**Executive Summary**
This document outlines steps taken by the Ministry of Health and Family Welfare to strengthen drug quality monitoring and surveillance in India. Key initiatives include increased inspections of drug manufacturing units, enforcement actions, and significant investment in expanding drug testing laboratory infrastructure. A total of ₹756 Crore in central share has been released for this purpose, with 19 new drug testing labs constructed and 28 existing ones upgraded.
**Key Points / Main Content**
* **Drug Testing and Surveillance Data:**
* Over the past five years (2020-21 to 2024-25), nearly 5 lakh drug samples have been tested.
* During this period, a total of 16,822 drug samples were declared Not of Standard Quality.
* Furthermore, 1,832 drug samples were declared Spurious/Adulterated.
* **Intensified Regulatory Vigilance:**
* Since December 2022, over 960 drug manufacturing units have undergone risk-based inspections.
* Based on these inspections, more than 860 enforcement actions have been taken.
* Actions include issuing show cause notices, stop production orders, suspensions, cancellation of licenses, and warning letters, all in accordance with the Drugs Rules 1945.
* **Enhanced Audits and Market Surveillance:**
* Over 1100 cough syrup manufacturers and 380 blood centres have been subjected to intense audits.
* Market surveillance sampling of syrup formulations has been increased by Central and State drug regulators.
* **Food Safety Surveillance:**
* The Food Safety Standard Authority of India (FSSAI) and its regional offices, in conjunction with State/UT Food Safety Departments, conduct regular surveillance and inspections of food products.
* This aims to ensure compliance with quality and safety standards under the Food Safety and Standards Act (FSSA), 2006.
* **Strengthening Drug Testing Infrastructure:**
* The Ministry of Health and Family Welfare has implemented the 'Strengthening of States' Drug Regulatory System (SSDRS)' scheme.
* This scheme involves upgrading existing state laboratories, establishing new drug testing laboratories, and improving state drug control offices.
* Under SSDRS, ₹756 Crore has been released as central share to States/UTs.
* 19 new drug testing laboratories have been constructed, and 28 existing laboratories have been upgraded.
**Impact Analysis**
**Drug Manufacturing Companies**
* **Impact:** Subject to increased regulatory scrutiny, risk-based inspections, and potential enforcement actions for non-compliance with quality standards.
* **Action Required:** Ensure adherence to the Drugs & Cosmetics Act, 1940 and its rules; comply with quality and safety standards; respond to show cause notices and orders issued by regulatory authorities.
**State/Union Territory Drug Controllers (SDCs)**
* **Impact:** Involved in conducting inspections, surveillance, market sampling, and taking enforcement actions against non-compliant firms.
* **Action Required:** Continue and intensify risk-based inspections and market surveillance; implement enforcement actions as per the Drugs Rules 1945; collaborate with CDSCO.
**Central Drugs Standard Control Organization (CDSCO)**
* **Impact:** Leading the charge in risk-based inspections and enforcement actions, and overseeing the strengthening of drug testing infrastructure.
* **Action Required:** Continue to collaborate with state regulators for effective drug quality monitoring and enforcement.
**Consumers**
* **Impact:** Benefit from enhanced drug quality monitoring and surveillance, leading to increased assurance of safe medicines.
* **Action Required:** No direct action is required from consumers as this relates to regulatory and industry actions.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: The primary law regulating the manufacture, sale, and distribution of drugs in India.
Central Drugs Standard Control Organization (CDSCO): The national regulatory body responsible for drug standards and surveillance in India.
Strengthening of States' Drug Regulatory System (SSDRS): A Centrally Sponsored Scheme aimed at enhancing drug testing infrastructure and laboratory capacity.
Food Safety and Standards Act, 2006: Legislation under which food safety standards are established and enforced by FSSAI.
Ministry of Health and Family Welfare: The government ministry overseeing health and family welfare, including drug regulation.
Ministry of Health and Family Welfare
Steps taken for Testing and Surveillance of Drugs
Strengthened Drug Quality Monitoring: Nearly 5 Lakh
Samples Tested in Five Years to Ensure Safe Medicines
Intensified Regulatory Vigilance: 960+ Drug Manufacturing
Units Inspected Since Dec 2022; 860+ Actions Taken to
Enforce Quality Standards
Major Boost to Drug Safety Infrastructure: ₹756 Crore Central
Share Released for Expansion of Drug Testing Laboratories
Posted On: 10 MAR 2026 6:16PM by PIB Delhi
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:
Financial Year No. of drugs samples No. of drugs No. of drugs samples declared
tested samples declared Spurious/ Adulterated
Not of 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
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 December2022. Firms have been 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.
Also, more than 1100 cough syrup manufacturers and 380 blood centres have been subjected to intense
audit in coordination with State authorities. Increased market surveillance sampling of syrup formulations
by Central and State drugs regulators has also been done.
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.
To strengthen the drug testing infrastructure and enhance laboratory capacity across 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 19 New Drug Testing Labs have been constructed and 28 existing labs have been up-
graded in various States/UTs.
The Union Minister of State for Health and Family Welfare, Smt. Anupriya Patel stated this in a written
reply in the Rajya Sabha today.
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SR
HFW/ Steps Taken for Testing and Surveillance of Drugs/10 March 2026/6
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