CBI arrests Joint Drugs Controller for accepting bribe to waive off 3rd phase trial of Biocon’s Insulin Aspart Injection

Our Bureau | | Updated on: Jun 21, 2022

CBI investigators recover “incriminating documents and articles” during search operation

The Central Bureau of Investigation (CBI) has arrested a Joint Drugs Controller (JDC) of the Central Drugs Standard Control Organisation on charges of accepting a ₹4 lakh bribe from leading biopharmaceutical company, Biocon Biologics, for waiving off the third phase trial of Insulin Aspart Injection.

On Monday,S Eswara Reddy, the JDC in the Directorate General of Health Services of the Ministry of Health and Family Welfare, was caught by CBI sleuths while accepting the bribe from Dinesh Dua, the director of Delhi-based Synergy Network India Private Limited, who has been working as a conduit for Biocon, alleged the agency.

The CBI said its investigators have recovered “incriminating documents and articles” during search operations at 11 places in Delhi, Noida, Gurugram, Patna and Bengaluru.

According to the CBI, "the accused agreed to pay bribe amount of ₹9 lakh to the JDC, CDSCO, for favourably processing the said three files related to private company based at Bangalore and also for favourably recommending the file of Insulin Aspart injection to the Subject Expert Committee (SEC) meeting". Guljit Sethi, Director of M/s Bioinnovat Research Services Private Limited, directed Dinesh Dua, who has business relations with the former, to deliver a part of the agreed bribe amount on behalf of the company to Reddy at his Chanakypuri residence.

Biocon Biologics, however, denied the CBI charges of bribing to get its drug trials cleared from 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 bAspart (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 also remarked that the entire application process in India is online and all meeting minutes are in the public domain. The spokesperson of the biopharmaceutical company, however, said "we are cooperating with the investigation agency”.

Though the company has washed its hand off, the CBI, in its FIR, has clearly stated that Reddy had attended the SEC meeting on May 18 and “supported for waiver of Phase Ill clinical trial for the Insulin Aspart Injection drug of Biocon Biologics”.

The CBI has also alleged that the joint director controller has “manipulated the minutes of the meeting of SEC by changing the word ‘data’ to ‘protocol’ in the recommendations, thereby causing substantial wrongful gain to Biocon”.

The information further revealed, the agency FIR stated, that Sethi also colluded with Reddy and his junior Assistant Drug Inspector (ADI), Animesh Kumar, for including a third file of Biocon for the SEC meeting on June 15. Animesh Kumar, charged the agency, was paid ₹30,000 by Sethi for placing the Biocon file before the SEC meeting.

Published on June 21, 2022
This article is closed for comments.
Please Email the Editor

You May Also Like

Recommended for you