Lok Sabha Question No. 3101 (UNSTARRED), answered on 2024-08-09
Subject: Cases of Spurious and Substandard Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Anand Bhadauria

## GOVERNMENTOFINDIA MINISTRYOF HEALTH AND FAMILY WELFARE DEPARTMENTOFHEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 3101 TO BE ANSWERED ON 09 TH AUGUST, 2024

## CASES OFSPURIOUS AND SUBSTANDARD DRUGS

## 3101. SHRI ANAND BHADAURIA:

Will the Minister of HEALTHANDFAMILYWELFARE be pleased to state:

- (a) whether the Government is aware that market is flooded with spurious and substandard drugs;
- (b) if so, the details of instances reported during the last three years and current year, yearwise and State-wise;
- (c) whether the Government has granted approvals to those substandard drugs which had failed in test also during the last five years in the country, year-wise; and
- (d) if so, the details thereof and reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL)

- (a) to (d): Isolated complaints regarding quality of drugs as and when received are referred to State Licensing Authorities for taking action as per the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945.

As per information received from various States/U.Ts Drugs Controllers, the details of number of drugs sample tested and declared Not of Standard Quality/ spurious/ adulterated drugs during the last five years is as under.

| Year (April to March)   | Number of drugs samples tested   | Number of drugs samples declared Not of Standard Quality   |   Number of drugs samples declared Spurious/ Adulterated |
|-------------------------|----------------------------------|------------------------------------------------------------|----------------------------------------------------------|
| 2018-2019               | 79,604                           | 2,549                                                      |                                                      205 |
| 2019-2020               | 81,329                           | 2,497                                                      |                                                      199 |
| 2020-2021               | 84,874                           | 2,652                                                      |                                                      263 |
| 2021-2022               | 88,844                           | 2,545                                                      |                                                      379 |
| 2022-2023               | 96,713                           | 3,053                                                      |                                                      424 |

Under the Drugs and Cosmetics Act, 1940 and Rules thereunder the license for manufacture of drugs are granted by the State Licensing Authority appointed by the respective State Government. Licensee is required to comply with all the conditions of license including

Good manufacturing practices (GMP) as prescribed under Drugs Rules, 1945 to ensure quality of drugs. State Licensing Authorities are empowered to take action on violation of any conditions of such licenses including prosecution in appropriate Court of law.

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