Karnataka cancels Biocon's licence

Karnataka government has cancelled Biocon's licence to manufacture 'methylcobalamin' (a drug for treatment of neurological disorders), citing violation of import norms.

Replying to a query from M P Nadagouda of the Janata Dal-United (JDU) in the Karnataka Legislative Council on Monday, minister for health and family welfare, R Ashok, said the "licence has been cancelled in view of violation of import norms by the company."

However, the company on Monday said it was sticking to its earlier stance that it had not violated any laws. According to its statement, the company said it had obtained a license to manufacture 'methylcobalamin' as per a specific process and for commercial reasons, it revised the process and stared manufacturing the said product. Biocon further admitted that this revised process however was not updated with the Drug Controllers office and this was a procedural lapse by the company.

Biocon said that based on a routine inspection, it received a show cause notice early this year from the state's Drugs Control Department for not updating the process change and the initial license to manufacture was revoked.

The company maintained that it had stopped manufacturing methylcobalamin upon receiving the showcase notice and had also stopped importing the intermediate that is required for the manufacture of the drug (importing of an intermediate does not require a license). The company had also promptly filed the new process seeking a fresh license which was issued by the office of the Drugs Control Department, Karnataka (March 2006) and the situation stands rectified.

However, the minister said the company had violated rules by importing the raw material used in the drug from China 'under a different name.'
Terming this as a serious offence, Ashok said the government had already written to the Centre in this regard and an inquiry was expected to be conducted by the Drugs Controller shortly, who would be visiting the company. On the basis of the inquiry report, stringent measures would be taken against the company as it concerns public health, the minister said.

Earlier Nadagouda, opposition leader H K Patil and V S Ugrappa (Congress) alleged that the company did not have the import permission and had 'smuggled the input used for the drug from China under a different name.'

The members wanted to know what action had been taken by the government in such a case of 'blatant violation' of import rules.