On July 23, S Eswara Reddy, Joint Controller of Central Drugs Standard Control Organisation (CDSCO), was sanctioned for prosecution by the government, marking a key step forward in the trial against him. He is alleged to have taken bribes to endorse an insulin injection developed by Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw’s Biocon.
The prosecuting sanction was presented to a special court by the Central Bureau of Investigation (CBI) with the backing of the Union Ministry for Health and Family Welfare’s Director (Vigilance). This follows Reddy’s suspension and subsequent reinstatement last year, along with Animesh Kumar, Assistant Drugs Inspector and co-accused in the case.
The series of arrests last June, also ensnared Biocon Biologics’ Associate VP L Praveen Kumar and director of Synergy Network India Private Limited, Dinesh Dua, who allegedly funnelled Rs 4 lakh as a bribe to Reddy. Guljit Sethi, presumed to be a conduit for Biocon Biologics, was also taken into custody.
The bribery case allegedly revolves around bypassing Phase 3 clinical trials for Biocon’s ‘Insulin Aspart’ injection, a product for managing diabetes. Biocon Biologics has adamantly denied these allegations.
The prosecution sanction, which was a prerequisite for beginning legal proceedings against a government official under the Prevention of Corruption Act, was pending till now. The chargesheet filed by the agency in August last year implicated Reddy and his accomplices.
In the face of these accusations, Biocon has maintained its innocence and adherence to global regulatory science best practices. The company points to its numerous regulatory approvals in International Council for Harmonisation (ICH) countries as a testament to its commitment to due process. They insist that the approval of Insulin Aspart was within the bounds of Indian and international regulations and deny any wrongdoings in its endorsement.
