Lok Sabha Question No. 204 (STARRED), answered on 2016-03-11
Subject: Clinical Trials for Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: VINAYAK BHAURAO RAUT, NAGENDRA KUMAR PRADHAN

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO. 204 TO BE ANSWERED ON THE 11 TH MARCH, 2016 CLINICAL TRIALS FOR DRUGS

## *204. SHRI VINAYAK BHAURAO RAUT:

## SHRI NAGENDRA KUMAR PRADHAN:

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

- (a)  whether  the  Supreme  Court  in  2013  had  urged  the  Government  to  crea mechanism  for  monitoring  clinical  trials  for  new  drugs  in  the  country,  if details in this regard along with follow - up action taken thereon;
- (b)  the  details  of  infrastructure developed  so  far  in  the  country,  after  the  sa direction of Apex Court;
- (c) whether the Government has received the requests from various health ex and organizations for setting up of clinical trial facilities in public se prevent drug companies going abroad for the purpose; and
- (d) if so, the details thereof and the steps taken by the Government thereon?

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

- (a) to (d ):  A statement is laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 204* FOR 11 TH MARCH, 2016

(a): In Writ Petition (Civil) No . 33 of 2012, Swasthya Adhikar Manch, Indore & another v ersus Union of India & Ors., the Hon'ble Supreme Court , in its O rderdated 03- 01- 2013, directed that  clinic al  trials  of  new  chemical  entities be  conducted strictly  in  accord  with  the  procedure  prescribed  in  Schedule  'Y'  of the Drugs  & CosmeticsRules, 1945 ,under the direct supervision of Secretary , Ministry of Health & Family Welfare, Government of India.

(b): In compliance of the order of the Hon'ble Court, a system of supervision of clinical trial has been put in place by consti tuting an Apex Committee under the chairmanship of Secretary, Health and Family Welfare ;and a Technical Committee under  c hairmanship  of  Director  General He lth  Services  (DGHS). Accordingly, clinical trial proposals of new chemical entities (NCEs) are evaluated throug a three tier  system comprising :  (i) Subject  Expert  Committee  (SEC) ,  (ii) a Technical Com mittee and (iii) the Apex Committee. Other clinical trial proposals are evaluate througha two tier system of SEC and Technical Committee.Other measures taken by the Government for strengthening the regulatory provisions in respect of clinical trials include amendments intheDrugs & Cosmetic sRules , 1945 laying down:

- (i) the procedures to analyse the reports of Serious Adverse Events (SA and payment of compensation in case of trial related injury or death;
- (ii) conditions for conduct of clinical trials, authority for conducting 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/new  molecular (NCE/NME).  In  case  of  anti - HIV  and  anti - Leprosy  drugs,  only  audio recording of the informed consent has been specified;
- (v) f urther, it has been made mandatory to submit thefollowing details in the clinical  trial/new  drug  application  of  New  Chemical  Entity  and  Glo 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 detail ed guidelines  for  examination  of  reports  of  deaths  and  also prepared  formula(s)  for  determining  the  quantum  of  compensa ti n  in case of cli nical trial related deaths and i njury (other than death).

(c) and (d): Suggestions for improvement in the system for conduct of clinical tria have been received from time to time from various stakeholders. The suggestions received  also  include  creation  of  conditions  conducive  for  improving  the  e conducting clinical trials in the country so that such clinical trials are n other countries. The Government has examined all such suggestions and taken pro -active  steps  to  ensure  that  patient  safety  is  not  compromised  at  any  cost approval process is expedited. These include:

- -subject experts to be on the pan els of Subject Expert Committee s (SECs) have been increased to 350.
- -m eeting s of Subject  Expert  Committee s,  Technical  Committee  and  Apex Committee are being organized frequently and at regular intervals of time.
- -on- line portal for application of clinical trial has been created and i - I has been operationalized. ….