Lok Sabha Question No. 2278 (UNSTARRED), answered on 2025-12-12
Subject: Use of Banned and Counterfeit Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Shri K Gopinath

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

## LOK SABHA UNSTARRED QUESTION NO. 2278 TO BE ANSWERED ON 12 TH DECEMBER, 2025

## USE OFBANNED AND COUNTERFEIT MEDICINES

## 2278. SHRI K GOPINATH:

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

- (a) whether the Government has conducted any study on the availability and use of banned and counterfeit medicines in the market in the country and if so, the details thereof;
- (b) whether the Government is aware that large-scale use of counterfeit and banned medicines is causing adverse effects on people's health in the country and if so, the details thereof; and
- (c) whether the Government has taken any action in this regard during the last three years and the current year, year-wise and if so, the details thereof?

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

(a) to (c): 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 and misbranded drugs which includes counterfeit drugs.

Anation-wide survey (2014-16) was conducted to assess the extent of Not of Standard Quality (NSQ)/Spurious drugs. A total 47,012 drug samples were drawn from both Governments and private sources.

The manufacture of Spurious/Adulterated/ Not of Standard Quality (NSQ) drugs is a punishable offence under the provisions of the Drugs and Cosmetics Act, 1940. The Act empowers the concerned licensing authorities to take necessary legal action in such cases including cases of manufacture, sale, and distribution of any prohibited or banned drug. Isolated complaints regarding such drugs as and when received are investigated along with the concerned licensing authorities for taking action.

The details of number of drug samples reported Not of Standard Quality/spurious/ adulterated and enforcement action taken by the States/UTs Drugs Controller during last three years of various States/U.Ts 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 |   Number of prosecution launched for manufacturing, sale and distribution of spurious/adulterated drugs |
|-------------------------|----------------------------------|------------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 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 |

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