National Pharmaceutical Pricing Authority (NPPA) has 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) for the preceding calendar year 2015, effective from April 1st, 2016.
As per the order, in exercise of the powers, conferred by paragraph 4, 10, 11, 14, 16 and 17 of the Drugs (Prices Control) Order, 2013, read with SO 1394(E) dated the May 30th, 2013 issued by the government of India in the ministry of chemicals and fertilizers, 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.
All the existing manufacturers of 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 till March 31, 2016 and they shall further make corresponding reduction in MRP as per WPI @2.7105 per cent with effect from April 1, 2016.
The manufacturer may add local taxes only if they have paid actually or it is payable to the government on the ceiling price mentioned in the order.
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 above 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.