Lok Sabha Question No. 582 (UNSTARRED), answered on 2017-12-19
Subject: Quality Tests of Life Saving Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: AJAY (TENI) MISRA

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

## LOK SABHA UNSTARRED QUESTION No. 582 TO BE ANSWERED ON THE 19 th  December, 2017

## Quality Tests of Life Saving Drugs

†582. SHRI AJAY MISRA TENI:

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

- (a)  whether  there  are  reports  of  sharp  increase  in  the  incidents  of  life  saving  drugs failing the quality tests/checks during the last few years;
- (b) if so, the details thereof;
- (c)  whether  the  Government  is  contemplating  to  issue  good  manufacturing  practices certificate to all pharmaceutical companies in the country after high quality test and if so, the details thereof; and
- (d) whether the Government proposes to take action against pharmaceutical companies for failing to conform to the quality standards and if so, the details 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):  As  per  the  information  received  from  Central  Drugs  Standards  Control Organization (CDSCO), no such report of sharp increase in the incidents of life saving drugs failing the quality tests has been reported to them. As per information received from  States/U.Ts  Drugs  Controllers,  Number  of  drugs  samples  tested,  Number  of drugs samples declared not of standard quality, percent of drugs samples declared not of standard quality and Number of drugs samples declared spurious/adulterated and percent of drugs samples declared spurious/adulterated during last three years i.e. 2014-15, 2015-16 and 2016-17  are as under:

| Year    |   No. of drugs samples tested |   No. of drugs samples declared not of standard quality |   % of drugs samples declared not of standard quality |   No. of drugs samples declared spurious/ adulterated |   % of drugs samples declared spurious/ adulterated |
|---------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------------|
| 2014-15 |                         74199 |                                                    3702 |                                                  4.98 |                                                    83 |                                                0.11 |
| 2015-16 |                         74586 |                                                    3703 |                                                  4.96 |                                                   234 |                                                0.31 |
| 2016-17 |                         76721 |                                                    2780 |                                                  3.62 |                                                   123 |                                                0.16 |

Over the years, through the concerted efforts of Ministry of Health & Family Welfare, CDSCO and States, there has been increase in testing capacities of both Central and State Drug Testing Laboratories from 32264 samples per annum in 2006-07 to 76721

samples per annum in 2016-17. With continuous improvement in monitoring of quality of drugs  by  State  Drug  Control  Authorities  and  CDSCO,  %  of  Not  Of  Standard  Quality (NSQ) Drugs reported in the country has been reduced from 6.20% in the year 2007 to 3.62 % in 2016-17.

(c)  &  (d):  Manufacturing  sale  and  distribution  of  Drugs  in  the  country  are  regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder through  a  system  of  licensing  and  inspection.  License  for  manufacturing,  sale  and distribution of Drugs are granted by State Licensing Authorities appointed by respective State Governments. Licensees are required to comply with all the condition of license and  follow  Good  Manufacturing  Practices  (GMP)  as  per  the  Rule  to  ensure  that  the drugs  manufactured  by  them  are  safe  and  of  standard  quality . The  State  Licensing Authorities  (SLA)  are  empowered  to  take  action  in  case  of  any  violation  of  above requirements.

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