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Astrazeneca's osemertinib is only approved in India

 

Clinical courses

In last month, there was lot of hike about osemertinib is being sold illegally in the Hyderabad by private and government hospitals despite a ban by the Drug Controller General of India (DCGI). But on last Friday, DCGI confirmed that only AstraZeneca Pharma India Limited, Bangalore has given permission for import and marketing of cancer drug.

Actually, this confusion occured with notice (F. No. 12-38/2017-DC) from CDSCO which states that, "Osimertinib mesylate is not yet approved for use in India. Quality, Safety and Efficacy of Osimertinib mesylate tablets is under review by CDSCO. It was noticed that Osimertinib mesylate tablets was being sold through online and other sources by illegal means by some manufacturers/importers under various brand names, flic Quality, Safety and Efficacy of which is unknown and it may cause harm to the patients and public."

But as per CDSCO's recent notice CDSCO, itself gave permission to Astrazeneca India on 29th May, 2017 for import and market Osimertinib Film coated Tablets 40mg/80mg (as Osimertinib Mesylate). In India it is indicated for the treatment of patient with metastatic epidermal growth factor receptor (EGFR) T790 M mutation-positive non-small cell lung cancer (NSCLC), as detected by an appropriate test, whose disease has progressed on or after EGFR TKI therapy.

Then how this confusion occured ? Well, there are some online and other sources which are selling this cancer drug by some manufacturers/importers under various brand names, flic Quality, Safety and Efficacy of which is unknown and it may cause harm to the patients and public.

DCGI also asked all the State Drugs Controllers, CDSCO zonal or sub-zonal offices and port officers to have strict look on the illegal manufacture/import, sale or distribution of Osimertinib mesylate tablets.

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