Allegations 'serious' & 'grave', says special court in Biocon Biologics case

A special court dealing in a bribery case allegedly involving Biocon Biologics, a top official of the central drug regulator and Director of a Delhi based company has said the allegations were “not only serious … but of grave nature”.

The special CBI court, in an 80-page order rejecting the bail pleas of all the five accused in the case earlier this week, said: “The questions involved are with larger ramifications to the welfare of the common public and the credit/reputation of the institution of which the applicant/public servants involved are associated.”

It is alleged that the Director of a Delhi based company hired by Bengaluru-based Biocon’s subsidiary Biocon Biologics for securing regulatory approvals bribed government officials to facilitate product approvals for Biocon Biologics, an allegation the Bengaluru based drug maker has denied.


The CBI last month arrested S Eswara Reddy, joint drug controller Central Drugs Standard Control Organisation (CDSCO); L Praveen Kumar, Biocon Biologics head of national regulatory affairs; Animesh Kumar, an assistant drug inspector of the CDSCO and two others including a person who allegedly acted as a conduit.

The CBI has alleged that the conduit, Director of a Delhi based company, acted as a middleman for several pharmaceutical companies.


According to the order, seen by ET, it cannot be ruled out that releasing them on bail could lead to them influencing yet-unexamined witnesses and others who the prosecution might be intending to enquire from.

Refusing to concur with the contentions raised by the accused, the court said: “Merely, because accused are having permanent residences and hold suited credentials in society and are equipped with higher education and may be willing to tender undertakings and are stating themselves to be a non?flight risk … at this stage the benefit (of bail) cannot be extended."

The court has taken stock of recorded phone conversations purportedly between two co-accused. It reproduced an excerpt of the alleged conversation between the assistant drug inspector and an alleged conduit, Guljit Singh, which says: “Apki file pe progress ho gaya (there has been progress in your file)”.

The assistant drug inspector tried to justify the call, stating that it was a “normal practice” to receive calls from those whose files were pending. He claimed he was not paid a single penny by the co-accused and that he was merely informing Sethi about the status of her file. He claimed that he had raised 13 objections on a file pertaining to Biocon Biologics.

The court, however, held that when the entire application process was made online and he claimed that he had raised 13 objections on Biocon Biologics’ file on the portal itself, the need to share his personal contact number with an official of the applicant and the requirement of a direct connect sidelining the online process was “unexplained”.

Biocon Biologics has denied any wrongdoing. A spokesperson for Biocon Biologics, in a news release on Tuesday, said: “Whilst we are disappointed that bail was not granted to our employee, L Praveen Kumar, we have complete faith in the Indian judicial system. We will continue to extend our full cooperation to the investigative agencies and take appropriate steps as per law.”

Guljit Sethi, an alleged conduit, told the court that she was hired by Biocon Biologics for doing “regulatory work”. She placed on record the agreement dated December 2019 and an invoice dated June 15, 2022.

The court, in its order on Tuesday, observed that the agreement was for only two years and expired before she extended service as per the June 15 invoice on three files of Biocon Biologics. It added that the genuineness of the agreement and invoice was “a subject of trial”.

The two arrested officials of the drug controller alleged that they had “been mischievously framed in proceedings at the instance of their rivals intending to prevent them from climbing the promotional ladder”. The court, however, held that it “is another averment which is vague and unsupported”.

In a related development, the court has allowed the CBI’s plea to record voice samples of the accused, and noted that the accused were willing to provide voice samples. It has directed the director of the Central Forensic Science Laboratory, New Delhi, to submit to it a transcript of the recorded conversation in a sealed envelope.

The CBI has alleged that Sethi conspired with Kumar and other executives of Biocon Biologics to pay a bribe of Rs 9 lakh to Reddy for "favourably processing three files" related to the company’s insulin aspart injection.

According to the FIR, which ET has seen, "information revealed" that Reddy attended the subject expert committee (SEC) of CDSCO on May 18 and supported the waiver of the phase-III clinical trial for the product.

It also alleged that Reddy manipulated the minutes of the meeting of the SEC by changing the word "data" to "protocol" in the recommendations made, "thereby causing wrongful gain" to the company.

The company said that all its product approvals were legitimate and backed by science and clinical data.