This document summarizes data regarding substandard, spurious, and adulterated drugs in India, as reported to the Lok Sabha on August 1, 2025, by the Ministry of Health and Family Welfare. While the Drugs and Cosmetics Act, 1940 does not define "counterfeit medicines," it does address spurious, adulterated, and misbranded drugs, which include counterfeit drugs.
The Central Drugs Standard Control Organization (CDSCO) monitors drug quality and publishes monthly drug alerts on its website (www.cdsco.gov.in) regarding samples declared Not of Standard Quality (NSQ). The data provided reflects the findings of State/UT Drugs Controllers.
Key data points from the past five years (April to March) are as follows:
* **2020-21:** 84,874 samples tested; 2,652 declared NSQ; 263 declared spurious; 236 prosecutions launched.
* **2021-22:** 88,844 samples tested; 2,545 declared NSQ; 379 declared spurious; 592 prosecutions launched.
* **2022-23:** 96,713 samples tested; 3,053 declared NSQ; 424 declared spurious; 663 prosecutions launched.
* **2023-24:** 106,150 samples tested; 2,988 declared NSQ; 282 declared spurious; 604 prosecutions launched.
* **2024-25:** 116,323 samples tested; 3,104 declared NSQ; 245 declared spurious; 961 prosecutions launched.
When drug samples are declared NSQ by CDSCO drug testing laboratories, manufacturing firms are instructed to immediately recall the affected batches and cease further distribution. Licensing authorities take actions based on investigation outcomes which may include stop production orders, stop testing orders, license suspensions/cancellations, warning letters, and show-cause notices, in accordance with the Drugs and Cosmetics Act and Rules.
Key Entities Referenced
Central Drugs Standard Control Organization (CDSCO): A national regulatory body in India responsible for the quality control of drugs.
Drugs and Cosmetics Act, 1940: An act in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
Ministry of Health and Family Welfare: A ministry of the Government of India responsible for health policy in India.
Lok Sabha: The lower house of the Parliament of India.
SMT. ANUPRIYA PATEL: The Minister of State in the Ministry of Health and Family Welfare.
States/UTs: Refers to the States and Union Territories of India. These entities have their own Drugs Controllers.
Drug Alert: A monthly publication by CDSCO to make public the details of drugs that are failing quality checks.
Drugs Testing laboratories: Laboratories under CDSCO that test drugs for quality.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2212
TOBE ANSWERED ON01ST AUGUST,2025
COUNTERFEITMEDICINES
2212.SHRIADHIKARIDEEPAKDEV:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the number of the counterfeit medicines seized by Central Drugs Standard Control
Organization (CDSCO) inthe countryduring 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 OFSTATE IN THE MINISTRYOFHEALTH 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
definesspurious, adulterated,misbranded drugs which includescounterfeitdrugs.
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 variousStates/U.Tsisprovidedbelow:
Year No. of drugs No. of drugs No. of drugs Number of
(April to samples tested samples samples declared prosecution
March) declaredNot of Spurious/ launchedfor
Standard Adulterated manufacturing,sale
Quality anddistribution 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 monthlydrug alerts to make itavailable publicly. Details of these drugs are available on the CDSCO website under the
headingof 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 inthe market. Further, based on investigation
outcome, actions are taken by the licensing authorities concerned under the provisions of
Drugs & Cosmetics Act & Rulesmade thereunder such asstop productionorders, stop testing
orders, license suspensions/cancellations, warning lettersandshowcause notices.
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