**Executive Summary**
This document provides the Minister of Health and Family Welfare's response to questions regarding drug quality in India between 2020-2025. It includes details on drugs categorized as "Not of Standard Quality (NSQ)", actions taken against pharmaceutical companies, and inspections of manufacturing premises. The information is based on data received from States/UTs Drugs Controllers.
**Key Points / Main Content**
* **Drug Quality Data (2020-2025):**
* The document contains a table showing the number of drug samples tested, those declared NSQ/Spurious/Adulterated, and the number of prosecutions launched for manufacturing, sale, and distribution of spurious/adulterated drugs for each financial year from 2020-21 to 2024-25.
* **Availability of NSQ/Spurious/Adulterated Drug Lists:**
* Lists of companies whose drugs are declared NSQ/Spurious/Adulterated are available on the CDSCO website under the "Drug Alert" section (www.cdsco.gov.in).
* Actions against these companies are initiated according to the Drugs and Cosmetics Act, 1940 and its rules.
* **Inspections and Actions Taken:**
* CDSCO and State Drugs Controllers (SDCs) have conducted Risk-Based Inspections of over 960 drug manufacturing premises since December 2022.
* Based on inspection findings, over 860 actions have been taken by State Licensing Authorities, including issuing show cause notices, stop production orders, suspension/cancellation of licenses/product licenses, and warning letters, following the Drugs Rules 1945.
**Impact Analysis**
**States/UTs Drugs Controllers**
* **Impact:** Data provided is used to inform parliament about the drug quality and actions taken.
* **Action Required:** Continue to monitor and report drug quality data to CDSCO.
**Pharmaceutical Companies:**
* **Impact:** Subject to inspections, potential actions like show cause notices, production stoppages, and license suspensions/cancellations if GMP violations or NSQ drugs are found.
* **Action Required:** Ensure compliance with GMP, cooperate with inspections, and address any deficiencies identified.
**Central Drugs Standard Control Organisation (CDSCO)**
* **Impact:** Responsible for monitoring drug quality and coordinating with States/UTs Drugs Controllers.
* **Action Required:** Continue conducting Risk-Based Inspections, maintain the Drug Alert database on the website, and enforce the Drugs and Cosmetics Act, 1940.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: Governs the regulation of drugs and cosmetics in India.
Ministry of Health and Family Welfare: The central ministry responsible for health policies and programs in India, including drug regulation.
Good Manufacturing Practices (GMP): A system for ensuring that products are consistently produced and controlled according to quality standards.
Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India.
Drugs Rules 1945: Rules formulated under the Drugs and Cosmetics Act, 1940 for regulation and licensing.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARRED QUESTION NO. †1325
TO BE ANSWERED ON06THFEBRUARY, 2026
QUALITYOFDRUGS
†1325.SHRIPATELUMESHBHAI BABUBHAI:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the details regardingthe quality of drugs categorized as "Not of Standard Quality(NSQ)",
the cancellation of licenses and compliance with Good Manufacturing Practices (GMP) by
pharmaceutical companiesduring the period2020-2025;
(b) the number of pharmaceutical companies in India whose drugs were found to be "Not of
StandardQuality(NSQ)" during the periodfrom 2020-2025;
(c)the list of such companiesalong with the details of penalactions takenagainst them, year-
wise;
(d) the number of companies whose manufacturing licenses were suspended or cancelled
during the period2020-2025 alongwith the detailsof the grounds onwhich such actionswere
taken;
(e) whether any serious violations of Good Manufacturing Practices (GMP) were found
during inspections conducted by the Central Drugs Standard Control Organisation (CDSCO)
at anypharmaceutical factoryduring the aforementionedperiod; and
(f) if so, the specific parameters of such violations and the actions taken against the
concernedentities?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SHRI PRATAPRAO JADHAV)
(a)to(f): As perinformation receivedfrom States/UTs Drugs Controllers, the numberof
drug samples tested in last five years by various States/U.Ts and status regarding number of
drug samples declared Not of Standard Quality/spurious/ adulterated including enforcement
actionstakenisasunder:Financial No.ofdrugs No.ofdrugs No.ofdrugs Numberofprosecution
Year samples samples samples launchedfor
tested declaredNotof declared manufacturing,saleand
Standard Spurious/ distributionof
Quality Adulterated spurious/adulterateddrugs
2020-21 84,874 2,652 263 236
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
List of drugs of various companies, which are declared Not of Standard Quality/
Spurious/ Adulteratedby the Central Drugs Testing Laboratories isuploadedand availableon
the website of CDSCO under the heading of Drug Alert (www.cdsco.gov.in) and actions
initiatedasperprovisions of the DrugsandCosmetics Act, 1940 andrulesthereunder.
In order to assess the regulatory compliance of drug manufacturing premises in the
country, the CDSCO along with State Drugs Controllers (SDCs) have conducted Risk-Based
Inspections of more than 960 premises since December, 2022 and based on findings, more
than 860 actions like issuance of show cause notices, stop production order, suspension,
cancellation of licenses /product licenses, warning letters have been taken by the State
LicensingAuthorities asperthe provisions of the Drugs Rules1945.
*******