New Delhi/Chennai: In a latest development in connection with the CDSCO bribery case, the Central Bureau of Investigation (CBI) on Tuesday arrested all the remaining accused, who were allegedly involved in waiving the Phase-3 trial of ‘Insulin Aspart Injection’ of Biocon Biologics.
Meanwhile, the company in a statement denied the bribery allegations against it and its employees.
The CBI said that they have arrested Guljit Sethi, the Director of Bioinnovat Research Service Private Limited; L. Praveen Kumar, the Associate Vice President and Head of National Regulatory Affairs of Biocon Biologics Limited; and Animesh Kumar, the Assistant Drug Inspector of CDSCO.
The CBI had on Monday arrested E. Eswara Reddy, the Joint Drug Controller (JDC) of Central Drugs Standard Control Organisation (CDSCO) and Dinesh Dua, the Director of Delhi-based Synergy Network India Private Limited. Reddy is currently posted as JDC with CDSCO headquarters in New Delhi.
A case was lodged against Reddy, Dua, Sethi, Praveen and Animesh and others.
“It was alleged that Reddy was trying to exert undue influence on officers of CDSCO to waive the Phase-3 trial of 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 Limited and also for favourably recommending the file of Insulin Aspart injection to the Subject Expert Committee meeting.
The CBI laid a trap wherein Reddy was caught while accepting a bribe of Rs 4 lakh from Dua.
The CBI had on Monday conducted searches at 11 locations in Delhi, Noida, Gurugram, Patna and Bengaluru, which led to the recovery of incriminating documents.
The Biocon Biologics had issued a statement saying its Aspart was approved in Europe and many other countries.
“We deny few allegations reported in India. All our product approvals are legitimate and backed by science and clinical data. Our Aspart is approved in Europe and many other countries. We follow due the regulatory process for all our product approvals by DCGI. The entire application process in India is online and all meeting minutes are in public domain. We are co-operating with the investigation agency,” it said.
Claiming that it adopts global best practices in corporate governance, Biocon 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 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)
