The Central Bureau of Investigation (CBI) on June 20 apprehended Joint Drug Controller (JDC) of CDSCO S Eswara Reddy for allegedly taking a Rs 4 lakh bribe to waive the Phase III trial of ‘Insulin Aspart’ Injection.2
CDSCO stands for Central Drugs Standard Control Organisation.
Searches were conducted at 11 places located in Delhi, Noida, Gurugram, Patna, and Bengaluru which led to the recovery of incriminating documents and articles.
After receiving inputs of an alleged bribe exchange, the CBI laid a trap wherein the JDC of CDSCO was caught while accepting a bribe of Rs 4 lakh from the director of a Delhi-based private company, who has also been apprehended along with the Associate Vice-President of Biocon Biologics.
Biocon Biologics is a subsidiary of Bangalore-based biopharmaceutical company Biocon.
A case was registered against the JDC of CDSCO Headquarters, New Delhi, and others including Directors, Associate Vice President, and Head of the National Regulatory Affairs (NRA) of separate private companies, two based in New Delhi and another in Bengaluru; Assistant Drug Inspector (ADI), CDSCO, New Delhi and other unknown officials of CDSCO, New Delhi & unknown others.
According to CBI, it was alleged that the accused was trying to exert undue influence on officers of CDSCO (Central Drugs Standard Control Organisation) under the Directorate General of Health Services, Ministry of Health & Family Welfare (GOI), Delhi to waive the Phase III trial of Insulin Aspart Injection.
It was further alleged that the accused agreed to pay a bribe amount of Rs 9 lakh to JDC, CDSCO for favorably processing the said three files related to a private company based in Bangalore and also for favourably recommending the file of "Insulin Aspart injection" to the Subject Expert Committee (SEC) meeting.
Meanwhile, Biocon Biologics, in its reply, said they deny the allegations. "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 the due regulatory process for all our product approvals by DCGI. The entire application process in India is online and all meeting minutes are in the public domain. We are co-operating with the investigation agency," Biocon Biologics' spokesperson told Moneycontrol.
The CBI said the investigation was still on in this case.