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Centre proposes schedule K exemption for emergency contraceptive pills, mandates boxed warnings

New Delhi, Sep 17 (UNI) The Centre has proposed bringing levonorgestrel 0.75 mg and 1.5 mg emergency contraceptive tablets under Schedule K of the Drugs Rules, 1945, while requiring their packs to carry prominent warnings against regular or repeated use.
Under the draft amendment issued by the union Health and Family Welfare Ministry, levonorgestrel emergency contraceptive tablets will be added as Serial No. 6 under Entry No. 15 of Schedule K, subject to specified conditions.
The proposed exemption relates to the provisions of Chapter IV of the Drugs and Cosmetics Act and the rules made thereunder "for which sale licence is required", according to the notification.
The packaging and package insert will have to carry boxed warnings stating that the pill is meant for emergency contraception and should not be used as a regular contraceptive.
It must also warn that repeated use may cause adverse effects and advise women seeking regular contraception to approach the nearest health facility or registered medical practitioner.
Two other mandatory warnings state that the medicine is not an abortion pill and that it does not protect against HIV or any other sexually transmitted infection.
The Health Ministry issued a draft notification after consultation with the Drugs Technical Advisory Board. The Gazette record identifies the proposal specifically as an amendment to Schedule K covering levonorgestrel 0.75 mg and 1.5 mg emergency contraceptives.
Notably, the government has invited objections and suggestions for 30 days from the date copies of the Gazette containing the draft are made available to the public.
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