|
Even as the much-hyped Goods and Services Tax (GST) has come into force in the country from July 1 this year, and the Union Finance Ministry has notified the applicable GST rates on pharmaceutical products, the National Pharmaceutical Pricing Authority (NPPA) has fixed/revised ceiling prices/retail prices of 814 scheduled formulations of Schedule-I under Drugs (Price Control) Amendment Order,2016 under DPCO, 2013 in related Notification/order dated 30.06.2017.
Earlier, in its 46th meeting held on 08.6.2017, the NPPA had decided to notify the ceiling prices of scheduled formulations, exclusive of GST rates, after the GST rates are notified by the government. As per that decision, in case of scheduled formulations, where presently excise duty is levied on MRP, the revised ceiling price exclusive of applicable GST rates would be calculated by applying a factor of 0.95905 to the existing notified ceiling price.
In exercise of the powers, conferred by paragraph 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. Number and date specified in column no. 5(a) & 5(b) mentioned in the table below, the National Pharmaceutical Pricing Authority, hereby fixes the prices after excluding excise duty levied prior to GST regime, being subsumed in the GST consequent to its implementation with effect from 1.7.2017 by applying the factor of 0.95905 on existing ceiling price, wherever applicable as specified in column (6) of the table herein below as ceiling prices exclusive of goods and Services Tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof, the NPPA said.
As per the latest NPPA notification , the ceiling prices are applicable with effect from 1.7.2017. In respect of gentamycin injection 40mg/ml, dexamethasone injection 4mg/ml, paracetamol injection 150mg/ml, glucose injection 5%, glucose 10%, sodium chloride injection 0.9%, glucose + sodium chloride injection 5%+0.9%, water for injection, dicyclomine injection 10mg/ml, snake venom antiserum, pheniramine injection 22.75 mg/ml and tetanus toxoid injection, for any other pack size manufactured, the manufacturer shall approach NPPA for specific price approval for its formulations. The formulation of sodium valproate includes combination of sodium valproate and valproic acid both together corresponding to sodium valproate of the stated strength.
In respect of any other scheduled formulation, for which ceiling price is not mentioned above or in S.O 412(E) dated 13.2.2017, the manufacturer shall approach the NPPA for specific price approval for its formulations along with the relevant information. All manufacturers of scheduled formulations, selling branded or generic or both the versions of scheduled formulations at price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus goods and Services tax as applicable, if any.
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 goods and Services Tax as applicable, if any), shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013 except increase in MRP due to difference of duties and taxes on implementation of Goods and Services Tax. The manufacturers may add goods and Services tax only if they have actually paid or payable to the Government on the ceiling price mentioned in column (5) of the above said table.
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 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 from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.
As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same. 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 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of 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. The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955. Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.
In view of the anti profiteering clause of Goods and Services Tax Act, manufacturers are only authorized to pass additional burden of tax/ duties on scheduled formulations to consumers on account of implementation of GST for any additional tax paid/ payable by the manufacturer/ manufacturers. While revising the ceiling price, the inputs received from pharmaceutical companies, Pharmaceutical Associations/ federations etc till 5:00 PM of 29.06.2017 have been taken into consideration. However, in cases of any inadvertent discrepancy in respect of revised ceiling price of any scheduled formulation requiring further revision, the manufacturers shall maintain their maximum retail price till the revised ceiling price is notified by NPPA.
|