CBI in its charge sheet filed had alleged that bribe payment was made to Joint Drug Controller.
The CBI has filed a charge sheet against five persons, including a Joint Drug Controller of the Central Drugs Standard Control Organisation(CDSCO) and a Biocon Biologics executive, in a Rs nine lakh bribery case. The agency in its charge sheet filed on August 18 had alleged that the bribe payment was made to Joint Drug Controller S Eswara Reddy after clearance from associate vice president of Biocon Biologics L Praveen Kumar, they said.
The agency has also named Dinesh Dua, director at Synergy Network India Private Limited, who allegedly gave the bribe to Reddy, Guljit Sethi, an alleged conduit of Biocon Biologics, as well as assistant drug inspector Animesh Kumar in the charge sheet, they said.
The bribe was allegedly for favourably recommending the file of Insulin Aspart Injection to the Subject Expert Committee (SEC) meeting on May 18 for waiving the phase 3 clinical trial, they said. The sanction for prosecution against Reddy and other CDSCO officials is awaited, they said. In a coordinated operation, the CBI had arrested all five accused.
Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, however, has denied the allegations of bribery.
"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 said it follows global best practices in regulatory science which has earned it the distinction of being the only Indian company with the largest number of regulatory approvals for Biosimilars in ICH countries like USA, Canada, EU, Japan and ANZ amongst 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 said under the Indian regulations, approval for a foreign approved drug is not an exception as surmised by the investigating agency and is in fact within the rules. “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.