The Central Bureau of Investigation (CBI) on Tuesday arrested Biocon Biologics Associate Vice President L Praveen Kumar in a bribery case involving Joint Drugs Controller S Eswara Reddy.
Kumar and Reddy are among the five persons arrested by the CBI in a case for allegedly involving bribes for the clearance of Biocon Biologics files.
Reddy was allegedly caught accepting Rs 4 lakh in cash as a bribe for clearance of three files of Biocon Biologics pending with him.
The other three persons who have been arrested in the case include Director of Synergy Network India Pvt Ltd Dinesh Dua, Director of Bioinnovat Research Services Private Limited Guljit Sethi and CDSCO Assistant Drug Inspector Animesh Kumar.
Reacting on the development Biocon Biologics issued a statement: "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."
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.
The company further said, "Besides our employees, all our consultants, suppliers and partners are also bound by a strong code of conduct that has a detailed clause on anti-bribery and anti-corruption."
Denying the bribery allegation, the company said, "Biocon Biologics follows due regulatory process for all our product approvals by the DCGI. The entire application process in India is online and all meeting minutes can be found on the website of the Central Drugs Standard Control Organisation (CDSCO)."
Biocon Biologics condemns all Acts of Corruption and Bribery. It is unfortunate that Biocon Biologics has been named in this controversy. We reiterate that we strongly condemn all acts of bribery and corruption and have been co-operating with the investigation agency, the company said.
Referring to the waiver of Phase 3 Clinical Trials for Insulin Aspart in India, Biocon Biologics said, "all our product approvals are backed by science and clinical data."
It said the waiver of Phase 3 clinical trials was based on the Indian regulatory guidance.
The guidelines 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, the design of which should be approved by the Central Licencing Authority.
In line with the above regulations, Biocon Biologics presented a proposal for import and marketing of Insulin Aspart with a waiver of Phase 3 clinical trial in India. The Company presented a detailed proposal along with CMC, pre-clinical and clinical trial data.
The Subject Expert Committee (Endocrinology and Metabolism) in its meeting held on May 18, 2022 at CDSCO, New Delhi, noted that Biocon Biologics has conducted Phase 1 and Phase 3 trials with Aspart in Germany and USA, respectively, and based on the results of this global trial, Biocon Biologics' product, Aspart, has been granted marketing authorization by EMA and Health Canada, the company claimed.
( With inputs from ANI )
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