New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority(NPPA) has fixed the ceiling prices for the 4 scheduled formulations including Tenofovir Alafenamide Fumarate (TAF), Buprenorphine and etc. under Drugs (Prices Control) Order, 2013.
This came in line with the decisions of the 106th authority meeting dated 30.12.2022, where the ceiling price fixation of scheduled formulation under the Drugs (Price Control) Order,2013 ( National List of Essential Medicine 2022) was discussed.
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 the 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, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices 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:
| Sl. No | Name of the Scheduled Formulation | Dosage form and Strength | Unit | Ceiling Price (Rs.) |
| (1) | (2) | (3) | (4) | (5) |
| 1 | Buprenorphine (A) +Naloxone (B) | Tablet (Sub-lingual) 2mg(A)+0.5mg(B) | 1 Tablet | 32.98 |
| 2 | Buprenorphine (A) +Naloxone (B) | Tablet (Sub-lingual) 0.4mg(A)+0.1mg(B) | 1 Tablet | 10.54 |
| 3 | Buprenorphine | Tablet (Sub-lingual) 0.4mg | 1 Tablet | 8.41 |
| 4 | Tenofovir Alafenamide Fumarate (TAF) | Tablet 25mg | 1 Tablet | 43.59 |
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 (5) in the above table plus goods and services tax as applicable, if any.
(b) All the existing manufacturers of above mentioned scheduled formulations having 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 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 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 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 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 (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 return 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 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 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 ceiling or retail price, if any, issued prior to the above-said date of notification, stand(s) superseded.
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