Jurisdiction - India
India – Intellectual Property September Review

24 October, 2013


Legal News & Analysis – Asia Pacific – India – Intellectual Property 


The Drugs and Cosmetics Rules, 1945 (‘DCR’) had been amended in January 2013, thereby inserting a Rule 122DAB and a new Appendix XII in Schedule Y (‘DCR Compensation Rules’). The DCR Compensation Rules inter alia specify a procedure for processing of reports of Serious Adverse Events (‘SAEs’), including deaths occurring during clinical trials to arrive at the cause of death and to determine the quantum of compensation.

Subsequently, on March 14, 2013, the Drugs Controller General of India (‘DCGI’) constituted three independent expert committees under the chairmanship of Dr AK Agarwal, Maulana Azad Medical College (‘Expert Committee’) to inter alia examine the SAEs of deaths occurring during clinical trials, and to recommend the cause of death, and further, to determine the quantum of compensation, if any, to be paid by the sponsor or his representative, whoever had obtained permission from DCGI.

The Expert Committee has now arrived at a formula to be followed for the determination of quantum of compensation in case of clinical trial related death. The Expert Committee has relied on the Workmen’s Compensation Act, 1923 (‘WC Act’) and the factors mentioned under the WC Act for calculating the amount of compensation in case of clinical trial related deaths. The Expert Committee was of the view that a constant base amount should be decided on which the variables such as age and risk should be applied to determine the quantum of compensation. The Expert Committee arrived at a formula factoring in age, risk and base amount for computing the quantum of compensation in case of SAEs related to clinical trial death. The Expert Committee has also mandated that a fixed amount of INR 200,000 should be paid to patients whose expected mortality is 90% or more within 30 days. As the Expert Committee has been constituted by DCGI, it appears that DCGI will henceforth take the above formula into consideration for determination of the quantum of compensation in the cases of clinical trial related SAEs resulting in death.




For further information, please contact:


Zia Mody, AZB & Partners
[email protected]


Abhijit Joshi, AZB & Partners 
[email protected]

Shuva Mandal, AZB & Partners 

[email protected]


Samir Gandhi, AZB & Partners
[email protected]

Percy Billimoria, AZB & Partners 

[email protected]


Aditya Bhat, AZB & Partners 
[email protected]



Comments are closed.