Following the revelation by the US Food and Drug Administration (FDA) of the trace presence of carcinogenic substances in Ranitidine, a commonly used drug for acidity and ulcers, the Central Drugs Standard Control Organisation (CDSCO) of India has commanded further examination of this issue. Although the directive is not an order to halt production, manufacturers of the active pharmaceutical ingredient (API) in Ranitidine are instructed to ensure their products are verified and patient safety is secured.
Ranitidine and its Common Use
Ranitidine is an often-prescribed medicine that counteracts acidity and treats upper intestinal ulcers. Its popularity is demonstrated by its inclusion on the World Health Organization’s ‘Model List of Essential Medicines’. Available in varying formulations such as tablets and injections, Ranitidine is sold via numerous companies like GlaxoSmithKline, Dr. Reddy’s, and Sun Pharmaceuticals, with over 180 different versions of the drug available in India alone. Well-known brands include Zantac, Aztec, and Giran.
Nitrosamine Impurity in Ranitidine
A notable point of concern in Ranitidine is the presence of a Nitrosamine impurity identified as N-nitrosodimethylamine (NDMA), considered a potential carcinogen due to its capacity to promote the formation of cancer. However, it should be stressed that while harmful in large quantities, the levels of NDMA found in Ranitidine from preliminary FDA tests are marginally above those found in everyday foods.
Regulation of Ranitidine Sales
In response to these findings, CDSCO has requested states to regulate the sale of Ranitidine to ensure it is only distributed on prescription, as it falls under Schedule H of controlled substances. Under the Drugs and Cosmetics Rules, 1945, Schedule H drugs must bear labels displaying “Rx” and “Schedule H”, and can only be sold by retail on prescription from a registered medical practitioner.
| Company | Brand |
|---|---|
| GlaxoSmithKline | Zantac |
| Dr. Reddy’s | Aztec |
| Sun Pharmaceuticals | Giran |
About N-nitrosodimethylamine (NDMA)
NDMA is an environmental contaminant found in water and foods and has been classified as probably carcinogenic to humans by the International Agency for Research on Cancer (IARC). Notably, it is not a new finding to the FDA, who had previously investigated its presence in blood pressure drugs valsartan and losartan over the previous year.
What Are Carcinogenic Substances?
Carcinogens are substances or types of radiation that can trigger the formation of cancer. They are found in various forms and places such as asbestos, gamma rays, and Aflatoxin B1, produced by fungi growing on stored nuts and grains. The effect of exposure to these substances can vary greatly, from negligible to severely harmful, depending on the concentration and duration of exposure.
