News:Central Drugs Standard Control Organisation(CDSCO) has started looking into the concerns of potential cancer-causing substances contaminating popular acidity drug ranitidine.
Facts:
What is Ranitidine?
- Ranitidine is an over-the-counter prescription antacid used in the treatment of acid reflux and peptic ulcer diseases.
- It is commonly prescribed medicine for countering acidity and also on the World Health Organisation’s ‘Model List of Essential Medicines’.
- However,it has been found that some Ranitidine medicines contain a Nitrosamine Impurity called N-nitrosodimethylamine(NDMA) at low levels which are considered as Carcinogenic.
- Hence,CDSCO has asked states to ensure that the drug is sold only under prescription as it is a prescription drug included in Schedule H.
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 food.
- It is the same impurity that the US FDA had investigated in blood pressure drug valsartan and losartan over the last year.
Additional information:
About CDSCO:
- The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device
- CDSCO functions under the Drugs and Cosmetics Act.It comes under Directorate General of Health Services,Ministry of Health & Family Welfare.
- CDSCO is responsible for (a)approval of New Drugs (b)Conduct of Clinical Trials, (c)laying down the standards for Drugs (d)control over the quality of imported Drugs in the country and (e)coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about uniformity in the enforcement of the Drugs and Cosmetics Act.
