Lok Sabha Question No. 361 (STARRED), answered on 2019-12-13
Subject: Functioning of CDSCO
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sunil Kumar Mondal

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO. 361 TO BE ANSWERED ON THE 13 TH DECEMBER , 2019 FUNCTIONING OF CDSCO

## *361. SHRI SUNIL KUMAR MONDAL:

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

- (a)  whether  the  Government  has  reviewed  the  functioning  of  Central  Dru Standard Control Organisation (CDSCO);
- (b) if so, the details and the outcome thereof;
- (c) whether any compla int has been registered regarding the death of any pers due  to  use  of  spurious/counterfeit  medicine  during  the  last  five  years current year; and
- (d) if so, the details thereof along with the action taken on such complaints

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

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

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 361* FOR 13 TH DECEMBER , 2019

(a) & (b) The Government of India is continuously involved in monitoring/review  of  the  functioning  of  Central  Drugs  Standard  Contr Organisation (CDSCO) to strengthen the Drugs regulatory system.

Earlier  in  2011  and  2012,  Department  Related  Parliamentary  Standin Committee  on  Health  and  Family  Welfare  reviewed  the  functioning  of CDSCO  in  respect  of  various  aspects  such  as  mandate  and  structure CDSCO,  role  of  the  State  drug  regulatory  authority,  capacity  buildin CDSCO  and  Central  &  State  Drug  Testing    Labora tories,  New  Drugs  and Clinical Trial approval, banning of drugs, issue of granting licence o Dose  Combinations  without  approval  of  Drugs  Controller  General  (India [DCG(I)], issues regarding similar brand names, post marketing surveilla spurious /sub - standard  drugs,  advertisement  of  prescription  drugs  in  medi etc.

Further, during the last five years, based on regular review of CD and its functioning, a number of measures has been taken to address t issues  which  include  strengthe ning  of  infrastructure  and  manpower  of CDSCO; framing of Medical Devices Rules, 2017; New Drugs and Clinical Trials Rules, 2019; online submission and processing of various applica under SUGAM portal; evaluation of applications of clinical trials; new drugs and Investigational New Drug (IND) including r - DNA derived products and vaccines; new medical devices in consultation with Subject Exper Committees/IND  committee;  amendments  in  Drugs  and  Cosmetics  Rules including prohibition of advertisement of Sc hedule H, H 1 & X drugs and provision to address issues related to similar brands etc.

(c): The  manufacture,  sale  and  distribution  of  drugs  in  the  country regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rule 1945 thereunder thro ugh a system of licensing and inspection. Licenses fo manufacture, sale and distribution of drugs are granted by the State Lic Authorities  (SLAs)  appointed  by  respective  State  Governments.  SLAs  ar legally empowered to take stringent action against violation of provisions of the Act and Rules.

As  per  information  received  from  State/UT  Drugs  Controllers,  n complaint  has  been  registered  regarding  death  of  any  person  due  to  us spurious/counterfeit medicine during the last five years and t he current year.

- (d):     Does not arise.

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