The Hindu Business Line : Karnataka refers Biocon's procedural lapse to DCGI

The Karnataka Government has referred the issue of Biocon Ltd's lapses in making methyl cobalamin to the Drugs Controller General of India (DCGI) for further action, the Health Minister, Mr R. Ashok, told the Legislative Council on Monday.

Methyl cobalamin or vitamin B12 is used to treat nervous problems (neuropathy) among diabetics. Biocon holds a manufacturing licence for cobalamin since June 2003 and was to follow a seven-step procedure.

Mr Ashok said in reply to a member's question that the State Drugs Controllerate found in January that Biocon had cut short the steps and violated Section 18a (vi) read with Rule 78(b) of the Drugs & Cosmetics Rules by not intimating the changes in the standard operating procedure. It had changed the process by using an intermediate drug (dimethyl benziamidazole) imported without licence from Auspure Biotech Ltd, China.

The Minister said the State drugs control authorities cancelled the licence in late January. On February 10, Biocon applied for a fresh licence and received it in March. A Biocon spokeswoman in reply to queries told Business Line that the situation was rectified and the company continues to make the drug based on the new March licence. However, methyl cobalamin in terms of its sales and revenue was a "very insignificant product" to the company.

"We continue to stand by our earlier statements (of March 20 and 22) and there is nothing to add," she said.

In its statements, Biocon said it had admitted to inspecting officials in January this year to a "procedural lapse" in the manufacturing process. Also, import of an intermediate does not need a licence. It had now stopped importing the intermediate.

The statement of March 22 said, "For commercial reasons, Biocon revised the process and started manufacturing the said product. The revised process, however, was not updated with the Drug Controller's offices and this was a procedural lapse on the part of the company. Biocon promptly filed the new process seeking a fresh licence, which was issued by the office of the Drugs Control Department, Karnataka (March 2006) and the situation stands rectified."