Biocon says 'all product approvals are legitimate' in bribery case for insulin approval

Drug major Biocon has denied allegations related to a bribery case filed by the Central Bureau of Investigation (CBI) involving executives of firms related to Biocon and a top official with the Central Drugs Standard Control Organisation (CDSCO), for speedy approval process for an insulin injection.

The CBI yesterday said it has apprehended a joint drug controller (JDC), posted at CDSCO Headquarters, New Delhi and a director of a private company based at Delhi in an alleged bribery of ₹4 lakh. "A case was registered against the official and others including directors, associate vice president & head-National Regulatory Affairs (NRA) of separate private companies, two based at New Delhi and another at Bengaluru, assistant drug inspector (ADI), CDSCO, New Delhi and other unknown officials of CDSCO, New Delhi & unknown others," said a CBI statement. Reports said the accused are JDC S Eswara Reddy, Dinesh Dua, Director of Synergy Network India, L Praveen Kumar of Biocon Biologics, Guljit Sethi alias Guljit Chaudhary, Director of Bioinnovat Research Services Pvt. Ltd., Delhi; and CDSCO Assistant Drug Inspector Animesh Kumar.

The investigation agency said the accused was trying to exert undue influence on officers of CDSCO to waive the Phase III trial of "Insulin Aspart Injection". The accused agreed to pay bribe amount of ₹9 lakh to the joint drug controller for favourably processing three files for favourably recommending the file of "Insulin Aspart injection" to the Subject Expert Committee (SEC) meeting. CBI laid a trap wherein the JDC of CDSCO and director of the firm were caught while accepting bribe of ₹4 lakh. Searches were conducted at 11 places located at Delhi, Noida, Gurugram, Patna and Bengaluru which led to recovery of incriminating documents/articles. The investigation is continuing, said the CBI statement.

Biocon denied the allegations and said all its product approvals are legitimate and backed by science and clinical data. "We deny the bribery allegations made in certain media stories. All our product approvals are legitimate and backed by science and clinical data. Our Aspart is approved in Europe and many other countries. We follow due regulatory process for all our product approvals by DCGI. The entire application process in India is online and all meeting minutes are in public domain. We are co-operating with the investigation agency," said a Biocon Biologics spokesperson.

In India, a new drug is approved after a Subject Expert Committee (SEC) scrutinises safety and efficacy of the drug, verifying the trial data at various stages of a three phase clinical development. Once satisfied, the SEC recommends the Drug Controller General of India (DCGI) to approve the drug.

The insulin Aspart injection branded as Kixelle, co-developed by Biocon Biologics with Viatris (formerly Mylan), had received marketing authorisation approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in February 2021. It is a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. In February, Biocon had acquired Viatris' biosimilars business, including this injection, in a $3.335 billion deal.