Biocon Bribery Case: Delhi HC grants bail to Joint Drug Controller, 2 others

Justice Anu Malhotra granted bail to Joint Drug Controller at CDSCO, S. Eswara Reddy; associate vice president of Biocon Biologics, Dr. L. Praveen Kumar; and director at Synergy Network India Private Limited, Dinesh Dua on a personal bond of Rs 1 lakh each with two sureties of the like amount.

In June this year, CBI had filed an FIR under sec. 120B, 420, 468, 471 of the Indian Penal Code, 1860 and sec. 7, 7A and 8 of the Prevention of Corruption Act, 1988.

Medical Dialogues team had earlier reported that CBI had filed a charge sheet against five persons in the Rs 9 lakh bribery case.

Also Read: Rs 9 Lakh Biocon Bribery Case: CBI Charge Sheet Against Joint Drug Controller, Biocon Biologics Executives

The agency has claimed that the bribe was allegedly for favourably recommending the file of Insulin Aspart Injection to the Subject Expert Committee (SEC) meeting on May 18 for waiving the phase 3 clinical trial.

The agency, in its charge sheet filed on August 18, alleged that the bribe payment was made to Reddy after clearance from Kumar.

The agency has also named Dua, who allegedly gave the bribe to Reddy; Guljit Sethi, an alleged conduit of Biocon Biologics; as well as assistant drug inspector Animesh Kumar in the charge sheet.

The high court opined that the alleged offences in question were grave. However, while granting relief it observed that though the offence alleged is grave, the trial in the matter would take ample time. The Court observed;

"On a consideration of the entire available record, taking into account the factum that the charge sheet in the matter has been filed and the investigation in the matter has also been completed and voice samples of the accused persons have been taken, though undoubtedly the offence alleged to have been committed (if proved) by the applicants is grave, the trial in the matter would take ample time," it said.

It also considered that the investigation in the case was complete, voice samples of the accused persons were also taken and the charge sheet has been filed and the trial in the matter would take ample time.

"The applicants, i.e., Dr. L. Praveen Kumar, Dinesh Dua, and S. Eswara Reddy apparently are not flight risks and are thus allowed to be released on bail on their furnishing a personal bond in the sum of Rs. one lakh each with two sureties of the like amount," the court noted.

In its order granting bail to the three accused who were arrested in June, the high court noted that there was nothing to indicate that in spite of the recommendation made by the SEC, the same has been so far approved and given effect by the Drug Controller General of India of the Central Drugs Standard Control Organisation. It observed;

"There is nothing to indicate that despite the recommendation made by the Special Expert Committee for waiver of Phase-III clinical trial in the country to M/s Biocon Biologics to import and market Insulin Aspart Injection for the treatment of the diabetic condition subject to the condition that the Phase-IV clinical trial in India would be conducted which also includes a sub-set population to generate pharmacokinetic/ pharmacodynamic (PK/PD) and immunogenicity and to submit the protocol to CDSCO before placing the drug in the market as per guidelines in the country that the said recommendation of the SEC has so far been approved and given effect to by the Drug Controller General of India of the Central Drugs Standard Control Organisation."

"The submission of the said applicant (Reddy) that it is only after the approval of the minutes of the SEC members that the minutes are published on the CDSCO website by the concerned authority has also to be taken into account as has already been observed herein above there is nothing on the record to indicate that the approval of the recommendation of the SEC has been approved by the Drugs Controller General of India," it added.

The court further noted that the alleged recovery in the instant case was not pursuant to any usual trap proceedings and the consideration of the credibility of circumstantial evidence would have to be assessed and the offences alleged to have been committed are punishable with imprisonment to a maximum of seven years of imprisonment.

Biocon Biologics, a subsidiary of the Kiran Mazumdar Shaw-led Biocon, has denied the allegations of bribery.

PTI reports that the bail pleas were opposed by the CBI on the ground that the matter has huge implications on the economy and the health standards of the country, which were being compromised by the accused persons by indulging in a conspiracy with each other.

It also said that the accused persons could influence the investigation and tamper with the evidence, being in influential positions.

To view the full order, click on the link below: