NPPA fixes ceiling Price of Levonorgestrel intrauterine device

Written by Dr. Divya Colin Published On 2023-04-07T18:00:27+05:30 | Updated On 7 April 2023 6:00 PM IST

NPPA fixes ceiling Price of Levonorgestrel intrauterine device

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)

Hormone Releasing IUD

Contains 52 mg of

Levonorgestrel

1 IUD

3456.44

3659.68

The notice further added:

(a) All manufacturers of scheduled formulation, selling the branded or generic or both versions of scheduled formulations at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (6) in the above table plus goods and services tax as applicable, if any.

(b) All the existing manufacturers of the above-mentioned scheduled formulations having MRP lower than the ceiling price specified in column (6) in the above table plus goods and services tax as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.

(c) The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (6) of the above-said table.

(d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (6) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V/VI from the date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.

(e) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

(f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2(1)(u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of a such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.

(g) The manufacturers of above said scheduled formulations shall furnish a quarterly returns to the NPPA, in respect to the production/import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and/or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.

(h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955.

(i) Consequent to the issue of the ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above-said date of notification, stand(s) superseded

Also Read: NPPA revises ceiling price of 80 scheduled formulations, details

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Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.