New insulin treatments for diabetes are hitting the market fast and furious these days.
Biocon Biologics’ effort to move its insulin through the approval process in India, however, has landed the generic manufacturer in trouble with India’s Central Bureau of Investigation, which has alleged a bribery scheme.
CBI officials say Biocon had agreed to pay an Indian drug regulator about $11,500 to waive a phase 3 clinical trial of Insulin Aspart Injection, which treats of Type 1 and Type 2 diabetes, India's Tribune News Service reports. Tuesday, the CBI said it had arrested the regulator, plus Biocon Associate Vice President Praveen Kumar and three others.
“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 said in a statement posted on its website. “We strongly condemn any acts of corruption and violation of rules by way of offering or paying bribes or undue favors, either directly or indirectly.”
The CBI alleges that Guljit Sethi, acting as a go-between for Biocon, conspired with Biocon's Kumar and other company executives to bribe Central Drugs Standard Control Organization official S. Eswara Reddy, Ph.D., for recommending that the trial be waived. Reddy made the recommendation last month, according to the Tribune News Service.
Also arrested was Dinesh Dua, director at Synergy Network India Private Limited, who is alleged to have given the bribe to Reddy. Reddy and Dua were detained in a “trap" operation after the alleged bribe took place, the publication reports.
In its statement, Biocon said Insulin Aspart Injection has received marketing authorization from Health Canada and the European Medicines Agency. The company pointed out that Indian regulators, after "detailed deliberation," recommended the company have permission to import the drug and be required to conduct a postmarketing study in India.