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CBI arrests Biocon Biologics official in bribery case involving joint drugs controller

The federal agency has 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.

June 22, 2022 / 04:59 PM IST
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The Central Bureau of Investigation (CBI) has arrested L Praveen Kumar, the Associate Vice President of Biocon Biologics, in the bribery case involving Joint Drugs Controller S Eswara Reddy, news agency PTI reported on June 21.

The federal agency has 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, according to the PTI report. The injection has been developed by the company for treatment of Type 1 and Type 2 diabetes.

The arrest of Praveen Kumar was reported hours after the CBI confirmed that it has taken Reddy into its custody.

Dinesh Dua, director at Synergy Network India Private Limited who was allegedly giving Reddy a bribe, has also been arrested, officials told PTI.

Reddy, posted at the Central Drugs Standard Control Organisation (CDSCO) in New Delhi, and Dua were nabbed on June 20 during a trap operation while the alleged bribe exchange was going on. They were arrested after the necessary paper work was completed, the officials added.


Besides Dua, Reddy and Praveen Kumar, the CBI has also booked Guljit Sethi, Director, Bioinnovat Research Services Pvt Ltd, as well as Assistant Drug Inspector Animesh Kumar in the FIR registered under IPC sections of criminal conspiracy, cheating, forgery and corruption, according to the PTI report.

Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, issued a fresh statement to distance itself from the bribery row. "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 co-operating 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 Organization (CDSCO)," it added.

Reddy came under the CBI's radar after the agency learnt that three files of Biocon Biologics, including one related to the waiver of the phase 3 clinical trial of Insulin Aspart injection, was referred to him for processing and approval, the PTI report claimed.

The CBI also received information that Sethi handled government regulatory works related to Biocon Biologics and had business relations with Dua, the news agency further reported, citing the details from the FIR.

The investigators dug into her background to find that she had several pharmaceutical companies as her clientele, the report added.

She allegedly delivered huge bribes through Dua and others to senior officers of CDSCO on different occasions for processing the files favourably on behalf of her clients, the PTI report said, citing officials privy to the case.

Sethi also allegedly conspired with Animesh Kumar and other officers for including the Biocon Biologics file for the SEC meeting on June 15 on payment of Rs 30,000 in bribe to Kumar, the report added, citing the accusations made by the CBI.

Praveen Kumar allegedly gave Sethi the go ahead to pay a total bribe of Rs 9 lakh to Reddy, the PTI report further noted, based on the inputs its received from CBI officials.

(With PTI inputs)
Moneycontrol News
first published: Jun 21, 2022 06:17 pm
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