NPPA revises ceiling price of 847 formulations including Metformin, Atrovastatin; Details

New Delhi: Through a recent notification, National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling prices of 847 formulations under the Drugs (Prices Control) Order, 2013 exclusive of goods and services tax (GST).

The drug formulations whose prices have been fixed include Acetazolamide, Abacavir (A) + Lamivudine (B), Acetylsalicylic acid, Acyclovir, Albendazole, Amlodipine, Atorvastatin, Baclofen, Calcium gluconate, Clofazimine, Glucose, Gentamicin, Glycerin, Metformin, Morphine and numerous other medicines. These medicines are in various dosage form inclusive of tablets, capsules, oral liquid, ointment, injection, powder for injection, inhalation, lotion, cream, drops, dispersible tablet, Nasal and Jelly.

Trastuzumab Injection 440 mg/50ml stands to be the most expensive drug in the revised list of drugs release. Each Pack of the Injection costs Rs 58867.50 while the second most expensive drug in the list is Alteplase Powder for Injection in the strength of 50 mg. Each Pack of the formulation costs Rs 38810.18

The revision comes in order to take into account inflation. As per the NPPA calculation, the new price has been determined after accounting for the Wholesale Price Index at the rate of 4.2662%. The new prices will take effect from April 1, 2019.

The notice further reads;

• In respect of formulation where pack wise ceiling price is notified, for any other pack size manufactured, the manufacturer shall approach NPPA under para 11(3) of DPCO, 2013 for specific price approval for its formulations along with the relevant market data duly authenticated for fixation of the ceiling price. The formulation of Sodium Valproate includes combination of Sodium Valproate and Valproic Acid both together corresponding to Sodium Valproate of the stated strength.


• In respect of any other scheduled formulation, for which ceiling price is not mentioned above, the
  manufacturer shall approach NPPA for specific price approval for its formulations along with the relevant market data duly authenticated for fixation of the ceiling price.


• All manufacturers of scheduled formulations, selling branded or generic or both the versions of scheduled formulations at price higher than the ceiling price (plus goods and services taxes as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the revised ceiling price plus goods and services taxes as applicable, if any.


• All the existing manufacturers scheduled formulations having MRP lower than the ceiling price specified in the latest released list may revise the existing MRP of their formulations, on the basis of WPI @ 4.2662% for year 2018 in accordance with paragraph 16(2) of DPCO, 2013, read with para 13(2) of DPCO, 2013.


• The manufacturers may add goods and services taxes only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in the release.


• The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price as specified in the list 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 list 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 NPPA in Form I as specified under Schedule-II of the DPCO, 2013.


• The manufacturers of said scheduled formulations shall furnish quarterly return to 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 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.


• 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 prices of such formulations as specified in the list of the notification released, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.

Below is the attachment for the same;

http://www.nppaindia.nic.in/wp-content/uploads/2019/04/847_English.pdf

Medical Dialogues had earlier reported that through a recent official release, National Pharmaceutical Pricing Authority (NPPA) has informed about the revision in the ceiling price of 8 IV fluids.

Also Read: Price Fixation: NPPA revises ceiling price of 8 IV fluids including Glucose; Details