Representational.
New Delhi: Giving a glimpse into the shady sides of drug trials, CBI on Monday arrested a top official accepting bribe for waiving the clinical trial of Biocon Biologics's new drug.
Joint Drugs Controller S. Eswara Reddy allegedly received a ₹4-lakh bribe to waive phase-three clinical trial of Insulin Aspart injection, an underdevelopment product of Biocon Biologics, officials said.
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.
Working for over a month on inputs about the deal, the CBI 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.
The CBI conducted searches at 11 places in Delhi, Noida, Gurugram, Patna and Bengaluru which led to the recovery of incriminating documents and articles.
"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 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.
Biocon spokesperson did not immediately reply to messages and phone calls made for comments.
The CBI has alleged 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.
Source: PTI with edits