Lok Sabha Question No. 395 (UNSTARRED), answered on 2020-09-15
Subject: Norms for Drug Manufacturing
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Naranbhai Bhikhabhai Kachhadiya, Parbatbhai Savabhai Patel, Gitaben Vajesingbhai Rathva, John Barla, Pradeep Kumar Singh, Shantanu Thakur

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

LOK SABHA UNSTARRED QUESTION NO. †395

TO BE ANSWERED ON 15 th  September, 2020

## Norms for Drug Manufacturing

## †395.   SHRI NARANBHAI KACHHADIYA:

SHRI PRADEEP KUMAR SINGH:

SHRI JOHN BARLA:

SHRIMATI RATHVA GITABEN VAJESINGBHAI:

SHRI PARBATBHAI SAVABHAI PATEL:

SHRI SHANTANU THAKUR:

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

- (a) whether the Government has laid down any norms for drug manufacturers;
- (b) if so, the details thereof;
- (c)  whether  any  notice  has  been  issued  to  such  drug  manufacturers  who  are  not adhering to the said norms;
- (d) if so, the details thereof during the last three years and the till date; and
- (e)  the  details  of  the  action  taken  by  the  Government  so far against the said drug manufacturers?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

(a) to (e):         The details of requirement for manufacturing of drugs are prescribed under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. License for manufacture of drugs is granted through a system of licensing and inspection by the State Licensing Authorities (SLAs) appointed by the respective State Governments under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made there under.

The  manufacturer  is  required  to  comply  with  the  conditions  of  license including the requirement of compliance of Good Manufacturing Practices which are prescribed under Schedule-M of Drugs and Cosmetics Rules, 1945.

Details of the enforcement actions taken by various SLAs based on the drugs samples tested, drugs samples declared sub-standard quality, spurious/adulterated drugs and percentage of thereof during 2016-17 to 2018-19 is at Annexure-A. Such information  received  from  various  Zonal/Sub-zonal  offices  of the Central  Drugs Standard Control Organisation (CDSCO) is at Annexure-B.

## Annexure-A

## Enforcement actions taken by States/UTs Drugs Controller during last three years

| Year    | No. of drugs samples tested   |   No. of drugs samples declared not of standard quality |   %No. of drugs samples declared not of standard quality |   No. of drugs samples declared spurious/ adulterated |   %No. of drugs samples declared spurious/ adulterated |   No. of prosecution launched for manufacturing, sale and distribution of spurious/ adulterated drugs |   No. of cases (as mentioned in the earlier column) decided |   No. of persons arrested | Approx. value of drug seized (in INR)   | No. of Raids Conducted   |
|---------|-------------------------------|---------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------|-----------------------------------------|--------------------------|
| 2016-17 | 76,721                        |                                                    2780 |                                                     3.6  |                                                   123 |                                                   0.16 |                                                                                                   186 |                                                          17 |                       106 | 7,72,68,717.5                           | 10,921                   |
| 2017-18 | 82,599                        |                                                    2783 |                                                     3.36 |                                                   236 |                                                   0.28 |                                                                                                   131 |                                                          16 |                       163 | 17,86,08,008                            | 7067                     |
| 2018-19 | 76,101                        |                                                    2549 |                                                     3.35 |                                                   205 |                                                   0.27 |                                                                                                   484 |                                                          77 |                       153 | 8,03,89,057 (Approx.)                   | 33,492                   |

## Annexure-B

## Enforcement actions taken by Zonal/Sub-zonal offices of CDSCO during last three years

| Year    |   No. of drugs samples tested |   No. of drugs samples declared not of standard quality |   %No. of drugs samples declared not of standard quality | No. of drugs samples declared spurious/ adulterated   |   %No. of drugs samples declared spurious/ adulterated |   No. of prosecution launched for manufacturing, sale and distribution of spurious/ adulterated drugs |   No. of cases (as mentioned in the earlier column) decided | No. of persons arrested   | Approx. value of drug seized (in INR)   |   No. of Raids Conducted |
|---------|-------------------------------|---------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|---------------------------|-----------------------------------------|--------------------------|
| 2016-17 |                          5207 |                                                     146 |                                                     2.8  | Nil                                                   |                                                  0     |                                                                                                    21 |                                                           4 | Nil                       | 39,11,850                               |                       56 |
| 2017-18 |                          7088 |                                                     381 |                                                     5.37 | 2                                                     |                                                  0.028 |                                                                                                    17 |                                                           1 | 6                         | 88,20,385                               |                        8 |
| 2018-19 |                         10382 |                                                     310 |                                                     2.98 | 5                                                     |                                                  0.048 |                                                                                                    31 |                                                           9 | 4                         | 3,82,18,920                             |                       52 |