Panasam Akshara , Delhi HC , Jun 29, 2022
Central Bureau of Investigation (CBI)moved to Delhi High Court seeking the custody of officials accused in Biocon case.Earlier custody was refused by a special court.The officials were accused for allegedly demanding bribe to waive off phase-3 trial of ' Insulin Aspart Injection ' that's been produced by Biocon Biologics.The court has now issued notices to the respondents,and posted it for July 2.
Earlier on June 21, many officials were arrested by the CBI such as Guljit Sethi,the director of Bioinnovat Research Service Private Ltd,L.Praveen Kumar,the Associate Vice President and Head of National Regulatory Affairs of Biocon Biologics and Animesh Kumar,the Assistant Drug Inspector of the Central Drugs Standard Control Organization (CDSCO) for demanding bribe.A case was lodged against them for exertion of undue influence on officers to waive off the phase-3 trials.
The accused also agreed to pay bribe amount of Rs 9 lakh to Reddy for processing the given 3files relating to Biocon.Biocon while replying to the allegations says that waiver was based on the regulatory guidance under (Biologics Guidelines 2016 & New Drugs and Clinical Trials 2019(GSR 227E).It claims to practice the best corporate governance in the global market .As per Biocon,after due deliberation CDSCO has recommended to import and market the drug waiving phase-3 trial with a condition to conduct phase-4 trials in India.