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CBI Court Discharges Former CDSCO Official in 2022 Biocon Biologics Bribery Case

Bribery Case
New Delhi: A special Central Bureau of Investigation (CBI) court at Rouse Avenue in Delhi has discharged former Joint Drugs Controller Dr S. Eswara Reddy and three others in the 2022 Biocon Biologics bribery case, observing that the prosecution failed to establish a prima facie case of bribery, criminal conspiracy or manipulation of the drug regulatory approval process.
In its 60-page order, the court held that the allegations did not raise even suspicion, let alone grave suspicion, and that the evidence presented by the CBI was insufficient to proceed with a trial. The accused were discharged under Section 250 of the Bharatiya Nagarik Suraksha Sanhita (BNSS), 2023, corresponding to Section 227 of the Code of Criminal Procedure (CrPC).
The CBI registered the case in June 2022 under the Prevention of Corruption Act against Dr. Reddy, Animesh Kumar, an official at the Central Drugs Standard Control Organisation (CDSCO), Guljit Sethi alias Guljit Chaudhri, Director of Bioinnovat Research Services, and L. Praveen Kumar, Head of National Regulatory Affairs at Bengaluru-based Biocon Biologics Ltd.
According to the CBI chargesheet, Dr. Reddy allegedly manipulated the Subject Expert Committee (SEC) review of three product approval files submitted by Biocon Biologics. These included a proposal seeking a waiver of Phase III clinical trials for the company's Insulin Aspart Injection. The agency alleged that Reddy proactively participated in the SEC meeting and influenced the proceedings to secure favourable recommendations for the company.
The CBI further alleged that Sethi conspired with Kumar to arrange a bribe of Rs 9 lakh for Dr. Reddy in exchange for processing the three regulatory files. The alleged payment was reportedly routed through Dinesh Dua and others to senior CDSCO officials, reports ET.
On June 20, 2022, during a CBI trap operation, the agency recovered Rs 4 lakh from Dr. Reddy's residence in Chanakyapuri, Delhi, through Dinesh Dua. The CBI claimed that the recovered amount was part of the total promised bribe of Rs 9 lakh. Dua subsequently turned approver in the case and was granted pardon in 2023.
However, while examining the chargesheet and the material placed before it, the court observed that the prosecution had failed to produce direct or circumstantial evidence establishing that Dr. Reddy had demanded illegal gratification. The court emphasised that demand for a bribe was an essential requirement for establishing an offence under Section 7 of the Prevention of Corruption Act and noted that the CBI had failed to establish "when, where and how" Dr. Reddy allegedly demanded Rs 9 lakh.
The court also found no sufficient evidence to establish criminal conspiracy under Section 120B of the Indian Penal Code (IPC). It rejected the allegation that Dr. Reddy had improperly expedited Biocon's proposal seeking a waiver of Phase III clinical trials for Insulin Aspart Injection. According to the court, the proposal had reached the Subject Expert Committee through standard official email communications, without any intervention by Dr. Reddy.
The court further observed that the prosecution had failed to establish that he had dishonestly performed his official duties in exchange for an undue advantage. It concluded that the overall circumstances and evidence did not establish a prima facie case against the accused, making their discharge appropriate.
Reacting to the court's decision, Dr. Reddy told Live Mint, "I have always maintained complete faith in the judicial process, and this discharge order brings substantial relief."
The case had drawn attention in 2022 as Dr. Reddy was among the shortlisted contenders for the country's top Drugs Controller General of India (DCGI) post at the time of his arrest.
M. Pharm (Pharmaceutics)
Parthika Patel has completed her Graduated B.Pharm from SSR COLLEGE OF PHARMACY and done M.Pharm in Pharmaceutics. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

