The CBI has filed a charge sheet in an alleged bribery case in which a senior official of the Central Drugs Standard Control Organisation(CDSCO) and a Biocon Biologics executive were arrested in June this year, officials said.
It is alleged that the bribe payment of ₹9 lakh to Joint Drug Controller S. Eswara Reddy was cleared by the associate vice president of Biocon Biologics L. Praveen Kumar, they said.
The bribe was allegedly for favourably recommending the file of Insulin Aspart Injection to the Subject Expert Committee (SEC) meeting on May 18 for waiving the phase 3 clinical trial, they said.
The agency had filed a charge sheet on August 18, they said.
In a coordinated operation, the CBI had arrested Mr. Reddy, Mr. Kumar, Dinesh Dua, director at Synergy Network India Private Limited, who allegedly gave the bribe to Mr. Reddy, Guljit Sethi, an alleged conduit of Biocon Biologics, as well as assistant drug inspector Animesh Kumar in the case.
Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, however, had denied the allegations of bribery.
"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 is approved in Europe and many other countries", the spokesperson had said.
"We follow the due regulatory process for all our product approvals by DCGI (Drugs Controller General of India). 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 had said.
