Parliament Question: Laxity in the prevention of counterfeit medicines

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE RAJYASABHA UNSTARREDQUESTION NO. 1249# TO BE ANSWERED ON10THFEBRUARY, 2026 LAXITYIN THE PREVENTION OFCOUNTERFEITMEDICINES 1249#SHRIRAMJI LALSUMAN: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) the details of the success achieved in prevention of banned and counterfeit medicines in the countryduring the last three years, year-wise; (b) whether any study has been conducted to assess the adverse effects of the use of counterfeitandbannedmedicines onconsumers; and (c) whether it is a fact that the concerned drug regulatory authorities have been negligent in enforcinginspection andtesting standards aftergrantingdrug manufacturinglicences,leading tothe large-scale productionof counterfeitmedicines? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT.ANUPRIYAPATEL) (a): The terminology “Counterfeit Medicines” is not defined under the Drugs and Cosmetics Act, 1940 and Rules made thereunder. However, the Drugs and Cosmetics Act definesspurious, adulterated,misbranded drugs which includescounterfeitdrugs. As per information received from States/UTs Drugs Controllers, the number of drug samples tested in last three years by various States/U.Ts and status regarding number of drug samples declared Not of Standard Quality/spurious/ adulterated including enforcement actionstakenisasunder: 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 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(b): Use of anyBanned/Spurious/Adulterated/Not of StandardQualitydrugs isdetrimental and may cause adverse effects on patient’s health. Therefore, under the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder, manufacture of Banned/Spurious/Adulterated/ Not of StandardQuality drugs etc. isa punishable offenceandconcerned licensing authorities are empoweredtotake appropriate actioninsuch cases. (c): The manufacture, sale and distribution of drugs are primarily regulated in the country under the provisions of Drugs & Cosmetics Act, 1940 & Rules made thereunder through a system of licensing and inspection by State Licensing Authorities appointed by respective State Governments. Under the Drugs Rules, State licensing authorities shall cause inspection, by the Inspector appointed under the Act, of each premises licensed to verify the compliance with the conditions of license andthe provisions of the said Act and Rules, not less than once inthree yearsor asneededasperrisk based approach. Further, in order to assess the regulatory compliance of drug manufacturing premises inthe country,CDSCO alongwith 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 etc. have been taken by the State LicensingAuthorities asperthe provisions of the Drugs Rules1945. *******