Parliament Question: Incidents of food contamination and cough syrup controversy

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARREDQUESTION NO.2054 TO BE ANSWERED ON10th MARCH, 2026 INCIDENTS OF FOOD CONTAMINATION AND COUGH SYRUP CONTROVERSY 2054. SHRIVIVEK K. TANKHA: Will the Ministerof HEALTHANDFAMILYWELFAREbe pleasedtostate: (a) whether the repeated incidents of food contamination and the recent cough syrup controversy exposes serious regulatory lapses and how the Union Government assesses the effectiveness of the national food and drug safety framework in preventing adulteration and protecting public health; (b) the number of inspections, sample tests, prosecutions, and licence cancellations initiated under the Food Safety and Standard (FSS) Act in the last three years, State-wise; (c) the mechanisms being used by Government and FSSAI to monitor and audit State enforcement capacity and laboratories; and (d) the concrete reforms proposed to strengthen early detection, independent testing, accountability of manufacturers, and deterrence against large-scale adulteration across the country? ANSWER THE MINISTEROFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SHRIPRATAPRAO JADHAV) (a) to (d): Food Safety and Standards Authority of India (FSSAI) is mandated to lay down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption. The implementation and enforcement of the Food Safety and Standards (FSS) Act, 2006isa shared responsibility between the Central andStateGovernments. Further, the manufacturing, sale and distribution of drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and rules thereunder. The regulatorycontrol over the manufacture, sale and distribution of drugs in the country is exercised through a system of licensing and inspection by the State Licensing Authorities (SLAs). Compliance with the conditionsof licence grantedunder the said Act and Rulesis mandatory for manufacture, sale and distribution of drugs in the country. SLAsare legally empoweredto take actionagainst violationof provisions of the said Act andRules. While the FSSAI, is responsible for laying down science-based standards and ensuring overall coordination, the State Food Safety Authorities are primarily responsible for enforcement at the field level. Designated officers (DOs) and Food Safety Officers (FSOs) underthe Commissioner of Foodsafety in the States/UTs are entrusted with the responsibility of enforcingthe provisions of FSS Act, 2006. To ensure compliance with the set standards, limits, & other statutory requirements under the Act, 2006 and Food Safety & Standards Regulations (FSSR), FSSAI, through State/UT food safety authorities and its four (04) regional offices, conducts regular localized/targeted special enforcement and surveillance drives including National Annual Surveillance Plan (NASP), inspections and sampling activities throughout the year. If any deviations from the standards or violations to the FSSR are observed, the defaulting Food Business Operators (FBOs) are subjected to regulatory actions, including punitive measures, asstipulatedunderthe FSS Act, 2006andrulesandregulationsmade thereunder. State wise details of food samples analysed and action taken against the defaulting Food Business Operators for non-compliance for last three years are attached at Annexure-I, II andIII respectively. As per the requirements of ISO/IEC 17025:2017 mandated by the Food Safety and Standards (Recognition and Notification of Laboratories) Regulations, 2018, FSSAI Notified Laboratories including State Food Testing Laboratories are required to obtain and retain National Accreditation Board for Testing and Calibration Laboratories (NABL), which includes periodic surveillance assessments and re-assessments to verifycontinued conformity with the prescribed standards andregulatory provisions. In addition,FSSAI extends financial and technicalassistance for the up-gradation and strengthening of State Food Testing Laboratories (SFTLs). Periodic and systematic reviews of their functional status, infrastructure adequacy, human resource availability and capacity gaps are conducted through structured field visits, technical evaluations by assessingperformance through Monthly ProgressReports and during Central Advisory Meeting (CAC). FSSAI has facilitated rapid food testing methods to reduce the screening time of the food products at the field level and accelerate surveillance as well as monitoring activities. RAPID Kits are advanced, easy to use, portable and handheld devices and they don't require any sophisticated equipment or conventional reagents to conduct the tests. Currently, 86 RAFTKits are approved byFSSAI. Central Drugs Standard Control Organization (CDSCO) in recent years has taken several measures to ensure the quality and safety of medicines in the country, few are mentionedbelow:- i. In order to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO along with StateDrugs Controllers (SDCs) have conductedRisk- 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 takenby the 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 andState drugs regulatorshasalso beendone. iii. 