**Executive Summary**
This document addresses Unstarred Question No. 2474 in Lok Sabha, concerning drug testing and monitoring, to be answered on February 13th, 2026. It details actions taken by the government regarding substandard, spurious, and adulterated drugs, including testing statistics, inspection initiatives, and measures to strengthen drug regulation. It also provides information up to the period 2024-2025.
**Key Points / Main Content**
* **Drug Regulation:** The manufacture, sale, and distribution of drugs are regulated under the Drugs & Cosmetics Act, 1940 and associated rules, through licensing and inspection.
* **Drug Sample Testing Statistics (2020-2025):**
* States/UTs Drugs Controllers (SDCs) reported the following data:
* The document provides a table showing the number of drug samples tested, the number declared Not of Standard Quality, and the number declared Spurious/Adulterated, for each financial year from 2020-21 to 2024-25.
* For example, in 2024-25, 1,16,323 samples were tested, with 3,104 declared Not of Standard Quality and 245 declared Spurious/Adulterated.
* **Food Safety Monitoring:**
* The Food Safety Standard Authority of India (FSSAI) and its regional offices, through State/UT Food Safety Departments, perform regular surveillance, monitoring, inspections, and random sampling of food.
* **Risk-Based Drug Manufacturing Inspections:**
* The Central Drugs Standard Control Organization (CDSCO), in collaboration with state regulators, initiated risk-based inspections of drug manufacturing and testing firms in December 2022.
* Over 960 premises have been inspected since December 2022, leading to over 860 actions, including show cause notices, stop production orders, suspensions, and cancellations of licenses.
* **Drug Alert System:**
* Lists of drugs declared Not of Standard Quality/Spurious/Adulterated by Central Drugs Testing Laboratories are available on the CDSCO website under "Drug Alert".
* **Strengthening Drug Regulatory System:**
* The Ministry of Health and Family Welfare implemented the Centrally Sponsored Scheme 'Strengthening of States' Drug Regulatory System (SSDRS).
* The scheme focuses on upgrading existing State laboratories, setting up new drug testing laboratories, and upgrading existing State drug control offices.
* Under the SSDRS Scheme, ₹756 Crore has been released to States/UTs. 19 New Drug Testing Labs have been constructed and 28 existing labs have been up-graded.
**Impact Analysis**
**States/Union Territories (UTs)**
* **Impact:** States/UTs are impacted by the implementation of the SSDRS, increased regulatory scrutiny, and the need to enforce drug quality standards within their jurisdictions.
* **Action Required:** States/UTs need to upgrade their drug testing laboratories, enforce regulatory compliance by manufacturers, and take actions based on inspection findings. They should also adhere to the guidelines and utilize the funds provided under the SSDRS.
**Drug Manufacturers and Distributors**
* **Impact:** Manufacturers and distributors face increased scrutiny and risk of enforcement actions (show cause notices, suspension, license cancellation) if their products are found to be substandard, spurious, or adulterated.
* **Action Required:** Manufacturers and distributors must ensure their products meet quality standards and comply with regulatory requirements to avoid penalties.
**Consumers**
* **Impact:** Consumers are indirectly impacted, as they are the end users of the drugs and nutritional products.
* **Action Required:** Consumers can stay informed by consulting the CDSCO website's "Drug Alert" section to check the quality status of drugs and nutritional products they use.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: Regulates the manufacture, sale and distribution of drugs in India.
Central Drugs Standard Control Organization (CDSCO): National regulatory body for pharmaceuticals and medical devices.
Strengthening of States' Drug Regulatory System (SSDRS): A Centrally Sponsored Scheme to strengthen the drug regulatory system in India.
Ministry of Health and Family Welfare: Indian government ministry responsible for public health.
Drugs Rules 1945: Rules under Drugs & Cosmetics Act, 1940.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2474
TO BE ANSWERED ON13THFEBRUARY, 2026
TESTING AND MONITORINGOFDRUGS
2474.SHRIPRADYUTBORDOLOI:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the details of the samples of cough syrups, medicines, oral rehydration salts (ORS),
protein powders and other nutritional supplements tested by the Central Drugs Standard
Control Organisation (CDSCO) during the last five years, State/UT-wise;
(b) the numberof samples found tobe substandard or adulterated, along with the action taken
against the concerned manufacturers or distributors and any public notification issued
warning against adulteration;
(c) whether the Government has launched any special drives to track and prevent counterfeit
health and nutritional products and if so, the details thereof and if not, the reasons therefor;
and
(d) the steps taken/proposed to be taken by the Government to strengthen drug testing
infrastructure andlaboratory capacityinStates/UTs?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)& (b) : The manufacture, sale and distribution of drugs are regulated in the country
under the provisions of Drugs & Cosmetics Act, 1940 and Rulesthereunder through a system
of licensing andinspection.
As per information received from various States/Union Territories Drugs Controllers
(SDCs), number of drug samples reported Not of Standard Quality/spurious/adulterated by
the States/UTs Drugs Controller during the last five yearsisasfollows:
FinancialYear No.ofdrugssamples No.ofdrugs No.ofdrugssamples
tested samplesdeclared declaredSpurious/
NotofStandard Adulterated
Quality2020-21 84,874 2,652 263
2021-22 88,844 2,545 379
2022-23 96,713 3,053 424
2023-24 1,06,150 2,988 282
2024-25 1,16,323 3,104 245
Further, Food Safety Standard Authority of India (FSSAI) and its regional offices
through the State/UT Food Safety Departments, carry out regular surveillance, monitoring,
inspections, and random sampling of food to ensure compliance with the quality & safety
standards established under the Food Safety and Standards Act (FSS), 2006, and the Rules
andRegulationsmade thereunder.
(c): As a part of quality monitoring and in order to assess the regulatory compliance of
drug manufacturing premises in the country, the Central Drugs Standard Control
Organization (CDSCO), in collaborationwith state regulators, initiated risk-based inspections
of drug manufacturing andtesting firms inDecember 2022. Firms have been identified based
onrisk criteria like number of drugs declaredasnot of standard quality, complaints,criticality
of the products etc. As of now, CDSCO along with 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 States/UTs
asperthe provisions of the Drugs Rules1945.
List of drugs of various companies, which are declared Not of Standard Quality/
Spurious/ Adulterated bythe Central Drugs TestingLaboratoriesisuploaded andavailableon
the website of CDSCO under the heading of Drug Alert (www.cdsco.gov.in) and actions
initiatedasperprovisions of the DrugsandCosmetics Act, 1940 andrulesthereunder.
(d): Further, for strengthening the drug regulatory system in the country, Ministry of
HealthandFamily Welfarehasimplementeda CentrallySponsored Scheme'Strengthening of
States’ Drug Regulatory System (SSDRS). The scheme envisages upgrading existing State
laboratories, setting up of new drug testing laboratories and upgradation of existing State
drug control offices in the country. Under the SSDRS Scheme, funds totalling Rs. 756 Crore
has been released to States/UTs as part of the Central Share and 19 New Drug Testing Labs
have beenconstructed and28existing labshave beenup-gradedinvariousStates/UTs.
*******