Twenty-six drugs, including the common gastrointestinal medicines ranitidine and sucralfate, have been deleted from the revised National List of Essential Medicines (NLEM) 2022 released on Tuesday by Health Minister Mansukh Mandaviya.
Three hundred and eighty-four drugs find place in the NLEM, 2022 with the addition of 34 drugs, while 26 from the previous list have been dropped. The medicines have been categorised into 27 therapeutic categories.
The National List of Essential Medicines was first compiled in 1996 and it was revised thrice earlier in 2003, 2011, and 2015.
According to a Health Ministry official, drugs deleted from the NLEM include medicines banned in India and those having reports of concerns on the safety profile.
“Drugs also go off the list if medicine with better efficacy or favourable safety profile and better cost-effectiveness become available. Also if the disease burden for which a medicine is indicated is no longer a national health concern, it is deleted from the NLEM,” explained the official. He added that in case of antimicrobials, if the resistance pattern has rendered them ineffective, the drugs are taken off the list.
Four drugs under patent
The new list also includes four drugs that are still under patent — bedaquiline and delamind used in the treatment of multiple drug-resistant tuberculosis, dolutegravir used to treat human immunodeficiency virus (HIV) infection, and daclatasvir used in treating viral infections such as Hepatitis C, noted the Health Ministry.
It added that no drugs used specifically for the treatment of COVID-19 have been made part of the list as the committee in charge of the list was of the view that the clinical trials to check the efficacy of the drugs were not yet conclusive.
Anti-cancer drugs
Also, several antibiotics, vaccines and anti-cancer drugs are set to become more affordable with their addition to the list. Ivermectin, mupirocin and nicotine replacement therapy have been added. Endocrine medicines and contraceptives fludrocortisone, ormeloxifene, insulin glargine and teneligliptin have been added to the list. Montelukast, which acts on the respiratory tract, and ophthalmological drug latanoprost figure in the list.
Cardiovascular medicines dabigatran and tenecteplase also find place in the list, as also medicines used in palliative care. The drugs in the NLEM are included in the Schedule category and their price is regulated by the National Pharmaceutical Pricing Authority.
In a tweet on Tuesday, the Health Minister said that several antibiotics, vaccines, anti-cancer drugs and many other important drugs would become more affordable, and the “out-of-pocket expenditure” on health care would come down.
“The primary purpose of the NLEM is to promote rational use of medicines considering the three important aspects — cost, safety and efficacy. It also helps in optimum utilisation of healthcare resources and budget; drug procurement policies, health insurance; improving prescribing habits; medical education and drafting pharmaceutical policies,” he said.
Bharati Pravin Pawar, Minister of State for Health, stressed the need to enhance awareness regarding antimicrobial resistance (AMR) which she said “is emerging as a big challenge for our scientists and community and we need to create awareness in the society about AMR”.
Meanwhile Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance noted that the pharmaceutical industry in India is a strategic sector that is recognised around the world for providing affordable and high-quality medicines.
Malini Aisola, of the All India Drug Action Network, said that the release of the NLEM 2022 comes after a long gap of seven years, when it is recommended for an NLEM to be revised more frequently, every two-three years, to be responsive to changing health needs. She said that the industry associations had been rallying to keep patented medicines out of the NLEM which to some degree was successful.
“However, in respect of cancer it is disappointing that more of the highly priced, effective treatments for various cancers have not been included in the list. It is positive that the diabetes section has been expanded to include teneligliptin and insulin glargine. However, there was a need to include more synthetic insulins and other classes of oral antidiabetics keeping in view the diabetes epidemic in the country and the unmet need for insulins,” she said.
