‘Product approvals legitimate’: Kiran Mazumdar-Shaw on bribe allegations against Biocon 

Hours after bribery allegations against a subsidiary of biopharmaceuticals firm Biocon -- Biocon Biologics-- surfaced, Executive Chairperson Kiran Mazumdar-Shaw took to Twitter to refute them. She denied these allegations and said product approvals are legitimate and backed by science and clinical data.  

She was replying to a Twitter user who shared the news item regarding Biocon. Shaw wrote, “We deny the allegations made in the PTI story. All our product approvals are legitimate and backed by science and clinical data. Our bAspart is approved in Europe and many other countries. The regulatory process in India is online and all meeting minutes are in public domain.” 

An official spokesperson of the company also denied these allegations in a statement. The statement shared on the official Twitter handle of Biocon Biologics read, “We deny the allegations made in the PTI story. All our product approvals are legitimate and backed by science and clinical data. We follow due process for all our product approvals by DCGO. bApsart is approved in Europe. We are cooperating with the investigation agency.” 

Central Bureau of Investigation (CBI) apprehended Joint Drugs Controller S Eswara Reddy for allegedly receiving Rs 4 lakh bribe to waive phase-three clinical trial of Insulin Aspart injection, an underdevelopment product of Biocon Biologics.  

After getting inputs about an exchange of bribesthe , the CBI registered a case of criminal conspiracy and corruption against Reddy, posted a CDSCO headquarters, and Dinesh Dua, Director at Synergy Network India Private Limited, among others.  The CBI carried out a raid and Dua was caught giving a Rs 4 lakh bribe to Reddy of the total promised amount of Rs 9 lakh on behalf of Biocon Biologics. 

An official told news agency PTI, “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.” 

Others named in the FIR include Associate Vice President and Head of National Regulatory Affairs at Biocon Biologics L Praveen Kumar, Director of Bioinnobvat Research Services Private Linited Guljit Sethi (alias Guljit Chaudhary) and CDSCO Assistant Drug Inspector (ADI) Animesh Kumar.  

(With inputs from PTI) 

Also read: Joint drugs controller nabbed taking bribe to clear Biocon Biologics’ diabetes injection