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Government of India
Ministry of Health and Family Welfare
21-February-2014 19:05 IST
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 are given in the table below:

Details of compensation paid in the cases of clinical trial related deaths in 2010

 

S. No

Sponsor

Investigational Product

Compensation paid

1

Merck

Safinamide

Rs.1,50,000/-

2

Wyeth

Temsirolimus

Rs.1,50,000/-

3

Quintiles

MLN0002/Placebo

Rs.20,00,000/-

4

Quintiles

BI 1744/Trial Procedure

Rs.3,00,000/-

5

Lilly

H3E-MC-JMHR

Rs.1,08,000/-

6

Lilly

H3E-EW-S124

Rs.2,00,000/-

7

Lilly

Pemetrexed

Rs.2,00,000/-

8

Bayer

Rivaroxaban/ Placebo/Warfarin

Rs.2,50,000/-

9

Bayer

Rivaroxaban

Rs.2,50,000/-

10

Bayer

Clexane/Placebo

Rs.3,50,000/-

11

Bayer

Rivaroxaban

Rs.2,50,000/-

12

Bayer

Rivaroxaban

Rs.2,50,000/-

13

Amgen

AMG-706

Rs.1,50,000/-

14

Amgen

AMG-479/AMG102

Rs.1,50,000/-

15

Bristol Myers

Brivanib alaninate/ Sorafenib

Rs.2,50,000/-

16

Sanofi

AVE005/Placebo

Rs.1,50,000/-*

17

Sanofi

AVE005/Placebo

Rs.1,50,000/-

18

Sanofi

AVE005/Placebo

Rs.2,00,000/-

19

PPD

XL-184/Placebo

Rs.10,00,000/-

20

Pfizer

Sitaxsentan/Placebo

Rs.1,50,000/-

21

Pfizer

Sitaxentan/Placebo/Sildenafil

Rs.2,25,000/-

22

Pfizer

Axitinib

Rs.1,50,000/-

 

*Compensation remained unpaid as whereabouts of the legal heir could not be located by the Investigator and his team inspite of their best effort                                                                                                          

                                                                                                               

Details of compensation paid in the cases of clinical trial related deaths in 2011

 

S. No

Sponsor

Investigational Product

Compensation paid

1

Apothecaries

Moxifloxacin or Placebo

Rs.2,16000/-

2

Fresenius

Paclitaxel Nanoparticle

Rs.1,80,000/-

3

Fresenius

Paclitaxel Nanoparticle

Rs.1,35,000/-

4

Icon

CS-7017, Erlotinib

Rs.2,02,500/-

5

Icon

CS-7017, Erlotinib

Rs.2,7 0,000/-

6

Icon

UT-15C SR

Rs.1,8 0,000/-

7

Lambda

Amphotericin B Lipid Suspension for injection

Rs.2,00,000/-

8

Pfizer

AG-013736 Axitinib Tablets

Rs.1,50,000/-

9

Pfizer

Tascotinib/Placebo

Rs.5,00,000/-

10

Sanofi

Cabazitaxel

Rs.1,00,000/-

11

Sun Pharma

Paclitaxel Injection concentrate for Nano-dispersion

Rs.3,00,000/-

12

Sun Pharma

Paclitaxel Injection concentrate for Nano-dispersion

Rs.3,00,000/-

13

Sun Pharma

Docetaxel   nano-dispersion

Rs.3,00,000/-

14

Sun Pharma

Paclitaxel Injection concentrate for Nano-dispersion

Rs.3,00,000/-

15

Sun Pharma

Paclitaxel Injection concentrate for Nano-dispersion

Rs.3,00,000/-

16

Veeda

MT 102/Placebo

Rs.50,000/-

   

Details of compensation paid in the cases of clinical trial related deaths in 2012

S. No

Sponsor

Investigational Product

Compensation paid

1

BMS

Brivanib

Rs.5,00,000/-

2

BMS

Belatacept

Rs.2,00,000/-

3

BMS

Brivanib

Rs.3,72,637/-

4

Daichii- Sankyo Pharma

DU176b

Rs.2,19,447/-

5

Quintiles

DU-176b or warfarin

Rs.5,26,638/-

6

Novartis

Aliskiren vs Enalapril

Rs.2,50,000/-

7

SUN

Docetaxel concentration Nano-Dispersion

Rs.50,000/-

8

Manipal

TRC4186/Placebo

Rs.4,38,600/-

9

Boehringer

BI 10773

Rs.5,00,000/-

10

PPD

Albiglutide

Rs.1,00,000/-

11

George

Aleglitazar

Rs.5,23,845/-

12

Parexel

LA294LY2127399

Rs.2,00,000/-

13

Piramal

P2745

Rs.1,36,028/-

14

Biogen Idec

BIIB017

Rs.7,99,000/-

15

Astra Zeneca

AZD8931/Arimidex

Rs.9,62,475/-

16

Novartis

Vidagliptin

Rs.1,50,000/-

 

Details of compensation paid in the cases of clinical trial related deaths in 2013*

S. No

Sponsor

Investigational Product

Compensation amount & date of order

1

Fortis Escorts Heart Hospital

Taxus element (Xience Prime)

Rs. 16,00,000

14.02.2013

2

Fortis Escorts Heart hospital

Taxus element

Rs. 8,00,000

14.02.2013

3

Reliance Life Science

Bevacizumab

Rs. 5,45,700                 

14.02.2013

4

Reliance Life Science

Bevacizumab

Rs. 5,16,600

14.02.2013

5

Johnson & Johnson Ltd.

Epoetin Alfa

Rs. 4,00,000

14.02.2013

 

*Out of the cases of SAEs of death reported during the year 2013, the competent authority has so far issued orders for payment of compensation in these 5 cases only.

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 Hon’ble Supreme Court, on 30.9.2013, while taking note of various measures taken by the Government, asked for the report of Prof. Ranjit Roy Chaudhury 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 Chaudhury Committee before the Hon’ble 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 Hon'ble 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 of the trial 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 Hon’ble 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.

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MV/GM/BK