Carcinogen Substances in Ranitidine

• 25 Sep 2019

After the US Food and Drug Administration (FDA) flagged the low-level presence of the carcinogenic substances in Ranitidine, the Central Drugs Standard Control Organisation (CDSCO) has also issued directives to check the presence of carcinogenic substances in Ranitidine.

• However, the directive to the manufacturers of ranitidine API (active pharmaceutical ingredient) and formulations is just to verify their products and take appropriate measures to ensure patient safety and not to stop production.
• The drug Ranitidine is commonly prescribed medicine for countering acidity and is available in various formulations including tablets, injections, etc.
• Some Ranitidine medicines contain a Nitrosamine Impurity called N-nitrosodimethylamine (NDMA) at low levels which are considered as Carcinogenic.
• Although NDMA may cause harm in large amounts, the levels the FDA found in Ranitidine from preliminary tests barely exceed amounts even found in common foods.
• CDSCO has also asked states to ensure that the drug is sold only under prescription as it is a prescription drug included in Schedule H.

Ranitidine

• Ranitidine is one of the oldest drugs to be used in acidity and upper intestinal ulcers and has been considered to be safer than similar other drugs like proton pump blockers.
• It is a commonly prescribed medicine for countering acidity and also on the World Health Organisation’s ‘Model List of Essential Medicines’.
• In India, a host of companies including GlaxoSmithKline, Dr. Reddy’s, Sun Pharmaceuticals sell over 180 versions of the drug. Some commonly known brands of Ranitidine are Zantac, Aztec, Giran, etc.
  

N-nitrosodimethylamine (NDMA)

• N-nitrosodimethylamine (NDMA) has been classified by the International Agency for Research on Cancer (IARC) as probably carcinogenic to humans.
• It is an environmental contaminant found in water and foods.
• It is the same impurity that the US FDA had investigated in blood pressure drugs valsartan and losartan over the last year.

Schedule H drugs

• Under the Drugs and Cosmetics Rules, 1945 drugs under Schedule H shall have labels displaying the texts "Rx" and "Schedule H” drug.
• Drugs under this schedule are to be sold by retail on the prescription of a Registered Medical practitioner only.

Carcinogenic Substances

• A carcinogen is any substance or radiation that promotes carcinogenesis, the formation of cancer.
• Examples: Abestos, Gamma rays, and Aflatoxin B1, which is produced by the fungus growing on stored grains, nuts, etc.

Source: IE