3 more held in Biocon Biologics injection bribery case

NEW DELHI: In the 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.

The CBI said that they have arrested Guljit Sethi, the Director of Bioinnovat Research Service Private Limited; L. Praveen Kumar, the Associate Voice President and Head of National Regulatory Affairs of Biocon Biologics Limited; and Animesh Kumar, the Assistant Drug Inspector of CDSCO.

The CBI 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, 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 bribe amount of Rs 9 lakh to Reddy for favourably processing the said three files related to Banglore-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, Bengaluru which led to the recovery of incriminating documents.

The Biocon Biologics had issued a statement saying their 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 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 had said.

Further investigation in the matter is underway.