GSK Pharma suspends sale of ranitidine on detection of carcinogen
5 years, 3 months ago

GSK Pharma suspends sale of ranitidine on detection of carcinogen

Live Mint  

New Delhi: GlaxoSmithKline Pharmaceuticals Ltd has suspended the distribution and supply of ranitidine hydrochloride products to all markets, including India, as a precautionary measure after regulatory authorities detected a carcinogen N-nitrosodimethylamine in its products. Based on the information received and correspondence with regulatory authorities, GSK made the decision to suspend the release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome of ongoing tests and investigations,” a spokesperson for the company said in a statement. Following the suspension of the certificate, GSK Pharmaceuticals has initiated a voluntary recall at the retail level of Zinetac tablets manufactured in India using active pharmaceutical ingredients from Saraca Laboratories Limited, the spokesperson said. GSK Pharmaceuticals manufactures Ranitidine Hydrochloride IP Tablets 150 mg and 300 mg under its brand Zinetac using API from Saraca Laboratories Ltd and another supplier, SMS Lifesciences India Ltd, for supply to Indian market.

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History of this topic

This popular heartburn drug is banned in US but widely sold in India. Why?
1 week, 4 days ago

This popular heartburn drug is banned in US but widely sold in India. Why?

India Today  

Popular heartburn drug Ranitidine, long under scrutiny, will continue to be available in India as the government confirmed it had no plans to ban its manufacture or sale. The government had informed Rajya Sabha earlier this month that the Central Drugs Standard Control Organisation, India's drug regulatory body, had taken steps to address safety concerns regarding the presence of N-nitrosodimethylamine, …

No plan to ban heartburn drug Ranitidine, says Health Ministry
3 weeks, 1 day ago

No plan to ban heartburn drug Ranitidine, says Health Ministry

India Today  

There are no plans to ban the manufacture, distribution, or sale of Ranitidine, a common medication for reducing stomach acid, Minister of State for Health Anupriya Patel informed the Rajya Sabha on Tuesday. Responding to concerns about the presence of N-nitrosodimethylamine, a potentially harmful impurity, in Ranitidine, Patel stated that India's drug regulator, the Central Drugs Standard Control Organisation, has …

India to conduct carcinogen test on ranitidine even as USFDA downplays risks
5 years, 1 month ago

India to conduct carcinogen test on ranitidine even as USFDA downplays risks

Live Mint  

New Delhi: India will continue testing for known carcinogen N-nitrosodimethylamine in popular antacid ranitidine, two senior officials of the Central Drugs Standard Control Organization said, even as the US regulator, which had flagged the issue first, has downplayed the risk. Earlier this month, the US Food and Drug Administration downplayed the risk associated with ranitidine, saying that levels of the …

GSK Pharma recalls stomach ulcer tablets, suspends sales, distribution
5 years, 3 months ago

GSK Pharma recalls stomach ulcer tablets, suspends sales, distribution

India TV News  

GlaxoSmithKline Pharmaceuticals Ltd on Wednesday announced recall of ranitidine hydrochloride tablets produced in India using API sourced from Saraca Laboratories Ltd following detection of genotoxic nitrosamine NDMA by authorities. The company has also decided to suspend release, distribution and supply of all dose forms of ranitidine hydrochloride products to all markets, including India, as a precautionary action pending the outcome …

After US FDA flags ranitidine, DCGI asks state regulators to get antacid tested for carcinogens
5 years, 3 months ago

After US FDA flags ranitidine, DCGI asks state regulators to get antacid tested for carcinogens

Live Mint  

New Delhi: India’s apex drug regulator has asked its state-level counterparts to get manufacturers to test anti-acidity drug ranitidine for the impurity N-nitrosodimethylamine. The directive by the Central Drugs Standard Control Organisation comes just days after the US Food and Drug Administration flagged low-level presence of carcinogenic substance in ranitidine. These investigations include continued engagement with GSK’s API suppliers, including …

Doctors issue warning against heartburn drug
5 years, 3 months ago

Doctors issue warning against heartburn drug

The Hindu  

Days after drugmakers and global public health regulators claim to have taken steps to remove supplies of a popular heartburn medication currently under invesigation by US-Food and Drug Administration for the presence of human carcinogen called NDMA, or N-Nitrosodimethylamine in Zantac and its generic forms, doctors in India too have cautioned the general public about this popular drug and asked …

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