 "Biocon likely to channelise investments towards non-insulin biologics")
The government has granted the sanction to prosecute Central Drugs Standard Control Organisation's joint drugs controller S Eswara Reddy, clearing the decks for initiating a trial against him for allegedly taking a bribe to favourably recommend Biocon Biologics' insulin injection, officials said Sunday.
The CBI submitted the sanction for prosecution, accorded by the Director (Vigilance) in the Union Ministry for Health and Family Welfare, before a special court here.
Repeated calls made to the office phone of Reddy seeking his comments remained unanswered.
The agency has also received the sanction against Animesh Kumar, Assistant Drugs Inspector, who is a co-accused in the case, they said.
Apart from Reddy and Animesh Kumar, the CBI had also arrested Biocon Biologics' Associate Vice President L Praveen Kumar, Synergy Network India Private Limited director Dinesh Dua, who allegedly gave Reddy Rs 4 lakh as bribe, and Guljit Sethi, an alleged conduit of Biocon Biologics.
The arrests were made in June last year in the bribery case allegedly to waive the Phase 3 clinical trial of 'Insulin Aspart' injection, a product developed by the company to manage Type 1 and Type 2 diabetes.
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However, Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, denied the allegations of bribery.
Reddy was suspended but the health ministry revoked his last year and reinstated him as the joint drugs controller.
The agency had filed the charge sheet in August last year against the accused persons, but the trial had not commenced as the sanction for prosecution, a mandatory requirement before proceedings in a case against a government servant under the Prevention of Corruption Act can be initiated, was awaited, they said.
In its charge sheet filed in August last year, the agency alleged the bribe payment was made to Reddy after clearance from associate vice president of Biocon Biologics L Praveen Kumar, they said.
After the charge sheet was filed, the company had said in a statement that it follows global best practices in regulatory science which have earned it the distinction of being the only Indian company with the largest number of regulatory approvals for Biosimilars in ICH countries like the USA, Canada, EU, Japan 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 had 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 of wrongdoings 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 had said.
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