The Central Bureau of Investigation (CBI) on Monday detained a Joint Drug Controller of the Central Drugs Standard Control Organization (CDSCO) and the director of a Delhi-based private company for allegedly exchanging a bribe of Rs 4 lakh. Meanwhile, the agency also booked three others, including an Associate Vice President of Biocon Biologics Ltd, who alleged that bribes were paid to gain regulatory approval for an insulin injection manufactured by the company. However, Biocon Biologics has denied the allegations.
“We strongly deny the bribery allegations against the company and its officials in connection with the approval process of one of our products in India. We strongly condemn all acts of corruption and violation of rules through the offer or payment of bribes or improper favors, directly or indirectly. We apply global best practices in corporate governance and corporate responsibility. In addition to our employees, all of our consultants, suppliers and partners are also bound by a strong code of conduct that includes a detailed anti-bribery and anti-corruption clause,” Biocon Biologics, spokesman told Financial Express.com Tuesday.
The spokesperson also informed that Biocon Biologics has submitted a proposal for the import and marketing of Insulin Aspart from a Phase 3 clinical trial waiver in India. The company presented a detailed proposal along with CMC, preclinical and clinical trial data.
“The Subject Expert Committee (Endocrinology and Metabolism) noted at its meeting on May 18, 2022 in CDSCO, New Delhi, that Biocon Biologics has conducted Phase 1 and Phase 3 studies with Aspart in Germany and the US, respectively, and based on the results of this global trial, Biocon Biologics’ product, Aspart, has received marketing authorization from the EMA and Health Canada,” the spokesperson said.
“It is unfortunate that Biocon Biologics is mentioned in this controversy. We reiterate that we strongly condemn all acts of bribery and corruption and have cooperated with the investigative agency,” the Biocon Biologics spokesperson added.
According to a report by PTI news agency, CBI officials identified the detained men as S Eswara Reddy, Joint Drug Controller posted at CDSCO headquarters in New Delhi, and Dinesh Dua, director of Synergy Network India Pvt Ltd. The others booked in the case are L Praveen Kumar, Associate Vice President and Head — National Regulatory Affairs of Biocon Biologics Ltd; Guljit Sethi aka Guljit Chaudhary, Director of Bioinnovat Research Services Private Limited, Delhi; and, CDSCO Assistant Drug Inspector Animesh Kumar.
“It was alleged that the accused tried to improperly influence officials of CDSCO (Central Drugs Standard Control Organization) under the Directorate General of Health Services, Ministry of Health and Family Welfare (GOI), Delhi to waive the phase III study of ‘Insulin Aspart Injection,’ said a CBI spokesperson as quoted by
“It was further alleged that the accused agreed to pay a bribe of Rs 9 lakh to JDC, CDSCO for the favorable processing of the said three files related to a private company based in Bangalore and also for favorably recommending the file of ‘Insulin Aspart Injection’ to the Subject Expert Committee (SEC) meeting,” the spokesperson said.
Reportedly, CBI officers alleged that a trap had been set and that Reddy was caught taking bribes of Rs 4 lakh from Dua. “Searchs have been carried out at 11 sites in Delhi, Noida, Gurugram, Patna, Bengaluru, resulting in the recovery of incriminating documents/articles,” a statement from the CBI said.
In addition, CBI officials claimed that Bioinnovat Research Services Private Limited had been asked for regulatory approval for the Biocon product. Bioinnovate, in turn, engaged Synergy Network to get the job done, the agents claimed. “Dua, who negotiated and paid the bribe, is the director of Synargy. Both Reddy and Dua have been detained and are being questioned,” said a CBI official. Meanwhile, Kiran Mazumdar-Shaw and Biocon Biologics rejected the CBI claims.
Mazumdar-Shaw said: “We deny the bribery allegations. All our product approvals are legitimate and supported by scientific and clinical data. Our bAspart has been approved in Europe and many other countries. The regulatory process in India is online and all meeting minutes are in the public domain.”
A similar statement was later issued by the Biocon Biologics spokesperson.
“All of our product approvals are legitimate and supported by scientific and clinical data. Our bAspart is approved in Europe and many other countries. We follow the proper regulatory process for all of our DCGI product approvals. The entire application process in India is online and all meeting minutes are in the public domain. We are working together with the research agency,” said the spokesman.