New Delhi: Denying CBI allegations of “exerting undue influence” on officers of the Central Drugs Standard Control Organisation (CDSCO) and paying them a bribe to get regulatory clearance for an insulin injection manufactured by them, Biocon Biologics said Monday that their product approvals are “legitimate and backed by science and clinical data”.
In a statement issued Monday night, a Biocon Biologics spokesperson said that the injection in question is approved in Europe and many other countries.
“We deny the allegations. All our product approvals are legitimate and backed by science and clinical data. Our bAspart (insulin injection) is approved in Europe and many other countries. We follow a due regulatory process for all our product approvals by DCGI. The entire application process in India is online and all meeting minutes are in the public domain. We are cooperating with the investigation agency,” the spokesperson said.
Biocon Biologics has been founded by entrepreneur Kiran Mazumdar-Shaw.
CBI Monday apprehended CDSCO joint drug controller (JDC), S. Eswara Reddy, for allegedly accepting a bribe of Rs 4 lakh to “favour Biocon”. A case has been registered against Reddy and four others, according to sources in the CBI.
Among the ones booked are, Guljit Sethi, director at Bioinnovat Research Services Private Limited, Dinesh Dua, director at Synergy Network India Private Limited, L. Praveen Kumar, associate vice president and head-national regulatory affairs (NRA), at Biocon Biologics Limited, Bangalore, Animesh Kumar, assistant drug inspector (ADI), CDSCO, Delhi and other unknown officials of CDSCO and private individuals, the sources said.
According to CBI sources, Bioinnovat Research Services had been asked to get regulatory clearance for the Biocon product and Bioinnovat had then engaged Synergy Network for the job. It was Dua who allegedly negotiated and paid the bribe.
While Reddy and Dua have been apprehended by CBI, more arrests are likely in the coming days, said CBI sources.
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‘Agreed to pay Rs 9 lakh as bribe’
According to sources in the CBI, the accused agreed to pay a bribe amount of Rs 9 lakh to the JDC of CDSCO, for favourably processing files related to a private company based in Bangalore (Biocon), and also for favourably recommending the file of “Insulin bAspart injection” at the subject expert committee (SEC) meeting.
“The accused were trying to influence the officers of CDSCO, which comes under the directorate general of health services, ministry of health & family welfare, to waive the Phase III trial of ‘Insulin bAspart Injection’. We suspect that many others in the department too were involved,” a CBI officer said.
A CBI statement issued Monday said that a trap was laid and the JDC was caught while accepting a bribe of Rs. 4 lakh from the director of a Delhi-based private company (Synergy Network). The said director of the Delhi-based private company (Dinesh Dua), was also caught, the CBI statement added.
Searches were also conducted at 11 places across Delhi, Noida, Gurugram, Patna, Bengaluru and documents pertaining to the investigation have been seized, the CBI quoted above officer said.
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(Edited by Poulomi Banerjee)
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