Lok Sabha Question No. 3988 (UNSTARRED), answered on 2018-08-10
Subject: Transparent Clinical Trials
Ministry: HEALTH AND FAMILY WELFARE
Asked by: C. N. JAYADEVAN

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

LOK SABHA UNSTARRED QUESTION NO. 3988 TO BE ANSWERED ON  10 TH AUGUST, 2018

## TRANSPARENT CLINICAL TRIALS

## 3988. SHRI C.N. JAYADEVAN:

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

- (a) whether the number of clinical trials being done in India has increased since 2013;
- (b) if so, the details thereof and the reasons therefor;
- (c) whether it is a fact that the guidelines for conducting the clinical trials are very favour pharmaceutical companies, if so, the details thereof; and
- (d) the necessary steps taken by the Government for strict clinical trials in the country?

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

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

The number of clinical trials permissions, including for Global Clinical trials,  g Central Drugs Standard Control Organization since 2012 are as under: -

| Year                          |   Total CT Issued |
|-------------------------------|-------------------|
| 2012                          |               253 |
| 2013                          |                73 |
| 2014                          |               198 |
| 2015                          |               216 |
| 2016                          |               129 |
| 2017                          |               213 |
| 2018 (As on 31 - July - 2018) |               106 |

Contd……..

Gradual increase in number of clinical trial permission may be due to various mea taken  to  strengthen  and  streamline  the  regulation  of  clinical  trials  in  more  predict transparent manner.

(c) & (d): Streamlining and strengthening regulatory provisions is a continuous process. is  done  keeping  in  view  the  interest  of  all  stakeholders.      Various  measures  taken Government  for  strengthening  the  regulatory  provisions  in  respect  of clinical  trials  include amendments in the Drugs & Cosmetics Rules, 1945 laying down:

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

iii. requirements and guidelines for registration of Ethics Committee;

ii. conditions for conduct of cli nical trials, authority for conducting clinical trial inspec 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 inical 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 clinical trials. These Expert Committees have prepared detailed guidelines for examination of rep of deaths and also prepared formula(s) for determining the quantum of compensation in ca of clinical tri al related deaths and injury (other than death).

Vii.  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  S ecretary,  Health  and  Family  Welfare;  and  a  Technical  Committee  under chairmanship of Director General, Health Services (DGHS).

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