Probe finds more oral insulin in stores

Probe finds more oral insulin in stores

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has uncovered more instances of a suspended drug being available in the Capital.

Investigations by the north zone office of CDSCO revealed that 151 batches of oral insulin, out of a total of 360 introduced in the Capital, were in stores despite the Drug Controller General of India (DCGI) suspending its marketing approval and import licence.

The drug regulator moved against Oral Recosulin in March 2009 following a Mint report that revealed the drug, which is manufactured by Canada-based Generex Biotechnology Corp., had been approved for sale in India without local human clinical trials, as mandated by the Drug and Cosmetics Act. The drug is marketed in the country by Shreya Life Sciences Pvt. Ltd.

Shreya officials did not respond to emails or phone calls from Mint.

“After our exercise from yesterday, we have frozen four units that were found in the market and are also in the process of tracking others," said a senior official for north zone at CDSCO. The official said 209 units of Oral Recosulin have been returned.

“After Mint’s story, some retailers have called and told us that Shreya is trying to recall the remaining units as well," the CDSCO official said.

On Monday, 11 months after the drug’s sale was suspended by DCGI, Mint was able to purchase Oral Recosulin from a pharmacy in New Delhi.

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