India's drug regulatory authority has ordered lifting samples of heartburn drug ranitidine, after the US regulator red-flagged presence of a cancer-causing impurity in some products. The Drug Controller General of India has written to state drug controllers, asking them to draw samples from major manufacturers of ranitidine and send those to Central Drug Laboratory (CDL) in Kolkata to test for the impurity Nnitrosodimethylamine (NDMA).
The Drug Controller General of India has written to state drug controllers, asking them to draw samples from major manufacturers of ranitidine and send those to Central Drug Laboratory (CDL) in Kolkata to test for the impurity Nitrosodimethylamine (NDMA). “You are requested to draw samples of ranitidine API (active pharmaceutical ingredient) from major manufacturers as well as fast-running product formulations of ranitidine and send it to CDL Kolkata for specific testing in respect of levels of NDMA, if any,” said the letter, a copy of which EThas seen.
Meanwhile, sources told ET that the appellate laboratory in Kolkata may not have the equipment to conduct the LC-HRMS test which has been recommended by the US Food and Drug Administration for testing NDMA in ranitidine products. Avenues have now been explored to get these tests done by private analytical laboratories, they said. Ranitidine is a commonly prescribed medicine for countering acidity and is on the World Health Organization’s ‘Model List of Essential Medicines’. In India, a host of companies including GlaxoSmithKline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy’s and Sun Pharmaceuticals sell over 180 versions of the drug. The market size for ranitidine in India is Rs 688.6 crore, as per data from market research firm AIOCD PharmaTrac.
The US FDA announced an update of testing of NDMA in ranitidine, warning manufacturers not to use a high-temperature test for NDMA as it generates high levels of the impurity. "The protocols and equipment for this test is not available at any central governmentrun laboratory," a person in the know said. Email sent to the CDL Kolkata and phone calls made to the drug controller did not elicit any response till press time Friday. Meanwhile, Indian companies have started getting the tests done from private companies. “The product has been in the market for the last 35 years and there is a need for data and the limit of NDMA needs to be looked at carefully before any decision is taken. A thorough review needs to be done. We have sent our samples to a private laboratory for testing and are awaiting results,” JB chemicals president Pranabh Mody said.
In India, as a precautionary action, GSK has initiated a voluntary recall of its ranitidine products - Zinetac Tablets 150 mg and 300 mg in September. “GSK is continuing with investigations into the potential source of NDMA. These investigations include continued engagement with our API suppliers. Patient safety remains our utmost priority and we are taking this issue very seriously,” said a company spokesperson. GSK was contacted by the Indian drug regulatory authority regarding the detection of genotoxic nitrosamine NDMA in ranitidine 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,” added the spokesperson.
[Courtesy: https://health.economictimes.indiatimes.com/news/pharma/drug-regulator-steps-up-monitoring-of-ranitidine/71573166]