Bribery case: Biocon Biologics senior executive among 5 arrested

Bribery case: Biocon Biologics senior executive among 5 arrested

India News


The CBI on Tuesday arrested five persons, including Biocon Biologics Associate Vice-President L Praveen Kumar, in connection with the bribery case in which S Eswara Reddy, the Joint Drug Controller (JDC) with Central Drugs Standard Control Organization (CDSCO), was caught allegedly accepting Rs 4 lakh in cash on Monday.

Apart from Kumar and Reddy, others arrested include Dinesh Dua, Director of Synergy Network India Pvt Ltd; Guljit Sethi alias Guljit Chaudhary, Director of Bioinnovat Research Services Private Limited, Delhi; and CDSCO Assistant Drug Inspector Animesh Kumar.

According to the CBI FIR, Reddy had three files of Biocon Biologics pending with him for clearance and bribes had been allegedly negotiated for clearing all of them. Biocon, a company founded by industrialist Kiran Mazumdar Shaw, has denied the CBI allegations, saying it abides by all the rules.

The CBI has alleged that Sethi’s company Bioinnovate used to handle regulatory affairs of Biocon along with several pharmaceutical companies and regularly paid bribes to get regulatory clearances. Bioinnovate had business relations with Dua’s company, Synergy Network, and Dua had been asked by Sethi to allegedly bribe Reddy to waive Phase III trials of Biocon’s Insulin Aspart Injection.

“Sethi… has conspired with Shri L. Praveen Kumar, Associate Vice President and Head — National Regulatory Affairs (NRA) and other senior executives of M/s Biocon Biologics Limited, Bangalore to pay a total bribe amount of Rs 9 lakh to Dr S Eswara Reddy for favourably processing the said three files related to M/s Biocon Biologics Limited, Bangalore and also for favourably recommending the file of ‘Insulin Aspart Injection’ to the Subject Expert Committee (SEC) meeting on 18.05.2022,” the CBI FIR said.

Rejecting the allegations, Mazumdar-Shaw said on Monday, “We deny the bribery allegations. All our product approvals are legitimate and backed by science and clinical data. Our bAspart is approved in Europe and many other countries. The regulatory process in India is online and all meeting minutes are in public domain.”

A similar statement was issued by the spokesperson for Biocon Biologics. “All our product approvals are legitimate and backed by science and clinical data. Our bAspart 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 cooperating with the investigation agency,” the spokesperson said.

According to the CBI, Reddy attended the SEC meeting on May 18 and supported for waiver of Phase Ill clinical trial for the “Insulin Aspart Injection” of Biocon. The agency alleged that Reddy manipulated the Minutes of the Meeting of SEC held on May 18, changing the word “Data” to “Protocol” in the recommendations and “thereby causing substantial wrongful gain to M/s Biocon Biologics Limited”.





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