Karnataka Government has ordered an inquiry into the incident where the biotechnology major Biocon Limited has allegedly procured a drug "methylcobalamin' for peripheral neuropathy from China without the required license.
CPM Member GV Srirama Reddy told the State Assembly during the zero hour that Biocon was importing the drug "methylcobalamin from China and selling it as its own product in the Indian market for the last seven years.
The CPM member further stated that that Biocon had a manufacturing license for the drug. But instead of manufacturing it they had been importing the drug from China without a license for the same.
Health Minister R Ashok while replying to the query and statement in the Assembly stated that Karnataka drugs control department has visited the Biocon facility on January 17, to verify whether the drug was being manufactured there.
They issued notices to Biocon on January 27. On February 10, Biocon had obtained an import license for the drug. But we have ordered an inquiry into the allegations made by the CPM Leader Reddy, explained health minister Ashok.
Biocon has thus responded about the issue stating that the company had obtained a license to manufacture "methylcobalamin" as per a specific process. For commercial reasons, Biocon revised the process and started manufacturing the said product.
The revised process however was not updated with the Drug Controllers offices and this was a procedural lapse on part of the company.
Based on a routine inspection, Biocon received a show-cause notice from the state drugs control department for not updating the process change and the initial license to manufacture was revoked.
Upon receiving the show-cause notice Biocon stopped manufacturing of 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, which was issued, by the office of the Drugs Control Department, Karnataka (March 2006) and the situation stands rectified.