Joint Drug Controller (India), Central Drugs Standard Control Organisation (CDSCO), Dr S Eswara Reddy has attended a Subject Expert Committee (SEC) meeting to support for waiver of the phase III clinical trial for Biocon Biologics Ltd’s (BBL) Insulin Aspart Injection and manipulated the minutes of the meeting of SEC held on May 18, 2022 “causing substantial wrongful gain to the company”, alleges the Central Bureau of Investigation (CBI) in its First Information Report (FIR).
The CBI has conducted search operations in the CDSCO headquarters earlier and apprehended Reddy, and a few others in an alleged bribery of Rs. 4 lakh. Reddy has been dealing with processing of file related to applications for approval of drugs and vaccines by various pharma companies.
According to the FIR document, Guljit Sethi, director of Delhi-based Bioinnovat Research Services Pvt Ltd, who has also been booked along with Reddy, has been handling the government regulatory works related to BBL, Bengaluru and acted as a conduit on behalf of various pharmaceutical companies and has delivered or arranged to deliver huge amount of bribe, through Dinesh Dua, director, of Synergy Network India Private Limited, Delhi and others to the senior officers of CDSCO for processing the file favourably.
Biocon has repeatedly denied the allegation of CBI, stating that the company follows due regulatory process for all its product approvals by the DCGI and the entire application process in India is online and all meeting minutes can be found on the website of the CDSCO.
Sethi has allegedly conspired with L Praveen Kumar, associate vice president and head, national regulatory affairs (NRA) and other senior executives of BBL to pay a total bribe amount of Rs 9 lakh to Reddy, for favourably processing the said three files related to Biocon Biologics Limited, Bangalore and also for favourably recommending the file of ‘Insulin Aspart Injection’ to the Subject Expert Committee (SEC) meeting on May 18, 2022.
The Joint Drug Controller had attended the SEC meeting on that day and had supported for waiver of Phase Ill clinical trial for the drug.
“Information has also revealed that Dr. S. Eswara Reddy, JDC has manipulated the minutes of the meeting of SEC held on May 18, 2022 by changing the word "Data" to "Protocol" in the recommendations and thereby causing substantial wrongful gain to Biocon Biologics Limited, Bengaluru,” alleges the CBI.
Sethi has further colluded with Reddy, Animesh Kumar, assistant drug inspector (ADI), CDSCO, New Delhi and other unknown officials of CDSCO for including the third file of BBL for SEC Meeting on June 15, 2022. In pursuance of the conspiracy, Animesh Kumar has processed and put up the file for including the application of BBL in the SEC Meeting on June 15, 2022, for which Sethi had paid Rs. 30,000 to him as illegal gratification.
Dinesh Dua met Reddy at CDSCO office on June 15, in connection with the approval of the third file during the SEC meeting scheduled on the same day. The official assured Dua about a favourable decision in the SEC meeting. Further on the same day, Praveen Kumar, associate vice president of BBL informed Sethi that the file was approved in the SEC Meeting.
During the meeting on June 15, at CDSCO office, Reddy has provided his new residential address at Chanakyapuri to Dua to meet him personally at his residence at the end of the week. Praveen Kumar has agreed to pay a total of Rs. 9 lakh bribe amount as a motive/ reward to Reddy, to favourably process the files of the company. Sethi directed Dua to deliver the part of the agreed bribe amount on behalf of the company to Reddy at his residence. Dua was expected to meet Reddy at his residence on June 20 to deliver the bribe amount after collecting it from Sethi.
The CBI alleged that the acts of accused persons namely Dr S Eswara Reddy, Guljit Sethi, Dinesh Dua, L Praveen Kumar, Animesh Kumar and other unknown officials of CDSCO, New Delhi, prima facie discloses criminal conspiracy, cheating, forgery for the purpose of cheating, using as genuine a forged document, for obtaining undue advantage and taking undue advantage to influence public servant by corrupt or illegal means & offence relating to bribery of public servant.
Following this, a Regular Case has been registered against these persons under Section 120B, 420, 468, 471 of Indian Penal Code and Section 7, 7A, 8 of Prevention of Corruption Act, 1988 (as amended in 2018).
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