Centre Gives Sanction To Prosecute Joint Drugs Controller In Bribery Case

New Delhi:

The federal government has granted the sanction to prosecute Central Medicine Normal Management Organisation’s joint medicine controller S Eswara Reddy, clearing the decks for initiating a trial in opposition to him for allegedly taking a bribe to favourably advocate Biocon Biologics’ insulin injection, officers mentioned Sunday. The CBI submitted the sanction for prosecution, accorded by the Director (Vigilance) within the Union Ministry for Well being and Household Welfare, earlier than a particular court docket right here.

Repeated calls made to the workplace cellphone of Reddy looking for his feedback remained unanswered.

The company has additionally obtained the sanction in opposition to Animesh Kumar, Assistant Medicine Inspector, who’s a co-accused within the case, they mentioned.

Aside from Reddy and Animesh Kumar, the CBI had additionally arrested Biocon Biologics’ Affiliate Vice President L Praveen Kumar, Synergy Community India Non-public Restricted director Dinesh Dua, who allegedly gave Reddy Rs 4 lakh as bribe, and Guljit Sethi, an alleged conduit of Biocon Biologics.

The arrests have been made in June final yr within the bribery case allegedly to waive the Section 3 medical trial of ‘Insulin Aspart’ injection, a product developed by the corporate to handle Kind 1 and Kind 2 diabetes.

Nevertheless, Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, denied the allegations of bribery.

Reddy was suspended however the well being ministry revoked his final yr and reinstated him because the joint medicine controller. The company had filed the cost sheet in August final yr in opposition to the accused individuals, however the trial had not commenced because the sanction for prosecution, a compulsory requirement earlier than proceedings in a case in opposition to a authorities servant beneath the Prevention of Corruption Act will be initiated, was awaited, they mentioned.

In its cost sheet filed in August final yr, the company alleged the bribe fee was made to Reddy after clearance from affiliate vp of Biocon Biologics L Praveen Kumar, they mentioned.

After the cost sheet was filed, the corporate had mentioned in an announcement that it follows international finest practices in regulatory science which have earned it the excellence of being the one Indian firm with the biggest variety of regulatory approvals for Biosimilars in ICH nations just like the USA, Canada, EU, Japan amongst others.

“We have now adopted due course of in looking for section 3 waiver from DCGI for our biosimilar product Insulin Aspart, as per the present provisions and with priority of the phrase ‘protocol’ used for such approvals. Insulin Aspart was accredited by the EU and Canada respectively previous to the submitting of an software earlier than the Indian CDSCO, and this is likely one of the concerns for the grant of an Indian approval,” the assertion had mentioned.

It mentioned beneath the Indian rules, approval for a foreign-approved drug shouldn’t be an exception, as surmised by the investigating company and is in actual fact, throughout the guidelines.

“The corporate has not made any funds to Bioinnovat Analysis or every other celebration named to facilitate the alleged bribe to the CDSCO official. We deny different allegations of wrongdoings in looking for approval for Insulin Aspart beneath present provisions and priority. We reiterate our confidence within the judicial system and have totally cooperated with the investigating company,” it had mentioned.

(Apart from the headline, this story has not been edited by NDTV employees and is revealed from a syndicated feed.)