Lok Sabha Question No. 3425 (UNSTARRED), answered on 2015-12-18
Subject: Testing Norms for Clinical Trials of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dr. BHOLA SINGH, G. HARI, SUNIL BALIRAM GAIKWAD, KUNWAR HARIBANSH SINGH, SUDHEER GUPTA, GAJANAN CHANDRAKANT KIRTIKAR, ASHOK SHANKARRAO CHAVAN, V. PANNEER SELVAM

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

## LOK SABHA UNSTARRED QUESTION NO. 3425 TO BE ANSWERED ON 18 TH DECEMBER, 2015

## TESTING NORMS FOR CL INICAL TRIALS OF DRUGS

## 3425. SHRI BHOLA SINGH:

SHRI G. HARI:

DR. SUNIL BALIRAM GAIKWAD:

KUNWAR HARIBANSH SINGH:

SHRI SUDHEER GUPTA:

SHRI GAJANAN KIRTIKAR:

SHRI ASHOK SHANKARRAO CHAVAN:

SHRI V. PANNEERSELVAM:

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

- (a)  whether the  Government  proposes to  ease  the  norms  for  clinical  trials  of  new drugs including  those  already  approved  in other  countries  and  fast  track  their approvals  in  the country;
- (b) if so, the details thereof and the reasons therefor;
- (c)  whether  the  Ethics Committee  hasbeen  given  more  freedom  and responsibilities  to monitor clinical trials of new drugs;
- (d) if so, the details thereof along with the trials approved by the Ethics Committee till date; and
- (e) the other steps taken/proposed to be taken by the  Government  to  ensure patient safety while approving clinical trials of new drugs?

## ANSWER

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

(a) & (b): The process of approval of new drugs and conduct of clinical trials has b ratio nalized by the Government with a view to ensure a careful assessment of the risk ve benefit to the patients, innovation vis - à- vis  existing therapeutic options and unmet medical needs in the country. These criteria have been made an integral part of the approval process. Besides, a module for online submission of Clinical Trial applications has b operationalized. Further, the pool of Subject Experts has been increased manifold and -lines fixed for all activities. At the same time, adequate measure s have been put in place to ensure the safety and welfare of patients / clinical trial subjects. It has also been due consideration will be given to the fact that the drug has been approved and is in other countries.

- (c)& (d): In order to put the clinical trial processes on a scientific footing and closer supervision of such trials Ethics Committees are now required to be registered w Drugs  Controller  General  (India)  [DCG(I)].  These  Committees  are  entrusted  with  t e responsibility to analyse Serious Adverse Events during Clinical Trials. As on 15/12 1027 Ethics Committee(s) are registered with the DCG (I). Most of the permissions gra for conduct of clinical trials by Central Drugs Standard Control Organiza tion (CDSCO) are in multiple sites across the country. Clinical Trial on a new drug at any site can be ini after permission has been granted by the Licensing Authority and the approval obtained the  respective  Ethics  Committee(s).  The  number of  permission(s)  granted  by  CDSCO  for clinical trial of new drug(s) during year 2012, 2013, 2014 and current year (as on 27/1 is 253, 73, 198 and 191, respectively.
- (e): Other steps taken include laying down the formulae for determining compensat ion in all cases of Serious Adverse Events of injury or death, obligation to pay compensation payable within the stipulated time - frame and recording of audio - visual informed consent of the trial subject.