Karnataka Health and Family Welfare Minister R Ashok on Thursday informed the Assembly that an inquiry would be ordered against Biocon for allegedly importing and marketing a neurological drug, methylcobalamin, from China without an import license.
He said Biocon was marketing the drug in the country for the last seven years.
"The state drugs controller detected the lapse on January 17 this year. A notice was issued to Biocon on January 27. Subsequently, Biocon obtained an import license on February 10. An inquiry will be conducted to find out how Biocon managed to market the drug for the last seven years without a valid import license," he added.
Biocon, in a statement, said it had obtained a license to manufacture methylcobalamin in step with a specific process. For commercial reasons, it revised the process and started manufacturing the product.
But the revised process was not updated with Drug Controllers' offices and this was a procedural lapse on the part of the company.
After receiving a showcase notice, it stopped manufacturing methylcobalamin. The company also stopped importing the intermediate that is required for the manufacture of the drug (importing of an intermediate does not require a license).
Biocon promptly filed the new process seeking a fresh license issued by the office of the Drugs Control Department, Karnataka in March, 2006, and the situation stands rectified.
