The Karnataka government has submitted a report to the Drugs Control General of India asking to investigate Biocon's violation of import norms for the drug Methylcobalamin. The State cannot initiate action on its own as import of drugs comes under procedures of 10 C of CDSCO (Central Drugs Standard Control Organization) Chapter 3 and is overseen by the DCGI.

Methylcobalamin is an advanced intermediate, and sold in India both as a nutraceutical and as a pharmaceutical product. Companies importing the drug under the former category don't require an import licence.
Karnataka Drugs Control Department said that Biocon is not exempted from import rules as Methylcobalamin it has been importing, was never used for production of nutraceuticals.

According to state government sources, Biocon was importing the drug from China under a chemical name' CO (A)- (A) A -(5-6) Dimethyl Benzimidazole CO (B), which the company subjected to
a deviation in process, packed and sold it as manufactured by Biocon. According to officials, this was a change in standard operating procedures (SOPs), under production norms for Methylcobalamin.. This, despite having a manufacturing license dated August 5, 2003, valid till 2006-07.

Hence, action against Biocon was initiated under Section 18 (a) (VI) and 18 (b) of the Drugs and Cosmetics Act 1940 by the state drugs control department.

These violations were detected by officials of the State drugs control department during a routine inspection to the premises of Biocon. The company's manufacturing license was cancelled in January 2006, after which it immediately went on record to admit its procedural lapse. It also got itself a new manufacturing license dated March 8, 2006, valid for three years and also sought an import license especially for Methylcobalamin which is valid up to 2009.

Though the drugs control officials had no complaints about the quality of the drug which they termed as 'top class', they were forced to cancel licenses because of lapses in manufacture and import procedures by the company.

Karnataka Drugs Controller in-charge, Prabha Kumar, confirmed that the new license has been issued and the action had been taken.

When contacted, sources in Biocon stated that it has already accepted the
procedural lapse and has rectified the situation.