RANITIDINE NOT BANNED, CLAIM DOCTORS
Context: A group of doctors from prominent government hospitals in Bengaluru came forward to clear “misconceptions” about Ranitidine, an active pharmaceutical ingredient (API) used in drugs to treat gastric acidity.
- Following a U.S. Food and Drug Administration (FDA) warning about the presence of low levels of carcinogens in Ranitidine, there are a lot of misconceptions about its use
- On September 13, the U.S. FDA issued an alert for patients and healthcare professionals stating that Ranitidine medicines contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
- NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.
- Ranitidine is an H2 (histamine-2) blocker, which decreases the amount of acid created by the stomach.
- It is also prescribed for ulcers of stomach and intestines, gastroesophageal reflux disease etc.
DRUG CONTROLLER GENERAL OF INDIA
- Drugs Controller General of India(DCGI) is a department of the Central Drugs Standard Control Organization of the Government of India.
- It is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
- Drug Controller General of India comes under the Ministry of Health & Family Welfare.
- DCGI sets standards for manufacturing, sales, import, and distribution of drugs in India.