DoP amends DPCO, 2013 to include NLEM 2022 into Schedule I

New Delhi, November 15, 2022:

The Department of Pharmaceuticals (DoP) has issued a notification amending the Drugs (Prices Control) Order, 2013, in order to replace the previous version of National List of Essential Medicines (NLEM) with NLEM, 2022, which was launched in September, this year by the Union health minister Dr MansukhMandaviya.

The Drugs (Prices Control) Amendment Order, 2022, according to the notification issued by the DoP on November 11, substitutes the Schedule I of the DPCO 2013, which was originally carrying the NLEM, 2011 details, with the NLEM 2022. The amendment has come into force on the date of publication of the Notification in the Official Gazette.

The amended list, thus will include, medicines used in anaesthesia; analgesics, antipyretics, non-steroidal anti-inflammatory drugs, medicines used to treat gout and disease modifying agents used in rheumatoid disorders; anti allergies and medicines used in anaphylaxis; antidotes and other substances used in management of poisonings/envenomation; medicines used in neurological disorders; anti-infective medicine including medicines used in the management HIV; anti-cancer agents including immunosuppressives and medicines used in palliative care; medicines affecting blood; blood products and plasma substitutes; cardiovascular medicines; dermatological medicines; dialysis components; antiseptics and disinfectants; diuretics; ear, nose and throat medicines; gastrointestinal medicines, among others.

The NLEM 2022 contains 384 medicines, compared to 376 medicines in NLEM 2015. The NLEM 2022 had 34 medicines added and 26 medicines deleted, while the previous list had 106 medicines added and 70 medicines were deleted. Out of the 384 medicines listed in the NLEM 2022, 342 appear in a single therapeutic category, 41 drugs in two therapeutic categories, 11 appear in three therapeutic categories and four drugs appear in four therapeutic categories.

“Hence, the total list is 440 items long. There are a relatively lesser number of deletions and additions in the current list,” said the NLEM 2022 report with the ministry.

The committee, which created the list of medicines under NLEM 2022, said that it has ensured that the critical ‘go/no go’ decision regarding the inclusion of medicines in NLEM was taken considering the main themes of safety, efficacy, and disease burden in the country, their affordability and accessibility, even though the issue issue related to price control sometimes became the main focus of discussions.

While the NLEM 2015 had medicines in 30 therapeutic categories, the 2022 list merged four categories (antiepileptic medicines, antiparkinsonism medicines, anti migraine and medicines used in dementia) into a single therapeutic category and named it as medicines for neurological disorders. Similarly the erstwhile category of ‘Muscle relaxants and cholinesterase inhibitors’ was merged into one category and named as ‘medicines used in anaesthesia’. The list also added a new section of medicines for Covid-19 management. Thus, NLEM 2022 contains 27 therapeutic categories.

The maximum number of additions in the anti-infective therapeutic category of medicines. In this category, 18 medicines have been added and nine have been deleted. The second maximum numbers of medicines 63 (including duplication) are in anti-cancer agents including immunosuppressive and medicines used in palliative care therapeutic category, it said.Pharmabiz