 "Clinical trial liability insurance to see sustainable growth")
The clinical trial liability insurance segment could see a period of stable and sustained growth, as the market is expected to become more professional for trials. General insurers are of the view the recent apex court view on the issue would lead to a more orderly growth.
General insurance companies Raheja QBE General Insurance, ICICI Lombard General Insurance, Bajaj Allianz General Insurance and New India Assurance offer the product. The average size of the policies ranges from Rs 1 lakh to Rs 50 lakh and above, depending on the size of the company and the magnitude of their research.
Pharmaceutical companies and contract research organisations (CROs) are consumers of the product. Sanjay Datta, head-underwriting and claims, ICICI Lombard said they expected a sustainable growth in this segment. He added that primarily Indian pharma firms took this insurance, compared to international pharma companies.
Clinical trial liability insurance is taken by companies to protect themselves from the risks arising from bodily/physical injury caused to the individual during the process of clinical trials. The policy covers legal liability in some cases. Post-trial risks of up to two months are also covered. However, effects such as failure of drugs and nuclear chemical risks are usually excluded from coverage.
Gisha George, head-liability insurance, Bajaj Allianz General Insurance said there could be a drop in the number of clinical trial policies after the new regulations covering the process.
“There is a healthy mix of Indian companies and foreign pharma players in this segment. Looking at the size of the business, the claims ratio is manageable. The exclusions include deviation from protocol knowingly by the company/CRO taking the policy for the subject,” she said.
While companies do offer this policy, it is not a big business generator. Segar Sampathkumar, general manager at New India Assurance said there is no significant growth in this area.
Experts say this may be due to the fact that clinical trial liability insurance is not mandatory.
Hence, while the number of trials conducted may be high, there is no corresponding increase in the number of policies sold.
Industry sources also said that the risks associated with the process are very high and there should be a balance between risk management practices and safeguarding the general public. A senior insurance official said that though there is expected to be a slower growth in the segment owing to recent decisions, the growth would be more stable, without many fluctuations. The insurance industry is also awaiting more clarity on the issue, so that product structures and pricing can be altered appropriately.
Early this year, the Supreme Court has raised serious concerns about clinical trial of drugs on humans by multinational companies. It had said that all drug trials will be done under the supervision of the Union Health Secretary. While some guidelines have been put in place by the health ministry, the amendment to the Drugs and Cosmetics Act to introduce penal provisions for those flouting the rules is still to be passed.
General insurance companies Raheja QBE General Insurance, ICICI Lombard General Insurance, Bajaj Allianz General Insurance and New India Assurance offer the product. The average size of the policies ranges from Rs 1 lakh to Rs 50 lakh and above, depending on the size of the company and the magnitude of their research.
Pharmaceutical companies and contract research organisations (CROs) are consumers of the product. Sanjay Datta, head-underwriting and claims, ICICI Lombard said they expected a sustainable growth in this segment. He added that primarily Indian pharma firms took this insurance, compared to international pharma companies.
Clinical trial liability insurance is taken by companies to protect themselves from the risks arising from bodily/physical injury caused to the individual during the process of clinical trials. The policy covers legal liability in some cases. Post-trial risks of up to two months are also covered. However, effects such as failure of drugs and nuclear chemical risks are usually excluded from coverage.
Gisha George, head-liability insurance, Bajaj Allianz General Insurance said there could be a drop in the number of clinical trial policies after the new regulations covering the process.
“There is a healthy mix of Indian companies and foreign pharma players in this segment. Looking at the size of the business, the claims ratio is manageable. The exclusions include deviation from protocol knowingly by the company/CRO taking the policy for the subject,” she said.
While companies do offer this policy, it is not a big business generator. Segar Sampathkumar, general manager at New India Assurance said there is no significant growth in this area.
Experts say this may be due to the fact that clinical trial liability insurance is not mandatory.
Hence, while the number of trials conducted may be high, there is no corresponding increase in the number of policies sold.
Industry sources also said that the risks associated with the process are very high and there should be a balance between risk management practices and safeguarding the general public. A senior insurance official said that though there is expected to be a slower growth in the segment owing to recent decisions, the growth would be more stable, without many fluctuations. The insurance industry is also awaiting more clarity on the issue, so that product structures and pricing can be altered appropriately.
Early this year, the Supreme Court has raised serious concerns about clinical trial of drugs on humans by multinational companies. It had said that all drug trials will be done under the supervision of the Union Health Secretary. While some guidelines have been put in place by the health ministry, the amendment to the Drugs and Cosmetics Act to introduce penal provisions for those flouting the rules is still to be passed.