New Delhi: CBI Three people, including Bengaluru-based L Praveen Kumar, Associate Vice President and Head-National Regulatory Affairs, were arrested on Tuesday. Biocon Biologics Ltd.a company established by Kiran Mazumdar-ShawIn connection with their investigation into the alleged nexus between the officials of certain pharma firms and Central Drugs Standard Control Organization (CDSCO).
Those arrested include Guljit Sethi of Bioinnovate Research Services, Delhi and Animesh Kumar, Assistant Drug Inspector, CDSCO.
The agency had on Monday arrested Joint Drug Controller S Easwar Reddy and Synergy Network India Pvt Ltd director Dinesh Dua. Both of them were also formally arrested on Tuesday, taking the total number of arrests in the alleged bribery case to five.
The FIR, filed by the CBI in the alleged bribery case involving pharma companies and drug control officials, claimed that Central Drugs Standard Control Organization (CDSCO) officer S Easwar Reddy, who was processing files related to applications for approval of drugs and vaccines were working. Three files of Biocon Biologics Ltd, Bengaluru were sent to various pharma companies, one of which pertains to the relaxation of Phase III clinical trials of “insulin aspart” injection. TOI has reviewed the FIR.
Mazumdar-Shaw had reacted to the allegation that L Praveen Kumar of Biocon Biologics and other accused had used bribes to gain approval for one. insulin injectionand dismissed the charges.
The FIR claimed that Sethi, director of Delhi-based BioInnovate Research Services, was handling government regulatory functions related to Biocon Biologics and acted as a conduit on behalf of various pharmaceutical companies. According to the FIR, he had arranged to bribe senior officials of CDSCO through co-accused Dinesh Dua and others to process the files favorably on various occasions. The CBI has alleged that Reddy had supported the relaxation of Phase III clinical trials at the Subject Expert Committee (SEC) meeting on May 18 this year. insulin aspart injection, It also accused the officer of manipulating the minutes of the meeting by changing the word “data” to “protocol” in the recommendations, thus causing “wrongful profit” to M/s Biocon Biologics.
According to the FIR, Sethi, along with Praveen Kumar and other senior officials of Biocon Biologics, allegedly paid a bribe of Rs 9 lakh to Reddy for processing the files related to the firm promoted by Majumdar-Shaw and favorably recommending the relevant file. There was a conspiracy. Insulin aspart injection at SEC meeting.
Sethi and Reddy reportedly agreed to include Biocon Biologics’ third file at the SEC meeting on June 15. Co-accused drug inspector Animesh processed and kept the file in exchange for Rs 30,000, after which Dua met Reddy and was assured about it. A favorable decision at the SEC meeting, the agency claimed.
Later in the day, the CBI said that Praveen Kumar informed Sethi that the file had been cleared in that meeting.
During the June 15 meeting, Reddy reportedly offered Dua his new official residence in Delhi’s Chanakyapuri to meet him over the weekend. Sethi then directed Dua to pay part of the bribe amount (Rs 4 lakh out of Rs 9 lakh) agreed by the company to Reddy. The CBI received information that Dua would meet Reddy at his residence on June 20 to collect the bribe taken from Sethi and laid a trap, which resulted in the arrests. The agency said searches have been conducted at several places, resulting in the recovery of incriminating documents and articles.
Those arrested include Guljit Sethi of Bioinnovate Research Services, Delhi and Animesh Kumar, Assistant Drug Inspector, CDSCO.
The agency had on Monday arrested Joint Drug Controller S Easwar Reddy and Synergy Network India Pvt Ltd director Dinesh Dua. Both of them were also formally arrested on Tuesday, taking the total number of arrests in the alleged bribery case to five.
The FIR, filed by the CBI in the alleged bribery case involving pharma companies and drug control officials, claimed that Central Drugs Standard Control Organization (CDSCO) officer S Easwar Reddy, who was processing files related to applications for approval of drugs and vaccines were working. Three files of Biocon Biologics Ltd, Bengaluru were sent to various pharma companies, one of which pertains to the relaxation of Phase III clinical trials of “insulin aspart” injection. TOI has reviewed the FIR.
Mazumdar-Shaw had reacted to the allegation that L Praveen Kumar of Biocon Biologics and other accused had used bribes to gain approval for one. insulin injectionand dismissed the charges.
The FIR claimed that Sethi, director of Delhi-based BioInnovate Research Services, was handling government regulatory functions related to Biocon Biologics and acted as a conduit on behalf of various pharmaceutical companies. According to the FIR, he had arranged to bribe senior officials of CDSCO through co-accused Dinesh Dua and others to process the files favorably on various occasions. The CBI has alleged that Reddy had supported the relaxation of Phase III clinical trials at the Subject Expert Committee (SEC) meeting on May 18 this year. insulin aspart injection, It also accused the officer of manipulating the minutes of the meeting by changing the word “data” to “protocol” in the recommendations, thus causing “wrongful profit” to M/s Biocon Biologics.
According to the FIR, Sethi, along with Praveen Kumar and other senior officials of Biocon Biologics, allegedly paid a bribe of Rs 9 lakh to Reddy for processing the files related to the firm promoted by Majumdar-Shaw and favorably recommending the relevant file. There was a conspiracy. Insulin aspart injection at SEC meeting.
Sethi and Reddy reportedly agreed to include Biocon Biologics’ third file at the SEC meeting on June 15. Co-accused drug inspector Animesh processed and kept the file in exchange for Rs 30,000, after which Dua met Reddy and was assured about it. A favorable decision at the SEC meeting, the agency claimed.
Later in the day, the CBI said that Praveen Kumar informed Sethi that the file had been cleared in that meeting.
During the June 15 meeting, Reddy reportedly offered Dua his new official residence in Delhi’s Chanakyapuri to meet him over the weekend. Sethi then directed Dua to pay part of the bribe amount (Rs 4 lakh out of Rs 9 lakh) agreed by the company to Reddy. The CBI received information that Dua would meet Reddy at his residence on June 20 to collect the bribe taken from Sethi and laid a trap, which resulted in the arrests. The agency said searches have been conducted at several places, resulting in the recovery of incriminating documents and articles.