Biocon Biologics denies allegations of bribery against the company and executives
New Delhi:
Biocon Biologics, a branch of Biocon Ltd, on Tuesday denied allegations of bribery against the company and its executives in relation to approvals for one of its products in India, and said it was following due process to get approval from regulators. follows.
The CBI has arrested Joint Drug Controller S Easwar Reddy, Biocon Biologics Associate Vice President L Praveen Kumar and three others in connection with alleged bribery to waive Phase III clinical trials of ‘insulin aspart’ injections. Type 1 and type 2 diabetes.
In a response filed by Biocon Ltd to the stock exchanges, which sought clarification on the matter, the company said that its demand for relaxation of Phase 3 clinical trials for insulin aspart in India was based on Indian regulatory guidance.
“We strongly deny allegations of bribery against the company and its executives in connection with the approval process of one of our products in India,” Biocon Biologics said in the filing.
Explaining the reasons behind the demand for relaxation of Phase III clinical trials for insulin aspart in India, Biocon Biologics said it will follow the Indian regulatory guidance – Similar Biologics Guidelines 2016 and on New Drugs and Clinical Trials 2019 was based.
The guidelines provide a framework for relaxation of Phase 3 clinical trials to be conducted in India based on a commitment to conduct Phase 4 trials, the design of which should be approved by the Central Licensing Authority, it said.
“In line with the above regulations, Biocon Biologics submitted a proposal for import and marketing of Insulin Aspart with relaxation of Phase 3 clinical trial in India. Submitted a detailed proposal with test data.” added this.
Biocon Biologics claimed that the Subject Expert Committee (Endocrinology and Metabolism) in its meeting held on May 18, 2022 at CDSCO, New Delhi mentioned that the company has conducted Phase 1 and Phase 3 trials with Aspart in Germany and US respectively Is. Based on the results of this global trial, its product aspart has been granted marketing authorization by the European Medicines Agency (EMA) and Health Canada.
It further said that the committee recommended allowing import and marketing of the drug with the exemption of Phase III clinical trials in the country, subject to the condition that the firm should conduct Phase 4 clinical trials in India and the drug The protocol should be submitted to CDSCO before placing it. market, as per extant guidelines.
Stating that the company follows the proper regulatory process for all its product approvals by the Drugs Controller General of India (DCGI), Biocon Biologics said, “The entire application process in India is online and all meeting minutes can be viewed on Central’s website. Drugs Standard Control Organization (CDSCO).”
Reiterating that it strongly condemns all acts of bribery and corruption, the company said, “We adopt global best practices in corporate governance and business responsibility. In addition to our employees, all our consultants, suppliers and partners are also involved in the same Bound by a strong code of conduct. There is a detailed section on anti-bribery and anti-corruption.”
The company also said that it is cooperating with the investigating agency.
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