Lok Sabha Question No. 239 (UNSTARRED), answered on 2017-02-03
Subject: Report on Spurious Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SUKENDER REDDY GUTHA

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

LOK SABHA UNSTARRED QUESTION NO. 239 TO BE ANSWERED ON 3 RD FEBRUARY, 2017

## REPORT ON SPURIOUS D RUGS

## 239. SHRI GUTHA SUKENDER REDDY:

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

- (a) whether the National Institute of Biologicals and National survey of Drug have sub their report conducted on Spurious drugs and if so, the details thereof;
- (b) the steps take n by the Government to curtail the marketing of spurious drugs in the coun and
- (c) the details of the action being taken by the Government on the erring companies whi responsible for the increase of spurious drugs in the market?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE ( FAGGAN SINGH KULASTE )

- (a): The  National  Institute  of  Biologicals  has  submitted  the  report  on  Survey  of  Exte Problems  of  Spurious  and  Not  of  Standard  Quality  Drugs  in  the  Country  to the  Ministry  of Health  &  Family  Welfare  on  25.01.2017.  Based  on  a  scientifically  planned  design,  47, samples of drugs were picked up by Sample Drawing officers from the designated outlets i the presence of representative s of Civil Society or the Pharm acy Council of India. Of these, 47012 drug samples were subjected to test/analysis in 10 NABL accredited laboratories of the C and State Governments. The samples were drawn from retailers, Government sources and Port The overall percentage of Not o f Standard Quality drugs was found to be 3.16% and spurious drugs around were  0.0245%.
- (b): The Government is committed to ensuring the quality, safety and efficacy of drugs and this in view, a series of measures have been taken. These include:

- (i ) stringent penalties including making certain offences cognizable and non - bailable;

- (ii)  establishment  of  special  designated  Courts  for  trial  of  offences  under  Dru Cosmetics Act for speedy disposal of cases;

Contd……..

(iii) announcement of a Whistle Blower Scheme to encourage vigilant public participatio for detection of movement of spurious drugs in the country;

(iv) issuance of guidelines to the State Drugs Controllers for taking action on sam drugs declared spurious, adulterat ed, misbranded or 'not of standard quality';

(v) instructions to the concerned staff to keep a vigil and draw samples of drugs for analysis for monitoring the quality of drugs moving in the country;

(vi) increase in the number of posts in the Cen tral Drugs Standard Control Organization (CDSCO);

(vii) re -equipping drug testing laboratories with state - of - the - art equipment;

(viii) conducting workshops and training programmes for skill enhancement in areas as  Good  Manufacturing  Practices  (GMP) ,  Good  Laboratory  Practices  (GLP),  Good Distribution  Practices  (GDP),  Good  Clinical  Practice  (GCP)  and Good  Storage  and Distribution  Practices  (GSP)  to  regulators  and  industry  in  partnership  with Departments,  industry  and  regulators  of  other  countri es  including  USA  and  European Union;

(ix)  Conducting  training  programmes  for  laboratory  personnel  of  State  and  Cent laboratories to upgrade their analytical capabilities and skill sets; and

(x) risk based inspection of manufacturing facilities.

(c): As per information available with CDSCO, during 2015 - 16, out of 74,586 drugs samples tested,  234 were declared as spurious/adulterated and 258 prosecutions were launched unde provisions of Drugs and Cosmetics Act, 1940.

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