 "Biocon")
The Central Bureau of Investigation (CBI) on Tuesday moved the Delhi High Court seeking the custody of officials accused of allegedly demanding bribes to waive the Phase-3 trial of "Insulin Aspart Injection", produced by Biocon Biologics.
Earlier, a special court refused to allow the custody of the accused.
Issuing notices to the respondents in the matter, the court posted it for further hearing on July 2.
On June 21, the CBI had arrested 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 Organisation (CDSCO) for allegedly demanding bribe to waive the Phase-3 trial of "Insulin Aspart Injection".
E. Eswara Reddy, the Joint Drug Controller at the CDSCO's headquarters in the national capital, and Dinesh Dua, the Director of Delhi-based Synergy Network India Private Ltd, were also arrested.
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A case was lodged against Reddy, Dua, Sethi, Praveen Kumar, Animesh Kumar, and others, alleging that Reddy was trying to exert undue influence on officers of the CDSCO to waive the Phase-3 trial of the Insulin Aspart Injection. The accused agreed to pay a bribe amount of Rs 9 lakh to Reddy for favourably processing the said three files related to Bengaluru-based Biocon Biologics Ltd and also for favourably recommending the file to the Subject Expert Committee.
Reacting to the allegations, Biocon, claiming that it adopts global best practices in corporate governance, said that the rationale for waiver of Phase 3 clinical trials was based on the following Indian regulatory guidance {Similar Biologics Guidelines 2016 & New Drugs and Clinical Trials 2019 (GSR 227 E)}.
The guidelines provide a framework for waiver of Phase 3 clinical trials to be conducted in India based on a commitment to undertake Phase 4 trial, the design of which should be approved by the Central Licencing Authority, Biocon said.
"In line with the above regulations, Biocon Biologics presented a proposal for import and marketing of Insulin Aspart with a waiver of Phase 3 clinical trial in India. The company presented a detailed proposal along with CMC, pre-clinical and clinical trial data," the company said.
According to Biocon, after detailed deliberation, the Subject Expert Committee (Endocrinology and Metabolism) at the CDSCO recommended for grant of permission to import and market the drug with waiver of Phase 3 clinical trial in the country with the condition that the firm should conduct Phase 4 clinical trials in India.
--IANS
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