Joint drugs controller nabbed taking bribe to clear Biocon Biologics's diabetes injection
The CBI on Monday apprehended Joint Drugs Controller S Eswara Reddy for allegedly receiving a Rs 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 Reddy, posted at CDSCO headquarters, L Praveen Kumar, Associate Vice President and Head-National Regulatory Affairs (NRA), Biocon Biologics Limited, Bangalore; 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 Dua was caught giving Rs 4 lakh bribe to Reddy of the total promised amount of Rs 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 them off can have serious public health safety repercussions,'' an official said.
The CBI has also named Guljit Sethi alias Guljit Chaudhary, Director, Bioinnovat Research Services Private Limited, Delhi; and Animesh Kumar, Assistant Drug Inspector (ADI), CDSCO, New Delhi, in its FIR.
Bioinnovat and Synergy Network have business dealings hence Dua agreed to make the bribe payment, the probe agency has alleged.
Denying allegations, a Biocon Biologics spokesperson said, ''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,'' he said.
The spokesperson said the company is cooperating with the investigation agency.
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 Rs 9 lakh to 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 Rs 4 lakh from the director of a Delhi-based private company. The said director was also caught,'' CBI spokesperson R C Joshi said.
(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)
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- Directorate General of Health Services
- Biocon Biologics Limited
- Mazumdar Shaw
- Eswara Reddy
- C Joshi
- Chairperson Kiran
- Central Drugs Standard Control Organisation
- Guljit Sethi
- Expert Committee
- Synergy Network
- L Praveen Kumar