The new National List of Essential Medicines (NLEM), released by the Union Health Ministry in September, has now been brought under the Drug Prices Control Order, which fixes ceiling prices for these essential formulations based on average cost to retailers. The gazette notification was issued on November 11 by the Ministry of Chemicals and Fertilizers, which is responsible for ensuring the pricing cap. The price cap on 34 new essential medicines brought under NLEM will kick in now. With the inclusions, the NLEM has 384 drugs. The ceiling price is determined by calculating the average price to retailers of all generics and branded generics with market share of more than 1% and then adding a small retailer margin to it. This current revision is likely to bring down the cost of newer therapies for diabetes, such as the medicine Teneligliptin and the insulin Glargine, both included in the 2022 list. The list has included more anti-cancer therapies such as Bendamustine Hydrochloride, used to treat certain type of blood and lymph node cancers; Irinotecan HCI Trihydrate, used alone or in combination with other drugs to treat colorectal and pancreatic cancers; Lenalidomide for treating various type of cancers; and Leuprolide acetate, used to treat prostate cancer. In the explanation section after the revised schedule, the notification stated that any dosage or form of a drug with the same activity would come under the price ceiling. Similar salts, analogues of an active ingredient, or vaccines manufactured by different processes would also come under price control, even if explicitly not mentioned in the schedule. However, it noted that any innovation will be considered to be under price control only if explicitly mentioned. The notification stated, “Innovation in medicine must be encouraged. Formulations developed through incremental innovation or novel drug delivery systems like lipid/liposomal formulations etc. should be considered as included only if specified in the list against any medicine.” The recently published DPCO amendment notification also states that other than the vaccines already under the government’s universal immunisation programme, vaccines that are under consideration such as pneumococcal and HPV (Human Papilloma Virus that causes cervical cancer) will also be brought under price control as and when they are included in the immunisation programme.
