Lok Sabha Question No. 965 (UNSTARRED), answered on 2020-09-18
Subject: Illegal Clinical Trials
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Darshana Vikram Jardosh

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 965 TO BE ANSWERED ON 18 th SEPTEMBER, 2020

## ILLEGAL CLINICAL TRI ALS

## 965. SHRIMATI DARSHANA VIKRAM JARDOSH:

Will the Minister of HEALTH AND FAMILY WELFARE

be pleased to state:

- (a) the number of cases of illegal clinical trials that came to light during last five years and the action taken by the Government thereon, case -wis ;
- (b) the number of clinical trial d eaths reported during the said period along with the amount of compensation paid and pending, case - wise; and
- (c) whether Government proposes to put in place a proper regulatory mechanism to ensure time - bound andcommensurate compensation to the persons volunteering for clinical trials or the families of persons who die during such trials; and
- (d) if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a) : Some complaints of violations of Clinical Trials Rules have been received by Cen Drugs Standard Control Organisation (CDSCO) as detailed below:

|   Year | No. of complains   |
|--------|--------------------|
|   2015 | 04                 |
|   2016 | Nil                |
|   2017 | Nil                |
|   2018 | 02                 |
|   2019 | Nil                |
|   2020 | Nil                |

Such complaints, as and when received, are investigated and action taken as per provisions of Drugs and Cosmetics Act, 1940 and Rules thereunder.

- (b) : The number of Serious Adverse Events (SAE) of death, clinical trials related death compensation paid since 2015 is enclosed as Annexure - A .
- (c) & (d): Rule  42  of  New  Drugs  and  Clinical  Trials  Rules  2019,  provides  details mechanism for reporting and examination of SAEs including death, to decide the related of such events with cli ni al trial and also to determine quantum of compensation in a tim bound manner.

| S.No   | Year                     |   No. of Serious Adverse Events (SAE) of Death related to Clinical Trial based on available status of examination done. | No. of cases in which Compensation was paid related to Serious Adverse Events (SAE)   | Total amount of compensation paid by the applicant/companies/sp onsor to Serious Adverse Events (SAE) Death cases till date (INR).   |
|--------|--------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 1      | 2015                     |                                                                                                                      18 | 18                                                                                    | 2,05,94,866                                                                                                                          |
| 2      | 2016                     |                                                                                                                      27 | 27                                                                                    | 1,71,59,902                                                                                                                          |
| 3      | 2017                     |                                                                                                                      31 | 29                                                                                    | 1,84,00,749                                                                                                                          |
| 4      | 2018                     |                                                                                                                      54 | 51                                                                                    | 5,06,88,176                                                                                                                          |
| 5      | 2019                     |                                                                                                                      44 | 31                                                                                    | 3,16,88,355                                                                                                                          |
| 6      | 2020 (till 09.0 9.20 20) |                                                                                                                       2 | Nil                                                                                   | Nil                                                                                                                                  |
| Total  | Total                    |                                                                                                                     176 | 156                                                                                   | 13,85,32,048                                                                                                                         |