The Central Bureau of Investigation (CBI) on Monday apprehended joint drug controller S Eswara Reddy for allegedly receiving a Rs 4 lakh bribe to waive phase-three clinical trial of Insulin Aspart injection, an underdevelopment product of Biocon Biologics.

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A case was registered against Reddy, posted at Central Drugs Standard Control Organisation (CDSCO) headquarters, and Dinesh Dua, director at Synergy Network India Private Ltd, among others.

It was alleged that the accused was trying to exert undue influence on officers of CDSCO under the Directorate General of Health Services, Ministry of health & family welfare to waive the Phase III trial of "Insulin Aspart Injection".

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The CBI has alleged that the regulatory work of Biocon Biologics was looked after by Guljit Sethi of Bioinnovat Research Services Private Ltd.

Bioinnovat and Synergy Network have business dealings hence Dua agreed to make the bribe payment, the probe agency has alleged. The others named in the FIR include Guljit Sethi alias Guljit Chaudhary, director, Bioinnovat Research Services Private Ltd, Delhi; L Praveen Kumar, associate vice president and head-National Regulatory Affairs (NRA), Biocon Biologics Ltd, Bengaluru; and Animesh Kumar, assistant drug inspector, CDSCO, New Delhi.

The CBI has alleged that executives of Biocon Biologics were trying to exert undue influence on officers of CDSCO under the Directorate General of Health Services, Ministry of Health and Family Welfare, to waive the phase 3 trial of 'Insulin Aspart Injection', officials said.

It was alleged that they agreed to pay a bribe of Rs 9 lakh to Reddy for "favourably processing" three files related to Biocon Biologics and also to favourably recommend the file of "Insulin Aspart injection" to the Subject Expert Committee (SEC) meeting, they said.

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"The CBI laid a trap wherein the JDC of CDSCO was caught while accepting a bribe of Rs 4 lakh from the director of a Delhi-based private company. The said director was also caught," CBI spokesperson R C Joshi said.

The CBI conducted searches at 11 places in Delhi, Noida, Gurugram, Patna, and Bengaluru which led to the recovery of incriminating documents and articles, he said.

Biocon Biologics, the spokesperson, said, "All our product approvals are legitimate and backed by science and clinical data. Our bAspart is approved in Europe and many other countries. We follow the 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 co-operating with the investigation agency."

(With inputs from PTI)

First Published:Jun 20, 2022 11:41 PM IST