Ranitidine is among 26 medicines which have been dropped from NLEM 2022
If you are a regular consumer of antacid Ranitidine which is popularly sold as Zantac, you should know that this medicine has been removed by the Indian government in its recent National List of Essential Medicines 2022. The reason: cancer concerns around the medicine led to this decision.
In the recently released National List of Essential Medicines 2022, Ranitidine is among 26 medicines which have been dropped.
Cancer concerns over Ranitidine
In 2019, N-nitrosodimethylamine or NDMA was found in samples of ranitidine.
Ranitidine has been under scanner since 2019 when the US Food and Drug Administration (FDA) found carcinogenic elements in it. "The agency is examining levels of NDMA in ranitidine and evaluating any possible risk to patients. The FDA will take appropriate measures based on the results of the ongoing investigation. The agency will provide more information as it becomes available," it had said then.
It had urged people that, "the FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine."
Ranitidine was introduced in 1981 and since then has been one of the most sought after medicines for GERD related conditions. It has been sold in more than 120 countries, formulated for the treatment of 222 million patients worldwide, a research report says.
How does NDMA affect human health
NDMA is toxic to humans and overexposure to this compound can put the human body through several damages. It is a member of N-ni-trosamines, a family of
potent carcinogens.
As per a report by the U.S. Environmental Protection Agency (EPA) Federal Facilities Restoration and Reuse Office (FFRRO) exposure to NDMA damages the liver in humans. It can cause abdominal cramps, enlarged liver, reduced function of liver, kidneys and lungs and dizziness.
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetable, the US FDA defines it and classifies it as a probable human carcinogen.
Many animal studies have demonstrated the carcinogenic effects of NDMA.
The list of 26 medicines which have been removed from NLEM 2022
1. Alteplase
2. Atenolol
3. Bleaching Powder
4. Capreomycin
5. Cetrimide
6. Chlorpheniramine
7. Diloxanide furoate
8. Dimercaprol
9. Erythromycin
10. Ethinylestradiol
11. Ethinylestradiol(A) Norethisterone (B)
12. Ganciclovir
13. Kanamycin
14. Lamivudine (A) + Nevirapine (B) + Stavudine (C)
15. Leflunomide
16. Methyldopa
17. Nicotinamide
18. Pegylated interferon alfa 2a, Pegylated interferon alfa 2b
19. Pentamidine
20. Prilocaine (A) + Lignocaine (B)
21. Procarbazine
22. Ranitidine
23. Rifabutin
24. Stavudine (A) + Lamivudine (B)
25. Sucralfate
26. White Petrolatum
Medicines for COVID 19 management
Dexamethasone and Enoxaparin have been added as medicines for COVID management.
Dexamethasone has also been listed under antiallergics and Medicines used in Anaphylaxis, Anti-cancer agents including Immunosuppressives, and Medicines used in Palliative are- Medicines used in Palliative Care and Hormones, other Endocrine Medicines and Contraceptives - Adrenal hormones and synthetic substitutes.
Enoxaparin has been listed under medicines affecting coagulation and Antiplatelet and Antithrombotic Medicines.
List of medicines approved
A total of 34 medicines have been approved in the NLEM 2022, which is an upgrade of NLEM 2015.
Ivermectin, a medication used to treat parasitic roundworm infections, which was widely prescribed during the initial days of the COVID pandemic has been included in the list under antifilarial category.
Likewise, Meropenem, Cefuroxime, Phenoxymethyl penicillin, Procaine, Benzylpenicillin, Amikacin, Bedaquiline, Delamanid, Itraconazole, Mupirocin, Terbinafine, Valganciclovir, Lamivudine, Tenofovir (A) + Lamivudine (B) + Dolutegravir (C), Dolutegravir, Darunavir (A) + Ritonavir (B), Daclatasvir, Tenofovir Alafenamide Fumarate (TAF), Bendamustine Hydrochloride, Irinotecan HCI, Trihydrate, Lenalidomide, Leuprolide acetate, Dabigatran, Tenecteplase, Fludrocortisone, Ormeloxifene, Insulin Glargine, Teneligliptin, Rotavirus vaccine, Latanoprost, Buprenorphine, Buprenorphine (A) + Naloxone (B), Nicotine (for nicotine replacement therapy), Montelukast.
How many medicines have been approved?
A total of 384 medicines have been approved in NLEM 2022.
The medicines listed in 2015 were decided based on the report submitted by a Core Committee constituted by the government.
"The Government of India had constituted a Core Committee under the Chairmanship of Dr. V.M. Katoch the then Secretary, Department of health Research and Director General, ICMR, Ministry of Health & Family Welfare for reviewing and revising the National List of Essential Medicines (NLEM), 2011 in the context of contemporary knowledge of use of therapeutic products," an official statement says.
In 2018, a Standing National Committee on Medicines (SNCM) was constituted "to review and revise the National List of Essential Medicines by way of additions and deletions in the existing NLEM in the context of contemporary knowledge of use of therapeutic products in health & hygiene of general public."
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