CBI Arrests Biocon Biologics Official, 4 Others In Bribery Case. Company Denies Allegation
Denying the allegations, Biocon Biologics said it is unfortunate that the company has been named in the controversy and it is co-operating with the investigation agency
New Delhi: Biocon Biologics associate vice-president L Praveen Kumar has been arrested by the Central Bureau of Investigation (CBI) on Tuesday in connection to a bribery case along with Joint Drugs Controller S Eswara Reddy. They are among the five people arrested allegedly for their involvement in bribes regarding clearance of Biocon Biologics files, reported news agency ANI. Reddy has been allegedly found taking Rs 4 lakh in cash as a bribe for clearing three files of Biocon Biologics pending with him.
There are other three persons arrested in the case including Director of Synergy Network India Pvt Ltd Dinesh Dua, Director of Bioinnovat Research Services Private Ltd Guljit Sethi, and CDSCO Assistant Drug Inspector Animesh Kumar.
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What’s the stance of Biocon Biologics?
On its part, Biocon Biologics has issued a statement denying the allegations. “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 company statement read, according to the ANI report. Dismissing the allegations, Biocon Biologics said, “We strongly condemned 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 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.”
The company noted that it follows due regulatory process for all our product approvals by the DCGI. The company clarified its stance saying that 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).
Condemning all acts of corruption and bribery, Biocon Biologics said 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 noted.
The company also pointed out at the waiver of Phase 3 Clinical Trials for Insulin Aspart in India and claimed that the waiver was based on the Indian regulatory guidance. The company said, “All our product approvals are backed by science and clinical data.”
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.
Following 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.
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