**Executive Summary**
This document responds to a parliamentary question regarding the distribution of substandard cough syrups. It details actions taken following reports of child deaths linked to contaminated syrups, including investigations, sample testing, and regulatory measures. Key actions include license cancellations, product recalls, and amendments to drug regulations to enhance quality control and traceability. The response addresses the period from 2020-2025 and outlines ongoing efforts to prevent future incidents.
**Key Points / Main Content**
* **Incident Investigation and Sample Testing:**
* A central team investigated child deaths in Madhya Pradesh linked to contaminated cough syrup.
* Out of 19 samples tested, 4 were declared Not of Standard Quality (NSQ), with one containing 46.28% Diethylene Glycol (DEG).
* Data on drug samples tested and status (NSQ/spurious/adulterated) from 2020-21 to 2024-25 is provided, along with prosecution numbers.
* **Regulatory Actions:**
* Manufacturing license of M/s Sresan Pharmaceuticals in Tamil Nadu was cancelled.
* Immediate ban and recall of affected cough syrup batches were ordered in Madhya Pradesh, Tamil Nadu, Odisha, and Puducherry.
* Criminal case registered in Madhya Pradesh with arrests made.
* Show cause notice issued and manufacturing activities stopped for M/s Maiden Pharmaceuticals in Haryana following a joint investigation in relation to cases in Gambia.
* Manufacturing license of Marion Biotech in Uttar Pradesh was suspended following investigation in relation to cases in Uzbekistan.
* **Preventive and Corrective Measures:**
* Advisory issued to State/UT Health Departments and healthcare facilities for rational use of paediatric cough syrups.
* State/UT Drug Controllers directed to ensure strict testing compliance and maintain vigilance against substandard drugs.
* Amendment to Indian Pharmacopoeia (IP) 2022 mandates testing for DEG and Ethylene Glycol (EG) in oral liquids before market release.
* Over 960 drug manufacturing premises subjected to risk-based inspections, leading to over 860 actions (show cause notices, stop production orders, etc.).
* Over 1100 cough syrup manufacturers subjected to intense audit.
* Increased market surveillance sampling of syrup formulations.
* **Amendments to Drug Regulations:**
* Drugs Rules 1945 amended to revise Schedule M related to Good Manufacturing Practices (GMP), effective 29.06.2024 for manufacturers with turnover > Rs. 250 crores and 01.01.2026 for manufacturers having lower turnover.
* Regulatory guidelines for sampling of drugs, cosmetics, and medical devices published in February 2024.
* Drugs Rules amended to mandate bar/QR codes on packaging for top 300 drug brands and Active Pharmaceutical Ingredients (APIs).
* **System Improvements:**
* SUGAM labs online portal in place since September 2023 to integrate drug testing labs.
* Regular training and workshops provided to CDSCO and State Drug Regulatory Authorities on GMP.
**Impact Analysis**
**State/UT Health Departments and Healthcare Facilities**
* **Impact:** Required to ensure the rational use of paediatric cough syrups.
* **Action Required:** Implement and enforce the advisory issued on 03.10.2025.
**State/UT Drug Controllers**
* **Impact:** Required to ensure strict compliance with testing requirements and vigilance against substandard drugs.
* **Action Required:** Enforce the Drugs Rules, maintain vigilance, and take prompt action against violations.
**Drug Manufacturers (All)**
* **Impact:** Subject to stricter regulatory oversight, GMP requirements, and labeling requirements.
* **Action Required:** Implement revised Schedule M requirements based on turnover, and ensure QR codes on packaging of top 300 brands and APIs.
**CDSCO and State Drug Regulatory Authorities Personnel**
* **Impact:** Required to conduct inspections, audits, and enforce regulations.
* **Action Required:** Participate in regular training and workshops to improve GMP practices.
Key Entities Referenced
Drugs & Cosmetics Act, 1940: The primary law governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. Referenced in actions taken against manufacturers of substandard cough syrups.
Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India. Involved in investigations, inspections, and regulatory actions regarding substandard cough syrups.
