New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA), the Ministry of Chemicaks and Fertilizers,the Government of India has revised and fixed the ceiling price of Hormone Releasing Intrauterine Devices (IUD) containing 52 mg of Levonorgestrel at Rs 3659.68 under the Drugs (Prices Control) Order, 2013.
A hormonal intrauterine device (IUD), also known as an intrauterine system (IUS) with progestogen is an intrauterine device that releases a progestogenic hormonal agent such as levonorgestrel into the uterus. It is used for birth control, heavy menstrual periods, and to prevent excessive build of the lining of the uterus in those on estrogen replacement therapy. It is one of the most effective forms of birth control with a one-year failure rate of around 0.2%. The device is placed in the uterus and lasts three to eight years. Fertility often returns quickly following removal.
Levonorgestrel is in a class of medications called progestins. Levonorgestrel binds to progesterone and androgen receptors and slows the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus. This process results in the suppression of the normal physiological luteinizing hormone (LH) surge that precedes ovulation.
The hormonal IUD releases 20 micrograms of levonorgestrel each day which thickens the cervical mucus and inhibits sperm movement and viability. Both IUDs affect the endometrial lining and may prevent implantation of a fertilized egg.
Kyleena, Liletta, Mirena, and Skyla are a few brands of levonorgestrel intrauterine system.
Scheduled formulation means any formulation, included in the First Schedule whether referred to by generic versions or brand name (mainly products covered under National List of Essential Medicines are Scheduled Formulation). In other words, all medicines that are covered in National List of Essential Medicine, which are notified in Schedule 1, by the Govt. are scheduled formulation.
“Ceiling Price” refers to a price fixed by the Government for Scheduled Formulations in accordance with the provisions of drugs (prices control) order, 2013. Ceiling Price is the Maximum Price to Retailer (excluding Taxes, if any)for the given product.
The notice declared that in exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated 30th May, 2013 and S.O. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. 879(E) dated 24th February, 2023 in so far as it relates to formulation pack mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority has fixed the price as specified in column (6) of the table herein below as ceiling price exclusive of goods and services tax applicable, if any, in respect of the Scheduled formulation specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
Sl.
No.
Name of the Scheduled Formulation
Dosage form and strength
Unit
Ceiling Price (Rs) as per
S.O. 879(E) dt 24/02/2023
Ceiling Price (Rs.)
(1)
(2)
(3)
(4)
(5)
(6)
1
Hormone Releasing IUD
Contains 52 mg of
Levonorgestrel
1 IUD
3456.44
3659.68
Also Read: NPPA revises ceiling price of 80 scheduled formulations, details
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