CBI, on Monday, arrested Joint Drugs Controller for accepting Rs. 4 lakh bribe to waive off 3rd phase trial of Biocon’s Insulin Aspart Injection; company denies.
- JDC Reddy was arrested under charges of accepting a bribe from Biocon Biologics.
- He was caught accepting a bribe of Rs. 4 lakh from Dinesh Dua on behalf of the company.
- The bribe was exchanged in return for getting regulatory clearance for their insulin injection and other favors at the SEC meeting.
The Central Bureau of Investigation (CBI) on Monday detained a Joint Drugs Controller (JDC) of the Central Drugs Standard Control Organisation (CDSCO). He is charged with allegedly accepting a Rs 4 lakh bribe from a leading biopharmaceutical company, Biocon Biologics. Meanwhile, the agency also booked Dinesh Dua, Director of a Delhi-based private company, along with three others, including an Associate Vice President of Biocon Biologics Ltd. The bribe money was exchanged for waiving off the third phase trial and getting regulatory clearance for Insulin Aspart injection manufactured by the company.
JDC S Eswara Reddy, in the Directorate General of Health Services of the Ministry of Health and Family Welfare, was caught by CBI investigators while accepting the bribe from Dinesh Dua, the director of Delhi-based Synergy Network India Private Limited. Dinesh is reported to have been working as a conduit for Biocon. The others booked in the case are L Praveen Kumar, Associate Vice President and Head-National Regulatory Affairs of Biocon Biologics Ltd; Guljit Sethi alias Guljit Chaudhary, Director of Bioinnovat Research Services Private Limited, Delhi; and CDSCO Assistant Drug Inspector Animesh Kumar.
CBI investigators have recovered incriminating documents and articles during their search operations at 11 locations in Delhi, Noida, Gurugram, Patna, and Bengaluru.
According to the CBI, the accused agreed to pay a bribe amount of Rs. 9 lakh to the JDC, Central Drugs Standard Control Organisation (CDSCO), for favorably processing the three files related to private company Biocon Biologics, based in Bangalore. Another favor of recommending the file of Insulin Aspart injection to the Subject Expert Committee (SEC) meeting was also agreed to. Gurjit Sethi, Director of M/s Bioinnovat Research Services Private Limited, directed Dinesh Dua to deliver a part of the agreed bribe amount on behalf of the company to Reddy at his Chanakypuri residence. Dinesh has business relations with Sethi.
Claims of the Company
Biocon Biologics has, however, washed its hands off of these charges by the CBI of bribing to get its drug trials cleared by the Health Ministry.
“We deny the bribery allegations made in certain media stories. All our product approvals are legitimate and backed by science and clinical data. Our BASS PART (the injection in question) is approved in Europe and many other countries. We follow the due regulatory process for all our product approvals by DCGI (Drug Controller General of India),” said Biocon Biologics stated in a public statement on Tuesday.
The company drew attention to the fact that the complete application process in India is online. Along with this, all meeting minutes are in the public domain. The spokesperson of Biocon Biologics assured us that they are cooperating with the investigation agency.
The SEC Meeting
Though the company has denied all allegations, the CBI, in its FIR, has noted that Reddy had attended the Subject Expert Committee (SEC) meeting on May 18. There he supported the waiver of the Phase III clinical trial for the Insulin Aspart Injection drug of Biocon Biologics.
The CBI has also purported that JDC Reddy manipulated the minutes of the meeting of the SEC by changing the word ‘data’ to ‘protocol’ in the recommendations. This would cause considerable wrongful gain to Biocon.
The agency’s FIR further revealed that Sethi also colluded with Reddy and his junior Assistant Drug Inspector (ADI), Animesh Kumar, to include a third file of Biocon for the SEC meeting on June 15. Animesh Kumar is claimed to have been paid Rs. 30,000 by Sethi for placing the Biocon file before the SEC meeting.
