NPPA Fixes Ceiling Price Of 9 Scheduled Formulations, Details

New Delhi: Through a recent notification, the National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of 9 scheduled formulations under the Drugs (Prices Control) Order, 2013 (NLEM 2022).

The list includes surfactant suspension for intratracheal instillation (as licensed), betamethasone valerate lotion 0.05%, and gel 0.05%. The list also includes 5-aminosalicylic acid (mesalazine/mesalamine) in the following forms: 500 mg suppository, retention enema (foam), and retention enema (liquid).

Apart from the above, the ceiling price of Efavirenz Capsule 600 mg, which is used along with other medications to treat human immunodeficiency virus (HIV) infection, has been set at Rs 56.66 per capsule. Further, the ceiling price of rifampicin Tablet 300 mg, an antibiotic medication primarily used to treat tuberculosis (TB) and certain other bacterial infections, has been fixed at Rs 3.70 per tablet.

In addition, the ceiling price of a nonsteroidal anti-inflammatory drug (NSAID), Ibuprofen Capsule 400 mg, has been set at Rs 1.33 per capsule.

Scheduled formulation means any formulation, included in the First Schedule whether referred to by generic versions or brand names (mainly products covered under the National List of Essential Medicines are Scheduled Formulation). In other words, all medicines that are covered in the 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 the drugs (prices control) order, 2013. The ceiling Price is the Maximum Price to Retailer (excluding Taxes, if any)for the given product.

The notice stated 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 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. 1487(E) dated 27th March, 2025 in so far as it relates to formulation packs 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 (5) 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:

Table

The notification further added,

(a) All manufacturers of scheduled formulations 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 (5) 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 an MRP lower than the ceiling price specified in column (5) 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 it actually or if it is payable to the government on the ceiling price mentioned in column (5) 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 (5) 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 from the date of notification as per paragraph 24 of the DPCO, 2013, to NPPA through IPDMS and submit a copy to the State Drug Controller and dealers.

(e) As per para 24(4) of DPCO 2013, every retailer and dealer shall display the 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 a 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 such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.

(g) The manufacturers of the above-said scheduled formulations shall furnish quarterly returns to the NPPA in respect of 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 the above-said scheduled formulation shall furnish information to the NPPA in respect of the discontinuation of production and/or import of the 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 the 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 the ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.

To view the official notice, click the link below: