Lok Sabha Question No. 2714 (UNSTARRED), answered on 2020-03-06
Subject: Reviewing the Functioning of CDSCO
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Giridhari Yadav, Jyotsna Charandas Mahant, Ranjeeta Koli

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

LOK SABHA UNSTARRED QUESTION NO. 2714 TO BE ANSWERED ON 06 TH MARCH, 2020

## REVIEWING THE FUNCTI ONING OF CDSCO

## 2714. SHRI GIRIDHARI YADAV: SHRIMATI JYOTSNA CHARANDAS MAHANT: SHRIMATI RANJEETA KOLI:

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

- (a) whether the Government has reviewed the functioning of Central Drugs Standard Control Organization (CDSCO) mandated to check the cir culation of spurious and sub - standard medicine in the country;
- (b)  if  so,  the  details  thereof  and  the  outcome  thereof and strategies  chalked  out  by  the Government based on the outcome;
- (c) whether any complaints have been filed regarding death of an individual due to consumption of spurious drugs, if so, the details thereof during the last three years and current year, State/UT -wise particularly Chhattisgarh along with the action taken thereon; and
- (d) the measures being taken by the Government to st op the circulation of fake medicines?

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

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

Earlier in 2011 and 2012, Department Related Parliamentary Standing Committee on Health and Family Welfare reviewed the functioning of CDSCO in respect of various aspe such as mandate and str uc ure of CDSCO, role of the State drug regulatory authority, capaci building of CDSCO and Central & State Drug Testing  Laboratories, New Drugs and Clinica Trial approval, banning of drugs, issue of granting licence of Fixed Dose Combinations w approval of Drugs Controller General (India) [DCG(I)], issues regarding similar brand n post marketing surveillance, spurious/sub - standard drugs, advertisement of prescription drugs in media, etc.

Further, during the last five years, based on r egular review of CDSCO and its functioning, a number  of  measur es  havebeen  taken  to  address  these  issues  which  include  strengthening  o infrastructure and manpower of CDSCO; framing of Medical Devices Rules, 2017; New Drugs and Clinical Trials Rules, 2019; online submission and processing of various applications under SUGAM portal; evaluation of applications of clinical trials; new drugs and Investigation Drug  (IND)  including  r - DNA  derived  products  and  vaccines;  new  medical  devices  in consultation  wit h  Subject  Experts  Committees/IND  committee;  amendments  in  Drugs  and Cosmetics  Rules  including  prohibition  of  advertisement  of  Schedule  H,  H  1  &  X  drugs  a provision to address issues related to similar brands etc.

(c): The  manufacture,  sale  and  distribu tion  of  drugs  in  the  country  is  regulated  under  the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 thereunder through a system licensing and inspection. Licenses for manufacture, sale and distribution of drugs are gr the State Licensi ng Authorities (SLAs) appointed by respective State Governments. SLAs are legally empowered to take stringent action against violation of provisions of the Act and

As per information received from State/UT Drugs Controllers including Chhattisgarh as on November, 2019, no complaint has been registered regarding death of any person due to of spurious/counterfeit medicine during the last three years and the current year.

(d): The Government is committed to ensuring that the quality, safety and efficacy of drugs are  not  compromised.  With  this  in  view,  the  Government  has  taken  a  series  of  measu including strengthening of legal provisions, workshops and training programmes manufacturers and regulatory officials and measures such a s risk based inspections.