‘Minutes manipulated’: CBI arrests Biocon executive, 4 others
Biocon Biologics denied the allegations, saying its request and the waiver recommendation it received conformed to the standards and protocols
The Central Bureau of Investigation (CBI) on Tuesday placed under arrest a top executive of Biocon Biologics, a drugs inspector and a joint drug controller (JDC) at India’s pharma regulator, a day after the agency disclosed it booked several people over alleged bribes paid to fast-track the approval of an insulin injection developed by the company.

The arrest of the JDC of the Central Drugs Standards Control Organisation (CDSCO) and the associate vice president of Biocon Biologics among five people held till now represents a controversy embroiling the top of the country’s regulatory and pharma industry circles.
The company denied the allegations, saying its request and the waiver recommendation it received conformed to the standards and protocols, and said it was cooperating with the authorities over the probe. At the heart of the probe is Aspart, an insulin injection made by Biocon Biologics meant for diabetes patients.
<img src="https://www.hindustantimes.com/static/ht2022/6/2206_pg10.jpg" width="100%"/>
The CBI detained the JDC, S Eswara Reddy, and Synergy Network India Pvt Ltd director Dinesh Dua when the two were caught exchanging ₹4 lakh on Monday, a payment that Dua was allegedly making on behalf of Biocon Biologics.
The bribe, the agency alleged, was meant to secure the approval from CDSCO’s subject approval committee (SEC) for Aspart to be recommended for market authorisation without phase 3 clinical trials. The CDSCO’s recommendations are then relied upon before the Drugs Controller General of India (DCGI) issues the final authorisation.
The others arrested, including Biocon Biologics associate vice president and the head of national regulatory affairs, L Praveen Kumar, Bioinnovat Research Services Pvt Ltd director Guljit Sethi, and assistant drug inspector Animesh Kumar, were picked up after raids at 11 locations, including Delhi, Gurugram and Bengaluru.
Kumar was arrested from Bengaluru and was being brought to Delhi on Tuesday on a transit remand -- officials said he will be produced before a court in the Capital on Wednesday.
“Reddy had manipulated the Minutes of the Meeting of SEC by changing the word ‘Data’ to ‘Protocol’ in the recommendations and thereby causing substantial wrongful gain to M/s Biocon Biologics Limited, Bangalore,” the agency said.
Biocon Biologics, a subsidiary of Kiran Mazumdar Shaw-led Biocon, denied the allegations. “Biocon Biologics is governed by a strong code of conduct… We strongly condemn any acts of corruption and violation of rules by way of offering or paying bribes or undue favours, either directly or indirectly. We adopt global best practices in corporate governance and business responsibility,” the company said in a statement.
It said its request to waive the trial was based on India’s regulatory guidelines, which “provide a framework for waiver of phase 3 clinical trials to be conducted in India based on a commitment to undertake a Phase 4 trial…”
It added that the SEC had noted phase 1 and phase 3 trials were done in Germany and USA and “based on the results of this global trial, Biocon Biologics’ product, Aspart, has been granted marketing authorisation by EMA (European Medicines Agency) and Health Canada.”
In other words, the company contends that it applied Indian provisions that say a product seek approval if it has been approved by a foreign regulator.
In the statement on Tuesday, the CBI alleged that Sethi, who was handling the government regulatory works for Biocon Biologics, conspired with Kumar and other senior executives of the company to pay Reddy a bribe of ₹9 lakh in all.
The agency also claimed that Sethi had been acting as a ‘conduit on behalf of various pharmaceutical companies’, suggesting the corruption involving the country’s drugs regulator could be wider in scope.
On May 18, Reddy attended am SEC that “supported the waiver of phase III clinical trial for the ‘Insulin Aspart Injection’ drug” of Biocon Biologics, the CBI said.
It added that three files of Biocon Biologics were approved as assured by JDC Reddy to Dua during a prior meeting.
The minutes of the SEC meeting that HT reviewed on the CDSCO website said the committee had recommended the injection’s import and marketing under certain conditions.
“After detailed deliberation, the committee recommended for grant of permission to import and market the drug with waiver of phase III clinical trial in the country with the condition that firm should conduct phase IV clinical trial in India (which also includes a sub-set population to generate PK/PD and immunogenicity and submit the protocol to CDSCO before placing the drug in the market) as per existing guidelines in the country,” it added.
The Drugs Controller General of India (DCGI), directorate general of health services and the Union ministry of health and family welfare formally did not respond to the bribery allegations and measures being taken, a senior central government official said, adding that this was because the case is currently under probe.
“The agency concerned is investigating the matter and it will not be appropriate to speculate or make any comments regarding the investigation. There is no room for corruption and steps will be taken accordingly against those found guilty, as has happened in the past,” the official said, seeking anonymity.
In 2019, the health ministry had suspended a deputy drugs controller with CDSCO after the controller was apprehended by the CBI on charges of bribery.
