Fortis Clinical Research (FCRL), a Fortis-Religare group company which used to be an exclusive partner of Ranbaxy in its generic product development, is planning to become a full-service clinical research organisation (CRO) to tap the $64-billion global clinical research market.
Full-service CROs undertake all phases of drug trials in humans (Phase I to III), unlike FCRL’s current focus on bio-equivalence and bio-availability studies. The two statutory studies are needed to prove that a generic medicine is equivalent to its originally discovered (and patent protected) drug in terms of safety and efficacy.
The move will see Fortis Healthcare promoters — the Singh brothers who quit pharmaceutical business after selling their family stake in Ranbaxy — reentering their former core business to tap an emerging business opportunity.
According to Ernst & Young and Federation of Indian Chambers of Commerce & Industry, India is one of the fastest growing clinical research destinations, with a growth rate that is two and a half times the overall (global) market growth.
FCRL had joined hands with the group’s hospital chain, Fortis Healthcare, and pathology and diagnostic lab chain, Super Religare Laboratories (SRL), to offer complete clinical trial services to global pharmaceutical firms, said FCRL CEO Ashok Rattan. “We have all the components required to become a full-service clinical trials provider. Our aim is to knit all of these strengths (the countrywide network of hospitals and laboratories) into one composite force.” Fortis has 48 hospitals, while SRL operates about 200 laboratories across the country.
To begin with, FCRL has asked all Fortis doctors to express their interest in becoming clinical trial investigators. The panel of such doctors, who are willing to take up research assignments, will be given back-end support by FCRL.
“We have requested all network hospitals to provide space for our support staff. A central ethics committee to approve trials is already in place.” FCRL chief said at least 70 clinical trials were going in various Fortis hospitals. “These trials are being undertaken by doctors on their individual capacities. While they will continue to have the freedom to participate in such trials, we will give them an additional opportunity to be part of the multi-site clinical trials we intend to take up.”
FCRL sees the countrywide network of its group hospitals and laboratories as an added advantage to bag multi-centric clinical research contracts. “Even now, the value of the clinical trials that are happening in Fortis, SRL and FCRL together could be about Rs 100 crore. If we leverage each other, this growth could be several times.”
After the exit of Singh family from Ranbaxy, FCRL has been seeing its Ranbaxy contracts dwindling. From 90 per cent in 2008, its Ranbaxy contracts have come down to less than 50 per cent. The company has repeated orders from companies such as Torrent, Unichem, IPCA, In-Swift and Panacea for bio-equivalence and bio-availability studies. Rattan expects this to grow bigger, and also include foreign clients for new drug clinical trials soon.
