CBI arrests Jt Drug Controller, Biocon Biologics execs over fishy approvals

All five apprehended will be presented in court on Tuesday afternoon, agency to seek police custody

The Central Bureau of Investigation (CBI) alleged that senior officials of the Central Drugs Standards Control Organisation (CDSCO) colluded with Bengaluru-based pharmaceutical company Biocon Biologics to waive the phase-3 clinical trial of the Insulin Aspart injection, and also “manipulated” the minutes of the subject expert committee (SEC) meeting causing “substantial wrongful gain” to Biocon Biologics.

India’s Joint Drugs Controller Eswara Reddy was arrested on Tuesday by the investigating agency along with L Praveen Kumar, associate vice-president and head of national regulatory affairs (NRA) at Biocon Biologics. Guljit Sethi (alias Guljit Chaudhary) of Bioinnovat Research Services and Dinesh Dua, director of Synergy Network – both of whom allegedly acted as “conduits” on behalf of pharma companies – were arrested along with Animesh Kumar, assistant drug inspector at CDSCO. CBI sources said that all five were presented in court on Tuesday afternoon and that the agency had sought police custody.

In a statement, Biocon Biologics 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 CBI has alleged that Sethi, who has been handling government regulatory work for Biocon Biologics, conspired with Praveen Kumar and other senior executives to pay Rs 9 lakh as a bribe to Reddy. The money was allegedly offered in lieu of a favourable recommendation on the Insulin Aspart injection at an SEC meeting on May 18 for waiving phase-3 clinical trials, the agency said. 

Insulin Aspart has already been approved in the EU. While regulators in many countries approve drugs based on approvals already received in regulated markets, at times they also seek local clinical trial data.

In its FIR, the CBI has said Reddy had attended the SEC meeting on May 18, and had also supported the waiver. Not only that, the agency goes on to add that Reddy allegedly “manipulated” the minutes of the SEC meeting held that day by changing some key words like replacing “data” with “protocol”, thereby giving “substantial wrongful gain” to the company.

Three files of Biocon Biologics, including one related to the waiver of phase-3 clinical trials, was referred to him for processing and approval. The agency was acting on inputs it received that Reddy was dealing and processing files related to applications for drug approvals and vaccines by various pharmaceutical companies.

In fact, Sethi was acting on behalf of several pharmaceutical companies and was allegedly delivering bribes to various senior CDSCO officials through Dua on various occasions, the CBI said.

In the case of Biocon, Sethi conspired with Kumar and other CDSCO officials to include the Biocon Biologics file for the SEC meeting held on June 15, and Kumar received a bribe of Rs 30,000 for this, the CBI FIR noted.

It added that Reddy met Dua in the CDSCO office on June 15 in connection with the approval of the third file. The CBI said Reddy assured Dua of a favourable outcome. Later in the day, Kumar allegedly informed Sethi that the file had been approved in the SEC meeting.

The FIR further states that Reddy shared his residential address at Chanakyapuri, New Delhi, with Dua. Kumar allegedly agreed to pay Rs 9 lakh to Reddy, and Sethi arranged for a part of the bribe to be delivered to Reddy at his residence on June 20, the CBI said.

The CBI said these acts prima facie disclose criminal conspiracy, cheating, and forgery and thus a case has been registered against them.

What the FIR says

•    Guljit Sethi acted on behalf of several pharma cos to deliver bribes to CDSCO officials

•    Sethi was handling government regulatory work for Biocon Biologics

•    Dinesh Dua was working with Sethi to deliver bribes to CDSCO officials 

•    L Praveen Kumar of Biocon Biologics agreed to pay Rs 9 lakh to Eswara Reddy for favourable outcomes for 3 files 

•    Reddy attended SEC meeting on May 18 and supported waiver of phase 3 clinical trials of insulin Aspart

•    Reddy and Dua met in CDSCO office on June 15 

•    Reddy assured Dua of favourable outcome in SEC meeting on June 15

•    Biocon Biologics file approved on June 15

•    Sethi asks Dua to deliver part of agreed sum of bribe to Reddy

•    Reddy asks Dua to meet at Chanakyapuri residence 

•    Dua delivers part of the bribe to Reddy on June 20