health facility/Registered Medical Practitioner for regular contraception as soon as possible.
(c) It is not an abortion pill.
(d) It does not offer any protection against HIV or any sexually transmitted infections.
