The CBI on Monday apprehended Joint Drugs Controller S Eswara Reddy for allegedly receiving a Rs 4 lakh bribe to waive the Phase 3 clinical trial of Insulin Aspart injection, an under-development 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 it 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.
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 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.
A similar statement was also tweeted by Biocon Executive Chairperson Kiran Mazumdar Shaw.
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.
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.