Anti-acidity medicine Ranitidine under cancer cloud over contamination
The DCGI has sent a letter to all state regulators asking them to communicate with manufacturers of ranitidine under their jurisdiction. The state regulators have been asked to verify the drugs with ranitidine and take appropriate measures for patient safety.
After the US and EU drug regulators sounded the alarm for possible carcinogens in blood pressure drug Valsartan, attention has shifted to a commonly prescribed heartburn drug ranitidine, the generic version of Sanofi’s drug Zantac. The USFDA on September 13 issued a statement alerting patients that some drugs that contain ranitidine as the active ingredient were contaminated with N-Nitrosodimethylamine (NDMA), a substance that could cause cancer.
NDMA is the same substance that the US regulator was investigating in drugs such as Valsartan last year. The USFDA had recommended the recall of blood pressure drugs such as Valsartan and Losartan globally after ‘unacceptable’ levels of chemical nitrosamines were found in them.
The issue involving ranitidine, however, seems to have hit home more. As many as 60 million people suffer from heartburn in the US alone with ranitidine available both over the counter and via prescriptions.
In fact, Sanofi’s drug Zantac saw its sales jump 13.7 percent YoY in 2018 to 127 million euros with an over 13 percent growth in the US and almost 17 percent growth in its rest-of-the-world markets. Ranitidine is also one of the oldest molecules in the market. It was introduced in India over 30 years ago in 1985.
Affordable and effective
Currently, the US and EU are examining whether the levels of NDMA found in ranitidine pose a risk. In the meantime, the FDA has not directed patients to stop taking the medicine. Meanwhile, where do Indian consumers stand? Are ranitidine drugs banned in India? Is the Indian drug controller checking the efficacy of the current supply?
Ranitidine drugs continue to be sold in India at present. The Drug Controller General of India (DCGI) has not asked for a withdrawal of the drugs as yet. The DCGI, however, has sent a letter to all state regulators on September 23 asking them to communicate with manufacturers of ranitidine under their jurisdiction.
The state regulators have been asked to verify the drugs with ranitidine and take appropriate measures for patient safety. According to regulators, ranitidine is a very affordable and effective drug and no adverse cases of cancer have been linked to it since it was introduced over three decades ago. Hence banning the drug might be a hasty step, they say.
Preventive measures
Ranitidine is sold under different names by various drug companies in the domestic market. Two of the companies with a large presence in the market are GSK Pharma and JB Chemicals. GSK sells ranitidine under the brand name Zinetac and JB Chemicals under the brand name Rantac.
Analysts estimate that Zinetac is a Rs 200-crore brand for GSK, comprising 5 percent of the company’s secondary market sales in India. For JB Chemicals, the Rantac group of brands comprised 25 percent of their domestic sales in FY19. The company generated Rs 159 crore of sales in FY19, a growth rate of 13 percent. Rantac features in the Top 100 brands in value terms in the domestic market.
While the next step from regulators will be closely watched, some companies are taking preventive measures. Novartis has halted distribution of the generic version of Zantac while Dr Reddy’s has stopped global supplies until the USFDA probe is over. Some like JB Chemicals have given their drug batches for testing independently.
GSK Pharma told CNBC-TV18 that regulatory authorities have contacted the company regarding the detection of genotoxic nitrosamine NDMA and that it is probing the potential source of the NDMA.
"These investigations include continued engagement with GSK’s API suppliers, including Dr. Reddy’s and Saraca Laboratories Limited. GSK has engaged external laboratories to conduct tests on the API and on the finished product batches of Zantac IV (injection). Initial results are expected by the end of September 2019," said GSK in a statement to CNBC-TV18.
"Patient safety remains our utmost priority and we are taking this issue very seriously. We sincerely regret any inconvenience caused to patients and healthcare professionals," the company added.
First Published: Sept 24, 2019 1:43 PM IST
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