CBI court to pronounce order in CDSCO bribery case today

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A special CBI court will on July 19 rule on the bail application of arrested joint drug controller (JDC) S Eswara Reddy and four other accused in the alleged Central Drugs Standard Control Organisation (CDSCO) bribery case involving Biocon Biologics.

The Central Bureau of Investigation (CBI) has opposed the bail of all the accused. The agency has charged senior CDSCO officials with colluding with Biocon Biologics to waive phase-3 trials for a diabetes drug. Reddy was arrested on June 21.

In a June 27 statement, Biocon Biologics said, “We strongly deny the allegations of bribery against the company and its officials associated with the approval process of one of our products in India.”

The court will also give its order on an application to test voice samples of all the arrested in a bribery scandal reportedly involving a joint senior executive of Biocon Biologics.

The CBI has requested the court for voice samples of all accused to compare them with recorded conversations.

The lawyers appearing for L Praveen Kumar, the associate vice-president of Biocon Biologics, said there was no evidence of payments made by him.

According to CBI sources, Reddy on May 18 had attended the SEC (subject expert committee) meeting for the waiver of phase-3 clinical trials for the Insulin Aspart Injection drug developed by Biocon Biologics, Bangalore.

“The information has revealed that Reddy, JDC, manipulated the minutes of the meeting of SEC held on May 18 by changing word ‘data’ to ‘protocol’ in the recommendations, thereby causing substantial wrongful gain to Biocon Biologics Limited, Bangalore,” a CBI official said.

A Biocon Biologics official, speaking on condition of anonymity as the matter is sub judice, said, “The ‘data’ (results) arising from this trial will likely take 18 months post-approval and will be submitted to DCGI (Drugs Controller General of India) as part of the process. Such data cannot be provided before approval obviously, and hence the final minutes of the meeting are accurately worded requiring the phase-4 trial ‘protocol’ to be submitted,” the official said.

According to the company’s lawyers, the “data” follows only once the product is in the marketing stage or a post-marketing plan is followed by the drug company.

“Therefore, there is no dishonest or fraudulent alteration of the document as to attract Section 464 subsequently No. 468/471,” the lawyers told the court.

Arguing for grant of bail, they said the investigating agency had no explanation on how the money was recovered. The lawyers submitted that the SEC was a multi-member body, and all the members haven't been accused here.

The CBI had on June 21 arrested Reddy, Kumar, Dinesh Dua, director at Synergy Network India Private Limited, who allegedly gave a bribe to Reddy, Guljit Sethi, an alleged conduit of Biocon Biologics, and assistant drug inspector Animesh Kumar.