Those arrested include a Joint Drug Controller (JDC), posted at CDSCO Headquarters, New Delhi, an executive of M/s Biocon Biologics Limited and others.
The agency has appealed against the order of a lower court which had granted only one day of custodial interrogation of the accused and refused to grant further remand. The agency has challenged the said order seeking custodial interrogation of all the accused.
The petition will come up for hearing on July 2, said sources.
Denying allegations of any wrongdoing, a spokesperson for Biocon Biologics had previously told ET “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 due regulatory process for all our product approvals by DCGI. 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 case was registered against a Joint Drug Controller (India) (JDC), CDSCO Headquarters, New Delhi and others including Directors, Associate Vice President & Head-National Regulatory Affairs (NRA) of separate private companies, two based at New Delhi and another at Bengaluru; Assistant Drug Inspector (ADI), CDSCO, New Delhi .
It was alleged that the accused was trying to exert undue influence on officers of CDSCO (Central Drugs Standard Control Organisation) under Directorate General of Health Services, Ministry of Health & Family Welfare, Delhi to waive the Phase III trial of “Insulin Aspart Injection”.
It was further alleged that the accused agreed to pay bribe amount of nine lakh rupees to JDC, CDSCO for favorably processing the said three files related to M/s Biocon Biologics Limited, a Bangalore based company and also for favourably recommending the file of “Insulin Aspart injection” to the Subject Expert Committee (SEC) meeting.
The agency laid a trap wherein the JDC of CDSCO was allegedly caught while accepting bribe of four lakh rupees from the Director of M/s Synergy Network India Private Limited. The said Director was also caught.
A total of six accused have been booked by the CBI including “unknown officials of CDSCO”. The two arrested are S Eswara Reddy, Joint Drug Controller (India), CDSCO and Dinesh Dua, Director M/s Synergy Network India Private Limited. Amongst others booked are L Praveen Kumar, Associate Vice President and Head-National Regulatory Affairs (NRA), M/s Biocon Biologics Limited.