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Synopsis

The Delhi High Court on Tuesday, granted bail to three officials namely, S Eswara Reddy, L Praveen Kumar, and Dinesh Dua, accused in connection with the Biocon biologics Central Drugs Standard Control Organisation (CDSCO) bribery case. The matter is being probed by the the Central Bureau of Investigation (CBI).

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

Court noted that the charge sheet in the matter has been filed, the investigation has been completed, and voice samples of the accused persons have been taken and stated that while the offence alleged to have been committed (if proven) by the applicants is serious, the trial in the matter would take ample time.

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

The CBI alleged that Dr. L. Praveen Kumar conspired with other co-accused Guljit Sethi to pay Rs.9 Lacs to CDSCO officials for getting favor in matters of Biocon Biologicals Limited pertaining to 3 files, including one file related to waiver of the phase-III clinical trial of "Insulin Aspart Injection" pending in CDSCO, and that Rs.4 Lacs was delivered to the accused S. Eswara Reddy on June 20, 2022.

CBI in its report stated that the matter has huge implications for the country's health standards, which are being jeopardized by the accused persons' collusion, and that the applicants are involved in a serious economic offence with serious implications for the country's health standards and economy.

The Court 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 Organization”.

The court stated another important consideration that the alleged intercepted calls between the accused persons must be weighed against the admissibility, and legality of evidence.

Furthermore, Court stated that though public health would undoubtedly be an issue in relation to a public emergency or the existence of a public safety interest, there is currently nothing on record to indicate the CBI invoking Section 5(2) of the Indian Telegraph Act, 1885.

Accordingly, while granting bail to the three accused the court directed them:

• to surrender their passports before the trial court at the time of submitting their bail bonds
• To keep their mobile phone on at all times and drop a pin on the Google map to ensure that their location is available to the Investigating Officer (IO)

Case Title: Dr. L. Praveen Kumar v. Central Bureau of Investigation