Drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) has revised ceiling prices of 31 scheduled formulations packs of IV Fluids of Schedule-I under Drugs (Price Control) Amendment Order, 2016 and another 25 scheduled formulations of Schedule-I under Drugs (Price Control) Amendment Order, 2016. Retail Price of 8 formulations have also been fixed.
Name of the Scheduled Formulations are Glucose Injection, Sodium Chloride Injection, Glucose+ Sodium Chloride Injection, Diclofenac Tablet, Paracetamol Tablet, Cetirizine Tablet, Phenobarbitone Tablet, Amoxycillin Capsule, Ceftriaxone Powder For Injection Amoxicillin+ Clavulanic Acid Oral Liquid, Fluconazole Tablet , Propranolol Tablet, Imatinib Tablet, Azathioprine Tablet, Allopurinol Tablet, Ondansetron Tablet, Trihexyphenidyl Tablet, Metoprolol Tablet, Metoprolol Tablet, Pantoprazole Injection, Hyoscine Butyl Bromide Tablet, Bisacodyl Tablet, Ethinylestradiol+Levonorgestrel Tablet, Metformin Immediate Release Tablet, Norethisterone Tablet, Carbimazole Tablet and Ascorbic Acid (Vitamin C) Tablet.
Retail Price of 8 formulations which have also been fixed are Cefixime + Ofloxacin Tablet (Cefaclass - O Tablet), Adapalene + Benzoyl Peroxide Gel, Diclofenac sodium Tablet (Zeldinac 100 SR), Dextromethorphan Hydrobromide + Chlorpheniramine Maleate syrup, Paclitaxel (Protein bound particle) for Injectable Suspension, Escitalopram Oxalate +Clonazepam Tablet (Megapose-Plus New).
All the existing manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified plus local taxes as applicable, if any.
All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
The manufacturer shall issue a price list in Form-V as per paragraph 24 (2) of the DPCO, 2013.
For formulation in Non-PVC packaging, ceiling price mentioned in column (5) of the above said table shall be admissible provided such packs are (i) self collapsible; (ii) not having air-vent; and (iii) there is no chance of contamination at manufacturing as well as admixing levels. Otherwise the ceiling price for PVC packs shall be applicable for such Non-PVC packaging also. For any other pack size manufactured, the manufacturer shall approach NPPA for specific price approval for its formulations.
For any other packaging material used or special features claimed, the manufacturer shall approach NPPA for specific price approval for its formulations. Otherwise the ceiling price for PVC or Glass packs, as the case may be, shall be applicable.
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 formulations shall furnish quarterly return 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.