Drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has fixed ceiling prices of 70 scheduled formulations of Schedule-I under Drugs (Price Control) Amendment Order, 2016.and retail price of 2 formulations under DPCO, 2013.
Name of the 70 scheduled formulation are Gemcitabine Injection, Glycopyrrolate Injection, Ampicillin Injection, Cefazolin Injection, Cefotaxime Injection, Ceftriaxone Injection, Methotrexate Injection, Methotrexate, Piperacillin+, Tazobactam Injection, Piperacillin+, Capreomycin Injection, Kanamycin Injection, Fluconazole Injection, Artesunate Injection, Bortezomib Injection, Dacarbazine Injection, Dacarbazine-200mg (Powder for Inj), Docetaxel Injection, L-Asparaginase Injection, Rituximab Injection, Filgrastim Injection, Erythropoietin Injection, Tranexamic Acid Injection, Coagulation Factor VIII, Somatostatin Injection, Chlorambucil Tablet, Gefitinib Tablet, Bicalutamide Tablet, Letrozole Tablet, Mycophenolate Mofetil Tablet, Amitriptyline Tablet, Haloperidol Tablet, Loperamide Tablet, Clozapine Tablet, Risperidone Tablet, Escitalopram Tablet, Clonazepam Tablet, Zolpidem Tablet, Temozolomide Capsule, Thalidomide Capsule, Tacrolimus Capsule and Fluoxetine Capsule.
Besides, the NPPA has fixed retail price of 2 formulations under DPCO, 2013. (Clobetasol Propionate + Salicylic Acid Ointment and Sodium Chloride+Sodium Citrate+Potassium Chloride+ Dextrose Anhydrous Oral Liquid/ Oral Rehydration Salt).
As per the order, NPPA hereby fixes the ceiling prices as specified with immediate effect and revised ceiling prices as specified, exclusive of local tax applicable, if any, in respect of the scheduled formulations specified with the strength and unit.
The drug pricing regulator had 15 days back fixed ceiling prices of 103 scheduled formulations of Schedule-I under Drugs (Price Control) Amendment Order, 2016 on the basis of Wholesale Price Index (WPI).
NPPA has set targets to fix price for 799 formulations within 2 months time. It is for the first time that NPPA is working based on a timeline to fix the prices as per Drug Price Control Order (DPCO), as it took 3 years to fix prices for 535 drugs in NLEM 2011.
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 as per provisions contained in paragraph 11 of the Drugs (Price Control) Order, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013.
The manufacturer shall follow revised ceiling price as mentioned in the order and report to the government in Form II as prescribed under Schedule II of the Drugs (Price Control) Order, 2013 within a period of 15 days of such revision. Non submission of Form II in this regard shall be construed as non-revision in MRP as per WPI and the concerned manufacturers shall be liable to deposit the amount charged over and above the pre-revised/revised MRP, as the case may be, along with interest thereon from the date of overcharging.
Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 then such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as prescribed under Schedule-II of the DPCO, 2013.
The manufacturers of said scheduled formulation shall furnish quarterly return to the NPPA, in respect of production/import and sale of scheduled formulation in Form-III as prescribed under Schedule-II of the DPCO, 2013. Any manufacturer intending to discontinue the 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 as prescribed under Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.
The manufacturer not complying with the ceiling price and notes specified shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the Drugs (Price Control) Order, 2013 read with the Essential Commodities Act, 1955. Consequent to the issue of ceiling price of the scheduled formulation as specified in this notification, the price order(s) if any in respect of such scheduled formulations, issued prior to the above said date of notification, stand superseded.