Prelims Level
Mains Level
Prelims Syllabus : Science & Technology- Medicine and Pharmaceuticals Mains Syllabus : GS-III- GS-II- Issues relating to development and management of Social Sector or Services relating to Health, Education, Human Resources.

Context-

  • The Ranitidine drug has been found to have levels of a carcinogen above the US FDA prescri

Background

  • Ranitidine Hydrochloride capsules in the US has confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the Food and Drug Administration (FDA) in batches of Sandoz Ranitidine Hydrochloride capsules.
  • Sandoz has withdrawn 14 batches of the drug which it manufactured in 2017 and 2018 and which were set to expire in 2020 and 2021.

N-Nitrosodimethylamine (NDMA)

  • According to the FDA, NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
  • NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Ranitidine

  • Ranitidine is a prescription drug but is also sold over the counter (OTC).
  • As an OTC drug, it is used to decrease the volume of acid produced in the stomach.
  • It is also used to prevent and relieve heartburn associated with acid ingestion and sour stomach.
  • As a prescription drug, it has multiple uses, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease or GERD.

Outside America:

  • Besides the FDA, the European Medicine Agency has also launched a similar enquiry, the results of which are awaited.
  • The Singapore drug regulator banned the supply of the drug in the country early this month.
  • Meanwhile, in India, Central Drugs Standard Control Organisation (CDSCO) has also asked state drug controllers to ensure that the drug is safe.
  • Indian doctors have advised patients here to avoid over-the-counter (OTC) use of popular antacid ranitidine.

US FDA:

  • The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.
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