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Twenty-six drugs, including gastrointestinal medicines like Ranitidine, have been removed from the revised National List of Essential Medicines (NLEM) 2022, released on 13 September. Ranitidine, popularly known as Rantac and Zantac, and one of the most commonly used antacids in India, has been removed from the NLEM too.
A total of 384 drugs find a place in the latest NLEM, with the addition of 34 drugs.
Which are the 26 drugs that were dropped? Does this mean these drugs will no longer be available? Here's all you need to know.
What is the purpose of the National List of Essential Medicines?
Government regulatory agency National Pharmaceuticals Pricing Authority (NPPA) controls the prices of medicines in India and comes out with a list every three years.
Through the National List of Essential Medicines or NLEM, prices of essential medicines are regulated so that the medicines are not only affordable but also more easily available.
When is a drug dropped from the NLEM?
A drug is deleted for the following reasons:
Concerns about drug safety emerge.
A more cost-effective medicine is available.
Change in the country’s disease burden.
Why has ranitidine been dropped from NLEM?
The antacid salt was put under scanner in 2019, when studies showed that it contained a potentially carcinogenic compound called N-Nitrosodimethylamine (NDMA), a cancer causing property.
Just before the COVID-19 pandemic, the US Food and Drug Administration, and the European Medicines Agency (EMA), banned the sale of the drug in their respective regions.
“In the summer of 2019, the FDA became aware of an independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans,” the FDA had said in a report in April 2020.
But not India. It remains available as an over-the-counter drug, where a strip of 20 tablets costs around Rs 30.
Will it not be available now?
It will be available in the pharmacies as there is no ban on the sale of the drug. Removal of drugs from the NLEM has no impact on its availability in the market but it may have an impact on the pricing, depending on what the manufacturers choose.
Which other drugs have been dropped from the list?
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 Petroleum
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