New Delhi: The popular acidity drug, Ranitidine, is being investigated by India’s apex drug controlling body. The Drug Controller General of India who is the head of the Central Drugs Standard Control Organisation has written to various state drug regulators to check samples of the medicine, issue alerts about concerns over the quality of the drug and to ensure patients’ safety.
“You are requested to communicate to the manufacturers of Ranitidine API[footnote]Active Pharmaceutical Ingredient[/footnote] and formulations under your jurisdiction to verify their products and take appropriate measures to ensure patient safety,” says a letter from the DCGI, to different states.
The matter has also been referred to an expert committee.
While the government has not recalled these drugs, two companies have taken precautionary steps. Indian pharma company Dr Reddy’s Laboratories announced the suspension of its Ranitidine supply worldwide, last week. JB Chemicals and Pharmaceuticals Ltd has sent some samples for voluntary testing.
Drug regulators in Canada and Singapore have initiated a recall of the drug as a precaution.
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Ranitidine is available under different brand names in India. JB Chemicals sells it as Rantac, Cadila Pharmaceuticals as Aciloc and GlaxoSmithKline Pharmaceuticals as Zinetac. In India, it is supposed to be sold only if prescribed by a registered medical practitioner.
US FDA and EU role in crackdown
The drug controller’s action comes a few days after US’s Food and Drug Administration (FDA) issued a medical safety alert for this drug, noting that carcinogenic substances have been found in Ranitidine medicine samples.
Many companies make the drug but the FDA has specifically flagged the brand name ‘Zantac’ which is produced by the French company Sanofi.
It said that the samples tested showed the presence of low levels of N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a “probable human carcinogen” and an environmental contaminant. It makes its way into water, food, meat, dairy products and vegetables.
Ranitdine, an over-the-counter drug, helps decrease the amount of acid created in the stomach. Thus it can relieve heart burn and prevent ulcers in the stomach and intestine.
Last week, the FDA said it was neither asking for a recall, nor asking patients to stop taking the medicine but that patients on the medicine should speak to their doctors about “other treatment options” as there are many other approved drugs that can be alternatives.
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The European Union is also looking into carcinogens in Zantac. The European Medicines Agency said recently that it “is evaluating the data to assess whether patients using Ranitidine are at any risk from NDMA and will provide information about this as soon as it is available.”
Other drugs with the same problem
This case bears similarities with the drug Valsartan over which the FDA sent out a warning letter to a Chinese company, speaking of the presence of the same NDMA impurities, last year. Vikas Dandekar at Economic Times investigated and found that Indian company Hetero had changed their manufacturing process for the Valsartan API soon after this. Hetero supplied this API to other companies like Lupin.
Dandekar’s investigation showed that Lupin’s internal reports had also found NDMA impurities in their product. Lupin in turn alerted Hetero, which ended up recalling some drugs.