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A day after the Subject Expert Committee (SEC) meeting discussed the Kiran Majumdar Shaw-led Biocon Biologics Limited (BBL)’s Insulin Aspart injection, an executive of her company asked middlewoman Guljit Sethi to modify the recommendations of the committee, the Central Bureau of Investigation (CBI) said.
Agency sources told The New Indian that while investigating the alleged bribery case, they had found that the company had asked Sethi to modify the word ‘data’ to ‘protocol’ in the recommendations of the committee.
Sensational and explosive details have emerged out of the WhatsApp chats shared between L Praveen Kumar, Associate Vice President and Head National Regulatory Affairs (NRA) of Bengaluru-based BBL, and middlewoman Sethi aka Guljit Chaudhary, Director of Bioinnovat, which are part of the CBI charge sheet.
The CBI investigation revealed that on May 18, Praveen Kumar on WhatsApp requested Sethi to check with Animesh Kumar, Assistant Drug Inspector (ADI) Central Drugs Standard Control Organisation (CDSCO), regarding draft SEC minutes and share.
The source said that on May 19, in a WhatsApp chat, Sethi informed Praveen Kumar about the draft SEC.
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She wrote, “After detailed deliberation, the committee recommended for grant of permission to Import and market the drug with the waiver of Phase 3 clinical trial in the country with a condition that firm shall conduct Phase 4 clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and submit the data to this office before placing the drug in the market) as per existing guidelines in the country.”
She described the message as: “Highly confidential. Even the time was set up at 310 pm.” To WhatsApp messages Sethi, the Biocon AVP replied, “Thanks Guljit.”
He then said, “‘And submit the data to this office before placing the drug in market’ means cannot launch the product until Phase IV trial is completed & data submitted to CDSCO? Which is like the Phase Ill trial, we should try to see whether it can get modified as follows:
“…..firm shall conduct Phase 4 clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and get the protocol approved by’ this office before placing the drug in the market) as per existing guidelines in the country,” he said in his message to Sethi.
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The CBI arrested Praveen Kumar, Sethi, S Eswara Reddy, Joint Drug Controller, CDSCO, Animesh Kumar and director of Delhi-based Synergy Network India Private Limited, Dinesh Dua, after registering a case and carrying out searches at 11 locations on June 20. Reddy was caught accepting a bribe of ₹4 lakh to clear an under-trial injection of India’s top drug firm, Biocon Biologics.
A CBI source said, “In its charge sheet, the agency alleged that on May 18 this year, the applications of BBL were taken up in the SEC meeting. During the said meeting, Reddy was present online through Webex.”
The source said that the CBI probe found that the draft recommendation prepared by Animesh Kumar on May 18, in respect of BBL’s applications read: “After detailed deliberation, the committee recommended grant of permission to import and market the drug with a waiver of Phase 3 clinical trial in the country with the condition that firm shall conduct Phase 4 clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and submit the ‘data’ to this office before placing the drug in the market) as per existing guidelines in the country.”
In her WhatsApp message to Praveen Kumar, Sethi wrote, “Firm presented a proposal for import and marketing the drug with a waiver of Phase 3 trial in the country. The firm presented a detailed proposal along with CMC, pre-clinical and clinical trial data. The committee noted that the firm has conducted Phase 1 and Phase 3 trials with the drug in Germany and USA respectively and based on the results of the trial, the drug has been granted marketing authorization by EMA and Health Canada.”
The source said that the CBI during its probe found that on May 20, just a day after the two shared messages to modify the recommendations, Animesh Kumar modified the draft recommendations dated May 18 and substituted the word ‘data’ with ‘protocol’ in the draft recommendations pertaining to BBL as per directions of Reddy.
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The source said that following the conspiracy, thereafter, a draft recommendation pertaining to the aforesaid meeting was finally approved by SEC on May 23.
The new modified recommendations read: “After detailed deliberation, the committee recommended for grant of permission to import and market the drug with a waiver of Phase III clinical trial in the country with the condition that firm should conduct Phase IV clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and submit the ‘protocol’ to CDSCO before placing the drug in the market) as per existing guidelines in the country”.
The source said the CBI probe found that the draft recommendation dated May 18 was “modified by substituting the word from ‘data’ to ‘protocol’ to favour BBL”.
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 the bribe to waive the phase III trial of Insulin Aspart Injection”.
