Lok Sabha Question No. 1651 (UNSTARRED), answered on 2022-02-11
Subject: Manufacturing of Faulty and Adulterated Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Lavu Sri Krishna Devarayalu

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

## LOK SABHA UNSTARRED QUESTION NO. 1651 TO BE ANSWERED ON 11 th  FEBRUARY, 2022

## MANUFACTURING OF FAULTY AND ADULTERATED DRUGS

## 1651. SHRI LAVU SRI KRISHNA DEVARAYALU:

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

(a)  whether  the  Government  is  taking  any  steps  to  combat  the  manufacturing  of  faulty  and adulterated drugs, if so, the details thereof and if not the reasons therefor;

(b) the steps taken by the Government to improve manpower in the area of drug regulation, i.e.

drug regulators and the details thereof;

(c) whether the Government has taken measures to combat the huge time gap between the sale of faulty  drugs  in  the  market  and  the  notification  given  for  recall  of  the  batch,  if  so,  the  details

thereof and if not, the reasons therefor; and

(d) whether the Government has any data on the number of faulty drugs manufactured in the last five years, if so, the action taken against the manufacturers in such cases?

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

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

The licensees are required to comply with all the conditions of license and follow Good Manufacturing Practices (GMP) of Drugs Rules to ensure that the drugs manufactured by them are safe and of standard quality.

The Government has taken a series of measures including strengthening of legal provisions, workshops and training programmes for manufacturers and regulatory officials and measures such as risk based inspections.

Further,  under  the  Centrally  Sponsored  Scheme  for  'Strengthening  of  the  States'  Drug Regulatory System', funds have been released for upgrading of existing State Drugs laboratories, setting up of new drug testing laboratories and upgrading of existing State Drugs Control Offices.

(d):  As  per  information  received  from  various  State/UT  Drugs  Controllers,  number  of  drugs samples tested, number of drugs samples declared sub-standard and spurious/ adulterated during the last five years are as below:

| Year           | No. of drugs sample s tested   | No. of drugs samples declared not of standar d quality   | %No. of drugs samples declared not of standar d quality   |   No. of drugs samples declared spurious/ adulterat ed | % No. of drugs samples declared spurious/ adulterate d   | No. of prosecuti ons   | No. of person s arrest ed   |
|----------------|--------------------------------|----------------------------------------------------------|-----------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------|------------------------|-----------------------------|
| 76,721         | 2,780                          | 3.6                                                      | 123                                                       |                                                   0.16 | 186                                                      | 106                    | 2016-17                     |
| 82,599         | 2783                           | 3.36                                                     |                                                           |                                                 236    | 0.28                                                     | 131 163                | 2017-18                     |
| 2018-19 79,604 | 2,549                          |                                                          | 3.35                                                      |                                                 205    | 0.27                                                     | 484                    | 153                         |
| 81329          | 2497                           | 3.07                                                     |                                                           |                                                 199    | 0.24 421                                                 | 220                    | 2019-20                     |
| 84874          | 2652                           | 3.12                                                     | 263                                                       |                                                   0.31 | 236                                                      | 164                    | 2020-21                     |

In respect of Zonal/Sub-Zonal offices of CDSCO, the information is as below:

|   Year |   No. of drugs samples tested |   No. of drugs samples declared not of standar d quality | %No. of drugs samples declared not of standar d quality   |   No. of drugs samples declared spurious / adultera ted | %No. of drugs samples declared spurious / adultera ted   | No. of prosecution s   | No. of perso ns arrest ed   |
|--------|-------------------------------|----------------------------------------------------------|-----------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|------------------------|-----------------------------|
|   5207 |                           146 |                                                     2.8  | NIL                                                       |                                                   0     | 21                                                       | NIL                    | 2016-17                     |
|   7088 |                           381 |                                                     5.37 | 2                                                         |                                                   0.028 | 17                                                       | 6                      | 2017-18                     |
|  10382 |                           310 |                                                     2.98 |                                                           |                                                   5     | 0.048 31                                                 | 4                      | 2018-19                     |
|   9299 |                           307 |                                                     3.3  | 12                                                        |                                                   0.12  | 28                                                       | 6                      | 2019-20                     |
|   5460 |                           170 |                                                     3.11 | 3                                                         |                                                   0.055 | 12                                                       | NIL                    | 2020-21                     |

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