The Central Bureau of Investigation (CBI) has apprehended a Joint Drug Controller (JDC) of Central Drugs Standard Control Organisation (CDSCO) and the Director of a private company for allegedly demanding bribe to waive the Phase-3 trial of "Insulin Aspart Injection".
The accused JDC identified as E. Eswara Reddy is posted with CDSCO headquarters while his aide identified as Dinesh Dua is the Director of Delhi-based Synergy Network India Private Limited.
A senior CBI official said that a case was lodged against Reddy, Dua and others which includes Guljit Sethi, the Director of Bioinnovat Research Service Private Limited; L. Praveen Kumar, the Associate Voice President and Head of National Regulatory Affairs of Biocon Biologics Limited; Animesh Kumar, the Assistant Drug Inspector of CDSCO and others. "It was alleged that Reddy was trying to exert undue influence on officers of CDSCO to waive the Phase-3 trial of "Insulin Aspart Injection". The accused agreed to pay bribe amount of Rs 9 lakh to Reddy for favourably processing the said three files related to Banglore-based Biocon Biologics Limited and also for favourably recommending the file of "Insulin Aspart injection" to the Subject Expert Committee meeting.
The CBI laid a trap and Reddy was caught while accepting a bribe of Rs 4 lakh from Dua.The CBI also conducted searches in11 locations in Delhi, Noida, Gurugram, Patna, Bengaluru which led to the recovery of incriminating documents.
Meanwhile, the Biocon Biologics issued a ststement saying their Aspart was approved in Europe and many other countries.
"We deny few allegations reported in India. All our product approvals are legitimate and backed by science and clinical data. Our Aspart 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," said Biocon Biologics in a press release.
Further investigations are on.