NPPA fixes ceiling price of Tazofic Injection made by Gufic Biosciences
New Delhi: Observing the special packaging in dual chamber bag, the National Pharmaceutical Pricing Authority (NPPA) has decided to allow an additional 15% price over the present applicable ceiling price of Tazofic Injection in two different strengths, Tazofic Injection 2.25 gm containing Piperacillin 2gm plus Tazobactum 250mg and Tazofic Injection 4.5 gm containing Piperacillin 4gm plus Tazobactum 500 mg for Gufic Biosciences.
Accordingly, the revised ceiling prices for Tazofic Injection 2.25 mg per dual chamber bag and Tazofic Injection 4.5 gm per dual chamber bag have been set at Rs. 220.26 and Rs. 459.28, respectively.
This came after Gufic Biosciences applied for separate ceiling prices of Tazofic Injection 2.25 gm containing Piperacillin 2gm plus Tazobactum 250mg and Tazofic Injection 4.5 gm containing Piperacillin 4gm plus Tazobactum 500 mg having special features of dual chamber bags stating that it is designed to allow the separation of different solutions that require admixing just before administration helping to reduce the administration time, assurance of right dosages, avoidance of hospital contamination, provides high stability & convenience etc.
These fixed-dose combinations, Piperacillin 2gm plus Tazobactum 250mg and Piperacillin 4gm plus Tazobactum 500 mg are scheduled formulations under Schedule-I of DPCO 2013 and their ceiling price is fixed.
The Multidisciplinary Committee of Experts in its 45th meeting and 52nd meeting dated 13.09.2022 and11.07.2023 respectively observed that (i) Tazofic Injection 2.25 gm containing Piperacillin 2gm + Tazobactum 250mg and (ii) Tazofic Injection 4.5 gm containing Piperacillin 4gm + Tazobactum 500 mg are scheduled formulation.
The Committee further observed that packages in (i) Tazofic Injection 2.25 gm containing Piperacillin 2gm + Tazobactum 250mg and (ii) Tazofic Injection 4.5 gm containing Piperacillin 4gm + Tazobactum 500 mg of Gufic Biosciences have special feature of dual chamber bag helping in reduction of administration time, reconstitution of the drug with distilled water in accurate dose with reduction in the possibility of contamination.
In light of the above observation, the Multidisciplinary Committee of Experts recommended that an increase of 15% over and above the ceiling price of Tazofic Injection 2.25 gm and Tazofic Injection 4.5 gm be allowed to Gufic Biosciences for the formulation (i) Tazofic Injection 2.25 gm containing Piperacillin 2gm+Tazobactum 250mg and (ii) Tazofic Injection 4.5 gm containing Piperacillin 4gm+Tazobactum 500 mg on account of special packaging in dual chamber bag.
After that, the NPPA in its 116th Authority meeting dated 06.09.2023 decided to accept the recommendation of the Multidisciplinary Committee of Experts.
Therefore, in exercise of powers, conferred by sub paragraph (3) and (4) of paragraph 11 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013, S.O. 5249(E) dated 11th November, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers in so far as it relates to (i) Tazofic Injection 2.25 gm containing Piperacillin 2gm+Tazobactum 250mg and (ii) Tazofic Injection 4.5 gm containing Piperacillin 4gm+Tazobactum 500 mg having special feature of dual chamber bag helping in reduction of administration time, reconstitution of the drug with distilled water in accurate dose with reduction in the possibility of contamination., manufactured by the manufacturers specified in Table ‘B’, the National Pharmaceutical Pricing Authority has fixed the price as specified in column (5) of the table ‘A’ 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/packaging specified respectively in the corresponding entries in columns (3) and (4) thereof:
Table ‘A’
Sl. No. | Name of the Scheduled Formulation | Dosage Form and Strength | Unit | Ceiling Price excluding GST (Rs.) |
(1) | (2) | (3) | (4) | (5) |
1 | Piperacillin (A) + Tazobactam (B) | Powder for Injection 2 g (A) + 250 mg(B) | Per Dual chamber bag | 220.26 |
2 | Piperacillin (A) + Tazobactam (B) | Powder for Injection 4 g (A) + 500 mg(B) | Per Dual chamber bag | 459.28 |
Table ‘B’
Sl. No. | Name of Manufacturer |
(1) | (2) |
1 | M/s Gufic Biosciences Limited |
The notification further added,
(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 column (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 paid actually 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 having the special feature of dual chamber bag helping in reduction of administration time, reconstitution of the drug with distilled water in 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 scheduled formulation with dosage or strength or both as specified in the above Table A, launches a new drug as per paragraph 2 (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 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. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the 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.
(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 Essential Commodities Act, 1955.
(j) Consequent to the issue of ceiling prices of such formulations 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.
