Biocon Bribery Business: Top Official Calls on Health Department to ‘Do Justice’ and Revoke Suspension

Amid ongoing controversy over Biocon corruption, India’s top drug regulatory agency official, Dr S Eswara Reddy, has called on the Health Ministry to ‘do him justice’ and revoke his prescriptions suspension, News18.com has learned.

India’s Comptroller General of Drugs, Dr Reddy, was arrested by the Central Bureau of Investigation (CBI) in June for accepting bribes to speed up the approval of a drug for Biocon Biologics , based in Bengaluru.

Following the arrest, Reddy – who has worked at the Central Drugs Standard Control Organization (CDSCO) for 23 years – was suspended until further notice.

In September, the Delhi High Court granted bail to Reddy, who also served as Drugs Comptroller General of India (DCGI) – the head of CDSCO – from February 2018 to August 2019.

In his letter, he informed the Ministry of Health and Family that he was involved in a “totally false affair in order to deprive me of promotion, tarnishing my image and damaging my reputation as an honest and sincere officer” .

He wrote in the letter that there is “no evidence” and that the facts are “misrepresented” either “deliberately or have not been able to figure out the matter”.

“The allegations are vague and without my direct or indirect involvement in any of the events in which my name was mentioned by others, thus showing a clear attempt to entrap me for unknown reasons,” he said.

His letter was accompanied by a copy of the High Court order which shows the court’s consideration and reservations to his pleas.

He asked the ministry to “do him justice” by highlighting certain points such as his previous career.

“I have worked at CDSCO for about 24 years in various capacities, occasionally taking on responsible and confidential assignments, proving my utmost sincerity, diligence, dedication to work and above all my honesty,” he said.

“DCGI holds the final power, no approval without his nod”

Reddy, in the letter, explained the procedure followed at CDSCO to submit questions to the Committee of Subject Matter Experts (SEC) and how it becomes impossible to make decisions in favor of a company.

In a lengthy memo explaining the role of each department and expert group, including the subject matter expert committee, Reddy added that the final responsibility for approving or rejecting any drug rests with the drug controller general of the India (DCGI).

“…The Joint Drug Controller (JDCI) submits the draft minutes for “approval in principle” by the DCGI, which in turn, after finally verifying the contents, forwards it to the SEC Division’s JDCI for further transmission to all SEC members present in the relevant meeting by e-mail for approval,” he said. “After receipt of the approval by return mail, the SEC Division uploads the minutes approved/formal of the SEC meeting on the CDSCO website.”

His letter also clarified that the SEC’s recommendations are not binding on CDSCO.

“It is very important to note that the recommendations of the SEC are not binding on the implementation of CDSCO, because it is CDSCO’s responsibility to ensure the quality of the product in addition to its safety and effectiveness”, a- he declared. “It is only after satisfactory evidence regarding the safety, efficacy and quality of the drug is proven that only DCGI, the licensing authority, gives final approval for marketing. In other words, the mere recommendation of a product by the SEC does not in itself mean that final approval to market that product has been granted.

‘Pass data to appropriate protocol’

It was alleged that Reddy changed the word “data” to “protocol” in the meeting minutes while giving his endorsement to Biocon.

He argued in the letter that the use of the word “protocol” is appropriate. In a subtitle titled “Government Policy Regarding Waiver of Local Clinical Trials”, he argued that there are explicit provisions for the waiver of local clinical trials under Subrule 7 of Rule 75 of the Rules. of 2019 on new drugs and clinical trials.

The guidelines, according to the letter, “clearly state that the company should generate immunogenicity data after bringing the product to market and as part of the post-approval Phase IV study.”

“The mode of data collection, during the phase IV study, must be specified in a protocol which must be submitted to the regulatory authority. The data must be collected according to the approved protocol. If no protocol has been approved, data collection becomes meaningless,” he said.

In view of the above, he writes, “the use of the word ‘Protocol’ is appropriate…”

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