The CBI has filed a charge sheet in an alleged bribery case in which a senior official of the Central Drugs Standard Control Organization (CDSCO) and an executive of Biocon Biologics was arrested in June this year.
It is alleged that L Praveen Kumar, Associate Vice President, Biocon Biologics, had sanctioned a bribe payment of Rs 9 lakh to Joint Drug Controller S Easwar Reddy.
He said the bribe was allegedly for recommending a file of insulin aspart injection to the Subject Expert Committee (SEC) meeting on May 18 to waive the Phase III clinical trial.
The agency had filed the charge sheet on August 18, he said.
In a coordinated operation, the CBI had arrested Reddy, Kumar, Dinesh Dua, director of Synergy Network India Pvt Ltd, who allegedly bribed Reddy, Guljit Sethi, an alleged conduit of Biocon Biologics, as well as assistant drug inspector Animesh Kumar.
Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, however, denied the allegations of bribery.
“We deny allegations of bribery made in some media stories. All of our product approvals are valid and backed by science and clinical data. Our bAspart has been approved in Europe and many other countries”, the spokesperson had said.
“We follow the regulatory process laid down by DCGI (Drugs Controller General of India) for all our product approvals. The entire application process is online in India and all meeting minutes are in the public domain. We are cooperating with the investigating agency,” the spokesperson had said.
