Health ministry includes coronary stents in NLEM 2022
New Delhi, November 15, 2022:
The Union ministry of health and family welfare (MoHFW) has notified inclusion of Coronary Stents in the National List of Essential Medicines (NLEM), 2022, with immediate effect based on the recommendations by the expert committee constituted to review and revise the list based on requirement.
The Standing National Committee on Medicines (SNCM), on November 6 submitted its recommendation for inclusion of ‘Coronary Stents’ in the NLEM, 2022, in two categories - Bare Metal Stents (BMS) and Drug Eluting Stents (DES) which include metallic DES and Bioresorbable vascular scaffold (VBS)/Biodegradable stents.
The MoHFW accepted this recommendation and notified Coronary Stents in NLEM, with immediate effect as per the categories recommended.
The SNCM, under the chairmanship of Dr Rajiv Bahl, secretary of Department of Health Research and Director General of Indian Council of Medical Research (ICMR), constituted by the MoHFW in July 3, 2018 to review and revise the NLEM by way of additions and deletion’s in the existing NLEM in the context of contemporary knowledge of use of therapeutic products in health and hygiene of general public.
It has submitted its final report on NLEM on September 10, 2022 and the MoHFW accepted the recommendations in toto and adopted the List. It has issued a notification on September 13, to this effect, releasing the NLEM 2022, in the country.
It may be noted that the Coronary Stent was also added to the previous version of NLEM, the NLEM 2015, similarly following the recommendation of a sub-committee after the list was released.
The sub-committee, headed by Prof Y K Gupta, professor and head, Department of Pharmacology, AIIMS, New Delhi, during the period, recommended inclusion of the Stent into the List, considering the high burden of coronal artery disease (CAD) in the country, which is associated with high morbidity and mortality, and that the coronary artery disease is a public health problem.
Although, medical devices are different from drugs in respect of their nature, mechanism of action, manufacturing, quality control, mode of administration/implantation, etc, coronary stents are among the categories of Medical Devices which have been notified by the government of India as “Drug'' under the provisions of the Drugs and Cosmetics Act, 1940.
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.Pharmabiz