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After US red-flag, Modi govt asks states to check samples of acidity drug for cancer agent

Drug Controller General of India has written to state drug regulators, asking them to alert manufacturers about Ranitidine & take steps to ensure patient safety.

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New Delhi: Days after US health regulator FDA flagged popular acidity drug Ranitidine for containing cancer-causing substances, the Modi government has now written to drug regulators in all states and union territories to check the samples of the medicines as a precaution.

The US Food and Drug Administration on 13 September had alerted about Ranitidine as it contains low-levels of N-nitrosodimethylamine (NDMA) — a substance that causes cancer.

“It has been reported from other countries that some ranitidine medicines contain a nitrosamine impurity called N-nitro (NDMA) at low levels,” stated the letter written by V.G. Somani, Drug Controller General of India (DCGI).

“You are requested to communicate to the manufacturers of ranitidine API and formulations under your jurisdiction to verify their products and take appropriate measures to ensure patient safety,” said the letter, dated 23 September, which has been accessed by ThePrint.

The letter added that “the action taken in the matter may please be intimated to this office at the earliest”.

Ranitidine is commonly prescribed by doctors in India to cure acid-related cough, indigestion, stomach pain and heartburn.

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Drug hasn’t been recalled

The DCGI has, however, not issued a recall of the drug. But two private drug manufacturers have already taken measures from their end.

Hyderabad-based pharma giant, Dr Reddy’s Laboratories, last week announced the suspension of the supply of Ranitidine worldwide, while JB Chemicals and Pharmaceuticals Ltd in Mumbai sent samples of the drug for testing on a voluntary basis.

JB Chemicals manufactures Ranitidine under the brand name of Rantac. The drug is available in India under other brand names too, such as Aciloc and Zinetac.

According to the DCGI letter, “the drug ranitidine is approved for multiple indications in the country and available in various formulations including tablets and injections, etc…

“The drug ranitidine is a prescription drug included in schedule H and therefore it should be sold by retail under the prescription of registered medical practitioners,” the letter stated.

The DCGI also intimated the drug regulators that NDMA “has been classified by the International Agency for Research on Cancer as probably carcinogenic to humans”.

FDA had alerted about the Zantac brand of Ranitidine

The FDA, in its statement, had specifically mentioned about the brand Zantac — manufactured by French pharma major, Sanofi.

“Some Ranitidine medicines, including some products commonly known as the brand name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels,” it had stated.

Sanofi, however, said it doesn’t sell the drug in India.

The FDA is still evaluating whether the low-levels of NDMA — found in both the generic and brand versions of Ranitidine — pose any kind of risk to patients.

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