Howden Insurance Brokers India Pvt. Ltd, the Indian broking arm of the London-based Hyperion Insurance Group, is extending its services to the Indian clinical research services sector, trying to capitalize on a fast-emerging opportunity.
India now attracts hundreds of clinical research service projects from both domestic and multinational drug makers and contract research organizations (CROs) because of its cost advantages, availability of a varied genetic pool of subjects and a growing pharmaceuticals market.
At the same time, the high risk due to involvement of human subjects for testing new drugs has still not been brought under a foolproof monitoring system even as the regulator gets about 30 applications a month for new drug trials.
A clinical trial insurance will cover the risk of any legal liability arising out of physical injury, death or any harm caused to the health of the subject. According to industry analysts, Howden is the first insurance broking company looking at this opportunity in India.
In India, many players, including the four state-owned general insurance firms and a few private sector ones such as Bajaj Allianz General Insurance Co. Ltd and Cholamandalam General Insurance Co. Ltd , are ready to offer policies for clinical trials.
In most cases, these companies are going for re-insurance with international insurance firms as claims could possibly be huge.
As an insurance brokerage firm, Howden’s role will be to identify the suitable risk cover offered by the insurers looking at the nature of trials, number of human volunteers required for the trials, the capability of CROs, risk nature of the drugs under test, etc. A right risk analysis and a project-long follow-up by the broking firm would also help both the parties settle claims in the event of mishaps and litigations.
“The entry of globally experienced clinical trial insurance players into India will also help developing the right regulatory framework for this sector. In the recent past, litigations against clinical trials has increased manifold. CROs and their sponsors are sued for lack of care and negligence by human subjects for bodily injury and even death,” says Arun Bhatt, president, ClinInvent Research Pvt. Ltd, a local CRO.
“Clinical research is one of the areas which our group has expertise in. Since India is emerging as a preferred global destination for clinical trials, this is the right time to enter this space,” says Anup K. Mathur, vice-president (corporate business division) Howden India.
“Initially, we are not looking at expanding our topline by entering this sector. But it is more of an experimentation phase now in India and also a service to this high-risk sector,” adds Mathur.
According to him, insurance companies were not coming forward in the absence of a proper legal framework pertaining to clinical research, risk clauses of test subjects, recruitment procedures and compensation of volunteers.
“There is a need to create strong awareness about the possibilities of risk cover for all stakeholders, such as sponsors, CROs and the human volunteers,” Mathur adds.