The list of 15 scheduled formulations includes Amoxicillin, Azithromycin, Azathioprine, Benzoyl peroxide, Cefuroxime, Cholecalciferol, Dexamethasone, Ivermectin, Linezolid, Metoprolol, Vancomycin and others.
This came in line with the decision of the 111th Authority meeting date March 29th 2023, where the ceiling price fixation of scheduled formulations under the Drug (Price Control) Order 2013 (National List Of Essential Medicine 2022) was discussed.
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, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the ceiling prices exclusive of goods and services tax applicable, if any, as specified in column (5) and increased by Wholesale Price Index (WPI) of 12.1218% under para 16 (1) of DPCO 2013, with effect from 1.04.2023 as specified in column (6)of the table in respect of the Scheduled formulations 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:
Name of the
Dosage form and strength
Powder for Injection 250 mg
Powder for Injection 500 mg
Sachet/Granuels/Powder 60000 IU
Tablet 4 mg
The notification further added:
(a) The above-mentioned ceiling prices as fixed under NLEM 2022 shall be effective from 1st April 2023 after the application of the Wholesale Price Index (WPI) and as specified in column (6) above.
(b) 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 and then they may further make a corresponding increase in MRP (excluding GST) up to the level of WPI @12.1218% with effect from 1st April 2023 not exceeding ceiling prices as specified in column (6) in the above table.
(c) All the existing manufacturers of the above-mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus GST as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013 and they may further make the corresponding increase in MRP upto the level of WPI @12.1218% with effect from 1st April 2023.
(d) 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.
(e) Information about the revision, if carried out, shall be forwarded to the Government in either electronic or physical form in Form-II within a period of fifteen days of such revision and non-submission of the information under this subparagraph shall be construed as non-revision of maximum retail price (MRP) and the concerned the manufacturer shall be liable to deposit the amount charged over and above the pre-revised maximum retail price (MRP), alongwith interest thereon from the date of overcharging.
(f) 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 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.
(g) As per para 24(4) of DPCO 2013, every retailer and dealer shall display a 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.
(h) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launch 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.
(i) The manufacturers of above said scheduled formulations shall furnish a 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 above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and/or import of scheduled the formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.
(j) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955.
(k) 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.