No more Rantac, Zinetac as Ranitidine gets removed from National Essential Medicines’ List over cancer concerns

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Centre has removed Ranitidine (popularly sold under the brand names Aciloc, Zinetac, and Rantac) from the essential medicine list over cancer-causing concerns. 

The Health Ministry of India has released the new National List of Essential Medicines (NLEM), 2022, which contains 384 drugs. Meanwhile, 26 medicines removed from the list will cease to exist in the country.

What is the National Essential Medicines' List 

The National Essential Medicines List (NEML) is a list of basic medicines that satisfy the health care needs of the majority of the population in India. The main goal was to safeguard the accessibility and affordability of essential medicines to the Indian population. In addition, this list aims to rationalise the procurement of medicines and encourage the rational use of medicines. The medicines in the appropriate dosage forms should be made accessible to individuals or the communities, in appropriate quantities with guaranteed quality and at affordable prices.

Adapted from the World Health Organization (WHO) Model List of Essential Medicines, the NEML consists of locally registered medicines based on national needs. This NEML aims to act as a guide for facilities in formulating their essential lists according to their needs.

NLEM, 2022 - Download PDF

Concerns regarding Ranitidine

Ranitidine is a H2 receptor antagonist, used to treat diseases like PUD (peptic ulcer disease) and GERD. [Also, it is worth mentioning that Sucralfate, which is yet another popular drug used as an ulcer protective agent, lies among the 26 removed drugs.]

Ranitidine is under the scanner throughout the world for concerns related to cancer and the Health Ministry has discussed the details with the Drug Controller General of India and All India Institute of Medical Sciences (AIIMS) about taking the salt out of the essential stock.

The salt has been under investigation since 2019 when the US-based Food and Drug Administration found probable cancer-causing impurity in the drug. Drug regulators found cancer-causing impurity N-nitrosodimethylamine (NDMA) at “unacceptable levels” in samples of drugs containing ranitidine.