Compensation for Clinical Trial Subjects

A Statement containing the details of the compensation paid in respect of Serious Adverse Events (SAEs) of death attributable to clinical trials reported during the years 2010, 2011, 2012 and 2013 is as follows:

 The independent expert committee constituted in accordance with the requirements of Rule 122 DAB and Appendix XII of the Drugs & Cosmetic Rules.

 1945 for examination of SAEs of death occurring during the clinical trials after detailed deliberations prepared a compensation formula taking into consideration a base amount, age and risk factor  of the subject. 
The risk factor,   in a scale of 0.5 to 4 is based on the seriousness and severity of the disease, presence of co-morbidities and duration of disease of the trial participant at the time of enrolment in the clinical trial. 

However in case of patients/  trial participant whose expected mortality is 90% or more (within 30 days), the committee  has recommended that a fixed amount of Rs. 2 lakh may be given for clinical trial related death.

In the Writ Petition (Civil) No. 33 of 2012 - Swathya Adhikar Manch vs. Union of India & others, the  Supreme Court, on 30.9.2013, while taking note of various measures taken by the Government, asked for the report of Prof. Ranjit RoyChaudhury Committee and also the details of the existing regime which ensures the safety of the subjects of clinical trials.

Accordingly, the Government submitted the report of Prof. Ranjit Roy ChaudhuryCommittee before the Supreme Court, actions proposed to be taken on the recommendations of the committee and details about the regulatory provisions, guidelines and requirements for conduct of clinical trials in the country. 

The Court was informed about the various recent measures taken by the Government in this regard, as follows:

1. Amendments to Drugs & Cosmetics Rules, 1945 vide (i) G.S.R. 53 (E) dated 30.1.2013 specifying the procedures for payment of compensation to the subjects ofthetrial in case of injury or death (ii) G.S.R. 63 (E) dated 1.2.2013 specifying various conditions for inspection of clinical trial and (iii)   G.S.R. 72 (E) dated 8.2.2013 specifying the detailed guidelines for registration of ethics committee.

2. The Drugs & Cosmetics (Amendment) Bill, 2013, introduced in the Parliament on 29.8.2013, contains a separate chapter containing penal provisions for violation and non-compliance of the provisions relating to the conduct of the clinical trials.

3. In light of the order dated 3.1.2013 of the Hon`ble Supreme Court, a system of supervision of clinical trials of new chemical entities through a Technical Committee under the chairmanship of DGHS and an Apex Committee chaired by the Secretary, Ministry of Health and Family Welfare has been put in place.

4. Further, in light of Supreme Court’s Order dated 21.10.2013, it has been decided that for all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required to be done while adhering to the principle of confidentiality.

This was stated by Shri Ghulam Nabi Azad, Union Minister for Health and Family Welfare in a written reply to the Lok Sabha today.