Mumbai : The National Pharmaceutical Pricing Authority (NPPA)’s pricing committee has asked the manufacturers to maintain existing maximum retail price (MRP) till April 2023 and then increase the MRP by up to 10% after 12 months period based on the National List of Essential Medicines (NLEM- 2022), in adherence to the Drug Prices Control Order -2013.
This is applicable for manufacturers whose branded generic was in NLEM- 2015 but has been deleted from NLEM 2022.
“Such molecules will become non-scheduled formulations with immediate effect and will not be under price control. Ideally one can immediately increase price by up to 10% but as the Wholesale Price Index (WPI) price increase last year was 10.76% therefore existing MRP shall be maintained till April 2023,” according to an official associated with the development.
“If the manufacturer’s brand was in NLEM 2015 and is retained in NLEM 2022, WPI prices of April 2022 will continue till March 2023. The manufacturer has to update price in Form II and V if price is revised in Para 18 (1) of Drug Prices Control Order (DPCO-2013),” the official added.
“If the manufacturer brand was not in NLEM 2015 but has been included under NLEM 2022, then the molecule will be under price control. The manufacturer has to liquidate stocks, keep minimum stocks so once ceiling price is notified the manufacturer does not have to call back too many stocks for price revision. Once ceiling price is notified, the price list has to be entered and submitted in Form II and V under Integrated Pharmaceutical Database Management System (IPDMS 2.0) and stockiest and C&F need to be intimated. Further billing has to be stopped and price revision of existing stocks need to be done as per the ceiling price and manufacturing of fresh batches need to be done with new ceiling price only,” the official further explained.
Union minister for health & family welfare and chemicals and fertilizers, Dr. Mansukh Mandaviya released the NLEM 2022 on September 13, 2022. The NLEM list has expanded to 384 medicines in NLEM 2022. There were 376 medicines in the list that was issued in 2015. 26 medicines have been removed from the list and 34 new medicines were added in the NLEM list.
“The new NLEM list being published will ensure the accessibility, affordability and safety of some of the most needed drugs in India” said the Union minister while releasing the list.
The NLEM-2022 comprises 384 drugs and over 1,000 formulations across 27 therapeutic categories. New 34 drugs have been added to the NLEM 2015 including 4 patented drugs and 26 drugs have been deleted from NLEM 2015. The value of medicines under price control is around 20% of the total market value.