The National Pharmaceutical Pricing Authority (NPPA) has issued a three notifications regarding the fixation of retail prices for certain formulations. This action aims to regulate drug prices in the country. These notifications were issued on February 28, 2024.
Types of Formulations Covered
Price Fixation for Specified Formulations
Under these notifications, NPPA has set the retail prices, exclusive of Goods and Services Tax (GST), for specified formulations. The prices are determined with respect to the formulation’s strength, unit, and the manufacturer and marketing company involved.
Price Fixation for Scheduled Formulations
Moreover, NPPA has also fixed ceiling prices for certain scheduled formulations. The ceiling prices specified are exclusive of GST and apply to the respective dosage forms, strengths, and units detailed in the entries.
All manufacturers of scheduled formulation, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus Goods and Services Tax as applicable) shall revise the prices of all such formulations downward not exceeding the ceiling price specified. Additionally, existing manufacturers of the specified scheduled formulations having MRP lower than the ceiling price specified shall continue to maintain the existing MRP.
Price Fixation for New Drug Formulations
Additionally, NPPA has also fixed ceiling prices for certain new drug formulations manufactured by specified manufacturers. These ceiling prices specified are exclusive of GST and apply to the respective dosage forms, strengths, and units detailed in the entries.
The specified retail price is applicable only to the identified individual manufacturer / marketer i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013. It is also subject to fulfilment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturer/marketing companies.
Compliances Arising From Price Fixations:
Inclusion of GST
The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the Government on the ceiling price.
Furnish Price List to NPPA, Drug Controller and Dealers
The manufacturer shall issue a price list in Form–V from date of Notification to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.
Display of Price Lists
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.
These measures represent NPPA’s ongoing efforts to ensure affordability and accessibility of essential drugs for the Indian population. The new prices will be effective upon their final publication, marking a significant step towards regulating pharmaceutical pricing and promoting public health interests.
