BENGALURU: The Central Bureau of Investigation (CBI) has arrested five persons including Joint Drug Controller (JDC), Central Drugs Standard Control Organisation (CDSCO), S Eswara Reddy; Director, Bioinnovat Research Services Pvt Ltd, Delhi, Guljit Sethi alias Guljit Chaudhary; Director, Synergy Network India Pvt Ltd, Dinesh Dua; Associate Vice-President & Head, National Regulatory Affairs (NRA), Biocon Biologics, Bangalore, L Praveen Kumar; Assistant Drug Inspector, CDSCO, Animesh Kumar in an alleged bribery case.
Praveen Kumar was arrested from Bengaluru and taken to Delhi on Tuesday on transit remand. The CBI had laid a trap on June 20 and caught Reddy while allegedly accepting Rs four lakh in cash as bribe to reportedly waive the phase three clinical trial of the ‘Insulin Aspart injection.’ Sethi, according to CBI, was handling the government regulatory works for Biocon Biologics and Dua has business relations with Sethi.
Biocon Biologics, which is a subsidiary of the Kiran Mazumdar Shaw-led Biocon in a media statement on Tuesday, strongly denied allegations of “bribery against the company and its officials associated with the approval process of one of our products in India,” and added that, “all our product approvals are legitimate and backed by science and clinical data… We follow due regulatory process for all our product approvals by DCGI. The entire application process in India is online and all meeting minutes can be found on the website of the CDSCO.”
The company added that the “rationale for waiver of Phase 3 clinical trials was based on the following Indian regulatory guidance (Similar Biologics Guidelines 2016 & New Drugs and Clinical Trials 2019 (GSR 227E)”.
Searches in Delhi, Noida, Gurugram, Patna and Bengaluru
The CBI in its FIR (RC0032022A0037), dated June 19 has registered a case against the accused including some unknown officers of CDSCO under Sections 7, 7A and 8 of the Prevention of Corruption (PC) Act and 120B, 468 and 471 of the Indian Penal Code amounting to criminal conspiracy, cheating, cheating for the purpose of cheating, using as genuine a forged document for obtaining undue advantage, taking undue advantage to influence a public servant by corrupt or illegal means and offence related to bribing of public servants.
According to the CBI, a case was registered against Reddy and others including Dua, Sethi, Praveen Kumar, Animesh Kumar and others for “allegedly trying to exert undue influence on officers of CDSCO under Directorate General of Health Services, Ministry of Health & Family Welfare to waive the Phase III trial of ‘Insulin Aspart’ Injection. The accused had allegedly agreed to pay bribe amount of Rs 9 lakh to Reddy for favourably processing the said three files related to Biocon Biologics and also for favourably recommending the file of ‘Insulin Aspart’ injection to the Subject Expert Committee (SEC) meeting on May 18,” the CBI stated.
“Reddy had attended the SEC meeting and had supported for waiver of Phase Ill clinical trial for the ‘Insulin Aspart Injection’ drug of Biocon Biologics. He manipulated the minutes of the meeting of SEC by changing the word “Data” to “Protocol” in the recommendations and thereby causing substantial wrongful gain to Biocon Biologics Limited, Bangalore,” the CBI has stated in the FIR. The agency conducted searches at 11 places located at Delhi, Noida, Gurugram, Patna and Bengaluru which “led to recovery of incriminating documents/articles,” the CBI stated.