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NEW DELHI: In a sensational breakthrough on Monday, the Central Bureau of Investigation (CBI) filed an FIR against one of India’s premier biotech companies and officials of the government agency responsible for the approval of new drugs.
The case is related to an alleged graft case involving Rs 4 lakhs to waive off the Phase III clinical trial of Insulin Aspart Injection, an underdeveloped product by Bengaluru-based Biocon Biologics Limited.
The central agency had so far arrested S Eswara Reddy, joint drug controller of the Central Drugs Standard Control Organisation (CDSCO) and Dinesh Dua, director at Synergy Network India Private Limited, in the case.
The agency had also named Praveen Kumar, associate vice president and head, National Regulatory Affairs (NRA) Biocon Biologics Limited, Bengaluru, Animesh Kumar, assistant drug inspector (ADI), CDSCO, Guljit Sethi, alias Guljit Chaudhri, director of Delhi-based Bioinnovat Research Services Private Limited along with unknown officials at CDSCO, in the case.
The accused were charged with criminal conspiracy, cheating, forgery for the purpose of cheating, using a forged document for obtaining an undue advantage and taking undue advantage to influence public servants by corrupt or illegal means and offences relating to bribery of public servants.
The CBI FIR copy stated that the functions of CDSCO include approval of new drugs, conducting clinical trials, and laying down the standards for Drugs among other responsibilities.
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“Reliable information has been received that Reddy, Joint Drug Controller (JDC) at Head Quarter, CDSCO, New Delhi has been dealing with processing of files related to applications for approval of drugs and vaccines by various Pharma Companies. Further information has also been received that three files of Biocon Biologics Limited including one file related to waiver of Phase III Clinical Trial of Insulin Aspart Injection have been referred to Reddy for processing and approval,” the FIR said.
The FIR also alleged that Sethi has been handling the government regulatory works related to Biocon Biologics Limited and that Dua is having business relations with Sethi.
“Information has also been received that Sethi is acting as a conduit on behalf of various pharmaceutical companies and has delivered/arranged to deliver a huge amount of bribe, through Dua and others, to the senior officers of CDSCO on different occasions for processing the files favourably,” the CBI alleged.
The CBI said that the probe revealed that Sethi has conspired with Kumar and other senior executives of Biocon Biologics Limited, Bengaluru to pay a total bribe amount of Rs 9 lakh to Reddy. It is for favourably processing the said three files related to Biocon Biologics Limited and also for favourably recommending the file of Insulin Aspart Injection to the Subject Expert Committee (SEC) meeting on May 18 this year.
“Information further revealed that Reddy had attended the SEC meeting on May 18 and had supported for waiver of Phase III clinical trial for the Insulin Aspart Injection drug of Biocon Biologics Limited and Reddy has manipulated the minutes of the meeting of SEC held on the same day by changing the word “Data” to “Protocol’ in the recommendations and thereby causing substantial wrongful gain to Biocon Biologics Limited,” the CBI alleged.
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The CBI said that it came to notice that Sethi has further colluded with Reddy, Kumar and other unknown officials of CDSCO, New Delhi for including the third file of Biocon Biologics Limited, Bangalore for the SEC Meeting on June 15.
Even it came to notice that in pursuance of the conspiracy, Kumar has processed and put up the file for including the application of Biocon Biologics Limited in the SEC Meeting on June 15 for which Sethi had paid Rs 30,000 to him as illegal gratification, the CBI said.
The CBI said that 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.
“Reddy also assured Dua about a favourable decision in the SEC meeting. Further, on the same day, Praveen Kumar, associate vice president of Biocon Biologics limited informed Sethi that the said file of Biocon Biologics Limited was approved in the SEC Meeting,” the CBI said.
The CBI alleged that during the meeting on June 15 at the CDSCO office Reddy provided his new residential address at Chanakyapuri to Dua to meet him personally at his residence at the end of the week.
It was also found that the associate vice president and Head of National Regulatory Affairs of Biocon Biologics Limited have agreed to pay a total of Rs. Nine lakh bribe amount as a motive or reward to Reddy to favourably process the files of the company.
Sethi then directed Dua to deliver the part of the agreed bribe amount on behalf of the company to Reddy at his residence, the CBI said.
The information further revealed that Dua would meet Reddy at his residence on June 20 to deliver the bribe amount after collecting it from Sethi, the CBI FIR alleged.
