Parliament Question: Inquiry against contaminated cough syrups

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARREDQUESTION NO. 1212 TO BE ANSWERED ON10THFEBRUARY, 2026 INQUIRYAGAINSTCONTAMINATEDCOUGH SYRUPS 1212.SHRIRANDEEPSINGH SURJEWALA: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) whether Government has conducted an independent inquiry into the allegations of contamination in cough syrups produced by Indian pharmaceutical companies, if so, the findingsthereofandthe actions taken; (b) the number of licenses revoked or suspended for manufacturing the affected cough syrup brands; (c)the compensation,if any, providedtothe families of the victims; and (d) the steps taken by Government to ensure accountability in the pharmaceutical industry to preventsuch incidents? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL) (a)& (b): 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 State Authorities. 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 had been registered in the matter by the State of Madhya Pradesh and strict actionhadtakenincluding the arrest of persons involved. Further, State Drugs Control, Gujarat team also inspected the premises of M/s. Rednex Pharmaceuticals Pvt Ltd. Survey No. 586 & 231, NR. SKF Bearing Bavla Bagodra N.H. 8A, Tal, Bavla, Dist. Ahmedabad-383220 and M/s. Shape Pharma Pvt Ltd. Plot No. 4, Surendranagar Rajkot Highway Rd. Shekhpur 363510 Gujarat, whose cough syrup samples failed in DEG content. On the basis of recommendation of inspecting team, State Licensing authorityissued Stopproduction orderstobothmanufacturers. (c): Section 27 (a) of Drugs and Cosmetics Act 1940 has provisions that in case of death of a person likely to be caused by drugs deemed to be adulterated/spurious, court can order compensationtothe victim from the fine collected. (d): 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) 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 lettershave beentakenbythe State LicensingAuthorities. (ii) 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. (iii) Advisory has been issued on 03.10.2025 to all State/UT Health Departments 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 on27.10.2025 instructed them tomaintain heightened vigilance against spurious and substandard drugs andtake prompt actionunderthe Drugs & Cosmetics Act, 1940. (iv) 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 mandate the testing for DEG and Ethylene Glycol (EG) inoral liquidsat finished product stage before market release.(v) List of drugs of various companies, which are declared Not of Standard Quality/ Spurious/ Misbranded/ 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) andactionsinitiated. (vi) 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. (vii) 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. (viii) InFebruary2024,CDSCO publishedregulatoryguidelinesfor the sampling ofdrugs, cosmetics, and medical devices by Central and State Drugs Inspectors. These guidelines provide a structured approach to ensure the quality and efficacy of productsavailableinthe marketthrough uniform drug sampling methodology. (ix) An online portal, SUGAM labs is in place since September 2023 for integrating the drug testing labs of the CDSCO. It automates the entire workflow for testing of Medical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the qualityspecificationandtracingthe testing status inthe laboratories. (x) The 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. **********