NPPA fixes price of 3 drug formulations; Check out details
New Delhi: The apex drug price regulator, National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling prices of 3 drug formulations. These formulations include Amphotericin B (Lipid), Amphotericin B (Liposomalare) and Silver Sulphadiazine which indicated for treating serious fungal infections while one of them is a topical antibiotic used in partial-thickness and full-thickness burns to prevent infection.
The NPPA price fixation of Amphotericin B (Lipid) and Amphotericin B (Liposomal), in powder dosage form for injections at Rs 3136.81 and Rs 7306.60 respectively for per pack of 50 mg came in compliance with the directions given by the Delhi High Court following the writ petition filed by Lifecare Innovations Pvt. Ltd. in respect of the ceiling prices of the same.
Exercising the powers conferred by paragraphs 4, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, the NPPA fixed the ceiling price of the said formulations exclusive of goods and service tax (GST).
Amphotericin B (Liposomal) and Amphotericin B (Lipid), which is sold under common brand names including Abelcet, Ambisome is used for treating a variety of serious fungal infections.
The details of the price as fixed by NPPA read;
|Sl. No.||Name of the Scheduled Formulation||Dosage form & Strength||Unit||Ceiling Price (Rs.)|
|1.||Amphotericin B (Lipid)||Powder for Injection 50mg||Per Pack||3136.81|
|2.||Amphotericin B (Liposomal)||Powder for Injection 50mg||Per Pack||7306.60|
Apart from this, NPPA has also fixed the price of Silver Sulphadiazine Cream 1%. Silver Sulphadiazine is sold under various brand names including Silvadene, Silverex, Silverol, Silveleb, Silvazine, Flamazine, Thermazene, BurnHeal, and others. The medication is sold by different drugmakers.
This prescription medicine works by stopping the growth of bacteria that may infect an open wound.
The details of the NPPA order in this regard reads;
|Sl. No.||Name of the Scheduled Formulation||Dosage form & Strength||Unit||Ceiling Price|
|2.||Silver Sulphadiazine||Cream 1%||1 gm||0.50|
The NPPA notice further added;
- All manufacturers of scheduled formulation, selling the branded or generic or both the versions of scheduled formulation 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 formulation downward not exceeding the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any.
- All the existing manufacturers of above mentioned scheduled formulation 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.
- 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.
- 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.
- As per para 24(4) of DPCO 2013, every retailer and dealer shall display 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.
- 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 such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.
- The manufacturers of above said scheduled formulation shall furnish a quarterly return to the NPPA, in respect of production/import and sale of scheduled formulation 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 ScheduleII of the DPCO, 2013 at least six months prior to the intended date of discontinuation.
- 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 Essential Commodities Act,1955.
- Consequent to the issue of 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.