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) andactions initiated. iv. The Drugs Rules, 1945 have been amended in year 2023 to mandate that manufacturersof the top300 drug formulation brandslisted inScheduleH2 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 applicationstofacilitate trackingandtracing. 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 drugmanufacturers with turnover > Rs. 250 crores from 29.06.2024 and for manufacturers havingturnoverof less thanRs. 250Cr from 01.01.2026. vi. InFebruary2024,CDSCOpublishedregulatoryguidelinesforthesamplingofdrugs, cosmetics, and medical devices by Central and State Drugs Inspectors. These guidelines provide a structured approachtoensure the qualityandefficacy of products availableinthe marketthrough uniform drug sampling methodology. vii. An online portal,SUGAM labsisinplace since September2023for integratingthe drug testing labs of the CDSCO. It automates the entire workflow for testing of Medical Products (Drugs, Vaccine, Cosmetics & Medical devices) to meet the quality specificationandtracing the testing status inthe laboratories. *****Annexure–I Detailsoffoodsamplesanalysedandpenal actiontakenduring2024-2025. DetailsofEnforcement (2024-2025) S.No. State/UT No.ofSamples CivilCases CriminalCases Cancelledlicense Analysed Decided with No.ofConvictions Penalty 1 AndamanAndNicobarIslands 810 0 0 1 2 AndhraPradesh 5984 464 8 15 3 ArunachalPradesh 125 7 0 5 4 Assam 1705 0 0 19 5 Bihar 2863 25 0 7 6 Chandigarh 374 116 41 5 7 Chhattisgarh 2069 143 6 1 8 Dadra and Nagar Haveli & 56 0 0 0 Daman&Diu 9 Delhi 2624 18 16 1 10 Goa 1172 11 0 0 11 Gujarat 12387 859 91 8 12 Haryana 2233 599 59 20 13 HimachalPradesh 1587 471 0 3 14 Jammu&Kashmir 6955 1,239 29 17 15 Jharkhand 364 52 0 1 16 Karnataka 9371 283 32 34 17 Kerala 10767 1,088 206 40 18 Ladakh 417 38 0 0 19 Lakshadweep 0 0 0 0 20 MadhyaPradesh 13920 2,597 22 3 21 Maharashtra 5403 1,147 0 9 22 Manipur 126 2 0 1 23 Meghalaya 388 0 0 0 24 Mizoram 0 0 0 0 25 Nagaland 223 0 0 0 26 Orissa 2282 27 0 2 27 Puducherry 173 0 0 0 28 Punjab 4131 333 8 1 29 Rajasthan 13840 3,114 30 2 30 Sikkim 254 0 0 0 31 TamilNadu 18071 1,536 492 7 32 Telangana 3347 125 0 1 33 Tripura 123 0 0 0 34 UttarPradesh 30380 14,920 215 16 35 Uttarakhand 1509 256 4 1 36 WestBengal 14502 672 6 0 Total 170535 30142 1265 220Annexure-II Detailsoffoodsamplesanalysedandpenalactiontakenduring2023-2024 DetailsofEnforcement(2023-24) S. State/UT No.of CivilCases CriminalCases Cancelled N Samples license o. Analysed Decidedwith DecidedwithFine penalty andImprisonment 0 0 0 0 1 AndamanAndNicobarIslands 2 AndhraPradesh 6439 646 8 40 3 ArunachalPradesh 501 2 0 25 4 Assam 1139 0 0 0 5 Bihar 2806 79 0 10 311 87 52 1 6 Chandigarh 7 Chhattisgarh 1373 86 2 0 185 0 0 0 8 DadraandNagarHaveli&Daman&Diu 3412 36 12 1 9 Delhi 10 Goa 599 17 0 1 11 Gujarat 15841 1701 65 7 12 Haryana 3485 593 47 15 13 HimachalPradesh 1618 376 2 6 14 Jammu&Kashmir 9057 1612 22 19 15 Jharkhand 384 59 0 2 16 Karnataka 5492 75 16 50 10792 854 134 137 17 Kerala 18 Ladakh 638 19 0 1 0 0 0 0 19 Lakshadweep 20 MadhyaPradesh 13998 1938 46 10 12 5087 154 0 4 1 Maharashtra 22 Manipur 168 0 0 0 23 Meghalaya 123 0 0 0 24 Mizoram 0 0 0 0 25 Nagaland 138 3 0 1 2003 0 0 24 26 Orissa 27 Puducherry 31 0 0 0 28 Punjab 6041 1204 102 0 29 Rajasthan 18536 2181 12 0 30 Sikkim 231 0 0 0 18146 2195 478 36 31 TamilNadu 6156 425 0 6 32 Telangana 87 0 0 0 33 Tripura 27750 14627 163 9 34 UttarPradesh 35 Uttarakhand 1998 332 0 1 36 WestBengal 5948 285 0 2 Total 170513 29586 1161 408Annexure-III Detailsoffoodsamplesanalysedandpenalactiontakenduring2022-2023 Details of Enforcement(2022-23) S. NameofState/UT No.ofSamples CivilCases CriminalCases No. Analysed Cancelledlicense Decidedwith penalty Decidedwithfine& Imprisonment 1200 58 0 0 Andaman&Nicobar 1 Islands 3607 339 12 64 2 AndhraPradesh 258 0 0 20 3 ArunachalPradesh 602 0 0 0 4 Assam 2935 39 0 10 5 Bihar 473 27 8 4 6 Chandigarh 1468 119 8 0 7 Chhattisgarh 164 13 0 0 DadraNagarHaveli& 8 Daman&Diu 3133 86 10 0 9 Delhi 699 11 0 4 10 Goa 14562 547 24 15 11 Gujarat 4445 915 35 25 12 Haryana 2720 93 1 9 13 HimachalPradesh 13502 1592 15 42 14 Jammu&Kashmir 943 44 8 1 15 Jharkhand 3416 191 15 56 16 Karnataka 8533 454 33 90 17 Kerala 220 23 0 0 18 Ladakh 0 0 0 0 19 Lakshadweep 12507 1908 71 22 20 MadhyaPradesh 11077 198 5 17 21 Maharashtra 169 0 0 3 22 Manipur 409 0 0 0 23 Meghalaya 140 0 0 0 24 Mizoram 109 0 0 1 25 Nagaland1368 47 0 40 26 Odisha 0 0 0 1 27 Puducherry 8179 1404 5 1 28 Punjab 13184 2435 4 1 29 Rajasthan 279 4 0 0 30 Sikkim 24188 3714 678 47 31 TamilNadu 4809 315 0 9 32 Telangana 31 0 0 0 33 Tripura 30140 13148 251 50 34 UttarPradesh 1839 507 5 1 35 Uttarakhand 6203 233 0 0 36 WestBengal Total 177511 28464 1188 533