The Central Bureau of Investigation (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 an Rs nine lakh bribery case.
According to a report by news agency PTI, the agency in its charge sheet filed on August 18 has alleged that the bribe payment was being paid to Joint Drug Controller S Eswara Reddy after clearance from associate vice president of Biocon Biologics L Praveen Kumar.
Reportedly, 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.
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. The sanction for prosecution against Reddy and other CDSCO officials is awaited, as per PTI.
In a coordinated operation, the CBI had arrested all five accused. Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, however, had denied the allegations of bribery.
“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”, the spokesperson had said.
“We follow the 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 the public domain. We are cooperating with the investigation agency,” the spokesperson had said as quoted by PTI.
Meanwhile, in a statement sent to Financial Express.com, the company spokesperson said: “It is unfortunate that parts of the charge sheet filed in the court have been leaked and some media outlets are carrying stories based on the same. Biocon has not received a copy of the chargesheet yet; hence we cannot comment further in detail.”
The spokesperson also said added: “We follow global best practices in regulatory science which has earned us 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.”
The spokesperson also added that they have followed due process in seeking phase 3 waiver from DCGI for their 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. Under the Indian Regulations, Indian 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,” the spokesperson added.
(With inputs from PTI)