Biocon Biologics bribery case: CBI seeks custodial interrogation of accused

The Central Bureau of Investigation (CBI), which is conducting a probe into the alleged bribery case involving an official of drug-maker Biocon Biologics and a joint drugs controller, on June 28 moved the Delhi High Court after a special court denied granting them the custody of the accused, news agency PTI reported.

The high court has issued notices to the parties concerned and will hear the case on July 2, the report added.

The CBI had arrested L Praveen Kumar, the Associate Vice President of Biocon Biologics, and S Eswara Reddy, Joint Drugs Controller posted at the Central Drugs Standard Control Organisation (CDSCO) in New Delhi, on June 21.

The federal agency alleged that a bribe, amounting to Rs 4 lakh, was offered to waive the phase-3 clinical trial of ‘Insulin Aspart’ injection, produced by Biocon Biologics. The injection has been developed by the company for the treatment of Type 1 and Type 2 diabetes.

Sources told PTI that CBI officials were disappointed that the special court rejected their application for custody as immediate questioning of the accused arrested through a “trap” is of extreme importance for the agency so they do not get a chance to develop an alibi in their defence.

The CBI, apart from booking Kumar and Reddy, also named Guljit Sethi, Director, Bioinnovat Research Services Pvt Ltd, Dinesh Dua, director at Synergy Network India Pvt Ltd, as well as Assistant Drug Inspector Animesh Kumar in the FIR registered under IPC sections of criminal conspiracy, cheating, forgery and corruption, PTI had reported.

Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, has denied the allegations levelled against the company’s officials. “It is unfortunate that Biocon Biologics has been named in this controversy. We reiterate that we strongly condemn all acts of bribery and corruption and have been cooperating with the investigation agency,” it said.

“We strongly deny the allegations of bribery against the company and its officials associated with the approval process of one of our products in India,” the company added.

According to PTI, the CBI has alleged that Sethi, acting as a conduit for Biocon Biologics, conspired with Praveen Kumar, head of the company’s National Regulatory Affairs (NRA), and other senior executives of the company to pay Reddy a total bribe of Rs 9 lakh.

Reddy had attended the Subject Expert Committee (SEC) on May 18, 2022, and supported the waiver of phase-3 clinical trial for Insulin Aspart injection, the CBI has reportedly alleged in the FIR.

Biocon Biologics, which has rejected the allegations, said the SEC on May 18 noted that the company had conducted phase-1 and phase-3 trials with Aspart in Germany and USA, and based on the results of this global trial, Aspart has been granted marketing authorisation by European Medicines Agency (EMA) and Health Canada.

“Biocon Biologics follows due regulatory process for all our product approvals by the DCGI. The entire application process in India is online and all meeting minutes can be found on the website of the Central Drugs Standard Control Organisation (CDSCO),” it added. Moneycontrol