**Executive Summary**
This document is the answer to Unstarred Question No. 2278 in Lok Sabha to be answered on December 12th, 2025, regarding the use of banned and counterfeit medicines in India. The Minister of State in the Ministry of Health and Family Welfare addresses concerns about the availability, adverse effects, and government action regarding banned and counterfeit medicines. The answer includes data from the last three years (2022-23 to 2024-25) on drug samples tested, declared as Not of Standard Quality (NSQ)/Spurious/Adulterated, and prosecutions launched.
**Key Points / Main Content**
* **Definitions:**
* The term "Counterfeit Medicines" is not defined under the Drugs and Cosmetics Act, 1940.
* The Act defines spurious, adulterated, and misbranded drugs, including what are commonly referred to as counterfeit drugs.
* **Nationwide Survey:**
* A survey conducted from 2014-2016 assessed the extent of Not of Standard Quality (NSQ)/Spurious drugs.
* 47,012 drug samples were drawn from both government and private sources.
* **Legal Provisions:**
* Manufacturing Spurious/Adulterated/Not of Standard Quality (NSQ) drugs is a punishable offense under the Drugs and Cosmetics Act, 1940.
* The Act empowers licensing authorities to take legal action against manufacture, sale, and distribution of prohibited or banned drugs.
* **Action on Complaints:**
* Isolated complaints regarding such drugs are investigated along with the concerned licensing authorities.
* **Data on Drug Samples and Enforcement (2022-23 to 2024-25):**
* Number of drug samples tested.
* Number of drug samples declared Not of Standard Quality.
* Number of drug samples declared Spurious/Adulterated.
* Number of prosecutions launched for manufacturing, sale, and distribution of spurious/adulterated drugs.
| Year | Drug Samples Tested | NSQ Samples | Spurious/Adulterated Samples | Prosecutions Launched |
| --------- | -------------------- | ----------- | ----------------------------- | --------------------- |
| 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 |
**Impact Analysis**
**Stakeholders Impacted**
* **Government (Ministry of Health and Family Welfare):**
**Impact:**
* Accountability for monitoring and regulating drug quality.
* Requirement to address public concerns regarding counterfeit/banned medicines.
**Action Required:**
* Continue conducting surveys and enforcing regulations.
* Investigate complaints and take necessary legal actions.
* **State/UT Drugs Controllers:**
**Impact:**
* Responsible for drug regulation and enforcement within their respective jurisdictions.
**Action Required:**
* Collect and test drug samples.
* Investigate complaints, and prosecute offenders.
* Report data on drug quality and enforcement actions.
* **Citizens/Public Health:**
**Impact:**
* Directly affected by the availability and use of substandard, spurious, or banned medicines.
* Potential health risks from ineffective or harmful drugs.
**Action Required:**
* Trust that the Ministry of Health and Family Welfare are continuing surveys and enforcing regulations.
* Continue to trust that State/UT Drug Controllers collect and test drug samples, investigate complaints, and prosecute offenders.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The principal legislation governing drug regulation in India, defining standards and penalties related to the manufacture, sale, and distribution of drugs.
Ministry of Health and Family Welfare: The central ministry responsible for health policy and regulations, including those related to drug quality and safety.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2278
TOBE ANSWERED ON12TH DECEMBER, 2025
USEOFBANNED AND COUNTERFEITMEDICINES
2278.SHRIK GOPINATH:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government has conducted any study on the availability and use of banned
andcounterfeitmedicines inthe marketinthe countryandif so, the details thereof;
(b) whether the Government isaware thatlarge-scaleuse of counterfeitandbannedmedicines
iscausing adverse effects onpeople’shealthinthe countryandif so, the details thereof; and
(c)whether the Government hastakenany actioninthisregard during the last three yearsand
the current year, year-wiseandif so, the details thereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH 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
definesspurious, adulteratedandmisbranded drugs which includescounterfeitdrugs.
Anation-wide survey (2014-16) wasconductedtoassess the extentof Not of Standard
Quality (NSQ)/Spurious drugs. A total 47,012 drug samples were drawn from both
Governmentsandprivate 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 concernedlicensing authoritiesfor takingaction.
The details of number of drug samples reported Not of Standard Quality/spurious/
adulteratedandenforcement actiontakenbythe States/UTs Drugs Controller during last three
yearsof variousStates/U.Ts isasunder:Year Number of Number of Number of Number of prosecution
(April to drugs drugs samples drugs samples launchedfor
March) samples declaredNot declared manufacturing,sale and
tested of Standard Spurious/ distribution of
Quality Adulterated 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
*******