Lok Sabha Question No. 666 (UNSTARRED), answered on 2017-12-19
Subject: Sub-standard Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: ANTO  ANTONY

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA UNSTARRED QUESTION No. 666 TO BE ANSWERED ON THE 19 th  December, 2017

## Sub-standard Drugs

666. SHRI ANTO ANTONY:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the Government has taken note of the report of World Health Organisation (WHO)  that  1  in  10  medical  products  in  developing  countries  are  substandard  or falsified?
- (b) if so, the details thereof and the steps taken/being taken by the Government in this regard;
- (c) whether the Government has conducted any enquiry in this regard; and
- (d) if so, the details and outcome thereof?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY  OF  SHIPPING  AND  MINISTRY  OF  CHEMICALS  AND  FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a)  &  (b):  Director-General,  WHO  Geneva  has  launched  two  documents  concerning substandard and falsified medical products, at the Graduate Institute, Geneva:
- (i)  a  study  on  the  public  health  and  socioeconomic  impact  of  substandard  and falsified medical products ; and
- (ii)  WHO  global  surveillance  and  monitoring  system  for  substandard  and  falsified medical products

They include estimations on the observed failure rates of sampled medicines in quality surveys carried out 2007-2016 involving over 48,000 samples from 88 Member States. The aggregate observed failure rates in low and middle income countries is estimated at 10.5%.

The  Government  of  India  has  taken  various  steps  to  check  the  quality  of  drugs manufactured in the country. Details are as under:

- (i)  The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics (Amendment) Act  2008  to  provide  stringent  penalties  for  manufacture  of  spurious and adulterated drugs. Certain offences have also been made cognizable and nonbailable.

(ii)  The  States  /  UTs  were  requested  to  set  up  special  Courts  for  trial  of  offences under  the  Drugs  and  Cosmetics  Act  for  speedy  disposal.  So  far,  22  States  have already set up designated special Courts. (iii)  A  Whistle  Blower  Scheme  was  announced  by  the  Government  of  India  to encourage  vigilant  public  participation  in  the  detection  of  movement  of  spurious drugs in the country. The scheme provides for suitably rewarding the informers for providing concrete information to the regulatory authorities in respect of movement of spurious drugs. The details of policy are available at the website of Central Drugs Standard Control Organization (CDSCO) (www.cdsco.nic.in). (iv)  Guidelines  for  taking  action  on  samples  of  drugs  declared  spurious  or  not  of standard  quality  in  the  light  of  enhanced  penalties  under  the  Drugs  &  Cosmetics (Amendment) Act, 2008 were forwarded to the State Drugs Controllers for uniform implementation. (v) The inspectorate staffs have been instructed to keep a vigil and draw samples of drugs for test and analysis to monitor the quality of drugs moving in the country. (vi) The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 510 in 2017.

(c) & (d): As per the information received from CDSCO, no enquiry has been conducted by  them  on  this  report.  In  India,  with  strengthening  of  Drug  regulatory  system  and continuous improvement in monitoring of quality of drugs, % of Not Of Standard Quality (NSQ) Drugs reported in the country has been reduced from 6.20% in the year 2007-08 to 3.6% in 2016-17.

xxxxx