Biocon arm Syngene ends contract with Bioinnovat Research over graft case

Guljit Sethi of Bioinnovat research was named in CBI FIR on a bribery case involving CDSCO official and Biocon Biologics executive

After the controversy surrounding Central Drugs Standards Control Organisation (CDSCO) and Biocon Biologics emerged, another Biocon Group arm Syngene International has distanced itself from Bioinnovat Research Services, whose promoter has been mentioned in the anti-graft case. The company has terminated its retainer advisory contract with Bioinnovat recently.

Syngene International, the research, development and manufacturing organisation (CRDMO) that serves global pharmaceutical, biotech clients among others, has terminated the contract it had with Bioinnovat.

Guljit Sethi (alias Guljit Chaudhary), Bioinnovat Research Services was arrested by the Central Bureau of Investigation (CBI) in connection to the bribery case that involved joint drugs controller Eswara Reddy,  Dinesh Dua, director, Synergy Network and  L Praveen Kumar, associate vice president and head, national regulatory affairs (NRA), Biocon Biologics. The CBI had said in its FIR that both Dua and Sethi acted as conduits on behalf of pharma companies.

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Sethi is the owner of Bioinnovat Research and her LinkedIn profile says that Bioinnovat is a knowledge resource organisation on pharmaceutical drug development and real world clinical outcomes serving global and local biopharmaceutical companies, contract research organisations etc.

“Bioinnovat provides regulatory and compliance services, corporate affairs, advisory services culminating in strategic alliances, pharma executive search and contract resourcing. Bioinnovat has operational staff in India, UK and emerging markets with offices in Delhi NCR, Ahmedabad, Mumbai & London,” the profile adds.

Confirming the development a Syngene International spokesperson said: “Bioinnovat is known as a leading provider of advisory services to the pharma industry and, like many other companies, Syngene has had a retainer advisory contract with the company. We have now terminated this relationship.”

The spokesperson further added that Syngene does not own any products and does not market the products of others, so its business model is different to that of Biocon Biologics.  “In most cases our clients manage the relationship with regulators around the world. Syngene is a research, development and manufacturing services company,” the spokesperson explained.

Syngene does drug discovery work from early stage research; development work spanning pre-clinical development, active pharmaceutical ingredient development etc; and also offers manufacturing services to its clients which span industries like pharmaceutical, biotech, nutrition, animal health, consumer goods and speciality chemical sectors.

The company spokesperson further added that, “In the normal course of business, Syngene is routinely visited and audited by both Indian and other international regulators in order to obtain approvals for processes and equipment. From time-to-time, the company uses professional support to prepare for such audits and approvals.”

At the time the controversy around bribing a senior CDSCO official to get ‘files’ approved erupted, Biocon Biologics had denied allegations of bribery, and said that the rationale for waiver of Phase 3 clinical trials was based on Indian regulatory guidance. The company had said that it condemns all acts of corruption and bribery and is cooperating with the investigating agency.