As the central government is set to announce the much-hyped revision of the National List of Essential Medicines (NLEM) on Tuesday, commonly sold antacid, Ranitidine, is likely to be off the list, News18 has learnt. The most sought-after anti-diabetic drug Teneligliptin is likely to be added to the list.
According to official sources, 26 items have been deleted from the upcoming NLEM, whereas 34 new items have been added.
News18 had first reported in January that the government is considering the inclusion of high-in-demand medicines under price control.
While the revised list of 399 formulations was submitted by an expert committee under the Indian Council of Medical Research (ICMR) last year and the list officially released by the government in September 2021, major changes were sought by Union Health Minister Mansukh Mandaviya.
Sold under the popular brand names Aciloc, Zinetac and Rantac among others, the salt in Ranitidine is under question across the globe due to multiple reports of cancer causing concerns. Ranitidine is commonly prescribed by doctors in India to cure acid-related cough, indigestion, stomach pain and heartburn.
As concerns over the safety of products were increasing in the Indian market too, the health ministry in discussions with the Drug Controller General of India and All India Institute of Medical Sciences (AIIMS) have agreed to take out the salt from the nation’s essential stock of medicines.
Anti-diabetic gliptins could be added
Gliptins could be included as they are the latest set of medicines used to treat Type 2 diabetes.
While the gliptin market in India values over Rs 4,000 crore, Teneligliptin market value is Rs 1,000 crore, with Mumbai-based Glenmark as top manufacturer.
For the medicines included in NLEM, manufacturers are required to sell their product equal to or lower than the ceiling price fixed using a formula set by the government.
A ceiling price calculation is based on the simple averaging of the market prices of different brands of medicines having a market share of at least 1%.
The medicines, which are included in the list reduce the profit for the manufacturer but are deemed important for national health and emergency scenarios, hence, it’s production cannot be reduced or stopped.
Why is Ranitidine out?
In an ongoing global investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in Ranitidine medications, several concerns have been raised that NDMA is a probable human carcinogen — the substance that causes cancer. However, no concrete evidence has been established.
In 2020, the US Food and Drug Administration (USFDA) had announced the withdrawal of all prescription and over-the-counter (OTC) Ranitidine drugs from the market citing contamination by carcinogens.
Since then, the Central Drug Standards Control Organisation (CDSCO), has been reviewing the FDA decision in the Indian context.
Another formulation likely to not be taken out from the essential medicines’ list includes heavily used antibacterial injection in hospital settings, Meropenem, which may get added to the list, News18 had earlier reported.
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