Scheduled Medicines – Leflunomide (Including its salts, esters, sterio isomers and derivatives).
(Please Check / Confirm the Ceiling Price from Official Gazette before use)
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- The manufacturers of above mentioned scheduled formulations having maximum retail price higher than the ceiling price specified in column (5) of the table hereinabove, shall revise the MRP to an amount not exceeding the ceiling price plus local taxes, wherever applicable in accordance with paragraph 13 (1) and 24 of the DPCO,2013.
- The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the above table.
- The ceiling price for a pack of the schedule formulation shall be arrived at by the 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 as per the paragraph 24 (2) of the DPCO, 2013.
- All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
- 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 DPCO,2013 then 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 quarterly return to the NPPA, in respect of production / import and sale of scheduled formulation in Form-III of scheduled-II of the DPCO, 2013. Any manufacturer intending to discontinue above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of schedules formulation in Form-IV of scheduled-II of the DPCO, 2013 at least six months prior to the indented date of discontinuation.
- The manufacturer not complying with the ceiling price and notes specified hereinabove in this notification, shall be liable to deposit overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with the Essential Commodities Act, 1955.
Last Page Updated: 10-03-2019