Lok Sabha Question No. 1523 (UNSTARRED), answered on 2023-02-10
Subject: Drugs Quality Control Test
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dushyant Singh

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

## LOK SABHA UNSTARRED QUESTION NO.1523 TO BE ANSWERED ON 10 TH  FEBRUARY, 2023

## DRUGS QUALITY CONTROL TEST

## 1523: SHRI DUSHYANT SINGH:

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

(a) the instances and the details of drugs failing quality-control tests in the last eight years, yearwise; (b)  whether  it  is  a  fact  that  neither  the  inspectors  nor  the  State  Drug  Regulatory  Authorities (SDRAs) are required to maintain a record of non-compliant and offending drug manufacturers; and

- (c) if so, the details thereof along with the reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a) to (c): As per information received from various States/UTs Drugs Controller, year wise data  of  Not  of  Standard  Quality/Adulterated/Spurious  Drugs  reported  and  enforcement  action taken thereof in the last eight years (year wise) is annexed .

The manufacturing, sale and distribution of drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945. The regulatory control over the manufacture,  sale  and  distribution  of  drug  in  the  country  is  exercised  through  a  system  of licensing and inspection by the State Licensing Authorities (SLAs) appointed by the respective State  Governments.  Manufacturers  are  required  to  comply  with  the  conditions  of  Licence granted under the said Act and Rules to manufacture any drugs for sale and distribution in the country. The SLAs are legally empowered to take action of violation of any conditions of such licenses including prosecution in appropriate Court of law.

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Annexure

| Year (1 st April of preceding year to 31 st March of following year)   | No. of drugs samples tested   | No. of drugs samples declared not of standard quality   |   No. of drugs samples declared spurious/ adulterated |   No. of prosecution launched for manufacturing, sale and distribution of spurious/ adulterated drugs |   No. of persons arrested | No. of Raids Conducted   |
|------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------|--------------------------|
| 2014-15                                                                | 74,199                        | 3,702                                                   |                                                    83 |                                                                                                   152 |                        85 | 14,042                   |
| 2015-16                                                                | 74,586                        | 3,703                                                   |                                                   234 |                                                                                                   289 |                        59 | 3,648                    |
| 2016-17                                                                | 76,721                        | 2,780                                                   |                                                   123 |                                                                                                   186 |                       106 | 10,921                   |
| 2017-18                                                                | 82,599                        | 2,783                                                   |                                                   236 |                                                                                                   131 |                       163 | 7,067                    |
| 2018-19                                                                | 79,604                        | 2,549                                                   |                                                   205 |                                                                                                   484 |                       153 | 33,492                   |
| 2019-20                                                                | 81,329                        | 2,497                                                   |                                                   199 |                                                                                                   421 |                       220 | 15,641                   |
| 2020-21                                                                | 84,874                        | 2,652                                                   |                                                   263 |                                                                                                   236 |                       164 | 20,922                   |
| 2021-22                                                                | 88,844                        | 2,545                                                   |                                                   379 |                                                                                                   592 |                       450 | 15,973                   |

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