Lok Sabha Question No. 6486 (UNSTARRED), answered on 2018-04-06
Subject: Deaths due to Clinical Trials
Ministry: HEALTH AND FAMILY WELFARE
Asked by: DUSHYANT CHAUTALA

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

LOK SABHA UNSTARRED QUESTION NO. 6486 TO BE ANSWERED ON  6 TH APRIL, 2018

## DEATHS DUE TO CLINIC AL TRIALS

## 6486. SHRI DUSHYANT CHAUTALA:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether it is a fact that a total of 24,117 cases of deaths have been reported during years due to clinical trials across the country and there is a serious lack of tran sparency in the availability of data;
- (b) if so, the details thereof;
- (c) whether the Government has constituted any mechanism to regularise clinical trials monitor the clinical trial of pharma companies; and
- (d) if so, the details thereof and the steps taken by the Government in this regard?

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

- (a) & (b): No. A total of 4604 Serious Adverse Events (SAEs) of death including thos related and not related to clinical trials were reported from 2008 to 2017.

Drugs  and  Cosmetics  Rules,  1945  were  amended  in  January,  2013  and  December,  2014 incorporating provisions for reporting of Serious Adverse Events (SAEs) of injuries inc death and exa mination within prescribed timeline to determine the cause of death and quant of compensation  in cases of clinical trial related deaths. Cases of SAEs of deaths repor sponsor,  investigator  and  Ethics  committee  are  examined  as  per  the  above  pro visions  and maintained at Central Drugs Standard Control Organisation (CDSCO) in a transparent manner.

- (c) & (d): Clinical trials of new drug s are regulated under Rules122 DA, 122DAB, 122DAC, 122DD, 122E and Schedule - Y oftheDrugs and Cosmetics Rules , 1945 .

Contd………

Various measures  have been taken by the  Government for strengthening the  regulato provisions in respect of clinical trials including amendments in the Drugs & Cosmetics 1945 laying down:

i. the procedures to analyse the reports of Serious Adverse Events (SAEs) and payment of compensation in case of trial related injury or death;

iii. require ments and guidelines for registration of Ethics Committee;

ii. conditions for conduct of clinical trials, authority for conducting clinical trial and actions in case of non - compliance;

iv. audio - video  recording  of  informed  consent  process  in  case  of  vulnerable  subjects clinical trials of new chemical entity/new molecular entity (NCE/NME).In case of anti - HIV and anti - Leprosy drugs, only audio recording of the informed consent has been specified;

v. further,  it  has  been  made  mandatory  to  submit  the  following  details  in  the  cl trial/new drug application of New Chemical Entity and Global Clinical Trials: -

- -Assessment of risk versus benefit to the patients .
- -Innovation vis - à- vis existing therapeutic option.
- -Unmet medical need in the country.

vi. Expert Committees have been constituted to examine the reports of deaths in clinic trials. These Expert Committees have prepared detailed guidelines for examination of reports of deaths and also prepared formula(s) for determining the quantum of compensation in ca of clinical trial related deaths and injury (other than death).

In compliance of the order dated 03.01.2013 of the Hon'ble Supreme Court, a system of supervision of clinical trial has been put in place by constituting an Apex Committee un chairpersonship  of  Secretary,  Health  and  Family  Welfare;  and  a  Technical  Committee  un chairpersonship  of  Director  General ,  Health  Services  (DGHS).  Accordingly,  clinical  trial proposals of new chemical entities (NCEs) are evaluated through a three tier system compr (i) Subject Expert Committee (SEC), (ii) a Technical Committee and (iii) the Apex Commit Other  clinica l  trial  proposals  are  evaluated  through  a  two  tier  system  of  SEC  and  Techn Committee.

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