Drugs Rules, 1945: Rules under the Drugs and Cosmetics Act, 1940, which contain provisions related to drug manufacturing, testing, and quality control. Specifically mentioned in relation to ensuring compliance and amended schedule M.
Ministry of Health and Family Welfare: The government ministry responsible for health policy in India. They are the primary respondent to the parliamentary question about cough syrup contamination.
Gambia and Uzbekistan: Countries where Indian-made contaminated cough syrups were allegedly linked to child deaths, prompting investigations and regulatory action.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2382
TO BE ANSWERED ON13THFEBRUARY, 2026
DISTRIBUTION OFSUBSTANDARDCOUGH SYRUPS
2382.SHRIRAHULGANDHI:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) the number of deathslinked tocontaminated cough syrups during the last five years along
with detailsof brandsandmanufacturers, State-wise;
(b) the total number of cough syrup samples tested/number found containing diethylene
glycol (DEG) and/or ethylene glycol (EG) beyond permissible limits during the last five
years, year-wiseandState-wise alongwith the detailsof data isavailable;
(c) the action taken against manufacturers and regulatory officials responsible for
manufacture,approvaland distribution of substandard coughsyrups;
(d) whether the Government is aware of alerts by the World Health Organization regarding
Indianmade contaminated coughsyrups linkedtochilddeathsinGambia andUzbekistan and
if so, the detailsthereof;
(e) the steps taken/proposed to be taken by the Government to strengthen drug testing
protocolstopreventsuch incidents from recurring; and
(f) whether any compensation has been provided to families of victims of contaminated
coughsyrups andif so, the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT. ANUPRIYAPATEL)
(a)to(f): Upon receipt of reports of a cluster of child deaths from Chhindwara, Madhya
Pradesh, a Central team of experts comprising an epidemiologist, a microbiologist, an
entomologist, and drug inspectors from the National Centre for Disease Control (NCDC),
National Institute of Virology (NIV), and Central Drugs Standard Control Organisation
(CDSCO), respectively visited Chhindwara and Nagpur and undertook a detailed
investigation of the reported cases and deaths in coordination with the Madhya Pradesh StateAuthorities. A total of 19 drug samples, reportedly consumed by the affected children, were
collected from the treating private practitioners and nearby retail stores for testing. Chemical
analysis of these 19 samples indicated that 15 samples were of Standard Quality, while 4
samples were declared Not of Standard Quality (NSQ). As per the test report, the content of
Diethylene Glycol (DEG) in Syrup Coldrif (B.No. SR-13) manufactured by M/s Sresan
Pharmaceutical located in Kancheepuram, Tamil Nadu and consumed by the deceased
childrenwas found tobe 46.28% w/v.
The premises of M/s SresanPharmaceuticalswas inspected.Severalcriticalandmajor
Good Manufacturing Practices (GMP) violations including unhygienic storage conditions
were observed. The matter regarding the criminal action against the manufacturer was taken
up by CDSCO with the State Government of Tamil Nadu. The State Drugs Controller, Tamil
Nadu cancelled the manufacturing licence. Further, following the incident, the States of
Madhya Pradesh, Tamil Nadu, Odisha and the Union Territory of Puducherry to which the
impugned cough syrup batches were supplied, ordered immediate ban and recall of the same.
Criminal case has been registered in the matter by the State of Madhya Pradesh and strict
actionhasbeentakenincluding the arrest of persons involved.
As per information received from States/UTs Drugs Controllers, the number of drug
samples tested including cough syrups during the last five years by various States/U.Ts and
status regarding number of drug samples declared Not of Standard Quality/spurious/
adulteratedincluding enforcementactionstakenisasunder:
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
The World Health Organisation, on an ongoing basis, issues medical product alerts as
and when quality related incidents are reported to it by its member nations. Such alerts relate
to incidentspertaining to various membernations, including Gambia and Uzbekistan,and are
accessible tothe member nations.
