Drug pricing regulator seeks data ahead of setting price ceilings for formulations

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has asked drug manufacturers and marketing companies for the retail price data of 134 generic drugs and four IV fluids as of October to set their ceiling prices.

The information on price to retailer (PTR) and moving annual turnover (MAT) has been sought in a specified format and has to be submitted within 10 days of issuing the order dated June 5, 2024, it said.

PTR refers to the price at which a drug is sold to a retailer, which includes duties but not local taxes. MAT measures total annual sales, in this case, from November 2022 to October 2023.

Also Read: Amid global concerns over India-made drugs, Govt plans an exports revamp

The four IV fluid formulations for which data has been sought are glucose, glucose and sodium chloride, sodium chloride, and ringer lactate. Drug ceiling prices were last set based on data of July 2022.

The NPPA said the October 2023 database would capture the duly revised PTR based on the Wholesale Price Index for 2023, as availed by companies.

At its meeting in January this year, the authority noted that, using the July 2022 database, it had set ceiling prices for 700 formulations under the National List of Essential Medicines (NLEM), 2022, which was issued in November that year. The ceiling prices of about 225 drugs were left to be determined.

As per provisions of the Drugs (Prices Control) Order of 2013, formulations are categorised as scheduled and non-scheduled. Formulations listed in Schedule I are scheduled formulations and include essential medicines. Drugs that are not specified in Schedule I are non-scheduled formulations.

The NPPA revises the ceiling prices of scheduled medicines annually on the basis of the Wholesale Price Index.

The Department of Pharmaceuticals (DoP) notified the NPPA on November 11, 2022, and last year, the authority altered Schedule I, replacing the list of essential medicines of 2015 with NLEM 2022. As of now, the authority has started setting ceiling prices for drugs in the new Schedule I.

In November 2022, the NPPA also revealed its updated Schedule I-based pricing revision approach. As part of this process, it determined that July 2022 data and the database of Pharmatrac, a market research firm, will be considered while setting ceiling prices. 

The authority said new prices would be fixed for about 954 formulations, comprising 388 medicines. While ceiling prices are to be fixed for 819 unique formulations, in view of the expansion to the revised Schedule 1, the number may increase beyond 954 formulations to about 1,000, the NPPA said.

Also read: Mint Explainer: The trigger for DCGI alert on Abbott’s Digene, Takeda cancer jab