Biocon subsidiary caught offering bribe to waive off trial of new drug

The CBI on Monday, June 20, 2022, apprehended Joint Drugs Controller S. Eswara Reddy for allegedly receiving a ₹4-lakh bribe to waive phase-three clinical trial of Insulin Aspart injection, an underdevelopment product of Biocon Biologics, officials said.

After getting inputs about an exchange of bribe, the CBI registered a case of criminal conspiracy and corruption against Mr. Reddy, posted at the CDSCO headquarters, and Dinesh Dua, Director at Synergy Network India Private Limited, among others.  The CBI, which was working on the input for over a month, carried out a raid and Mr. Dua was caught giving ₹4-lakh bribe to Mr. Reddy of the total promised amount of ₹9 lakh on behalf of Biocon Biologics, a subsidiary of Kiran Majumder Shaw-led Biocon, officials said.

“Phase 3 clinical trial is an important regulatory mechanism to assess the safety of a pharma product. Any attempt to waive it can have serious public health safety repercussions,” an official said.

The CBI has alleged that the regulatory work of Biocon Biologics was looked after by Guljit Sethi of Bioinnovat Research Services Private Ltd. Bioinnovat and Synergy Network have business dealings hence Mr. Dua agreed to make the bribe payment, the probe agency has alleged.

The others named in the FIR include Mr. Guljit Sethi alias Guljit Chaudhary, Director,  Bioinnovat Research Services Private Limited, Delhi; L. Praveen Kumar, Associate Vice-President and Head-National Regulatory Affairs (NRA), Biocon Biologics Limited, Bengaluru; and Animesh Kumar, Assistant Drug Inspector (ADI), CDSCO, New Delhi.

The CBI has alleged that executives of Biocon Biologics were trying to exert undue influence on officers of Central Drugs Standard Control Organisation (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare, to waive the phase 3 trial of ‘Insulin Aspart Injection’, officials said.

It was alleged that they agreed to pay a bribe of ₹9 lakh to Mr. Reddy for “favourably processing” three files related to Biocon Biologics and also to favourably recommend the file of “Insulin Aspart injection” to the Subject Expert Committee (SEC) meeting, they said.

“The CBI laid a trap wherein the JDC of CDSCO was caught while accepting a bribe of ₹4 lakh from the director of a Delhi-based private company. The said director was also caught,” CBI spokesperson R.C. Joshi said.

The CBI conducted searches at 11 places in Delhi, Noida, Gurugram, Patna and Bengaluru which led to the recovery of incriminating documents and articles, he said.

Biocon denies allegations

A spokesperson on Biocon Biologics has denied 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. 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,” the spokesperson said.