KOCHI: With social media abuzz with speculations over Ranitidine, a popular drug used for gastrointestinal disorders, the State Drugs Control Department has asked people not to panic.
According to it, the conjectures that are doing the rounds on social media are based on an alert from the US Food and Drug Administration (FDA). It points out that though the FDA reported traces of N-nitrosodimethylamine (NDMA) in low levels in some Ranitidine medicines, including some products are commonly known by the brand-name Zantac, it has not issued a ban on the same. Also, the Drugs Controller General of India (DCGI) has not issued a ban on the sale of Ranitidine.
“The reports on social media are speculative. The trigger for the same is because NDMA is classified as a probable human carcinogen, a substance that could cause cancer,” said Ravi S Menon, State Drugs Controller.
He further added, “The DCGI had indeed asked the state regulators to communicate to the manufacturers of Ranitidine and to verify their products and take appropriate measures to ensure patient safety.”
According to him, as the state had no companies that manufacture neither Ranitidine nor Ranitidine API (active pharmaceutical ingredient, a part of any drug that produces its effects), the DCGI directive is not applicable.
“In India, three to four companies are selling Ranitidine. In the wake of NDMA traces, samples will be collected from them and will get tested at the Central Drugs Laboratory, Kolkata. At present its sale is not banned in the country,” said Ravi.
At the same time, a section of officers with the Health Department said that in the wake of the controversies surrounding Ranitidine at the global level, it will be appropriate if the DCGI banned it. But they also pointed out that NDMA is a known environmental contaminant and is found in water and food items, including meat, dairy products and vegetables.
While Ranitidine is an over-the-counter drug in the US, in India, it is a prescription drug included in Schedule H and therefore it should be sold by the retailer only under the prescription of a registered medical practitioner.
In an update issued by the FDA on Thursday, it is highlighted that the agency has asked manufacturers of Ranitidine to conduct their laboratory testing to assess levels of NDMA in their products and to send samples of the same to FDA scientists.