Biocon Biologics on Tuesday denied allegations of bribery against the company and its officials associated with the approval process of its product insulin aspart injection bAspart.
The Bengaluru-headquartered company, in a statement, said it is governed by a strong code of conduct and condemns 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. 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 biopharmaceutical company said.
Phase III Trials
The company had sought waiver of phase III clinical trial for its insulin aspart injection bAspart which is used to treat diabetes. The waiver was given by the Central Drugs Standard Control Organsation's (CDSCO) subject expert committee (SEC) on the condition that the company do a phase IV trial in India.
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"All our product approvals are backed by science and clinical data. The rationale for waiver of phase III clinical trials was based on the Similar Biologics Guidelines 2016 and the New Drugs and Clinical Trials 2019," Biocon Biologics said.
The guidelines provide a framework for waiver of phase III clinical trials in India based on a commitment to undertake a phase IV trial, the design of which should be approved by the central licensing authority. In line with this, Biocon presented a proposal for import and marketing of insulin aspart with a waiver of phase III clinical trial in India, the statement added.
The company presented a detailed proposal along with pre-clinical and clinical trial data. The SEC on May 18 noted that Biocon has conducted phase I and phase III trials on aspart in Germany and the US, respectively, and based on the results of this global trial, aspart had been granted marketing authorisation by EMA and Health Canada, it said.
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