CBI arrests Biocon Biologics official for allegedly bribing JDC at CDSCO

|HT|

Biocon Biologics on Tuesday denied allegations of bribery even as the Central Bureau of Investigation (CBI) arrested an executive of a company allegedly operating on its behalf on charges of allegedly bribing a joint drugs controller (JDC) at the Central Drugs Standard Control Organisation (CDSCO) to waive off phase 3 clinical trial of its diabetes injection. “CBI laid a trap wherein the JDC of CDSCO was caught while accepting bribe of Rs. 4,00,000/- from the Director of Delhi based private company. The said Director of Delhi based private company was also caught,” the notice said.

On Monday, the federal investigating agency arrested JDC S Eswara Reddy and the director of Synergy Network India Private Limited, Delhi, Dinesh Dua.

In a statement, the agency also named the director of Bioinnovat Research Services Private Limited, Delhi, Guljit Sethi, associate vice president and head-national regulatory affairs of Biocon Biologics Limited, Bangalore, L Praveen Kumar, assistant drug inspector, CDSCO, New Delhi, Animesh Kumar, and other unknown officials. Synergy is believed to have been working on behalf of Bioinnovat, which, in turn, is believed to handle all regulatory issues for Biocon Biologics, a subsidiary of Biocon Ltd. Phase 3 studies provide establish efficacy in a larger population group and monitor adverse reactions. Phase 3 trial also provides most of the safety data.

“We deny the bribery allegations made in certain media stories. All our product approvals are legitimate and backed by science and clinical data. Our bAspart (the injection in question) is approved in Europe and many other countries. We follow due regulatory process for all our product approvals by DCGI (Drug Controller General of India) . The entire application process in India is online and all meeting minutes are in public domain. We are co-operating with the investigation agency,” a spokesperson of Biocon Biologics said in a statement on Tuesday.

CBI has registered a case of criminal conspiracy and corruption against Reddy, posted at CDSCO headquarters, Kumar, Dua, and others. Reddy also worked as Drugs Controller General (India) between February 2018 and August 2019 and is a senior official.

He started his career in 1998 as a drugs inspector at CDSCO, Mumbai. He was promoted as assistant drugs controller of India in 2009 and appointed as deputy drugs controller (India) in 2012.

In 2014, he was appointed as JDC. In February 2018, he joined as a youngest drugs controller general (India).

The agency carried out a raid on Monday, and Dua was allegedly caught giving a ₹4 lakh bribe to Reddy out of the total amount of ₹9 lakh on behalf of Biocon Biologics.

CBI has alleged that executives of Synergy were trying to exert undue influence on officers of CDSCO, under the ministry of health and family welfare, to waive the phase 3 trial of ‘Insulin Aspart Injection’. They allegedly agreed to pay a bribe of ₹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 meeting.

CBI conducted searches at 11 places in Delhi, Noida, Gurugram, Patna and Bengaluru that reportedly led to the recovery of incriminating documents and articles, according to people familiar with the matter.

To approve any new drugs, the national drugs regulator considers recommendations of its subject expert committee.

While both, the drugs controller general of India, VG Somani, and the Union health ministry formally did not respond to the bribery allegations, a senior central government official said that the case was currently being investigated and people should not speculate. “The agency concerned is investigating the matter and it will not be appropriate to speculate or make any comments regarding the investigation. There is no room for corruption and steps will be taken accordingly against those found guilty, as has happened in the past.”

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