The Union Health Ministry on Tuesday launched the new National List of Essential Medicines (NLEM), expanding the list to include newer therapies for diabetes, such as the medicine Teneligliptin and the insulin Glargine, and also incorporating four more anti-cancer therapies.
The new anti-cancer therapies included are Bendamustine Hydrochloride, which is 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.
Updated for the first time since 2015, NLEM has changed anti-microbials, keeping in mind the resistance pattern, including drugs that are part of national missions such as Bedaquiline, used for treatment of TB, and added nicotine and two opioids for replacement therapy.
The NLEM guides the government’s procurement policy and decides the price cap for medicines. The updated list has deleted 26 drugs from the previous one and added 34 drugs, increasing the list to 384 drugs.
“It is positive that the diabetes section has been expanded to include Teneligliptin and insulin Glargine (Lantus). However, there was a need to include more synthetic insulins and other classes of oral antidiabetics, keeping in view the diabetes epidemic,” said Malini Aisola, co-convener of All-India Drug Action Network.
What is NLEM?
The National List of Essential Medicine (NLEM) is created to rationalise the use of limited resources for drugs needed the most by the greatest number of people. Prices of medicines included in NLEM are controlled by the Centre, ensuring lower prices. It is a dynamic list that takes into account any changing profile of diseases, newer drugs available in the market, and changing treatment protocols.
As for cancer, she said, it is “disappointing that more of the highly priced, effective treatments for various cancers have not been included in the list. This is an area where pharma innovation is fastest, and recognising this the WHO has in recent years taken steps to expand the cancer section of the global Model Essential Medicines List.”
Welcoming the move to include nicotine and two opioids, Dr Ravindra Rao, additional professor at National Drug Dependence and Treatment Centre of AIIMS, said: “It is well documented that without nicotine replacement therapy, the quit rate of tobacco — be it smoking or chewing tobacco — is only about 2% per year, compared to more than 10% with the therapies. A pack of nicotine gum is much more expensive than a pack of beedi or gutkha, so it is unaffordable for most.”
He added, “Opioid replacement therapy is also known to increase retention of patients in the programme and higher quit rates. And, opioids lead to the highest illicit drug-related mortality and morbidity.”
The rotavirus vaccine, now part of the government’s universal immunisation programme, has also been added. Keeping the national programme on Lymphatic Filariasis (elephantiasis) in mind, the new NLEM has included the anti-parasitic drug Ivermectin, which was empirically prescribed — without scientific data — by many for Covid-19 at the height of the pandemic. A highly effective broad-spectrum antibiotic, Meropenem, has also been included.
Even as newer TB drugs like Bedaquiline were included, the committee removed three anti-tubercular drugs from the previous NLEM, including Kanamycin injection that was used in patients with drug-resistant TB. With the government now introducing an all-oral regimen for such patients, the drug was also associated with severe side-effects such as kidney problems and hearing loss.
This is also the first time that the committee decided to include drugs that are still under patents in the list — such as Bedaquiline and Delaminid for TB, Dolutegravir for HIV, and Daclatasvir for Hepatitis C. “A question raised time and again is whether patented drugs should be included in NLEM,” said Dr YK Gupta, who heads the committee. “The committee, as well as stakeholders and the ministry, decided that patented drugs can also a part of NLEM if they fulfil the criteria (of need, safety, efficacy, and cost effectiveness), and (that) these medicines are very important and should be a part (of the list).”
Aisola said, “Industry associations had been rallying to keep patented medicines out of NLEM, which to some degree was successful. It is positive that the ministry has explicitly clarified that patent status cannot be the basis to exclude a medicine from NLEM.”
He also said that even though drugs that were approved for Covid-19 were considered, they weren’t included in the list since data on these drugs is inconclusive and they have received only emergency-use authorisation in the country. Dr Gupta said the committee wanted to highlight the increasing use of fixed-dose combination drugs, and only medicines that need to be consumed in fixed-dose combinations, such as those for Parkinson’s or some for hypertension, have been included in the NLEM.
His presentation said, “Although, many antibiotic FDCs with multiple antibiotics, analgesics, vitamins, minerals, etc have been banned, still many combinations are in the market with doubtful rationality. Though the committee wished to publish such negative list of such disease, it is restricting itself because the list will become only example and cannot be exhaustive.”
The NLEM was first formulated in 1996 and was revised in 2003, 2011, and 2015. It takes into account any changing profile of diseases, newer drugs available in the market, and changing treatment protocols. The price of medicines in the list is controlled by the Centre and cannot be changed by companies themselves. Many of these medicines are also available free at government health facilities.
At the launch event, Union Health Minister Mansukh Mandaviya said, “The Prime Minister has said that citizens should be able to get cheaper medicines, (and) get them wherever and whenever needed. To assure this, the NLEM will be very useful. Based on this list, the NPPA (National Pharmaceuticals Pricing Authority) will decide the ceiling prices….”
He said, “Prices of medicines under NLEM cannot be increased by companies themselves, but every year prices are increased or decreased as per the Wholesale Price Index, meaning the prices of these medicines cannot be increased unreasonably.”
Mandaviya also said, “When medicines are cheaper, naturally the burden on healthcare expenditure and out-of-pocket spending of people will also go down and benefit the country.”
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