The Central Bureau of Investigation (CBI) on Monday detained Joint Drug Controller of the Central Drugs Standard Control Organisation (CDSCO) S Eswara Reddy for accepting a bribe of Rs 4 lakh to clear phase three trial of ‘Insulin Aspart’, an underdevelopment diabetes drug. The Insulin Aspart is a product of Biocon Biologics under development to manage Type 1 and Type 2 diabetes.
The agency also arrested Dinesh Dua, director at Synergy Network India Private Limited, who was allegedly giving Reddy a bribe, they said.
Besides Dua and Reddy, the CBI has also booked Associate Vice President of Biocon Biologics Ltd, Bangalore, L Praveen Kumar, Director, Bioinnovat Research Services Pvt Ltd, Delhi, Guljit Sethi as well as Assistant Drug Inspector Animesh Kumar in the FIR registered under IPC sections of criminal conspiracy, cheating, forgery and corruption.
“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," said a spokesperson for Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon.
"We follow 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 public domain. We are cooperating with the investigation agency,” the spokesperson said.
The CBI has alleged that Sethi, acting as a conduit for Biocon Biologics, conspired with Praveen Kumar, head of the company's National Regulatory Affairs (NRA), and other senior executives of the company to pay Reddy a total bribe of Rs 9 lakh. This was for favourably recommending the file of "Insulin Aspart Injection" to the Subject Expert Committee (SEC) meeting on May 18, 2022 for waiving the Phase 3 clinical trial, it alleged.
Reddy had attended the SEC meeting on May 18, 2022 and supported the waiver, the CBI has alleged in the FIR, while further contending that he manipulated the minutes of the meeting of SEC held that day by changing some key words in the recommendations, giving “substantial wrongful gain” to the company.
The CBI was working on the sensational case for over a month after getting inputs that Reddy was dealing with the processing of files related to applications for approval of drugs and vaccines by various pharmaceutical companies.
CDSCO functions include approval of new drugs, the conduct of clinical trials and laying down the standards for drugs.
Image source: The Financial Express