Lok Sabha Question No. 257 (STARRED), answered on 2018-08-03
Subject: Clinical Trials
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SUDHEER GUPTA, HARI BABU KAMBHAMPATI

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

## LOK SABHA STARRED QUESTION NO. 257 TO BE ANSWERED ON THE 3 RD AUGUST ,2018 CLINICAL TRIALS

## *257. SHRI SUDHEER GUPTA:

DR. KAMBHAMPATI HARIBABU:

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

- (a) the rules governing clinical trial in the country at present;
- (b)  whether  the  World  Health  Organisation  (WHO)  has  expressed  that  str clinical  trial  rules  will  drive  away  drug  f irms  and  the  United  Nations  (UN) agency's work with India would be hampered, if so, the details thereof including the details of suggestions made by WHO in this regard and the response of Government thereto;
- (c)  whether the  Government  has  held  a  meeting  with  the  stakeholders comprising pharma companies and pharma lobby groups in this regard and if the details and the outcome thereof;
- (d) the steps taken/being taken to carry out clinical trials in a transpar er in the country; and
- (e) the number of deaths occurred during the last three years across the by clinical trials, State/UT - wise along with the details of companies penalized for negligence in clinical trials during the said period?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE ( SHRI JAGAT PRAKASH NADDA )

- (a)to ( e) A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 257* FOR 3 RD AUGUST , 20 18

(a): Clinical trials of new drug sare regulated under Rules122 DA, 122DAB, 122DAC, 122DD, 122E and Schedule - Y oftheDrugs and Cosmetics Rules, 1945.

(b) Yes. Draft New Drugs & Clinical Trials Rules, 2018 was published on 01- 02- 2018  inviting  public/stakeholder  comments.  In  the  light  of  cer provisions  of  the  said  draft  Rules,  an  email  was  received  from  WH expressing apprehension that there was a possibility that sponsors wou ld not conduct clinical trials in India and go elsewhere due to such provisi was  also  stated  that  it  would  hamper  WHO's  work  with  India  as  WHO considers that it is a public health priority to conduct clinical tria The  following  three  pos sible  scenarios  were  mentioned  in  respect  of compensation in case of permanent disabilities /deaths in clinical trial

1.When the Ethics Committee (EC) and sponsor agree that the disability/death is due to clinical trial participation and the sponsor ys the compensation as EC determines.

2. When both parties agree that the disability/death is not due to parti in clinical trial, no compensation needs to be paid.
3. When  the  EC  determines  that  the  cause  of  disability/death  is  due participation ,  but  the  sponsor  wants  the  expert  committee  of  the  Centr Drugs  Standard  Control  Organisation  (CDSCO)  to  adjudicate,  and  the sponsor agrees, the decision is binding.

It  was  also  stated  that  under  the  third  s cenario,  payment  of  60%  interim compensation wh ich was not recoverable may not be acceptable to sponsors.

The purpose of publishing draft Rules is to get the comments of stakehol

The  Government  appreciates  and  welcomes  all  such  comments,  including those  from  the  WHO.  The  comments  have  been  duly  co nsidered  for preparing final draft of the Rules.

(c): Yes, meetings were held with stakeholders comprising indust representatives and experts. The issues highlighted by the industry/stake were noted for due consideration in preparing the final dr aft of the Rules.

- (d): Various measures taken by the Government for strengthening the regulato provisions in respect of clinical trials include amendments in the Dr Cosmetics Rules, 1945 laying down:
- i. the  procedures  to  analyse  the  reports  of  Seri ous  Adverse  Events (SAEs) and payment of compensation in case of trial related injury death;
- ii. conditions  for  conduct  of  clinical  trials,  authority  for  cond clinical trial inspections and actions in case of non - compliance;
- iii. requirements and guidelines for registration of Ethics Committee;
- iv. audio - video recording of informed consent process in case of vulnerable  subjects  in  clinical  trials  of  new  chemical  entity molecular  entity  (NCE/NME).In  case  of  anti - HIV  and  anti - Leprosy drugs,  only  audi o  recording  of  the  informed  consent  has  been specified;
- v. further, it has been made mandatory to submit the following detail the  clinical  trial/new  drug  application  of  New  Chemical  Entity 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 death in  clinical  trials.  These  Expert  Committees  have  prepared  detaile guidelines  for  ex amination  of  reports  of  deaths  and  also  prepared formula(s) for determining the quantum of compensation in case of clinic trial related deaths and injury (other than death).
- vii. In  compliance  of  the  order  dated  03.01.2013  of  the  Hon'ble  Supreme Court, a syst em of supervision of clinical trial has been put in place constituting an Apex Committee under the chairpersonship of Secretary, Health and Family Welfare; and a Technical Committee under chairmanship of Director General, Health Services (DGHS).

(e):Death may occur during clinical trial due to various reasons such a disease from which the patient may be suffering or due to the investiga product  or  any  other  reason.  Clinical  trials  are  mostly  multi - cen ric, conducted  simultaneously  in  many  C enters/States  across  the  country.  The number of persons who died during clinical trial in the last three yea number of such cases which are related to clinical trials and the amo compensation paid is enclosed as Annexure.

Annexure

|   S.No. |   Year |   No. of Serious Adverse Event (SAE) of Death reported |   No. of Serious Adverse Event (SAE) of Death related to clinical trial based on available status of examination done | Total amount of Compensation paid by the applicant companies/sponsor to Serious Adverse Event (SAE) Death cases till date (INR)   |
|---------|--------|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
|       1 |   2015 |                                                    381 |                                                                                                                    18 | Rs.2,05,94,866/-                                                                                                                  |
|       2 |   2016 |                                                    378 |                                                                                                                    24 | Rs.1,46,21,351/-                                                                                                                  |
|       3 |   2017 |                                                    345 |                                                                                                                     7 | Rs.29,95,055/-                                                                                                                    |

*******