[ad_1]
The Delhi High Court Tuesday granted bail to three accused, including S Eswara Reddy, the former joint drug controller in the biological division of the Drug Controller General of India (DGCI), in connections with the Biocon bribery case being probed by the CBI.
The other two accused who were also granted bail are Dinesh Dua, Director, Synergy Network India Private Limited, and L Praveen Kumar, Associate Vice-President and Head National Regulatory Affairs of Biocon Biologics Limited (BBL).
Justice Anu Malhotra said in the order there is nothing to indicate that the recommendation made by the Special Expert Committee (SEC) for waiver of Phase-III clinical trial in India to Biocon Biologics for import and marketing of Insulin Aspart injection has been approved and given effect to by the DGCI of the Central Drugs Standard Control Organisation (CDSCO).
The court noted the charge sheet has been filed in the case and voice samples of the accused persons have been taken. “Though undoubtedly the offence alleged to have been committed (if proved) by the applicants is grave, the trial in the matter would take ample time,” it added.
The Central Bureau of Investigation (CBI) in June arrested Reddy, who has since been suspended, after he and Synergy Networks’ Dua were caught allegedly red-handed with a bribe amount of Rs 4 lakh.
According to the central agency, BBL’s Kumar had conspired with other accused to pay Rs 9 lakh to CDSCO officials to get favour in matters of the pharmaceutical company in relation to three files. These files included one related to waiver of the Phase-III clinical trial of ‘Insulin Aspart’ on the basis of already generated clinical data.
There are a total of five accused in the case.
The court said Reddy’s contention that he is neither part of the SEC nor the final authority to approve the content of its minutes of the meeting cannot be overlooked. It also said recorded Kumar’s argument that no decision has been taken by the SEC to date and a mere commendation was made after which multiple stages are to be followed.
The bench also said Reddy’s argument regarding the rule that permits the licensing authority to consider waiver of local clinical trials has to be considered.
“That the medicine in question has already been launched by the BBL and had undergone Phase I clinical trial in Germany and Phase III trial in the USA and the drug had been approved and granted marketing authorisation by European Medicine Agency (EMA) and Health Canada, after enquiring its quality, safety, and efficacy was only a case of a launch of an approved drug and only protocol had to be provided … are aspects which merit consideration,” it said.
Regarding the CBI’s case that the accused were caught red-handed, the court said it cannot be overlooked that the alleged recovery in the case is “not pursuant to any usual trap proceedings”. The consideration of the credibility of circumstantial evidence would have to be assessed, said Justice Malhotra.
“Another aspect which cannot be overlooked is that the alleged intercepted calls between the accused persons have to be weighed at the altar of admissibility and legality of evidence,” read the court’s order.
Granting bail to the accused, the court said offences alleged to have been committed by the three applicants are punishable with imprisonment of a maximum of seven years and they apparently are not flight risks. “The applicants through the record appear to have roots in society,” it said.
[ad_2]
Source link