Lok Sabha Question No. 2212 (UNSTARRED), answered on 2025-08-01
Subject: Counterfeit Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri Adhikari Deepak Dev

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

LOK SABHA UNSTARRED QUESTION NO. 2212 TO BE ANSWERED ON 01 ST AUGUST, 2025

## COUNTERFEIT MEDICINES

## 2212. SHRI ADHIKARI DEEPAK DEV:

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

- (a) the number of the counterfeit medicines seized by Central Drugs Standard Control Organization (CDSCO) in the country during the last five years, year-wise; and
- (b) the details of action taken/proposed to be taken by the Government against those manufacturers?

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

(a) & (b): The terminology 'Counterfeit Medicines' is not defined under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. However, the Drugs and Cosmetics Act defines spurious, adulterated, misbranded drugs which includes counterfeit drugs.

The information on number of drug samples reported Not of Standard Quality/spurious/adulterated and enforcement action taken by the States/UTs Drugs Controller during last five years of various States/U.Ts is provided below:

| Year (April to March)   | No. of drugs samples tested   | No. of drugs samples declared Not of Standard Quality   |   No. of drugs samples declared Spurious/ Adulterated |   Number of prosecution launched for manufacturing, sale and distribution of spurious/adulterate d drugs |
|-------------------------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 2020-21                 | 84,874                        | 2652                                                    |                                                   263 |                                                                                                      236 |
| 2021-22                 | 88,844                        | 2,545                                                   |                                                   379 |                                                                                                      592 |
| 2022-23                 | 96,713                        | 3,053                                                   |                                                   424 |                                                                                                      663 |
| 2023-24                 | 1,06,150                      | 2,988                                                   |                                                   282 |                                                                                                      604 |
| 2024-25                 | 1,16,323                      | 3,104                                                   |                                                   245 |                                                                                                      961 |

As part of quality monitoring, the samples failing in quality check, as received by CDSCO are uploaded on the website of CDSCO as part of the monthly drug alerts to make it available publicly. Details of these drugs are available on the CDSCO website under the heading of Drug Alert ( www.cdsco.gov.in ).

In case of drug samples declared as NSQ by the Drugs Testing laboratories under CDSCO, the respective manufacturing firms are asked for immediate recall and stop further distribution of the not of standard quality drugs in the market. Further, based on investigation outcome, actions are taken by the licensing authorities concerned under the provisions of Drugs & Cosmetics Act & Rules made thereunder such as stop production orders, stop testing orders, license suspensions/cancellations, warning letters and showcause notices.

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