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The CBI charge sheet in the bribery case states that the WhatsApp chat between senior Biocon Biologics Limited official L Praveen Kumar and Guljit Sethi aka Guljit Chaudhary has revealed that the pharma giant was trying to waive off the trial of the Insulin Aspart injection
The explosive chats over WhatsApp between a private employee and that of Kiran Mazumdar-led Biocon have now become part of the sensational charge sheet in the bribery scandal involving the licence of an important drug being used to cure diabetes in India.
The Central Bureau of Investigation (CBI) charge sheet in the bribery case stated that the WhatsApp chat between L Praveen Kumar, Associate Vice President and Head National Regulatory Affairs (NRA) of Bengaluru-based Biocon Biologics Limited (BBL), and Guljit Sethi aka Guljit Chaudhary, has revealed that the pharma giant was trying to waive off the trial of the Insulin Aspart injection.
The source said, in her WhatsApp message to Praveen Kumar, Sethi wrote: “Have to make the invite happen.” Praveen Kumar replied, “Yeah Guljit. Please discuss with Dr (S Eswara) Reddy and get it included.”
Sethi then responded to Praveen Kumar’s message, saying, “DI has to process. These are older apps. Will do.” Praveen Kumar then replied, “Ok, thanks Guljit.”
According to the CBI, almost a month after submitting four applications for Insulin Aspart with the Central Drugs Standard Control Organisation (CDSCO)’s SUGAM portal, Praveen Kumar had asked Sethi to include the waiver of the Phase III trial of Insulin Aspart Injection in the agenda.
The CBI filed a charge sheet against the five accused on August 19 this year. The court is yet to take cognizance of the charge sheet. Besides Praveen Kumar and Sethi, the CBI has named Joint Drugs Controller S Eswara Reddy, Assistant Drug Inspector (ADI) Animesh Kumar and director of Delhi-based Synergy Network India Private Limited Dinesh Dua.
According to the sources, the CBI, in its charge sheet, has alleged that the Bengaluru-based Biocon Biologics had requested permission from the CDSCO to grant permission to import and market the drug Insulin Aspart. The company also requested a waiver of local clinical trials on the basis of already generated clinical data.
An agency source told The New Indian, “On April 19, 2022, Praveen Kumar shared the details of the applications with Sethi, director of Delhi-based Bioinnovat Research Private Limited, in WhatsApp chat.”
The source said that the applications were marked by Jayant Gangakhedkar, Assistant Drug Controller (ADC), the nodal officer to the reviewing officers – Chinmay Patel, Drug Inspector (DI); Animesh Kumar, ADI and Navin Yadav, DI on April 20.
The source said that almost a month after the request was made, Sethi shared the invitation letter dated May 13, 2022 (the proposal of BBL was not included in this), sent by CDSCO to the experts regarding the SEC meeting scheduled to take place on May 18, with Praveen Kumar on WhatsApp.
The source further said that the CBI probe also revealed that, thereafter, an email dated May 16 was sent by Amita Nawani of Biocon Biologics Ltd to CDSCO requesting therein for inclusion of the applications related to Insulin Aspart in the upcoming SEC dated May 18.
The source said, during the probe, it was found that after receiving the email from Nawani, on May 17, Reddy directed Jayant Gangakhedkar to include the agenda of BBL in the upcoming SEC meeting on May 18.
“Accordingly, on the same day, Gangakhedkar directed Animesh Kumar to put up the proposal for sending the same to the SEC division for including the agenda of BBL as additional agenda in the SEC Meeting scheduled on May 18.
“As directed by Gangakhedkar, Animesh Kumar put up the said proposal on May 17 and marked the same to Gangakhedkar who further marked the proposal to AK Pradhan, Joint Drug Controller, SEC Division, CDSCO.
“Thereafter the invitation letter dated May 17 was sent to the experts mentioning the agenda of BBL,” the source said.
The CBI then also found the WhatsApp chats of Praveen Kumar and Sethi on May 17, where Sethi said, “Am At DcGi working on Insulin Aspart. You should receive the SEC invite for tomorrow… Have prepared Dr Reddy for the same.”
“Thereafter, Praveen Kumar shared with Sethi an invitation letter dated May 17 sent by CDSCO to the experts regarding the additional agenda of Biocon Biologics Limited in respect of Insulin Aspart for inclusion of the same in the SEC meeting scheduled to take place on May 18,” the source revealed.
The source said that its probe also found that on May 18, the applications of BBL were taken up in the SEC meeting.
“During the said meeting, Reddy was present online through Webex. The draft recommendations of the meeting pertaining to the biological division were prepared by Animesh Kumar,” the source added.
Earlier, on June 20, the CBI carried out searches at the premises of Reddy. He was caught accepting a bribe of ₹4 lakh to clear an under-trial injection of India’s top drug firm, Biocon Biologics.
Besides Reddy, the CBI also arrested Dua for giving the bribe. The CBI arrested Praveen Kumar, Sethi, and Animesh Kumar later.
The agency also carried out searches at 11 locations in Delhi, Noida, Gurugram, Bihar’s Patna, and the tech city of Bengaluru where Biocon’s headquarters is situated.
The CBI has registered an FIR in which, along with Reddy and Dua, it has named Sethi, Praveen Kumar, Animesh Kumar and other unknown officials of CDSCO. Reddy was paid a bribe to waive the phase III trial of Insulin Aspart Injection”.
