Biocon Biologics, an arm of Biocon Ltd, on Tuesday denied allegations of bribery against the company and its officials regarding approval for one of its products in India, asserting that it follows the due process to get nod from regulators.
The CBI has arrested Joint Drugs Controller S Eswara Reddy, Associate Vice President of Biocon Biologics L Praveen Kumar and three others in a case of alleged bribery to waive Phase 3 clinical trials of ‘Insulin Aspart’ injection, a product developed by the company to manage Type 1 and Type 2 diabetes.
In a response filed by Biocon Ltd to stock exchanges, which sought clarification on the matter, the company said its seeking of waiver of Phase 3 clinical trials for Insulin Aspart in India was based on the Indian regulatory guidance.
“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,” Biocon Biologics said in the filing.
Explaining reasons behind seeking waiver of Phase 3 clinical trials for Insulin Aspart in India, Biocon Biologics said it was based on the Indian regulatory guidance — 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 licensing authority, it said.
“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 presented a detailed proposal along with CMC, pre-clinical and clinical trial data,” it added.
Biocon Biologics claimed that the subject expert committee (endocrinology and metabolism) in its meeting held on May 18, 2022 at CDSCO, New Delhi, noted that the company has conducted Phase 1 and Phase 3 trials with Aspart in Germany and US, respectively. Based on the results of this global trial, its product Aspart has been granted marketing authorisation by European Medicines Agency (EMA) and Health Canada.
It further said the committee recommended grant of permission to import and market the drug with waiver of Phase 3 clinical trial in the country with the condition that the firm should conduct Phase 4 clinical trial in India and submit the protocol to CDSCO before placing the drug in the market, as per existing guidelines.
Asserting that the company follows due 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 found on the website of the Central 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. 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 also said it has been cooperating with the investigating agency.
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