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Biocon Biologics Denies Bribery Charge, Says Followed Regulations

Biocon Biologics has denied allegations of bribery towards the corporate and officers

New Delhi:

Biocon Biologics, an arm of Biocon Ltd, on Tuesday denied allegations of bribery towards the corporate and its officers concerning approval for certainly one of its merchandise in India, asserting that it follows the due course of 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 medical trials of ‘Insulin Aspart’ injection, a product developed by the corporate to handle Type 1 and Type 2 diabetes.

In a response filed by Biocon Ltd to inventory exchanges, which sought clarification on the matter, the corporate mentioned its looking for of waiver of Phase 3 medical trials for Insulin Aspart in India was primarily based on the Indian regulatory steerage.

“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 mentioned within the submitting.

Explaining causes behind looking for waiver of Phase 3 medical trials for Insulin Aspart in India, Biocon Biologics mentioned it was primarily based on the Indian regulatory steerage — Similar Biologics Guidelines 2016 and New Drugs and Clinical Trials 2019.

The pointers present a framework for waiver of Phase 3 medical trials to be performed in India primarily based on a dedication to undertake a Phase 4 trial, the design of which needs to be accredited by the central licensing authority, it mentioned.

“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 topic professional committee (endocrinology and metabolism) in its assembly held on May 18, 2022 at CDSCO, New Delhi, famous that the corporate has performed Phase 1 and Phase 3 trials with Aspart in Germany and US, respectively. Based on the outcomes of this world trial, its product Aspart has been granted advertising and marketing authorisation by European Medicines Agency (EMA) and Health Canada.

It additional mentioned the committee advisable grant of permission to import and market the drug with waiver of Phase 3 medical trial within the nation with the situation that the agency ought to conduct Phase 4 medical trial in India and submit the protocol to CDSCO earlier than inserting the drug available in the market, as per current pointers.

Asserting that the corporate follows due regulatory course of for all its product approvals by the Drugs Controller General of India (DCGI), Biocon Biologics mentioned, “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 corporate mentioned, “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 firm additionally mentioned it has been cooperating with the investigating company. 

(Except for the headline, this story has not been edited by NDTV employees and is printed from a syndicated feed.)

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