The Central Bureau of Investigation on Tuesday arrested five persons, including a senior executive of biotechnology firm Biocon Biologics, in an alleged bribery case, The Indian Express reported.
The CBI said that it caught, S Eswara Reddy, the joint drug controller of the Central Drugs Standard Control Organisation, while accepting a bribe of Rs 4 lakh on Monday. The agency alleged that he had three files of Biocon Biologics pending with him and that bribes had been negotiated to clear them.
The central agency on Tuesday arrested Reddy, associate vice president with Biocon Biologics L Praveen Kumar, Central Drugs Standard Control Organisation Assistant Drug Inspector Animesh Kumar, director of Synergy Network India Dinesh Dua and director of Bioinnovate Research Services Guljit Sethi alias Guljit Chaudhary.
According to the CBI, Bioinnovat handled the regulatory affairs of Biocon and regularly paid bribes in exchange for clearances from regulatory authorities. The agency claimed that Bioinnovate had business ties with Synergy Network and Sethi had asked Dua to pay a bribe to Reddy. Bioinnovate allegedly intended to pay a total bribe of Rs 9 lakh to the drug regulatory official so that the phase-III trial of Biocon’s Insulin Aspart injection could be waived.
Biocon Executive Chairperson Kiran Mazumdar-Shaw denied the allegations of bribery, according to The Indian Express. “All our product approvals are legitimate and backed by science and clinical data,” she said. “Our bAspart [insulin injection] is approved in Europe and many other countries. The regulatory process in India is online and all meeting minutes are in [the] public domain.”
Biocon Biologics also denied allegations of bribery against the company and its officials. It said that it sought a waiver of the phase-III trial based on regulatory guidelines, which state that the requirement can be waived based on a commitment to carry out a phase-IV trial.
The phase-IV trial has to be approved by the Central Licencing Authority, the firm added.
Biocon Biologics said that the Subject Expert Committee (Endocrinology and Metabolism), in a meeting on May 18, had noted that the company had conducted phase-I and phase-III trials in Germany and the United States.
“Biocon Biologics follows due regulatory process for all our product approvals by the DCGI [Drug Controller General of India],” it 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.”