In case of Gambia, joint investigation was undertaken by CDSCO and State Drug
Controller, Haryana. Based on investigations conducted, which revealed violation of Good
Manufacturing Practices (GMP), StateDrugs Controller,Haryana issued showcause notice to
M/s Maiden Pharma under Rule 85(2) of the Drugs Rules, 1945 and order was issued for
stopping all the manufacturing activities of M/s Maiden Pharmaceuticals at Sonipat, Haryana
with immediateeffect for violationof GMP.In the case of Uzbekistan, CDSCO in coordination with State Drugs Controller, Uttar
Pradesh conducted a joint investigation at M/s. Marion Biotech Pvt. Ltd., Noida, Uttar
Pradesh. Drug samples were drawn from the manufacturing premises under the provisions of
Drugs & Cosmetics Act, 1940 for test & analysis. Further, manufacturing license of the firm
was suspended by State Licensing Authority, Uttar Pradesh on 09.01.2023. Further, an FIR
was lodgedinthe concernedpolice station andthree persons were arrested.
CDSCO and Ministry of Health and Family Welfare have taken following regulatory
measures to ensure the import and manufacture of safe, efficacious and quality medicines
across the country:
(i) An advisory has beenissued on03.10.2025 to allState/UT HealthDepartments and
healthcare facilities to ensure rational use of paediatric cough syrups. Further, the
Drugs Controller (India) directed all State/UT Drug Controllers on 07.10.2025 to
ensure strict compliance with testing requirements under the Drugs Rules, 1945,
and on 27.10.2025 instructed them to maintain heightened vigilance against
spurious and substandard drugs and take prompt action under the Drugs &
Cosmetics Act, 1940.
(ii) In addition to the existing requirements of testing the raw materials, the Indian
Pharmacopoeia Commission, Ghaziabad has issued an amendment to Indian
Pharmacopoeia(IP) 2022,to also mandatethe testing for DEG andEthylene Glycol
(EG) inoral liquidsat finished product stage before market release.
(iii) 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 than960premises since December, 2022andbased
on findings, more than 860 actions like issuance of show cause notices, stop
production order, suspension, cancellation of licenses /product licenses, warning
lettershave beentakenbythe State LicensingAuthorities.
(iv) Further, more than 1100 cough syrup manufacturers have been subjected to intense
audit in coordination with State authorities. Increased market surveillance sampling
of syrup formulationsbyCentral andStatedrugs regulators hasalso beendone.
(v) The Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E)
dated 28.12.2023 to revise the schedule M to the said rules related to Good
Manufacturing Practices and requirements of premises, plant and equipment for
pharmaceutical products. Revised Schedule M has become effective for the drug
manufacturers with turnover > Rs. 250 crores from 29.06.2024 and for
manufacturershavingturnoverof less thanRs. 250Cr from 01.01.2026.
(vi) In February 2024, CDSCO published regulatory guidelines for the sampling of
drugs, cosmetics, and medicaldevicesby Central andState Drugs Inspectors. These
guidelines provide a structured approach to ensure the quality and efficacy of
productsavailableinthe marketthrough uniform drug sampling methodology.
(vii) An online portal, SUGAM labs is inplace since September 2023 for integrating the
drug testing labs of the CDSCO. It automates the entire workflow for testing ofMedical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the
qualityspecificationandtracing the testing status inthe laboratories.
(viii) The Drugs Rules, 1945 have been amended in year 2023 to mandate that
manufacturers of the top 300 drug formulation brands listed in Schedule H2 shall
print or affix a Bar Code or QR Code on the primary packaging label, or on the
secondary label where space is insufficient, to store data readable through software
applications for authentication. Similarly, the Rules have also been amended to
require that every Active Pharmaceutical Ingredient (bulk drug), whether
manufactured or imported, shall bear a QR Code on each level of packaging
containing data readable through software applications to facilitate tracking and
tracing.
(ix) Central regulator coordinates activities of State Drug Control Organisations and
provides expert advice through the Drugs Consultative Committee (DCC) meetings
held with State Drugs Controllers for uniformity in administration of the Drugs and
Cosmetics Act.
(x) Central government is providing regular residential, regional training and
workshops to officials of CDSCO and State Drug Regulatory Authorities on Good
Manufacturing Practices. In the Financial Year 2023-24 CDSCO has trained 22854
persons while inFinancialYear 2024-25, 20551persons have beentrained.
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