NPPA fixes Special Ceiling Price for Gufic's Meropenem Dual Chamber Bags

The ceiling price of Meropenem Powder for Injection 500 mg has been fixed at Rs 845.94 per dual chamber bag and Meropenem Powder for Injection 1000 mg has been fixed at Rs 1114.72 per dual chamber bag excluding GST. This came as Gufic Biosciences Limited applied for separate ceiling prices for Meropenem Powder for Injection 500 mg (as trihydrate) and Meropenem Powder for Injection 1000 mg (as trihydrate) having special features viz. (i) self-collapsibility and self-sealability; (ii) not having an air vent; and (iii) there is no chance of contamination during manufacture/ infusion/ admixing levels in dual chamber bags. Meropenem Powder for Injection 500 mg and 1000 mg (as trihydrate) are already scheduled formulations under Schedule-I of the Drugs (Prices Control) Order, 2013 (DPCO, 2013), with a notified ceiling price. However, Gufic Biosciences had sought a separate ceiling price for its dual chamber bag presentations, citing special features such as self-collapsibility, self-sealability, absence of air-vent, and zero risk of contamination during manufacture, infusion, or admixing. The proposal was reviewed by the Multidisciplinary Committee of Experts in its 69th and 70th meetings held on July 3, 2025 and August 5, 2025, respectively. After considering the unique characteristics, the committee recommended an increase of 15% over and above the ceiling price. The recommendation was subsequently accepted by NPPA in its 136th Authority meeting on August 28, 2025. Table ‘A’ Table ‘B’ Note: (a) The ceiling price specified in column (5) of Table A is only applicable to the manufacturer mentioned in Table B. The manufacturer specified in Table B, selling the branded or generic or both versions of scheduled formulations with dosage form and strength specified in columns (2) and (3) of Table A, respectively, at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise their prices of all such formulations downward, not exceeding the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any. (b) The manufacturer may add Goods and Services Tax only if they have actually paid it or if it is payable to the government on the ceiling price mentioned in column (5) of the above-said table. (c) The manufacturer shall issue a price list in Form V in compliance from the date of this notification as per paragraph 24 of the DPCO, 2013. (d) 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. (e) Any other manufacturer claiming a separate ceiling price for having the special feature of a dual-chamber bag helping in the reduction of administration time and reconstitution of the drug with distilled water in an accurate dose with a reduction in the possibility of contamination shall apply to NPPA for separate ceiling price approval. (f) For other special features claimed or any other pack size manufactured, the manufacturer shall approach the NPPA for specific price approval for its formulation. (g) Where an existing manufacturer of a scheduled formulation with dosage or strength or both as specified in the above Table A 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. (h) The manufacturer(s) of the above said scheduled formulations shall furnish a quarterly return to the NPPA in respect of the production/import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013. Any manufacturer intending to discontinue production of the above-said scheduled formulation shall furnish information to the NPPA in respect of the discontinuation of the 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. (i) The manufacturer(s) 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 (Price Control) Order, 2013, read with the Essential Commodities Act, 1955. (j) Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above Table A 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.