Hyderabad: The US Food and Drug Administration (USFDA) has ordered pharmaceutical companies to take off Ranitidine, a drug used to treat and prevent ulcers in the stomach, from store shelves immediately. As the latest research revealed that the usage of this drug can cause cancer, the FDA has issued clear directives to the drug stores too.
At the moment, Ranitidine is not banned, but the pharma companies were asked to stop manufacturing and supply. The health risks of this medication have been made clear to the public. The concerned authorities believe that the Drug Controller General of India (DCGI) will take a similar course of action.
The main reason behind USFDA’s mandate against usage of Ranitidine, sold under the brand name Zantac; is the finding of N- Nitroso dimethylamine (or shortly NMDA, a carcinogenic agent) traces in it.
About a year and half ago, the USFDA regulated the supply of Ranitidine owing to suspicion of carcinogenic traces. Subsequently, it gave a leeway saying the drug can be used if NMDA was within permissible limits. But the current decision is completely different.
Recent tests have proved that the NMDA levels in the drug increased with time. Since the age of a drug cannot be determined, the FDA stated that it is better to stop the usage of Ranitidine. It has therefore asked the pharma companies to stop supplying the drug.
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Drug regulatory agencies all over the world usually abide by the rules set by the USFDA. Local pharmaceutical industries are awaiting the DCGI’s call on Ranitidine. In the past when the USFDA confirmed finding traces of carcinogens in Ranitidine, the DGCI instructed the local pharma companies to submit their findings.
Domestic pharma companies are currently exporting the drug to global markets, specially to the US. The Bangalore based Strides Pharma Science Ltd., is the leading manufacturer and exporter of Ranitidine.
Ranitidine is one of the five major drugs being sold by Strides Pharma in the US market. The company said that they will stop the supply and distribution of this drug following the USFDA mandate. During the first 9 months of this fiscal year, Strides Pharma reported sales worth INR 1,350 crores in the US.
With the ban of Ranitidine, there may be a blow to the company revenue. Other pharma companies will face the same challenge. But Strides Pharma is confident of covering up this loss with other drug sales. The company said that they have applied to the ANDA for approvals of 123 drugs out of which 85 got approved.
The USFDA specified the usage of Famotidine (Pepcid), Cimetidine (Tagamet), Esomeprazole (Nexium), Lansoprazole (Prevacid) and Omeprazole (Prilosec) as substitutes for Ranitidine. It has confirmed to not have found NMDA traces in these drugs.
