BENGALURU: India’s top biopharmaceutical company, Biocon Biologics, on Tuesday rubbished the allegations that they paid kickbacks to the tune of Rs 4 lakh to Joint Drugs Controller S Eswara Reddy to waive phase-three clinical trial of Insulin Aspart injection.
“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. We condemn any acts of corruption and violation of rules by way of offering or paying bribes or undue favours, either directly or indirectly. We adopt global best practices in corporate governance and business responsibility,” the statement said.
The organisation also claimed besides their employees, all consultants, suppliers and partners associated with the company are also bound by a strong code of conduct that has a detailed clause on anti-bribery and anti-corruption.
About Insulin Aspart, which is their underdevelopment product, the statement by Biocon stated, “The rationale for waiver of Phase 3 clinical trials was based on the Indian regulatory guidance. 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 Licencing Authority.”
It continued: “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 is unfortunate that Biocon Biologics has been named in this controversy. We reiterate that we strongly condemn all acts of bribery and corruption and have been cooperating with the investigation agency,” the statement concluded.
The Central Bureau of Investigation (CBI) registered a case of criminal conspiracy and corruption against Reddy and nabbed him on Monday. The CBI spokesperson RC Joshi had said that along with Reddy, Synergy Network India Private Limited director Dinesh Dua was also arrested for giving the bribe.
The agency also registered an FIR in which, along with Reddy and Dua, it named Guljit Sethi aka Guljit Chaudhary, director of Delhi-based Bioinnovat Research Services Private Limited, L Praveen Kumar, associate vice-president and head-National Regulatory Affairs (NRA) of Bengaluru-based Biocon Biologics Limited, Animesh Kumar, assistant drug inspector (ADI), CDSCO New Delhi and other unknown officials of CDSCO.
According to the CBI spokesperson Dua agreed to pay a bribe amount of Rs 9 lakh to Reddy for favourably processing three files of Biocon and also for recommending “Insulin Aspart Injection” to the Subject Expert Committee (SEC).