A charge sheet has been filed by the CBI for the Rs 9 lakh Biocon Biologics bribery case and cites several individuals, including Joint Drug Controller S Eswara Reddy.
In a case involving a bribe of Rs. 9 lakh, the CBI has filed a charge sheet against five people, including a Joint Drug Controller of the Central Drugs Standard Control Organization (CDSCO) and a Biocon Biologics executive.
In its charge sheet submitted on August 18, the agency said that the bribe payment was sent to Joint Drug Controller S Eswara Reddy only after receiving approval from Biocon Biologics associate vice president L Praveen Kumar, they added.
Additionally cited in the charge sheet by the agency are Dinesh Dua, director at Synergy Network India Private Limited, who is accused of giving the bribe to Reddy, Guljit Sethi, a purported conduit for Biocon Biologics, and assistant drug inspector Animesh Kumar.
According to them, the bribe was given in exchange for favourably approving Insulin Aspart Injection’s file at the Subject Expert Committee (SEC) meeting on May 18 in order to waive the phase 3 clinical trial.
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They stated that they were awaiting the decision on whether to prosecute Reddy and other CDSCO officials.
The CBI had detained each of the five defendants in a coordinated operation.
However, Biocon Biologics, a division of Kiran Mazumdar Shaw-led Biocon, has refuted the bribery claims.
“Biocon has not received a copy of the charge sheet yet; hence we cannot comment further in detail,” a spokesperson for Biocon Biologics said.
The company claimed that because it adheres to international best practises in regulatory science, it is the only Indian company to have received the most regulatory approvals for biosimilars in ICH nations including the USA, Canada, EU, Japan, and ANZ, among others.
“We have followed due process in seeking phase 3 waiver from DCGI for our biosimilar product Insulin Aspart, as per the current provisions and with precedence of the word ‘protocol’ used for such approvals. Insulin Aspart was approved by the EU and Canada respectively prior to the filing of an application before the Indian CDSCO and this is one of the considerations for the grant of an Indian approval,” the statement said.
It stated that in accordance with Indian legislation, approval of a drug that has received overseas approval is not an exception as the investigating agency had surmised and is actually permitted.
“The company has not made any payments to Bioinnovat Research or any other party named to facilitate the alleged bribe to the CDSCO official. We deny other allegations on wrong doings in seeking approval for Insulin Aspart under existing provisions and precedence. We reiterate our confidence in the judicial system and have fully cooperated with the investigating agency,” it said.