**Executive Summary**
This document is a response to Starred Question No. 199 in Lok Sabha on December 12, 2025, regarding the testing and monitoring of drugs by the Central Drugs Standard Control Organisation (CDSCO). The response details the regulation of drugs under the Drugs & Cosmetics Act, 1940, actions taken against substandard drugs, and measures to strengthen the drug regulatory system, including risk-based inspections since December 2022 and the implementation of the SSDRS scheme. A statement is laid on the Table of the House.
**Key Points / Main Content**
* **Drug Regulation and Licensing:**
* Manufacture, sale, and distribution of drugs are regulated by the Drugs & Cosmetics Act, 1940, and rules through licensing and inspection.
* **Drug Sample Quality:**
* Data on drug samples tested, found Not of Standard Quality, adulterated, or spurious from 2020-21 to 2024-25 from State/UT Drug Controllers is provided.
* **Food Safety Standards:**
* The Food Safety Standard Authority of India (FSSAI) monitors food quality through surveillance, inspections, and random sampling.
* **Quality Monitoring and Inspections:**
* CDSCO, with state regulators, initiated risk-based inspections of drug manufacturing premises in December 2022.
* Over 960 premises have been inspected, resulting in over 860 actions, including show cause notices, stop production orders, and license suspensions.
* **Drug Alert Information:**
* A list of drugs declared Not of Standard Quality/Spurious/Adulterated by Central Drugs Testing Laboratories is available on the CDSCO website under "Drug Alert".
* **Strengthening Drug Regulation:**
* The Ministry of Health and Family Welfare implemented the 'Strengthening of States' Drug Regulatory System (SSDRS) scheme.
* The scheme involves upgrading state laboratories and drug control offices.
* Under SSDRS, Rs. 756 Crore has been released to States/UTs, with 17 new drug testing labs constructed and 24 existing labs upgraded.
**Impact Analysis**
* **State/Union Territory Drug Controllers (SDCs):**
* **Impact:** Responsible for licensing, inspection, and reporting of drug samples that are Not of Standard Quality, spurious, or adulterated.
* **Action Required:** Conduct risk-based inspections, take actions based on findings, and enforce the Drugs & Cosmetics Act, 1940.
* **Food Safety Standard Authority of India (FSSAI) and State/UT Food Safety Departments:**
* **Impact:** Responsible for food quality surveillance, monitoring, inspections, and sampling.
* **Action Required:** Ensure compliance with the Food Safety and Standards Act, 2006, and rules.
* **Drug Manufacturers and Distributors:**
* **Impact:** Subject to regulatory compliance, inspections, and potential penalties (e.g., show cause notices, production halts, license suspensions) if drugs are found substandard.
* **Action Required:** Comply with quality standards, undergo inspections, and address any identified deficiencies.
* **Central Drugs Standard Control Organization (CDSCO):**
* **Impact:** Responsible for coordinating quality monitoring, risk-based inspections, and providing information on substandard drugs.
* **Action Required:** Conduct inspections, publish drug alerts, and collaborate with state regulators.
* **Ministry of Health and Family Welfare:**
* **Impact:** Oversees and implements schemes to strengthen the drug regulatory system.
* **Action Required:** Continue to implement and monitor the SSDRS scheme.
* **States/Union Territories:**
* **Impact:** Benefit from the SSDRS scheme to upgrade drug testing infrastructure.
* **Action Required:** Utilize funds to upgrade laboratories and drug control offices.
Key Entities Referenced
Central Drugs Standard Control Organisation (CDSCO): India's national regulatory body for pharmaceuticals and medical devices.
Drugs & Cosmetics Act, 1940: Legislation in India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Ministry of Health and Family Welfare: The Indian government ministry responsible for public health in India.
Strengthening of States' Drug Regulatory System (SSDRS): A centrally sponsored scheme for upgrading State laboratories, setting up of new drug testing laboratories and upgrading of existing State drug control offices in the country.
Food Safety and Standards Authority of India (FSSAI): Statutory body responsible for ensuring the safety and quality of food in India.
GOVERNMENT OFINDIA
MINISTRY OFHEALTH AND FAMILYWELFARE
DEPARTMENT OF HEALTH AND FAMILYWELFARE
LOK SABHA
STARRED QUESTION NO. 199
TO BE ANSWERED ON THE 12TH DECEMBER, 2025
TESTING AND MONITORING OF DRUGS BY CDSCO
*199. DR. MOHAMMAD JAWED:
Will the MINISTER OF HEALTH AND FAMILY WELFARE be pleased
to state:
(a) the details of 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 number of samples found to be sub-standard or adulterated, along with the
action taken against the concerned manufacturers or distributors;
(c) whether the Government has launched any special drives to track and prevent
counterfeit health and nutritional products, 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 and laboratory capacity in the country, States/UT-wise?
ANSWER
THE MINISTER OFHEALTH AND FAMILYWELFARE
(SHRI JAGAT PRAKASH NADDA)
(a)to (d) AStatement is laid on the Table of the House.STATEMENT REFERRED TO IN REPLYTO LOK SABHA
STARRED QUESTION NO. 199 FOR 12TH DECEMBER, 2025
(a) & (b) The manufacture, sale and distribution of drugs are regulated in the country
under the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder through a
system of licensing and inspection.
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
years is as follows:
FinancialYear No. of drugs No. of drugs No. of drugs samples
samplestested samples declared Spurious/
declared Not of Adulterated
Standard
Quality
2020-21 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 and Regulations made 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 collaboration with state regulators, initiated risk-based
inspections of drug manufacturing and testing firms in December 2022. Firms havebeen identified based on risk criteria like number of drugs declared as not 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 as per the provisions of
the Drugs Rules 1945.
List of drugs of various companies, which are declared Not of Standard
Quality/ Spurious/ Adulterated by the Central Drugs Testing Laboratories is uploaded
and available on the website of CDSCO under the heading of Drug Alert
(www.cdsco.gov.in) and actions initiated as per provisions of the Drugs and
Cosmetics Act, 1940 and rules thereunder.
(d) Further, for strengthening the drug regulatory system in the country, Ministry of
Health and Family Welfare has implemented a Centrally Sponsored 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 17 New Drug Testing Labs have been constructed and 24 existing
labs have been up-graded in various States/UTs.
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