Biocon Biologics injection bribery case: CBI arrests joint drugs controller, private person

Tribune News Service

Tribune News Service

New Delhi, June 21

The CBI today said that it has arrested Joint Drugs Controller S Eswara Reddy for allegedly accepting a bribe of Rs 4 lakh from a conduit to waive the Phase 3 clinical trial of the ‘Insulin Aspart’ injection, which has been an under development product of Biocon Biologics to manage Type 1 and Type 2 diabetes. Biocon Biologics is a subsidiary of Bangalore-based Kiran Mazumdar Shaw-led Biocon.

Officials in the agency said the CBI has also arrested Dinesh Dua, director at Synergy Network India Private Limited, who was allegedly giving Reddy a bribe. They also indicated that several more arrests are likely in the case.

Reddy, posted at the Central Drugs Standard Control Organisation (CDSCO) in New Delhi, and Dua were apprehended and detained yesterday following a trap laid by the CBI and the alleged bribe was being exchanged.

The accused persons were arrested after the necessary paperwork was completed, the officials said.

Besides Dua and Reddy, the CBI has also booked Associate Vice President of Biocon Biologics Ltd, Bangalore, L Praveen Kumar, Director, Bioinnovat Research Services Pvt Ltd, Delhi, Guljit Sethi as well as Assistant Drug Inspector Animesh Kumar in the FIR, which has been registered under various sections of the IPC pertaining to conspiracy, cheating, forgery and corruption.

A spokesperson for Biocon Biologics is reported to have said, “We deny the bribery allegations made in certain media stories. All our product approvals are legitimate and backed by science and clinical data. Our bAspart is approved in Europe and many other countries.”

The spokesperson further said, “We follow due regulatory process for all our product approvals by DCGI (Drugs Controller General of India). The entire application process in India is online and all meeting minutes are in the public domain. We are cooperating with the investigation agency.”

The CBI has alleged that Sethi, acting as a conduit for Biocon Biologics, conspired with Praveen Kumar, head of the company’s National Regulatory Affairs (NRA), and other senior executives of the company to pay Reddy a total bribe of Rs 9 lakh.

This was for favourably recommending the file of “Insulin Aspart Injection” to the Subject Expert Committee (SEC) meeting on May 18, 2022 for waiving the Phase 3 clinical trial, it alleged.

Reddy had attended the SEC meeting on May 18, 2022 and supported the waiver, the CBI has alleged in the FIR, while further contending that he manipulated the minutes of the meeting of SEC held that day by changing some key words in the recommendations, giving “substantial wrongful gain” to the company.

The CBI was working on the sensational case for over a month after getting inputs that Reddy was dealing with the processing of files related to applications for approval of drugs and vaccines by various pharmaceutical companies.

The central agency, which was following Reddy’s activities, learnt that three files of Biocon Biologics, including one related to the waiver of the Phase 3 clinical trial of the under development Insulin Aspart Injection, was referred to him for processing and approval.

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