Drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has fixed ceiling prices of 54 scheduled formulations of Schedule-I under Drugs (Price Control) Amendment Order, 2016.
Name of the 54 scheduled formulation are Prednisolone Drop, Carboplatin Injection, Cisplatin Injection, Paclitaxel Injection, Mefenamic Acid Oral liquid, Prednisolone Oral liquid, Mebendazole Oral liquid, Diethylcarbamazine Oral Liquid, Amoxicillin Oral liquid, Clavulanic Acid Dry Syrup, Cefadroxil Oral liquid, Clarithromycin Oral liquid, Metronidazole Oral liquid, Nitrofurantoin Oral liquid, Ranitidine Oral liquid, Capecitabine Tablet, Lactulose Oral liquid, Sucralfate Oral liquid, Levetiracetam Oral liquid, Mesna Injection, Labetalol Injection, Xylometazoline Nasal Drops, Xylometazoline Nasal Drops, Cyclosporine Oral liquid, Alprostadil Injection, Caffeine Injection, Natamycin Drops, Proparacaine Drops, Hydroxypropyl Methylcellulose Injection, Carboxymethylcellulose Drops, Carboxymethylcellulose Drops, Fluphenazine Depot Injection, Risperidone Oral Liquid, Budesonide Respirator Solution for use in Nebulizer, Potassium Chloride Injection, Thiamine Injection, Ipratropium Respirator Solution for use in Nebulizer, Fusidic Acid Cream, Benzoyl Peroxide Gel, Dinoprostone Gel, Acyclovir Ointment, Salicylic Acid Ointment, Human Chorionic Gonadotropin Injection, Vecuronium Powder for Injection, Budesonide Inhalation, Budesonide+ Formoterol Inhalation.
Retail price of formulations have also been fixed like Diclofenac Sodium + Benzyl Alcohol Injection (New Rhumacort) and Dextrometharpahan HBr+ Chlorphenaramine Maleate Syrup(Sudin D+).
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 70 scheduled formulations of Schedule-I under Drugs (Price Control) Amendment Order, 2016 on the basis of Wholesale Price Index (WPI) and retail price of 2 formulations.
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.