₹4 lakh to the CDSCO official. The CBI also booked three others including an associate vice-president of Biocon Biologics Ltd, a subsidiary of Biocon, founded by one of India’s most famous woman entrepreneurs, Kiran Mazumdar-Shaw.
The agency charged that the bribe was paid to get regulatory clearances for an insulin injection, Insulin Aspart, manufactured by the company without undergoing mandatory Phase III clinical trials.
It has also named Praveen Kumar, head of Biocon’s national regulatory affairs section, and other senior executives of the company and its subsidiaries and associates as co-conspirators in the bid to bypass regulatory processes and manipulate the minutes of the Subject Expert Committee of the CDSCO, which actually considered the case.
Mazumdar-Shaw and Biocon Biologics have rejected all the charges and claimed that all their drugs product approvals were “legitimate", backed by “science and data" and obtained after following all regulatory due processes.