Biocon Biologics not only denied allegations of bribery, but said that the rationale for waiving phase-3 clinical trials for its Insulin Aspart injection was based on Indian regulatory guidance.
The company said its product approvals are backed by science and clinical data, and the rationale for waiver was based on the Similar Biologics Guidelines, 2016, and New Drugs and Clinical Trials, 2019.
“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 said.
It added that it presented a detailed proposal along with pre-clinical and clinical trial data.
The Subject Expert Committee (Endocrinology and Metabolism) in its meeting held on May 18 at CDSCO, New Delhi, noted that Biocon Biologics had conducted phase-1 and phase-3 trials in Germany and the USA, respectively, and based on the results of this global trial, Aspart was granted marketing authorisation by the EMA and Health Canada, Biocon Biologics said.
“Due regulatory process followed for all our product approvals 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),” it added.
The company said it condemns all acts of corruption and bribery and is cooperating with the investigating agency.